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12:00 AM
Aug 13, 2012
 |  BioCentury  |  Strategy

Merck's new mark in HIV

Merck setting up to compete in HIV combo market with Chimerix, Yamasa deals

Merck & Co. Inc. may be positioning itself to compete in the HIV combination therapy market dominated by Gilead Sciences Inc. and ViiV Healthcare LLC, the joint venture of GlaxoSmithKline plc and Pfizer Inc.

Merck has in-licensed a pair of early stage compounds from Chimerix Inc. and Yamasa Corp. and unveiled plans to move an internal molecule into Phase IIb testing this fall.

While last month's deals get Merck closer to developing a next-generation combination product capable of killing resistant HIV strains, the pharma also appears to have an interest in a second strategy: attacking the reservoirs where the virus is believed to hide from current therapies.

The HIV news is something of a coming-out-again party for Merck, which played a leading role in the discovery of the first wave of HIV drugs decades ago. Although the pharma did win FDA approval for Isentress raltegravir in 2007, and reported $1.4 billion in sales of the HIV integrase inhibitor in 2011, the company had otherwise been largely quiet on the HIV front in recent years after a series of late-stage disappointments.

In the late 1980s, Merck scientists were the first to show that protease inhibition could prevent HIV replication and to publish the crystal structure of HIV protease.

In the 1990s, the company discovered efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was approved in the U.S. in 1998. Bristol-Myers Squibb Co. markets efavirenz in the U.S. as Sustiva, while Merck markets it elsewhere as Stocrin.

In addition to small molecules, Merck studied other modalities to treat and/or prevent HIV, including vaccines and microbicides, though these efforts did not generate any approved products.

In 2007, Merck discontinued a trivalent HIV vaccine after it failed a Phase II trial to prevent or reduce the rate of infection. Also that year, an internally discovered prophylactic microbicide was shelved before reaching the clinic. The company granted the not-for-profit International Partnership for Microbicides a royalty-free license to the microbicide in 2008.

The company's last disclosed in-licensing foray was in a 2006 deal for a protease inhibitor program in Phase I testing from Ambrilia Biopharma Inc. But the pharma put development of a lead compound on hold to evaluate other formulations and compounds in 2008, and returned the assets a year later.

In 2010, Merck shelved vicriviroc after the CC chemokine receptor 5 (CCR5; CD195) inhibitor failed a pair of Phase III trials. Merck gained the compound through its 2009 merger with...

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