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Achillion, J&J's HCV Combo Drug Positive in Phase IIa Trial
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Achillion Pharmaceuticals, Inc. announced positive interim results from a phase IIa study on an all-oral triple combination of AL-335, odalasvir (also known as ACH-3102) and Johnson & Johnson’s (JNJ - Free Report) Olysio (simeprevir) for the treatment of patients suffering from genotype 1 chronic hepatitis C virus (HCV) infection.
In Jun 2015, Achillion outlicensed its HCV portfolio to Johnson & Johnson. Under the agreement, J&J has global rights to develop and commercialize one or more of Achillion's lead HCV candidates, including ACH-3102, ACH-3422 and sovaprevir.
The phase II study is being conducted by Alios BioPharma, Inc., part of a Johnson & Johnson subsidiary, Janssen. Note that AL-335 is a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir an HCV NS5A inhibitor and Olysio an HCV NS3/4A protease inhibitor.
The phase 2a study was designed to determine pharmacokinetics, efficacy and safety of odalasvir and AL-335, with or without simeprevir.
Cohort 1 consisted of 20 patients who received the triple combination of once-daily odalasvir (50mg), AL-335 (400mg) and simeprevir (100mg) for eight weeks. Interim results from the phase IIa study showed that 100% patients in cohort 1 remained HCV RNA-undetectable at 24 weeks after completing therapy. The phase IIa study also confirmed the required dose for each component and treatment duration.
The all-oral combination regimens, containing odalasvir, AL-335, with or without simeprevir, were well tolerated with no serious adverse events.
Interim results from phase IIa study were published as part of the abstracts released for the upcoming European Association for the Study of the Liver (EASL) Special Conference, Sep 23–24, in Paris, France.
Based on the interim results of the phase II study, Janssen plans to initiate a global phase IIb study on both treatment-naïve and treatment-experienced patients with genotypes 1–6 HCV, including patients with or without cirrhosis.
Achillion’s collaboration with Johnson & Johnson for the HCV portfolio makes sense given the latter’s expertise in development and commercialization capabilities. Moreover, the deal could see Achillion receiving up to $1.1 billion in the form of development, regulatory and sales milestone payments, apart from a separate equity investment. Achillion is also entitled to receive tiered royalties in the mid teens to low twenties on future worldwide sales. All development and commercialization costs will be borne by Johnson & Johnson.
Achillion Pharmaceuticals currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical genetics sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Cambrex Corporation . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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Achillion, J&J's HCV Combo Drug Positive in Phase IIa Trial
Achillion Pharmaceuticals, Inc. announced positive interim results from a phase IIa study on an all-oral triple combination of AL-335, odalasvir (also known as ACH-3102) and Johnson & Johnson’s (JNJ - Free Report) Olysio (simeprevir) for the treatment of patients suffering from genotype 1 chronic hepatitis C virus (HCV) infection.
In Jun 2015, Achillion outlicensed its HCV portfolio to Johnson & Johnson. Under the agreement, J&J has global rights to develop and commercialize one or more of Achillion's lead HCV candidates, including ACH-3102, ACH-3422 and sovaprevir.
The phase II study is being conducted by Alios BioPharma, Inc., part of a Johnson & Johnson subsidiary, Janssen. Note that AL-335 is a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir an HCV NS5A inhibitor and Olysio an HCV NS3/4A protease inhibitor.
The phase 2a study was designed to determine pharmacokinetics, efficacy and safety of odalasvir and AL-335, with or without simeprevir.
Cohort 1 consisted of 20 patients who received the triple combination of once-daily odalasvir (50mg), AL-335 (400mg) and simeprevir (100mg) for eight weeks. Interim results from the phase IIa study showed that 100% patients in cohort 1 remained HCV RNA-undetectable at 24 weeks after completing therapy. The phase IIa study also confirmed the required dose for each component and treatment duration.
The all-oral combination regimens, containing odalasvir, AL-335, with or without simeprevir, were well tolerated with no serious adverse events.
Interim results from phase IIa study were published as part of the abstracts released for the upcoming European Association for the Study of the Liver (EASL) Special Conference, Sep 23–24, in Paris, France.
Based on the interim results of the phase II study, Janssen plans to initiate a global phase IIb study on both treatment-naïve and treatment-experienced patients with genotypes 1–6 HCV, including patients with or without cirrhosis.
Achillion’s collaboration with Johnson & Johnson for the HCV portfolio makes sense given the latter’s expertise in development and commercialization capabilities. Moreover, the deal could see Achillion receiving up to $1.1 billion in the form of development, regulatory and sales milestone payments, apart from a separate equity investment. Achillion is also entitled to receive tiered royalties in the mid teens to low twenties on future worldwide sales. All development and commercialization costs will be borne by Johnson & Johnson.
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Zacks Rank & Key Picks
Achillion Pharmaceuticals currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical genetics sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Cambrex Corporation . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>