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November 4, 2015

J&J to Acquire HBV Drug Developer Novira Therapeutics

  • Johnson & Johnson said this afternoon it will acquire Novira Therapeutics for an undisclosed price, in a deal intended to strengthen the pharma giant’s pipeline with a portfolio of antivirals against chronic hepatitis B virus (HBV).

    Novira’s pipeline is led by NVR 3-778, an oral, small-molecule direct acting antiviral for patients with HBV. NVR 3-778 is a core inhibitor designed to work by inhibiting the HBV core or capsid protein. That prevents productive infection after viral entry by blocking steps required for the formation of covalently closed circular DNA (cccDNA) and accumulation of HBV core in the nuclei, the company reasons.

    “NVR 3-778 offers the potential for efficient suppression of virus production and replication, which could help address the remaining unmet medical needs,” William N. Hait, M.D., Ph.D., global head, research & development with J&J’s Janssen Pharmaceutical Companies, said in a statement. “We are excited about the prospect this acquisition offers to accelerate the development of curative treatments for people affected by chronic hepatitis B.”

    J&J’s planned acquisition of Novira is the pharma giant’s second significant hepatitis-related deal in recent months. In May, Janssen launched an up-to-$1.1 billion-plus collaboration with Achillion Pharmaceuticals  to co-develop at least one of Achillion’s lead hepatitis C virus (HCV) drug candidates. Achillion also received a $225 million equity investment from J&J’s venture capital subsidiary Johnson & Johnson Innovation-JJDC.

    The planned Novira acquisition comes more than four months after the company presented positive preclinical antiviral data for NVR 3-778 at the 2015 annual meeting of the European Association for the Study of the Liver in Vienna.

    In a humanized UPA/SCID mouse model, according to Novira, NVR 3-778 showed HBV DNA suppression efficacy that was superior to that of pegylated interferon (PEG-IFN) and similar to that of the nucleoside analog entecavir. The highest efficacy was observed in mice that received NVR 3-778 in combination with PEG-IFN. All mice responded to treatment and there was no evidence for drug resistance, the company added.

    And in a cell-based model, NVR 3-778 showed additional antiviral activity in combination with entecavir or two other nucleoside analogs, lamivudine and tenofovir. NVR 3-778 also showed additive antiviral activity in combination with “an HBV core inhibitor from another chemical class,” the company disclosed on April 27.

    A year ago this month, Novira presented positive safety and pharmacokinetic data for NVR 3-778 from a Phase Ia trial. The trial of 40 adult volunteers assessed the effects of the compound after single oral doses of 50 to 800 mg/day, followed by an assessment of 200 mg once-daily dosing for 14 days. Study results indicated that NVR 3-778 was well-tolerated at all doses, the company said.

    Novira’s pipeline also includes two discovery-phase compounds—a second-generation core inhibitor, and a cccDNA inhibitor.

    Headquartered in Doylestown, PA, Novira is a privately held biopharma that completed a $25 million Series A financing in 2013. New investor Versant Ventures contributed $7.5 million, joining 5AM Ventures and Canaan Partners, which led the first closing of the Series A a year earlier.

    J&J will acquire 100% of Novira’s capital stock under the deal, which is expected to close during the fourth quarter of this year, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

    “This acquisition will enhance the ability of Novira’s research and development teams to continue to advance novel therapeutic candidates for chronic HBV infection,” added Novira CEO Christian S. Schade in a separate statement from his company.

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