Biotech Values

[DewDiligence]

Here’s JNJ’s PR on the GILD collaboration in HIV. Note that the
agreement covers all “developed” markets except Japan (where
Japan Tobacco has commercial rights to Truvada). A feature of the
deal not mentioned in this PR is that JNJ agreed to sell TMC-278 to
GILD for use in the combo pill at a 30% discount to the standalone
price of TMC-278. (This 30% discount may be less consequential than
it seems, however; TMC-278 will probably be little used as a standalone
drug and JNJ will likely be able to “game” the price charged to GILD.)
GILD and JNJ will ink a separate deal to commercialize the combo pill
in emerging markets, but the companies probably won’t make much
money in those countries. See comments below about the first-line vs
second-line setting.

http://finance.yahoo.com/news/Tibotec-Pharmaceuticals-prnews-1737699048.html?x=0&.v=1

›Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada With Gilead Sciences

- Product Could Represent a New, Once-Daily Antiretroviral Treatment Option -

Thursday July 16, 2009, 4:28 pm EDT

CORK, Ireland, July 16 /PRNewswire/ --Tibotec Pharmaceuticals today announced that it has entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a new once-daily fixed-dose antiretroviral product containing Tibotec's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride 25 mg) and Gilead's Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for treatment-naive adult patients with HIV-1. [This is unintentionally misleading, IMO; if approved in the first-line setting, the combo pill will almost certainly be widely used in the second-line setting too.] Fixed-dose combinations contain multiple medicines formulated into one tablet and help to simplify HIV therapy.

"A simplified regimen may help improve patient adherence and decrease overall pill burden," said Roger Pomerantz, MD, President Tibotec R&D. "We are very pleased to collaborate with Gilead, one of the leading companies in the fight against HIV/AIDS, and look forward to advancing this new fixed-dose product in addition to TMC278 as a single agent."

This agreement represents the first fixed dose combination product collaboration for Tibotec and, when approved, it would become the first complete once-daily antiretroviral treatment regimen for HIV to include an antiretroviral from Tibotec. Tibotec is currently studying the combination of Truvada and TMC278 in its Phase III program; the two ongoing pivotal clinical trials, TMC278-C209 and TMC278-C215 are fully recruited having enrolled over 1,300 treatment-naive adult patients with HIV-1. Current HIV treatment guidelines issued by the U.S. Department of Health and Human Services list emtricitabine and tenofovir (the components of Truvada) in combination with a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor as a preferred regimen for patients initiating therapy.

Tibotec will remain uniquely responsible for the commercialization of TMC278 as a single product and additionally will have the right to promote the fixed-dose combination product to healthcare professionals in all countries except Japan and the access countries [“access countries” is a euphemism for emerging markets, i.e. the Third World]. Gilead will assume the lead role in manufacturing, registration and, subject to regulatory approval, commercialization of the fixed-dose combination of TMC278 and Truvada throughout the territory. [Although not stated here, development and commercialization expenses on the combo pill that are solely funded by GILD are capped at $100M; above this amount, the expenses are presumably shared.]

Tibotec and Gilead are committed to working together to make the fixed-dose combination of TMC278 and Truvada available in the developing world and will work towards a separate agreement for these countries.

About TMC278

TMC278 is an investigational non-nucleoside reverse transcriptase inhibitor, and the safety and efficacy of it, in combination with other antiretroviral agents, has not been established. Two major phase III trials for TMC278 are currently being conducted in the United States, Canada, Africa, Asia, Europe and South America.

About Tibotec Pharmaceuticals

Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need. Tibotec Pharmaceuticals is a subsidiary of Johnson & Johnson.‹