SciClone - gegen Aids und HepathitisB - neuer Riesenerfolg! - 500 Beiträge pro Seite

[TaiPanInvest]

Als kleine Depotbeimischung empfehle ich Euch SCLN,aber lest bitte selber,sehe Riesenpotential!Hier geht einiges!!!

Nach Bekanntgabe über die Zulassung von Zadaxin(R) auf den Philippinen v.2 Tagen bringt Sciclone gestern die 2. positive Nachricht: siehe unten!!!

SciClone ist ein reinrassiger Medikamenten-Entwickler, der an der NASDAQ gerade mal zu einem Unternehmenswert von 300 Mio. US-$ gehandelt wird und bereits für ein Medikament die Zulassung in verschiedenen Staaten, einschließlich Italien und China erhalten hat.
Strategie: Der Biotech-Mini von der amerikanischen Westküste verfolgt eine interessante Strategie. Während viele Medikamentenentwickler sich auf die Märkte in den USA, Japan und Europa fokussiert haben, betritt SciClone, mit den Märkten vieler bevölkerungsreicher Entwicklungsländern, Schlachtfelder, die von den meisten anderen Unternehmen nur "nebenbei" bedient werden. SciClone unterhält, neben dem Hauptbüro in den USA, Standpunkte in Peking, Hong Kong, Shanghai, Singapur, aber auch London. Die Strategie der ambitionierten Amerikaner wird einem schnell klar, wenn man sich mit der Vermarktung des Präparates ZADAXIN auseinandersetzt.

Pipeline: ZADAXIN ist ein Medikament, dass grundsätzlich nur das Immunsystem stärken kann, indem es den Körper bei der Herstellung der sogenannten T-Helferzellen unterstützt, was sich natürlich auf den ersten Blick eher langweilig anhört. Die Story zu ZADAXIN ist aber alles andere als langweilig. Der Einsatz des Präparates zeigte bei Hepatitiserkrankten (B und C) teils lebensrettende Hilfe. Da das Medikament das Immunsystem eines Menschen stabilisieren kann, führt SciClone nun Studien für den US-Markt durch, die den Einsatz des Präparates gegen Haut- und Leberkrebs und auch gegen Aids überprüfen. Insgesamt wird das Präparat für den US-Markt in 7 Indikationen getestet. Für 4 dieser Indikationen steht man bereits in Phase 3 (also in der letzten Phase) der klinischen Entwicklungsreihe. Das Hauptaugenmerk liegt auch hier auf Hepatitiserkrankungen

Wichtig ist hierbei zu wissen, daß das Präparat ZADAXIN, weder die Symptome, noch die Ursache der Erkrankungen behandeln kann. ZADAXIN stabilisiert den Patienten so, daß weitere Infektionen deutlich geringere Chancen für eine Ausbreitung finden. Wie bedeutend dies ist, zeigt das Beispiel AIDS. So ist der HIV-Virus bei AIDS-Patienten nie die Todesursache, da es nicht töten kann. Todesgrund ist immer eine Infektion, oft z. B. eine Lungenentzündung, die durch HIV-Virus massiv begünstigt wird.

Doch ZADAXIN ist bereits jetzt eine kleine Erfolgsstory, ohne in den USA überhaupt eine Zulassung zu besitzen. Aktuell wird das Medikament also, wie oben schon genannt, bei den Erkrankungen Hepatitis B und Hepatitis C begleitend eingesetzt. Vorsichtigen Schätzungen zu Folge, dürfte es weltweit etwa 500 Mio. Menschen geben, die an einer dieser beiden Krankheiten erkrankt sind. Die meisten von Ihnen leben in den Entwicklungsländern, genau dort, wo ZADAXIN bereits vermarktet wird. ZADAXIN ist aktuell in 20 Ländern zugelassen, darunter in China (!), Argentinien und Süd Korea. Das ZADAXIN vermutlich auch den sehr hohen japanischen, europäischen und nordamerikanischen Zulassungsanforderungen genügen wird, zeigen bereits jetzt die Zulassungen in Italien, Kuwait und allen voran in Singapur an, dass über einen der höchsten medizinischen Standards der Welt verfügt. Die Zulassung von ZADAXIN wurde in weiteren 17 Ländern beantragt. Unter Ihnen sind nicht nur die bevölkerungsreichen Länder Brasilien, Indien, Indonesien und Türkei, sondern mit Neuseeland und Hong Kong auch zwei weitere Länder, die westlichen Standards in Ihrer medizinischen Versorgung in jedem Fall entsprechen. In weiteren 8 Ländern soll noch dieses Jahr die Beantragung gestellt werden. Im 1. Halbjahr 2000 konnten mit dem Medikament 7,7 Mio. US-$ umgesetzt werden. Im 1. Halbjahr 1999 waren 3,6 Mio. US-$ und im 1. Halbjahr 1998 sogar nur 1,4 Mio. US-$ umgesetzt worden. Für das Gesamtjahr rechne ich mit einem Mindestumsatz von 18,5 Mio. US-$ für das Medikament. Für 2001 belaufen sich die Mindesterwartungen auf einen Umsatz von etwa 30 Mio. US-$. Für den Vermarktungsbeginn von ZADAXIN in den USA ist dann mit einem weiteren Umsatzschub zu rechnen. In den USA wurde ZADAXIN nämlich der "Orphan Drug Status" zur Behandlung von einer bestimmten Form von Leberkrebs verliehen. Die FDA vergibt diesen Status für Krankheitsindikationen, mit einem relativ geringen Patientenpotential, um Unternehmen zu motivieren für diese Krankheiten Medikamente zu entwickeln. ZADAXIN erhält hierdurch spezielle Steuervorteile, ein auf 7 Jahre laufendes, exklusives Vermarktungsrecht für die spezielle Krankheitsindikation und besondere Unterstützungen durch die FDA.
Der ganz große Renner des Unternehmens steckt aber noch im Übergang von Phase 2 zu Phase 3 der klinischen Testreihen. CPX heißt das Medikament, das die sogenannte "zystische Fibrose" bekämpfen können soll. SciClone wird bei der Entwicklung des Präparates neben einer Stiftung für an dieser Krankheit leidende Patienten, auch von dem "National Institute of Health", von dem SciClone im April 1996 die Weiterentwicklung des Medikamentes gekauft hat, und sogar der FDA (die Behörde, die für Medikamentenzulassungen in den USA zuständig ist) unterstützte die Entwicklung von CPX mit 200.000 US-$.

Das Ziel von CPX ist eine sehr tragischste Krankheit. Es handelt sich hierbei um die "zystische Fibrose", ein genetischer Defekt, der zu einer stark verkürzten Lebenserwartung führt, so dass die meisten Erkrankten vor dem Erreichen des 30. Lebensjahres sterben. Ist gibt derzeit kein Mittel, das die Ursache dieser Krankheit bekämpfen kann, sondern es werden nur die Symptome bekämpft. Das bekannteste Medikament dieser Art ist Pulmozyme von Genentech. Nach vorsichtigen Schätzungen kostet selbst die Behandlung der Symptome eines Patienten mindestens 30.000 US-$ jährlich. Weltweit dürfte es etwa 70000 Opfer dieser seltenen Krankheit geben, 30.000 davon allein in den USA und 1.000 Fälle kommen alleine dort jedes Jahr hinzu. SciClone rechnet mit einem Marktvolumen für Europa und die USA von insgesamt gut 600 Mio. US-$.

Bereits jetzt hat SciClone mit der Entwicklung des Nachfolgers begonnen, das Medikament, das noch in der vorklinischen Testphase ist, wird den Namen DAX tragen. Doch die Pipeline wurde bei SciClone noch weiter verstärkt. Hinter dem Kürzel SCV-07, einer Entwicklung der University of California, verbirgt sich ein Mittel, das später einmal gegen resistente Tuberkulose, Hepatitis und Formen des Krebs eingesetzt werden soll. Ende Februar erhielt SciClone für die Entwicklung von SCV-07 ein Sponsoring von 300.000 US-$, das die Kosten für die vorklinischen Forschungen und Tests abdecken soll. Diese zukünftigen Medikamente befinden sich alle noch in der vorklinischen Phase.
Finazielles: Im 1. Halbjahr 2000 schrieb SciClone einen Verlust von noch 1,46 Mio. US-$. 875.000 US-$ entfielen hiervon auf das erste Quartal des Jahres, nur noch 589.000 waren es im zweiten Quartal. Die Cashreserve beträgt etwa 18 Mio. US-$ .

SciClone Pharmaceuticals announced that the
U.S. Patent and Trademark Office has issued a Notice of Allowance for use of the Company`s lead drug, ZADAXIN® plus
lamivudine and famciclovir for the treatment of hepatitis B.
(Kopie moonlight)

[SpezialInvestor]

Bin investiert,Riesenchance!
Haben 4 X Strong buy bekommen.
Nichts negatives.Kurziel 20 Dollar!

[TaiPanInvest]

SCiClone WPKNR.886644 am besten in den USA handeln oder
hier nur mit Limit.Volatiles Papier,aber mit Pfeffer.
20-30 % sind schnell erorbert. Gehen die Bios wieder hoch,
ist das Papier mit der Insider-Renner.

[maria1963]

Kann mir jemand das US-Kürzel füe diese Aktie geben?

Danke.

[Geonimo]

hallo Maria,

Kürzel ist SCLN

Wenn Du Deinen Tagescheck machst, mußt Du gewappnet
sein.SCLN wird bei einem gutem Biotech-Markt und wieder
überraschenden News einfach explodieren.Bin mir sicher.
Die haben wirklich nur Strong buys,keiner kennt die Boys
aus dem süßen Californien.


Gruß Geonimo

[Geonimo]

Ich wußte es,

unser Baby macht heute 5%,

Da kommt doch keiner dran vorbei!

Leiht mir mal einer mal für 6 Monate 500.000 DM!

Nix Neuer Markt und scheiß EM-TV

Rein in SciClone!!!!!!und fünffach Auzzahlung

Ende 2001 !Was soll ich sonst noch predigen!!!!!!!

[TaiPanInvest]

SciClone Pharmaceuticals Reports Second Quarter Results
THURSDAY, AUGUST 02, 2001 6:30 AM
- PRNewswire

SAN MATEO, Calif., Aug 2, 2001 /PRNewswire via COMTEX/ -- SciClone Pharmaceuticals (Nasdaq:SCLN), today reported that total revenues for the quarter ended June 30, 2001 from sales of ZADAXIN(R), the Company`s immune system enhancer, were $3,250,000 compared to $4,206,000 for the same quarter last year. Net loss for the quarter was $2,219,000, or $0.07 per share, compared to a net loss of $589,000, or $0.02 per share, for the same quarter of 2000.

"We are taking advantage of the opportunities presented by the U.S. phase 3 hepatitis C program, our ZADAXIN cancer programs, the European and Japanese ZADAXIN programs as well as the CPX clinical program," said Richard A. Waldron, SciClone`s Chief Financial Officer. "We expect patient enrollment and research and development expenses for our U.S. and international clinical programs to accelerate over the next several quarters, while anticipating quarter-to-quarter sales growth for the remainder of 2001. We are managing the cash flow derived from our international sales to help fund these clinical programs.

SciClone`s cash and short-term investments totaled $20,202,000 at June 30, 2001. Net cash used in operating activities for the quarter was $1,152,000.

The decrease in total revenue for the second quarter of 2001 compared to the same quarter last year was primarily due to greater sales last year to certain countries using ZADAXIN on a pre-approval named patient basis and to increased competition from other hepatitis B therapies.

We have initiated a phase 3 clinical program in the U.S. for the treatment of hepatitis C using ZADAXIN as part of a combination therapy with Pegasys(R), pegylated interferon alfa-2a, a proprietary product of F. Hoffmann-La Roche Ltd. In addition, ZADAXIN is in two phase 2 clinical trials in the U.S. for the treatment of liver cancer and in a phase 2 clinical program in combination with lamivudine for the treatment of hepatitis B. A ZADAXIN phase 3 clinical program for European marketing registration currently is being planned for one or more indications that complement the Company`s U.S. clinical program. ZADAXIN is also in clinical trials in Japan and in Australia.

ZADAXIN is a synthetic preparation of thymosin alpha 1, a peptide that occurs naturally in humans and is an immune system enhancer ("ISE") that helps stimulate, maintain and direct the body`s antiviral or anticancer responses. ZADAXIN has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases and to many thousands of patients commercially around the world with virtually no serious drug related adverse events or toxicities. ZADAXIN is approved for sale in 24 countries, principally for the treatment of hepatitis B and hepatitis C, and also in certain countries as a vaccine adjuvant for patients with weakened immune systems and as an adjuvant to chemotherapy for the treatment of various cancers.

SECOND QUARTER 2001 HIGHLIGHTS

-- ZADAXIN`s critical biological role in treating chronic hepatitis C as
part of a combination therapy with alpha interferon was supported in a
study published in the Journal of Viral Hepatitis. The study results
demonstrate that ZADAXIN increases the production of specific cytokines
that fight viral infection while at the same time decreasing the
production of other cytokines that make hepatitis C viral infection
more impervious to the body`s immune response.
-- ZADAXIN used in combination therapy with alpha interferon showed
significantly greater sustained response rates in difficult-to-treat
chronic hepatitis B patients compared to treatment with alpha
interferon alone. This study was presented in a poster session at the
American Association for the Study of Liver Disease (AASLD) session at
the Digestive Disease Week (DDW) meeting.
-- We initiated our U.S. phase 2 liver cancer trial using ZADAXIN plus
transarterial chemoembolization (TACE). This complements our U.S. phase
2 liver cancer trial using ZADAXIN plus radio frequency ablation (RFA)
initiated earlier this year.
-- U.S. Patent and Trademark Office allowed SciClone a U.S. patent for
analogs of ZADAXIN. The new patent will give SciClone exclusive
"composition of matter" rights to several families of ZADAXIN analogs
the Company has determined could have proprietary therapeutic or
biologic distinctions from its current "natural synthetic" formulation,
such as length of circulation in the blood or alternative delivery
techniques.
-- ZADAXIN was approved in Mexico for treatment of hepatitis C and
hepatitis B. ZADAXIN had previously been approved in Mexico as
influenza vaccine adjuvant.
-- CPX was granted Orphan Drug Status throughout the European Union for
cystic fibrosis.
-- We presented at four investment conferences: the UBS Warburg Global
Specialty Pharmaceuticals Conference (New York); the Fourth Annual H.C.
Wainwright & Co. Select Stock Conference (New York); the 6th Biotech
& Partnering Conference (Milan, Italy); and the RedChip.com Investor
Conference (Portland).

SciClone Pharmaceuticals is a global specialty pharmaceutical company that develops and commercializes novel medicines for treating a broad range of the world`s most serious diseases. The Company has focused its current product development and commercialization activities on hepatitis C, cancer, hepatitis B, drug-resistant tuberculosis and cystic fibrosis. Press releases and corporate information from SciClone Pharmaceuticals are available on the Internet at www.sciclone.com or by calling the Company`s Investor Relations Department at 800-724-2566. SciClone`s Common Stock is listed on The Nasdaq National Market(R) under the symbol SCLN.

The information in this press release includes certain forward-looking statements concerning the Company`s current expectations regarding the planning for clinical trials in Europe and future events including the Company`s expectations regarding trends in cash flow and expenses and plans and expectations regarding clinical trials and statements using the words "expects," "believes," "anticipates" or similar words. These statements include statements regarding the ongoing and prospective development, clinical trials and commercialization of ZADAXIN immunotherapy for hepatitis C, cancer, and hepatitis B. Actual events could differ materially from those projected herein, due to risks and uncertainties including market factors, competitive product introductions, the nature of product development, the progress or failure of clinical trials and the regulatory approval process. Additional risks and uncertainties include those reflected in the Company`s filings with the Securities and Exchange Commission, particularly the Company`s Annual Report on Form 10-K for the year ended December 31, 2000.

SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Three Months Three Months Six Months Six Months
Ended Ended Ended Ended
June 30, June 30, June 30, June 30,
2001 2000 2001 2000

Product revenue $3,250,000 $4,206,000 $6,363,000 $7,705,000
Cost of product 636,000 849,000 1,234,000 1,584,000

Gross margin 2,614,000 3,357,000 5,129,000 6,121,000

Operating expenses:
Research and
development 1,586,000 1,297,000 3,327,000 2,556,000
Marketing 2,651,000 2,036,000 4,928,000 3,952,000
General and
administrative 961,000 897,000 1,791,000 1,540,000
Total operating
expenses 5,198,000 4,230,000 10,046,000 8,048,000

Loss from
operations (2,584,000) (873,000) (4,917,000) (1,927,000)
Interest and
investment income,
net 365,000 284,000 573,000 463,000

Net loss ($2,219,000) ($589,000) ($4,344,000) ($1,464,000)

Basic and diluted
net loss per share ($0.07) ($0.02) ($0.13) ($0.05)

Weighted average
shares used in
computing basic and
diluted net loss
per share amounts 32,289,857 31,442,890 32,266,474 29,599,825


SCICLONE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

ASSETS

June 30, December 31,
2001 2000
(unaudited)

Cash and cash equivalents and short-term
investments $20,202,000 $22,497,000
Accounts receivable, net 7,934,000 8,621,000
Inventory 2,296,000 2,020,000
Other assets 3,672,000 3,029,000
Total assets $34,104,000 $36,167,000

LIABILITIES AND SHAREHOLDERS` EQUITY

Total liabilities $9,588,000 $8,090,000
Total shareholders` equity 24,516,000 28,077,000
Total liabilities and shareholders` equity $34,104,000 $36,167,000


MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X80808432

SOURCE SciClone Pharmaceuticals

CONTACT: Ruth Koh, Investor Relations, [phone], or Richard
Waldron, Chief Financial Officer, [phone], both of SciClone
Pharmaceuticals
/Company News On-Call: http://www.prnewswire.com/comp/775865.html" target="_blank" rel="nofollow ugc noopener">http://www.prnewswire.com/comp/775865.html

URL: http://www.sciclone.com
http://www.prnewswire.com

[TaiPanInvest]

10-Q: SCICLONE PHARMACEUTICALS INC
FRIDAY, AUGUST 03, 2001 2:26 PM
- Edgar Online

(EDGAR Online via COMTEX) -- ITEM 2. MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this report. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. "Forward - looking statements" include those relating to expense levels and expectations regarding clinical trials as well as statements including the words "expects", "anticipates", "believes" or similar words. The actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, such as those set forth under "Risk Factors" and the risks discussed in our other SEC filings, including our Annual Report on Form 10-K filed March 29, 2001 with the SEC.

OVERVIEW
We develop and commercialize novel medicines for treating a broad range of the world`s most serious diseases. Our current product development and commercial activities are focused on the following diseases:

- hepatitis C, an infectious disease affecting 170 million people
worldwide;

- hepatocellular carcinoma, the most common and deadliest form of
liver cancer worldwide;

- malignant melanoma, the deadliest form of skin cancer and one of the
most rapidly increasing types of cancer worldwide;

- hepatitis B, an infectious disease affecting 350 million people
worldwide;

- HIV, the virus that causes AIDS;
- drug-resistant tuberculosis, an infectious disease reaching pandemic
proportions worldwide; and

- cystic fibrosis, the most common fatal genetic disease among
Caucasians.

Our flagship drug is ZADAXIN, an immune system enhancer or ISE. An ISE
drug, such as ZADAXIN, is one that helps stimulate, maintain and direct the
body`s antiviral or anticancer responses. ZADAXIN boosts the body`s immune
system in the fight against multiple types of cancer and infectious diseases.
ZADAXIN is in or expected to enter phase 2 and phase 3 development in the U.S.,
Europe and Japan, the three markets that represent approximately 90% of the
world`s pharmaceutical market. We have initiated a phase 3 clinical program in
the U.S. for the treatment of hepatitis C using ZADAXIN as part of a combination
therapy with Pegasys(R), pegylated interferon alfa-2a, proprietary product of F.
Hoffmann-La Roche Ltd. In this U.S. phase 3 program site selection has been
completed, the clinical research organization has been engaged and the
investigational review board approval process has commenced. In addition to
hepatitis C, current ZADAXIN clinical research focuses on hepatocellular
carcinoma, malignant melanoma and hepatitis B. Approximately 3,000 patients have
been treated with ZADAXIN in over 70 clinical trials covering a broad range of
life-threatening diseases in which the immune system plays a key role in the
patient`s ability to fight back.

ZADAXIN has been approved for sale in many emerging growth nations, principally for the treatment of hepatitis B and hepatitis C, and we are currently selling ZADAXIN primarily in the People`s Republic of China. The net cash flow from our international sales efforts are used to partially fund our U.S. clinical trial programs. Our total ZADAXIN sales for 2000 were $15,357,000, a 69% increase over 1999 sales of $9,091,000, and for the six months ended June 30, 2001, sales were $6,363,000, a 17% decrease compared to sales of $7,705,000 for the six months ended June 30, 2000.

Our second product in clinical development, CPX, is a novel protein-repair therapy for cystic fibrosis, the most common fatal genetic disease among Caucasians. Currently approved drugs treat only the symptoms of cystic fibrosis, not the underlying cause of the disease. CPX, which we have in-licensed from the U.S. National Institutes of Health, is designed to repair the underlying protein-associated defect responsible for cystic fibrosis in most patients, not just the symptoms of the disease. CPX is currently in a phase 2 development program in the U.S.

Additional drug candidates in our pipeline include SCV-07, the lead, orally active, compound in our new class of immune system enhancer drugs and DAX. SCV-07 has entered phase 1 testing for drug-resistant tuberculosis and we expect to develop SCV-07 for cancer and viral hepatitis. DAX is targeted at cystic fibrosis.

RESULTS OF OPERATIONS
Total revenue was approximately $3,250,000 and $6,363,000 for the three-month and six-month periods ended June 30, 2001, as compared to approximately $4,206,000 and $7,705,000 for the corresponding periods in 2000. This 17 percent decrease for the six-month period was primarily due to lower sales to importing agents in the People`s Republic of China who supply our distributors in China with ZADAXIN, greater sales last year to certain countries using ZADAXIN on a pre-approval named patient basis and to increased competition from other hepatitis B therapies. For the three-month period ended June 30, 2001, all of our total revenue was derived from sales of ZADAXIN, and China accounted for 88% of this revenue. Sales emphasis is concentrated in China because, as one of our more developed markets, marketing expenditures are more likely to benefit sales and profits compared to newer markets-which require investment and development spending.

Cost of product sales was approximately $636,000 and $1,234,000 for the three-month and six-month periods ended June 30, 2001, as compared to approximately $849,000 and $1,584,000 for the corresponding periods in 2000. We expect cost of product sales to vary from quarter to quarter, depending primarily on the level of ZADAXIN sales to distributors who tend to place a few larger orders during the year, the absorption of fixed product-related costs, and any charges associated with excess or expiring finished product.

Research and development expenses were approximately $1,586,000 and $3,327,000 for the three-month and six-month periods ended June 30, 2001, as compared to approximately $1,297,000 and $2,556,000 for the corresponding periods in 2000. The increase was primarily attributable to increases in clinical trial expenses, product research expenses and payroll expenses. The initiation and continuation of ZADAXIN, CPX and other product clinical development programs has had, and will continue to have, significant effect on our research and development expenses and may require us to seek additional capital resources. In general, we expect product research and development expenses to increase significantly in absolute dollars over the next several years and to vary quarter to quarter as we pursue our strategy of initiating additional preclinical and clinical trials and testing, acquiring product rights, and expanding regulatory activities.

Marketing expenses were approximately $2,651,000 and $4,928,000 for the three-month and six-month periods ended June 30, 2001, as compared to approximately $2,036,000 and $3,952,000 for the corresponding periods in 2000. The increase primarily relates to increased payroll expenses and expenses for advertising associated with the expansion in our existing ZADAXIN markets. We expect our marketing expenses to increase in absolute dollars in the next several quarters as we expand our commercialization and marketing efforts and pursue additional strategic collaborations.

General and administrative expenses were approximately $961,000 and $1,791,000 for the three-month and six-month periods ended June 30, 2001, as compared to approximately $897,000 and $1,540,000 for the corresponding periods in 2000. The increase was primarily attributable to increased fees for professional services. In the near term, we expect general and administrative expenses to vary quarter to quarter as we augment our general and administrative activities and resources to support increased expenditures on preclinical and clinical trials and testing, and regulatory, pre-commercialization and marketing activities.

Net interest and investment income was approximately $365,000 and $573,000 for the three-month and six-month periods ended June 30, 2001, as compared to approximately $284,000 and $463,000 for the corresponding periods in 2000. The increase primarily resulted from increase in other income due to the repayment of a loan from a former officer, offset by decreased interest and investment income due to lower average invested cash balances.

Management intends to give priority use of the Company`s financial resources to its clinical programs in the United States.

LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2001 and 2000, we had approximately $20,202,000 and $18,001,000, respectively, in cash, cash equivalents, short-term investments and marketable securities. The marketable securities consist primarily of highly liquid short-term investments.

Net cash used by us in operating activities amounted to approximately $4,651,000 for the six-month period ended June 30, 2001. Net cash used in operating activities in the 2001 period was greater than our net loss for that period due to decreases in accounts payable, decreases in accrued compensation and benefits and increases in prepaid expenses and inventory, partially offset by decreases in accounts receivable.

Net cash used by us in investing activities amounted to approximately $344,000 for the six-month period ended June 30, 2001 and related to the net purchase of approximately $316,000 of marketable securities and the purchase of approximately $28,000 in equipment and furniture.

For the six-month period ended June 30, 2001, net cash provided by financing activities amounted to approximately $2,320,000 in net proceeds. Of this amount, net cash provided by the issuance of common stock under our employee stock purchase plan amounted to approximately $51,000 in net proceeds; net cash provided by the exercises of outstanding options under our employee stock option plans amounted to approximately $315,000; net cash provided by the issuance of a convertible note amounted to approximately $1,600,000; net cash resulting from the issuance to certain investors of a right to purchase approximately $2,300,000 of senior unsecured convertible notes amounted to approximately $360,000 offset by approximately $6,000 in financing costs.

Management believes our existing capital resources and interest on funds available are adequate to maintain our current and planned operations into 2003. The initiation and continuation of U.S. and Japanese clinical development programs could require additional

funding either from a collaborative source or through equity or debt financing. The need, timing and amount of additional funding will depend upon numerous factors, including the level of ZADAXIN sales, the timing and amount of manufacturing costs related to ZADAXIN and CPX, the availability of complementary products, technologies and businesses, the initiation and continuation of preclinical and clinical trials and testing, particularly ZADAXIN trials in the U.S. and Japan, the timing of regulatory approvals, developments in relationships with existing or future collaborative parties and the status of competitive products. In the event we need to raise additional financing, the unavailability or the timing of any financing could prevent or delay our long-term product development and commercialization programs, either of which would severely hurt our business.

RISK FACTORS
You should carefully consider the risks described below, together with all of the other information included in this report on Form 10-Q, before making an investment decision. The risks below are not the only ones we face. If any of the following risks actually occurs, our business, financial condition or operating results could be harmed. In such case, the trading price of our common stock could decline, and you may lose all or part of your investment.

IF WE FAIL TO SATISFY AND COMPLY WITH GOVERNMENTAL REGULATIONS OR IF GOVERNMENT

REGULATIONS CHANGE, OUR BUSINESS WILL SUFFER.

All new drugs, including our products which have been developed or are under development, are subject to extensive and rigorous regulation by the FDA, and comparable agencies in state and local jurisdictions and in foreign countries. These regulations change from time to time. In prior years, legislation was introduced in the U.S. Congress that would restrict the duration of the marketing exclusivity of an orphan drug. There can be no assurances that this type of legislation will not be reintroduced and passed into law, or that the benefits of the existing statute will remain in effect. Our failure to satisfy and comply with regulations by the FDA, and comparable agencies in state and local jurisdictions and in foreign countries can delay or stop approval of our drugs. These regulations govern, among other things, the development, testing, manufacturing, labeling, storage, premarket approval, importation, advertising, promotion, sale and distribution of our products. Satisfaction of these regulations typically takes several years and the time needed to satisfy them varies substantially, based on the type, complexity and novelty of the pharmaceutical product. As a result, government regulation may cause us to delay the introduction of, or prevent us from marketing, our existing or potential products for a considerable period of time and to impose costly procedures upon our activities. If regulatory approval of our products is granted, such approval may impose limitations on the indicated uses for which our products may be marketed. The pegylated interferon we will use in our phase 3 program in the U.S. has not yet been approved by the FDA. While we anticipate that such approval will be obtained, we would need to conduct an additional trial with an approved form, resulting in additional delays and expenses, if it is not obtained.

IF WE FAIL TO OBTAIN REGULATORY APPROVALS IN COUNTRIES WHERE WE HAVE TARGETED

REGULATORY APPROVAL FOR OUR PRODUCTS, WE MAY NOT BE ABLE TO SUSTAIN OR INCREASE

OUR REVENUES AND OUR STOCK PRICE MAY DECLINE.

The research, preclinical and clinical development, manufacturing, marketing and sale of ZADAXIN, CPX and our other drug candidates are subject to extensive regulation by governmental authorities. ZADAXIN, CPX and any other products we may sell must be approved by the FDA or its foreign counterparts before they can be sold in any jurisdiction. Obtaining regulatory approval is time-consuming and expensive. In some countries where we are contemplating marketing and selling ZADAXIN, the regulatory approval process for drugs that have not been previously approved in countries with established clinical trial review procedures

is uncertain, and this may delay the grant of regulatory approvals for ZADAXIN. In addition, to secure these regulatory approvals, for ZADAXIN and CPX, we will need, among other things, to demonstrate favorable results from additional clinical trials of ZADAXIN and the safety and efficacy of CPX as a treatment for cystic fibrosis in preclinical and clinical trials. Our failure to obtain the required regulatory approvals so that we can develop, market and sell our products in countries where we currently do not have such rights may limit our revenues.

There can be no assurance that we will ultimately obtain regulatory approvals in our targeted countries in a timely and cost-effective manner or at all. Failure to comply with applicable U.S. or foreign regulatory requirements can, among other things, result in warning letters, fines, suspensions of regulatory approvals, product recalls or seizures, operating restrictions, injunctions, total or partial suspension of production, civil penalties, and criminal prosecutions. Further, additional government regulation may be established or imposed by legislation or otherwise, which could prevent or delay regulatory approval of ZADAXIN, CPX or any of our future products. Adverse events related to our products in any of our existing or future markets could cause regulatory authorities to withdraw market approval for such products, if any, or prevent us from receiving market approval in the future.

We may not be able to commence or complete the clinical trials we have sponsored or are planning relating to ZADAXIN and CPX in a timely or cost-effective manner. Even if completed, these trials may not fulfill the applicable regulatory approval criteria, in which case we will not be able to obtain regulatory approvals in these countries. Failure to obtain additional regulatory approvals will harm our operating results. In addition, adverse results in our development programs also could result in restrictions on the use of ZADAXIN and, if approved, CPX.

WE ARE IMPLEMENTING A PHASE 3 PROGRAM IN THE U.S. FOR THE APPROVAL IN THE U.S.

OF ZADAXIN IN COMBINATION WITH PEGYLATED INTERFERON FOR THE TREATMENT OF

HEPATITIS C. OUR SCIENTIFIC AND CLINICAL RESEARCH DATA RELATING TO ZADAXIN IN

COMBINATION WITH INTERFERON FOR THE TREATMENT OF HEPATITIS C IS BASED ON THE USE

OF THE NON-PEGYLATED FORM OF INTERFERON.

The results from our previous phase 2 and phase 3 hepatitis C studies have enabled us to produce a conservatively designed phase 3 study program based on the use of ZADAXIN in combination with non-pegylated interferon. We are proceeding with this program and have completed site selection and engaged the clinical research organization, and the investigational review board approval process has commenced. However, there can be no assurances that the results that produced this conservative design will carryover to the design of the study program using the combination of ZADAXIN and pegylated interferon. The pegylated form of interferon may perform better than anticipated in comparison to the combination of ZADAXIN and pegylated interferon. If that results, our efforts to market and sell ZADAXIN in combination with pegylated interferon will be delayed, which will hurt our expectations.

WE HAVE A HISTORY OF OPERATING LOSSES AND AN ACCUMULATED DEFICIT. WE EXPECT TO

CONTINUE TO INCUR LOSSES IN THE NEAR TERM AND MAY NEVER ACHIEVE PROFITABILITY.

We have experienced significant operating losses since our inception and as of June 30, 2001, we had an accumulated deficit of $121,090,000. We expect our operating expenses to increase over the next several years as we plan to dedicate substantially all of our resources to expanding our development, testing and marketing capabilities, particularly in the U.S. Accordingly, we may never achieve profitability. Our failure to achieve profitability may cause our stock price to decline.

IF WE DO NOT INCREASE THE AMOUNT OF REVENUE WE DERIVE FROM SALES OF ZADAXIN WE

WILL NEED TO OBTAIN ADDITIONAL CAPITAL TO SUPPORT OUR LONG-TERM PRODUCT

DEVELOPMENT AND COMMERCIALIZATION PROGRAMS.

Our strategy in the near term is to invest in phase 2 and 3 clinical studies in the U.S. Europe and Japan and continue to maintain and develop our international ZADAXIN business. Our ability to achieve and sustain operating profitability depends in large part on our ability to:

- commence, execute and complete clinical programs for, and obtain
additional regulatory approvals for, ZADAXIN, CPX, and/or future
products, particularly in the U.S., Europe and Japan;

- increase ZADAXIN sales in existing markets; and
- launch ZADAXIN in new markets;
Although we remain optimistic regarding the prospects of ZADAXIN, we
cannot assure you that we will ever achieve significant levels of sales or that
we will receive additional ZADAXIN market approvals.

If we do not increase the revenue we derive from the sales of ZADAXIN and achieve operating profitability, we will need to obtain additional financing to support our long-term product development and commercialization programs. We may seek additional funds through public and private stock offerings, arrangements with corporate partners, borrowings under lease lines of credit or other sources. If we cannot raise the necessary funds, we will have to reduce our capital expenditures, scale back our development of new products, reduce our workforce and out-license to others products or technologies that we otherwise would seek to commercialize ourselves.

The amount of capital we need will depend on many factors, including:

- the level of future ZADAXIN sales;
- the timing, location, scope and results of ongoing and planned
preclinical studies and clinical trials;

- the cost of manufacturing or obtaining preclinical and clinical
materials;

- expense levels for our international sales and marketing efforts;
- the timing and cost involved in applying for and obtaining FDA and
international regulatory approvals;

- the costs involved in filing, prosecuting and enforcing patent
claims;

- competing technological and market developments;
- whether any or all of our outstanding common stock warrants are
exercised and the timing and amount of these exercises;

- our ability to establish and maintain strategic arrangements for
development, sales, manufacturing and marketing of our products; and

- whether we elect to establish additional partnering arrangements for
development, sales, manufacturing, and marketing of our products.

Many of the foregoing factors are not within our control. If we need to
raise additional funds and such funds are not available on reasonable terms, we
may be required to delay or cancel our product development and commercialization
programs. Any additional equity financing will be dilutive to shareholders, and
any debt financing, if available, may include restrictive covenants.

WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP OR COMMERCIALIZE OUR PRODUCTS.
Many of our products are in the development stage and will require the commitment of substantial resources, devoted to extensive research, development, preclinical testing, clinical trials, manufacturing scale-up and regulatory approval prior to being ready for sale. We can not assure you that commercially viable products will result from these efforts. We face significant technological risks inherent in developing these products. We may also abandon some or all of our proposed products before they become commercially viable. If any of our products, even if developed and approved, cannot be successfully commercialized in a timely manner, our business will be harmed and the price of our stock may decline.

We have not yet sold any product other than ZADAXIN. Our future revenue growth depends on increased market acceptance and commercialization of ZADAXIN in additional countries, particularly the U.S. and European countries. If we fail to successfully market ZADAXIN, or if we cannot commercialize this drug in the U.S. and other additional markets, our revenue and operating results will suffer. Our future revenue will also depend in part on our ability to develop other commercially viable and accepted products. Market acceptance of our products will depend on many factors, including our ability to:

- convince prospective customers that our products are an attractive
alternative to other treatments and therapies;

- convince prospective strategic partners that our products are an
attractive alternative to other treatments and therapies; and,

- manufacture products in sufficient quantities with acceptable
quality and at an acceptable cost.

WE ARE DEPENDENT ON THE SALE OF ZADAXIN IN FOREIGN COUNTRIES, PARTICULARLY

CHINA, AND IF WE EXPERIENCE DIFFICULTIES IN OUR FOREIGN SALES EFFORTS, OUR

FINANCIAL CONDITION WILL BE HARMED.

Our financial condition in the near term is highly dependent on the sale of ZADAXIN in foreign countries. If we experience difficulties in our foreign sales efforts, our business will suffer and our financial condition will be harmed. The majority of our ZADAXIN sales are to customers in the People`s Republic of China. Sales of ZADAXIN in China may be limited due to its low average income, poorly developed infrastructure and existing and potential competition from other products, possibly including generics. China uses a tiered method to import and distribute finished pharmaceutical products. At each port of entry, and prior to moving the product forward to the distributors, government licensed importing agents must process and evaluate each shipment to determine whether such shipment satisfies China`s quality assurance requirements. In order to efficiently manage this process, the importing agents place relatively few orders from time to time over any six month period and each order is typically for large quantities. Therefore, our sales to an importing agent can vary substantially from quarter to quarter depending on the size and timing of the orders, which may cause our quarterly results to

fluctuate. In addition, our ZADAXIN sales and operations in other parts of Asia, as well as in Latin America and the Middle East, are subject to a number of risks, including:

- difficulties and delays in obtaining pricing approvals and
reimbursement;

- difficulties and delays in obtaining product health registration;
- difficulties and delays in obtaining importation permits;
- unexpected changes in regulatory requirements;
- difficulties in staffing and managing foreign operations;
- long payment cycles;
- difficulties in accounts receivable collection;
- currency fluctuations; adverse or deteriorating economic conditions;
and

- potential adverse tax consequences.
We do not have product sales in the U.S. with which to offset any decrease
in our revenue from ZADAXIN sales in Asia, Latin America and the Middle East. In
addition, some countries in these regions regulate pharmaceutical prices and
pharmaceutical importation. These regulations may reduce prices for ZADAXIN to
levels significantly below those that would prevail in an unregulated market or
limit the volume of product which may be imported and sold, either of which may
limit the growth of our revenues or cause them to decline.

WE HAVE LIMITED SALES, MARKETING AND DISTRIBUTION CAPABILITIES, WHICH MAY

ADVERSELY AFFECT OUR ABILITY TO SUCCESSFULLY COMMERCIALIZE OUR PRODUCTS.

We currently have limited sales, marketing and distribution capabilities, and we anticipate that we will be relying on third-party collaborators to sell, market and distribute our products in the foreseeable future. If our arrangements with these third parties are not successful, or if we are unable to enter into additional third-party arrangements, we may need to substantially expand our sales, marketing and distribution force. Our efforts to expand may not succeed, or we may lack sufficient resources to expand in a timely manner, either of which will harm our operating results. If we are able to further develop our sales, marketing and distribution capabilities, we will compete with other companies that have experienced and well funded operations. If we cannot successfully compete with them, our revenues may not grow and our business may suffer.

IF WE ARE NOT ABLE TO ESTABLISH AND MAINTAIN ADEQUATE MANUFACTURING AND SUPPLY

RELATIONSHIPS, THE DEVELOPMENT AND SALE OF OUR PRODUCTS COULD BE IMPAIRED.

To be successful, our products must be manufactured in commercial quantities, in compliance with regulatory requirements and at an acceptable cost. We may not be able to maintain the long-term manufacturing relationships we currently have with our suppliers of ZADAXIN and CPX. Manufacturing interruptions, if any, could significantly delay clinical development of potential products and reduce third-party or clinical researcher interest and support of proposed trials. These interruptions could also impede commercialization of our products, including sales of ZADAXIN in approved markets, and impair our competitive position. Any of these developments would harm our business. In some countries, a change may require additional regulatory approvals. If we do not obtain the required regulatory approvals of

this manufacturing change in a timely fashion, new ZADAXIN marketing approvals may be delayed or sales may be interrupted until the manufacturing change is approved. Either of these results will hurt our business.

Manufacturing, supply and quality control problems may arise as we, either alone or with subcontractors, attempt to scale-up our manufacturing procedures. We may not be able to scale-up in a timely manner or at a commercially reasonable cost. Problems could lead to delays or pose a threat to the ultimate commercialization of our products and harm us.

IF WE DO NOT OBTAIN RIGHTS TO ADDITIONAL PRODUCTS FROM THIRD PARTIES, OUR

PROSPECTS FOR FUTURE REVENUE MAY DECLINE.

We are only actively pursuing clinical development of ZADAXIN and CPX at this time. If we do not advance SCV-07 and DAX, the other products to which we have in-licensed rights, from preclinical into clinical development we may lose the rights to these products. We may also have a shortage of drugs to develop and commercialize if we do not license or otherwise acquire rights to additional drugs. Any shortage in the number of drugs that we are able to develop and commercialize may reduce our prospects for future revenue.

COMMERCIALIZATION OF SOME OF OUR PRODUCTS DEPENDS ON COLLABORATIONS WITH OTHERS.

IF OUR COLLABORATORS ARE NOT SUCCESSFUL, OR IF WE ARE UNABLE TO FIND FUTURE

COLLABORATORS, WE MAY NOT BE ABLE TO PROPERLY DEVELOP AND COMMERCIALIZE OUR

PRODUCTS.

We depend in part on our distributors and business partners to develop and/or promote our drugs, and if they are not successful in their efforts or fail to do so, our business will suffer. We generally do not have control over the amount and timing of resources that our business partners devote to ZADAXIN and they have not always performed as or when expected. If they do not perform their obligations as we expect, our development expenses would increase and the development and/or sale of our products could be limited or delayed, which could cause our business to suffer and our stock price to decline. In addition, our relationships with these companies may not be successful. Disputes may arise over ownership rights to intellectual property, know-how or technologies developed with our collaborators, and we may not be able to negotiate similar additional arrangements in the future to develop and commercialize ZADAXIN.

IF WE FAIL TO PROTECT OUR PRODUCTS, TECHNOLOGIES AND TRADE SECRETS, WE MAY NOT

BE ABLE TO SUCCESSFULLY USE, MANUFACTURE OR MARKET AND SELL OUR PRODUCTS OR WE

MAY FAIL TO ADVANCE OR MAINTAIN OUR COMPETITIVE POSITION.

Our success depends significantly on our ability to obtain and maintain meaningful patent protection for our products and technologies, to preserve our trade secrets and to avoid infringing on the proprietary rights of third parties. Our pending patent applications may not result in the issuance of patents in the future. Our patent applications may not have priority over others` applications and, even if any patents are issued, they may not provide a competitive advantage to us or may be invalidated or circumvented by our competitors. Others may independently develop similar products or design around patents issued or licensed to us. Patents issued to, or patent applications filed by, other companies could harm our ability to use, manufacture or market our products or maintain our competitive position with respect to our products. Many of our patents relating to ZADAXIN have expired, and we have rights to other patents and patent applications relating to ZADAXIN under exclusive licenses. If we breach the terms of any of these licenses, we could lose our rights to these patents and patent applications.

Our commercial success also depends in part on us not infringing valid, enforceable patents or proprietary rights of third parties, and not breaching any licenses that may relate to our technologies and products. We are aware of third-party patents that may relate to our products. It

is possible that we may unintentionally infringe these patents or other patents or proprietary rights of third parties. We may in the future receive notices claiming infringement from third parties as well as invitations to take licenses under third-party patents. Any legal action against us or our collaborative partners claiming damages and seeking to enjoin commercial activities relating to our products and processes affected by third-party rights may require us or our collaborative partners to obtain licenses in order to continue to manufacture or market the affected products and processes. Our efforts to defend against any of these claims, even if unmeritorious, would require us to devote resources and attention that could have been directed to our operation and growth plans. In addition, these actions may subject us to potential liability for damages. We or our collaborative partners may not prevail in a patent action and any license required under a patent may not be made available on commercially acceptable terms, or at all.

Pharmaceuticals are either not patentable or have only recently become patentable in some of the countries other than the U.S., in which we have exclusive rights to ZADAXIN. Past enforcement of intellectual property rights in many of these countries has been limited or non-existent. Future enforcement of patents and proprietary rights in many other countries will likely be problematic or unpredictable. Moreover, the issuance of a patent in one country does not assure the issuance of a similar patent in another country. Claim interpretation and infringement laws vary by nation, so the extent of any patent protection is uncertain and may vary in different jurisdictions.

IF WE MAKE ANY ACQUISITIONS, WE WILL INCUR A VARIETY OF COSTS AND MAY NEVER

REALIZE THE ANTICIPATED BENEFITS.

If appropriate opportunities become available, we may attempt to acquire products, product candidates or businesses that we believe fit strategically with our business. We currently have no commitments or agreements with respect to material acquisitions. If we do undertake any transaction of this sort, the process of integrating an acquired product, product candidate or business may result in operating difficulties and expenditures and may absorb significant management attention that would otherwise be available for our ongoing business development plans. Moreover, we may never realize the anticipated benefits of any acquisition. Future acquisitions could result in potentially dilutive issuances of equity securities, the incurrence of debt, contingent liabilities and/or amortization expenses related to goodwill and other intangible assets, which could adversely affect our business, financial condition and results of operations.

WE MAY LOSE MARKET SHARE OR OTHERWISE FAIL TO COMPETE EFFECTIVELY IN THE

INTENSELY COMPETITIVE BIOPHARMACEUTICAL INDUSTRY.

Competition in the biopharmaceutical industry is intense and we expect that competition to increase. Our success depends on our ability to compete. We believe that the principal competitive factors in this industry include the efficacy, safety, price, therapeutic regimen and manufacturing quality assurance associated with a given drug. Our competitors include biopharmaceutical companies, biotechnology firms, universities and other research institutions, both in the U.S. and abroad, that are actively engaged in research and development of products in the therapeutic areas we are pursuing, particularly cancer, hepatitis B, hepatitis C, HIV and cystic fibrosis. In certain instances, our competitors are currently marketing drugs for cancer, hepatitis B, hepatitis C and HIV or have products in late-stage clinical trials.

Most of our competitors, particularly large biopharmaceutical companies, have substantially greater financial, technical, regulatory, manufacturing, marketing and human resource capabilities than we do. Most of them also have extensive experience in undertaking the preclinical and clinical testing and obtaining the regulatory approvals necessary to market drugs. Additional mergers and acquisitions in the pharmaceutical industry may result in even more resources being concentrated with our competitors. Principal competitive factors in the

pharmaceutical field include efficacy, safety, and therapeutic regimen. Where comparable products are marketed by other companies price is also a competitive factor. Increased competitive pressure could lead to intensified price-based competition resulting in lower prices and margins, which would hurt our operating results.

We currently rely on sales of ZADAXIN as a treatment for hepatitis C and hepatitis B as our primary source of revenue. However, several large biopharmaceutical companies have substantial commitments to alpha interferon, an approved drug for treating hepatitis B and hepatitis C and to lamivudine, an approved drug to treat hepatitis B. We cannot assure you that we will compete successfully against our competitors or that our competitors, or potential competitors, will not develop drugs or other treatments for hepatitis C, hepatitis B, cystic fibrosis, cancer and other diseases that will be superior to ours. However, in the area of immune system enhancer therapy, we anticipate that our competition for ZADAXIN may be reduced by the fact that ZADAXIN, administered in combination with numerous antiviral and anti-cancer agents, is expected to be complementary rather than competitive to these agents in enhancing the immune system. We believe that we can position ZADAXIN as a complementary rather than competitive drug to many therapies, but cannot guarantee that we will be successful in this endeavor. We expect continuing advancements in and increasing awareness of the use of immune system enhancer therapy to fight cancer and infectious diseases may create new competitors as well as numerous new opportunities for expanded use of ZADAXIN worldwide.

IF THE CURRENT ECONOMIC SLOWDOWN IN THE U.S. CAUSES THE ECONOMIES OF OTHER

COUNTRIES, PARTICULARLY THOSE IN ASIA, LATIN AMERICA AND THE MIDDLE EAST TO

EXPERIENCE A SLOWDOWN OR RECESSION, OUR BUSINESS WILL SUFFER.

The U.S. is the world`s largest consumer and as such, the current economic slowdown in the U.S. may adversely affect the economies of other countries, including the developing countries in Asia, Latin America and the Middle East from which we derive all of our revenues. If the economic conditions in the U.S. continue or worsen, these developing countries may also experience an economic slowdown or recession, which would likely result in a decrease of sales of ZADAXIN. Any decrease in sales of ZADAXIN would harm our operating results, delay our efforts to achieve profitability, and likely cause our stock price to decline.

WE RELY ON A CONTINUOUS POWER SUPPLY TO CONDUCT OUR OPERATIONS, AND CALIFORNIA`S

CURRENT ENERGY CRISIS COULD DISRUPT OUR BUSINESS AND INCREASE OUR EXPENSES.

California is in the midst of an energy crisis that could disrupt our operations and increase our expenses. In the event of an acute power shortage, that is, when power reserves for California fall below 1.5%, electricity providers have on some occasions implemented, and may in the future continue to implement, rolling blackouts. The majority of our operations are located in California; however, we currently do not have backup generators or alternate sources of power in the event of a blackout. If blackouts interrupt our power supply, we would be temporarily unable to continue operations at our facilities. Any such interruption in our ability to continue operations at our facilities could damage our reputation and harm our development efforts, which could adversely affect our business and results of operation.

IF THIRD-PARTY REIMBURSEMENT IS NOT AVAILABLE OR PATIENTS CANNOT OTHERWISE PAY

FOR ZADAXIN, WE MAY NOT BE ABLE TO SUCCESSFULLY MARKET ZADAXIN.

Our ability to successfully commercialize our products may depend in part on the extent to which coverage and reimbursement to patients for our products will be available from government health care programs, private health insurers and other third party payors or organizations. Significant uncertainty exists as to the reimbursement status of new therapeutic products, such as ZADAXIN, and we cannot assure you that third party insurance coverage and

reimbursement will be available for therapeutic products we might develop. In most of the emerging markets in which we sell ZADAXIN or intend to sell ZADAXIN, reimbursement for ZADAXIN under government or private health insurance programs is not yet widely available. The failure to obtain third-party reimbursement for our products, particularly in the U.S., Europe and Japan, will hurt our business. In the U.S., proposed health care reforms could limit the amount of third-party reimbursement available for our products. We cannot assure you that future additional limitations will not be imposed in the future on drug coverage and reimbursement. In many emerging markets where we have marketing rights to ZADAXIN, government resources and per capita income may be so low that our products will be prohibitively expensive. In these countries, we may not be able to market our products on economically favorable terms, if at all.

Efforts by governmental and third-party payors to contain or reduce health care costs could cause us to reduce the prices at which we market our drugs, which will reduce our gross margins and may harm our business. Various governments and third-party payors are trying to contain or reduce the costs of health care through various means. We expect that there will continue to be a number of legislative proposals to implement government controls. The announcement of proposals or reforms could cause us to reduce the prices at which we market our drugs, which will reduce our gross margins and may harm our business.

IF WE LOSE KEY PERSONNEL OR ARE UNABLE TO ATTRACT AND RETAIN ADDITIONAL, HIGHLY

SKILLED PERSONNEL REQUIRED FOR THE EXPANSION OF OUR ACTIVITIES, OUR BUSINESS

WILL SUFFER.

We are highly dependent upon our ability to attract and retain qualified personnel because of the specialized, scientific and international nature of our business. There is intense competition for qualified management, scientific and technical personnel in the pharmaceutical industry, and we may not be able to attract and retain the qualified personnel we need to grow and develop our business globally. In addition, numerous key responsibilities at SciClone are assigned to a small number of individuals. If we are unable to attract and retain qualified personnel as needed or promptly replace those employees who are critical to our product development and commercialization, the development and commercialization of our products would adversely be affected. At this time, we do not maintain "key person" life insurance on any of our key personnel.

WE MAY BE SUBJECT TO PRODUCT LIABILITY LAWSUITS AND OUR INSURANCE MAY BE

INADEQUATE TO COVER DAMAGES.

Clinical trials or marketing of any of our current and potential products may expose us to liability claims from the use of these products. We currently carry product liability insurance. However, we cannot be certain that we will be able to maintain insurance on acceptable terms for clinical and commercial activities or that the insurance would be sufficient to cover any potential product liability claim or recall. If we fail to have sufficient coverage, our business, results of operation and cash flows could be adversely affected.

IF WE ARE UNABLE TO COMPLY WITH ENVIRONMENTAL LAWS AND REGULATIONS, OUR BUSINESS

MAY BE HARMED.

We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous materials and waste products. We currently maintain a supply of hazardous materials at our facilities. In the event of an accident, we could be liable for any damages that result, and the liability could exceed our resources. While we outsource our research and development programs involving the controlled use of biohazardous materials, if in the future we conduct these programs ourselves, we might be required to incur significant cost to comply with the environmental laws and regulations.

THE PRICE OF OUR COMMON STOCK HAS EXPERIENCED SUBSTANTIAL VOLATILITY AND MAY

FLUCTUATE DUE TO FACTORS BEYOND OUR CONTROL.

There has been significant volatility in the market prices for publicly traded shares of pharmaceutical and biotechnology companies, including ours. The following factors may have an adverse impact on the market price of our common stock:

- significant negative changes in the major equity market indices;
- announcements of technical or product developments by us or our
competitors;

- governmental regulation;
- health care legislation;
- public announcements regarding advances in the treatment of the
disease states that we are targeting;

- public announcements from government officials relating to the
biotechnology or pharmaceutical industries;

- patent or proprietary rights developments;
- changes in third-party reimbursement policies for our products; and
- fluctuations in our operating results.
The price of our common stock may not remain at or exceed current levels.
OUR INDEBTEDNESS MAY RESULT IN FUTURE LIQUIDITY PROBLEMS.
As of June 30, 2001, we had $5.6 million in convertible notes payable, of which $4.0 million were issued in the quarter ended December 31, 2000 and $1.6 million were issued in the quarter ended March 31, 2001. This increased indebtedness has and will continue to impact us by increasing expense and making it more difficult to obtain additional financing. The notes are payable five years after issuance unless converted into common stock at the sole discretion of the holder. If we are unable to satisfy our debt service requirements, substantial liquidity problems could result which would negatively impact our future prospects. As of June 30, 2001 we had cash and short-term investments of $20.2 million.

SUBSTANTIAL SALES OF OUR STOCK OR CONVERTIBLE SECURITIES MAY IMPACT THE MARKET

PRICE OF OUR COMMON STOCK.

As of June 30, 2001, stock options for 5,065,696 shares of common stock were outstanding, of which options for 3,105,411 shares were exercisable, and there were warrants exercisable for 1,970,500 shares of common stock outstanding. Two issues of convertible notes payable as of June 30, 2001 were convertible into a total of 684,137 shares of common stock beginning one year from date of issuance of the notes. In addition, the investors were given the right to purchase senior unsecured convertible notes due December 2005 and March 2006. If issued, the additional notes will bear no interest (zero coupon) and will be convertible into 684,137 shares of our common stock. Upon exercise of options or warrants, or conversion of the notes, these issued shares of common stock will be freely tradable.

Future sales of substantial amounts of our common stock could adversely affect the market price of our common stock. Similarly, if we raise additional funds through the issuance of common stock or securities convertible into or exercisable for common stock, the percentage ownership of our shareholders will be reduced and the price of our common stock may fall.

ISSUING PREFERRED STOCK WITH RIGHTS SENIOR TO THOSE OF OUR COMMON STOCK COULD

ADVERSELY AFFECT HOLDERS OF COMMON STOCK.

Our charter documents give our board of directors the authority to issue additional series of preferred stock without a vote or action by our shareholders. The board also has the authority to determine the terms of preferred stock, including price, preferences and voting rights. The rights of holders of our common stock may be adversely affected by the rights granted to holders of preferred stock. For example, a series of preferred stock may be granted the right to receive a liquidation preference a pre-set distribution in the event SciClone is liquidated that would reduce the amount available for distribution to holders of common stock. In addition, the issuance of preferred stock could make it more difficult for a third party to acquire a majority of our outstanding voting stock. As a result, common shareholders could be prevented from participating in transactions that would offer an optimal price

[joachimo]

Gibt es irgend welche Gründe für den heutigen Anstieg, oder ist es nur eine technische Reaktion. Weiß jemand etwas?

[biologist]

@joachimo

Moin!
Der Anstieg gestern hat mich auch überrascht. Über die letzten Monate gesehen befindet sich SCLN deutlich in einem Abwärtskanal. Durch die letzten Ereignisse wurde dieser sogar deutlich nach unten durchbrochen. Die untere Marke des Abwärtskanals liegt derzeit bei ca. $3.30. RSI-14 steht bei 29. Somit wäre SCLN die letzten Tage klar überverkauft, was eine technische Reaktion nach oben förmlich erzwingt. Trotzdem halte ich SCLN für eine gute Anlage, schon alleine wegen der letzten Pressemeldungen.

Ich hoffe, daß Dir diese Infos erst einmal reichen!

cu biologist

[joachimo]

@ TaiPanInvest

Danke für die schnelle Info.

Gruß Joachimo

[TaiPanInvest]

Hallo zusammen,
Sorry bin momentan privat im Stress.
SCLN halte ich sowieso long!
Das Papier ist überverkauft Speziell dieser Wert wird bald wieder seine 5-6 E haben.Sehr ausgewogene Pipeline.
Kleine Nebenwerte kommen bekanntlich immer erst später zum Erfolg.

SciClone Named One of Silicon Valley`s Fastest Growing Technology Companies in Deloitte & Touche`s Fast 50 Program
9/20/01 11:25 AM
Source: PR Newswire

SAN MATEO, Calif., Sept. 20 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: SCLN) today announced that the Company has been named as a part of Deloitte & Touche`s prestigious "2001 Technology Fast 50" Program for Silicon Valley, a ranking of the 50 fastest growing technology companies in the area. Rankings are based on the percentage of growth in revenues for the five-year period from 1996-2000. This marks the second straight year SciClone has earned a "Fast 50" ranking from Deloitte & Touche.


"In an era where technology companies come and go like shooting stars, making the Deloitte & Touche Fast 50 is a testament to a company`s leadership and its ability to not only have the right solution for that moment in time, but also the vision that allows growth over five years," said Roy Avondet, managing partner of Deloitte & Touche. "SciClone has proven that its leadership has the right stuff to succeed, and we at Deloitte & Touche salute their accomplishments."

SciClone`s revenues over the five-year period of 1996 to 2000 were 2,084 percent.

To qualify for the Fast 50, companies must have had operating revenues of at least $50,000 in 1996 and $1,000,000 in 2000; must be public or private companies headquartered in the Silicon Valley; and be "technology companies" defined as companies that produce technology, manufacture a technology product, or devote a high percentage of effort to research and development of technology.

SciClone Pharmaceuticals is a global specialty pharmaceutical company that develops and commercializes novel medicines for treating a broad range of the world`s most serious diseases. The Company has focused its current product development and commercialization activities on hepatitis C, cancer, hepatitis B, drug-resistant tuberculosis and cystic fibrosis. Press releases and corporate information regarding SciClone Pharmaceuticals are available on the Internet at www.sciclone.com or by calling the Company`s Investor Relations Department at 800-724-2566. SciClone`s Common Stock is listed on The Nasdaq National Market(R) under the symbol SCLN.

Deloitte & Touche LLP, one of the nation`s leading professional services firms, provides assurance and advisory, tax, and management consulting services through nearly 30,000 people in more than 100 U.S. cities. The firm is dedicated to helping its clients and its people excel. Known as an employer of choice for its innovative human resources programs, Deloitte & Touche has been recognized as one of the "100 Best Companies to Work For in America" by Fortune magazine for four consecutive years. Deloitte & Touche is the U.S. national practice of Deloitte Touche Tohmatsu. Deloitte Touche Tohmatsu is a Swiss Verein, and each of its national practices is a separate and independent legal entity. For more information, please visit Deloitte & Touche`s web site at www.us.deloitte.com.

The Deloitte & Touche`s Technology & Communications Group is composed of service professionals who have a wealth of experience serving technology and communications companies throughout the world in areas including Internet, software, semiconductors, cable, media and publishing, communication utilities, networking, wireless, computers and peripherals, and related industries. These specialists understand the challenges that technology and communications companies face throughout all stages of their business growth cycle and are committed to helping them succeed. Deloitte & Touche is a leader in providing strategic, financial, operational, and information technology assistance to its technology and communications clients.

[TaiPanInvest]

Nachtrag zum Einstieg mit Hepatitis C Patent in Japan.


SAN MATEO, Calif., Aug 28, 2001 /PRNewswire via COMTEX/ -- SciClone Pharmaceuticals (Nasdaq:SCLN) today announced that the Company has received a Notice of Allowance for patent protection in Japan covering the use of ZADAXIN, the Company`s lead immune system enhancer (ISE) drug, for the treatment of hepatitis C. The new patent, which extends through 2012, also covers the use of ZADAXIN in combination with alpha interferon for the treatment of hepatitis C. SciClone previously was granted a Japanese patent for the use of ZADAXIN in the treatment of hepatitis B, and recently announced completed enrollment of its Japanese phase 3 ZADAXIN hepatitis B trial.

"While SciClone`s principal focus continues to be our 1,000 patient ZADAXIN hepatitis C phase 3 program in the U.S., we believe that Japan, as the world`s second largest pharmaceutical market, represents a potential for significant long term value to the Company," said Donald R. Sellers, SciClone`s President and Chief Executive Officer. "ZADAXIN`s intellectual property position for both hepatitis C and hepatitis B treatments is now well established in the U.S., Europe and Japan for the next decade. SciClone is well positioned to take advantage of our broadening opportunities in these important markets."

According to the World Health Organization (WHO), hepatitis C affects approximately 170 million people, or 3% of the total world`s population. In Japan, it is estimated that over four million people are infected with the hepatitis C virus.

SciClone has initiated a phase 3 clinical program in the U.S. for the treatment of hepatitis C using ZADAXIN as part of a combination therapy with Pegasys(R), pegylated interferon alfa-2a, a proprietary product of F. Hoffmann-La Roche Ltd. SciClone recently completed enrollment of a phase 3 ZADAXIN monotherapy hepatitis B clinical trial in Japan. In addition, ZADAXIN is in two phase 2 clinical trials in the U.S. for the treatment of liver cancer and in a phase 2 clinical program in combination with lamivudine for the treatment of hepatitis B. The Company is planning a ZADAXIN phase 3 clinical program for European marketing registration for one or more indications that complement the Company`s U.S. clinical program. ZADAXIN is also in a malignant melanoma clinical trial in Australia.

ZADAXIN is a synthetic preparation of thymosin alpha 1, a peptide that occurs naturally in humans and is an immune system enhancer (ISE) that helps stimulate, maintain and direct the body`s antiviral and anticancer responses. ZADAXIN has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases and to many thousands of patients commercially around the world with virtually no serious drug related adverse events or toxicities. ZADAXIN is approved for sale in 24 countries, principally for the treatment of hepatitis B and hepatitis C, and also in certain countries as a vaccine adjuvant for patients with weakened immune systems and as an adjuvant to chemotherapy for the treatment of various cancers.

SciClone Pharmaceuticals is a global specialty pharmaceutical company that develops and commercializes novel medicines for treating a broad range of the world`s most serious diseases. The Company has focused its current product development and commercialization activities on hepatitis C, cancer, hepatitis B, drug-resistant tuberculosis and cystic fibrosis. Press releases and corporate information regarding SciClone Pharmaceuticals are available on the Internet at www.sciclone.com or by calling the Company`s Investor Relations Department at 800-724-2566. SciClone`s Common Stock is listed on The Nasdaq National Market(R) under the symbol SCLN.

The information in this press release includes certain forward-looking statements regarding, among other things, the Company`s intellectual property position in Japan, ongoing and prospective development and commercialization of ZADAXIN for hepatitis in Japan, Europe, Australia and the U.S. and the potential success of such efforts. Actual events could differ materially from those projected herein due to risks and uncertainties including the progress or failure of clinical trials, future actions by the Food and Drug Administration or equivalent regulatory authorities in foreign countries, including the Japanese Ministry of Health and Welfare, the regulatory approval process, unexpected adverse results to patients during the trials and programs, other events that could prolong the studies or result in unanticipated expense and possible entry of competition based on competitive approvals for indication not covered by "use" patents, as well as other risks and uncertainties including those reflected in the Company`s filings with the Securities and Exchange Commission, particularly its Annual Report on Form 10- K for the year ended December 31, 2000. The Company is under no obligation to, and expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

[TaiPanInvest]

Intrady - Verlauf!
Nix für schwache Nerven.
Trotzdem sage ich dem Papier eine Erfolgsstory vorraus.
Läuft der Biotech-Index maschieren die Jungs gewaltig.
Absolute Einsammlerstücke!!
Gruß an alle weitschauenden Investoren.

[lepppi]

hat sciclone die Phase III für zadaxin in den Usa durchgeführt?? Sonst kaum zulassungschancen in den usa

gruß
lepppi

[lepppi]

Hab mal in Sec fillings nachgesehen auf basisdaten august braucht sind shorties mit 18 fachen tagesvolumen short . sci hat ca 2.2mio dollar im letzten quartal verbraten cash ca 20. mio dollar rückgang der umsätze auf verstärkte konkurrenz für zadaxin zurückzuführen. Zadaxin befindet sich in den Usa grad in Phase II. Mal sehen wie so weiter läuft sollten daten bezüglich zadaxin oder dem zweiten produkt kommen oder sollten die revenues wieder ansteigen müssen sich die Shorties eindecken scln würd dann durch die decke gehen. High risk aktie offen wirmal

Gruß
Lepppi

[lepppi]

Hab mal in Sec fillings nachgesehen auf basisdaten august braucht sind shorties mit 18 fachen tagesvolumen short . sci hat ca 2.2mio dollar im letzten quartal verbraten cash ca 20. mio dollar rückgang der umsätze auf verstärkte konkurrenz für zadaxin zurückzuführen. Zadaxin befindet sich in den Usa grad in Phase II. Mal sehen wie so weiter läuft sollten daten bezüglich zadaxin oder dem zweiten produkt kommen oder sollten die revenues wieder ansteigen müssen sich die Shorties eindecken scln würd dann durch die decke gehen. High risk aktie offen wirmal

Gruß
Lepppi

[lepppi]

Hab mal in Sec fillings nachgesehen auf basisdaten august braucht sind shorties mit 18 fachen tagesvolumen short . sci hat ca 2.2mio dollar im letzten quartal verbraten cash ca 20. mio dollar rückgang der umsätze auf verstärkte konkurrenz für zadaxin zurückzuführen. Zadaxin befindet sich in den Usa grad in Phase II. Mal sehen wie so weiter läuft sollten daten bezüglich zadaxin oder dem zweiten produkt kommen oder sollten die revenues wieder ansteigen müssen sich die Shorties eindecken scln würd dann durch die decke gehen. High risk aktie offen wirmal

Gruß
Lepppi

[DolleMARK]

Heute habe ich die Nachricht gefunden:

SciClone Pharmac. - erfreuliche Tests

05.03. / 16:56

Vorläufige Testdaten zeigen, dass das Immunsytem stärkende Medikament Zadaxin von SciClone Pharmaceuticals bei 26 Hepatitis B Patienten in Japan die Virusreplikation gestoppt hat.

So wurden 319 Hepatitis B Patienten in Japan bei einem Phase III Test sechs Monate mit Zadaxin behandelt. Dabei zeigen bislang Daten von einem Drittel der Patienten, dass bei 24% der Testkandidaten die Virusproduktion gestoppt werden konnte.

Des weiteren teilte das Unternehmen noch mit, dass man im Plan liege bezglich der Vorbereitungen für einen Phase III Test in den USA an Hepatitis C Patienten. Zudem plane man das Medikament in den USA, Europa und Japan zu vermarkten.

© BörseGo

Mit vielen Grüssen,

DolleMARK

[FLOTSAM_AND_JETSAM_US]

Wednesday March 13, 9:00 am Eastern Time
Press Release
SOURCE: SciClone Pharmaceuticals

ZADAXIN in Combination Therapy Has Significantly Superior Sustained Response Rates Compared to Interferon Monotherapy for Hepatitis B
71% for ZADAXIN in Combination Therapy Versus 10% for Interferon Monotherapy

SAN MATEO, Calif., March 13 /PRNewswire-FirstCall/ -- SciClone Pharmaceuticals (Nasdaq: SCLN - news) today announced that data presented at the World Congress of Gastroenterology in Bangkok, Thailand this month indicate that, after an additional 12-month follow-up period for difficult to treat chronic hepatitis B patients in Turkey, 71% of patients that used ZADAXIN in combination therapy with interferon continued to show a sustained response, versus only 10% for the patients that used interferon alone.

``One of the most difficult challenges in successfully treating a viral disease is to achieve a durable sustained response. All too often a successful end of therapy result changes into patient relapse weeks or months later,`` observed Alfred Rudolph, M.D., SciClone`s Chief Operating Officer. ``The durability of ZADAXIN therapy demonstrated in this study is reflective of the durable sustained responses we have observed in other ZADAXIN clinical studies.``

The original data were presented at Digestive Disease Week in May of 2001. The original study analyzed patients in Turkey with antiHBe-positive chronic hepatitis B, a very difficult to treat group infected with the precore mutant of the hepatitis B virus, for which no therapy is consistently effective. Interferon is one of the most widely used approved therapies for the treatment of hepatitis B virus.

In the original study, 21 patients received 26 weeks of ZADAXIN plus interferon followed by 26 weeks of interferon monotherapy and 10 patients received 52 weeks of interferon monotherapy alone. At the end of the 6-month, treatment-free follow-up period, 76% of patients receiving ZADAXIN plus interferon showed a sustained response, as measured by normalization of ALT and disappearance of hepatitis B virus DNA. By comparison, only 40% of patients receiving interferon monotherapy showed a sustained response after the 6-month follow-up period. When patients were observed for an additional 12-month follow-up period, 71% of patients receiving ZADAXIN plus interferon still showed a sustained response, versus only 10% of the patients receiving interferon monotherapy.

``These long-term data provide additional clinical evidence of ZADAXIN`s ability to increase sustained responses, in even the most difficult to treat cases of chronic hepatitis B,`` commented Eduardo Martins, M.D., Ph.D., Medical Director of SciClone. ``This independent study supports our efforts to develop ZADAXIN as a critical component of combination drug therapies for infectious diseases and cancer.``

ZADAXIN has been administered without side effects to over 10,000 patients and is approved for sale in 26 countries, principally for the treatment of hepatitis B and hepatitis C, and certain cancers. ZADAXIN, an immune system enhancer (ISE), is a synthetic preparation of thymosin alpha 1, an immune system peptide that exists naturally in humans and whose activities are recognized to regulate the body`s effective immune response to serious viral infections and certain cancers.

SciClone develops and commercializes pharmaceutical and biological therapeutic compounds that are acquired or in-licensed. SciClone`s goal, based on the broad therapeutic potential of its lead drug ZADAXIN, is to become the preeminent worldwide provider of immune system enhancers as critical components of combination drug therapies for infectious diseases and cancer. Other drugs in its pipeline are intended to protect and expand this franchise and to specifically address the protein-based disorder that causes cystic fibrosis.

[DolleMARK]

Wieder mal eine neue Nachricht von unserer schwarzen Perle.

15.04.2002 15:07 Uhr (gefunden bei finanznachrichten.de)
SciClone Begins ZADAXIN(R) U.S Phase 3 Hepatitis C Clinical ...

SciClone Pharmaceuticals today announced the first patients in its ZADAXIN U.S. phase 3 hepatitis C clinical trials have been enrolled and are receiving treatment.

"The injection of the first patients in our U.S. phase 3 clinical trials represents the end of years of preparation and the beginning of a new era at SciClone," said Donald R. Sellers, SciClone``s President and CEO. "Everyone at SciClone is proud of this accomplishment. Our ZADAXIN U.S. phase 3 trials are designed to demonstrate ZADAXIN contributing a safe, clinically significant benefit in the treatment of hepatitis C. Even more than our international successes, these clinical trials provide our shareholders and the medical community with a clear measurement of our company." SciClone plans to complete patient enrollment and have all patients begin treatment before the end of 2002.

SciClone``s U.S. phase 3 hepatitis C clinical trials include only patients who have not responded to previous therapy with either interferon or interferon plus ribavirin. The clinical trials consist of two 500-patient studies. The clinical trials are multi-centered with 20 major hepatology medical centers throughout the U.S. participating in each study. ZADAXIN is being administered in combination with Pegasys(R), F. Hoffmann LaRoche``s brand of pegylated alpha interferon to half of the patients while the other half receives a placebo plus Pegasys. Pegasys is provided by Roche without cost to SciClone. These studies are randomized, double-blinded, and placebo- controlled. Patients will be treated for 12 months and then followed for a 6-month observation period. The end points of the study are elimination of hepatitis C virus and histological improvement, both measured at the end of observation. The trial design is consistent with the U.S. FDA standard for demonstrating sustained response and is ideal for ZADAXIN``s mechanism of action.

The ZADAXIN plus Pegasys combination therapy clinical trials are designed to show a significant sustained response in non-responder patients, the most difficult to treat segment of the hepatitis C patient population. Current therapy of year-long treatment with pegylated alpha interferon and ribavirin is effective in only about 50% of all hepatitis C patients. The effectiveness of current therapy is highly dependent on the strain, or genotype, of the infecting virus and the viral load, or level of virus present in the patient. For genotype 1 patients with a high viral load, which characterizes about half of the 4 million hepatitis C patients in the U.S., current therapy is effective in only about 30% of the cases. Patients that fail to respond to therapy, the non-responders, seldom respond to a second 12-month regimen of treatment. For example, the success rate for re-treating non-responders with a second year of alpha interferon plus ribavirin therapy is only approximately 8 percent. SciClone estimates that there will be 500,000 non-responders to existing current therapy in the U.S. by 2005.

Hepatitis C is one of the most serious viral infections with complications such as cirrhosis, liver failure and liver cancer. Deaths related to hepatitis C virus in the U.S. are expected to triple by 2010, exceeding the estimated deaths caused by HIV (the virus which causes AIDS). There is no vaccine for hepatitis C.

ZADAXIN has been administered without side effects to over 10,000 patients and is approved for sale in 26 countries, principally for the treatment of hepatitis B and hepatitis C, and certain cancers. ZADAXIN, an immune system enhancer (ISE), is a synthetic preparation of a natural peptide, thymosin alpha 1, which among other positive actions, enhances the body``s Th1 immune response to serious viral infections and certain cancers.

SciClone develops and commercializes pharmaceutical and biological therapeutic compounds that are acquired or in-licensed at the stage of late pre-clinical or early clinical development. SciClone``s strategic goal, based on the broad therapeutic potential of its lead drug ZADAXIN, is to become the preeminent worldwide provider of immune system enhancers as monotherapies and as critical components of combination drug therapies for infectious diseases and cancer. Other drugs in SciClone``s pipeline are intended to protect and expand this franchise, and to address the protein-based disorder that causes cystic fibrosis.

Press releases and corporate information from SciClone are available on the Internet at http://www.sciclone.com/ or by calling the company``s Investor Relations Department at 800-724-2566. SciClone``s Common Stock is listed on The Nasdaq National Market(R) under the symbol SCLN.

The information in this press release contains forward-looking statements including the timing of completion of patient enrollment and commencement of treatment for our U.S. phase 3 hepatitis C clinical trials. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including our ability to enroll a sufficient number of eligible patients to yield statistically significant results, the speed with which patients are enrolled in the hepatitis C clinical trials and maintenance of the sufficiency and eligibility of the enrolled patient population, as well as other risks and uncertainties described in SciClone``s filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2001 and quarterly report on Form 10-Q for the quarterly period ended September 30, 2001.

SciClone Pharmaceuticals

© PR Newswire

[TomSawyer25]

hört sich ja gar nicht so schlecht an. ziehen die bios wieder an ist sciclone sicher dabei. hoffentlich sehen wir die lows nicht wieder.

[merx]

new`s

Reuters Company News
SciClone jumps on favorable Zadaxin cancer study
Thursday September 12, 11:20 am ET


NEW YORK, Sept 12 (Reuters) - Shares of SciClone Pharmaceuticals Inc. (NasdaqNM:SCLN - News) soared on Thursday after the firm said its drug Zadaxin boosted production of a protein that helps direct the body`s immune system to kill colorectal cancer cells.
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Shares of San Mateo, California-based SciClone were up 44 cents, or 18.6 percent, to $2.80, making it one of the top percentage gainers in morning activity on the Nasdaq.

Zadaxin, a synthetic form of a naturally occurring peptide meant to enhance the body`s immune system, is approved for sale in 29 countries, mainly to treat hepatitis B and hepatitis C. But it has not yet been approved in the United States.

SciClone said a new study showed a protein, or antigen, called TLP that appears only on the surface of colorectal cancer cells became more plentiful among cancer cells exposed to Zadaxin in the test tube.

The antigen acts as a flag, steering the body`s immune system to tumor cells to which it is attached, the company said. By increasing the percentage of tumor cells displaying the antigen, the immune system can theoretically better identify tumor cells and kill them.

"The (percentage) of cancer cells in culture with this protein on their surface normally ranges from 10 percent to 20 percent, but after treatment with Zadaxin this was increased to 90 percent" in the test tube experiment, SciClone said in a release.

A similar increase in the percentage of cancer cells displaying the antigen was seen in a study of animals with colorectal cancer that were treated with Zadaxin, the company said.

"To eradicate cancer cells, the immune system needs a specific target and Zadaxin has shown the potential to offer therapeutic benefit in this process," SciClone said.

Colorectal cancer kills over 50,000 Americans each year, making it nation`s second-biggest cause of cancer-related death.