Message #46 From:
NewsBot Date: January 4, 2007 05:30:00 AM
OSCI News Oscient Pharmaceuticals and Menarini Group Enter into European Commercialization Agreement for FACTIVE Tablets
WALTHAM, Mass.--(BUSINESS WIRE)--Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) has granted the
commercialization rights to FACTIVE(R) (gemifloxacin mesylate) tablets
in Europe to Menarini Group, a leading European pharmaceutical company
based in Italy. Menarini, with broad sales and marketing coverage
throughout Europe, has the fourth largest pharmaceutical sales force in
Europe and is second largest in terms of calls to primary care
physicians.
“With this agreement, we have successfully
granted FACTIVE commercialization rights in all of our licensed
territories to leading pharmaceutical companies –
a key step in building FACTIVE as a global brand,”
stated Steven M. Rauscher, President and Chief Executive Officer of
Oscient Pharmaceuticals. “Menarini, with
regulatory and marketing expertise that has helped build a portfolio of
57 products, is one of the fastest growing pharmaceutical companies in
Europe and is extremely well-positioned to pursue approval and launch
FACTIVE into the European market.”
In exchange for European rights, Menarini has agreed to make an upfront
payment, as well as a series of payments upon achievement of regulatory,
reimbursement and sales milestones. In addition, Menarini will pay
Oscient for product supply at a transfer price that includes product
costs and compensation to Oscient. Menarini will pursue European
regulatory approval in coordination with Oscient and will have access to
the clinical trial dossier for FACTIVE and the post-marketing data from
use in the U.S. market. As part of the regulatory collaboration, Oscient
will reimburse Menarini for regulatory expenses up to an agreed limit.
Additional financial terms were not disclosed.
Oscient licensed the rights to commercialize FACTIVE in North America
and Europe from LG Life Sciences. As recently announced, Oscient has
restructured its license agreement with LG Life Sciences to include over
40 countries in Europe, including all of the current members of the
European Union. The antibiotic market in Europe is estimated at $5
billion, with France, Germany, Italy and Spain representing the largest
markets. FACTIVE is not currently approved for use in Europe. In 2006,
Oscient forged partnerships for the commercialization of the drug in
Mexico and Canada. Pfizer, S.A. de C.V. has launched FACTIVE in Mexico
and Abbott Canada is planning to launch FACTIVE in Canada early this
year.
About Menarini
The Menarini Group is a privately owned pharmaceutical company
headquartered in Florence, Italy. Menarini employs approximately 12,500
people, with a strong presence in Western and Eastern Europe, Asia and
Central America. In addition to advancing products through internal
research and development, Menarini has strong experience in seeking
regulatory approval and marketing in-licensed products from a large
number of pharmaceutical companies. In 2006, the Menarini Group
generated revenue of $3.1 billion.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage
biopharmaceutical company marketing two FDA-approved products with its
national primary care sales force. ANTARA(R) (fenofibrate) capsules is
indicated for the adjunct treatment of hypercholesterolemia (high blood
cholesterol) and hypertriglyceridemia (high triglycerides) in
combination with diet. FACTIVE(R) (gemifloxacin mesylate) tablets is an
antibiotic approved for the treatment of acute bacterial exacerbations
of chronic bronchitis and community-acquired pneumonia of mild to
moderate severity. Oscient also has a novel, late-stage antibiotic
candidate, Ramoplanin, under investigation for the treatment of
Clostridium difficile-associated disease (CDAD).
For important information regarding the safety and use of ANTARA and
FACTIVE, please see the full prescribing information available at www.antararx.com
and www.factive.com.
Forward-Looking Statement
This news release contains forward-looking statements made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including statements relating to (i)the possible regulatory
approval of FACTIVE in Europe and the timing and nature of future
European commercialization of FACTIVE, and (ii)the planned launch of
FACTIVE in Canada. Forward-looking statements represent our management’s
judgment regarding future events. Forward-looking statements typically
are identified by use of terms such as “may,”“will,”“should,”“plan,”“expect,”“intend,”“anticipate,”“estimate,” and
similar words, although some forward-looking statements are expressed
differently. We do not plan to update these forward-looking statements.
You should be aware that our actual results could differ materially from
those contained in the forward-looking statements due to a number of
risks affecting our business. These risks include, but are not limited
to (i) our ability to successfully commercialize and market ANTARA or
FACTIVE due to: the limitations on our resources and experience in the
commercialization of products; lack of acceptance by physicians,
patients and third party payors; unanticipated safety, product
liability, efficacy, or other regulatory issues; delays in recruiting
and training sales personnel; problems relating to manufacturing or
supply; delays in the supply of products by the third party
manufacturers and suppliers on which we rely; inadequate distribution of
the products by wholesalers, pharmacies, hospitals and other customers;
and competition from other products; (ii) whether we will be able to
expand the indications for which FACTIVE is approved; (iii) the delay in
or inability to obtain additional regulatory approvals of our products
and product candidates due to negative, inconclusive or insufficient
results in ongoing or future clinical trials, the FDA requiring
additional information or data, delays in the progress of ongoing
clinical trials, safety concerns arising with respect to our products or
product candidates and disputes with the third parties from whom we
license our products or product candidate; (iv) delays by the FDA; (v)
the Company's inability to raise additional capital on favorable terms
or at all and (vi) claims against us by third parties, including claims
relating to our intellectual property position. Additional factors that
could cause actual results to differ materially from those projected or
suggested in any forward-looking statements are described under the
heading “Risk Factors”
in the Company’s Quarterly Report on Form
10-Q for the quarter ending September 30, 2006 and in other filings that
we may make with the Securities and Exchange Commission from time to
time.