Updated: Fast Track designation granted to Achillion's small molecule hepatitis C virus drug Print E-mail
By Staff and Wire Reports   
Wednesday, 04 January 2012 10:18
AchillionA small molecule drug to combat one of the most challenging infectious diseases and being developed by Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) received fast track designation, allowing for a quicker review by U.S. regulators.

Achillion said Wednesday the treatment, labeled ACH-1625, is in mid-stage clinical testing for the treatment of chronic hepatitis C virus (HCV). The designation allows drug developers to submit their applications to the Food and Drug Administration piece by piece instead of having to file all the paperwork at once.

"We are very pleased with the granting of a Fast Track designation for ACH-1625, which we believe highlights this protease inhibitor's attributes which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV," commented Michael Kishbauch, President and Chief Executive Officer of Achillion. "As we work toward achieving our near-term milestones, we remain eager to initiate an interferon-free, all-oral combination clinical study evaluating our protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of this year."

It also allows for more frequent interaction with regulators and a possible priority review.  The drug, ACH-1625, is currently in a mid-stage trial and the U.S. Food and Drug Administration's fast-track status is designed to expedite the review of drugs that aim to treat serious diseases and fill unmet medical needs.

Achillion Pharmaceuticals Inc., based in New Haven, Conn., said the drug received the designation due in part to its once-daily dosing and its potential to offer improved safety and tolerability compared to the current standard of care.

Hepatitis C treatments represent a big opportunity for drugmakers. The virus can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. Analysts expect the market for those treatments to expand in the coming years. The hepatitis C virus infects the liver and is the most common cause of viral hepatitis, which is an inflammation of the liver.

Other companies developing potential drugs include Pharmasset Inc. which is being acquired by Gilead Sciences Inc. Earlier this year, the FDA approved two pills that offered the first new breakthrough treatments for the liver disease in 20 years. The Vertex Pharmaceuticals Inc. hepatitis C pill Incivek rang up about $420 million in this year's third quarter. Another pill, Merck & Co.'s Victrelis had $31 million in sales.

Achillion Pharmaceuticals is dedicated to bringing important new treatments to patients with infectious disease. Its discovery and development teams have advanced multiple product candidates with novel mechanisms of action. The company is focused on solutions for the most challenging problems in infectious disease including hepatitis C, HIV infection and resistant bacterial infections. It was incorporated in August 1998.

Achillion Pharmaceuticals’ research and development is focused on three main categories which include antivirals, antibacterials (often referred to as antibiotics) and antifungals. The company has developed the following discovery tools that enable management of its compounds efficiently and advance its discovery programs which include: AACP (Achillion Automated Chemistry Platform), a proprietary software program that facilitates medium and high throughput synthesis of compounds; CART (Compound Acquisition and Repository Tracking), a software tool to select and acquire compounds for lead identification; CHEM-ACH, a data mining software to design and synthesis of compounds for lead optimization; and D2P2 (Drug Design through Pharmacophore Perception), a software to study interactions between a drug target and its inhibitors in three dimensions.

Achillion Pharmaceuticals’ product portfolio include: four clinical candidates for the treatment of chronic hepatitis C infection which include ACH-1625 (the once-daily NS3 protease inhibitor); ACH-2684, a pan-genotypic inhibitor of HCV NS3 protease with pico-molar potency; ACH -2928, a pico-molar potent inhibitor of HCV NS5A that demonstrates pan-genotypic activity; and ACH-1095, a candidate that specifically recognizes the HCV target, NS4A. The company is also developing ACH-702 for the treatment of serious nosocomial bacterial infections.

The BioMedReports FDA Calendar which tracks thousands of regulatory milestones and clinical trial dates shows a couple of early pipeline development catalysts for the stock, including one for ACH-3102, which is currently undergoing IND-enabling studies and is expected to be advanced into clinical trials during the first half of 2012. The firm re-affirmed that expectation in a news release last December.

 




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