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

Comments

Post a Comment

Popular posts from this blog

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R
Read more

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death
Read more

Tumour-targeting drug paves way for bone cancer treatment

 The treatment of osteosarcoma, the most common tumour of bone, is challenging, but a new study is offering hope to the patients with this disease. The study led by The University of  Texas MD Anderson Cancer Centre  found that a drug, known as bone metastasis-targeting peptidomimetic (BMTP-11), has potential as a new therapeutic strategy for this devastating illness. Results from the preclinical study looked at BMTP-11 alone and in combination with the chemotherapy agent gemcitabine. Although osteosarcoma is a relatively rare cancer, it is a leading disease-related cause of death in children and young adults ages 10 to 20. However, over the last 25 years, the five-year survival rate has remained unchanged, and the treatment options for these patients are few. In addition, the side effects of available treatment options often are significant and cumulative, and may cause other health problems and damage to major organs. "What's novel about this treatment is that BMTP
Read more