With one of the largest pipelines of any biotech company, Norbert Bischofberger has much to oversee as Gilead's top R&D executive. Since becoming Exec VP-R&D in 2000, Bischofberger has been instrumental in the development of Gilead products, including most recently, the pulmonary arterial hypertension treatment Letairis (ambrisentan) and, with Bristol-Myers Squibb, Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), for HIV.

Bischofberger joined Gilead in 1990 and was also named chief scientific officer earlier this year. Prior to Gilead, Bischofberger served as a senior scientist in Genentech's DNA Synthesis Group from 1986 to 1990. He holds a PhD in organic chemistry from Eidgenossische Technische Hochshule in Zurich.

[Editor's note: Parts 2 and 3 of the interview will appear later this week and next week.]

"The Pink Sheet" DAILY : Gilead is known for its infectious disease therapies (e.g. HIV/AIDS), even though the company's focus also includes chronic hepatitis, cardiopulmonary and respiratory diseases. Looking ahead, will Gilead tend to focus on these areas or just a couple in particular? Also, what's your feeling on licensing and/or acquisitions to boost your pipeline?

Norbert Bischofberger: Where we found ourselves and we still find ourselves is if you look at our R&D spending as a percentage of revenues, it's at a very, very low 12 to 13 percent, and this is really low by any standard. Certainly, if you think you are still a growing organization, the R&D spending could be somewhere around 25 percent, 20 percent. Big companies like Pfizer have R&D spending as a percent of revenues at 14 percent. We were really in a financially and strategic situation where we could afford to spend a lot more and invest a lot more in R&D. If you do that internally, it's a very difficult thing to do, to spend more money because you can only spend significant amounts of money if you have late-stage programs, but building out research and hiring more people in discovery, that doesn't substantially change the R&D spending. That was the main strategic and financial reason why we were looking at acquiring companies and programs.

So ... we're still in the situation where we have a very low R&D spending as a percent of revenues so we can spend more.

It's also clear that our biggest area of research and our biggest area of focus is still where our commercial products are. It's HIV and hepatitis, just to make that clear. We're not abandoning in any way HIV and hepatitis, but we absolutely are determined to maintain our leadership in HIV and that's why our biggest investment is still in the HIV area.

"The Pink Sheet" DAILY : Might we see some additional deals such as your recent licensing agreement with Parion?

Bischofberger: Absolutely. [Deals] like Parion, we would expect to do a lot more of. Those are relatively small deals for us. The Parion deal was a $5 million up-front payment. We have an R&D budget of about $520 million. It's not really a huge expense for us. We expect to do a lot more of these smaller deals. With regards to larger deals, there's nothing on the horizon because another difficulty is ... the integration piece. There are a limited number of these things that you can do if you have to integrate people and organizations and how do they work together. That's a little complicated. Parion [is] simply a licensing agreement. We give them some money [and] we have the rights to develop this compound ... We can very comfortably take [this] on.

[Parion licensed its preclinical epithelial sodium channel (ENaC) inhibitor, P-680, in an Aug. 15 deal to Gilead worth up to $146 million (¹ Also see "Parion Lands Monster Deal With Gilead For Cystic Fibrosis Candidate" - Pink Sheet, 16 August, 2007.).]

"The Pink Sheet" DAILY : Gilead has previously announced plans to submit Viread (tenofovir) for a hepatitis B indication. Are you evaluating making submissions for your other HIV drugs in other indications as well?

Bischofberger: HIV and hepatitis B share a common polymerase, a reverse transcriptor or polymerase that has some similarity. Often what you find is nucleosides that work in HIV also have activity in HBV. [GlaxoSmithKline's] lamivudine [ Epivir HBV ] is a good example. Viread is another example. But we don't really currently have any other agent in HIV that would also have activity in hepatitis B. The thing we are evaluating is the concept of combination therapy in hepatitis B. In HIV, the whole field has [moved] very quickly. Ten years ago or more, [treatment] moved to combination therapies because the experience was that treating with one single agent was just not enough - it doesn't do much. But that's not the case yet in hepatitis B. There's still a little bit of a debate in the community. Should you treat upfront with [a] combination or should one agent be enough? We are in the fortunate position to also have besides Viread, we also have Emtriva [emtricabine]. There's a combination product of the two, Truvada . Both of those agents have activity against hepatitis B and so we are actually looking at the combination of the two for the treatment of hepatitis B in an early exploratory Phase II study.

[In June, Gilead released results from a second Phase III trial of Viread in hepatitis B, meeting its primary endpoint (² Also see "Gilead Plans Viread Filing For Hepatitis B By Year End" - Pink Sheet, 25 June, 2007.).]

-Jonathan M. Block (j.block@elsevier.com)

Gilead Executive VP-R&amp;D Norbert Bischofberger: An Interview With “The Pink Sheet” DAILY (Part 1 of 3)

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Gilead Executive VP-R&D Norbert Bischofberger: An Interview With “The Pink Sheet” DAILY (Part 1 of 3)