Sciclone Pharmaceuticals -- Zadaxin Phase III in den USA - 500 Beiträge pro Seite

[CaptainChaos]

Hallo Leute,

Nach den gestrigen Nachrichten zu Sciclone meldete SCLN heute, dass das bereits in 20 Staaten weltweit zugelassene und vermarktete Medikament Zadaxin nun in den USA in der
Phase 3 zur Behandlung der Hepatitis C getestet wird. Dabei werden -500 - sog. "Non-Responders" behandelt. Diese " Non Responders" sind Patienten, die auf kein anderes im Handel befindliches Medikament angesprochen haben.

Zadaxin wird weltweit zur Behandlung weiterer Krankheiten eingesetzt und erforscht. Darunter befinden sich u.a. Kanada und Italien.
In Australien laufen Tests hinschtlich der Behandlung des Hautkrebses mit Zadaxin.
In Japan besteht bereits eine Kooperation mit Schering - Plough zur Vermarktung des Medikamentes.

Ich bin davon überzeugt, dass Sciclone im laufenden Jahr die Gewinnzone erreicht. Bei der derzeitigen Marktlage werden Anleger nicht mehr nur auf die mögliche mittelfristige oder langfristige Vermarktung eines Blockbusters
schauen, sondern auch auf Umsätze, Gewinne und Verluste der Biotech - Unternehmen.

Darum halte ich mich an aussichtsreiche Unternehmen aus der 2. Reihe. Bedenkt, dass eine Medarex vor einem einem Jahr noch einstellig war (und mangels Ergebnissen in den letzten 12 MOnaten vielleicht auchbalsd wieder ist).

Biotechwerte der 2. und 3. Reihe werden von einigen Boardteilnehmern als Cashburner bezeichnet. Das trifft zum Teil zu. Jedoch ist bei einigen Werten abzusehen (sofern das bei der derzeitigen Marktlage möglich ist), dass neben der Fantasie zukünftiger Produkte bereits jetzt Umsätze zur Finanzierung der Forschungsarbeit eingefahren werden.

Nun die News:

SciClone Pharmaceuticals Starts Pivotal U.S. Phase 3 Hepatitis C Program With ZADAXIN Plus Pegylated Alfa Interferon
SCLN


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SAN MATEO, Calif., Jan 10, 2001 (Canada NewsWire via COMTEX) -- SciClone Pharmaceuticals (Nasdaq:SCLN) today announced that it has initiated its pivotal U.S. Phase 3 hepatitis C clinical program for ZADAXIN(R) in combination with Pegasys(R), pegylated interferon alfa-2a. SciClone`s pivotal phase 3 hepatitis C program, its largest to date worldwide, will target exclusively the large group of hepatitis C patients in the U.S. who are non-responders to standard therapy (alpha interferon or alpha interferon plus ribavirin), most of whom are infected with genotype 1 of the hepatitis C virus.

"Based on clinical data in hand, SciClone`s management targeted the use of ZADAXIN as a novel and safe treatment for hepatitis C in the U.S. and Europe. It is gratifying that as the awareness of the hepatitis C problem is growing, the Company now has the people and the resources in place to initiate and execute this 1,000 patient U.S. program," said Jere E. Goyan, Ph.D., SciClone`s Chairman and a former Commissioner of the U.S. Food and Drug Administration.

ZADAXIN, SciClone`s lead drug, is an immune system enhancer ("ISE") which helps boost, maintain and direct the body`s antiviral or anticancer responses. Pegylated interferon alfa-2a is an alpha interferon formulation which lasts longer in the bloodstream than standard alpha interferon, providing a more convenient dosing schedule, a better safety profile and more consistent viral suppression. For its pivotal U.S. Phase 3 program, the pegylated interferon alfa-2a, Pegasys, is being supplied at no cost to SciClone by F. Hoffmann La-Roche, Ltd.

"The start of this pivotal phase 3 program is the most significant milestone to date for SciClone. The development of ZADAXIN as a treatment for hepatitis C in the U.S. is the first step to introduce the value of this immune system enhancer (ISE) to the American and European medical communities," said Donald R. Sellers, SciClone`s President and Chief Executive Officer. "The quality of our investigators, the magnitude and urgency of the hepatitis C medical problem and the design of the study suggest that this will be a very efficient program. The free supply of pegylated interferon alfa-2a plus the financial contributions to the U.S. program from our European partner, Sigma-Tau, also suggest that we can expect this to be an extremely cost-effective program for SciClone -- perhaps less than half of what a company would normally have to invest for a pivotal U.S. clinical program of this magnitude."

U.S. Phase 3 Study Design

SciClone`s U.S. program consists of two 500-patient, multicenter, randomized, double-blinded studies. All patients in SciClone`s U.S. phase 3 program will have documented chronic hepatitis C and will previously have completed a course of standard therapy that did not produce a virological response, i.e. the patients remain infected with the hepatitis C virus at the end of the treatment period (these patients are typically called "non-responders").

In each study, patients will be randomly assigned to one of two treatment arms: ZADAXIN plus pegylated interferon alfa-2a or placebo plus pegylated interferon alfa-2a. Patients in both treatment arms will receive 12 months of therapy (the same length of time as the current standard of care). The primary efficacy endpoints will be a sustained virological response and an improvement in histological activity index (HAI). Both primary endpoints will be measured six months after the end of the 12 months therapy, consistent with the FDA standard for demonstrating a sustained response to hepatitis C therapy. A sustained virological response is a qualitative change in the presence of the hepatitis C virus (HCV) RNA from positive to negative -- indicating a disappearance of the virus. HAI is a measure of liver biopsy inflammation and scarring according to the Knodell Score, the current standard used in clinical trials in hepatitis C. Secondary endpoints will be sustained biochemical response (normalization of ALT, a liver enzyme that reflects hepatic inflammation) at the end of the six month follow-up period and therapy efficacy data obtained at the end of the 12 month treatment period.

The first part of the Phase 3 program, led by principal investigator Dr. Adrian DiBisceglie, M.D., Chief of Hepatology at the Saint Louis University and Medical Director of the American Liver Foundation, will focus on non-responders to the current standard of therapy, alpha interferon or alpha interferon plus ribavirin, who do not exhibit signs of liver cirrhosis. A second part of the Phase 3 program, led by principal investigator Kenneth Sherman, M.D., Associate Professor of Medicine and Director of Clinical Trials at the Liver Unit of the University of Cincinnati Medical Center, will focus on non-responders who already exhibit early signs of liver cirrhosis.

"The combination of ZADAXIN, as an immune system enhancer (ISE) with its positive safety profile, plus pegylated interferon alfa-2a offers a promising alternative to current standards of therapy for treating chronic hepatitis C," said Adrian DiBisceglie, M.D. "Despite all available therapies and recent developments, there still remains a significant need for new treatments for hepatitis C patients not responding to conventional therapy."

Hepatitis C, Current Treatment and Previous ZADAXIN Studies

The Centers for Disease Control estimate that up to 4 million people in the U.S. are infected with HCV. In its chronic progression, HCV frequently leads to cirrhosis and liver cancer, both potentially fatal conditions. HCV has now emerged as the leading indication for liver transplantation. No optimal treatment yet exists for chronic HCV. Alpha interferon historically has been the treatment of choice, and increasingly is combined with other therapeutic agents, particularly ribavirin. However, in those 75-80 percent of patients with the most common form of the virus in the U.S., HCV genotype 1, up to 72 percent will not have a sustained clearance of their viral RNA following treatment with alpha interferon and ribavirin. Meta-analyses of studies on re-treatment for 12 months of those non-responders with either alpha interferon alone or in combination with ribavirin has resulted in viral RNA clearance in less than 8 percent of these primary non-responders. Conversely, in a pooled analysis of previous studies with non-responders to standard treatment, the combination of ZADAXIN plus standard alpha interferon demonstrated a 22 percent sustained virological response rate.

ZADAXIN, a synthetic peptide that enhances the immune response, has been administered to over 3,000 subjects in over 70 clinical trials covering a broad range of diseases, and an estimated 7,000 patients commercially, with virtually no serious drug related adverse events or toxicities. ZADAXIN is approved for sale in 20 countries, principally for the treatment of hepatitis B and hepatitis C and as a vaccine adjuvant for patients with weakened immune systems. ZADAXIN is currently in a phase 2 program in the U.S. in combination with lamivudine for the treatment of hepatitis B. In Europe, where SciClone has exclusively partnered with Sigma-Tau S.p.A., a pivotal phase 3 ZADAXIN hepatitis C program will complement the Company`s U.S. hepatitis C program. In Japan, where SciClone has exclusively partnered with Schering-Plough, K.K., ZADAXIN is in a pivotal phase 3 program for hepatitis B and a phase 2 program for hepatitis C.

SciClone Pharmaceuticals is a global specialty pharmaceutical company that develops and commercializes novel medicines for the treatment of a broad range of the world`s most serious diseases. The Company is currently targeting malignant melanoma, liver cancer, hepatitis B, hepatitis C, HIV, drug-resistant tuberculosis and cystic fibrosis. Press releases and corporate information from SciClone Pharmaceuticals 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 includes certain forward-looking statements concerning the Company`s current expectations regarding future events, prospective development and commercialization of ZADAXIN immunotherapy in the U.S., Europe and Japan for cancer, hepatitis B and hepatitis C, the timing of the start of Sigma-Tau`s ZADAXIN phase 3 program for hepatitis C in Europe, the potential for success of the Company`s U.S. phase 2 programs for cancer and hepatitis B and its ZADAXIN phase 3 program for hepatitis C. Due to market factors and the nature of product development and the regulatory approval process, the forward-looking statements contained in this press release are subject to risks and uncertainties, including those reflected in the Company`s filings with the Securities and Exchange Commission.


CONTACT: For further information: Ruth Koh, Investor Relations of SciClone
Pharmaceuticals, 650-358-3437; or Ana Kapor of Noonan Russo Communications,
Inc., 415-677-4455, for SciClone PharmaceuticalsURL: Web site: http://www.sciclone.com
News release via Canada NewsWire, Toronto 416-863-9350 -ME-Copyright (C) 2001 CNW, All rights reserved
-0-

KEYWORD: SAN MATEO, Calif.
INDUSTRY KEYWORD: MTC
BIO
STOCK SYMBOLS: [(scln)]

[CaptainChaos]

Kaufempfehlungen UBS Warburg

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PCLN - Reiterated Hold - patent infringement suit with EXPE settled

CRA - Reiterated Buy - it formed an agreement for subscriptions with Genset

SCLN - Reiterated Buy - Zadaxin in phase III trials

[Togotom]

Nicht nur die News und die Unternehmenszahlen sehen gut aus, sondern auch der Chart. Bodenbildung mit W-Formation. Klarer Fall, es geht Richtung Norden. Ich steige jetzt etwas höher ein.