CLIN: Clinigen Group plc: Clinigen Group and Theravance Entered into Exclusive Commercialization Agreement in the EU for

  CLIN: Clinigen Group plc: Clinigen Group and Theravance Entered into
  Exclusive Commercialization Agreement in the EU for Antibacterial VIBATIV®

UK Regulatory Announcement


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

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® (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® 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® 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®, ranging from 20% to 30%. The
agreement has a term of at least 15 years, with an option to extend
exercisable by Clinigen.

“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® and
Foscavir® while leveraging their operational synergies. VIBATIV® is a second
product for Clinigen’s Specialty Pharmaceuticals (SP) portfolio, complementing
the division’s anti-viral product, Foscavir®.”

“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®,” said Rick
E Winningham, Chief Executive Officer of Theravance. “We look forward to
working with Clinigen in making VIBATIV® available to patients with nosocomial
pneumonia in the EU."

About VIBATIV® (telavancin)

VIBATIV® is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic
with a dual mechanism of action whereby VIBATIV® both inhibits bacterial cell
wall synthesis and disrupts bacterial cell membrane function. VIBATIV®,
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® 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® because the former VIBATIV® drug product supplier,
Ben Venue Laboratories, Inc., at that time did not meet current Good
Manufacturing Practice requirements for the manufacture of VIBATIV®.
Theravance is currently working on re-establishing consistent product supply
that will meet European Commission requirements.

VIBATIV® Important Safety Information (US)

Fetal Risk

Women of childbearing potential should have a serum pregnancy test prior to
administration of VIBATIV®. Avoid use of VIBATIV® 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® treatment.


New onset or worsening renal impairment occurred in patients who received
VIBATIV®. 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® prior to
initiation of treatment, during treatment, and at the end of therapy. If renal
function decreases, the benefit of continuing VIBATIV® 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 ≤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 group.

Infusion Related Reactions

VIBATIV® 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® 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® may result in overgrowth of
nonsusceptible organisms, including fungi.

QTc Prolongation

Caution is warranted when prescribing VIBATIV® to patients taking drugs known
to prolong the QT interval. In a study involving healthy volunteers, VIBATIV®
prolonged the QTc interval. Use of VIBATIV® 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® 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 VIBATIV®.

Adverse Reactions

The most common adverse reactions (≥10% of patients treated with VIBATIV®)
observed in the Phase 3 cSSSI clinical trials were taste disturbance, nausea,
vomiting, and foamy urine.

In the Phase 3 cSSSI clinical trials, serious adverse events were reported in
7% of patients treated with VIBATIV® 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®, 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™ or BREO™
(FF/VI), ANORO™ (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

registered trademarks of Theravance, Inc.

RELVAR™ or BREO™ (FF/VI) and ANORO™ (UMEC/VI) are investigational medicines
and are not currently approved anywhere in the world. RELVAR™, BREO™ and
ANORO™ are trademarks of the GlaxoSmithKline group of companies. The use of
these brand names has not yet been approved by any regulatory authority.

VIBATIV® 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®, 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® 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®), 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

David Bryant, Global Business
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       Email:
Theravance, Inc.
                                    Tel: +1 650-808-4100
Michael W. Aguiar
Senior Vice President and Chief
Financial Officer


Clinigen Group plc
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