Roche, Emcure may end pact to make 2 blockbuster drugs

A joint venture between Swiss drug maker Roche and India’s EmcurePharmaceuticals to manufacture and distribute two blockbuster drugs may be coming apart five years after it was formed, ET has learnt. Leading drug distributors told ET that the two drugs – trastuzumab to treat breast cancer and rituximab for certain autoimmune diseases – were not available.

Industry executives said the joint venture is ending and Roche is looking for another distribution partner. Emcure did not respond to an email query by ET. A Roche spokesperson said Emcure is still the distributor for the two drugs in India. Roche had handed out the manufacturing and marketing of trastuzumab and rituximab to Pune-based Emcure in 2012 specifically to cater to the Indian market.

Emcure sold trastuzumab under the brand Bicletis and rituximab as Ikgdar. The partnership was hailed as an innovative way to bring multinational drug makers and generic manufacturers on the same platform to address the issue of access to medicines in middle-income countries like India.

 Rituximab, used as a combined therapy for treatment of rheumatoid arthritis in adults, is also an anti-cancer drug is prescribed for chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma. Trastuzumab is one of the most widely prescribed drugs to treat breast cancer.

However, several bio-similar versions of the drug entered the Indian market over the past two years, forcing the company to cut the price. “The JV is not working for Roche – the US FDA scrutiny on Emcure and the competition from Indian bio-similar manufacturers have forced the company to rethink its India strategy,” an executive from a drug MNC told ET, asking not to be identified.

“Roche is talking to other drug makers for a similar deal.” The past two years have been bumpy for Emcure. The company received a warning letter from the US Food & Drug Administration last year for violating good manufacturing practices. Emcure’s US-based arm Heritage Pharmaceuticals is under scrutiny by the US Department of Justice.

 Source:http://health.economictimes.indiatimes.com/news/pharma/roche-emcure-may-end-pact-to-make-2-blockbuster-drugs/59748502

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