On November 2, the Indian Intellectual Property Appellate Board (IPAB) revoked Hoffmann-La Roche’s patent on the hepatitis C drug Pegasys. In particular, the IPAB found that Roche failed to demonstrate Pegasys is more efficacious than an earlier version of the drug. Read the ruling here. The ruling brings three critical issues to the fore. Continue reading
My colleague Vikas Dandekar of Pharmasianews reports on a potentially pathbreaking event. Swiss drug maker Roche has struck a manufacturing deal with Pune’s Emcure to produce some portion of its blockbuster biologic Herceptin for breast cancer and Pegasys for hepatitis B and C in India for India.
Of course, it doesn’t look as if Emcure is going to start manufacturing the products from the cell culture stage – the story quotes a senior Roche executive referring to “late-stage” manufacturing. Don’t know exactly what that entails. This executive talks of “substantial” price adjustments that could take place as a result. Assuming its a deep engagement, the news is pretty exciting. Here’s why. Continue reading