TMC435 has Received Fast Track Designation From the FDAandTMC435 Will be Studied in Combination WithPharmasset’s PSI-7977 for HCV genotype-1

By Medivir, PRNE
Tuesday, July 5, 2011

HUDDINGE, Sweden, July 6, 2011 -


Medivir AB (OMX: MVIR), is an emerging research-based specialty
pharmaceutical company focused on infectious diseases.

Medivir today announced that its investigational protease
inhibitor TMC435 has received “Fast Track” designation by the U.S.
Food and Drug Administration (”FDA”) for the treatment of chronic
hepatitis C (CHC) genotype-1 infection. This is based on TMC435’s
potential to address unmet medical needs in the treatment of CHC
infection compared to currently approved therapies.

TMC435 may offer:

  • High sustained virological response (SVR) rates in genotype-1
    HCV-infected patients, including hard-to-treat subgroups
  • Short treatment duration
  • Favourable overall safety and tolerability profile
  • A convenient once-daily (q.d.) dosing regimen

Furthermore, Medivir also confirms the intention to start a
proof-of-concept oral, interferon-free phase 2 trial, investigating
the combination of TMC435, a once daily NS3/4A protease inhibitor
(PI) for the treatment of genotype-1 chronic hepatitis C virus
(HCV) infection and Pharmasset’s PSI-7977, a once daily nucleotide
NS5B polymerase inhibitor. The phase 2 study, which is being
managed by Tibotec Pharmaceuticals, will investigate the efficacy
and safety of 12 weeks or 24 weeks of TMC435 150 mg q.d. in
combination with PSI-7977 400 mg q.d. with or without ribavirin in
prior null responders to peginterferon/ribavirin therapy. The
primary endpoint of the trial will be sustained virological
response at 12 weeks (SVR12).

Bertil Samuelsson, CSO, of Medivir commented, “We are
delighted to have received the Fast Track designation for
TMC435 from the FDA. This shows that TMC435, with its high safety
profile, efficacy, short treatment duration and convenience of once
daily dosing, is believed to have the potential to provide benefit
over current treatments. We believe TMC435 has the potential to
become a cornerstone of future direct-acting antiviral combinations
for HCV therapy. We are thus very pleased over the clinical
collaboration agreement Pharmasset announced today with Tibotec,
and the coming start-up of a TMC435 combination trial with
Pharmasset’s once daily NS5B nucleotide inhibitor PSI-7977. This is
one of several ongoing TMC435 combination trials and we expect the
momentum to continue with regards to the development of

About Fast Track

Fast Track is a process designed to facilitate the
development, and expedite the review of drugs to treat serious
diseases and to fill an unmet medical need. The purpose is to get
important new drugs to the patient earlier. Fast Track
addresses a broad range of serious diseases. “Filling an unmet
medical need” is defined as providing a therapy where none exists
or providing a therapy that may potentially be superior to existing
therapy. If there are existing therapies, a fast track drug must
show some advantage over available treatment, such as:

  • Showing superior effectiveness
  • Avoiding serious side effects of an available treatment
  • Improving the diagnosis of a serious disease where early
    diagnosis results in an improved outcome
  • Decreasing a clinically significant toxicity of an accepted

A drug that receives Fast Track designation is eligible
for some or all of the following:

  • More frequent meetings with the FDA to discuss the drug’s
    development plan and ensure collection of appropriate data needed
    to support drug approval
  • More frequent written correspondence from the FDA about such
    things as the design of the proposed clinical trials
  • Eligibility for Accelerated Approval, i.e., approval on
    an effect on a surrogate or substitute endpoint reasonably likely
    to predict clinical benefit
  • Rolling Review, which means that a drug company can
    submit completed sections of its New Drug Application (NDA) for
    review by FDA, rather than waiting until every section of the
    application is completed before the entire application can be
    reviewed. NDA review usually does not begin until the drug company
    has submitted the entire application to the FDA
  • Dispute resolution if the drug company is not satisfied with an
    FDA decision not to grant Fast Track status.

In addition, most drugs that are eligible for Fast Track
designation are likely to be considered appropriate to receive a
Priority Review.

Once a drug receives Fast Track designation, early and
frequent communication between the FDA and a drug company is
encouraged throughout the entire drug development and review
process. The frequency of communication assures that questions and
issues are resolved quickly, often leading to earlier drug approval
and access by patients.

About TMC435

TMC435, an investigational CHC protease inhibitor currently in
phase 3 clinical development, is a highly potent, selective and
safe once-daily (q.d.) drug jointly developed by Tibotec
Pharmaceuticals to treat chronic hepatitis C virus infections.

TMC435 is being developed in combination with PegIFN/RBV and in
combination with Direct-acting Antiviral (DAA) agents without
peginterferon and with or without ribavirin (RBV). In June 2011 the
combination study of TMC435 with TMC647055, a non-nucleoside NS5B
polymerase inhibitor being developed by Tibotec Pharmaceuticals,
was initiated.

Three global clinical phase 3 response guided studies were
initiated in early 2011 by Tibotec:

  • TMC435-C208 or QUEST-1 includes approximately 375
    treatment-naïve patients
  • TMC435-C216 or QUEST-2 includes approximately 375
    treatment-naïve patients
  • TMC435-C3007 or PROMISE includes approximately 375 who have
    relapsed after prior interferon-based treatment

Phase 3 programs for TMC435 are also ongoing in Japan.

In parallel with the recent start of the global phase 3-studies,
TMC435 is currently in a follow up phase in three phase 2b clinical
trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1
treatment-naïve and in G1 patients that failed previous IFN-based
treatment. More safety and efficacy data from the phase 2b trials
will be presented at scientific meetings later in 2011.

For additional information from these studies, please see href=""> and href="file://C:\Documents%20and%20Settings\Local%20Settings\Temporary%20Internet%20Files\AppData\Local%20Settings\Temporary%20Internet%20Files\AppData\Local\Microsoft\Windows\Temporary%20Internet%20Files\AppData\Local\Microsoft\BERTIL\ADMINISTRATION\Ledningsgrupp\Local%20Settings\chaede.MEDIVIR\AppData\Local\Microsoft\Local%20Settings\Temporary%20Internet%20Files\Local%20Settings\AppData\Local\Local%20Settings\Temporary%20Internet%20Files\Users\E020454\AppData\Local\Microsoft\Windows\E020454\AppData\Local\Microsoft\Documents%20and%20Settings\bhvam\Local%20Settings\Temporary%20Internet%20Files\Local%20Settings\Temporary%20Internet%20Files\OLK5B\">

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and
is a leading cause of chronic liver disease and liver transplants.
The WHO estimates that nearly 180 million people worldwide, or
approximately 3% of the world’s population, are infected with
hepatitis C virus (HCV). The US Centers for Disease Control (”CDC”)
has reported that almost three million people in the United States
are chronically infected with HCV.

About Medivir

Medivir is an emerging research-based specialty pharmaceutical
company focused on the development of high-value treatments for
infectious diseases. Medivir has world class expertise in
polymerase and protease drug targets and drug development which has
resulted in a strong infectious disease R&D portfolio. The
Company’s key pipeline asset is TMC435, a novel protease inhibitor
is in phase 3 clinical development for hepatitis C and is partnered
with Tibotec Pharmaceuticals. In June 2011, Medivir acquired the
specialty pharmaceutical company BioPhausia to ensure timely
commercialization of TMC435 in the Nordic markets, once

Medivir’s first product, the unique cold sore product
Xerese™/Xerclear® was launched on the US market in
February 2011. Xerese™/Xerclear®, which has been
approved in both the US and Europe is partnered with
GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights
in North America, Canada and Mexico have recently been sold to Meda
AB. Medivir has retained the Rx rights for Xerclear® in
Sweden and Finland.

For more information about Medivir, please visit the
s website: href="">

For more information about Medivir, please contact:

Medivir ( href="">  
Rein Piir, CFO & VP Investor Relations    
Mobile: +46-708-537-292

Peter Laing / Amber Bielecka / Katja Toon

USA: Roland Tomforde          


will not be displayed