Re: [MOL] Fwd: SciClone Obtains First European Marketing Approval and... [07866] Medicine On Line


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Re: [MOL] Fwd: SciClone Obtains First European Marketing Approval and...



Dear Diana,

Thank you so very much for that information. Doesn't it seem strange and
sometimes disheartening, a smaller, much smaller country than ours is so
far ahead in research for certain diseases. I just can't understand it.
But, I am glad that there are many countries involved in seeing and
researching to goals of wellness.

God Bless and thank you for that.
marty


LINHILLIS wrote:
> 
> Dear All
> 
> FYI and file
> Diana
> 
>     ---------------------------------------------------------------
> 
> Subject: SciClone Obtains First European Marketing Approval and...
> Date: Tue, 21 Apr 1998 13:30:26 EDT
> From: AOL News <AOLNews@aol.com>
> Organization: AOL (http://www.aol.com)
> 
> SciClone Obtains First European Marketing Approval and New Drug Application
> For ZADAXIN(R) Thymosin Alpha 1
> 
> - Deal Positions the Company for a U.S. and
> 
> Pan European Partnering Arrangement -
> 
>  SAN MATEO, Calif., April 21 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq:
> SCLN) today announced the signing of an agreement with Sclavo S.p.A., an
> international pharmaceutical company, providing for SciClone's acquisition of
> Sclavo's marketing approval for ZADAXIN thymosin alpha 1 in Italy as an
> influenza vaccine adjuvant.  This agreement also includes a marketing
> application for use of ZADAXIN to treat non-small cell lung cancer, as well as
> all of Sclavo's development and marketing rights to ZADAXIN in Spain and
> Portugal.
> 
> Previously, Sclavo held all rights to ZADAXIN in Italy, Spain and Portugal
> under a sublicense which SciClone acquired in 1997.  This agreement terminates
> the sublicense and enables SciClone to pursue a corporate partnering
> arrangement for development and marketing of ZADAXIN in combination with
> interferon for treatment of hepatitis C and other indications throughout the
> entire European Union and the U.S.
> 
> "This acquisition and entry into Europe is another significant step in
> SciClone's strategy to capitalize on the commercial potential of ZADAXIN
> worldwide," said Donald Sellers, SciClone's President and Chief Executive
> Officer.  "Italy is a key market for ZADAXIN, representing well over 60% of
> the potential European market for viral hepatitis therapies, especially
> hepatitis C, our target indication in the U.S. and Europe."
> 
> Under the agreement, which is subject to certain standard closing conditions,
> the aggregate purchase price is approximately $1.84 million, consisting of
> approximately $296,000 in cash, 375,000 shares of SciClone common stock
> (valued at approximately $1.54 million at market close on April 20, 1998) and
> two-year warrants to purchase 375,000 shares of SciClone common stock at an
> exercise price of $4.125 per share, subject to certain standard adjustments.
> The acquisition is expected to close in May 1998.
> 
> SciClone markets ZADAXIN in the People's Republic of China, the Philippines
> and Singapore for the treatment of hepatitis B.  In February 1998, ZADAXIN was
> approved in Argentina and Peru as an influenza vaccine adjuvant and for
> hepatitis B, respectively.  In March 1998, ZADAXIN was approved in Kuwait for
> hepatitis B.  SciClone has 17 ZADAXIN market applications pending in Asia,
> Latin America and the Middle East.  In Japan, SciClone's exclusive Japanese
> partner, Schering-Plough K.K. (SPKK), the Japanese subsidiary of Schering-
> Plough Corporation (NYSE: SGP), has received government approval to commence a
> pivotal Phase 3 study of ZADAXIN for hepatitis B.  SPKK recently started a
> Phase 2 study of ZADAXIN as a monotherapy for hepatitis C.  In the U.S. and
> Europe, SciClone is planning a pivotal Phase 3 study of ZADAXIN in combination
> with interferon for hepatitis C.
> 
> SciClone Pharmaceuticals, Inc. is an international biopharmaceutical company
> that acquires, develops and commercializes specialist-oriented drugs for
> treating chronic and life-threatening diseases, including hepatitis B,
> hepatitis C, cystic fibrosis, cancer and immune system disorders.
> 
> Press releases and corporate information from SciClone Pharmaceuticals, Inc.
> are available on the Internet at www.sciclone.com and by fax at 800-996-7256.
> 
> The statements made in this press release contain certain forward looking
> statements that involve a number of risks and uncertainties, including without
> limitation, those associated with regulatory approvals in other markets and
> market acceptance in those markets where regulatory approvals are obtained.
> Actual events or results may differ from the Company's expectations.  In
> addition to the matters described in this release, future actions by the Food
> and Drug Administration or equivalent regulatory authorities in foreign
> countries, results of pending or future clinical trials, as well as the risk
> factors listed from time to time in the Company's SEC reports, including but
> not limited to its Annual Report on Form 10-K, may affect the actual results
> achieved by the Company.
> 
> SOURCE  SciClone Pharmaceuticals
> 
> CO:  SciClone Pharmaceuticals
> 
> ST:  California
> 
> IN:  MTC
> 
> SU:  PDT
> 
> 04/21/98 13:24 EDT http://www.prnewswire.com
> 
> To edit your profile, go to keyword <A HREF="aol://1722:NewsProfiles">
> NewsProfiles</A>.
> For all of today's news, go to keyword <A HREF="aol://1722:News">News</A>.
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