TMC435 for HCV Gets Fast Tracked, Studied with PSI-7977

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TMC435 for HCV Gets Fast Tracked, Studied with PSI-7977

Details Category: Experimental HIV Drugs Published on Tuesday, 12 July 2011

00:00 Written by Liz Highleyman . .

HCV © Kightley

The HCV NS3/4A protease inhibitor TMC435 was recently given FDA Fast Track

status for expedited approval; it will be studied in an all-oral regimen with

the HCV polymerase inhibitor PSI-7977.

showed good activity when combined with pegylated interferon plus ribavirin in

the Phase 2b ASPIRE trial, as reported at the European Association for the Study

of the Liver's International Liver Congress (EASL 2011) in April.

But many people with chronic hepatitis C are eager for all-oral regimens that

will offer a greater likelihood of a cure without the difficult side effects of

interferon.

Below is an edited excerpt from a press release issued by Medivir, which is

jointly developing TMC435 in collaboration with Tibotec.

Medivir: TMC435 Has Received Fast Track Designation from the FDA and TMC435 Will

be Studied in Combination with Pharmasset's PSI-7977 for HCV Genotype-1

Huddinge, Sweden -- July 6, 2011 -- Medivir AB (sto:MVIRB)(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

Favorable 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 sson, 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 TMC435 "

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 treatment

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-naive patients

TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive 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-naive 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 www.medivir.com and

www.clinicaltrials.gov

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 approved.

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 GlaxoKline 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 Company's website:

www.medivir.com.

7/12/11

Sources

Medivir. TMC435 Has Received Fast Track Designation from the FDA and TMC435 Will

be Studied in Combination with Pharmasset's PSI-7977 for HCV Genotype-1. Press

release. July 6, 2011.

Pharmasset. Pharmasset Enters into a Clinical Collaboration Agreement with

Tibotec Pharmaceuticals for a Combination Study in Patients Chronically Infected

with Hepatitis C. Press release. July 6, 2011.