Discovery Labs. - eine neue Bioperle??? - 500 Beiträge pro Seite

[matthiasch]

Discovery Labs.- ein vielversprechendes Small Cap-Biotechnologieunternehmen?

Durch den Wirkstoff Surfaxin versucht das Unternehmen verschiedene Medikamente gegen Atemwegserkrankungen zu entwickeln.
Der größte Vorteil des Unternehmens ist es, dass die Konkurrenten Surfaxin nur aus tierischen Quellen gewinnen können, was sich sehr schwierig und teuer gestaltet.(Probleme bsp. durch BSE der Rinder)

Das kurzfristige Ziel ist es,die Testreihen in der Phase 3 mit Surfaxin gegen IRDS und MAS erfolgreich abzuschließen.
(Das Marktpotenzial von IRDS liegt jährlich bei 250MILL$)

Um große Rückschläge im Zulassungsverfahren zu vermeiden will das Unternehmen in Zukunft eine agressive Akquisitionsstrategie fahren, also im großen und ganzen Kann das ´Teil ein ganz großer werden und wird auf Grund des Wirkstoffes Surfaxin, dessen Gewinnungsverfahren patentiert ist, eher aufgekauft, als das es einfach pleite geht!

IRDS= idiopathische Atemwegserkrankung bei Frühgeborenen
MAS= Kindspeech Atemwegsinfektion


Marktkapitalisierung: 73Mill$
Cashbestand: 16 Mill$

Bitte um Meinungen zu diesem Wert, wer kennt das Unternehmen?

Weiteres und die Zahlen gibts später!

[gholzbauer]

Mkt Cap bei 2.45$: 52 Mio.$

Jetzt lehne ich mich mal weit aus dem Fenster und erkläre DSCO zum 1000%-Kandidaten.

Siehe auch "Finanzen", Ausgabe September 2001, Seite 36ff

Sturza`s Medical Research nennt ein Kursziel von 13$

Zeitplan für Surfaxin:
Phase III bis Mitte 2002
Zulassung ca. 1 Jahr später, je nach Lust und Laune der FDA

[gholzbauer]

Friday September 21, 8:00 am Eastern Time
Press Release
SOURCE: Discovery Laboratories, Inc.
Discovery Laboratories Launches Phase 3 IRDS Clinical Trial in Europe and United States
DOYLESTOWN, Pa., Sept. 21 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - news) announces the initiation of patient enrollment in a supportive Phase 3 multinational clinical trial evaluating Surfaxin® (lucinactant) for the prevention and treatment of idiopathic respiratory distress syndrome (IRDS) in premature infants.

This second Phase 3 IRDS trial is designed to demonstrate the safety and non-inferiority of Surfaxin®, Discovery`s humanized, synthesized, peptide-containing surfactant, over a leading animal-derived surfactant in Europe thus providing support to Discovery`s previously announced pivotal Phase 3 multinational IRDS clinical trial. Approximately 500 patients in Europe as well as the United States will be enrolled in this Phase 3 trial. The trial will be managed by Discovery`s satellite office in Windsor, England. This trial is intended, if successful, to support marketing authorization applications for Surfaxin® with the U.S. Food and Drug Administration (FDA) and worldwide regulatory authorities. Discovery has previously demonstrated the performance of Surfaxin® in IRDS in a 47-patient Phase 2 trial and is currently enrolling patients in a landmark Phase 3 trial being conducted at sites in North and South America as well as Europe. Discovery expects to complete enrollment in this trial in mid 2002.

``We are very excited to begin enrolling patients into this comparative study,`` commented Dr. Robert J. Capetola, President and CEO of Discovery Laboratories. ``Based on what we know of the performance of competing surfactants in Phase 3 trials, we are confident that we will be able to demonstrate Surfaxin®`s efficacy. This trial is being run in collaboration with our European partner, Laboratorios del Esteve of Spain and is aimed at adding to the scientific and marketing rationale behind our IRDS Phase 3 pivotal trial.``

Surfaxin® is a humanized, peptide-containing surfactant that has demonstrated significant ability to lower surface tension at the air water interface (alveolar surface) in the lungs. Additionally, compared to animal-derived surfactants, Surfaxin® has the potential to be longer-acting, manufactured on a more consistent basis to meet worldwide demand, and does not have the potential to transmit animal-borne infections or prion-related diseases.

Discovery has two other late-stage clinical trials of Surfaxin® underway in the United States in which it employs its novel lavage delivery technique. Surfaxin® is the subject of a pivotal Phase 3 clinical trial in meconium aspiration syndrome (MAS) in full-term newborns and a Phase 2 clinical trial in acute respiratory distress syndrome (ARDS) in adults. Both are diseases for which no approved drug treatment presently exists. ARDS is a multifactorial syndrome that has numerous causes including pneumonia, septic shock and smoke and toxic gas inhalation. Discovery`s proprietary lavage, or ``lungwash`` approach, enables Surfaxin® to be delivered directly into the lungs while at the same time removing inflammatory exudates from the lung.

Discovery is a Pennsylvania-based bio-pharmaceutical company whose mission is to develop and commercialize medically novel therapeutics for critical care. The Company has received Fast Track designation for Surfaxin® from the FDA for MAS and ARDS. The Company has previously been granted Orphan Drug Status for Surfaxin® from the FDA for MAS, IRDS and ARDS, as well as an Orphan Product Designation for MAS by the EMEA. Surfaxin® was invented and initially developed at The Scripps Research Institute. Discovery is currently establishing a development strategy for its second product, SuperVent(TM), to treat certain inflammatory respiratory diseases such as cystic fibrosis and chronic bronchitis. More information about Discovery is available on the company`s web site at: http://www.discoverylabs.com.

[matthiasch]

Unterstützung bei 2$ hat gehalten.Seitdem 33% gestiegen.



Discovery Laboratories Completes $7.7 Million Private Placement
Financing Allows Discovery to Begin Surfaxin(R) - Based Respiratory Drug Delivery Program
DOYLESTOWN, Pa., Oct. 2 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - news) announced today the completion of a private placement in which the company raised approximately $7.7 million in gross proceeds. Pursuant to the offering, the Company sold units consisting of an aggregate of approximately 3.5 million shares of common stock, and warrants to purchase approximately 700,000 shares of common stock. The offering price per unit of $2.175 represented an ``at market`` price per common share based on the average of the daily closing bid price of the common stock for the five trading days immediately preceding the closing date of the offering plus a nominal price per warrant. The warrants are exercisable for five years from the date of issuance at an exercise price of $2.365 per share of common stock.

The lead investor in the offering was SAFECO through its Growth Opportunities and RST Growth Opportunities Funds for an aggregate investment of $3.75 million. Other investors included Ursus Capital LP; Ursus Offshore Ltd.; Deutsche Bank Securities; and Valor Capital Management, LP. Jesup and Lamont Securities Corporation acted as the placement agent for the financing.

The proceeds from the offering will be used for (i) the funding of development programs using Surfaxin® as a respiratory drug delivery vehicle and as an aerosol formulation for new therapeutic indications including severe, acute asthma, and (ii) for other working capital and general corporate purposes. Discovery has engaged Dr. Ralph Niven, an expert in the respiratory drug delivery field, to manage the program. Dr. Niven was formerly Vice President of Development at Advanced Inhalation Research. He also held drug delivery development positions at Amgen and Valentis. He will be responsible for establishing and running Discovery`s drug delivery operations on the West Coast.

``We are very pleased with the confidence and strong interest shown by investors in Discovery in this difficult market environment,`` commented Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery. ``This offering allows us to proceed with development work on Surfaxin® for pulmonary drug delivery and asthma. We believe that Surfaxin® can make an excellent drug delivery vehicle for pharmaceutical products due to its potentially superior surface active properties and its ability to penetrate deep in the lung.``

Discovery is a Pennsylvania-based bio-pharmaceutical company whose mission is to develop and commercialize medically novel therapeutics for critical care. Presently, Discovery has four late stage clinical trials of Surfaxin® underway. Surfaxin® is the subject of a landmark Phase 3 pivotal clinical trial in idiopathic respiratory distress syndrome (IRDS) in pre-mature newborns as well as a second supportive Phase B trial. Surfaxin® is also the subject of a pivotal Phase 3 clinical trial in meconium aspiration syndrome (MAS) in full-term newborns. In addition, Discovery is running a Phase 2 clinical trial in acute respiratory distress syndrome (ARDS) in adults in the United States. MAS and ARDS are diseases for which there are no approved therapies anywhere in the world. Discovery is also currently establishing a development strategy for its second product, SuperVent(TM), to treat certain inflammatory respiratory diseases such as cystic fibrosis and chronic bronchitis. The Company has been awarded an Orphan Products Development Grant for MAS and has received Fast Track designation for Surfaxin® from the FDA for MAS and ARDS. The Company has previously been granted Orphan Drug Status for Surfaxin® from the FDA for MAS, IRDS and ARDS, and has recently received Orphan Product Status from the European Medicines Evaluation Agency (EMEA) for MAS. Surfaxin® was invented and initially developed at The Scripps Research Institute. More information about Discovery is available on the company`s web site at: http://www.discoverylabs.com.

The shares of common stock issued in the private placement have not been registered under the Securities Act of 1933 and may not be reoffered or sold in the United States absent registration or an applicable exemption for the registration requirements of such Act. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company. The Company plans to file a registration statement covering such shares, as well as the shares issuable upon exercise of the warrants and the placement warrants, within 30 days.

To the extent that statements in this press release are not strictly historical, including statements as to the Company`s business strategy, outlook, objectives, plans intentions, goals, future financial conditions, future collaboration agreements, the success of the Company`s product development, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect the Company`s actual results and could cause results to differ from those contained in the forward- looking statements contained herein are the risk that financial conditions may change, the risk that the Company will not be able to raise additional capital or enter into additional collaboration agreements, risks relating to the progress of the Company`s research and development and the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in the Company`s periodic filings with the Securities and Exchange Commission including the most recent reports on Form 10-KSB, 8-K and 10-QSB, and amendments thereto.

SOURCE: Discovery Laboratories, Inc.

[matthiasch]

October 05, 2001

DISCOVERY LABORATORIES INC /DE/ (DSCO)
form 8-K
Item 5. Other Events
On October 2, 2001, Registrant issued a press release to announce the completion of a private placement on October 1, 2001, in which Registrant raised approximately $7.7 million in gross proceeds. Pursuant to the offering, Registrant issued units consisting of an aggregate of approximately 3.5 million shares of common stock, par value $.001 per share ("Common Stock"), and Class F Warrants to purchase an aggregate of approximately 700,000 shares of Common Stock with an initial exercise price of $2.365 per share of Common Stock. In addition, Registrant will pay Jesup & Lamont Securities Corp., the placement agent, a fee consisting of $359,940 and warrants to purchase 164,911 shares of Common Stock with an exercise price of $2.394 per share of Common Stock.

[matthiasch]

Keine Insiderverkäufe mehr seit dem 28.06.01


Insider & restricted shareholder transactions reported over

28-Jun-01 LERER, KENNETH
Shareholder 3,105
DSCO Proposed Sale (Form 144).
Estimated proceeds of $11,000.

27-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 508,845
DSCO Sold at $3.60/Share.
Proceeds of $1,831,842.

14-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 5,000
DSCO Sold at $4.32/Share.
Proceeds of $21,600.

13-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 1,000
DSCO Sold at $4.32/Share.
Proceeds of $4,320.

11-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 6,000
DSCO Sold at $4.40/Share.
Proceeds of $26,400.

8-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 2,500
DSCO Sold at $4.60/Share.
Proceeds of $11,500.

7-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $4.64/Share.
Proceeds of $46,400.

6-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $4.51/Share.
Proceeds of $45,100.

5-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 20,000
DSCO Sold at $5.24/Share.
Proceeds of $104,800.

4-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 20,000
DSCO Sold at $4.84/Share.
Proceeds of $96,800.

1-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 4,500
DSCO Sold at $4.60/Share.
Proceeds of $20,700.

1-Jun-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 3,000
DSCO Sold at $44.60/Share.
Proceeds of $133,800.

31-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $4.25/Share.
Proceeds of $42,500.

30-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 22,500
DSCO Sold at $4.06/Share.
Proceeds of $91,350.

29-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 22,500
DSCO Sold at $4.15 -- $4.16/Share.
Proceeds of $93,510.

25-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 31,000
DSCO Sold at $4.08/Share.
Proceeds of $126,480.

24-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 30,000
DSCO Sold at $4.12/Share.
Proceeds of $123,600.

23-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 17,000
DSCO Sold at $4.39/Share.
Proceeds of $74,630.

22-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 75,000
DSCO Sold at $4.13/Share.
Proceeds of $309,750.

21-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $3.95/Share.
Proceeds of $39,500.

18-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $3.96/Share.
Proceeds of $39,600.

17-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $3.71/Share.
Proceeds of $37,100.

16-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 6,000
DSCO Sold at $3.80/Share.
Proceeds of $22,800.

15-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 6,500
DSCO Sold at $3.76/Share.
Proceeds of $24,440.

14-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 5,000
DSCO Sold at $3.80/Share.
Proceeds of $19,000.

11-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 20,000
DSCO Sold at $4.03/Share.
Proceeds of $80,600.

10-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 2,500
DSCO Sold at $4.01 -- $4.09/Share.
Proceeds of $10,145.

9-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $4.11/Share.
Proceeds of $41,100.

8-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $4.01/Share.
Proceeds of $40,100.

7-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 5,000
DSCO Sold at $3.94/Share.
Proceeds of $19,700.

4-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $4.00/Share.
Proceeds of $40,000.

3-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 9,857
DSCO Sold at $4.05/Share.
Proceeds of $39,921.

2-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 143
DSCO Sold at $4.05/Share.
Proceeds of $579.15.

2-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $4.38/Share.
Proceeds of $43,800.

1-May-01 ROSENWALD, LINDSAY A
10% Beneficial Owner * 10,000
DSCO Sold at $3.83/Share.
Proceeds of $38,300.

27-Apr-01 SIEGEL, MARK S
Director * 296,560
DSCO Initial Indirect Holdings Statement

27-Apr-01 SIEGEL, MICHAEL S
Director * 296,560
DSCO Initial Indirect Holdings Statement

30-Mar-01 ZODDA, DENI M
Senior Vice President, Business Development 0
DSCO Initial Direct Holdings Statement

10-Jan-01 ROBINSON, LINDA G
Shareholder 3,105
DSCO Proposed Sale (Form 144).
Estimated proceeds of $17,078.

26-Dec-00 ROSENTHALE, MARVIN E
Director * 1,000
DSCO Purchased at $3.25/Share.
Cost of $3,250.

25-Dec-00 MYRIANTHOPOULOS, EVAN
Vice President of Finance, Officer 6,000
DSCO Gave as Gift at $3.88/Share.
Value of $23,280.

22-Dec-00 CAPETOLA, ROBERT J
Director, Officer 1,300
DSCO Gave as Gift at $3.88/Share.
Value of $5,044.

20-Dec-00 ROSENTHALE, MARVIN E
Director * 1,000
DSCO Purchased at $4.00/Share.
Cost of $4,000.

11-Dec-00 MCDADE, HERBERT H
Director 1,000
DSCO Purchased at $5.50/Share.
Cost of $5,500.

18-Oct-00 LINK, MAX
Director 20,000
DSCO Acquired Shares via Exercise of Options at $2.21/Share.
Paper gain of $55,800 at a fair market value of $5.00/share on 18-Oct-00.

11-Oct-00 SEGAL, ROBERT MD
Former, Vice President 0
DSCO Initial Direct Holdings Statement

25-Sep-00 NAVEH, DAVID
Director 10,000
DSCO Acquired Shares via Exercise of Options at $0.81/Share.
Paper gain of $48,150 at a fair market value of $5.62/share on 25-Sep-00.

[matthiasch]

DSCO steigt und steigt...war heute schon auf 3,1$.

[gholzbauer]

Folgende Infos (Links gefunden im Yahoo-Message-Board von DSCO) sind zwar nicht auf neuestem Stand, so wurden die Preise für Survanta in der Zwischenzeit angeblich stark gesenkt; aber zur Ergänzung der spärlichen Infos auf der DSCO-Homepage nützlich, um einen Überblick zu Einsatzgebiet und Konkurrenzsituation von Surfaxin zu gewinnen:

http://www.nhsconfed.net/Scotland/shpic/doc07.htm

http://www.engineering.ucsb.edu/~junqi/PressRelease.html

[matthiasch]

3,55$

[matthiasch]

3,95$

[matthiasch]

Jetzt kann bei DSCO wieder zugeschlagen werden: Aktueller Kurs 2,76$

[gholzbauer]

Gründe für den Kursverfall:
- MAS kann sich wg. Konzentration auf IRDS verzögern
- Supervent sieht nicht besonders gut aus
- Finanzlage hat sich durch die Platzierung im Oktober nicht wesentlich verbessert


aus dem 10Q vom 13.11.:
" ...
SURFAXIN ® (lucinactant)

Idiopathic Respiratory Distress Syndrome (IRDS) in premature infants

The Company has initiated two Phase 3 multinational clinical trials evaluating Surfaxin ® for the prevention and treatment of IRDS. The Company considers one of these a landmark Phase 3 trial that is designed to demonstrate the superiority of Surfaxin ® , the Company`s humanized, synthesized, peptide-containing surfactant, over certain currently available surfactant therapies. Approximately 1,500 patients in North and South America as well as Europe will be enrolled in this Phase 3 trial. This pivotal trial is intended, if successful, to provide the basis for marketing authorization applications for Surfaxin ® with the United States Food and Drug Administration (the "FDA" ) and worldwide regulatory authorities. The second Phase 3 trial is designed as a supportive trial and compares Surfaxin ® to an approved product that is animal-derived. The Company expects to complete recruitment for these trials in mid-2002. Conditioned upon the successful outcome of such trials, the Company has committed to provide Surfaxin ® to certain, but limited, Latin American regions that participate in the studies at a significantly reduced cost for a period of up to 10 years following commercialization. The Company has previously been granted Orphan Drug Status for Surfaxin ® from the FDA for IRDS.

Meconium Aspiration Syndrome (MAS) in full-term infants

The Company commenced enrollment of a pivotal Phase 3 trial in MAS in May of 2000 . The Phase 3 trial is intended to enroll up to 200 MAS patients. Results of a Phase 2 clinical trial in MAS in full-term newborns showed an improvement in oxygenation parameters and a savings of approximately three days on mechanical ventilation with the use of Surfaxin Ò as compared to controls. An Orphan Products Development Grant awarded to the Company by the FDA`s Office of Orphan Products Development is expected to contribute towards the cost of this Phase 3 trial. The Company has also received Fast Track designation for Surfaxin ® from the FDA for MAS. The Company has previously been granted Orphan Drug Status for Surfaxin ® from the FDA for MAS. In addition, Surfaxin ® has been granted orphan product designation by the European Agency for the Evaluation of Medicinal Products (EMEA). Given the Company`s belief in the importance of IRDS to the Company`s present development plan, resources have been and may continue to be reallocated from the MAS program to the IRDS program, which could effectively delay the completion of this trial. Given the current circumstances, patient recruitment is expected to be completed in fourth quarter 2002.

Acute Respiratory Distress Syndrome/ Acute Lung Injury (ARDS/ALI)

In November 2000, the Company initiated a Phase 2B clinical trial for the treatment of ARDS. This Phase 2B trial is designed in two parts -- Part A is a dose ranging study and Part B will consist of select doses identified in Part A compared to standard of care. The Company has received Fast Track designation for Surfaxin ® from the FDA for ARDS. The Company has previously been granted Orphan Drug Status for Surfaxin ® from the FDA for ARDS.

SUPERVENT™ (tyloxapol)

Cystic Fibrosis (CF)

The Company began a Phase 2A clinical trial of SuperVent™ for the treatment of CF on August 4, 1999. Analysis of the data from this randomized, double-blind, placebo-controlled trial show that SuperVent™ significantly decreased the amount of Interleukin 8 (IL-8) in the sputum of treated patients as compared to controls. IL-8 is an important body chemical that causes the migration of inflammatory cells to the site of release. The Phase 2A clinical trial involved eight patients. An additional Phase 2 trial will likely be required prior to commencement of a Phase 3 trial. Previously, the Company completed a Phase 1 trial in 20 normal healthy volunteers and determined a dose (1.25% tyloxapol concentration) that did not produce significant adverse effects. Presently, the Company is evaluating whether to continue development of SuperVent™ and if so, how such development would be conducted.

... "

[matthiasch]

Auf der Seite http://biz.yahoo.com/fin/l/d/dsco.html kann man die Zahlen von DSCO genauer unter die Lupe nehmen.



Übrigens: Seit langem wiedermal Insiderkäufe!



DSCO aktuell: 3,14$, ein Plus von 0,51$ bzw. 19,39%

[matthiasch]

Eine etwas ältere Einschätzung von Hornblower und Fischer:

....Die Cash-Position des Unternehmens von etwa 14 Mio. USD soll laut dem CFO, Evan Myrianthopoulos, und dem CEO, Dr. Robert Cape-tola, bis zum Ende des zweiten Quartals 2002 ausreichen. Für das Gesamtjahr 2001 erwarten wir einen Umsatz von 2 Mio. USD, die F&E-Ausgaben werden bei etwa 9,5 Mio. USD liegen. Discovery rechnet mit der Einführung von Surfaxin gegen MAS gegen Ende 2002, den Hauptumsatz soll aber Surfaxin gegen IRDS (idiopathic respira-tory distress syndrome; idiopathische Atemnot bei Babies) – die Markteinführung ist für das erste Halbjahr 2001 geplant – generieren. Hier rechnet Discovery mittelfristig mit einem Umsatzpotenzial von 250 Mio. USD pro Jahr. Aufgrund des frühen Stadiums und der recht dünnen Cash-Position ist ein Investment in Discovery mit sehr hohen Risiken verbunden. Langfristig sind wir jedoch ob des erfolgreichen und kompetenten Managements, ob des wachsenden Marktes für die Behandlung von „unmet medical needs“ wie MAS/IRDS und nicht zuletzt ob der kurzfristigen Aussicht auf neue, finanzstarke Vertriebspartnerschaften in Europa insgesamt optimistisch für den Titel gestimmt. Rating: kaufen...

[Kelbi]

So zur Abwechslung mal wieder was erfreuliches:
Discovery Laboratories and Quintiles to Commercialize Surfaxin(R)
DOYLESTOWN, Pa. and RESEARCH TRIANGLE PARK, N.C., Dec. 11 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - news) and Quintiles Transnational Corp. (Nasdaq: QTRN - news) today announced a sales and marketing alliance to commercialize in the United States Discovery`s Surfaxin® (lucinactant), a novel, humanized lung surfactant for the treatment of respiratory distress syndrome (RDS) in premature newborns and meconium aspiration syndrome (MAS) in full-term newborns. In addition, the alliance anticipates a collaboration on Surfaxin for the treatment of adult respiratory distress syndrome (ARDS). Currently, Discovery is conducting three Phase III clinical trials for RDS and MAS as well as a Phase II clinical trial for ARDS.

The agreement calls for Quintiles, through its strategic investment group, PharmaBio Development, to purchase $3 million of Discovery common equity at $3.79 per share and to make available a line of credit of up to $8.5 million to $10 million to fund pre-marketing activities associated with the launch of Surfaxin in the United States as Discovery achieves certain milestones. In addition, PharmaBio Development has agreed to fund the sales and marketing costs for Surfaxin for seven years of Surfaxin commercialization. PharmaBio Development may also make certain milestone payments which will be used to offset outstanding line of credit loans to Discovery. In return, PharmBio Development will receive a commission on net sales over a 10-year period.

Discovery has also provided PharmaBio Development with warrants covering approximately 350,000 shares of Discovery common stock at an exercise price of $3.48 per share. In addition, for each million dollars made available under the line of credit, PharmaBio Development will receive warrants to purchase approximately 38,000 shares of Discovery`s common stock at an exercise price of $3.03 per share.

Innovex, Quintiles` commercialization unit, will hire, train and deploy a dedicated sales force to promote Surfaxin in the United States. Quintiles also expects to deploy a wide range of commercialization services in pre- and post-launch periods to help drive product sales. The majority of the line of credit will be used to fund Quintiles` pre-marketing services, including a market verification study to be commenced by the Lewin Group, Quintiles` consultancy unit.

Discovery`s Surfaxin is the first humanized peptide-based synthetic surfactant that mimics protein B and is believed to be the only product in the world being developed for MAS. RDS in premature infants is a breathing disorder in which the lungs of infants do not stay open due to an insufficient amount of surfactant, which is produced naturally as lungs mature. Approximately 50,000 cases of RDS in premature infants occur in the United States annually. MAS results when a full-term baby inhales meconium, a material produced in the intestine of a full-term baby before birth. The aspirated meconium in the lungs produces inflammation, which degrades the natural lung surfactant. Severe respiratory distress is a result. Approximately 26,000 cases of MAS occur in the United States annually.

``We are extremely pleased to be partnered with Quintiles -- its reputation for uniquely tailored commercialization agreements with leading emerging biopharmaceutical companies is what attracted us to them,`` said Robert J. Capetola, President and Chief Executive Officer of Discovery Laboratories. ``Our agreement allows us to retain product ownership, have sales and marketing expertise in place for a maximum launch effort of Surfaxin in late 2003-2004, and forgo creating costly infrastructure investment prior to product approval to potentially achieve margins common to specialty pharmaceutical companies commercializing their own products.``

Ron Wooten, President, PharmaBio Development said: ``We are pleased to be involved in the potential commercialization of Surfaxin, which represents the next generation surfactant product, with its broad application in the areas of MAS and RDS. This alliance is yet another example of how Quintiles` commercialization services and our PharmaBio Development group create strategic and financial solutions to help bring important new medicines to market. We are excited that our financial resources and commercial expertise can play a part in introducing Surfaxin to the healthcare community.``

This agreement follows a sequence of investment and royalty or commission-based agreements between Quintiles and emerging pharma and biotechnology companies. Quintiles plans to immediately initiate pre-market assessment and readiness under the agreement.

About Quintiles Transnational, PharmaBio and Innovex

Quintiles Transnational Corp. is the world`s leading provider of information, technology and services to bring new medicines to patients faster and improve healthcare. Headquartered near Research Triangle Park, North Carolina, Quintiles Transnational is a member of the S&P 500 and Fortune 1000. For more information visit the company`s Web site at www.quintiles.com . PharmaBio Development is the corporate ventures group of Quintiles Transnational Corp. that is dedicated to innovative partnering solutions for pharmaceutical and biotech companies.

Innovex is the world`s leading commercial solutions provider that offers sales and marketing services designed to accelerate the success of pharmaceutical, biotech and medical device products. These services include contract sales services, strategic marketing solutions, customized information technologies and health management services. For more information, visit www.innovex.com .

[gholzbauer]

Das Abkommen sieht gut aus. DSCO scheint einen ziemlich großen Teil des Umsatzes zu bekommen.

[matthiasch]

Dem Kurs gehts ja heute auch wiedermal gut, Tageshoch lag bei 3,45$.

[gholzbauer]

12.12.2001 13:38
HORNBLOWER FISCHER

Discovery Laboratories "outperform"

Die Analysten von Hornblower Fischer stufen die Aktie Discovery Laboratories Inc. mit "outperform" ein. (WKN 918436) Discovery Laboratories habe gestern die bereits seit längerem angekündigte und von den Analysten noch für dieses Jahr erwartete Kooperationsvereinbarung für den Verkauf und die Vermarktung des Medikaments Surfaxin® in den USA bekannt gegeben. Mit Quintiles Transnational sei es gelungen, nicht unbedingt eine internationale Pharmagröße, aber ein in den USA aufgrund seiner Sales Force und v.a. Expertise in dem Design von klinischen Studien renommiertes Unternehmen für sich zu gewinnen. Ursprünglich seien die Analysten von einem unmittelbaren Abschluss einer Kooperation für die Vermarktung und Weiterentwicklung von Surfaxin® für mehrere Indikationen mit einem europäischen Partner ausgegangen. Diese sollte zur besseren strategischen Positionierung von Discovery im ersten Quartal 2002 zum Abschluss kommen. Surfaxin®, ein neuartiges, menschliches Surfactant, das normalerweise zur Aufrechterhaltung der Oberflächenspannung in den Alveolen der Lungen produziert werde, solle zur Behandlung des akuten/idiopathischen Atemnotsyndroms (A/IRDS, ca. 50.000 Fälle pro Jahr in den USA) und des Kindspech-Syndroms bei Neugeborenen (MAS, ca. 26.000 Fälle in den USA) zum Einsatz kommen. Discovery führe zur Zeit drei Studien der III. klinischen Phase für IRDS und MAS durch und eine Studie der II. klinischen Phase für ARDS. Laut dem Abkommen habe sich Quintiles verpflichtet, von Discovery Aktien im Wert von 3,0 Mio. US-Dollar zu einem Preis von 3,79 US-Dollar pro Aktie zu übernehmen. Außerdem müsse Quintiles 8,5 bis 10,0 Mio. US-Dollar für Discovery an Meilensteinzahlungen bereitstellen, um vorklinische Entwicklungs- und Forschungskosten, die mit der Zulassung von Surfaxin® in den USA im Zusammenhang stünden, abzudecken. Quintiles habe weiterhin zugestimmt, die Marketing- und Vertriebskosten für Surfaxin® für die nächsten sieben Jahre zu übernehmen. Im Gegenzug erhalte Quintiles eine zehnjährige Beteiligung an den Umsätzen von Surfaxin®. Zudem habe Discovery noch 350.000 Aktienoptionen im Wert von 3,48 US-Dollar zur Verfügung gestellt. Die Aktien beider Unternehmen hätten im Zuge dieser Nachricht Gewinne verbuchen können. Discovery sei um 0,28 US-Dollar auf 3,25 US-Dollar gestiegen. Quintiles habe mit einem Plus von 0,68 US-Dollar bei 17,41 US-Dollar geschlossen. Nach einem eher dürftigen "News-Flow" in den letzten Wochen und Monaten könne Discovery mit diesem für die Zukunft von Surfaxin® und somit für das Unternehmen äußerst wichtigen Abkommen das Vertrauen der Investoren - und auch von den Analysten - bestätigen. Dennoch sollten Anleger sich des nach wie vor hohen Risikos bewusst sein und einen langen Atem haben. Die Analysten von Hornblower Fischer bestätigen ihr "outperform"-Rating für Discovery Laboratories.

Quelle: AKTIENCHECK.DE AG

[matthiasch]

December 19, 2001

DISCOVERY LABORATORIES INC /DE/ (DSCO)
form 8-K
Item 5. Other Events
On December 11, 2001, Discovery Laboratories, Inc., a Delaware corporation ("Discovery"), issued a press release to announce that it had entered into a collaboration arrangement (the "Collaboration") with Quintiles Transnational Corp. ("Quintiles"), and its affiliate, PharmaBio Development Inc. ("PharmaBio"). In connection therewith, Discovery raised $3.0 million in gross proceeds and issued (i) 791,905 shares of its common stock, par value $.001 per share ("Common Stock") and (ii) warrants to purchase an aggregate of approximately 677,143 shares of Common Stock, subject to adjustment. After payment of fees and associated expenses, Discovery intends to use the net proceeds of approximately $2.7 million, for working capital and general corporate purposes.

Transaction Overview

In connection with the Collaboration, Discovery entered into a series of agreements with Quintiles and PharmaBio. As further discussed below and subject to the terms and conditions set forth in the agreements, Quintiles agreed to provide certain commercialization services in the United States for Discovery`s lead product candidate, Surfaxin(R), for the treatment of meconium aspiration syndrome ("MAS") and idiopathic respiratory distress syndrome ("IRDS"). In addition, PharmaBio agreed to fund up to $70 million of the sales and marketing costs for Surfaxin for seven years of Surfaxin commercialization. In addition to the $3.0 million equity investment in Discovery, PharmaBio also agreed to extend a line of credit of up to $8.5 million to $10 million to fund pre-marketing activities associated with the launch of Surfaxin in the United States as Discovery achieves certain milestones. Principal amounts owed by Discovery under the credit facility may be repaid out of the proceeds of milestone payments to be paid by PharmaBio at certain intervals upon the achievement of certain corporate milestones that are discussed in greater detail below.

Commercialization Arrangements

Pursuant to the commercialization agreement between Discovery and Quintiles (the "Commercialization Agreement"), Quintiles will provide pre- and post-launch marketing services for the promotion of Surfaxin for MAS or IRDS in the United States. Upon approval of Surfaxin by the United States Food and Drug Administration ("FDA") for sale in the United States for MAS or IRDS, Quintiles will hire and train a dedicated United States sales force that will be branded in the market as Discovery`s. Quintiles also will provide certain management and administrative personnel to assist in the Collaboration. Among other things, Quintiles will provide a product manager to coordinate pre-launch marketing activities. Quintiles has been granted the opportunity to provide outsourced services to Discovery for the development of Surfaxin for the treatment of an acute respiratory distress syndrome ("ARDS") indication conditioned upon Quintiles` satisfaction of certain performance-related and competitive criteria regarding the provision of such services. In addition, Quintiles has been granted a right of first negotiations solely as a preferred provider to provide competitive clinical trial development and commercialization services for other products that may be developed by Discovery and for which Discovery intends to outsource such services, whether related to Surfaxin or otherwise. Discovery will be responsible for order processing and fulfillment, invoicing and collection of accounts receivables from sales (which may upon agreement of Discovery and Quintiles be

performed by Quintiles or one of its affiliates). Discovery will also be responsible for supply and inventories of Surfaxin as well as regulatory and medical affairs. Under certain circumstances, Discovery has the option to hire the sales force created by Quintiles.

Pursuant to a related investment and commission agreement between PharmaBio and Discovery (the "Investment and Commission Agreement"), PharmaBio is obligated to pay 100% of specified sales and marketing expenses payable to Quintiles for services provided by it pursuant to the Commercialization Agreement. Following the commercial launch of Surfaxin for MAS or IRDS, such commitment is limited to a maximum of $70 million over a seven-year period. In consideration therefor, Discovery has agreed to pay PharmaBio a commission on net sales in the United States of Surfaxin for MAS, IRDS and all "off-label" uses for 10 years following first launch of the product in the United States.

The Collaboration will be managed and governed by a joint commercialization committee (the "Joint Commercialization Committee"), consisting of an equal number of representatives appointed by Discovery and Quintiles. A Discovery representative will chair the Joint Commercialization Committee. Subject to certain exceptions, Discovery will have a tie-breaking vote on all matters to be considered by the Joint Commercialization Committee, and, accordingly, it has final decision-making control on all strategic issues regarding Surfaxin throughout the term of the Commercialization Agreement.

Credit Facility

In connection with the Collaboration, PharmaBio is providing to Discovery a secured revolving credit facility (the "Credit Facility"). Under the Credit Facility, PharmaBio has committed to advance on a revolving basis up to $8.5 million, which may be increased to $10 million, at the discretion of the Joint Commercialization Committee. Interest on the Credit Facility will be payable on a quarterly basis in arrears. Discovery is obligated to use a significant portion of the funds borrowed under the Credit Facility for pre-launch marketing services to be provided by Quintiles pursuant to the Commercialization Agreement.

The Credit Facility of $8.5 million (subject to increase as stated above) will be available for borrowing by Discovery incrementally upon the occurrence of three milestones. One-third of the commitment will be available upon the later to occur of (i) the completion of a market opportunity assessment and report regarding Surfaxin and (ii) an extension for the deadline for the filing of a New Drug Application for Surfaxin with FDA ("NDA") under Discovery`s license agreement for Surfaxin until at least October 28, 2003 ("Milestone One").

Provided that Milestone One has occurred, one-third of the commitment will be available for borrowing by Discovery upon the later to occur of (i) Discovery`s successful completion of an aggregate of $10 million capital raise for general corporate purposes or (ii) the public disclosure by Discovery of Phase III clinical trial data for IRDS, and the completion by Quintiles of a favorable written assessment and report regarding such data and Discovery ("Milestone Two").

Provided that Milestone One and Milestone Two have occurred, one-third of the commitment will be available for borrowing by Discovery upon the later to occur of (i) the completion by Quintiles of a written assessment and report indicating the "approvability" by FDA of Discovery`s NDA for Surfaxin for either IRDS or MAS or (ii) the issuance by FDA of a

letter indicating that Discovery`s NDA for Surfaxin is "approvable" with respect to Discovery`s NDA for either IRDS or MAS.

Discovery is also entitled to two milestone payments under the Investment and Commission Agreement with PharmaBio, which will be used to offset and prepay principal amounts due under the Credit Facility.

Upon the occurrence of FDA approval for the commercialization of Surfaxin for MAS or IRDS, the first milestone payment will equal 70% of the outstanding amount of advances under the Credit Facility. Such milestone payment will be used to offset and prepay such advances, and the available commitment under the Credit Facility will be reduced by an equivalent amount.

Upon the earlier to occur of (i) the completion by Quintiles of a written assessment and report indicating the "approvability" by FDA of Discovery`s NDA for Surfaxin for whichever of the MAS or IRDS indications was not approved previously, or (ii) the issuance by FDA of a letter indicating that Discovery`s NDA for Surfaxin for such indication is "approvable," the second milestone payment will equal the outstanding amount of advances under the Credit Facility. Such milestone payment will be used to offset and prepay such advances, and the commitment under the Credit Facility will be terminated.

Notwithstanding the prepayment milestones, the Credit Facility will be payable in full on December 10, 2004.

Discovery`s obligations to PharmaBio under the Credit Facility are secured by limited collateral relating to Surfaxin pursuant to a security agreement (the "Security Agreement"). The pledged collateral includes all revenues derived from sales in the United States of Surfaxin for MAS, IRDS and for ARDS, as well as all clinical data and regulatory filings relating thereto, but does not include any intellectual property rights. Upon the occurrence of FDA approval for the commercialization of Surfaxin for MAS or IRDS, all pledged collateral that relates to ARDS will be released by Quintiles.

Equity Investment

Pursuant to the common stock and warrant purchase agreement between PharmaBio and Discovery (the "Purchase Agreement"), PharmaBio purchased 791,905 shares of Common Stock at a price of $3.79 per share. In addition, PharmaBio purchased two separate classes of warrants to purchase shares of Common Stock. Pursuant to the Class G warrant, PharmaBio may purchase 357,143 shares of Common Stock (subject to adjustment), at a price of $3.485 per share. PharmaBio also purchased a Class H warrant to purchase 320,000 shares of Common Stock at a price of $3.03 per share. The Class H warrant vests in three equal increments equal to one-third of the shares of Common Stock issuable thereunder, upon the occurrence of each of the three milestones pursuant to which the commitment under the Credit Facility becomes available. The Class G warrant and Class H warrant each expire on December 10, 2011. To the extent that the commitment under the Credit Facility is increased to an amount greater than $8.5 million, the amount of shares of Common Stock issuable pursuant to the Class H warrant will increase proportionally. Accordingly, for each additional $1 million that becomes available under the Credit Facility, the amount of shares of Common Stock issuable pursuant to the Class H warrant will be increased by approximately 38,500 shares.

The shares of Common Stock purchased by PharmaBio, or issuable pursuant to the Class G warrant and the Class H warrant, have not been registered under the Securities Act of 1933 (the "1933 Act") and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. In addition, all such shares of Common Stock are subject to certain restrictions on transfer as set forth in the Purchase Agreement. PharmaBio will have up to two "demand" registration rights that require Discovery to register its shares of Common Stock for resale under the 1933 Act, including shares issuable pursuant to the Class G warrant and the Class H warrant. In addition, subject to certain limitations, PharmaBio has customary "piggyback" rights to include such shares of Common Stock in other registrations of securities filed by Discovery for resale under the 1933 Act.

PharmaBio has agreed to certain limitations on its trading of, and purchase of additional shares of, Common Stock, as well as certain prescriptions regarding the voting of its shares. PharmaBio also has the right pursuant to the Purchase Agreement to maintain its percentage equity ownership of Discovery by purchasing additional securities on the same terms as any transaction in which Discovery proposes to raise additional equity capital. Such right will be inapplicable to (i) underwritten public offerings, (ii) bona fide acquisitions, mergers, joint ventures, collaborative arrangements, strategic alliances or similar transactions, the terms of which are approved by Discovery`s Board of Directors, or (iii) pursuant to any stock option, stock purchase or similar plan or arrangement for the benefit of Discovery`s employees.

A copy of the press release announcing the execution of the agreements relating to the Collaboration,the Purchase Agreement, the Class G warrant, the Class H warrant, the Commercialization Agreement, the Investment and Commission Agreement, the Credit Facility, the related Promissory Note, and the Security Agreement are attached as exhibits hereto. The descriptions of the Collaboration contained in the attached press release and in this Item 5 do not purport to be complete and are qualified in their entirety by reference to the agreements and instruments attached as exhibits hereto.

To the extent that statements in this report are not strictly historical, including statements as to Discovery`s business strategy, outlook, objectives, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of Discovery`s product development, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this report are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect Discovery`s actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, the risk that Discovery will not be able to raise additional capital or enter into additional collaboration agreements, risks that any collaborators may not perform their obligations under any such agreements, risks relating to the progress of Discovery`s research and development and the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in Discovery`s periodic filings with the Securities and Exchange Commission including its reports on Forms 10-KSB, 8-K and 10-QSB, and amendments thereto.

[gholzbauer]

Unsere Perle wird vermutlich die nächsten Tage etwas konsolidieren. Möglicherweise sehen wir sogar ein wenig tax loss selling.

Hier noch eine zweitrangige Meldung:

Thursday December 20, 2:15 pm Eastern Time
Press Release
SOURCE: Discovery Laboratories, Inc.
Discovery Laboratories Appoints Chief Financial Officer
DOYLESTOWN, Pa., Dec. 20 /PRNewswire/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - news) today announced the appointment of John G. Cooper, 43, to the position of Senior Vice President, Chief Financial Officer. In this new role, Mr. Cooper will be responsible for all of the company`s financial and investor relations matters, reporting directly to Robert J. Capetola, Ph.D., President and Chief Executive Officer.

Mr. Cooper brings to Discovery Laboratories extensive experience in managing the needs of emerging growth companies including public and private equity financings, investor relations, strategic alliances, mergers and acquisitions, strategic and financial planning, and development of financial management and accounting systems for international operations.

``With 20 years of financial management experience in international public companies, I am pleased to have John in this critical role,`` said Robert J. Capetola, CEO of Discovery Laboratories. ``His skills and leadership are an excellent fit to our team as we execute our strategy towards becoming a specialty pharmaceutical company commercializing our own products and pursuing development of our surfactant technology platform as an aerosol formulation for new therapeutic indications, and as a respiratory drug delivery vehicle.``

Mr. Cooper has held the position of Chief Financial Officer with several emerging technology companies, predominantly in the life sciences industry, including Mobility Technologies, Inc., a venture capital backed company constructing the nation`s first wireless digital sensor network for traffic and logistics data collection; Chrysalis International Corporation (currently part of MDS Pharmaceutical Services), a public global drug development service organization with operations in six countries; DNX Corporation, a public biotechnology company, which developed a joint venture with Baxter International to commercialize transplantation technologies; Taratec Development Corporation, a venture capital backed company providing information technology solutions to the pharmaceutical and life sciences industry; and he has held significant financial management positions at ENI Diagnostics (acquired by Pharmacia) and CR Bard, Inc.

Mr. Cooper is a Certified Public Accountant and received his Bachelor of Science in Commerce from Rider University.

[matthiasch]

Ich bin mit DSCO heute sehr zufrieden- einer der einzigen Biotechwerte, die sich im Plus halten:





Ich schätze, wir nehmen demnächst die 4$-Marke

[matthiasch]

Yuppie!!

Der beste Biotechtitel! Heute 7% auf 4,1$!

[matthiasch]

DSCO hält sich im Vergleich zu den anderen Bios richtig gut, gerade mal einen Abschlag von 10% in den letzten Wochen. Irgendwelche News diesbezüglich konnte ich jedoch nicht finden.


Naja, mir solls recht sein!

[Kelbi]

Dreimal auf Holz geklopft das es auch so bleibt.

Abwärts gehts schneller als man denkt:-)

[matthiasch]

Habe ich ganz vergessen:


Discovery Laboratories to Present at Emerald Investment Forum
LANCASTER, Pa.--(BUSINESS WIRE)--Jan. 29, 2002--Discovery Laboratories to present at Emerald Forum: Emerald Asset Management has announced that Discovery Laboratories (NASDAQSCO - news) will be presenting at the Ninth Annual Emerald Groundhog Day Investment Forum, scheduled for Tuesday, February 5, 2002 at the Wyndham Franklin Plaza Hotel in Philadelphia.

The Forum will again showcase investment opportunities in some of the region`s fastest growing companies, as well as industry leaders from across the country. Senior management of over forty companies are scheduled to make 30-minute formal presentations during concurrent sessions. The Forum is presented by Emerald Asset Management, Inc. and its subsidiaries.

This year`s Forum addresses the challenges and opportunities of the post-September 11th investment environment and will feature themes such as life sciences, consumer goods and emerging technology, as well as all-day focuses on private companies, hosted by Emerald Venture Capital, and on banking and financial services companies.

Emerald will be providing an audio feed of the entire Forum via their Internet website at www.teamemerald.com/ All company presentations will be broadcast live and will be available for replay following the conference.

Headquartered in Lancaster, Pennsylvania with satellite offices in King of Prussia, Pittsburgh and San Diego, California, Emerald Asset Management is a diversified investment services company whose subsidiaries include Emerald Advisers, Inc., Emerald Venture Capital and the Emerald Mutual Funds, offering research-driven investment products and services to retail, institutional and private/alternative investors.


DSCO: +8,5%

[topbasher]

matthiach





Bist natürlich bei 2$ eingestiegen

[gholzbauer]

Servus, matthiasch.
Scheint so, als würde sich außer uns niemand für DSCO interessieren?


Ich bin übrigens tatsächlich fast bei 2$ eingestiegen. Siehe z.B. Zeitpunkt meines ersten Postings oder auch mein User-Depot (alt).


Das folgende fand ich gerade im Yahoo-Board; Quelle ist scheinbar Price Waters Cooper.
Die Jungs im Yahoo-Board sind ausgesprochen kooperativ, fällt mir auf. (Fast) keine nervenden Basher.


Re: Research Report
by: animalpharm (31/M)
Long-Term Sentiment: Strong Buy 01/23/02 04:03 pm
Msg: 2261 of 2292

Quite the nice report. Some choice bits:

Why Surfaxin Versus Exosurf and Survanta?

We believe that Surfaxin has numerous important advantages over Exosurf and Survanta as well as the two other animal derived surfactants Curosurf (Chiesi) and Infasurf(Forest Labs). Perhaps most important, Surfaxin is a highly active peptide-mimic of human surfactant protein B, which is physiologically the most important of the four major proteins found in human lung surfactants. This is evidenced by the fact that deficiency of surfactant protein B is lethal in humans whereas deficiency of protein C, the predominant protein contained in Abbott’s Survanta, is not lethal. Surfaxin we believe has a number of other important advantages over competitive surfactants. Surfaxin unlike all the other FDA approved lung surfactants is not animal derived and as a result has no risk of transmitting deadly prion-related diseases such as Cruetzfelt Jacob Disease, which is commonly referred to as “Mad Cow Disease”. Because Surfaxin is synthetic and not animal-derived, it can be manufactured as a pharmaceutical grade product in consistent, stable large quantity batches with little dose to dose variability. In contrast, animal-derived surfactant’s such as Survanta, Curosurf and Exosurf have been observed to have a dose to dose variability as high as 50%. Moreover, because Surfaxin can be produced in large, consistent pharmaceutical-grade quantities, the cost of goods for Surfaxin is only a small fraction of the cost of animal derived products. As a result of these highly favorable pharmacoenomic attributes, much of the world market, which can not currently afford lung surfactant therapy for premature babies, will be able to afford DSCO’s Surfaxin. Finally, Surfaxin is more resistant to proteolytic degradation and oxidation and has a longer half-life than competitive lung surfactants, which should lead to fewer dosings, fewer invasive procedures and thus less lung scarring.

Financial Position

With a burn rate of approximately $1,000,000 per month, we estimate that DSCO will have approximately $17 million in cash and marketable securities by December 31, 2001. This would imply cash resources of approximately eighteen months, which would comfortably take the Company beyond the completion of its Phase III IRDS and Phase II ARDS clinical trials. However, by early 2002, we anticipate that DSCO will likely receive upfront cash payments from a European Surfaxin marketing partner. Moreover, if necessary, management has the option to sell the rights to its Cystic Fibrosis drug, Supervent, which is currently in Phase II clinical trials. Consequently, we estimate that DSCO currently has sufficient resources to fund its operations for the next two years without any additional external capital.

Re: Research Report 2
by: animalpharm (31/M)
Long-Term Sentiment: Strong Buy 01/23/02 04:13 pm
Msg: 2262 of 2292

More bits:

Second Generation Surfaxin

DSCO is in pre-clinical development to create an aerosol form of Surfaxin. An aerosol formulation of Surfaxin could generate multiple new therapeutic indications such as asthma, chronic obstructive pulmonary disea(COPD), acute pneumonia as well as a prophyllaxis treatment for ARDS/ALI. In addition, because of Surfaxin’s potentially superior surface active properties and its ability to penetrate deep in the lung we believe that an aerosolized form of Surfaxin could also be an effective vehicle for pulmonary drug delivery. These potential markets could be extremely large. For example, it is estimated that in the U.S. alone there are approximately one million emergency room visits each year for acute asthma attacks and worldwide there is at least 100 million people who suffer from COPD. In the case of acute asthma as well as most other acute respiratory diseases, endogenous lung surfactant is destroyed. If the endogenous lung surfactant is not replaced, the millions of tiny air sacs(alveoli) in the lung will collapse and the patient will require mechanical ventilation to survive. Moreover, because of the inherently limited supplies of animal derived lung surfactant, the only practical way to provide these millions of potential patients with lung surfactant therapy is by use of a synthetic aerosolized form of lung surfactant. We estimate, that the aerosolized form of Surfaxin could be in Phase I clinical trials as early as 2003.

The Quintiles Surfaxin Joint Commercialization Agreement

We would emphasize that QTRN is not being granted a license to market Surfaxin. Through Innovex, its commercialization unit, QTRN will hire, train and deploy a DSCO dedicated sales force of approximately 27 to 30 sales reps to commercialize IRDS and MAS in the United States. QTRN will receive a sales commission of approximately 30% and will be obligated to assume all marketing and sales costs. Consequently, we estimate that this deal will allow DSCO to generate profit margins on Surfaxin of at least 30% pre-tax. Under this agreement QTRN is obligated to invest $83 million to commercialize Surfaxin over the next seven years. QTRN will also make available to DSCO $8.5 million to $10 million line of credit for pre-launch commercialization activities. In addition, QTRN, through its strategic investment group, PharmaBio Development, purchased $3 million of DSCO common equity at $3.79 per share, which represented approximately a 30% premium to market at the time of the deal. DSCO has also provided PharmcBio Development warrants for approximately 350,000 shares of DSCO common stock at an exercise price of $3.48 per share and approximately 38,000 shares of DSCO common at an exercise price of $3.03 per share for each million dollars made available under the line of credit. In our analysis, we see the Quintiles alliance as providing very favorable commercialization terms for Surfaxin. Equally important, the deal provides major third party validation of the science underlying the Surfaxin family of products. Since Quintile’s major business is to conduct clinical trials and gain FDA approvals for other companies pharmaceutical products, its positive due diligence activities on Surfaxin should provide investors with a high comfort level regarding the product’s chances for FDA approval.

Re: Research Report 3
by: animalpharm (31/M)
Long-Term Sentiment: Strong Buy 01/23/02 04:19 pm
Msg: 2263 of 2292

In summary:

Investment Outlook and Summary

In our opinion, 2002 will be a pivotal year for DSCO common shares. Important corporate partnerships combined with anticipated positive data from Phase III IRDS and Phase II ARDS clinical trials, should lead to substantial price appreciation in DSCO common shares. We project that 2004 will be the first year Surfaxin will be on the market and estimate sales for the IRDS indication of $29 million. By 2005 the second year on the market, Surfaxin sales for IRDS should increase to $59.4 million, which would represent a 33% market share of a patient market estimated to be 100,000 combining Europe and North America. In addition, by 2005 Surfaxin should also be approved for MAS (Meconium Aspiration Syndrome) in both Europe and the U.S. We estimate an additional $25 million in product sales (5,000 infants at an estimated cost of therapy of $5,000) in 2005 for the MAS. With product sales of $84.4 million by 2005, we estimate DSCO can earn $1.42 per share fully diluted. Based on our 2005 EPS estimate of $1.42, discounted at a 30% interest rate, we arrive at a 2002 discounted EPS estimate or $0.49 per share fully diluted. Using a 30 times PE multiple of our discounted $0.49 EPS estimate, we project a one year once target of $14.70. This would represent an approximately 400% price appreciation in a span of just twelve months. Although this is an admittedly aggressive price target, we would point out that a $14.70 price would still only compute to a fully diluted market valuation of $434 million, which we believe is modest given the Company’s potential earnings power over the next three years. Consequently, we continue to strongly recommend purchase of DSCO common shares for aggressive, growth-oriented, risk-tolerant investors.

[matthiasch]

@ topbasher

DSCO kommt noch!

HELAU, DU PAPPNASE!

[gholzbauer]

Ach ja, Kelbi ist noch mit dabei, sehe ich gerade.

[matthiasch]

Natürlich ist DSCO nicht das Biotechunternehmen schlechthin und ich bin auch nicht zu 2$ eingestiegen. Trotzdem sehe ich eine Chance, dass DSCO irgendwann Richtung 6$ marschiert.

Außerdem hat sich DSCO im Vergleich zu den anderen Bios außerordentlich gut gehalten und ist bei einer Aufwärtsbewegung stets dabei (gestern + 8%).

@Gholzbauer

Wirklich nicht besonders viel los um DSCO in Deutschland. Auch in anderen Threads und Bords wird nichts über DSCO geschrieben.

Schönes Wochenende!

[gholzbauer]

6$?
Wenn man sich die Meinung von Price W. C. ansieht und das EPS 2005 von 1,42$ (verdächtig genaue Zahl ) mit einem P/E von 30 versieht, wären wir bei 43$ in gut 3 Jahren
Falls die Tests nicht klappen, sind wir natürlich ganz fix unter 1$, so viel ist klar.

[matthiasch]

Naja, bei Lifecell haben wir die gleiche Situation. LIFC hat ja momentan auch nur ein KGV von 5! Somit wäre ich schon mit 6-9$ bei DSCO zufrieden!

[Altaktionär]

04.02.2002
Discovery Laboratories "outperform"
Hornblower Fischer

Die Analysten von Hornblower Fischer stufen die Aktie von Discovery Laboratories (WKN 918436) mit "outperform" ein.

Discovery Laboratories entwickele Therapeutika gegen Atemwegserkrankungen mit dem Schwerpunkt auf der Behandlung von idiopathischer/akuter Atemnot (IRDS/ARDS). Das Kernprodukt sei Surfaxin, eine synthetische Version des im Menschen natürlich vorkommenden Surfactant. Ein Mangel an diesem Protein führe bei Babies zu kritischen Atembeschwerden durch Lungenkollaps (IRDS; Phase III). Daneben könnte Surfaxin auch bei akuten Atembeschwerden (ARDS; Phase II/III) bzw. Lungenverletzungen (ALI) von Erwachsenen eingesetzt werden. Weitere Indikationsgebiete seien Asthma und cystische Fibrose. Surfaxin für die Behandlung von MAS sei das am fortgeschrittenste Projekt und solle Ende des Jahres auf den Markt kommen. Bei MAS würden Ausscheidungen des Kindes noch im Mutterleib in die Lunge des Ungeborenen kommen, wo dies Entzündungen auslöse und das essentielle Surfactant abbaue.

Erst kürzlich habe Discovery mit Quintiles Transnational einen neuen Partner für die Vermarktung von Surfaxin in den USA präsentiert. Quintiles würde die Marketing- und Vertriebskosten für Surfaxin für die nächsten 7 Jahre übernehmen. Im Gegenzug solle Quintiles eine 10-jährige Beteiligung an den Umsätzen erhalten. Für die Vermarktung und Weiterentwicklung von Surfaxin gegen mehrere Indikationen in Europa und damit eine bessere strategische Positionierung würden die Analysten von Hornblower Fischer noch in diesem Quartal den Abschluss einer weiteren Kooperation erwarten. Discovery sei ein Unternehmen im frühen Stadium mit Fokus auf der klinischen Entwicklung und damit ein typisches Beispiel für ein viel versprechendes aber auch risikoreiches Investment. Obwohl die Cash-Position mit rund 21 Mio. USD recht dünn für die Verwirklichung aller ehrgeizigen Projekte sei, denken die Analysten von Hornblower Fischer, dass die Chancen die Risiken überwiegen.

Die Analysten von Hornblower Fischer bewerten die Aktie von Discovery Laboratories mit "outperform".

mfg
Altaktionär

[matthiasch]

Hier die News der Woche:

European Orphan Product Designation Awarded To Discovery`s Surfaxin(R) for Acute Lung Injury
Joins Orphan Drug Status in the United States
DOYLESTOWN, Pa., Feb. 15 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - news), a late-stage specialty pharmaceutical company leveraging its platform technology in humanized lung surfactants to develop potential novel respiratory therapies and pulmonary drug delivery products, today announced that it has been awarded Orphan Drug product designation from the European Agency for the Evaluation of Medicinal Products (EMEA). This award is for the Company`s lead product, Surfaxin®, for the treatment of Acute Lung Injury (which incorporates Acute Respiratory Distress Syndrome, known collectively as ``ALI/ARDS``). Surfaxin is currently in a Phase 2 U.S. clinical trial for ALI/ARDS, and has previously been granted both U.S. FDA Fast Track and FDA Orphan Drug designations.

ALI/ARDS is a life-threatening disorder for which there are currently no approved therapies anywhere in the world. ALI/ARDS is characterized by an excess of fluid in the lungs and decreased oxygen levels in the patient. One prominent characteristic is the destruction of substances, called surfactants, that are naturally present in the lung tissue and are essential to the lungs` ability to absorb oxygen. These conditions are caused by events such as smoke inhalation, near drowning, industrial accidents and other traumas and illnesses including pneumonia and septic shock. Because there are no approved treatments, the mortality rate can range from 35% to 50%. There are estimated to be between 150,000 and 250,000 ALI/ARDS patients per year in each of the U.S. and Europe. The current standard of care includes placing patients on mechanical ventilators in intensive care units. Surfaxin is intended to re-establish the lung`s capacity to absorb oxygen.

The EMEA orphan product designation joins the orphan drug designations already granted to Surfaxin in the U.S. for the treatment of respiratory distress syndrome (RDS) in premature newborns (currently in Phase 3) and for acute respiratory distress syndrome (ARDS) in adults, and in the U.S. and Europe for Meconium Aspiration Syndrome (MAS) in full term infants (currently in Phase 3). The EMEA allows six to ten years of marketing exclusivity for approved orphan drugs and may grant accelerated evaluation status to orphan drugs in instances where there is an insufficiency of alternative therapeutics treating a disease or where the EMEA anticipates a high therapeutic benefit.

``We are extremely pleased that our portfolio has been granted this fifth orphan product designation,`` commented Robert J. Capetola, Ph.D., President and CEO of Discovery Laboratories. ``A deficiency or degradation of lung surfactants has been associated with several severe respiratory diseases. Today, RDS in premature infants is the only respiratory disease in the world being treated with replacement lung surfactants. These surfactants are animal-derived, and presumably, due to limitations in quantities available as well as a complex and expensive manufacturing process, they are insufficient for ALI/ARDS therapy and other serious respiratory diseases. Even for RDS in premature infants, there are hundreds of thousands of premature babies born in the world each year that need and do not receive effective replacement therapy. Our hope is to solve this problem. Surfaxin mimics the most active protein found in human surfactant, can be produced economically and in mass quantities, and is absent of risk of potential transmission of animal-borne diseases. Additionally, we believe we can optimize the formulation for specific diseases, allowing for the possible expansion from critical care to the very large ambulatory markets.``

Surfactants, short for surface-active agents, are protein-lipid substances that are produced naturally in the lungs and are essential to the lungs` ability to absorb oxygen. They possess the ability to lower the surface tension of the fluid normally present within the air sacs that are inside the lungs. In the absence of sufficient surfactants, these air sacs tend to collapse. As a result, the lungs do not absorb sufficient oxygen. Discovery`s humanized surfactant platform technology, including Surfaxin, is based on a highly active peptide-mimic known as sinapultide, patterned after human surfactant protein B, considered physiologically the most important of the four major proteins found in human lung surfactants.

About Discovery Laboratories

Discovery Laboratories, Inc. is a specialty pharmaceutical company leveraging its platform technology in humanized lung surfactants to develop potential novel respiratory therapies and pulmonary drug delivery products. Surfaxin®, the Company`s lead product, is currently in two pivotal Phase 3 multi-national clinical trials for Respiratory Distress Syndrome (RDS) in premature infants, a Phase 3 clinical trial for Meconium Aspiration Syndrome (MAS) in full-term infants, and a Phase 2 clinical trial for Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in adults. Aerosol formulations of the Company`s surfactant technology are being developed in an effort to treat other respiratory conditions, including asthma and chronic obstructive pulmonary disease, and as a novel pulmonary drug delivery vehicle to efficiently deliver drugs to the respiratory tract that are currently delivered orally or by injection. To serve the U.S. critical care and neo-natal marketplace, the Company is developing a dedicated sales and marketing capability through a collaboration with Quintiles Transnational Corp, signed in December 2001. Interested parties can receive corporate updates by sending their email addresses to [e-mail] . More information about Discovery Laboratories is available on the Company`s Web site at http://www.discoverylabs.com .

To the extent that statements in this press release are not strictly historical, including statements as to the Company`s business strategy, outlook, objectives, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company`s product development, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect the Company`s actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, the risk that the Company will not be able to raise additional capital or enter into additional collaboration agreements, risks relating to the progress of the Company`s research and development and the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in the Company`s periodic filings with the Securities and Exchange Commission including the most recent reports on Form 10-KSB, 8-K and 10-QSB, and amendments thereto.

[matthiasch]

Tuesday February 19, 3:41 pm Eastern Time
Press Release
SOURCE: Discovery Laboratories, Inc.
Discovery Labs to Present at the BIO CEO & Investor Conference
DOYLESTOWN, Pa., Feb. 19 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - news), a late-stage specialty pharmaceutical company leveraging its platform technology in humanized lung surfactants to develop potential novel respiratory therapies and pulmonary drug delivery products, today announced that they will present at the BIO CEO & Investor Conference in New York City on February 22. President and CEO Robert J. Capetola will present at 9:30 AM on Friday morning at the Waldorf Astoria Hotel.

About Discovery Laboratories

Discovery Laboratories, Inc. is a specialty pharmaceutical company leveraging its platform technology in humanized lung surfactants to develop potential novel respiratory therapies and pulmonary drug delivery products. Surfaxin®, the Company`s lead product, is currently in two pivotal Phase 3 multi-national clinical trials for Respiratory Distress Syndrome (RDS) in premature infants, a Phase 3 clinical trial for Meconium Aspiration Syndrome (MAS) in full-term infants, and a Phase 2 clinical trial for Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in adults. Aerosol formulations of the Company`s surfactant technology are being developed in an effort to treat other respiratory conditions, including asthma and chronic obstructive pulmonary disease, and as a novel pulmonary drug delivery vehicle to efficiently deliver drugs to the respiratory tract that are currently delivered orally or by injection. To serve the U.S. critical care and neo-natal marketplace, the Company is developing a dedicated sales and marketing capability through a collaboration with Quintiles Transnational Corp, signed in December 2001. Interested parties can receive corporate updates by sending their email addresses to [e-mail]. More information about Discovery Laboratories is available on the Company`s Web site at http://www.discoverylabs.com .

[matthiasch]

Friday February 22, 8:20 am Eastern Time
Press Release
SOURCE: Discovery Laboratories, Inc.
Discovery Laboratories Appoints Dr. Ralph Niven as Senior Vice President to Lead its Aerosolized Surfactant Program
DOYLESTOWN, Pa., Feb. 22 /PRNewswire-FirstCall/-- Discovery Laboratories, Inc. (Nasdaq: DSCO - news) today announced the appointment of Dr. Ralph Niven to the position of Senior Vice President, Preclinical Development. In this new role, Dr. Niven leads the Company`s efforts, at its newly established facility in Redwood City, California, to develop aerosolized formulations of the Company`s proprietary humanized lung surfactants for potential use in the treatment of respiratory illnesses and as a respiratory drug delivery vehicle.

Dr. Niven brings fifteen years of experience in the respiratory therapeutic and drug delivery field. He was formerly Vice President of Development at Advanced Inhalation Research, (acquired by Alkermes, Inc.), Director of Pharmaceutical Sciences at Megabios, Inc. and was responsible for pulmonary drug delivery at Amgen, Inc. Dr. Niven has authored over forty publications on respiratory drug delivery, and has been issued four U.S. patents in the areas of pulmonary absorption of modified proteins, protein nebulization, and the formulation and delivery of gene therapeutics.

``I am very excited about the potential for Discovery`s surfactants to address unmet and inadequately met respiratory illnesses,`` said Dr. Niven. ``The benign nature and unique attributes of Discovery`s humanized surfactants suggests that they can be formulated for aerosol indications and furthermore may act as excellent vehicles for drug delivery.``

``Dr. Niven has been instrumental in launching our Redwood City operations,`` said Dr. Robert J. Capetola, President and Chief Executive Officer. ``To have his long-term commitment by joining our executive management team is further validation of the potential of our technology platform. Because of its surface tension lowering properties, we believe an aerosolized formulation of our humanized surfactant has the potential ability to be used in a variety of clinical conditions such as asthma, chronic obstructive pulmonary disease and acute and chronic bronchitis. Also, our humanized surfactant has the ability to penetrate deep in the lung, potentially making it an excellent drug delivery vehicle. Dr. Niven`s experience will be invaluable to our team members focused on this opportunity.``

About Discovery Laboratories, Inc.

Discovery Laboratories, Inc. is a specialty pharmaceutical company leveraging its platform technology in humanized lung surfactants to develop potential novel respiratory therapies and pulmonary drug delivery products. Surfaxin®, the Company`s lead product, is currently in two pivotal Phase 3 multi-national clinical trials Respiratory Distress Syndrome (RDS) in premature infants, a Phase 3 clinical trial for Meconium Aspiration Syndrome (MAS) in full-term infants, and a Phase 2 clinical trial for Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) in adults. Aerosol formulations of the Company`s surfactant technology are being developed in an effort to treat other respiratory conditions, including asthma and chronic obstructive pulmonary disease, and as a novel pulmonary drug delivery vehicle to efficiently deliver drugs to the respiratory tract that are currently delivered orally or by injection. To serve the U.S. critical care and neo-natal marketplace, the Company is developing a dedicated sales and marketing capability through a collaboration with Quintiles Transnational Corp, signed in December 2001. Interested parties can receive corporate updates by sending their email addresses to [e-mail]. More information about Discovery Laboratories is available on the Company`s Web site at www.discoverylabs.com .

To the extent that statements in this press release are not strictly historical, including statements as to the Company`s business strategy, outlook, objectives, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company`s product development, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect the Company`s actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, the risk that the Company will not be able to raise additional capital or enter into additional collaboration agreements, risks relating to the progress of the Company`s research and development and the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in the Company`s periodic filings with the Securities and Exchange Commission including the most recent reports on Form 10-KSB, 8-K and 10-QSB, and amendments thereto.

SOURCE: Discovery Laboratories, Inc.

[matthiasch]

Neuer Insiderkauf:

29-Jan-02 CAPETOLA, ROBERT J
Chief Executive Officer,Officer and Director 1,000
DSCO Purchased at $3.43 -- $3.44/Share.
Cost of $3,435.


Schlusskurs 3,15$

Hier der Wochenchart:

[gholzbauer]

Deutlich unter 3$ würde ich gerne ein paar k nachkaufen.
Hätte also nix dagegen, wenn`s nochmal nach unten ginge.

[matthiasch]

DSCO will aber nicht runter, hält sich im Gegensatz zu den anderen Bios recht gut

[papermaker]

Tripos , gerade 20 $ !!! Toll !!!


pp

[papermaker]

19,65 $


pp

[matthiasch]

@ gholzbauer

Bist du jetzt nochmal unter 3$ eingestiegen?

[gholzbauer]

Nö. Nicht tief genug gewesen bis jetzt.
Trotzdem weiter long

[Kelbi]

Discovery Laboratories & Esteve Expand Relationship to Develop and Commercialize Surfaxin(R) in Europe
DOYLESTOWN, Pa., March 7 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - news), a late-stage specialty pharmaceutical company leveraging its platform technology in humanized lung surfactants to develop potential novel respiratory therapies and pulmonary drug delivery products, today announced a significantly expanded alliance with Laboratorios Del Dr. Esteve S.A (``Esteve``) for the development, marketing and sales of Surfaxin throughout Europe, Central America and South America. This expanded collaboration supersedes existing sublicense and supply agreements between Discovery and Esteve in October 1999, which limited the European territory to Southern Europe.

Through the alliance, Esteve will market Surfaxin for respiratory distress syndrome (RDS) in premature infants, meconium aspiration syndrome (MAS) in full term babies, and acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in adults. Currently, Discovery is conducting two phase 3 clinical trials for RDS, a phase 3 trial for MAS and a Phase 2 trial for ARDS. In addition, the new arrangement anticipates an opportunity for Esteve to negotiate licenses for the development and marketing of future Discovery products in the above territories.

The agreement provides for an up-front licensing fee to Discovery of $500,000, a purchase by Esteve of $4 million of Discovery`s common stock at $4.867 per share (a 50% premium to the trailing 30 day average determined as of March 4, 2002), and milestone payments to be made to Discovery tied to attaining specific regulatory approvals for Surfaxin. Additionally, Esteve will sponsor clinical trial costs for ALI/ARDS to obtain European Agency for the Evaluation of Medicinal Products (EMEA) approval for marketing in Europe. Under the prior arrangement, Esteve had provided support for Discovery`s multinational clinical trials for RDS and MAS in Europe. Discovery retains manufacturing rights and, as part of the collaboration, Esteve has agreed to an exclusive supply agreement, whereby, they will purchase Surfaxin drug product from Discovery. Discovery will receive, as a potential ongoing revenue stream, a transfer price based on sales of Surfaxin by Esteve and/or its sublicensee(s).

Antoni Esteve, Ph.D., Esteve`s Director of Scientific and Commercial Operations, commented, ``Esteve is very proud to expand our collaboration with Discovery. Over the last several years, we have increased our confidence in the significant potential of humanized surfactants to improve therapies for the treatment of babies suffering from respiratory disorders, adults suffering from acute respiratory distress syndrome, and the downstream possibility of aerosolized surfactants treating a broader range of respiratory diseases and as a drug delivery platform. Our additional investment in Discovery supports this confidence and gives Esteve the opportunity to broaden our product portfolio for the medical communities we serve.``

``We have worked closely with Esteve since 1999 and they have been an excellent partner,`` said Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery. ``Expanding our relationship to now include all of Europe was a natural progression for us. Esteve has a superb reputation of marketing innovative pharmaceuticals, and we are pleased to be represented by their professional team to effectively market and distribute Surfaxin to the critical care hospital community. In combination with our recent Quintiles Transnational collaboration, Discovery now has in place the sales and marketing infrastructure to bring Surfaxin to the critical care markets in Europe, the United States and Latin America. Discovery will establish and maintain the global brand strategy for Surfaxin, while our collaborators will be responsible for regional implementation. Our objective is to have a uniform, recognizable Discovery/Surfaxin image visible to the critical care markets throughout the world. Meanwhile, Discovery will record a significant share of the revenues, and in the case of the United States, Discovery should generate margins typical of a fully-integrated specialty pharmaceutical company.``

Human lung surfactants are substances naturally present in the lung tissue and are essential to the lungs` ability to absorb oxygen. Discovery`s Surfaxin is the first humanized peptide-based surfactant that mimics the human surfactant protein B, considered physiologically the most important of the four major proteins found in human lung surfactants.

RDS in premature infants is a breathing disorder in which the lungs of infants do not stay open due to an insufficient amount of surfactant, which is produced naturally in normally developing infants as their lungs mature. Approximately 270,000 cases of RDS in premature infants occur in the developed world annually. MAS results when a full-term baby inhales meconium, a material produced in the intestine of a full-term baby before birth. Severe respiratory distress is a result and there are currently no approved therapies anywhere in the world. Approximately 60,000 cases of MAS occur in the developed world annually. ALI/ARDS is a life-threatening disorder for which there are currently no approved therapies anywhere in the world. ALI/ARDS is characterized by an excess of fluid in the lungs and decreased oxygen levels in the patient. One prominent characteristic is the destruction of surfactants. These conditions are caused by events such as smoke inhalation, near drowning, industrial accidents and other traumas and illnesses including pneumonia and septic shock. Because there are no approved treatments, the mortality rate can range from 35% to 50%. There are estimated to be between 150,000 and 250,000 ALI/ARDS patients per year in each of the U.S. and Europe. The current standard of care includes placing patients on mechanical ventilators in intensive care units. Surfaxin is intended to re-establish the lung`s capacity to absorb oxygen.

About Esteve

Privately owned, Esteve is one of the largest pharmaceutical corporations in Southern Europe. With a turnover of EURO 561 million in 2001, its own products distributed in more than 80 markets worldwide, patents granted in more than 40 countries, and employing more than 2,000 people, it is committed to research and international expansion as a key to its future and continued growth.

[matthiasch]

New insider trade data for DSCO

8-Feb-02 MYRIANTHOPOULOS, EVAN
Officer,Divisional Officer 11,675
DSCO Purchased at $0.51/Share.
Cost of $6,001.

[gholzbauer]

BioStocks Daily von Hornblower 2.4.2002
Thread: Hornblower BioStocks Daily 02.04.2002

[matthiasch]

Balnce Sheet:

Period Ending: Dec 31, 2001 Sep 30, 2001 Jun 30, 2001 Mar 31, 2001
Total Revenue ($461,000) $136,000 $679,000 $758,000
Cost Of Revenue N/A N/A N/A N/A
Gross Profit ($461,000) $136,000 $679,000 $758,000

Operating Expenses
Research And Development $2,809,000 $1,706,000 $1,828,000 $1,664,000
Selling General And Administrative Expenses $1,761,000 $948,000 $1,205,000 $1,153,000
Non Recurring N/A N/A N/A N/A
Other Operating Expenses N/A N/A N/A N/A

Operating Income ($5,031,000) ($2,518,000) ($2,354,000) ($2,059,000)
Total Other Income And Expenses Net $842,000 N/A N/A N/A
Earnings Before Interest And Taxes ($4,189,000) ($2,518,000) ($2,354,000) ($2,059,000)
Interest Expense $23,000 $1,000 $1,000 $1,000
Income Before Tax ($4,212,000) ($2,519,000) ($2,355,000) ($2,060,000)
Income Tax Expense N/A N/A N/A N/A
Equity Earnings Or Loss Unconsolidated Subsidiary N/A N/A N/A N/A
Minority Interest N/A N/A N/A N/A
Net Income From Continuing Operations ($4,212,000) ($2,519,000) ($2,355,000) ($2,060,000)

Nonrecurring Events
Discontinued Operations N/A N/A N/A N/A
Extraordinary Items N/A N/A N/A N/A
Effect Of Accounting Changes N/A N/A N/A N/A
Other Items N/A N/A N/A N/A
Net Income ($4,212,000) ($2,519,000) ($2,355,000) ($2,060,000)
Preferred Stock And Other Adjustments N/A N/A N/A N/A

Net Income Applicable To Common Shares ($4,212,000) ($2,519,000) ($2,355,000) ($2,060,000)

[matthiasch]

Period Ending Dec 31, 2001 Sep 30, 2001 Jun 30, 2001 Mar 31, 2001
Current Assets
Cash And Cash Equivalents $3,758,000 $3,136,000 $3,772,000 $908,000
Short Term Investments $12,938,000 $7,990,000 $9,901,000 $14,894,000
Net Receivables $2,000 $2,000 N/A N/A
Inventory N/A N/A N/A N/A
Other Current Assets $1,580,000 $150,000 $326,000 $378,000
Total Current Assets $18,278,000 $11,278,000 $13,999,000 $16,180,000

Long Term Assets
Long Term Investments $197,000 $198,000 N/A N/A
Property Plant And Equipment $822,000 $671,000 $673,000 $703,000
Goodwill N/A N/A N/A N/A
Intangible Assets N/A N/A N/A N/A
Accumulated Amortization N/A N/A N/A N/A
Other Assets $768,000 $21,000 $3,000 $3,000
Deferred Long Term Asset Charges N/A N/A N/A N/A
Total Assets $20,065,000 $12,168,000 $14,675,000 $16,886,000

Current Liabilities
Accounts Payable $1,750,000 $836,000 $1,072,000 $1,689,000
Short Term And Current Long Term Debt $44,000 $18,000 $18,000 $18,000
Other Current Liabilities N/A N/A N/A N/A
Total Current Liabilities $1,794,000 $854,000 $1,090,000 $1,707,000
Long Term Debt $33,000 $17,000 $21,000 $24,000
Other Liabilities N/A N/A N/A N/A
Deferred Long Term Liability Charges $615,000 $258,000 $456,000 $653,000
Minority Interest N/A N/A N/A N/A
Negative Goodwill N/A N/A N/A N/A
Total Liabilities $2,442,000 $1,129,000 $1,567,000 $2,384,000

Stock Holders Equity
Misc Stocks Options Warrants N/A N/A N/A N/A
Redeemable Preferred Stock N/A N/A N/A N/A
Preferred Stock N/A N/A N/A N/A
Common Stock $26,000 $21,000 $21,000 $21,000
Retained Earnings ($55,135,000) ($50,923,000) ($48,404,000) ($46,049,000)
Treasury Stock ($239,000) ($239,000) ($213,000) ($213,000)
Capital Surplus $73,163,000 $62,200,000 $62,175,000 $60,896,000
Other Stockholder Equity ($192,000) ($20,000) ($471,000) ($153,000)
Total Stockholder Equity $17,623,000 $11,039,000 $13,108,000 $14,502,000
Net Tangible Assets $17,623,000 $11,039,000 $13,108,000 $14,502,000

[matthiasch]

DSCO hält sich verdammt gut - im Gegensatz zum Rest der Biotechnologie.

[matthiasch]

DISCOVERY LABORATORIES INC /DE/ (DSCO)
Quarterly Report (SEC form 10-Q)
ITEM 2. MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS

Overview

We are a specialty pharmaceutical company applying our platform technology, based on humanized lung surfactants, to develop potential novel respiratory therapies and pulmonary drug delivery products. Surfaxin, our lead product, is currently in two Phase 3 clinical trials for Respiratory Distress Syndrome in premature infants, a Phase 3 clinical trial for Meconium Aspiration Syndrome in full-term infants, and a Phase 2 clinical trial for Acute Lung Injury/Acute Respiratory Distress Syndrome in adults. We are also developing aerosolized formulations of our humanized surfactant to treat respiratory conditions such as asthma and as a novel pulmonary drug delivery vehicle to render drugs more effective when delivered to or via the respiratory tract.

We are presently developing a dedicated sales and marketing capability through a collaboration with Quintiles Transnational Corp. to commercialize Surfaxin in the United States. We have expanded our relationship with Laboratorios del Dr. Esteve, S.A., by entering entered into a strategic alliance with Esteve Laboratorios del Dr. Esteve, S.A., to commercialize Surfaxin in Europe, Central and South America, and Mexico. In the non-critical care, ambulatory markets, we plan to establish strategic alliances for the development and commercialization of our products.

Since our inception, we have incurred significant losses and, as of March 31, 2002, had a deficit accumulated during the development stage of approximately $57.8 million (including historical results of predecessor companies). Most of our expenditures to date have been for research and development activities and general and administrative expenses. Research and development expenses represent costs incurred for clinical trials, regulatory filings and manufacturing efforts (including raw material costs). We expense our research and development costs as they are incurred. General and administrative expenses consist primarily of salaries and related expenses, rents and general corporate activities.

Plan of Operations

We expect to continue to incur increasing operating losses for the foreseeable future, primarily due to our continued research and development activities attributable to new and existing products, manufacturing, initial commercialization, and general and administrative activities.

We anticipate that during the next 12 to 24 months we will:

(i) significantly increase our research, development and regulatory activities. It is anticipated that the primary focus of our research and development activities will be the several clinical trials for Surfaxin indications and related regulatory filings. In the fall of 2001, we initiated two pivotal, landmark multinational Phase 3 trials for Respiratory Distress Syndrome in premature infants: a 1,500 patient trial and a 500 patient supporting trial. The majority of our development resources are focused on the completion of these trials and we anticipate completion of enrollment by the end of 2002 with data announced in the first half of 2003. For Acute Respiratory Distress Syndrome in adults, we currently are conducting a Phase 2 dose-ranging safety and efficacy study of up to 110 patients in the United States. We expect data from the Acute Respiratory Distress Syndrome trial to be available in the second half of 2002. For Meconium Aspiration Syndrome in full-term infants, we currently are conducting a Phase 3 clinical trial of up to 200 patients in the United States. Enrollment is ongoing but has been slower than expected and completion is now anticipated for late 2003. Given our belief in the importance of the pivotal Phase 3 trial for Respiratory Distress Syndrome in premature infants to our present development plan, resources have been and may continue to be reallocated from the Meconium Aspiration Syndrome program to the Respiratory Distress Syndrome program, as needed. The clinical trial and regulatory process is lengthy, expensive and uncertain and subject to numerous risks including, without limitation, the risks discussed in "Risks Related to Our Business - The clinical trial and regulatory approval process for our products will be expensive and time consuming, and the outcome is uncertain."



To develop new products, we are conducting research and development of aerosolized formulations of our humanized surfactant to treat respiratory conditions such as asthma and as a novel pulmonary drug delivery vehicle to deliver drugs via the respiratory tract.

(ii) invest in additional manufacturing capability in anticipation of optimizing the production process for Surfaxin and to allow scale up of the manufacturing process to meet our clinical and commercial needs as they expand.

(iii) invest in additional general and administrative resources primarily to support our business development initiatives, financial systems and controls and management information technologies.

(iv) invest in marketing and commercialization management infrastructure to manage the strategic relationships with our collaborative partners for the launch of Surfaxin, if approved, and the execution of our "Discovery/Surfaxin" worldwide marketing strategy.

On December 10, 2001, we entered into a collaboration arrangement with Quintiles, and its affiliate, PharmaBio Development Inc., to provide certain commercialization services in the United States for Surfaxin for the treatment of Respiratory Distress Syndrome in premature infants and Meconium Aspiration Syndrome in full-term infants. Quintiles will hire and train a dedicated United States sales force that will be branded in the market as ours. Quintiles made a financial commitment to us that included a $3 million equity investment, a secured, revolving credit facility of up to $8.5 to $10 million to fund Surfaxin pre-launch activities, and up to $70 million in post-launch funding to cover the first seven years of U.S. sales and marketing costs. In return, Quintiles will receive a commission on net sales of Surfaxin over a ten-year period. We may also receive milestone payments from PharmaBio that would be used to offset amounts owed under the credit facility. The Quintiles arrangement allows us to retain product ownership and have sales and marketing expertise in place for the commercialization of Surfaxin in the U.S., if approved. Additionally, the arrangement allows for the specialty sales force to become ours at the end of the seven year term, with an option to acquire it sooner.

In March 2002, we expanded our existing alliance with Esteve to develop, market and sell Surfaxin throughout Europe, Central and South America, and Mexico. In connection with this new Esteve collaboration, Esteve purchased $4 million of common stock (at a 50% premium over the average closing price for the 30 days prior to the closing date) and paid us a non-refundable licensing fee of $500,000. Esteve agreed to provide certain commercialization services for Surfaxin for the treatment of Respiratory Distress Syndrome in premature infants, Meconium Aspiration Syndrome in full-term infants and Acute Lung Injury/Acute Respiratory Distress Syndrome in adult patients. We have agreed to an exclusive supply agreement which provides that Esteve will purchase from us all of its Surfaxin drug product requirements at an established transfer price based on sales of Surfaxin by Esteve and/or its sublicensee(s). Esteve has also agreed to sponsor certain clinical trial costs related to obtaining regulatory approval in Europe for the Acute Lung Injury/Acute Respiratory Distress Syndrome indications. Esteve also agreed to make certain milestone payments to us upon the attainment of European marketing regulatory approval of Surfaxin. The license fees (including the premium paid for common stock) has been accounted for as deferred revenue and will be recognized as revenue using a straight line method through the anticipated date of FDA approval for the first Surfaxin neonatal indication.

We will need to generate significant revenues from product sales and or related royalties and transfer prices to achieve and maintain profitability. Through March 31, 2002, we have had no revenues from any product sales, and have not achieved profitability on a quarterly or annual basis. Our ability to achieve profitability depends upon, among other things, our ability to develop products, obtain regulatory approval for products under development and enter into agreements for product development, manufacturing and commercialization. In addition, our results are dependent upon the performance of our strategic partners and third party suppliers. Moreover, we may never achieve significant revenues or profitable operations from the sale of any of our products or technologies.

Through March 31, 2002, we had not generated taxable income. At December 31, 2001, net operating losses available to offset future taxable income for Federal tax purposes were approximately $47.5 million. The future utilization of such loss carryforwards may be limited pursuant to regulations promulgated under Section 382 of the Internal Revenue Code. In addition, as of December 31, 2001, we had a research and development tax credit carryforward of $846,000. The Federal net operating loss and research and development tax credit carryforwards expire beginning in 2008 and continuing through 2021.



Results of Operations

Net loss for the three months ended March 31, 2001 was 3,370,000 or $0.13 per common share and for the quarter ended March 31, 2001, was $2,060,000, or $0.10 per common share. The increase was primarily due to an increase in our research and development activities.

Revenues from research and development collaborative contracts were $237,000 and $456,000 for the three months ended March 31, 2002, and March 31, 2001, respectively. Such revenues are related to research and development funding received in connection with our strategic alliance with Esteve.

Research and development expenses increased to $2,605,000 for the first quarter of 2002, as compared to $1,762,000 for the same period of 2001. This increase primarily reflects clinical trial costs incurred for the Company`s lead product, Surfaxin, currently in three Phase 3 trials and one Phase 2 trial.

General and administrative expenses increased to $1,132,000 for the first quarter of 2002, as compared to $1,055,000 for the same period of 2001. General and administrative expenses consist primarily of the costs of executive management, financial and accounting, business development, legal, human resources, facility and other administrative costs. Included in general and administrative costs for the first quarter of 2002 is approximately $250,000 for pre-launch commercialization activities (market research and analysis) for Surfaxin conducted in connection with a collaboration arrangement with Quintiles.

Interest income: Interest income decreased to $160,000 for the quarter ended March 31, 2002, from $302,000 for the quarter ended March 31, 2001. Interest income decreased due to a decline in interest rates during the quarter ended March 31, 2002 as compared to the same period of 2001.

Liquidity and Capital Resources

As of March 31, 2002, we had working capital of approximately $17.2 million as compared to the working capital of approximately $16.5 million we had as of December 31, 2001. The increase in working capital is due to funds received in connection with the expansion, in March 2002, of our existing alliance with Esteve. We believe our current working capital is sufficient to meet our planned research and development activities into the second quarter of 2003. We will need additional financing from investors or collaborators to complete research and development and commercialization of our current product candidates under development.

In December 2001, we entered into a secured revolving credit facility of up to $8.5 million to $10 million with PharmaBio to fund pre-marketing activities for a Surfaxin launch in the United States. The credit facility is available for use until December 10, 2004, and monies become available in three tranches upon satisfying certain conditions. In connection with the credit facility, we issued to PharmaBio Class H warrants to purchase 320,000 shares of common stock. The Class H warrants are exercisable at $3.03 per share (subject to adjustment) and are exercisable proportionately only upon use of the credit facility. To the extent the credit facility availability is increased to greater than $8.5 million, for each $1 million increase, the amount of shares of common stock issuable pursuant to the Class H warrants shall be increased by approximately 38,000 shares.

Interest on amounts advanced under the credit facility will be payable quarterly in arrears. We may repay principal amounts owed by us under the credit facility from proceeds of milestone payments to be paid to us by PharmaBio upon the achievement of certain corporate milestones. As of March 31, 2002, no amounts were outstanding under the credit facility. We are obligated to use a significant portion of the funds borrowed under the credit facility for pre-launch marketing services to be provided by Quintiles and anticipate using this credit facility to fund approximately $250,000 of market research and analysis costs incurred in the first quarter of 2002.

Our working capital requirements will depend upon numerous factors, including, without limitation, the progress of our research and development programs, clinical trials, timing and cost of obtaining regulatory approvals, timing and cost of pre-launch marketing activities, levels of resources that we devote to the development of manufacturing and marketing capabilities, levels of resources that our collaboration partners devote to the development of sales and marketing capabilities, technological advances, status of competitors and our ability to establish collaborative arrangements with other organizations, the ability to defend and enforce our intellectual property rights and the establishment of additional strategic or licensing arrangements with other companies or acquisitions.



Historically, the Company`s working capital has been provided from the proceeds of private financings:

Pursuant to the collaboration arrangement we entered into with Esteve on March 6, 2002, we issued 821,862 shares of common stock to Esteve at a purchase price equal to $4.867 per share and received a licensing fee of $500,000, for approximate aggregate proceeds of $4.5 million.

Pursuant to the collaboration arrangement we entered into with Quintiles and PharmaBio on December 10, 2001, we issued to PharmaBio, for approximate net aggregate proceeds of $2.7 million: (i) 791,905 shares of common stock at a price equal to $3.79 per share; and (ii) Class G warrants to purchase 357,143 shares of common stock at an exercise price equal to $3.485 per share. The Class G warrants have a ten-year term.

On October 1, 2001, we received approximately $7.3 million in net proceeds from a private financing. In the financing, we issued 3,562,759 shares of common stock and 712,553 Class F warrants to purchase shares of common stock at an exercise price of $2.365 per share. The Class F warrants have a five-year term.

On April 27, 2001, we received approximately $1 million in gross proceeds in a private offering of 296,560 shares of common stock at a per share price equal to $3.37.

In March 2000, we received approximately $17,500,000 in net proceeds from the sale of 37.74 units from a private placement offering. Each unit consisted of 76,923 shares of common stock and Class E warrants to purchase an additional 15,385 shares of common stock for $7.38 per share. The Class E warrants issued in the offering aggregate approximately 581,000 shares and are exercisable through March 2005.

In October 1999, in connection with our strategic alliance with Esteve, we issued to Esteve in a private placement 317,164 shares of common stock at a purchase price of $2.68 per share.

In July 1999, we raised approximately $2,231,000 in net proceeds in a private placement offering of an aggregate of 2,024,792 shares of common stock and 2,024,792 Class D warrants to purchase common stock. All of the Class D warrants have been exercised.

During March and April 1999, we raised $1.0 million in a private placement offering of 826,447 shares of common stock and 569,026 Class C warrants to purchase common stock at an exercise price of $2.15 per share. The Class C warrants are exercisable through April 2006.

We will require substantial additional funding to conduct our business, including our expanded research and product development activities. Based on our current operating plan, we believe that our currently available resources will be adequate to satisfy our capital needs into the second quarter of 2003. Our future capital requirements will depend on the results of our research and development activities, clinical studies and trials, competitive and technological advances and the regulatory process. Our operations will not become profitable before we exhaust our current resources; therefore, we will need to raise substantial additional funds through additional debt or equity financings or through collaborative ventures with potential corporate partners. We may in some cases elect to develop products on our own instead of entering into collaboration arrangements and this would increase our cash requirements. We have not entered into any additional arrangements to obtain any additional financing. The sale of additional equity and debt securities may result in additional dilution to our stockholders, and we cannot be certain that additional financing will be available in amounts or on terms acceptable to us, if at all. If we fail to enter into collaborative ventures or to receive additional funding, we may have to reduce significantly the scope of or discontinue our planned research, development and commercialization activities, which could significantly harm our financial condition and operating results. Furthermore, we could cease to qualify for listing of our common stock on the NASDAQ SmallCap Market if the market price of our common stock declines as a result of the dilutive aspects of such potential financings. See "Risks Related to Our Business."

Risks Related to Our Business

The following risks, among others, could cause our actual results, performance, achievements or industry results to differ materially from those expressed in our forward-looking statements contained herein and presented elsewhere by management from time to time.



Because we are a development stage company, we may not successfully develop and market our products, and even if we do, we may not generate enough revenue or become profitable.

We are a development stage company. Therefore, you must evaluate us in light of the uncertainties and complexities present in a development stage biotechnology company. We are conducting research and development on our product candidates. As a result, we have not begun to market or generate revenues from the commercialization of any of these products. To date, we have only generated revenues from investments, research grants and collaborative research and development agreements. We will need to engage in significant, time-consuming and costly research, development, pre-clinical studies, clinical testing and regulatory approval for our products under development prior to their commercialization. In addition, pre-clinical or clinical studies may show that our products are not effective or safe for one or more of their intended uses. We may fail in the development and commercialization of our products. As of March 31, 2002, we have incurred a deficit accumulated during the development stage of approximately $57.8 million, and we expect to continue to incur significant increasing operating losses over the next several years. If we succeed in the development of our products, we still may not generate sufficient or sustainable revenues or we may not be profitable.

If we cannot raise additional capital, we may need to discontinue our research and development activities. In addition, any additional financing could result in equity dilution.

We may need substantial additional funding to conduct our research and product development activities. Based on our current operating plan, we believe that our currently available resources will be adequate to satisfy our capital needs into the second quarter of 2003. Our future capital requirements will depend on the results of our research and development activities, clinical studies and trials, competitive and technological advances and the regulatory process. If our operations do not become profitable before we exhaust our resources, we will likely need to raise substantial additional funds through collaborative ventures with potential corporate partners and through additional debt or equity financings. We may in some cases elect to develop products on our own instead of entering into collaboration arrangements. This would increase our cash requirements for research and development.

However, we have not entered into arrangements to obtain any additional financing, except for the credit facility with PharmaBio Development Inc., a subsidiary of Quintiles. Any additional financing could include unattractive terms or result in significant dilution of stockholders` interests and share prices may decline. If we fail to enter into collaborative ventures or to receive additional funding, we may have to delay, scale back or discontinue our research and development operations, and consider licensing the development and commercialization of products that we consider valuable and which we otherwise would have developed ourselves. Furthermore, we could cease to qualify for listing of our securities on the NASDAQ SmallCap Market if the market price of our common stock declines as a result of the dilutive aspects of such potential financings. See "Risks Related to Our Business-The market price of our stock may be adversely affected by market volatility."

The clinical trial and regulatory approval process for our products will be expensive and time consuming, and the outcome is uncertain.

In order to sell our products that are under development, we must receive regulatory approvals for each product. The FDA and comparable agencies in foreign countries extensively and rigorously regulate the testing, manufacture, distribution, advertising, pricing and marketing of drug products like our products. This approval process includes preclinical studies and clinical trials of each pharmaceutical compound to establish its safety and effectiveness and confirmation by the FDA and comparable agencies in foreign countries that the manufacturer maintains good laboratory and manufacturing practices (GMPs) during testing and manufacturing. The process is lengthy, expensive and uncertain. It is also possible that the FDA or comparable foreign regulatory authorities could interrupt, delay or halt our clinical trials. If we, or any regulatory authorities, believe that trial participants face unacceptable health risks, the trials could be suspended or terminated. We also may not reach agreement with the FDA and/or comparable foreign agencies on the design of clinical studies necessary for approval. In addition, conditions imposed by the FDA and comparable agencies in foreign countries on our clinical trials could significantly increase the time required for completion of our clinical trials and the costs of conducting the clinical trials.

To succeed, clinical trials require adequate supplies of drug substance and drug product, which may be difficult or uneconomical to procure or manufacture, and sufficient patient enrollment. Patient enrollment is a function of several factors, including the size of the patient population, the nature of the protocol, the proximity of the patients



to the trial sites and the eligibility criteria for the clinical trials. Delays in patient enrollment can result in greater costs and longer trial timeframes. Patients may also suffer adverse medical events or side effects that are common to this class of drug such as a decrease in the oxygen level of the blood upon administration.

Clinical trials generally take two to five years or more to complete, and, accordingly, our first product is not expected to be commercially available in the United States until at least 2004, and our other product candidates will take longer. The FDA has notified us that two of our intended indications for Surfaxin, Meconium Aspiration Syndrome in full-term infants and Acute Respiratory Distress Syndrome in adults, have been granted designation as "fast track" products under provisions of the Food and Drug Administration Modernization Act of 1997, and the FDA has awarded us an Orphan Products Development Grant to support our development of Surfaxin for the treatment of Meconium Aspiration Syndrome. Fast Track Status does not accelerate the clinical trials nor does it mean that the regulatory requirements are less stringent. The Fast Track Status provisions are designed to shorten the waiting period between the time the New Drug Application is filed and the FDA`s review of such application for new drugs intended to treat serious or life-threatening conditions. The FDA generally will review the New Drug Application for a drug granted Fast Track Status within six months instead of the typical one to three years. Our products may not, however, continue to qualify for expedited review and our other drug candidates may fail to qualify for fast track development or expedited review. Even though some of our drug candidates have qualified for expedited review, the FDA may not approve them at all or any sooner than other drug candidates that do not qualify for expedited review.

The FDA and comparable foreign agencies could withdraw any approvals we obtain. Further, if there is a later discovery of unknown problems or if we fail to comply with other applicable regulatory requirements at any stage in the regulatory process, the FDA may restrict or delay our marketing of a product or force us to make product recalls. In addition, the FDA could impose other sanctions such as fines, injunctions, civil penalties or criminal prosecutions. To market our products outside the United States, we also need to comply with foreign regulatory requirements governing human clinical trials and marketing approval for pharmaceutical products. The FDA and foreign regulators have not yet approved any of our products under development for marketing in the United States or elsewhere. If the FDA and other regulators do not approve our products, we will not be able to market our products.

Our strategy, in many cases, is to enter into collaboration agreements with third parties with respect to our products and we may require additional collaboration agreements. If we fail to enter into these agreements or if we or the third parties do not perform under such agreements, it could impair our ability to commercialize our products.

Our strategy for the completion of the required development and clinical testing of our products and for the manufacturing, marketing and commercialization of our products, in many cases, depends upon entering into collaboration arrangements with pharmaceutical companies to market, commercialize and distribute our products. On March 6, 2002, we expanded our relationship with Laboratorios Del Dr. Esteve, S.A., by entering into a collaboration arrangement with Esteve for Surfaxin covering all of Europe, Central America and South America, and Mexico. Esteve will be responsible for the marketing of Surfaxin for the treatment of Respiratory Distress Syndrome in premature infants, Meconium Aspiration Syndrome in full-term infants, and Acute Lung Injury/Acute Respiratory Distress Syndrome in adults. Esteve will also be responsible for the sponsorship of certain clinical trial costs related to obtaining European Medicines Evaluation Agency approval for the commercialization of Surfaxin in Europe for the Acute Lung Injury/Acute Respiratory Distress Syndrome indications. We will be responsible for the remainder of the regulatory activities relating to Surfaxin, including with respect to European Medicines Evaluation Agency filings.

On December 10, 2001, we entered into an exclusive collaboration arrangement in the United States with Quintiles, and its affiliate, PharmaBio, to commercialize, sell and market Surfaxin in the United States for indications of Respiratory Distress Syndrome in premature infants and Meconium Aspiration Syndrome in full-term infants. As part of our collaboration with Quintiles, Quintiles will build a sales force solely dedicated to the sale of Surfaxin upon the approval of a New Drug Application for either of the two indications. If Quintiles and we fail to devote appropriate resources to commercialize, sell and market Surfaxin, sales of Surfaxin could be reduced. As part of the collaboration, PharmaBio is obligated to provide us with certain financial assistance in connection with the commercialization of Surfaxin, including, but not limited to, a secured, revolving credit facility for at least $8.5 million which may be increased to $10 million. A failure by us to repay amounts outstanding under the credit facility would have a material adverse effect on us. To obtain the benefits of such financing, we are obligated to meet certain development and performance milestones. The failure by us to meet the



milestones, our failure to meet other terms and conditions of the financing leading to PharmaBio`s termination thereof or the failure of PharmaBio to fulfill its obligation to partially fund the commercialization of Surfaxin, may affect our ability to successfully market Surfaxin.

If Esteve, Quintiles or we breach or terminate the agreements that make up such collaboration arrangements or Esteve or Quintiles otherwise fail to conduct their Surfaxin-related activities in a timely manner or if there is a dispute about their respective obligations, we may need to seek other partners or we may have to develop our own internal sales and marketing capability for the indications of Surfaxin which Esteve and/or Quintiles have agreed to assist in commercializing. Accordingly, we may need to enter into additional collaboration agreements and our success, particularly outside of the United States, may depend upon obtaining additional collaboration partners. In addition, we may depend on our partners` expertise and dedication of sufficient resources to develop and commercialize our proposed products. We may, in the future, grant to collaboration partners rights to license and commercialize pharmaceutical products developed under collaboration agreements. Under these arrangements, our collaboration partners may control key decisions relating to the development of the products. The rights of our collaboration partners would limit our flexibility in considering alternatives for the commercialization of our products. If we fail to successfully develop these relationships or if our collaboration partners fail to successfully develop or commercialize any of our products, it may delay or prevent us from developing or commercializing our products in a competitive and timely manner and would have a material adverse effect on the commercialization of Surfaxin. See "Risks Related to Our Business-Our lack of marketing and sales experience could limit our ability to generate revenues from future product sales."

If we cannot protect our intellectual property, other companies could use our technology in competitive products. If we infringe the intellectual property rights of others, other companies could prevent us from developing or marketing our products.

We seek patent protection for our drug candidates so as to prevent others from commercializing equivalent products in substantially less time and at substantially lower expense. The pharmaceutical industry places considerable importance on obtaining patent and trade secret protection for new technologies, products and processes. Our success will depend in part on our ability and that of parties from whom we license technology to:

defend our patents and otherwise prevent others from infringing on our proprietary rights;

protect trade secrets; and

operate without infringing upon the proprietary rights of others, both in the United States and in other countries.

The patent position of firms relying upon biotechnology is highly uncertain and involves complex legal and factual questions for which important legal principles are unresolved. To date, the United States Patent and Trademark Office has not adopted a consistent policy regarding the breadth of claims that the United States Patent and Trademark Office allows in biotechnology patents or the degree of protection that these types of patents afford. As a result, there are risks that we may not develop or obtain rights to products or processes that are or may seem to be patentable.

Even if we obtain patents to protect our products, those patents may not be sufficiently broad and others could compete with us.

We, or the parties licensing technologies to us, have filed various United States and foreign patent applications with respect to the products and technologies under our development, and the United States Patent and Trademark Office and foreign patent offices have issued patents with respect to our products and technologies. These patent applications include international applications filed under the Patent Cooperation Treaty. Our pending patent applications, those we may file in the future or those we may license from third parties may not result in the United States Patent and Trademark Office or foreign patent office issuing patents. Also, if patent rights covering our products are not sufficiently broad, they may not provide us with sufficient proprietary protection or competitive advantages against competitors with similar products and technologies. Furthermore, if the United States Patent and Trademark Office or foreign patent offices issue patents to us or our licensors, others may challenge the patents or circumvent the patents, or the patent office or the courts may invalidate the patents. Thus, any patents we own or license from or to third parties may not provide any protection against competitors.

Furthermore, the life of our patents is limited. We have licensed a series of patents from Johnson & Johnson, Inc., and Ortho Pharmaceutical Corporation which are important, either individually or collectively, to our strategy



of commercializing our surfactant technology. Such patents, which include relevant European patents, expire on various dates beginning in 2009 and ending in 2017. We have filed, and when possible and appropriate, will file, other patent applications with respect to our products and processes in the United States and in foreign countries. We may not be able to develop additional products or processes that will be patentable or additional patents may not be issued to us. See also "Risks Related to Our Business-If we cannot meet requirements under our license agreements, we could lose the rights to our products."

Intellectual property rights of third parties could limit our ability to market our products.

Our commercial success also significantly depends on our ability to operate without infringing the patents or violating the proprietary rights of others. The United States Patent and Trademark Office keeps United States patent applications confidential while the applications are pending. As a result, we cannot determine which inventions third parties claim in pending patent applications that they have filed. We may need to engage in litigation to defend or enforce our patent and license rights or to determine the scope and validity of the proprietary rights of others. It will be expensive and time consuming to defend and enforce patent claims. Thus, even in those instances in which the outcome is favorable to us, the proceedings can result in the diversion of substantial resources from our other activities. An adverse determination may subject us to significant liabilities or require us to seek licenses that third parties may not grant to us or may only grant at rates that diminish or deplete the profitability of the products to us. An adverse determination could also require us to alter our products or processes or cease altogether any related research and development activities or product sales.

If we cannot meet requirements under our license agreements, we could lose the rights to our products.

We depend on licensing arrangements with third parties to maintain the intellectual property rights to our products under development. Presently, we have licensed rights from Johnson & Johnson and Ortho Pharmaceutical, and the Charlotte-Mecklenberg Hospital Authority. These agreements require us to make payments and satisfy performance obligations in order to maintain our rights under these licensing arrangements. All of these agreements last either throughout the life of the patents, or with respect to other licensed technology, for a number of years after the first commercial sale of the relevant product.

In addition, we are responsible for the cost of filing and prosecuting certain patent applications and maintaining certain issued patents licensed to us. If we do not meet our obligations under our license agreements in a timely manner, we could lose the rights to our proprietary technology.

In addition, we may be required to obtain licenses to patents or other proprietary rights of third parties in connection with the development and use of our products and technologies. Licenses required under any such patents or proprietary rights might not be made available on terms acceptable to us, if at all.

We rely on confidentiality agreements that could be breached and may be difficult to enforce.

Although we believe that we take reasonable steps to protect our intellectual property, including the use of agreements relating to the non-disclosure of confidential information to third parties, as well as agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees and consultants while we employ them, the agreements can be difficult and costly to enforce. Although we seek to obtain these types of agreements from our consultants, advisors and research collaborators, to the extent that they apply or independently develop intellectual property in connection with any of our projects, disputes may arise as to the proprietary rights to this type of information. If a dispute arises, a court may determine that the right belongs to a third party, and enforcement of our rights can be costly and unpredictable. In addition, we will rely on trade secrets and proprietary know-how that we will seek to protect in part by confidentiality agreements with our employees, consultants, advisors or others. Despite the protective measures we employ, we still face the risk that:

they will breach these agreements;

any agreements we obtain will not provide adequate remedies for this type of breach or that our trade secrets or proprietary know-how will otherwise become known or competitors will independently develop similar technology; and

our competitors will independently discover our proprietary information and trade secrets.



If the parties we depend on for manufacturing our pharmaceutical products do not timely supply these products, it may delay or impair our ability to develop and market our products.

We rely on outside manufacturers for our drug substance and other active ingredients for Surfaxin and to produce material that meets appropriate standards for use in clinical studies for our products. We will also rely on outside manufacturers for production of our products after marketing approval. We may also enter into arrangements with other manufacturers for the manufacture of materials for use in clinical testing and after marketing approval.

Our outside manufacturers may not perform as they have agreed or may not remain in the contract manufacturing business for a sufficient time to successfully produce and market our product candidates. If we do not maintain important manufacturing relationships, we may fail to find a replacement manufacturer or to develop our own manufacturing capabilities. If we cannot do so, it could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete any profit margins. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us and, there could be a substantial delay before a new facility could be qualified and registered with the FDA and foreign regulatory authorities.

We may in the future elect to manufacture some of our products on our own. Although we own certain specialized manufacturing equipment, are considering an investment in additional manufacturing equipment and employ certain manufacturing managerial personnel, we do not presently maintain a complete manufacturing facility or manufacturing department and we do not anticipate manufacturing on our own any of our products during the next 12 months. If we decide to manufacture products on our own and do not successfully develop manufacturing capabilities, it will adversely affect sales of our products.

In addition, the FDA and foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding foreign regulators inspect these facilities to confirm compliance with good manufacturing practices (GMPs) or similar requirements that the FDA or corresponding foreign regulators establish. If our third-party foreign or domestic suppliers or manufacturers of our products or, if we decide to manufacture our products on our own, we, fail to comply with GMP requirements or other FDA and comparable foreign regulatory requirements, it could adversely affect our ability to market and develop our products.

Our lack of marketing and sales experience could limit our ability to generate revenues from future product sales.

We do not have marketing, sales or distribution experience or marketing or sales personnel. As a result, we will depend on our collaboration with Quintiles for the marketing and sales of Surfaxin for indications of Respiratory Distress Syndrome in premature infants and Meconium Aspiration Syndrome in full-term infants in the United States and with Esteve for the marketing and sales of Surfaxin for the treatment of Respiratory Distress Syndrome in premature infants, Meconium Aspiration Syndrome in full-term infants and Acute Lung Injury/Acute Respiratory Distress Syndrome in adult patients in all of Europe, Central America and South America, and Mexico. See "Risks Related to Our Business-Our strategy, in many cases, is to enter into collaboration agreements with third parties with respect to our products and we may require additional collaboration agreements. If we fail to enter into these agreements or if we or the third parties do not perform under such agreements, it could impair our ability to commercialize our products." If we do not develop a marketing and sales force of our own, then we will depend on arrangements with corporate partners or other entities for the marketing and sale of our remaining products.

The sales and marketing of Surfaxin for indications of Respiratory Distress Syndrome in premature infants, Meconium Aspiration Syndrome in full-term infants, and Acute Lung Injury/Acute Respiratory Distress Syndrome in adult patients in the relevant territories depends, in part, on Quintiles` and Esteve`s performance of their contractual obligations. The failure of either party to do so would have a material adverse effect on the sales and marketing of Surfaxin. We may not succeed in entering into any satisfactory third party arrangements for the marketing and sale of our remaining products. In addition, we may not succeed in developing marketing and sales capabilities, our commercial launch of certain products may be delayed until we establish marketing and sales capabilities or we may not have sufficient resources to do so. If we fail to establish marketing and sales capabilities or fail to enter into arrangements with third parties, in a timely manner, it will adversely affect sales of our products.



We depend upon key employees and consultants in a competitive market for skilled personnel. If we are unable to attract and retain key personnel, it could adversely affect our ability to develop and market our products.

We are highly dependent upon the principal members of our management team, especially our Chief Executive Officer, Dr. Capetola, and our directors, as well as our scientific advisory board members, consultants and collaborating scientists. Many of these people have been involved in our formation or have otherwise been involved with us for many years, have played integral roles in our progress and we believe that they will continue to provide value to us. A loss of any of these personnel may have a material adverse effect on aspects of our business and clinical development and regulatory programs. We have an employment agreement with Dr. Capetola that expires on December 31, 2005. We also have employment agreements with other key personnel with termination dates in 2003 and 2004. Although these employment agreements generally provide for severance payments that are contingent upon the applicable employee`s refraining from competition with us, the loss of any of these persons` services would adversely affect our ability to develop and market our products and obtain necessary regulatory approvals, and the applicable noncompete provisions can be difficult and costly to monitor and enforce. Further, we do not maintain key-man life insurance.

Our future success also will depend in part on the continued service of our key scientific and management personnel and our ability to identify, hire and retain additional personnel, including marketing and sales staff. We experience intense competition for qualified personnel, and the existence of non-competition agreements between prospective employees and their former employers may prevent us from hiring those individuals or subject us to suit from their former employers.

While we attempt to provide competitive compensation packages to attract and retain key personnel, some of our competitors are likely to have greater resources and more experience than we have, making it difficult for us to compete successfully for key personnel.

Our industry is highly competitive and we have less capital and resources than many of our competitors, which may give them an advantage in developing and marketing products similar to ours or make our products obsolete.

Our industry is highly competitive and subject to rapid technological innovation and evolving industry standards. We compete with numerous existing companies intensely in many ways. We intend to market our products under development for the treatment of diseases for which other technologies and treatments are rapidly developing and, consequently, we expect new companies to enter our industry and that competition in the industry will increase. Many of these companies have substantially greater research and development, manufacturing, marketing, financial, technological, personnel and managerial resources than we have. In addition, many of these competitors, either alone or with their collaborative partners, have significantly greater experience than we do in:

developing products;

undertaking preclinical testing and human clinical trials;

obtaining FDA and other regulatory approvals or products; and

manufacturing and marketing products.

Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA or comparable foreign approval or commercializing products before us. If we commence commercial product sales, we will compete against companies with greater marketing and manufacturing capabilities who may successfully develop and commercialize products that are more effective or less expensive than ours. These are areas in which, as yet, we have limited or no experience. In addition, developments by our competitors may render our product candidates obsolete or noncompetitive.

Presently, there are no approved drugs that are specifically indicated for Meconium Aspiration Syndrome in full-term infants or Acute Lung Injury/Acute Respiratory Distress Syndrome in adults. Current therapy consists of general supportive care and mechanical ventilation. Four products are specifically approved for the treatment of Respiratory Distress Syndrome in premature infants. Curosurf(TM) is a porcine lung extract that is marketed in Europe by Chiesi Farmaceutici S.p.A., and in the United States by Dey Laboratories, Inc. Exosurf(TM) is marketed by GlaxoSmithKline, plc, outside the United States and contains only phospholipids (the fats normally present in the lungs) and synthetic organic detergents and no stabilizing protein or peptides. Survanta(TM), marketed by the Ross division of Abbot Laboratories, Inc., is an extract of bovine lung that contains the cow version of surfactant



protein B. Forrest Laboratories, Inc., markets its calf lung surfactant, Infasurf(TM) in the United States for the treatment of Respiratory Distress Syndrome in premature infants. Although none of the four approved surfactants for Respiratory Distress Syndrome in premature infants is approved for Acute Lung Injury or Acute Respiratory Distress Syndrome in adults, which are significantly larger markets, there are a significant number of other potential therapies in development for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome that are not surfactant-related. Any of these various drugs or devices could significantly impact the commercial opportunity for Surfaxin. We believe that engineered humanized surfactants such as Surfaxin will be far less expensive to produce than the animal-derived products approved for the treatment of Respiratory Distress Syndrome in premature infants and will have no capability of transmitting the brain-wasting bovine spongiform encephalopathy (commonly called "mad-cow disease") or causing adverse immunological responses in young and older adults.

We also face, and will continue to face, competition from colleges, universities, governmental agencies and other public and private research organizations. These competitors are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technology that they have developed. Some of these technologies may compete directly with the technologies that we are developing. These institutions will also compete with us in recruiting highly qualified scientific personnel. We expect that therapeutic developments in the areas in which we are active may occur at a rapid rate and that competition will intensify as advances in this field are made. As a result, we need to continue to devote substantial resources and efforts to research and development activities.

If product liability claims are brought against us, it may result in reduced demand for our products or damages that exceed our insurance coverage.

The clinical testing of, marketing and use of our products exposes us to product liability claims in the event that the use or misuse of those products causes injury, disease or results in adverse effects. Use of our products in clinical trials, as well as commercial sale, could result in product liability claims. In addition, sales of our products through third party arrangements could also subject us to product liability claims. We presently carry product liability insurance with coverages of up to $10,000,000 per occurrence and $10,000,000 in the aggregate, an amount we consider reasonable and customary relating to our clinical trials of Surfaxin. However, this insurance coverage includes various deductibles, limitations and exclusions from coverage, and in any event might not fully cover any potential claims. We may need to obtain additional product liability insurance coverage prior to initiating other clinical trials. We expect to obtain product liability insurance coverage before commercialization of our proposed products; however, the insurance is expensive and insurance companies may not issue this type of insurance when we need it. We may not be able to obtain adequate insurance in the future at an acceptable cost. Any product liability claim, even one that was not in excess of our insurance coverage or one that is meritless and/or unsuccessful, could adversely affect our cash available for other purposes, such as research and development. In addition, the existence of a product liability claim could affect the market price of our common stock.

We expect to face uncertainty over reimbursement and healthcare reform.

In both the United States and other countries, sales of our products will depend in part upon the availability of reimbursement from third party payors, which include government health administration authorities, managed care providers and private health insurers. Third party payors are increasingly challenging the price and examining the cost effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved health care products. Our products may not be considered cost effective. Adequate third party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in the research and development of our products.

The United States and other countries continue to propose and pass legislation designed to reduce the cost of healthcare. Accordingly, legislation and regulations affecting the pricing of our products may change before the products are approved for marketing to the public. Adoption of new legislation and regulations could further limit reimbursement for our products. If third party payors fail to provide adequate coverage and reimbursement rates for our products, the market acceptance of the products may be adversely affected. In that case, our business and financial condition will suffer.



Directors, executive officers, principal stockholders and affiliated entities own a significant percentage of our capital stock, and they may make decisions that you do not consider to be in your best interest.

As of March 31, 2002, our directors, executive officers, principal stockholders and affiliated entities beneficially owned, in the aggregate, approximately 24% of our outstanding voting securities. As a result, if some or all of them acted together, they would have the ability to exert substantial influence over the election of our Board of Directors and the outcome of issues requiring approval by our stockholders. This concentration of ownership may have the effect of delaying or preventing a change in control of the Company that may be favored by other stockholders. This could prevent transactions in which stockholders might otherwise recover a premium for their shares over current market prices.

The market price of our stock may be adversely affected by market volatility.

The market price of our common stock, like that of many other development stage pharmaceutical or biotechnology companies, has been and is likely to be volatile. In addition to general economic, political and market conditions, the price and trading volume of our stock could fluctuate widely in response to many factors, including:

announcements of the results of clinical trials by us or our competitors;

adverse reactions to products;

governmental approvals, delays in expected governmental approvals or withdrawals of any prior governmental approvals or public or regulatory agency concerns regarding the safety or effectiveness of our products;

changes in U.S. or foreign regulatory policy during the period of product development;

developments in patent or other proprietary rights, including any third party challenges of our intellectual property rights;

announcements of technological innovations by us or our competitors;

announcements of new products or new contracts by us or our competitors;

actual or anticipated variations in our operating results due to the level of development expenses and other factors;

changes in financial estimates by securities analysts and whether our earnings meet or exceed the estimates;

conditions and trends in the pharmaceutical and other industries;

new accounting standards; and

the occurrence of any of the risks described in these "Management`s Discussion and Analysis-Risks Related to Our Business."

Our common stock is listed for quotation on the NASDAQ SmallCap Market. For the 3-month period ended March 31, 2002, the price of our common stock has ranged from $4.19 to $2.70. We expect the price of our common stock to remain volatile. The average daily trading volume in our common stock varies significantly. For the 3-month period ending March 31, 2002, the average daily trading volume in our common stock was 31,225 shares and the average number of transactions per day was approximately 42. Our relatively low average volume and low average number of transactions per day may affect the ability of our stockholders to sell their shares in the public market at prevailing prices and a more active market may never develop.

In addition, we may not be able to continue to adhere to the strict listing criteria of the SmallCap Market. If our common stock were no longer listed on the SmallCap Market, investors might only be able to trade in the over-the-counter market in the Pink Sheets(R) (a quotation medium operated by the National Quotation Bureau, LLC) or on the OTC Bulletin Board(R) of the National Association of Securities Dealers, Inc. This would impair the liquidity of our securities not only in the number of shares that could be bought and sold at a given price, which might be depressed by the relative illiquidity, but also through delays in the timing of transactions and reduction in media coverage.

In the past, following periods of volatility in the market price of the securities of companies in our industry, securities class action litigation has often been instituted against companies in our industry. If we face securities litigation in the future, even if meritless or unsuccessful, it would result in substantial costs and a diversion of management attention and resources, which would negatively impact our business.



A substantial number of our securities are eligible for future sale and this could affect the market price for our stock and our ability to raise capital.

The market price of our common stock could drop due to sales of a large number of shares of our common stock or the perception that these sales could occur. As of March 31, 2002, we had 26,396,766 shares of common stock outstanding. In addition, as of March 31, 2002, up to approximately 8,268,000 shares of our common stock were issuable on exercise of outstanding options and warrants.

Holders of our stock options and warrants are likely to exercise them, if ever, at a time when we otherwise could obtain a price for the sale of our securities that is higher than the exercise price per security of the options or warrants. This exercise, or the possibility of this exercise, may impede our efforts to obtain additional financing through the sale of additional securities or make this financing more costly, and may reduce the price of our common stock.

Provisions of our Certificate of Incorporation and Delaware law could defer a change of our management which could discourage or delay offers to acquire us.

Provisions of our Certificate of Incorporation and Delaware law may make it more difficult for someone to acquire control of us or for our stockholders to remove existing management, and might discourage a third party from offering to acquire us, even if a change in control or in management would be beneficial to our stockholders. For example, our Certificate of Incorporation allows us to issue shares of preferred stock without any vote or further action by our stockholders. Our Board of Directors has the authority to fix and determine the relative rights and preferences of preferred stock. Our Board of Directors also has the authority to issue preferred stock without further stockholder approval. As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock. In addition, our Board of Directors, without further stockholder approval, could issue large blocks of preferred stock.

[matthiasch]

Kaufempfehlung am 16. Mai:

Discovery Laboratories DSCO Gerard Klauer Mattison to Buy



Hier noch der Link zu den aktuellen Financials:

http://biz.yahoo.com/fin/l/d/dsco.html

[gholzbauer]

DSCO hat sich lange gut gehalten, aber schließlich hat uns der Abwärtstrend doch erwischt.
Der Quartalsbericht ist ja zudem wieder voll mit Risikowarnungen und Ankündigungen weiterer Dilution.
Die nächsten Tage werde ich vermutlich, wie schon angekündigt, endlich nachkaufen (um die Dividende von Philip Morris CR zu verbraten ).
Schade, daß ich bei DSCO den Zwischengewinn im Januar nicht mitgenommen habe. Andererseits sollte man die langfristige Perspektive nicht aus den Augen verlieren.
2005 stehen wir entweder nahe 0$ oder über 10$.

[Altaktionär]

Nachdem es gestern unter relativ hohen Umsätzen abwärts bis 1 US$ ging, gehts heute wieder aufwärts:

Thursday July 18, 7:03 am Eastern Time
Press Release
SOURCE: Discovery Laboratories, Inc.
Discovery Laboratories Completes Dose-Ranging Stage of Its Phase 2 Clinical Trial of Surfaxin(R) for Acute Respiratory Distress Syndrome (ARDS)
DOYLESTOWN, Pa., July 18 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - News), a late-stage specialty pharmaceutical company leveraging its technology in humanized lung surfactants to develop novel respiratory therapies and pulmonary drug delivery products, successfully completed the dose-ranging part of its Surfaxin® Phase 2 clinical trial for the treatment of Acute Respiratory Distress Syndrome (ARDS) in adults and is presently enrolling patients in the final part of the trial.

ARDS is a life-threatening respiratory disorder for which there are currently no approved therapies anywhere in the world. It is estimated that there are between 150,000 and 250,000 ARDS patients per year in each of the U.S. and Europe. The mortality rate can range from 35% to 50%. The current standard of care includes placing patients on mechanical ventilators in intensive care units at an average estimated cost of approximately $8,500 per day. ARDS is characterized by an excess of fluid, inflammatory cells and debris in the lungs that leads to decreased oxygen levels in the patient`s blood. One prominent characteristic is the destruction of the lung`s natural surfactant that is essential to the ability to absorb oxygen. These conditions are caused by events such as pneumonia, aspiration of gastric contents, smoke inhalation, near drowning, industrial accidents, sepsis and other traumas.

The Company`s Phase 2 trial is an open-label, controlled, randomized, dose-ranging, multicenter trial comparing the safety and effectiveness of Surfaxin to standard of care. Up to 110 ARDS patients will receive either high dose Surfaxin or the standard of care including mechanical ventilation. Surfaxin will be administered via a proprietary sequential bronchopulmonary segmental lavage technique (a "lung wash" where Surfaxin is delivered through a tube, called a bronchoscope, to each of the 19 to 20 segments of the lung) which is intended to cleanse and remove inflammatory substances from the lungs, while approximately one-half of the Surfaxin remains to help re-establish the lung`s capacity to absorb oxygen. The objective is to restore functional surfactant levels in the lung and get critically ill patients off costly mechanical ventilation.

The first part of this trial was a dose escalation safety and tolerability study in 22 patients in four groups (of up to six patients per group). Each group received progressively escalating doses of Surfaxin. The primary endpoints of this part of the trial were safety and tolerability. The Independent Safety Review Committee, comprised of three prominent pulmonologists, reviewed the safety and tolerability data obtained from each of the four dosing groups. In each case, the Committee unanimously agreed to move forward to the next higher dosing group. At the completion of this portion of the trial, both the Company and the Committee determined that the trial procedure is generally safe and tolerable and that it is appropriate to proceed onto the larger safety and efficacy portion of the trial.

The following table presents summary data of certain key clinical endpoints from the dose-ranging part of the trial:


Clinical Results

Mortality Average Days On
Patient Number of Surfaxin ((#) and % Mechanical
Group Patients Dosage(1) of Patients) Ventilation

A 5 22,800 mg (3) - 60% 20.8
B 6 34,200 mg (2) - 33% 17.5
C 6 57,000 mg () - 0% 12.8
D 5 61,000 mg () - 0% 17.2

(1) Based on phospholipid content.


R. Duncan Hite, M.D., Director of Medical Intensive Care and Critical Care Research at Wake Forest University and ARDS Scientific Board Advisor, commented that "Patients with severe ARDS typically require mechanical ventilation in ICUs for an average of three to four weeks, some can require as long as several months. Time on mechanical ventilation is directly associated with adverse patient outcomes and increased cost of care. Reducing ventilator time or ICU stay is a significant benefit to patients as well as to the overall health care system. Surfactant replacement therapy holds great promise in addressing these issues. Although the number of patients in this part of the trial was small, I am encouraged by these results and am hopeful that the results from the larger ongoing Phase II study will be positive. Discovery`s humanized lung surfactant, Surfaxin, and its lavage technique is a logical approach to a surfactant-based therapy for ARDS."

Timothy J. Gregory, Ph.D., Senior Director of Clinical Development of Discovery and principal architect of Abbott Ross` ARDS surfactant trials, commented that "based on years of clinical experience with animal-derived surfactants, as reported in published articles, I and others in the field are convinced that surfactant-based therapy can be effective for the treatment of ARDS. However, the limited supply and the excessive cost of animal-derived surfactants precluded further development. With Surfaxin, we can make the considerable quantities necessary to address this indication at a reasonable cost. These advantages are important because the early results in our Phase 2 trial suggest that the most effective dosages are the higher Surfaxin concentrations. In fact, some of the sickest patients were in the high dose groups "C" and "D" and, nevertheless, we experienced the most promising results in these groups."

The last part of this Phase 2 trial will evaluate safety and efficacy in direct comparison to standard of care in up to 90 additional patients at approximately 30 centers in the U.S. The primary endpoint of this part is to determine the incidence rate of patients being alive and off mechanical ventilation at the end of day 28 with one of the key secondary endpoints being mortality. Assuming successful completion of this Phase 2 trial, Discovery plans to initiate a Phase 3 trial in 2003.

Surfactants are surface-active agents consisting of protein-lipid substances that are produced naturally in the lungs and are essential to the lungs` ability to absorb oxygen. They possess the ability to lower the surface tension of the fluid normally present within the air sacs in the lungs. In the absence of sufficient surfactant, these air sacs tend to collapse. As a result, the lungs do not absorb sufficient oxygen. Surfaxin, Discovery`s engineered version of natural human lung surfactant, is intended to re-establish the lung`s capacity to absorb oxygen. Surfaxin has been granted U.S. FDA Fast Track designation, and Orphan Drug designation by both the U.S. FDA and European Agency for the Evaluation of Medicinal Products.


mfg
Altaktionär
(der wieder erste Positionen in Biotechs gekauft hat)

[matthiasch]

Rallye

[js200]

Von Gestern

DSCO
DISCOVERY LABS
2.200
+0.380 +20.88%


Daily Commentary
HOLD

Our system recommends HOLD as of today. Previous BUY recommendation was made on 10/15/2002 (0) days ago, when the stock price was 2.200. Since then the stock gained 0.00% .

Today the stock closed higher, at its high (sign of strength) with a higher high and a lower low (sign of increase in volatility). The volume is extremely high. The security price is trending up and is overbought.

Candlestick Analysis

Today’s Candlestick Patterns:
Long White Candlestick

Today a Long White Candlestick formed. Buyers were aggressive and buying pressure was strong. Be careful, this may lead to excessive bullishness!

Stock Quote
Last 2.200
Previous Close 1.820
Change +0.380
% Change +20.88%
Volume 163,900
Stock Activity
Open 1.850
Day`s High 2.200
Day`s Low 1.730
52 Week High 4.150
52 Week Low 1.000

Stock Price History
3 Month % Change 64.18
6 Month % Change -26.67
12 Month % Change -20.00
Stock Statistics
50 Day Close MA 1.661
200 Day Close MA 2.388
65 Day Volume MA 41,263

JS200

[gholzbauer]

Ich sag nur: SARS

[matthiasch]

Nicht schlecht

[matthiasch]

Discovery Laboratories Announces Conference Call and Webcast To Update Progress of Phase 3 Clinical Trials For Respiratory Distress Syndrome in Premature Infants
Tuesday June 3, 4:32 pm ET


DOYLESTOWN, Pa., June 3 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - News), a late-stage specialty biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases, announces a conference call to be held Thursday, June 5th at 8:30 AM EDT. Management will update progress of the Company`s Phase 3 Clinical Trials for Respiratory Distress Syndrome in Premature Infants.
This audio webcast will be available to shareholders and interested parties through a live broadcast on the Internet at http://audioevent.mshow.com/1007370/ and www.discoverylabs.com. It is recommended that participants log onto one of these sites at least 15 minutes prior to the call. The Internet broadcast will be available for up to 30 days after the call at both website addresses. Please submit questions in advance to [e-mail].

About Discovery Laboratories, Inc.

Discovery Laboratories, Inc. is a specialty biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases including Respiratory Distress Syndromes, Acute Lung Injury (ALI), asthma, Chronic Obstructive Pulmonary Disease (COPD), and upper airway disorders. Discovery`s surfactant technology produces an engineered version of natural human lung surfactant that is designed to precisely mimic the essential properties of human lung surfactant. Discovery believes that through its surfactant technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for hospitalized and ambulatory patients. Surfaxin®, Discovery`s lead product, is in three Phase 3 and two Phase 2 clinical trials for critical care patients with life-threatening respiratory disorders where there are few or no approved therapies available. Discovery`s first aerosol surfactant product is positioned to enter clinical trials for hospital patients with severe asthma or acute lung injury. Discovery has a commercialization alliance with Quintiles Transnational Corp. and a strategic alliance with Laboratorios del Dr. Esteve S.A.

[matthiasch]

4,57 $ +17,78%

[gholzbauer]

Testergebnis scheint OK, oder?
Steht allerdings nicht besonders viel im PR.

[matthiasch]

@gholzbauer

Gruß und weitere 10% Anstieg auf 4,90$

Discovery Laboratories Announces Results of its Supportive Phase 3 Clinical Trial of Surfaxin(R) for Respiratory Distress Syndrome in Premature Infants
Wednesday June 4, 7:36 pm ET


DOYLESTOWN, Pa., June 4 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - News), a late-stage specialty biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases, announces today the conclusion of enrollment and results of key endpoints of its supportive Phase 3 multinational clinical trial of Surfaxin for Respiratory Distress Syndrome (RDS) in premature infants.
This supportive study was designed as a non-inferiority trial comparing Discovery`s humanized lung surfactant, Surfaxin®, to Curosurf®, an approved pig-lung extract. Surfaxin is engineered to precisely mimic the essential attributes of natural human lung surfactant. Curosurf is believed by many of the world`s leading neonatologists to be the best surfactant currently approved.

The key results from this supportive Phase 3 trial are derived from 252 patients enrolled at 23 trial sites located in the United States, United Kingdom, Spain, France, Poland, Hungary, Portugal, and Canada. The primary endpoint of this trial, considered to be one of the most clinically important factors in evaluating RDS infants, is the incidence of being both alive and without chronic lung disease (commonly called bronchopulmonary dysplasia, or BPD) at 28 days of age.

Based on preliminary analysis of the data, the following encouraging key results are summarized:

1. Patients Alive and Without BPD at 28 Days of Age -- Surfaxin
was statistically equivalent to Curosurf and demonstrated an
approximate 14% relative difference in favor of Surfaxin for
this endpoint.

2. All Cause Mortality at 28 Days of Age -- Surfaxin was statistically
equivalent to Curosurf and demonstrated an approximate 27% relative
difference in favor of Surfaxin for this endpoint.


Further evaluation of secondary endpoints and safety parameters of this supportive clinical trial are currently being conducted. A detailed analysis of the data from this trial will be presented at the European Society for Pediatric Research (ESPR) meeting in Bilbao, Spain in September 2003.

Thomas E. Wiswell, M.D., a Professor of Pediatrics, Division of Neonatology, SUNY at Stony Brook, a leading neonatologist and member of Discovery`s Scientific Advisory Board commented, "It is exciting to have this study, for the first time in neonatal medicine, demonstrate that an engineered humanized surfactant, Discovery`s novel Surfaxin, is at least as efficacious as one of the leading animal-derived surfactants. Although the currently approved animal-derived surfactants are clinically effective, they have potential drawbacks. There are hundreds of thousands of premature babies born in the world each year that need and do not receive effective surfactant replacement therapy.

"I am optimistic about Surfaxin. Surfaxin mimics the most active protein found in human surfactant (the essential surfactant protein, SP-B) and, in contrast to the animal-derived products, Surfaxin has the potential to be produced in virtually unlimited quantities, at lower costs, and without infectious or antigenic consequences. I anxiously await the results of Discovery`s ongoing pivotal, landmark trial in the fall of this year."

Premature babies are born with a lack of natural surfactant in their lungs. Without this surfactant the air sacs in the lungs will collapse and be unable to absorb sufficient oxygen. The current standard of care for treating these patients is Surfactant Replacement Therapy using animal-derived surfactants. These products are prepared using a chemical extraction process from minced cow and pig lung. Because of the inherent limitations of animal-derived products, the manufacture of large quantities of high quality product can be problematic. Discovery`s Surfaxin, as a synthetic, engineered surfactant, is intended to address this limitation. Surfaxin, unlike the animal products, can be produced in virtually unlimited quantities and has no risk of potential transmission of animal-associated diseases.

Sunil Sinha, M.D., Ph.D., F.R.C.P, a leading European neonatologist and a Professor of Paediatrics at South Cleveland Hospital, United Kingdom, stated, "Discovery`s Surfaxin is a surfactant of the highest quality and no other lung surfactant like it is currently available. In this trial, leading clinicians in Europe and North America treated infants at risk for RDS with this humanized, engineered lung surfactant. These results are very exciting for the paediatric community and strongly suggest that Surfaxin is as good as Curosurf, which is considered to be the "benchmark" of animal-derived surfactants. Surfaxin is designed to overcome the limitations of animal-derived surfactants, such as the inability to supply doctors outside of Western Europe and the United States with a surfactant to treat the approximately 2.5 million infants that are presently without this life-saving therapy.

"Doctors and parents currently have no choice in treating RDS infants other than with surfactants that are derived from pig and cow sources. These important results offer the promise that Surfaxin, without the drawbacks of the animal-derived versions, could be available to treat infants at risk for and suffering from RDS in the near future. The worldwide paediatric community looks forward with great anticipation to reviewing the full data at the ESPR meeting in September 2003."

Discovery is also conducting a pivotal, multinational landmark Phase 3 trial for RDS infants that is intended, if successful, to provide the basis for New Drug Applications with the FDA and other worldwide regulatory authorities. This pivotal trial is designed to treat up to 1,500 patients and demonstrate the superiority of Surfaxin over the only commercially available synthetic surfactant and has a reference arm comparing Surfaxin to a bovine-derived (cow) surfactant. This pivotal trial is expected to be completed and data announced early in the fourth quarter of 2003. In order to reallocate resources from our supportive Phase 3 RDS trial to this pivotal Phase 3 trial, we decided to conclude the supportive Phase 3 RDS trial at this time.

About Discovery Laboratories

Discovery Laboratories, Inc. is a specialty pharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases including Respiratory Distress Syndromes, Acute Lung Injury (ALI), asthma, Chronic Obstructive Pulmonary Disease (COPD), and upper airway disorders. Discovery`s surfactant technology produces an engineered version of natural human lung surfactant that is designed to precisely mimic the essential properties of human lung surfactant. Discovery believes that through its surfactant technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for hospitalized and ambulatory patients. Surfaxin, Discovery`s lead product, is in three Phase 3 and two Phase 2 clinical trials for critical care patients with life-threatening respiratory disorders where there are few or no approved therapies available. Discovery`s first aerosol surfactant product is positioned to enter clinical trials for hospital patients with severe asthma or acute lung injury. Discovery has a commercialization alliance with Quintiles Transnational Corp. and a strategic alliance with Laboratorios del Dr. Esteve S.A.

To the extent that statements in this press release are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company`s product development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect the Company`s actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, risks relating to the progress of the Company`s research and development, the risk that the Company will not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for our aerosol and Surfactant Replacement Therapies), risks relating to the progress of the Company`s research and development, risks relating to the lack of sufficient drug product for completion of any of the Company`s clinical studies, and risks relating to the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in the Company`s filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-KSB, 8-K, 10-QSB and 10-Q, and amendments thereto.




--------------------------------------------------------------------------------
Source: Discovery Laboratories, Inc.

[gholzbauer]

2:09PM Discovery Labs target raised to $8 at Gerard Klauer (DSCO) 4.88 +0.43: The target increase follows report this morning of "highly positive" top line results from a Phase III, non-inferiority trial of Surfaxin for Respiratory Distress Syndrome in premature infants. Because the positive outcome of this trial increases the probability of success for the Phase III pivotal and b/c of the general improvement in the biotech universe, firm raises target to $8 from $6.

[matthiasch]

Wahnsinn, schon 6,44$ - plus 10,5%

[logologo]

Umsatz 1425644 jetzt US$ 6,61

[logologo]

AH 7,30 Yeah

[matthiasch]

Leute, das ist der absolute Wahnsinn! Ich hab nachbörslich 7,20$ stehen.
Damit ist DSCO vom Tief 700%!! gestiegen!

[gholzbauer]

Dem Wahnsinn nahe bin auch ich.
Und gespannt auf das Gezocke der nächsten Tage.
Viel Glück allen!

[logologo]

Und weiter gehts
So langsam denke ich über ein Stop-loss nach

[matthiasch]

Noch keine News, dennoch von 7,20$ auf 5,74$

Gruß matthiasch

[matthiasch]

Discovery Laboratories Completes $27.5 Million Private Placement Financing
Friday June 20, 8:39 am ET


DOYLESTOWN, Pa., June 20 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - News), a late-stage biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases, today announced that it has completed the sale of securities in a private placement to selected institutional and accredited investors for gross proceeds of approximately $27.5 million.

Under the terms of the financing, Discovery sold approximately 5.0 million newly issued shares of Common Stock at a price of $5.50 per share and warrants exercisable for approximately 1.0 million shares of common stock with an exercise price of $6.875 per share.

The financing included Quaker BioVentures, Inc., BayStar Capital Management, LLC, Special Situations Funds, PharmaBio Development, Inc. (the investment subsidiary of Quintiles Transnational Corp.), Laboratorios Del Dr. Esteve S.A., and other selected investors including a well-known mutual fund. Gerard Klauer Mattison & Co., Inc. acted as the placement agent for this transaction.

"Surfactant replacement therapy has the potential to address life threatening respiratory disorders and large pharmaceutical markets," said Robert J. Capetola, Ph.D., President and CEO. "To my knowledge, we are the only company with the technology to produce high quality humanized surfactants for a variety of respiratory diseases. I am pleased that the financial community is responding positively to Discovery. The continued validation of our technology has been supported by a series of announcements since the third quarter of 2002 -- including positive clinical data from our Phase 3 supportive trial of Surfaxin® for Respiratory Distress Syndrome in premature infants, the encouraging results of Part A of our Phase 2 trial of Surfaxin for Acute Respiratory Distress Syndrome in adults, and the development of our engineered surfactant as an inhalable aerosol with the potential to treat Severe Asthma and Acute Lung Injury. Significant milestones are upcoming for Discovery, most notably, the results of our pivotal Phase 3 trial for Surfaxin for Respiratory Distress Syndrome in premature infants, the results of Part B of our Phase 2 clinical trial for Surfaxin in Acute Respiratory Distress Syndrome in adults, and entering the clinic in a Phase 1b/2a clinical trial with an aerosolized surfactant for acute asthma."

John G. Cooper, Senior Vice President and CFO commented, "We are very pleased with this successful financing. The announcement of positive data from our supportive Phase 3 trial of Surfaxin for RDS in premature infants allowed us to introduce Discovery and the potential of Surfactant Replacement Therapy to a new group of quality investors. Our financial resources as of March 31, 2003, included $14.2 million of cash, an $8.5 million line of credit with Quintiles, and a $1 million lease line with GECC Life Sciences. With the high level of investor interest to finance Discovery, we believed it was prudent to be opportunistic and strengthen our balance sheet. With the additional $26 million net proceeds from this financing, we are well positioned to conclude our ongoing late-stage clinical trials for Surfaxin, launch our aerosol clinical programs, and strengthen any future negotiations with potential corporate partners.

The securities sold have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration. Discovery has agreed to provide, no later than 90 days after the closing of the private placement, an effective SEC registration statement for the resale of the common shares and the common shares underlying the warrants.

About Discovery Laboratories

Discovery Laboratories, Inc. is a biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases including Respiratory Distress Syndromes, Acute Lung Injury (ALI), asthma, Chronic Obstructive Pulmonary Disease (COPD), and upper airway disorders. Discovery`s surfactant technology produces an engineered version of natural human lung surfactant that is designed to precisely mimic the essential properties of human lung surfactant. Discovery believes that through its surfactant technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for hospitalized and ambulatory patients. Surfaxin, Discovery`s lead product, is in Phase 3 and Phase 2 clinical trials for critical care patients with life-threatening respiratory disorders where there are few or no approved therapies available. Discovery`s first aerosol surfactant product is positioned to enter clinical trials for hospital patients with severe asthma or acute lung injury. Discovery has a commercialization alliance with Quintiles Transnational Corp. and a strategic alliance with Laboratorios del Dr. Esteve S.A.

To the extent that statements in this press release are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company`s product development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect the Company`s actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, risks relating to the progress of the Company`s research and development, the risk that the Company will not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for our aerosol and Surfactant Replacement Therapies), risks relating to the progress of the Company`s research and development, risks relating to the lack of sufficient drug product for completion of any of the Company`s clinical studies, and risks relating to the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in the Company`s filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-KSB, 8-K, 10-QSB and 10-Q, and amendments thereto.

[matthiasch]

DSCO Jun 24 6.35$ +0.82 +14.83%

[logologo]

DSCO heute schon bei USD 8,---
Umsätze sind auch ok

[logologo]

Was geht da ab?
Nachbörslich USD 8,32

[matthiasch]

Discovery Laboratories DSCO Analyst:Fulcrum to Buy

Kaufempfehlung

[logologo]

Von jetzt an nur noch bergauf

[matthiasch]

Discovery Laboratories Schedules Conference Call and Webcast
Tuesday September 30, 10:23 am ET
Presentation at European Society for Paediatric Research of Successful Supportive Phase 3 Clinical Trial of Surfaxin(R) for Respiratory Distress Syndrome


DOYLESTOWN, Pa., Sept. 30 /PRNewswire-FirstCall/ -- Discovery Laboratories, Inc. (Nasdaq: DSCO - News), a late-stage biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases, announces a conference call to be held Thursday, October 2 at 8:45 AM EDT.



Management will provide an overview of the presentation given on September 29, 2003, at the 44th annual meeting of the European Society for Paediatric Research (ESPR) in Bilboa, Spain. Sunil Sinha, M.D., Ph.D., F.R.C.P, a leading European neonatologist and a Professor of Paediatrics at South Cleveland Hospital, United Kingdom, presented an analysis of the data from the Company`s supportive Phase 3 multinational clinical trial of Surfaxin® for Respiratory Distress Syndrome (RDS) in premature infants. This supportive study was designed as a non-inferiority trial comparing the Company`s humanized lung surfactant, Surfaxin, to Curosurf®, an approved pig-lung extract.

This audio webcast will be available to shareholders and interested parties through a live broadcast on the Internet at http://audioevent.mshow.com/131860 and www.discoverylabs.com. It is recommended that participants log onto one of these sites at least 15 minutes prior to the call. The Internet broadcast will be available for up to 30 days after the call at both website addresses.

About Discovery Laboratories, Inc.

Discovery Laboratories, Inc. is a late-stage biopharmaceutical company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases including Respiratory Distress Syndromes, Acute Lung Injury (ALI), asthma, Chronic Obstructive Pulmonary Disease (COPD), and upper airway disorders. Discovery`s surfactant technology produces an engineered version of natural human lung surfactant that is designed to precisely mimic the essential properties of human lung surfactant. Discovery believes that through its surfactant technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for hospitalized and ambulatory patients. Surfaxin, Discovery`s lead product, is in Phase 3 and Phase 2 clinical trials for critical care patients with various life-threatening respiratory disorders where there are few or no approved therapies available. Discovery`s first aerosol surfactant product is positioned to enter clinical trials for hospital patients with severe asthma or Acute Lung Injury. Discovery has a commercialization alliance with Quintiles Transnational Corp. and a strategic alliance with Laboratorios del Dr. Esteve S.A.

Interested parties can receive corporate updates by sending their email addresses to [e-mail]. More information about Discovery Laboratories is available on the Company`s website at www.discoverylabs.com.

To the extent that statements in this press release are not strictly historical, including statements as to the Company`s business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company`s product development, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect the Company`s actual results and could cause results to differ from those contained in the forward-looking statements contained herein are the risk that financial conditions may change, the risk that the Company will not be able to raise additional capital or enter into additional collaboration agreements, risks relating to the progress of the Company`s research and development and the development of competing therapies and/or technologies by other companies. Those associated risks and others are further described in the Company`s periodic filings with the Securities and Exchange Commission including the most recent reports on Forms 10-KSB, 8-K, 10-QSB and 10-Q, and amendments thereto.

[matthiasch]

Discovery Laboratories DSCO Brean Murray to Strong Buy


Discovery Laboratories DSCO Rodman & Renshaw to Mkt Outperform

[logologo]

Positive Phase III

+19,9 %
http://finance.yahoo.com/q/bc?s=dsco&d=c

[matthiasch]

Absoluter Wahnsinn

9,11$ + 0,531$ + 6,19%

[logologo]

http://finance.yahoo.com/q/h?s=DSCO

alles klar .Oder?

[logologo]

Noch ein Weihnachtsgeschenk
DSCO heute USD 10,65

http://finance.yahoo.com/q?d=t&s=DSCO

[matthiasch]

Wirklich Wahnsinn

Ich denke an erste Gewinnmitnahmen.

Gruß matthiasch

[logologo]

Heute USD 11,40

Fulgram soll Kursziel 18,- gesetzt haben.

Schaun mer mal.

[matthiasch]

Nach Exodus vor etwa 4 Jahren der beste Werte, den ich je gekauft habe Momentan mit 600% im Plus

[logologo]

Schlußkurs USD 11,88 und sehr hoher Umsatz.

Jetzt bin ich mal gespannt auf die Konferenz am 22.01.

[matthiasch]

12,44$ - Wahnsinn

[logologo]

Mit der Pause ist es wohl vorbei.
Sehr gute Unternehmensnachrichten .

[logologo]

USD 12,98
frohe Ostern