TOKYO, Japan and SOUTH SAN FRANCISCO, CA/January 6, 2012 -
Astellas Pharma Inc. (Astellas) (Tokyo:4503) and Theravance,
Inc. (NASDAQ: THRX) today announced that Astellas has
exercised its right to terminate the global License,
Development and Commercialization Agreement for
VIBATIV® (telavancin) for injection, a
bactericidal, once-daily lipoglycopeptide antibiotic
discovered by Theravance.
Theravance is evaluating global commercialization
alternatives for VIBATIV either alone or with partners.
The rights granted to Astellas ceased upon termination of the
Agreement and Astellas has stopped promotional sales efforts.
Pursuant to the terms of the Agreement, there are no
termination payments required by either party and Astellas is
entitled to a ten-year,
2% royalty on net sales of VIBATIV.
To support a smooth transition, Astellas will transfer
inventory to Theravance, manage certain clinical and
regulatory activities and respond to medical inquiries with
respect to VIBATIV until no later than March 31, 2012.
"We are proud of the important milestones we have
achieved for patients throughout our partnership and are
committed to working with Theravance to ensure a smooth
transition," said Yoshihiko Hatanaka, Chief Executive Officer
of Astellas.
"We believe that VIBATIV is an important, life-saving
medicine, and we appreciate Astellas' commitment to a smooth
transition. We will continue the focus on re-establishing
consistent VIBATIV product supply. We will assess strategic
alternatives for VIBATIV, including repartnering, and will
provide updates later this year," said Rick E Winningham,
Chief Executive Officer of Theravance.
In September 2011 VIBATIV was approved in Europe for the
treatment of adults with nosocomial pneumonia, including
ventilator-associated pneumonia, known or suspected
to be caused by methicillin-resistant Staphylococcus aureus
(MRSA) when other
alternatives are not suitable. This approval included all
member states of the EU, Norway and Iceland. VIBATIV was not
approved for complicated skin and soft tissue infections in
Europe.
VIBATIV was approved in Canada in September 2009 for the
treatment of patients with complicated skin and skin
structure infections (cSSSI) caused by susceptible strains of
certain Gram-positive bacteria, including MRSA.
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VIBATIV was approved and launched in the United States in 2009 for the treatment of adult patients with cSSSI caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both MRSA and methicillin-susceptible (MSSA) strains. In January 2009 Theravance filed an NDA for approval of VIBATIV for treatment of patients with nosocomial pneumonia, which has not been approved.
For full Prescribing Information, including Boxed Warning and Medication Guide in the
U.S., please visit www.VIBATIV.com.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a
pharmaceutical company dedicated to improving the health of
people around the world through the provision of innovative
and reliable pharmaceuticals. Astellas has approximately
16,800 employees worldwide. The organization is committed to
becoming a global category leader in Urology; Immunology,
including Transplantation and Infectious Diseases; Oncology;
Neuroscience and DM Complications and Metabolic Diseases. For
more information on Astellas Pharma Inc., please visit the
company website at www.astellas.com/en.
VIBATIV® is a registered trademark of Astellas
Pharma Inc.
Theravance is a biopharmaceutical company with a pipeline of
internally discovered product candidates and strategic
collaborations with pharmaceutical companies. Theravance is
focused on the discovery, development and commercialization
of small molecule medicines across a number of therapeutic
areas including respiratory disease, bacterial infections,
and central nervous system (CNS)/pain. The Company's key
programs include: RELOVAIR™, LAMA/LABA
('719/vilanterol (VI)) and MABA (Bifunctional Muscarinic
Antagonist-Beta2 Agonist), each partnered
with
GlaxoSmithKline plc, and its oral Peripheral Mu Opioid
Receptor Antagonist (PµMA) program. By leveraging its
proprietary insight of multivalency to drug discovery,
Theravance is pursuing a best-in-class strategy designed to
discover superior medicines in areas of significant unmet
medical need. For more information, please visit the
company's web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES
THAT MAKE A DIFFERENCE®
are registered trademarks of Theravance, Inc.
RELOVAIRTM is a trademark of
GlaxoSmithKline.
This press release contains certain "forward-looking"
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995 regarding, among other things,
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statements relating to goals, plans, objectives and future
events. Theravance intends such forward-looking statements to
be covered by the safe harbor provisions for forward- looking
statements contained in Section 21E of the Exchange Act and
the Private Securities Litigation Reform Act of 1995.
Examples of such statements include statements relating to
the timing of product commercialization, statements regarding
the potential benefits and mechanisms of action of drug
candidates, statements concerning enabling capabilities of
Theravance's approach to drug discovery and its
proprietary insights, and statements regarding expectations
for product candidates through development and
commercialization and projections of revenue, expenses and
other
financial items. These statements are based on the current
estimates and assumptions of the management of Theravance as
of the date of this press release and are subject to risks,
uncertainties, changes in circumstances, assumptions and
other factors that may cause the actual results of Theravance
to be materially different from those reflected in its
forward-looking statements. Important factors that could
cause actual results to differ materially from those
indicated by such forward-looking statements include,
among
others, risks related to delays or failure to achieve
regulatory approvals for product candidates, risks of relying
on third-party manufacturers for the supply of our product
and product candidates and risks of collaborating with third
parties to develop and commercialize products. These and
other risks are described in greater detail under the heading
"Risk Factors" contained in Theravance's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) on November 2, 2011 and the risks discussed
in our other period filings with SEC. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. Theravance assumes no obligation
to update its forward-looking statements.
Senior Vice President and Chief Financial Officer
650-808-4100 investor.relations@theravance.com
Jenny Kite
Corporate Communications, Astellas US LLC
847-317-5450
Jenny.Kite@us.astellas.com
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