Gilead Grants New and Expanded Generics Licenses for HIV Drugs to Indian Firms

Gilead Sciences granted four India-based drug manufacturers, as well as the Medicines Patent Pool Foundation, licenses to manufacture generic versions of three of its late-stage HIV/AIDS drug candidates—Elvitegravir, Cobicistat, and the Quad—contigent upon their receipt of regulatory approval. The four companies are Hetero Drugs, Mylan’s Matrix Laboratories subsidiary, Ranbaxy Laboratories, and Strides Arcolab.

Elvitegravir (licensed by Gilead from Japan Tobacco) is an integrase inhibitor, Cobicistat is an antiretroviral boosting agent, and the Quad is a once-daily, single-tablet combination of four different Gilead drugs.

Gilead had previously provided Indian manufacturers with nonexclusive rights to produce and sell generic versions of the HIV drugs Viread®, Truvada®, and other tenofovir disoproxil fumarate (TDF)-based drugs in 95 developing countries. The expanded agreement means that the Indian firms will be also be able to market Viread, Truvada, and other TDF-based combinations in another 16 countries, as well as produce and sell Viread as a treatment for chronic hepatitis B in an expanded territory. Gilead will also provide its licensees with complete technology transfer of the manufacturing processes for the three pipeline drugs to support local regulatory approvals and production as soon as possible once FDA clearance for each candidate has been achieved.

The Pool has been granted similar licensing terms as the existing Indian partners. The Pool initiative was established in 2010 with the support of UNITAID to collaborate with pharmaceutical companies and expand global access to low-cost antiretroviral therapies through licensing agreements. It says the deal with Gilead is its first with a pharmaceutical company. Under terms of the agreement, other firms interested in producing generic versions of Gilead drugs for developing countries will be able to approach the Pool to negotiate licensing terms.

Matrix points out the new deal with Gilead follows on from last month’s immunity-from-suit agreement signed between Mylan and Bristol-Myers Squibb (BMS) relating to expanded access in sub-Saharan Africa and India for generic versions of BMS’ Reyataz® (atazanavir sulphate), Zerit® (stavudine), and Videx® (didanosine). Matrix says some 30% of HIV/AIDS patients in developing countries now rely on one of its antiretroviral products.

Mylan acquired API manufacturer Matrix in 2007, and in 2009 completed the two-stage acquisition of Merck KGaA’s generics business. Since then the firm has worked to integrate the two acquired businesses and has built a pharmaceuticals platform that achieved revenues of $5.5 billion in 2010 from sales in over 150 countries. In May Mylan announced plans to rebrand Matrix as Mylan. The firm said the move will lay the groundwork for continued expansion in India through marketing its own prescription pharmaceuticals over the next year.

“Changing Matrix' name to Mylan represents a natural next step for our business in India,” commented Mylan president Heather Bresch when the rebranding plan was announced. “We believe it will produce many benefits. By bringing Matrix under the Mylan brand and aligning it more directly with everything our global brand stands for, we believe we can better differentiate our company within the industry."