Cipla and Nacimbio in MoU on hep C, HIV therapies


Mumbai-based Cipla will work to transfer expertise in manufacturing to make new active pharmaceutical ingredients (APIs) that treat HIV/AIDS and hepatitis C to Russia's National Immunobiological Company (Nacimbio) in a deal that will be closely watched.

In a brief release, the two companies said that a memorandum of understanding (MoU) signed last week that they would seek to transfer know-how on innovative antiviral medical products for HIV and hepatitis C treatments. The company didn't name the drugs specifically, but noted they would be new to the Russian market.

"New drugs production will help to change therapeutic regimens and substantially increase availability of drugs for Russian patients," the companies said in a joint release, adding that the aim is to achieve commercial production by 2018 on an investment of nearly $43 million.

Cipla has a well-known program backed by civil groups such as the Clinton Global Initiative to make retroviral HIV drugs for use in poor countries. It also inked a pact in 2014 with Gilead Sciences ($GILD) to license production of its blockbuster hep C drug ledipasvir/sofosbuvir (Harvoni) for distribution in 91 developing countries as part of a landmark access pact--but Russia or China among other middle-income nations are not included.

China is currently in talks with Gilead on pricing for its other hep C drug Sovaldi in the country, even as a China FDA approval is pending.

Cipla was not immediately available to comment on the hepatitis C therapies involved in the MoU. A Gilead spokesman referred any questions to Cipla. The 2014 licensing pact also includes Cadila Healthcare, Hetero Labs, Mylan Laboratories ($MYL), Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab.

The move by Gilead for developing countries still drew criticism from civil society groups even though the cost was a fraction of the $84,000 price tag in the United States for a treatment regimen. As well Gilead won an Indian Patent Office approval for Sovaldi (sofosbuvir) in May in part based on its access program easing costs.

In the case of the HIV therapies, Cipla said the aim was to expand access to Russia.

“Currently, there is no technology for full-cycle manufacturing of HIV treatment drugs in Russia,” said Subhanu Saxena, managing director and CEO said in a statement. “We are glad that, as a responsible partner together with Nacimbio we will be able to improve drug availability for patients and make our contribution to the fight against HIV.”

- here's the release

Related Article:
India awards Gilead patent for Sovaldi, disappointing civic groups