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Gilead boosts liver disease pipeline with $1.2bn acquisition

Also has combination HIV therapy Descovy approved by FDA

Gilead SciencesGilead Sciences boosted its pipeline of treatments for liver disease by buying a subsidiary of Nimbus Therapeutics in a deal that could be worth up to $1.2bn to the US biotech.

Its acquisition of Nimbus Apollo brings with it the subsidiary's Acetyl-CoA carboxylase inhibitor programme, the lead candidate of which was granted fast track status by the FDA in February this year.

Norbert Bischofberger, Gilead's chief scientific officer and executive vice president of research and development, said: “The acquisition of Nimbus' ACC-inhibitor programme represents a timely and important opportunity to accelerate Gilead's ongoing efforts to address unmet needs in NASH.

“These molecules will complement and further strengthen Gilead's pipeline and capabilities to advance a broad clinical programme in NASH that includes compounds targeting multiple key pathways involved in the pathogenesis of the disease.”

NASH is a serious liver disease resulting from metabolic dysfunction associated with steatosis - fat within the liver. It currently affects up to 15 million people in the US and is predicted to become the leading indication of liver transplantation by 2020.

ACC inhibitors target the dysfunctional lipid production and so reduce the hepatic fat content, inflammation and fibrosis seen in the progression of NASH.

Phase I results for ACC inhibitor NDI-010976, Nimbus Apollo's lead NASH candidate, are due to be presented next month and may further shed light on its potential as a treatment for hepatocellular carcinoma (HCC) and other diseases.

In addition to the upfront payment of $400m, Nimbus Therapeutics also stands to receive an additional $800m in development-related milestones as Gilead accelerates the ACC inhibitor programme.

FDA approval for Descovy
Meanwhile, this week also saw Gilead win US approval for its fixed-dose combination therapy for the treatment of HIV-1 infection in adults and children 12 years of age and older.

Descovy (emtricitabine tenofovir alafenamide) can be paired with a range of third agents and is given at a dosage over 90% lower than Gilead's existing treatment Viread (tenofovir disoproxil fumarate).

Bischofberger said: “As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care.

“As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.”

The FDA's approval was based on phase III trials of the tenofovir alafenamide (TAF) based regimen showing non-inferiority to a tenofovir disoproxil fumarate (TDF) regimen and improvement in bone and renal safety in treatment naïve adults and adolescents and treatment-experienced adults.

Bischofberger added: “With today's approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide.”

Descovy is the third TAF-based HIV drug in Gilead's portfolio - joining its other once-daily treatments Genvoya and Odefsey - and adds to the biopharmaceutical firm's dominance in the HIV treatment sector.

However Gilead may soon face competition from ViiV Healthcare as the joint venture began phase III trials of its long-acting HIV regimen earlier this year.

Article by
Rebecca Clifford

6th April 2016

From: Sales, Regulatory



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