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Post# of 251696
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DewDiligence

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Re: DewDiligence post# 72837

Monday, 02/09/2009 3:43:14 AM

Monday, February 09, 2009 3:43:14 AM

Post# of 251696
The New Battle Lines in HIV (GILD JNJ IDIX/GSK RDEA)

GILD’s Truvada franchise is so firmly established as the backbone of therapy in the early lines of treatment that there is little to no chance of anything replacing it in the near future (#msg-26915314, #msg-35137606). Moreover, Truvada and BMY’s Sustiva have been combined into a single pill—Atripla—that is taken once daily and sets a standard for convenience (and hence compliance) that a twice-daily regimen cannot hope to match. Thus, from a business standpoint, the interesting question is which once-daily drugs, if any, will be able to supersede Sustiva as the favored “third” drugs in Truvada-based regimens.

Inasmuch as Truvada consists of two nucleoside reverse-transcriptase inhibitors—Viread and Emtriva—the third drug in a Truvada-based cocktail will clearly come from a different class. The main options are non-nucleoside reverse-transcriptase inhibitors (NNRTI’s), protease inhibitors (PI’s) and integrase inhibitors (II’s).

However, the market has been moving away from the use of PI’s in early lines of therapy because they have a relatively poor resistance profile and mediocre tolerability. Reyataz from BMY and Kaletra from ABT, the two biggest-selling PI’s, have been steadily losing share (e.g. #msg-35109525).

Thus, NNRTI’s and II’s that can be dosed qD are where the action will be. The leading candidates to gain traction (IMHO) are as follows.

1. Elvitegravir/Quadro from GILD. Elvitegravir is an II similar to MRK’s Isentress, which is already on the market and doing about $500M in annualized sales; however, Elvitegravir has the crucial advantage of being dosed qD with help from a PK-boosting agent.* Quadro is the name for the 4-drug combo that includes Elvitegravir, Truvada, and GILD’s proprietary PK-booster called GS9350. Elvitegravir is in phase-3 (#msg-30900183) and Quadro is about to enter phase-2 (#msg-35131829). As the owner of Truvada, GILD enjoys the advantage of not needing cooperation from any other company in order to formulate Quadro into a single pill.

2. TMC278 from JNJ, a qD NNRTI in phase-3 (#msg-31354706, #msg-30789106). TMC278 is similar to Intelence (a.k.a. TMC125), JNJ’s marketed NNRTI that has the drawback of being dosed BID.

3. IDX899 from GSK/IDIX, a qD NNRTI about to start phase-2 (#msg-31925486). IDX899 has antiviral efficacy even at extremely low doses (#msg-31944395), which fosters its ability to be combined with other HIV drugs in a single pill with a small form factor. Moreover, IDX899 has a stronger barrier to resistance than Sustiva (#msg-35431633) and it lacks cross-resistance to Sustiva, which preserves the option for patients to use Sustiva in a subsequent line of therapy. I thought the economic terms of the IDIX-GSK partnership announced last week were impressive for a drug that has not yet started phase-2 (#msg-26884307).

4. RDEA806 from RDEA, a qD NNRTI in phase-2b (#msg-33138650, #msg-31315602). Although RDEA806 is further advanced than IDX899, it is not yet partnered despite RDEA’s stated intention to partner it. This the reason I have ranked RDEA806 one notch below IDX899.

*MRK recently started a phase-3 Isentress trial with qD dosing and could submit an sNDA in 2011; however, I consider this trial a long shot.


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