UNIGENE - 500 Beiträge pro Seite

[torcidaa]

hat jemand schon von der aktie gehört. sollen ein ganz gutes produkt gegen osteporose in der pipeline haben, warten nur noch auf das approval.

meines wissens ist da ein riesen potential vorhanden, zumal es um pillen/spray geht.

[greenhorn1998]

Hallo zusammen!

Habe mich mal auf der Homepage ein bisschen umgesehen. Klingt wirklich ganz interessant.

Products and Markets
Injectable Calcitonin
 For Treatment of Osteoporosis
 Current Worldwide Market Approximately $150 Million
 Received Marketing Authorization in European Union for Paget`s Disease and Hypercalcemia in 1998 and for the Management of Osteoporotic Fractures in 2003; Licensing Discussions Underway
 Received Marketing Authorization in Switzerland for Osteoporosis, Paget`s Disease and Hypercalcemia in 2001
 New Drug Application Filed by Chinese Joint Venture in September 2003
 Available for Licensing in US and Other Markets with the Exception of China
Nasal Calcitonin
 For Treatment of Osteoporosis
 Current Worldwide Market Approximately $600 Million
 Licensed in US to Upsher-Smith Laboratories December 2002
 Licensed in Greece to Faran Laboratories, S.A. in September 2003
 US NDA filed in March 2003 and Accepted for Review in May 2003
 New Drug Application Filed in China in September 2003
 Centralized Submission Planned in the European Union in 2004
 Available for Licensing Outside the US, with the exception of Greece and China
Oral Calcitonin
 For Treatment of Osteoporosis
 Projected Worldwide Market in Excess of $1 Billion
 Completed Phase I/II Trial
 Available for Licensing in US and Other Markets
Parathyroid Hormone Analog
 For Treatment of Osteoporosis
 Projected Worldwide Market in Excess of $1 Billion
 Worldwide License Agreement Signed with GlaxoSmithKline in April 2002 to Develop and Market an Orally Delivered Parathyroid Hormone Analog
Oral Desmopressin
 For Treatment of Primary Nocturnal Enuresis
 Projected Worldwide Market Approximately $200 Million
 Oral Delivery Demonstrated in Preclinical Studies
 Available for Licensing in US and Other Markets
Oral Leuprolide (LHRH Analog)
 For Treatment of Prostate Cancer and Endometriosis
 Projected Worldwide Market in Excess of $1 Billion
 Oral Delivery Demonstrated in Preclinical Studies
 Available for Licensing in US and Other Markets
Glucose Regulatory Peptides and Analogs
 For Treatment of Type I and Type II Diabetes
 Projected Worldwide Market in Excess of $1 Billion
 Recombinant Production Methodology Established; Oral Delivery Demonstrated in Preclinical Studies
 Available for Licensing in US and Other Markets

Gruß, greenhorn

[greenhorn1998]

Und hier noch was zu Partnerschaften:

Contracts and Research Collaborations
Nasal Calcitonin (Fortical®)
In December 2002, Unigene signed an exclusive US licensing agreement with Upsher- Smith Laboratories to market Unigene`s patented nasal formulation, Fortical®, for the treatment of osteoporosis. Under the terms of the agreement Unigene will receive $10 Million in up-front and milestone payments as well as royalties on product sales. Unigene will be responsible for manufacturing and will sell the finished product to Upsher-Smith who will package, distribute and market the product nationwide. An NDA on the nasal calcitonin product was filed by Unigene in March 2003 and accepted for review in May 2003.
In September 2003, Unigene signed an exclusive license in Greece with Faran Laboratories, S.A. Unigene will sell the finished nasal calcitonin product to Faran for promotion and marketing in Greece. Unigene will receive an up-front payment and milestone payments. Faran will also pay Unigene a fixed price for each unit of product received.
Parathyroid Hormone Analogs
In April 2002, Unigene signed a major license agreement with SmithKline Beecham Corporation, a GlaxoSmithKline company (GSK) to develop an oral formulation of recombinantly produced parathyroid hormone (PTH) analog. Under the terms of this agreement, GSK will receive an exclusive worldwide license to develop and commercialize the product. In return, GSK will pay Unigene a total of $150 Million in upfront and milestone payments during the course of development and through to the market. In addition, GSK will underwrite all development activities during the program, including costs for the production of bulk PTH for development and for clinical supplies, and royalties on eventual sales of the marketed product.
Unigene has an ongoing research collaboration on preclinical and pharmacology studies on PTH analogs with Dr. Agnès Vignery, Associate Professor, Departments of Orthopaedics and Rehabilitation, and Cell Biology, Yale University School of Medicine.
Injectable Calcitonin (Forcaltonin®)
Unigene has established a joint venture with the Chinese Shijiazhuang Pharmaceutical Group to commercialize injectable salmon Calcitonin (sCT) for the treatment of Osteoporosis in China. Sales of injectable sCT under the joint venture began in April 2002. In addition to recognizing revenue on sales of bulk sCT by Unigene to the joint venture, Unigene will receive 45% of any profits achieved by the joint venture. Unigene`s approval in Switzerland for injectable sCT for osteoporosis enables the joint venture to promote and market the product in China for the treatment of osteoporosis in advance of filing a Chinese New Drug Application.


Was hat es denn mit dieser Citizen`s Petitition auf sich? Worum geht es da genau?

Gruß, greenhorn

[greenhorn1998]

Ich nochmal!

September 13, 2004 08:02 AM US Eastern Timezone

Fracture Management Products Leading Growth in the $4.7 Billion U.S. Osteoporosis Market, According to a New Analysis from Health Research International

CLEVELAND--(BUSINESS WIRE)--Sept. 13, 2004--Osteoporosis affects approximately 15 million Americans, predominantly postmenopausal women, and 30 million more are at risk for the disease. Despite increasing awareness of the condition and its cost to society, most patients are not diagnosed until they experience an osteoporotic fracture, as the disease lacks distinct symptoms, is not considered life-threatening, and, until recently, had limited treatment options.


This situation is expected to change with the availability of new drugs and minimally invasive surgical treatments that are facilitating cost-effective patient management. Percutaneous vertebral augmentation, encompassing vertebroplasty and kyphoplasty, will experience the fastest gains, and drug therapy--already a $3.7 billion market in 2003--will see impressive growth, driven by parathyroid hormones. Hip fracture management technologies will see above-average gains, while bone densitometers will see broader use in physician offices. In total, sales of products used to diagnose and treat osteoporosis are projected to increase 9.1% annually through 2008, or more than four times the growth rate of the U.S. osteoporosis population.

These are among the findings of a comprehensive new report published by Health Research International entitled "U.S. Opportunities in the Management of Osteoporosis," distributed exclusively by Medtech Insight, a division of Windhover Information. This 400-page report contains 110 exhibits describing the critical demographic, clinical and product developments driving the U.S. osteoporosis market. Competitive, technology and sales analyses are provided for: central and peripheral bone densitometry systems; bone marker assays; prophylactic and therapeutic drugs (hormone replacement therapy, selective estrogen modulators, bisphosphonates, calcitonins, parathyroid hormones, and emerging agents), internal fracture fixation and hip replacement products, and kyphoplasty devices, bone cements and cement delivery systems used to perform PVA, among others. Twenty detailed company profiles are also included.

Companies whose products and strategies are covered in the report include: Akzo Nobel, ArthroCare, Aventis, Biomet, Cardinal Health, Cook, CooperSurgical, DePuy, GE Healthcare, Glaxo SmithKline, Hologic, Kyphon, Ligand Pharmaceuticals, Eli Lilly, Merck, Novartis, OSI Systems, Quidel, Servier, Smith & Nephew, Spineology, Spine Wave, Stryker, Synthes, Unigene Laboratories, Wright Medical, Wyeth and Zimmer, among others (also see http://www.medtechinsight.com/ReportHRI085.html).

Since 1978, Health Research International (www.healthri.com) has been providing the pharmaceutical and medical device industries with reliable, comprehensive and meticulously researched custom market data and analysis. Quality, experience and a thorough understanding of competing medical technologies have been the cornerstones of our custom consulting, on-line surveys, and market reports.

Recently acquired by Windhover Information Inc. (www.windhover.com), publisher of IN VIVO: The Business & Medicine Report and Start-UP: Windhover`s Review of Emerging Technologies, Medtech Insight is a leading provider of business information for the medical technology marketplace. The company publishes the monthly "medtech insight" newsletter and a wide selection of comprehensive Market & Technology Reports, holds several medtech investment conferences annually, and provides custom consulting services.

Gruß, greenhorn

[coldplay]

..übrigens, Unigene hat erst kürzlich mit Novartis, dem Schweizer Pharmariesen, ein Joint-Venture im Zusammenhang mit Calcitonin abgeschlossen, das macht die ganze Sache wirklich interessant....

[greenhorn1998]

Hi!

Hier die passende Meldung dazu:

Unigene Announces Licensing and Manufacturing Agreements for Calcitonin with Novartis; Unigene Eligible to Receive $18.7 Million in Addition to Royalties

FAIRFIELD, N.J.--(BUSINESS WIRE)--April 8, 2004--Unigene Laboratories, Inc. (OTCBB: UGNE) has signed licensing and clinical supply agreements with Novartis Pharma AG (NYSE: NVS) to provide for the recombinant production of calcitonin, the active ingredient used in various formulations for the treatment of osteoporosis. Under the terms of these agreements Unigene is eligible to receive $18.7 million, including an initial payment of $5.6 million. In addition, Unigene is eligible to receive royalties on sales of any current or future Novartis products that will contain calcitonin made using Unigene`s process.

The license agreement grants Novartis a worldwide license to produce recombinant calcitonin under Unigene`s patented process for manufacturing recombinant peptides. Unigene will sell calcitonin to Novartis to support Novartis` development programs. Unigene remains free to develop and commercialize its own products containing calcitonin, including its oral product under development and FORTICAL(R), its nasal product that recently received an approvable letter from the U.S. Food and Drug Administration.

"This arrangement will allow Unigene and Novartis to independently advance their commercial interests in calcitonin using the same production platform," commented Dr. Warren Levy, President and CEO of Unigene. "Our patented manufacturing process allows for the cost-effective large-scale production of peptides to support their worldwide commercialization as oral or nasal therapeutics. In addition to potentially providing a highly desirable revenue stream, the agreements provide Unigene with a potential source of supply for recombinant calcitonin that far exceeds our current capacity, thereby avoiding the need for significant capital expenditures for construction of a larger production facility. This increased supply of recombinant calcitonin will be essential to support the development and commercialization of our oral calcitonin product."

About Unigene

Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Unigene has licensed the U.S. rights for its nasal calcitonin product to Upsher-Smith Laboratories and the worldwide rights for its oral PTH technology to GlaxoSmithKline. Unigene`s patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene`s patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics.


Gruß, greenhorn

[torcidaa]

wie ich schon in einem vorhergehenden thread geschrieben habe, wird voraussichtlich diese woche ein artikel in
"der aktionär" erscheinen. hoffe dies wird dem stock flügel verleihen, denn es ist in letzter zeit erstaunlich ruhig geworden um unigene, ich hoffe es ist die ruhe vor dem sturm.

[greenhorn1998]

Hi torcidaa!

Da muss ich dich leider enttäuschen. Konnte gerade einen Blick erhaschen, mein Nachbar bezieht den "Aktionär" im Abo und kriegt den deswegen einen Tag vorher. Unigene wird nicht vorgestellt. Finde ich aber auch nicht so schlimm. Sollte es in Kürze gute Neuigkeiten geben, dann wird sich der Kurs so oder so nach oben entwickeln. Die Empfehlungen kommen dann wahrscheinlich nach den ersten 100 oder 200 Prozent.

Könntest du noch mal ein kurzes Wort über diese Citizens Petition verlieren? Worum es genau geht und wie die Sache deiner Meinung nach ausgehen könnte?

Gruß, greenhorn

[torcidaa]

nun, dann wird der bericht nächste woche drinn sein, sofern meine quelle nicht total versagt hat. er meinte eventuell reiche es noch für diese ausgabe, könnte aber auch erst in der nächsten erscheinen.

weiss nicht viel über die citizen petition, hörte nur von jemandem, der ein ziemlich grosses aktienpaket hat und darum auch kontakt zum ceo hat (was uns kleinen läusen ja verwehrt ist :-), dass der levi meinte, er mache sich keine sorgen darüber. dies komme immer wieder vor und habe in der regel keine chance, nur zögert es natürlich das fda noch ein wenig hinaus.

habe auch gehört, dass eventuell leerink swan, eine us-bude, die spezialisiert auf biotechs ist, den stock eventuell covern will, das wär natürlich der hammer.

aber wie das halt so ist bei solchen stocks, man hört immer wieder von gerüchten, ich glaub`s erst wenn`s dann wirklich so ist.

[torcidaa]

gute news

nächsten dienstag wird unigene bei der biotech-konferenz der ubs ihr produkt presentieren.

12.00 us-time.

mal schauen, vieleicht werden einige investoren angelockt.

[greenhorn1998]

Was auch immer das zu bedeuten hat, aber das Volumen zieht ja seit gestern deutlich an.

Gruß, greenhorn

[torcidaa]

so, heute ist es so weit, unigene wird um 6 uhr unserer zeit in new york vor hoffentlich vielen investoren, analysten, spezialisten etc. eine presentation halten.

ich erwarte ehrlich gesagt keine bahnbrechenden news, denn unigene selber wusste bis vor kurzem gar nicht, dass sie bei der konferenz dabei sind, sind im letzten moment auf den zug aufgesprungen, deswegen würde mich ein kurseinbruch nicht wundern, da mir hier zu viel fantasie in hinsicht auf die konferenz hineingetragen wurde.

seis drum, es ändert sich nichts an der unigene story, kommt das fda explodiert der kurs, falls nicht, hm, könnt ihr euch ja denken.

[torcidaa]

aktie bei 1.05 geschlossen, so kann es weitergehen.

[BrauchGeld]

Hallo

In Mai 2003 NDA von der FDA akzeptiert,und wann rechnet man mit dem FDA ok ?

Bin gestern auch eingestiegen gefällt mir auch gut.

Grüsse
B.M.

[torcidaa]

na wenn man das wüsste. spekualationen mehren sich, dass sie für fortical (nasal calticonin) das fda-approval bis ende jahr haben sollten. aber genau weiss das wohl nich einmal die fda.

gerüchte mehren sich, dass calcitonin auch eine indication bekommt in sachen osteo-artrithis, das wär natrlich top, würde den markt auf einen schlag verdoppeln.

[greenhorn1998]

Hi torcidaa!

In diesem Aktionär steht tatsächlich etwas drin über Unigene. Nichts spektakuläres, oder was man nicht vorher hätte wissen können. Einschätzung: Nur für risikobereite Anleger, Verdopplungspotenzial auf mittlere bis lange Sicht.

Gruß, greenhorn

[torcidaa]

habe den bericht zugeschickt bekommen.

eigentlich ist er anfangs recht positiv, klar, nichts das wir nicht schon wussten, aber es gibt ja noch ganz viele leute auf dieser welt, die noch nie was von unigene gehört haben ;-)

ich fands eigentlich nur schade, dass sie nach all den guten worten dann ein target von 1,40 euro angesetzt haben, mir wär eine 3 vor dem komma lieber gewesen.

was soll`s vieleicht beissen ja einige leser an, man wird es sehen in den nächsten tagen.

[torcidaa]

ciao greenhorn.

das was neues drin steht hab ich auch nicht erwartet, was sollen die vom aktionär schon wissen was wir nicht schon lange wissen ;-)

geht mehr darum, dass neue investoren angelockt werden, in erster linie natürlich nur "retail" aber man nimmt was man kriegt.

ich war nur ein wenig enttäuscht vom target welches sie haben, 1.40 euro, hätte lieber eine 3 vor dem komma gesehen ansonsten war doch der bericht ziemlich positiv.

[torcidaa]

jetzt hab ich doch prompt zwei mal geantwortet, sorry, dachte beim ersten mal hätte ich was falsch gemacht da den thread nicht sofort sah.

[BrauchGeld]

Hi

Unigene`s Oral PTH Osteoporosis Product Successfully Tested in Phase I Study
Tuesday October 12, 8:01 am ET


FAIRFIELD, N.J.--(BUSINESS WIRE)--Oct. 12, 2004--Unigene Laboratories, Inc. (OTCBB: UGNE - News) announced that the preliminary results of an ongoing Phase I human trial conducted by GlaxoSmithKline (GSK) to test an oral formulation of parathyroid hormone (PTH) demonstrated that the formulation can deliver PTH into the bloodstream of human subjects and that the PTH molecule was intact and biologically active.
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The compound is being jointly developed for the treatment of osteoporosis by Unigene and GSK. Under the terms of the previously announced agreement that the parties executed in April 2002, GSK received an exclusive, worldwide license to develop an oral formulation of PTH using Unigene`s patented manufacturing and oral delivery technologies. The agreement could have a value to Unigene of up to $150 million before royalties, PTH sales and reimbursement for development activities.

"We are very encouraged that the formulation successfully delivered biologically active PTH in human subjects," commented Dr. Ronald S. Levy, Executive Vice President of Unigene. "While a Phase I study typically employs only small numbers of healthy subjects and much clinical and non-clinical work remains to be done before a product can be approved by the FDA, these results are extremely valuable and they will help to focus the development activities going forward."

Gruss
B.M.

[BrauchGeld]

hi

Aktie geht heute ab unter hohem Volumen.
Hoffentlich kommen bald positive News ,dann lache ich über die 1,40€ .
Bei Zulassung sind etliche €€€€€€€€€€€´s drin

Gruss
B.M.

[BrauchGeld]

Hallo

PR Newswire

October 19, 2004, Tuesday 4:59 AM Eastern Time

SECTION: LIFESTYLE

DISTRIBUTION: TO BUSINESS, MEDICAL AND HEALTH EDITORS

LENGTH: 470 words

HEADLINE: Half of All Americans Over 50 at Risk for Fractures from Osteoporosis,
New Study Says

DATELINE: FAIRFIELD, N.J., Oct. 19

BODY:
According to U.S. Surgeon General Richard H. Carmona, a new report indicates
that by 2020, half of all American citizens older than 50 will be at risk for
fractures from osteoporosis and low bone mass if no immediate action is taken by
individuals at risk, doctors, health systems, and policymakers.
Coinciding with the skyrocketing number of cases of osteoporosis has been
the marketing of new drugs to treat the condition. Fortical(R), a nasal
calcitonin treatment from Unigene Laboratories, is expected to be one of the
newest players in the osteoporosis therapy race.
In third-party clinical trials, calcitonin demonstrated a 62 percent
reduction in the incidence of new vertebral fractures for a subgroup of women
over 75 years of age, one of the most significant reductions demonstrated by any
current osteoporosis therapy.
In addition, calcitonin is the only therapy for the disease that can reduce
the severe bone pain associated with advanced stages of the disease. Currently,
calcitonin is available only as an injection or a nasal spray. Because
calcitonin is a peptide, it is very difficult to administer this drug orally, as
it would be digested before it could exert its therapeutic effect. However,
Unigene has developed a technology that in clinical trials has made oral
delivery of certain peptides possible and is currently developing an oral
formulation of calcitonin.
"Calcitonin has a proven, 30-year record of safe human use with virtually no
significant side effects and can be taken simultaneously with other
medications," said Dr. Warren Levy, president and CEO of Unigene. "Once therapy
is initiated with any osteoporosis treatment, it should ideally be taken for
life. We believe that an oral formulation of calcitonin could improve compliance
to facilitate long-term administration."
Another therapeutic option is parathyroid hormone (PTH), which can rebuild
bone mass lost due to osteoporosis. PTH has been proven to increase the volume
and strength of the honeycomb-like bone infrastructure. This inner framework
begins to erode in old age. In third-party studies, PTH injections have been
shown to reduce the incidence of fractures by restoring some of the lost bone,
although this method of administration is not preferred by most patients.
Unigene and GlaxoSmithKline are jointly developing an orally administered PTH
treatment.
According to "Bone Health and Osteoporosis: A Report of the Surgeon
General," 10 million Americans over the age of 50 currently have osteoporosis.
For more information on osteoporosis and calcitonin, visit
http://www.unigene.com

Gruss
B.M.

[BrauchGeld]

Hi

Kurz vor schluss noch ein schöner anstieg.
Hoffentlich kommen bald positive news bzgl. zulassung.

Gruss
B.M.

[BrauchGeld]

Hi

Die 2$ ist mit leichtigkeit genommen ,der weg ist somit frei für weitere kursanstiege.
Erinnert mich daran das ich bei 5$ verkaufe

Gruss
B.M.

[BrauchGeld]

Hi

Bei dieser aktie kriege ich $$$$$$$$$$ zeichen in den augen.
Leute wenn ich reich werde gehe ich zum chef und sage "du kannst mich mal".

Gruss
B.M.

[Kaleidoscape]

Hi. Bin jetzt auch dabei. Voll die Hammeraktie. Die fliegt durch die Decke.
Reich werden. Wieso, wieviele Stücke hast du denn ?
Hast du vielleicht auch eine Seite mit Realtime von Unigene?

[BrauchGeld]

Hi

Das neue Jahr fängt gleich mit neuem ATH an so kanns weiter gehen.


@Kaleidoscape

Das war eigentlich auf mein gesamtes Depot bezogen.Von Unigene hab ich lediglich 3000St.zu 1,05$ ist immerhin auch risikoreich.

Gruss
B.M.

[Kaleidoscape]

Bei 1,05 $ gekauft. Respekt. Wie bist du damals darauf gekommen? Was hastn sonst noch für Werte ?

[torcidaa]

jungs, nur cool bleiben, falls alles so wird wie ich mir das erhoffe, ist dies nur ein mickriger anfang.

trotz allem gibt`s halt immer noch die wenn und aber, vor allem sollte das verdammte fda endlich kommen.

[Kaleidoscape]

Was war das denn? Korrektur oder steckt mehr dahinter?

[BrauchGeld]

Hi

5-Jan-2005

Sale of Equity



ITEM 3.02. UNREGISTERED SALES OF EQUITY SECURITIES.
On December 29 and 30, 2004, Unigene sold 1,302,140 shares of common stock to Fusion Capital Fund II, LLC for gross proceeds of $2,500,002. All of such shares were issued by Unigene without registration in reliance on an exemption under
Section 4(2) of the Securities Act of 1933, because the offer and sale was made to a limited number of investors in a private transaction

@Kaleidoscape

Ich bin dank torcidaa in "Drugs To Watch" thread darauf aufmerksam geworden .
Ich hab u.a. noch Ym bioscience,Insmed,Biosyntech,Depomed und Prana.

Gruss
B.M.

[BrauchGeld]

hi

Unigene ist 2.grösste Position im Dac Biotech Fond:

http://www.finanzpartner.de/fi/LU0108117754/

Gruss
B.M.

[BrauchGeld]

Hi

Muss mich korrigieren Unigene ist nun Top-Position stand 03.02.2005 :

http://www.fondsweb.de/fonds/profil.php?ID=1820

Gruss
B.M.

[BrauchGeld]

Hi

Komischerweise steht hier das die Zulassung schon am 5.1.2005 hätte sein müssen.Also ist wohl damit zurechnen das es von heut auf morgen passieren kann hoffe ich zumindest.

http://www.medco.com/art/corporate/drugs_nda_pipeline_032604…

Viel glück an alle investierten.

Gruss
B.M.

[Kaleidoscape]

Wann kommen eigentlich die Zahlen ?

[torcidaa]

nächste woche ist wieder ein artikel über ugne im "aktionär", das könnte dem stock wieder ein wenig helfen, wie es vor ein paar monaten der fall war.

ansonsten erwarte ich auch täglich das approval!

[BrauchGeld]

Hi

Unigene Appoints Marvin L. Miller, Senior Pharmaceutical Executive, to Board of Directors
Friday February 11, 8:30 am ET


FAIRFIELD, N.J.--(BUSINESS WIRE)--Feb. 11, 2005--Unigene Laboratories, Inc. (OTCBB:UGNE - News) appointed Marvin L. Miller to its Board of Directors yesterday.
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Mr. Miller`s extensive healthcare background includes former senior management positions at Nextran, an affiliate of Baxter Healthcare Corporation, American Cyanamid, Johnson & Johnson and Hoffmann-La Roche. He currently serves as Executive Chairman of Onconova Therapeutics Inc. as well as a director of GTC Biotherapeutics Inc. and Tepnel Life Sciences PLC. Mr. Miller will serve on Unigene`s Audit and Compensation committees.

"With broad experience in managing biotechnology, pharmaceutical, diagnostic, laboratory service and instrumentation enterprises, and a strong focus in marketing and licensing, Marvin will provide a valuable perspective to management," commented Dr. Warren P. Levy, President and CEO of Unigene. "We believe that his skills will be especially useful given our anticipated approval and launch of our first U.S. product, Fortical®, and our licensing opportunities for the manufacture and oral delivery of peptide therapeutics."

Gruss
B.M.


Ps: Die Quartalszahlen müssten nächste Wochse rauskommen.

[BrauchGeld]

Wann kommt endlich die zulassung werde noch wahnsinnig.

Unigene Announces Results for 2004
Thursday March 31, 9:20 am ET


FAIRFIELD, N.J.--(BUSINESS WIRE)--March 31, 2005--Unigene Laboratories, Inc. (OTCBB: UGNE - News) announced its financial results for the year ended December 31, 2004.
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Revenue for the year ended December 31, 2004 was $8,400,000 compared to $6,024,000 for the year ended December 31, 2003. Unigene`s net loss for the year ended December 31, 2004 was $5,941,000 or ($.08) per share compared to a net loss of $7,398,000 or ($.11) per share for the year ended December 31, 2003.

"We are encouraged by our improved financial results last year and are very confident about our prospects for 2005," commented Dr. Warren Levy, President and CEO of Unigene. "We have filed all information and data requested to date by the FDA for Fortical®, our nasal calcitonin product, and are currently awaiting approval. Upsher-Smith and Unigene are enthusiastic about the prospect of rapidly launching Fortical following approval and are continuing in earnest our preparations for its launch. Furthermore, our partnerships with GlaxoSmithKline for oral PTH and with Novartis for calcitonin manufacturing continue to make important progress."

[BrauchGeld]

Die lassen sich aber ziemlich viel zeit mit der Zulassung jetzt schon über 2 jahre.

Unigene Completes $3 Million Private Placement with Fusion Capital Unigene Terminates Fusion Common Stock Purchase Agreement
Wednesday April 13, 5:03 pm ET


FAIRFIELD, N.J.--(BUSINESS WIRE)--April 13, 2005--Unigene Laboratories, Inc. (OTCBB: UGNE - News) announced that it has completed a $3 million private placement with Fusion Capital Fund II, LLC ("Fusion"). In conjunction with the private placement, Unigene has elected to terminate its common stock purchase agreement with Fusion, dated October 9, 2003, as amended.
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Under the private placement, Unigene sold 2,123,142 shares of common stock and a five-year common stock purchase warrant to purchase up to 1,061,571 shares of common stock at an exercise price of $1.77 per share to Fusion. The common stock and warrant shares are not registered for sale and Unigene will file a registration statement covering the sale of the purchase shares and the warrant shares. A description of this transaction is provided in our Form 8-K filed on April 13, 2005.

"Fusion Capital, a long-standing investor in the company, has provided significant and timely financial support to Unigene in the past and we are pleased that they have decided to increase their ownership in Unigene," commented Dr. Warren P. Levy, President and CEO of Unigene. "We believe that our future financial requirements primarily will be met through sales of our nasal calcitonin product, which is currently awaiting approval by the FDA, and milestones from agreements with pharmaceutical partners, including GlaxoSmithKline, Novartis and Upsher-Smith."

[BrauchGeld]

Hi

Die haben ihre position in Unigene erhöht.


http://www.hauck-aufhaeuser.lu/haig/pdf/fonds/fctsht_LU01081…

[rk091161]

hallo,ich fange mal wieder an über unigene zu diskutieren.hat jemand eine ahnung ,warum der anstieg heute da ist?zulassung bei durch die FDA?mfg...

[BrauchGeld]

Na endlich Unigene hat die Zulassung bekommen.

FDA Approves Fortical, Unigene`s Nasal Calcitonin Product for Postmenopausal Osteoporosis
Monday August 15, 7:00 am ET
Unigene to Receive $4 Million Milestone Payment from Upsher-Smith


FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 15, 2005--Unigene Laboratories, Inc. (OTCBB:UGNE - News) has received approval from the U.S. Food and Drug Administration ("FDA") for Fortical® calcitonin-salmon (rDNA origin) Nasal Spray, its patented nasal calcitonin product for the treatment of postmenopausal osteoporosis. FDA approval triggers the final milestone payment of $4 million under Unigene`s exclusive U.S. licensing agreement with Upsher-Smith Laboratories, Inc.
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Fortical® will be manufactured at Unigene`s production facility in Boonton, New Jersey. The final product will be packaged, marketed and sold in the United States by Upsher-Smith. Unigene will sell the filled product to Upsher-Smith and receive royalties on Upsher-Smith`s sales.

"We are understandably excited to receive FDA approval for our first pharmaceutical product in the U.S.," commented Dr. Warren Levy, President and CEO of Unigene. "This is a pivotal accomplishment for any company in our industry and it will provide the rapidly growing population of postmenopausal osteoporosis sufferers with an additional option for managing the disease. We are confident that Upsher-Smith`s enthusiasm and commitment to the product will give us the best opportunity to realize Fortical®`s potential. We expect that the revenues generated from sales of Fortical® will allow us to strengthen our financial position and expand our activities into new applications of our patented peptide manufacturing and oral delivery technologies."

"We are thrilled that the FDA has approved Unigene`s Fortical® as an important therapy for the osteoporosis market, which in 2004 grew nearly 18% to reach $4 billion," said Mark Evenstad, Upsher-Smith President and Vice Chair. "We look forward to engaging our marketing and distribution expertise to help make this important calcitonin product available to the millions of Americans affected by osteoporosis."

Fortical® Indication

Fortical® is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women.

[BrauchGeld]

Ich sehe in naher zukunft eine verdoppelung mindestens.
Unigene ist eine riesenchance.

Strong Buy

[BrauchGeld]

Ich sehe in naher Zukunft eine Verdoppelung mindestens stroooooooooooong Buuuuuuuuuuyyyyyy

[BrauchGeld]

Hab gar nicht gemerkt das ich zweimal dasselbe gepostet habe.sorry

Ich denke das bald die ersten Empfehlungen kommen dann gehts ab.


Pipeline:
http://www.unigene.com/products/index.html

[BrauchGeld]

Hallo

Ab sofort klingelt die Kasse bei Unigene.

Upsher-Smith launches NEW Fortical(R) Nasal Spray for postmenopausal osteoporosis
Tuesday August 16, 8:30 am ET


MINNEAPOLIS--(BUSINESS WIRE)--Aug. 16, 2005--Upsher-Smith Laboratories, Inc. announces the launch of new Fortical® calcitonin- salmon (rDNA origin) Nasal Spray, an effective treatment option for postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women. Upsher-Smith commercializes the product today with shipments to the retail and wholesale trade, and will begin aggressively promoting to physicians through sales force detailing, national conventions, professional advertising and other promotion. Fortical® was developed, and will be manufactured for Upsher-Smith by Unigene Laboratories, Inc. (OTCBB: UGNE - News). Unigene announced FDA approval of Fortical® on August 15, 2005.


"Fortical® presents an exciting new option for women with postmenopausal osteoporosis," says Phill Dritsas, Vice President, Marketing and Sales for Upsher-Smith. "Fortical® represents a pharmaceutically equivalent nasal calcitonin-salmon that provides a significant cost savings compared to the existing therapy. Further, Fortical® allows Upsher-Smith the opportunity to capitalize on our unique ability to offer an economical alternative and support physicians, retailers and managed care. Fortical® will conveniently fit into a woman`s normal routine and can be taken before, during, or even after meals. The convenience of Fortical® may be just what many patients need to help diminish progressive osteoporotic bone loss."

New Fortical® Nasal Spray contains the active ingredient calcitonin-salmon. Calcitonin-salmon has been proven to produce statistically significant increases in lumbar vertebral bone mineral density (BMD) at just 6 months compared to placebo, with persistence at this level for up to 2 years of observation.(1) Calcitonin-salmon has also been shown to increase hip BMD, at 12 months compared to placebo(1).

Mark Evenstad, Vice Chairman and President, reflects on the company`s pledge to market effective products to meet the ever-changing needs of both physicians and patients. "We continually strive to ensure the highest quality of our products. Fortical® is manufactured with a unique, patented recombinant DNA technology and safely treats postmenopausal osteoporosis with no reported serious drug-related gastrointestinal or esophageal adverse events."(1)

"We are impressed that Upsher-Smith has launched Fortical® so rapidly following FDA approval," commented Dr. Warren P. Levy, President and CEO of Unigene. "Upsher-Smith`s commitment to Fortical® is clear and we are enthusiastic about the product`s commercial prospects."

New Fortical® Nasal Spray is available now, with a prescription, and is recommended in conjunction with adequate intake of calcium and vitamin D. Periodic nasal examinations are recommended; if nasal ulceration occurs, discontinue treatment until healed. Because calcitonin-salmon is a protein, the possibility of systemic allergic reaction exists. For more information and complete product information/most common adverse events for Fortical® Nasal Spray, visit www.upsher-smith.com or call 1-800-654-2299.

[toothstone]

Aus ihub:


The current price around 2.50 does not nearly reflect the fair value at this stage of the co`s development. While approval of nasal calcitonin legitamizes the technology, it also permits all other events to possibly come to fruition. Cash flow will permit the company to continue R&D as well as starting up China sales. The $3.00 level will start a snowball effect as the company can then be listed on a more liquid exchange and not be subject to the vagaries of market maker manipuation. If you own enogh Mr. nitetrak you will be very wealthy soon.If you don`t, I encourage you to buy more at these levels sinc it won`t be here for long. Anyone of three ot for possible events should cause the price to move t the $4-5 level in a Vioxx heartbeat.

Daran kann ich mich nur anschließen.

[toothstone]

UGNE hat noch ein Riesenpotential:

Zulassung in Europa und China
Calcitoninmedikamentzulassung
Sandoz, Novartis und GSK
daran verknüpfter Börsenwechsel (Amex oder Nasdaq smallcap)

also ich bin long.

[toothstone]

NVS royalty stream will be serious news once it is used for commercial purposes.

Unigene and Novartis Complete Technology Transfer For Calcitonin Manufacturing
Monday August 22, 7:00 am ET
Sandoz Successfully Concludes First Full-Scale Production Campaign


FAIRFIELD, N.J.--(BUSINESS WIRE)--Aug. 22, 2005--The transfer of Unigene Laboratories, Inc. (OTCBB: UGNE - News) proprietary manufacturing technology to Novartis for manufacturing calcitonin has been completed successfully.


Sandoz, a Novartis affiliate, has concluded a manufacturing campaign based on Unigene`s process and produced multiple kilograms of calcitonin at a scale that represents a ten-fold increase above Unigene`s current production capacity. Calcitonin produced by Sandoz is projected to be used by Novartis in future studies including clinical trials.

According to the terms of the agreement between Unigene and Novartis signed in 2004, Novartis was granted an exclusive worldwide license to produce recombinant calcitonin using Unigene`s patented process for manufacturing recombinant peptides. Under that agreement, Unigene has received $8.2 million to date and is eligible to receive up to $10.5 million in milestones in addition to royalties on sales of any current or future Novartis products that will contain calcitonin made using Unigene`s process.

"The rapid implementation of our process in Sandoz`s large-scale facilities was made possible because of the efficient and productive collaboration between Sandoz and Unigene scientists coupled with the extensive recombinant manufacturing experience of Sandoz," commented Dr. Warren P. Levy, President and CEO of Unigene. "We believe that the Sandoz facility should be capable of supporting the future requirements of Novartis and Unigene for calcitonin."

[BrauchGeld]

Hallo

Unigene erreicht neues ATH ,könnte eventuell heute schon die 3$ knacken.

http://finance.yahoo.com/q?s=ugne.ob

[BrauchGeld]

Hallo

Unigene ist immer noch topposition im Dac Biotechfond.
Ich sehe kurse zwischen 5-7$ für dieses Jahr.


Top Ten (31.07.2005)
Name Anteil
1. Unigene Laboratories Inc. 9,48%
2. Biophan Technologies Inc. 7,20%
3. Acacia Research - CombiMatrix 5,97%
4. Macrogen Inc. 5,92%
5. Sosei Co. Ltd. 5,77%
6. Protherics Plc 5,14%
7. Vical Inc. 4,91%
8. Bio-Treat Technology Ltd. 4,25%
9. Medigene AG 3,65%
10. Ligand Pharmaceuticals-CL B 3,61%

[BrauchGeld]

Hallo



http://www.deraktionaer.de/xist4c/web/Unigene---Endlich-_id_…

Unigene - Endlich!
Unigene hat die lang ersehnte Zulassung für sein erstes Medikament erhalten. Jetzt stehen die Zeichen auf Wachstum. Langfristig orientierte Anleger können den aktuellen Rücksetzer zum Einstieg nutzen.

Von Frank Phillipps

So mancher Anleger mag schon gar nicht mehr daran geglaubt haben, doch nach mehrjähriger Wartezeit hat die kleine US-Biotech-Firma Unigene endlich die Zulassung für ihr Medikament Fortical erhalten. Die Geduld der Aktionäre wurde dabei vor allem durch die zögerliche Haltung der US-Gesundheitsbehörde FDA auf die Probe gestellt (siehe Kasten). Bereits wenige Tage nach der Zulassung hat die Auslieferung des Osteoporose-Mittels durch Unigene-Partner Upsher-Smith begonnen.

Upsher-Smith wird das Präparat in den USA vermarkten, Unigene wird an den Verkaufserlösen beteiligt. Vorab erhält Unigene eine Zahlung in Höhe von vier Millionen Dollar.


Meilenstein

Für Unigene ist die Zulassung von Fortical, das anders als Konkurrenzpräparate als Spray über die Nasenschleimhäute verabreicht werden kann, in jeder Hinsicht ein Meilenstein in der Firmengeschichte. Zum einen hat die Firma aus Fairfield in New Jersey damit bewiesen, dass sie in der Lage ist, ein Präparat bis zur Marktreife zu entwickeln. Zum anderen katapultiert der Fortical-Clou Unigene in neue Umsatzdimensionen: Schätzungen von US-Analysten gehen davon aus, dass das Unternehmen bereits im kommenden Jahr Umsätze von fast 40 Millionen Dollar erzielen wird - das entspräche einer Steigerung um mehr als 376 Prozent im Vergleich zum Jahresumsatz 2004.

Solche Wachstumsraten könnten in der näheren Zukunft eher die Regel als die Ausnahme sein. Denn auch in China, dem weltweit wachstumsstärksten Markt für Osteoporose-Mittel, wartet Unigene auf die Zulassung von Fortical und ist dort durch seine Partnerschaft mit Shijiazhuang Pharmaceutical hervorragend positioniert.

Rallye geht weiter

Auch nach dem jüngsten Kurssprung sollte die Rallye bei der Unigene-Aktie noch lange nicht gelaufen sein. In den kommenden Wochen und Monaten werden weitere Meldungen - zum Beispiel ein Update über die 150-Millionen-Dollar-Kooperation mit dem Pharmakonzern GlaxoSmithKline - erwartet. Das Unigene-Papier dürfte zukünftig auch stärker in den Fokus von US-Fonds und europäischen Investoren geraten - eine gute Voraussetzung für weitere Kurssteigerungen.

[BrauchGeld]

Unigene kassiert 4 Mio$ !


Unigene Receives $4 Million Milestone Payment for Fortical(R) Approval
Wednesday September 14, 8:30 am ET
Product Rollout on Target


FAIRFIELD, N.J.--(BUSINESS WIRE)--Sept. 14, 2005--Unigene Laboratories, Inc. (OTCBB:UGNE - News) has received a $4 million milestone payment from Upsher-Smith Laboratories, Inc. for receiving FDA approval for Fortical®, its nasal calcitonin product for the treatment of postmenopausal osteoporosis. This is the final milestone payment in Unigene`s exclusive U.S. licensing agreement with Upsher-Smith. Fortical, Unigene`s first U.S. product, was approved and launched last month and is currently available by prescription at retail pharmacies nationwide.

"The expected steady stream of revenue, from both product sales to Upsher-Smith as well as royalties, should greatly improve our cash flow," commented Dr. Warren Levy, President and CEO of Unigene. "We are working closely with Upsher-Smith to support their commercialization activities and continue to be impressed with their commitment to Fortical."

"Upsher-Smith is excited with the significant uptake Fortical has enjoyed since launch," says Phill Dritsas, Vice President, Marketing and Sales for Upsher-Smith. "Our customers are excited to be able to offer a low-cost, branded alternative in the osteoporosis market."

"The final milestone payment signifies what we hope to be the beginning of a long and profitable relationship for both Upsher-Smith and Unigene Laboratories," says Mark Evenstad, Vice Chairman and President of Upsher-Smith Laboratories, Inc.

[toothstone]

Und schon sind wir wieder auf 2,8$.
MO und Di sind zu Börsenbeginn einige hohe Stücke gefloge, deshalb kam der Kurs unter Druck, aber jetzt gefallt sie mir wieder super.

[BrauchGeld]

Unigene and Yale University Invent Technologies to Build New Bone
Monday September 19, 8:30 am ET


FAIRFIELD, N.J.--(BUSINESS WIRE)--Sept. 19, 2005--Unigene Laboratories, Inc. (OTCBB:UGNE - News) and Yale University have executed agreements to enable Unigene to acquire exclusive rights to their jointly-owned inventions for procedures that may provide physicians with new methodologies for treating and preventing fractures more effectively. Patent applications have been filed for two inventions.

The first invention is designed to facilitate and accelerate bone growth in precisely targeted locations in the body using a simple surgical procedure that can be performed with minimal intervention on an outpatient basis in combination with one or more therapeutic compounds. The second invention covers unique devices that could be used to facilitate bone repair or to create novel prostheses. Both inventions were conceived in collaboration with Dr. Agnes Vignery, Associate Professor of Orthopaedic Surgery at Yale School of Medicine.

Unigene is currently sponsoring developmental research activities at the University and is assembling an internationally distinguished group of orthopedic surgeons with whom it will evaluate the technologies in animal and human studies.

"The Unigene/Yale techniques have the potential to provide a dramatic new treatment for these problems," commented Dr. Donlin M. Long, M.D., Ph.D., Distinguished Service Professor of Neurosurgery at the Johns Hopkins University School of Medicine. "The ability to facilitate bone growth is of great practical importance for the treatment of spinal fractures, especially in the elderly. Compression fractures are common and can be very painful. Growing new bone with this invention offers potential relief for the large number of patients who cannot be helped by any treatment now in use. Improved bone healing can improve outcomes from many spinal surgeries and can reduce the incidence of pain and prolonged disability."

"These technologies further enhance our corporate profile in the field of bone-related therapies," said Dr. Ronald S. Levy, Executive Vice President of Unigene. "Both the physicians and the pharma industry representatives with whom we discussed this have confirmed the extensive potential of these inventions. They could have a major impact on the way in which serious bone fractures are treated."

[toothstone]

Wieder einmal eine super positive Überraschung.
Unigene ist sicher eine der bestaufgestellten Biotechfirmen
überhaupt.
Als nächstes sollte ein Glaxo-Smith-Update kommen.
Und ganz wichtig noch die Chinazulasung von Fortical in diesem Jahr. Der Kurs würde höher stehen, wenn nicht ein paar große Blöcke ins ask reingestellt worden wären. Vielleicht aber auch nur Mm-Spielchen, die wissen was kommt. Oder aber einige, die schon 1000% haben und Geld brauchen. Ich denke´, daß die Umschichtung in feste Hände abgeschloßen ist.
Am Donnerstag Ubs-Konferenz und im Oktober steht auch noch einiges an.
Von Calcitonin und anderen Überaschungen möchte ich gar nicht sprechen.

[torcidaa]

yes, jetzt gehn wir ab

[torcidaa]

Antwort auf Beitrag Nr.: 17.961.142 von toothstone am 20.09.05 09:04:36

hab so das dumpfe gefühl als würden wir nach oben ausbrechen in den nächsten paar wochen

[toothstone]

Mialcalcin in Usa -10%.
Hätte mir etwas mehr erwartet, aber mal schauen was die ammis dazu sagen.Jedes Quartal 10% weg , reicht aber eigentlich auch.
Freitag abend ging es ja noch ganz schön zur sache.
Aber eher wohl noch wegen fossamax, wird spannend heute.