Gilead Ramps Up For Ambrisentan; Calls For 75 To 100 Sales Reps
This article was originally published in The Pink Sheet Daily
Executive Summary
Company plans to go toe-to-toe with PAH competitors, CEO tells JP Morgan Healthcare Conference.
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Gilead expects to launch the pulmonary arterial hypertension candidate ambrisentan using a field force roughly the size of its existing HIV sales team CEO John Martin said during the JP Morgan Healthcare Conference in San Francisco Jan. 8. "We're already preparing," Martin said. "We will substantially build the sales force to about the size of our HIV team by the time ambrisentan is launched later this year." The firm's HIV franchise is its leading business. The ramp up for launch of the new endothelin receptor antagonist will ultimately include about 75 to 100 sales representatives, he added. Gilead submitted the NDA for ambrisentan Dec. 19 and is seeking a six-month priority review. If FDA grants priority review, ambrisentan would have a June 18 user fee date (1 (Also see "Gilead Submits NDA For Ambrisentan For PAH" - Pink Sheet, 19 Dec, 2006.)). PAH is set to become a fiercely competitive therapeutic area, with two new entrants - both endothelin receptor antagonists - possibly hitting the market this summer. In addition to Gilead's ambrisentan, Encysive Pharmaceuticals' Thelin (sitaxsentan) has a June 15 user fee date (2 (Also see "Encysive Thelin Approval Could Come Days Ahead Of Gilead’s Ambrisentan" - Pink Sheet, 28 Dec, 2006.)). Encysive had recruited and trained 52 sales reps in preparation for the launch of Thelin in April. Although the launch has been delayed by regulatory setbacks, including the company's receipt of an FDA "approvable" letter, Encysive has maintained its commercial organization in preparation for launch. The market currently includes one endothelin receptor antagonist approved for PAH, Actelion's Tracleer (bosentan). "We will be coming to market with a competitor," Gilead CFO John Milligan acknowledged during the conference. "We will commercially have to be on our toes and come to market with the right number of resources." Gilead already has a team of 17 reps ready to promote ambrisentan following its approval. The team is currently copromoting GlaxoSmithKline's Flolan (epoprostenol) in the U.S. through an agreement forged by the drug's previous owner, Myogen, which was acquired by Gilead for $2.5 billion in October (3 (Also see "Gilead Buys Myogen To Strengthen Pulmonology Franchise" - Pink Sheet, 2 Oct, 2006.)). Under its deal with Myogen, GSK gained rights to ambrisentan outside the U.S. GSK is on track to file the drug in the European Union by the end of the first quarter, according to Martin. Ambrisentan offers benefits over existing therapies for the treatment of PAH due to its lack of drug-drug interactions and improved liver safety, Martin maintained. "Ambrisentan has the profile to become what we believe is the best in class endothelin receptor antagonist and, therefore, the drug of choice for the treatment of this disease," he said. "It reminds me a lot of the profile of Viread and the comparative data we had there for the treatment of AIDS. ...Here again is an opportunity to have a better-tolerated therapy to be approved to treat a very serious disease." Gilead will consider undertaking head-to-head trials comparing ambrisentan to Tracleer, Milligan said. That decision will be based on the outcome of discussions with FDA and the final labeling for ambrisentan, he noted. In addition, Gilead is considering 12 other indications for ambrisentan in diseases associated with PAH, such as chronic kidney disease and liver disease. The Foster City, Calif. company also gained a second endothelin receptor antagonist through the Myogen acquisition, darusentan, which is in Phase III for treatment of resistant hypertension. However, due to slow enrollment in the trial because of the "labor intensive" protocol, Gilead is reconsidering "if this is the best way to get darusentan approved," Milligan said. But Gilead has no plans to sell darusentan, and will eventually move the drug candidate forward, he said. - Jessica Merrill ([email protected]) |