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Gilead Descovy Wins FDA Nod, To Buy Nimbus Liver Program

Gilead Sciences Inc. GILD has come up with two important corporate announcements – the company’s third tenofovir alafenamide (TAF)-based HIV drug, Descovy, has gained FDA approval and it has struck deal to acquire Acetyl-CoA Carboxylase (ACC) inhibitor program from a privately held MA-based biotech company, Nimbus Therapeutics.

Descovy Approved in the U.S. for HIV Treatment

Gilead announced that the FDA has approved Descovy as a fixed-dose combination for the treatment of HIV. Descovy comprises Gilead’s Emtriva (200 mg; emtricitabine) and TAF (25 mg). The FDA approved Descovy in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients aged 12 years and above. However, Descovy was not approved for use as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Moreover, Descovy’s U.S. approval was accompanied with a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post-treatment acute exacerbation of hepatitis B.

We note that Gilead has two other TAF-based regimens that recently gained FDA approval for the treatment of HIV-1 infection – Odefsey and Genvoya. While Genvoya is already approved in the EU, Descovy and Odefsey are under review in the same, where a decision could be out in the second and third quarters of 2016, respectively.

HIV is one of the primary areas of focus for the company. Gilead’s has a couple of additional TAF-based single-tablet regimens in its pipeline.

Acquisition of Nimbus’ Liver Disease Program

Gilead and Nimbus Therapeutics have announced a definitive agreement, under which Gilead will acquire Nimbus Apollo, Inc., a wholly owned subsidiary of Nimbus Therapeutics.

With this acquisition, Gilead will gain access to Nimbus’ ACC inhibitor program. The program consists of a lead candidate, NDI-010976 (an ACC inhibitor), and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma and other diseases.

Earlier this year, NDI-010976 was granted Fast Track status by the FDA. Meanwhile, phase I data on the candidate will be presented at the annual meeting of the European Association for the Study of the Liver next month.

The deal will see Gilead shelling out an upfront payment of $400 million plus $800 million in development-related milestones over time. Once the acquisition closes, Nimbus Apollo will become a wholly owned subsidiary of Gilead. While Nimbus Therapeutics will retain ownership of its other research and development subsidiaries, Gilead will be completely responsible for the future development and commercialization of NDI-010976 and other ACC inhibitors.

The acquisition is in line with the Gilead’s strategy of strengthening its presence in the liver diseases market. The company already has a strong position in this market owing to its blockbuster hepatitis C virus drugs, Harvoni and Sovaldi. Moreover, the ACC program would boost the company’s NASH pipeline, which currently comprises simtuzumab, GS-4977 and GS-9674.

Per the information provided by Gilead in its press release, NASH, a serious liver disease, affects up to 15 million people in the U.S. and could lead to more serious conditions like inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. It is expected to become the leading cause for liver transplantation by 2020.

Currently, there are no approved treatments for NASH. Other companies like Intercept Pharmaceuticals, Inc. ICPT are also working on bringing their own NASH treatments to market.

Gilead currently has a Zacks Rank #1 (Strong Buy). Other equally ranked stocks in the health care sector are AMAG Pharmaceuticals, Inc. AMAG and Emergent BioSolutions, Inc. EBS.

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