Date: 2015-01-26
Type of information: Licensing agreement
Compound: sofosbuvir, GS-5816
Company: Gilead Sciences (USA - CA) Mylan Laboratories (indian subsidiary of Mylan, USA - PA)
Therapeutic area: Infectious diseases
Type agreement: licensing
Action mechanism: direct-acting antiviral agent/nucleotide analog. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. This direct-acting agent interferes directly with the HCV life cycle by suppressing viral replication. GS-5816 is a second-generation investigational NS5A inhibitor.
Disease: hepatitis C
Details: * On January 26, 2015, Mylan announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences, Inc. to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir(Sovaldi®)/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014 , which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
Financial terms:
Latest news: * On April 23, 2015, Mylan announced that its subsidiary, Mylan Pharmaceuticals Private Limited , has launched generic Sofosbuvir 400 mg tablets under the brand name MyHep™ in India . In September 2014 , Mylan entered into a licensing and technology transfer agreement with Gilead granting Mylan the non-exclusive rights to manufacture and distribute generic Sofosbuvir in 91 developing countries, including India.
