Incyte’s CCR5 Antagonist Has “Meaningful Advantages” Over Pfizer’s Maraviroc, Firm Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Company says it is in active licensing discussions with “probably half a dozen” firms.
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Incyte is touting a potential dosing benefit and safety advantages for its CCR5 antagonist INCB9471 versus Pfizer's pending CCR5 agent maraviroc. 9471 "has the potential to be positioned as the preferred CCR5 antagonist for first- and ... second-line regimens on its own and potentially as a component of a combination," Incyte CEO Paul Friedman told investors during the firm's May 3 first-quarter earnings call and business update. "We continue to believe 9471 has the potential to provide meaningful advantages over maraviroc, which needs to be dosed twice-daily even when it's used with ritonavir," Friedman asserted. "9471 has what we consider a superior pharmacokinetic profile, consistent with once-daily dosing whether or not it's being used with ritonavir." "If approved, 9471 would be more appropriate for first-line use where once-daily regimens with ritonavir-boosting protease inhibitors predominates," Friedman said. "9471, but not maraviroc, has the potential to be formulated as part of a once-daily fixed-dose combination," the exec added. "We haven't seen any dose-limiting toxicities" with 9471, Friedman said, noting concerns relating to hypotension and myocardial risk seen with maraviroc. Maraviroc received a unanimous recommendation for accelerated approval from FDA's Antiviral Drugs Advisory Committee April 24 (1 (Also see "Pfizer’s Maraviroc Unanimously Recommended For Accelerated Approval" - Pink Sheet, 25 Apr, 2007.)). However, the panel suggested that the agency require several postmarketing commitments for safety in subpopulations as well as specific labeling precautions, including risk of hepatotoxicity. In January, Wilmington, Del.-based Incyte reported that the first seven patients in its Phase IIa study for 9471, dosed at 200 mg, had a 1.7 log viral load drop at day 14 and a further reduction of 2.1 log at day 20. Full results will be presented in July at the International AIDS Society meeting in Sydney, Australia. Also this summer, the firm plans to release findings of a study to evaluate two more once-daily dosing levels - 100 mg and 300 mg. Incyte's pipeline also includes the earlier-stage JAK2 inhibitors, which it believes could hold promise in chronic inflammatory conditions and myeloproliferative disorders. The firm received FDA clearance for three INDs for its oral JAK2 (Janus kinase) inhibitors during the first quarter. Another firm working on JAK inhibitors is Wyeth. In January, the company inked a development deal with Pharmacopeia to develop JAK3 inhibitors for potential use in immunological diseases (2 (Also see "Wyeth Taps Pharmacopeia Technology For Potential Small Molecule RA Therapies" - Pink Sheet, 4 Jan, 2007.)). Also during the first quarter, Incyte filed an IND for its CCR2 agent INCB8696 to investigate its use in multiple sclerosis and lupus nephritis. Phase I trials in healthy volunteers are expected to wrap up this year. Incyte's CCR2 antagonist program is funded in part via a November 2005 deal with Pfizer (3 (Also see "Multiple Internal Champions Can Propel Complex Licensing Deals, Pfizer Exec Says" - Pink Sheet, 12 Sep, 2006.)). The agreement could be worth upward of $800 million. Incyte is also working in another hot area: metabolic disease. The firm recently initiated a one-month placebo-controlled trial with its small molecule inhibitor of the enzyme 11-beta HSD1 in type 2 diabetics. Top-line results are expected by mid-year, Friedman said. During the earnings call, management said Incyte has encountered significant interest from potential licensing and development partners for multiple projects in its pipeline but is in no hurry to cut a deal. "We have active discussions going on with probably half a dozen different companies right now. And most of those were unsolicited approaches to us," CFO David Hastings said. The firm has enough cash to take it through three years of operations, Hastings noted. "We continue to be on track to incur between $88 million and $95 million for the year" in research and development expenses. - Pamela Taulbee ([email protected]) |