SangStat and Gensia Sicor Announce FDA Approval of Bulk Cyclosporine Drug Substance; SangStat's Marketing Application for Finished Cyclosporine Drug Product Under Review at FDA
Looks like I'm getting more than $5. Roader
Business Wire via Dow Jones
MENLO PARK and SAN DIEGO, Calif.--(BUSINESS WIRE)--July 7, 1997-- SangStat,
The Transplant Company(R) (NASDAQ:SANG) and Gensia Sicor Inc. (NASDAQ:GNSA)
announced today that SICOR S.p.A., Gensia Sicor's wholly owned subsidiary, has
received approval of an Abbreviated Antibiotic Drug Application from the Food
and Drug Administration (FDA) for the manufacture of bulk cyclosporine drug
substance. SangStat's AADA for U.S. marketing clearance of its finished
CYCLOSPORINE drug product, using SICOR's bulk cyclosporine drug substance, is
currently under review at the FDA.
"We are pleased with the timely U.S. approval for this difficult to
manufacture bulk cyclosporine drug substance. We look forward to meeting
SangStat's future cyclosporine drug substance requirements, subject to FDA
approval of their pending market clearance application," said David F. Hale,
President and Chief Executive Officer of Gensia Sicor.
"The FDA's approval of the bulk cyclosporine drug substance, which is the
active ingredient in our proprietary formulation, represents a major step in the
U.S. regulatory review process for our finished CYCLOSPORINE drug product," said
Philippe Pouletty, M.D., SangStat's Chairman and Chief Executive Officer.
The regulatory process for SICOR's bulk cyclosporine drug substance consisted
of a review and approval of an abbreviated antibiotic drug application. This
application had to contain information to ascertain that this cyclosporine is
identical to the USP reference standard cyclosporine. It included the
characterization of the cyclosporine molecule, analytical methods used to
elucidate cyclosporine structure and purity, determination and documentation of
the purity according to the USP standards. The application also contained
information on the manufacturing and purification of several lots of the drug
substance to show lot-to-lot reproducibility, stability data and validation
reports.
SICOR supplied the cyclosporine bulk drug substance for manufacture of the
exhibit batch used in SangStat's pivotal CYCLOSPORINE bioequivalence human
trials, but these bioequivalence data were not reviewed as part of SICOR's bulk
drug substance application. These bioequivalence data were submitted separately
in SangStat's AADA for the finished CYCLOSPORINE drug product in November 1996
and are currently under review at the FDA.
SangStat has spent several years developing its proprietary finished
CYCLOSPORINE drug product, and has agreements with prominent manufacturing
partners for the production of CYCLOSPORINE clinical trial supplies and future
commercial product. SangStat chose Gensia Sicor, a worldwide supplier of
specialty bulk pharmaceuticals, as the manufacturer of the bulk cyclosporine
drug substance which is to be used in the production of finished product, when
approved, for subsequent commercial sale and distribution worldwide by SangStat.
SangStat continues to retain worldwide commercial rights for its proprietary
CYCLOSPORINE formulation.
Cyclosporine is the leading immunosuppressive drug used in transplantation to
prevent graft rejection. Cyclosporine is marketed by Novartis, Ltd. in
different formulations as Sandimmune(R) and Neoral(R) with reported worldwide
sales of $1.2 billion in 1996. In the United States and Europe, there are more
than 200,000 transplant recipients requiring daily immunosuppressive therapy for
the rest of their lives, the majority of whom take cyclosporine.
SangStat is a specialty pharmaceutical company applying a disease management
approach to improve the outcome of organ transplantation. The Company has a
total of 12 monitoring and therapeutic products and product candidates to
address the pre-transplant, acute care and chronic phases of transplantation.
SangStat is located in Menlo Park, California., and operates The Transplant
Pharmacy(TM), a comprehensive pilot pharmacotherapy management program, and
wholly-owned subsidiaries, SangStat Atlantique S.A., SangStat's European base of
operation in Nantes, France, SangStat Canada, Ltd. in Mississauga, Ontario,
Canada and XenoStat, Inc., in Menlo Park, California.
Gensia Sicor Inc. is a specialty pharmaceutical company focused on the
development, manufacture and marketing of pharmaceutical products for the
worldwide oncology and injectable pharmaceutical markets. Gensia Sicor's
commercial pharmaceutical businesses include Gensia Laboratories, Ltd., a
California based manufacturer and marketer of multisource injectable drugs,
SICOR-Societa Italiana Corticosteroidi S.p.A. in Milan, Italy, and Sicor de
Mexico, S.A. de C.V. in Toluca, Mexico which produce specialty bulk drug
substances, and Lemery, S.A. de C.V. in Mexico City which manufactures
injectable and oral finished multisource drug products.
This press release contains forward-looking statements that involve risks and
uncertainties. Forward-looking statements reflect SangStat's and Gensia Sicor's
current views with respect to future events. Actual results may vary materially
and adversely from those anticipated, believed, estimated, or otherwise
indicated. Important factors common to the FDA drug review and approval process
could cause actual results to differ materially with regard to the approvability
and possible market acceptance of SangStat's finished CYCLOSPORINE drug product.
These factors include, without limitation: (1) that data obtained from clinical
trials are subject to varying interpretations, and there can be no assurance
that the FDA (or an FDA panel of experts) will agree with SangStat's assessment
of clinical trial results; (2) that there can be no assurance that the agency
will not issue new guidelines, guidance documents, policies, or regulations or
otherwise have new, different or previously unknown requirements that may
materially affect the approvability of the product; and (3) that there can be no
assurance of FDA approval of the product. Other factors that could cause actual
results to differ materially include, without limitation, uncertainty related to
the difficulty of manufacturing commercial quantities of CYCLOSPORINE, market
acceptance and potential litigation. For a discussion of other factors that
might result in different outcomes, see SangStat's 1996 Annual Report, in
particular "Risks Associated With CYCLOSPORINE" set forth therein, and
Sangstat's and Gensia Sicor's filings on Form 10-K and 10-Q with the Securities
and Exchange Commission.
CONTACT: SangStat
Maree Wall, 415/328-0300 ext. 331
maree_wall@sangstat.com
or
Gensia Sicor
Martha Hough/Claudia Baranowski, 619/546-8300
martha.hough@gensia.com |
