Clinigen and Theravance Announce Exclusive Commercialization Agreement in the EU for VIBATIV(R) (telavancin)

Clinigen and Theravance Announce Exclusive Commercialization Agreement in the 
EU for VIBATIV(R) (telavancin) 
(Marketwire) -- 03/11/13 --  Clinigen Group plc (LSE: CLIN) (AIM:
CLIN) and Theravance, Inc. (NASDAQ: THRX) today announced that they
have entered into an exclusive commercialization agreement in the
European Union (EU) and certain other countries located in Europe for
VIBATIV(R) (telavancin) for the treatment of nosocomial pneumonia
(hospital-acquired), including ventilator-associated pneumonia, known
or suspected to be caused by methicillin resistant Staphylococcus
aureus (MRSA) when other alternatives are not suitable. VIBATIV(R) is
a bactericidal, once-daily injectable lipoglycopeptide antibacterial
agent with a dual mechanism of action against Gram-positive bacteria,
including resistant pathogens such as MRSA. 
Under the terms of the agreement, Theravance has granted Clinigen
exclusive commercialization rights to VIBATIV(R) in the EU and
certain other European countries (including Switzerland and Norway).
In exchange, Theravance will receive a $5 million upfront payment
from Clinigen and is entitled to receive tiered royalties on net
sales of VIBATIV(R), ranging from 20% to 30%. The agreement has a
term of at least 15 years, with an option to extend exercisable by
"We are pleased to have Theravance, a leader in antibiotic
development, as a license partner," said Peter George, Chief
Executive Officer of Clinigen. "This agreement is of strategic
importance to us as it not only strengthens our anti-infective
offering with a product that has patent protection into the next
decade, but it is an exciting opportunity to commercialize VIBATIV(R)
and Foscavir(R) while leveraging their operational synergies.
VIBATIV(R) is a second product for Clinigen's Specialty
Pharmaceuticals (SP) portfolio, complementing the division's
anti-viral product, Foscavir(R)."  
"We are very excited to partner with Clinigen and we believe that its
innovative business model and experience in specialty pharmaceuticals
provide an ideal platform to maximize the growth opportunity for
VIBATIV(R)," said Rick E Winningham, Chief Executive Officer of
Theravance. "We look forward to working with Clinigen in making
VIBATIV(R) available to patients with nosocomial pneumonia in the
About VIBATIV(R) (telavancin) 
VIBATIV(R) is a bactericidal, once-daily, injectable lipoglycopeptide
antibiotic with a dual mechanism of action whereby VIBATIV(R) both
inhibits bacterial cell wall synthesis and disrupts bacterial cell
membrane function. VIBATIV(R), discovered and developed by
Theravance, is approved in the United States for the treatment of
adult patients with complicated skin and skin structure infections
(cSSSI) caused by susceptible isolates of Gram-positive bacteria,
including Staphylococcus aureus, both methicillin-susceptible (MSSA)
and methicillin-resistant (MRSA) strains, since 2009. In 2011, the
European Commission granted marketing authorization for VIBATIV(R)
for the treatment of nosocomial pneumonia (hospital-acquired),
including ventilator-associated pneumonia, known or suspected to be
caused by MRSA when other alternatives are not suitable. In May 2012,
the European Commission suspended marketing authorization for
VIBATIV(R) because the former VIBATIV(R) drug product supplier, Ben
Venue Laboratories, Inc., at that time did not meet current Good
Manufacturing Practice requirements for the manufacture of
VIBATIV(R). Theravance is currently working on re-establishing
consistent product supply that will meet European Commission
VIBATIV(R) Important Safety Information (US) 
Fetal Risk 
Women of childbearing potential should have a serum pregnancy test
prior to administration of VIBATIV(R). Avoid use of VIBATIV(R) during
pregnancy unless the potential benefit to the patient outweighs the
potential risk to the fetus. Adverse developmental outcomes observed
in three animal species at clinically relevant doses raise concerns
about potential adverse developmental outcomes in humans. If not
already pregnant, women of childbearing potential should use
effective contraception during VIBATIV(R) treatment. 
New onset or worsening renal impairment occurred in patients who
received VIBATIV(R). Renal adverse events were more likely to occur
in patients with baseline comorbidities known to predispose patients
to kidney dysfunction and in patients who received concomitant
medications known to affect kidney function. Monitor renal function
in all patients receiving VIBATIV(R) prior to initiation of
treatment, during treatment, and at the end of therapy. If renal
function decreases, the benefit of continuing VIBATIV(R) versus
discontinuing and initiating therapy with an alternative agent should
be assessed. Clinical cure rates in telavancin-treated patients were
lower in patients with baseline CrCl less than or equal to 50 mL/min
compared to those with CrCl >50 mL/min. Consider these data when
selecting antibacterial therapy for use in patients with baseline
moderate/severe renal impairment.  
Geriatric Use  
Telavancin is substantially excreted by the kidney, and the risk of
adverse reactions may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased
renal function, care should be taken in dose selection in this age
Infusion Related Reactions 
VIBATIV(R) is a lipoglycopeptide antibacterial agent and should be
administered over a period of 60 minutes to reduce the risk of
infusion-related reactions. Rapid intravenous infusions of the
glycopeptide class of antimicrobial agents can cause "Red-man
Syndrome" like reactions including: flushing of the upper body,
urticaria, pruritus, or rash.  
Clostridium difficile-Associated Diarrhea  
Clostridium difficile-associated diarrhea (CDAD) has been reported
with nearly all antibacterial agents and may range in severity from
mild diarrhea to fatal colitis. CDAD must be considered in all
patients who present with diarrhea following antibiotic use. 
Development of Drug-Resistant Bacteria 
Prescribing VIBATIV(R) in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria. As with other antibacterial drugs, use of VIBATIV(R) may
result in overgrowth of nonsusceptible organisms, including fungi.  
QTc Prolongation 
Caution is warranted when prescribing VIBATIV(R) to patients taking
drugs known to prolong the QT interval. In a study involving healthy
volunteers, VIBATIV(R) prolonged the QTc interval. Use of VIBATIV(R)
should be avoided in patients with congenital long QT syndrome, known
prolongation of the QTc interval, uncompensated heart failure, or
severe left ventricular hypertrophy. 
Coagulation Test Interference 
VIBATIV(R) does not interfere with coagulation, but does interfere
with certain tests used to monitor coagulation such as prothrombin
time, international normalized ratio, activated partial
thromboplastin time, activated clotting time, and coagulation based
factor Xa tests. Blood samples for these coagulation tests should be
collected as close as possible prior to a patient's next dose of
Adverse Reactions 
The most common adverse reactions (greater than or equal to 10% of
patients treated with VIBATIV(R)) observed in the Phase 3 cSSSI
clinical trials were taste disturbance, nausea, vomiting, and foamy
In the Phase 3 cSSSI clinical trials, serious adverse events were
reported in 7% of patients treated with VIBATIV(R) and most commonly
included renal, respiratory, or cardiac events. Serious adverse
events were reported in 5% of vancomycin-treated patients, and most
commonly included cardiac, respiratory, or infectious events. 
For full Prescribing Information, including Boxed Warning and
Medication Guide in the US, please visit 
About Clinigen  
Clinigen is a specialty global pharmaceutical products and services
business headquartered in the UK, with offices in the US and Japan.
The Group has three operating business; Specialty Pharmaceuticals
(SP), Clinical Trials Supply (Clinigen CTS), and Global Access
Programs (Clinigen GAP). The SP business focuses on acquiring and in
licensing specialist, hospital only medicines worldwide and
commercializing them within niche markets. The lead product is the
anti-infective, Foscavir(R), acquired from AstraZeneca in 2010. For
more information, please visit 
About Theravance 
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.
Theravance's key programs include: RELVAR(TM) or BREO(TM) (FF/VI),
ANORO(TM) (UMEC/VI) and MABA (Bifunctional Muscarinic
Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc,
and its oral Peripheral Mu Opioid Receptor Antagonist 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 Theravance's web site at  
THERAVANCE(R), the Theravance logo, and MEDICINES THAT MAKE A
DIFFERENCE(R) are registered trademarks of Theravance, Inc.  
investigational medicines and are not currently approved anywhere in
the world. RELVAR(TM), BREO(TM) and ANORO(TM) are trademarks of the
GlaxoSmithKline group of companies. The use of these brand names has
not yet been approved by any regulatory authority.  
VIBATIV(R) is a registered trademark of Theravance, Inc.  
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, 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 Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. Examples of such statements include
statements relating to the status and timing of clinical studies,
data analysis and communication of results, statements regarding the
potential benefits and mechanisms of action of drug candidates,
statements concerning the timing of seeking regulatory approval of
our product candidates (including, with respect to VIBATIV(R),
statements regarding any expectation (a) that we will be able to
respond fully or adequately to FDA's requests using currently
existing clinical data, (b) that the FDA will approve the VIBATIV(R)
nosocomial pneumonia NDA on the basis of existing preclinical and
clinical data or at all or (c) regarding the timing of the European
Commission releasing the suspended marketing authorization for
VIBATIV(R)), statements concerning the enabling capabilities of
Theravance's approach to drug discovery and its proprietary insights,
statements concerning expectations for the discovery, development and
commercialization of product candidates, 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
difficulties in commencing or completing clinical and non-clinical
studies, the potential that results of clinical or non-clinical
studies indicate product candidates are unsafe or ineffective, our
dependence on third parties in the conduct of our clinical studies,
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 discover, develop and
commercialize products. These and other risks are described in
greater detail under the heading "Risk Factors" contained in
Theravance's Annual Report on Form 10-K filed with the Securities and
Exchange Commission (SEC) on February 26, 2013 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.  
Contact Details 
Clinigen Group plc
Tel: +44 (0) 1283 495 010
Peter George
Group Chief Executive Officer 
Anton Jenkins
Chief Operating Officer 
David Bryant
Global Business Director  
Numis Securities Limited
Tel: +44 (0) 20 7260 1000
Michael Meade/Freddie Barnfield (Nominated Adviser) 
James Black/Tom Ballard (Corporate Broking) 
College Hill (media relations)
Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell/Stefanie Bacher
Theravance, Inc.
Michael W. Aguiar 
Senior Vice President and Chief Financial Officer
Tel: +1 650-808-4100 
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