ViiV May Dodge Compulsory License For Celsentri In India; Commits To Competitive Price Via Local Ally
This article was originally published in PharmAsia News
Executive Summary
Unfazed by the recent compulsory license granted to Natco for Bayer’s Nexavar, ViiV closes in on a local partnership.
MUMBAI – UK-headquartered ViiV Healthcare – the HIV joint enterprise formed by GlaxoSmithKline PLC and Pfizer Inc. in 2009 – will make available its anti-HIV medication Celsentri (maraviroc) at a “competitive and affordable price” compared to the newer anti-retroviral agents launched recently in India.
The response came in the wake of the compulsory license granted last week to India’s Natco Pharma Ltd.. for Bayer AG’s anti-cancer drug Nexavar (sorafenib) (Also see "India Grants First Compulsory License To Natco For Bayer’s Nexavar; Disappointed, Bayer May Challenge Decision" - Scrip, 11 Mar, 2012.). Natco had also sought a voluntary license from ViiV for Celsentri, claiming that the original brand costs about $1,446 compared to its own proposed price of $333 – which would cut the cost of treatment by more than one-fourth.
Closing In On Partnership
Pointing at an impending partnership, ViiV spokeswoman Rebecca Hunt told PharmAsia News that the company is in late-stage partnership discussions in India, and hopes to finalize a deal in the next few months. ViiV reiterated that it has a long-term commitment to develop partnerships in countries like India to manufacture and market its medicines locally.
Hunt declined to name the partner, but added that ViiV had contacted Natco as one of several Indian companies assessed through a due diligence process to see if it fulfilled ViiV’s criteria. “We are now in late-stage discussions with our preferred partner,” she said, suggesting that Natco may not have made it to ViiV’s short list for the proposed partnership.
Last April, ViiV's Asia Commercial Operations Head Francis Vaillant raised concerns about the technology barriers and distribution needs in India for products like Celsentri.
Vaillant observed "several inaccuracies" in Natco's voluntary license application, asserting that, "It is essential that such a candidate [for partnership] is well-qualified and able to commercialize the product for appropriate HIV patients, including but not limited to the ability to facilitate the availability of tropism testing, which is needed to identify which patients will benefit from maraviroc." Vaillant also questioned if Natco had the regulatory approvals to market maraviroc in India (Also see "ViiV Healthcare Questions Natco's Ability To Make And Sell Selzentry In India; Stays Silent On Voluntary License Issue" - Scrip, 2 Jun, 2011.).
Low Returns, Tough Technology Barriers?
A Natco official asking not to be named said that ViiV had reached out to Natco but that partnership discussions did not progress. The official said it would be speculative to discuss ViiV’s moves to license the drug to another Indian rival company.
The market in India is relatively small for Celsentri given the fact that the drug works on a very small proportion of HIV patients. Celsentri is specifically indicated for treatment-experienced patients that can be detected by a test known as CCR5-tropic HIV-1. As such, ViiV considers Celsentri "unique" and is concerned that some companies may not have the expertise to manufacture and sell the product.
An industry expert noted that Natco may have chosen not to press for a compulsory license to the Controller of Patents in India because of the small size of the market for Celsentri.