Gilead Sciences to buy Pharmasset for US$11bn
HIV drug manufacturer says firm is a strong strategic fit
Gilead Sciences is to buy biotechnology company Pharmasset for about US$11bn.
Gilead, a manufacturer of HIV drugs, will pay $137 for each Pharmasset share. Pharmasset’s board of directors has unanimously approved the deal.
Princeton, New Jersey based Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials. The lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase III studies in genotype 2 and 3 patients. Both studies will use 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients.
A third Phase III study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase II studies, which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial US regulatory approval of PSI-7977 in 2014.
PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase IIb interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase IIb trials. Roche is responsible for all aspects of the development of mericitabine.
‘The acquisition of Pharmasset represents an important and exciting opportunity to accelerate Gilead’s effort to change the treatment paradigm for HCV-infected patients by developing all-oral regimens for the treatment of the disease regardless of viral genotype,’ said John Martin, chairman and chief executive of Gilead.
He added that Pharmasset’s Phase II data further characterised the strong efficacy and safety profile of PSI-7977.
‘The compound, together with Pharmasset’s other pipeline candidates, represents a strong strategic fit with Gilead’s vision, pipeline and capabilities,’ he said.
‘This transaction will serve to drive the long-term growth of our business, and we look forward to working closely with the Pharmasset team to advance a broad clinical programme in HCV.’
Schaefer Price, president and chief executive of Pharmasset, added: ‘Gilead’s established expertise and leadership in the field of antiviral drug development and commercialisation, coupled with the company’s existing portfolio of promising compounds for HCV, make this partnership an ideal step to fully realise the potential of our promising molecules.’
Gilead has seven molecules in various stages of clinical development for the treatment of HCV. Pegylated interferon in combination with ribavirin is currently part of the standard of care treatment for patients with chronic hepatitis C. Gilead is focused on advancing multiple compounds with different mechanisms of action and resistance profiles in combinations that will support delivery of an all-oral regimen that would eliminate the need for pegylated interferon.