ACH-1625, a potential next-generation treatment for chronic hepatitis C virus

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ACH-1625, a potential next-generation treatment for chronic hepatitis C virus

Achillion Is a Small Biotech on the Verge of Big Moves

By GENE MARCIAL

Posted 7:30 AM 07/07/10

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It seems like the growing ranks of emerging biotechnology companies are always behind the eight ball in building up their financial resources to fund extensive research and clinical studies for novel therapies. The fountain of innovative drugs for Big Pharma, biotechs usually seek the help of financiers, venture capitalists and the like. But biotechs that are well on the road to advanced development of drugs resort to another funding strategy: Striking partnerships with large drugmakers.One such company is Achillion Pharmaceuticals , which had raised some $27 million last year but now needs a partner to advance development of its three products. One of them is a possible next-generation drug to fight chronic hepatitis C virus, an inflammation of the liver that has infected some170 million people worldwide."A Partnership or Two"?"We are in the midst of doing

several [Phase 2 clinical trials] for our products, so we have been in advanced talks with several of the major global pharmaceutical companies for almost a year now to forge one or two partnerships," says D. Kishbauch, Achillion's president and CEO. He expects that sooner rather than later "we will sign a partnership or two" to fund the clinical studies and complete development of its hepatitis programs, a potentially multibillion market.Major pharmaceuticals that are involved in or plan to participate in developing new treatments for hepatitis include Pfizer, Merck , Bristol Myers-Squibb , Glaxo, Novartis, Roche and Abbott Laboratories . Kishbauch declines to identify which of the companies he's in discussions with because "our negotiations are in a very advanced and delicate stage right now."Several of the drugmakers want to partner with Achillion on all three of its products. Those are ACH-1625, a potential

next-generation treatment for chronic hepatitis C virus that some analysts expects will be the "best-in-class" treatment; ACH-1095, an "NS4A antagonist" also for fighting the hepatitis virus; and ACHN-2684, a molecule that targets NS3 protease found to be effective against a broad range of natural hepatitis variants.However, Kishbauch says he would prefer having different partners for each of the drugs to make sure they all get all the attention and support they require. He's negotiating for a guarantee that the partners will advance the products to a level equal to standard-of-care products.

Once-a-Day Dosing

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Some analysts believe Achillion's hepatitis drugs would be superior to products now in the market, such as interferon and Vertex Pharmaceutical's Telaprevir, which is being marketed by & . The demonstrated potency and safety of Achillon's ACH-1625 looks very good," says Kolbert, analyst at National Securities, who rates Achillion's stock, now at $2.20 a share, a buy. It's down from its 52-week high of $3.89 reached on Dec. 16, 2009.

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"I believe the best is ahead for Achillion because of its strong hepatitis program," says Kolbert.In the recent IB clinical trials on ACH-1625, safety and tolerability in patients continued to be excellent, notes Kolbert. And the trials also showed "meaningful reductions in the key pharma paradigm for antiviral therapy," he adds. Telaprevir requires twice-a-day dosing, he notes, while ACH-1625 needs only once-daily dosing.Kolbert says when the Phase 2 clinical trials for ACH-1625 get under way -- and when clinical studies for the two other drugs start next year -- "Achillion's stock will see a sharp rise in valuation." Nash, senior analyst at Roth Capital Markets, says with the data he has seen on ACH-1625, the drug has a "strong chance of being as potent as, if not more than, Telaprevir." Importantly, he adds, the dosing schedule and better side-effect profile make Achillion a "very attractive partner candidate for the big

pharmaceuticals."

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ACH-1625From New Drugs Summary EASL

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April 14-18, 2010 The 45th Annual Meeting of theEuropean Association for the Study of the Liver (EASL 2010) Vienna Austria

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..Achillion Pharmaceuticals

lRealizing that some of its competitors are farther ahead with their protease inhibitor development -- like Vertex's (VRTX) telaprevir and Merck's (MRK) boceprevir -- Achillion expects that ACH-1625's demonstrated potency and safety will be enough to "differentiate it from the pack and push it ahead of competition once it hits the market."So far, says Kishbauch, ACH-1625 has shown four significant characteristics over competitors "that could make it a best in class." First, he says, is "its potency in reducing the [amount of virus] is at the top end vs. any of the other similar drugs discovered. Second, other first-generation protease inhibitors have safey and tolerability concerns such as rashes and anemia. ACH-1625's safety and tolerability profile is so far among the cleanest of any the

drugs in development."Third, ACH-1625 appears likely to be dosable at once-a-day, while first-generation drugs will need to be dosed every 8 to 12 hours. Fourth, one of the surprisingly serendipitous finding is its durability, meaning that once you discontinue dosing, the drug continues to have antiviral effect up to seven days after discontinuation of dosing. Other drugs return to baseline virus levels after 24-48 hours. This is important, in particular, with missed doses."Side Effects: ACH-1625's safety and tolerability profile is so far among the cleanest of any the drugs in development.The StudiesAnadys hep C drug shows promise in mid-stage trial

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Achillion Drug ACH-1625 achieved meaningful reductions in viral load after five days;

ACH-1625 Achillion's 'Very Promising' New Drug for Hepatitis C .llANTIVIRAL ACTIVITY, COMBINATION AND RESISTANCE OF ACH-1625, A POTENT HCV NS3 PROTEASE INHIBITOR ,l,CHARACTERIZATION OF THE HEPATOSELECTIVE DISTRIBUTION OF ACH-1625: A POTENT, CLINICAL STAGE HCV NS3 PROTEASE INHIBITOR -

k,VIROLOGICAL RESPONSE, SAFETY, AND PHARMACOKINETIC PROFILE FOLLOWING SINGLE - AND MULTIPLE-DOSE ADMINISTRATION OF ACH-1625 PROTEASE INHIBITOR TO HEALTHY VOLUNTEERS AND HCV GENOTYPE-1 PATIENTS

http://Hepatitis Cnewdrugs.blogspot.com/2010/07/ach-1625-potential-next-generation.html