Achillion pairs with Janssen for hep C collaboration

The companies' primary focus will be the development of a pan-genotypic oral regimen for the treatment of HCV

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NEW HAVEN, Conn.—Achillion Pharmaceuticals Inc. and Janssen Pharmaceuticals Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, have joined forces for the development and commercialization of one or more of Achillion's lead hepatitis C virus (HCV) assets, which include ACH-3102, ACH-3422 and sovaprevir.
 
Per the terms of the agreement, Janssen will be granted an exclusive worldwide license to develop and, should any products gain regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Janssen will assume responsibility for all development costs under the collaboration as well as all subsequent commercialization costs. In return, Achillion stands to receive a number of payments should certain development, regulatory and sales milestones be reached. Achillion is also eligible to receive tiered royalty percentages in the mid-teens or low twenties based on future worldwide sales.
 
In addition, the companies also announced an equity transaction separate from the license and collaboration agreement; under this transaction, Johnson & Johnson Innovation – JJDC Inc. will invest $225 million in Achillion, for which it will receive roughly 18.4 million newly issued, unregistered shares of Achillion stock at $12.25 per share. Both transactions are subject to customary closing conditions, including termination or expiration of the waiting period under the Hart-Scott-Rodino Act.
 
"We are excited to collaborate with Janssen for the worldwide development of our HCV assets in combination with their HCV portfolio. We believe that Janssen's renowned expertise in HCV development and commercialization enables a synergistic opportunity to rapidly advance our combined HCV assets toward the market while simultaneously achieving an optimized treatment regimen for all HCV patients," Dr. Milind Deshpande, president and CEO of Achillion, said in a press release regarding the deal. "Furthermore, we believe that their investment in Achillion through Johnson & Johnson Innovation - JJDC allows us to maximize the value from our HCV portfolio and also positions us to become a leader in complement factor D inhibition, applying our broad platform to a wide number of complement-related diseases. We believe this strategy provides an ideal scenario to create further value for our shareholders."
 
The collaboration will seek to develop a short-duration, pan-genotypic, oral regimen for the treatment of HCV, with an initial regimen to consist of ACH-3102 combined with an NS3/4A HCV protease inhibitor and an NS5B HCV polymerase inhibitor.
 
ACH-3102 is a structurally distinct second-generation NS5A inhibitor, and has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C. The compound has been shown to be be synergistic in combination with other HCV inhibitors, including NS5B polymerase inhibitors and NS3/4A protease inhibitors. It is the only NS5A inhibitor that has demonstrated a sustained virologic response (SVR) in GT 1b HCV-infected patients without the co-administration of interferon or a second direct-acting antiviral (DAA) agent. It is well tolerated with no serious adverse events to date, and it has an extended half-life that supports a once-daily dosing regimen.

ACH-3422 is a novel, nucleotide pro-drug of a uridine analog designed to inhibit HCV NS5B polymerase. It appears to have high oral bioavailability, with a pharmacokinetic profile that supports once-daily dosing, and has shown high anti-HCV potency against all HCV genotypes. It has also demonstrated a good non-clinical safety profile, proof-of-concept efficacy and good combinability. ACH-3422 is expected to begin Phase 2 development in the first half of this year.
 
Sovaprevir is a NS3/4A protease inhibitor in Phase 2 development. It has shown high rates of clinical cures when combined with pegylated-interferon and RBV in genotype 1 treatment-naive patients. To date, the compound is well tolerated and has shown activity against all HCV genotypes. As with ACH-3102 and ACH-3422, sovaprevir has a profile that supports once-daily dosing. The FDA granted sovaprevir Fast Track designation for the treatment of chronic hepatitis C viral infection in 2012.


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