Gilead aims for hep C lead with Pharmasset acquisition
pharmafile | November 22, 2011 | News story | Research and Development | Gilead, HCV, Pharmasset, Victrelis, hepatitis C
Gilead Sciences is to buy Pharmasset for $11 billion in a bid to become a leader in hepatitis C treatment.
The California-headquartered company is already one of the leading companies in HIV treatment, but wants to compete in the adjacent virology market of hepatitis C virus (HCV).
The $11 billion offer represents nearly double the market price of Pharmasset, which has no products on the market, leading some commentators to say Gilead has overpaid for the acquisition.
Gilead predicts the purchase will hit its earnings for the next three years, but says Pharmasset’s pipeline could yield blockbuster products which meet unmet need in HCV patients.
Roche’s Pegasys (peginterferon alfa-2a) and Merck’s PegIntron (peginterferon alfa-2b are the current standard of treatment, and are injectables. Moreover treatment with these drugs is successful in only about 50% of patients with genotype 1, the most common sub-type of the virus, leaving half of patients without successful treatment.
Competition in HCV is fierce, with two new highly effective oral treatments – Janssen and Vertex’s Incivo (telaprevir) and Merck and Roche’s Victrelis (boceprevir) were both launched this year. But these drugs must still be used in conjunction with alpha interferon, which is injected once a week, and can cause severe flu-like symptoms and other side effects.
Pharmasset has three promising mid- to late-stage hepatitis C drugs which are all are orally treatments, and need only be taken with ribavirin tablets, and promise to work regardless of viral genotype.
Pharmasset’s lead candidate is PSI-7977, a uracil nucleotide analogue which recently moved into two Phase III studies in genotype 2 and 3 patients. Both studies will utilise 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 study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients.
But as genotype 1 patients are most numerous, it is this sub-type that is the main target. A third Phase III study in genotype 1 patients will begin in the second half of 2012, the design of which is dependent on the outcome of Phase II studies evaluating the drug in various combinations in genotype 1-infected patients.
Pharmasset says if the trials go well, the drug could gain US approval by 2014.
Its next candidate is PSI-938, a guanosine nucleotide analogue. It 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.
Finally mericitabine (RG7128) is a cytidine nucleoside analogue, and is being developed in partnership with Roche. This drug is being evaluated in three Phase IIb trials, with Roche responsible for all aspects of its development.
“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 C. Martin, PhD, Chairman and Chief Executive of Gilead. “Pharmasset presented compelling Phase II data earlier this month further characterising 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. 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 to address the unmet needs of patients and the medical community.”
Schaefer Price, President and Chief Executive, Pharmasset. “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 realize the potential of our promising molecules as part of future all-oral combination therapies for millions of patients in need around the world.”
Gilead’s R&D portfolio includes seven molecules in various stages of clinical development for the treatment of HCV. 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. Three separate all-oral Phase II studies are currently ongoing, and Gilead expects clinical data from these studies to become available in 2012 and early 2013. Pharmasset’s compounds are complementary to Gilead’s existing HCV portfolio, and the transaction will help advance Gilead’s effort to develop an all-oral regimen for the treatment of HCV.
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