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Hyped for HBV
NEW BRUNSWICK, N.J.—Johnson & Johnson is rounding out a busy year with the completion of its acquisition of privately held Novira Therapeutics Inc., a clinical-stage biopharmaceutical company developing therapies for the curative treatment of chronic hepatitis B virus (HBV) infection. With the completion of the deal, Novira is now part of the Infectious Diseases & Vaccines Therapeutic Area of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Johnson & Johnson and Novira first shared news of the deal on Nov. 4 with the announcement that the former would be acquiring 100 percent of Novira's capital stock. No financial terms were disclosed.
“We are exploring several approaches in pursuit of a functional cure for this insidious disease. Bringing together NVR 3-778 with our own internal discoveries, we will leverage our vast experience in viral diseases to develop potentially transformational medicines for HBV patients,” Dr. William N. Hait, global head of Janssen Research & Development LLC, remarked in a press release.
This deal nets Johnson & Johnson Novira's novel antivirals portfolio, which includes its lead candidate, NVR 3-778, a small-molecule, direct-acting antiviral that inhibits the HBV core or capsid protein. The compound is being evaluated for oral administration. The HBV core represents a novel, promising drug target with multiple activities required for viral replication and persistence, and inhibition of its function via NVR 3-778 has the potential to offer more efficient suppression of virus production and replication. NVC 3-778 has established a promising preclinical safety profile, and is currently being evaluated in a Phase 1 clinical trial in New Zealand.
Novira's pipeline also includes a second-generation core inhibitor, which is approaching preclinical development, and a cccDNA inhibitor, which is still in the discovery phase. As the company notes on its website, “When used in combination with the current standard of care (nucleosides and interferon), Novira’s core inhibitors are expected to provide greater and faster suppression of cccDNA and new virus production. Directly or indirectly, core inhibitors may also reduce HBsAg levels and release the block on immune response pathways to further reduce the time to cure. Higher and faster cure rates promoted by core inhibitors will in turn enable finite therapy so that many CHB patients will no longer require lifelong treatment.”
“This acquisition will enhance the ability of Novira’s research and development teams to continue to advance novel therapeutic candidates for chronic HBV infection,” said Christian S. Schade, CEO of Novira Therapeutics. “Novira is developing important new investigational curative treatments for HBV infection, and this transaction is a great opportunity for the development of those assets to benefit from Johnson & Johnson's resources, expertise and dedication to delivering innovative treatment options to the many patients with life-threatening infections.”
Given the lack of released financial details for the deal, it's unknown how much of a risk Johnson & Johnson might be taking in betting on Novira and an indication with limited forecasted market growth compared to other therapeutic areas. The global hepatitis B market is forecast to reach roughly $3.5 billion by 2021 at a compound annual growth rate of 2.3 percent, according to a recent report by RnR Market Research. The Trefis team, a Forbes contributor, noted in a Nov. 10 article that “the overall market opportunity for Hepatitis B treatment is quite limited,” pointing out that diagnosis and treatment rates for hepatitis B are low, given that it is largely asymptomatic, and that “The current drugs are serving the market reasonably well, and there is threat from generic competition too.”
Still, the Johnson & Johnson group remains optimistic about the deal and the need within the hepatitis B market, with Dr. Lawrence Blatt, global head of Infectious Diseases and Vaccines at Janssen and CEO of Alios Biopharma, part of the Janssen Pharmaceutical Companies, pointing out in the original Nov. 4 press release that “approximately 60 percent of hepatocellular carcinoma [is] attributed to infection with the hepatitis B virus. With more than 350 million people affected worldwide, we seek to overcome treatment challenges, such as the requirement for people to endure lifelong therapy, through scientific innovation. Combining Novira’s recent breakthroughs with our vast experience in viral diseases, we endeavor to deliver novel medicines for patients suffering from this insidious disease.”