Date: 2014-09-15
Type of information: Licensing agreement
Compound: sofosbuvir (Sovaldi®) and ledipasvir/sofosbuvir (Harvoni®)
Company: Gilead (USA - CA) Zydus Cadila (India)
Therapeutic area: Infectious diseases
Type agreement: licensing
Action mechanism: Sofosbuvir is a nucleotide analogue NS5B polymerase inhibitor developed by Gilead Sciences. Ledipasvir is a NS5A inhibitor developed by Gilead Sciences.
Disease: chronic hepatitis C genotype 1 infection
Details: * On September 15, 2014, Zydus and Gilead Sciences announced that they signed a non-exclusive licensing agreement which
will allow the generic manufacture of sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 90 developing countries, including India. Zydus Heptiza, the specialty division of the Zydus group which will be marketing the therapy has been solely focused on improving treatment access in Chronic Viral Hepatitis. Over the last four years since launch,
Heptiza is the only division present with an entire range of antivirals approved for hepatitis B & C management in India. It has been reaching out to high risk population with free screening for hepatitis B & C patients and has made available hepatitis B vaccination to patients, free of cost.
Under the licensing agreement, Zydus will receive a complete technology transfer of the Gilead manufacturing process to enabling production to be scaled up as quickly as possible. Zydus will set its own prices for the generic product, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other business essential activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
Sofosbuvir was approved under the trade name Sovaldi® by the FDA in December 2013 and by the European Commission in January 2014. The FDA and the European Medicines Agency are currently reviewing the company’s applications for a single tablet regimen of ledipasvir/sofosbuvir.
Financial terms:
Latest news:
