PharmExec Blog

Roche Jumps into Medicines Patent Pool with Pricing and Licensing Deal

Roche tmpphis week has announced a partnership with the UN-backed Medicines Patent Pool (MPP) to provide its drug valganciclovir, better known in the developed world as Valcyte, in 138 countries for a reduced price. In addition to making the drug available in these markets for up to 90% cheaper than current price, Roche has decided to work with MPP to negotiate licensing and technology transfer agreements to spur the development of cheap generic alternatives to the drug. While Roche is following the lead of Gilead Sciences, ViiV (Pfizer and GSK), and a few generics companies, its agreement is the first of any drug company with MPP to include pricing considerations, as well as licensing provisions.

Daniel Grotsky, a media spokesperson for Roche said, “We’re willing to discuss further steps, such as licensing another medicine for HIV including saquinavir if a significant medical need is identified, but for now, we’re going to see how this cooperation works and how we can improve access now with the deal as it is.” In addition to this agreement with MPP, Roche also allows non-profit pricing for HIV medicines saquinivir and viracept in Sub-saharan Africa and other developing countries.

Valganciclovir is an oral medication used to treat cytomegalovirus, or CMV, an opportunistic viral infection that affects the sight of those patients with suppressed immune systems, particularly in those with HIV. While it is no longer a problem in the developed world, it remains an issue in developing nations. According to new research presented at this year’s International AIDS Society Conference, CMV affects patients at averaged rates of 14%, 12%, and 2.2% in Asia, Latin America, and Africa, respectively. CMV is normally treated with several injections to the eye, which requires hospitalization and highly trained medical staff to insure proper care. Valganciclovir, as an alternative, saves time and money in countries where current access to the drug for HIV-related CMV is limited.

Because of its limited use, this leaves little demand for generic competition through licensing agreements, in stark contrast to many HIV medicines that the MPP has sought out for in-licensing. It is for this lack of generic competition that the partnership includes a licensing element to ensure access to the drug through the development of quality copycats. These licensing and technology transfer negotiations will begin a year from Monday, August 5th, the date of the agreement.

The MPP will continue its work in collaboration with other key stakeholders to develop long-term strategies for treatment that scale up the use of valganciclovir for treatment of HIV-related CMV. It is currently in talks with Bristol-Meyers Squibb and Boehringer Ingelheim.

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