Gilead pursues ‘one-a-day’ HIV pill

Biopharma teams up with J&J to fight virus that causes AIDS

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FOSTER CITY,Calif.—California biopharmaceutical maker Gilead Sciences Inc. is teaming withJohnson & Johnson to devise a once-a-day pill for treating patientsinfected with the virus that triggers AIDS.
Gilead andJ&J's Tibotec Pharmaceuticals unit, with operations in New Jersey,announced last month they will partner in the commercial development of a pillcombining Gilead's cobicistat antiretrovirus treatment with Tibotec's proteaseinhibitor darunavir, branded as Prezista. Financial terms of the deal were notdisclosed.
Gileadspokeswoman Erin Rau explains that cobicistat is an investigationalpharmacoenhancing or "boosting" agent.
"We developedcobicistat for HIV antiretrovirals, including integrase inhibitors such aselvitegravir, and protease inhibitors such as Tibotec's darunavir," Rau says."Antiretrovirals such as these require a boosting agent in order to reach fullyeffective levels in the blood. By increasing and prolonging blood levels,boosting agents can also enable once-daily dosing."
Rau sayscobicistat essentially increases blood levels of certain HIV medicines to allowfor once-daily dosing. It is in Phase III as a standalone booster for proteaseinhibitors as well as part of Gilead's experimental "Quad" pill that combinesit with elvitegravir and Truvada.
According toJ&J spokeswoman Karen Manson, Gilead proved to be an attractivecollaborator because it presented the opportunity to develop the company's drugPrezista with an alternative boosting agent in a combination product that hasthe potential to reduce the number of tablets patients have to take.
Prezista isalready approved for use in combination with Abbott Laboratories' boostingagent Norvir.
If successful inproviding new treatment options for patients by co-formulating Prezista withcobicistat in a new combination product, Manson says "it will demonstrate ourcommitment to HIV and innovations that will provide new options for patients."
Norbert W.Bischofberger, Gilead's executive vice president of research and developmentand chief scientific officer, says cobicistat's formulation and clinicalprofile provides the company with the flexibility to coformulate and developnew combination products, including the potential to co-formulate with proteaseinhibitors such as Prezista.
"This agreementrepresents another important step forward in our commitment to developingsimplified treatment regimens that can help address the individual needs ofpeople living with HIV," he says.
Dr. Johan VanHoof, head of global therapeutics, infectious diseases and vaccines atJ&J's Janssen Pharmaceutica unit, says the company is excited to be able tostudy and develop Prezista with an alternative boosting agent in a combinationproduct which has the potential to reduce the number of tablets patientstake. 
"Tibotec iscommitted to developing new and innovative HIV treatment options, especiallythose which provide simplified treatment regimens that may help patients tobetter manage their HIV treatment," he says. "Prezista is one of the leadingprotease inhibitors, and coformulating it with cobicistat in a new combinationproduct demonstrates our commitment to HIV and innovations that will providenew options for patients."
Should thistreatment be approved, Tibotec would take responsibility for its globalproduction and sales, with Gilead retaining the rights to cobicistat as astandalone product and for use in combination with other drugs.
The companiesare also in discussions about a similar collaboration to create a single-tabletHIV regimen combining Prezista with Gilead's compounds Emtriva and GS 7340, aswell as cobicistat. Gilead would be responsible for the development andcommercialization of the new STR on a worldwide basis. The agreement to developthe fixed-dose combination of cobicistat and Prezista is contingent upon thesigning of the agreement to develop the Emtriva, GS 7340, cobicistat andPrezista STR.
Piper Jaffrayanalysts say the new deal was a modest positive for J&J as it builds afranchise in HIV medications. They said it's difficult, however, to assess thefinancial impact on J&J until the negotiations on the single-tablet regimenare complete and terms are disclosed.
For Gilead, thedeal further extends the company's dominance in HIV therapies, according toLazard Capital Markets analyst Joel Sendek. Gilead's HIV drug Atripla had salesof $2.93 billion for 2010, while Truvada sales were $2.65 billion.
The moves wouldexpand a partnership between J&J and Gilead formed in 2009. Under thatdeal, the companies developed a combination of Gilead's Truvada HIV drug andJ&J's Edurant.

Tibotec andPharmasset to study HCV drug combo
PRINCETON,N.J.—Tibotec Pharmaceuticals also announced last month that it has entered intoa clinical collaboration agreement with Pharmasset Inc. to evaluate in a PhaseII study the safety and efficacy of PSI-7977, Pharmasset's investigationalnucleotide polymerase inhibitor, in combination with TMC435, TibotecPharmaceuticals' investigational protease inhibitor, for the treatment ofchronic hepatitis C virus (HCV).
This Phase IIproof-of-concept study will evaluate the potential to achieve sustainedvirologic response 12 weeks post treatment with an all-oral, once-daily,interferon-free treatment regimen in patients infected with genotype 1 HCV.
Specifically,the study will assess the safety, pharmacokinetics and pharmacodynamics of 12and 24 weeks of PSI-7977 in combination with TMC435, with and withoutribavirin, in patients chronically infected with HCV genotype 1 who had a priornull response to peginterferon alfa and ribavirin treatment.
The study is planned to start in the second half of 2011.

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