- Subject: SciClone Obtains First European Marketing Approval and...
- From: AOL News <AOLNews@aol.com>
- Date: Tue, 21 Apr 1998 13:30:26 EDT
- 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
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
04/21/98 13:24 EDT http://www.prnewswire.com
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