Gilead Grabs Cicletanine For PAH From Navitas
This article was originally published in The Pink Sheet Daily
Executive Summary
Bargain-priced drug has orphan status pending, could complement Letairis.
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Gilead's acquisition of cicletanine for pulmonary arterial hypertension at an upfront price in the "mid-single-digit millions" looks like a good deal that will complement the firm's portfolio, analysts say. In announcing the deal on May 29, Foster City, Calif.-based Gilead said it would pay an undisclosed upfront price, plus payments linked to future sales, to the drug's developer Navitas Assets, of Laramie, Wyo. Gilead confirmed to "The Pink Sheet" DAILY that the upfront payment is worth in the range of "mid-single-digit millions" and includes worldwide rights, aside from France. Globally, an estimated 200,000 people have the disease. "Gilead is known for doing the smartest in-licensing deals in the biotech sector," said Bear Sterns analyst Mark Schoenebaum after the announcement of the sale. "Chances are, investors will give Gilead the benefit of the doubt and like this deal." Though off-patent, cicletanine has a shot at orphan drug status for PAH in the U.S., which would provide seven years' market exclusivity. Navitas applied for this status on an undisclosed date in April and a response is expected two to three months from the time of application. PAH and hypertension have been linked to decoupling of endothelial nitric oxide, which causes deficiencies in vascular nitric oxide. Taken once daily, cicletanine is aimed at enhancing coupling of eNOS. The drug is now being tested in PAH at the Massachusetts General Hospital via a compassionate use investigational new drug application. A Phase II trial of cicletanine as a monotherapy in PAH is planned for the end of this year. In Europe, cicletanine is marketed for hypertension under the name of Tenstaten in France, Germany, Belgium and Luxembourg. Use of the drug in 10,000 patients in Europe for hypertension supports ciceltanine's safety profile, Gilead said. Cicletanine has a novel mechanism and it remains to be determined which patient segments it might be useful in treating and whether it will ultimately be used as a monotherapy or in combination with another treatment, such as Gilead's Letairis (ambrisentan), observed Thomas Russo, analyst with Robert W. Baird & Co. The trend in PAH is toward combination therapy. Letairis was approved in 2007 as a once-daily PAH treatment in patients with World Health Organization Functional Class II or III symptoms (1 (Also see "Gilead Letairis Will Be Available Through LEAP Restricted Distribution Program" - Pink Sheet, 15 Jun, 2007.)). For a small investment, Gilead has acquired a "molecule with an existing safety database, potential in PAH and [possibly] complementary to Letairis," Russo said. Though tested in general hypertension, however, the drug still has to prove itself in PAH, he added. Given cicletanine's novel mechanism of action, there is no direct competition, though Actelion's Tracleer (bosentan) in another class comes the closest ("2 (Also see "Actelion Vows To Keep PAH Lead, Despite First-Quarter Dip" - Pink Sheet, 22 Apr, 2008.)). - Emily Hayes ([email protected]) |