Thursday, December 16, 2004

FDA GRANTS PRIORITY REVIEW FOR CHIRON'S PULMINIQ INHALATION SOLUTION

Chiron Corp.'s New Drug Application for Pulminiq (cyclosporine) inhalation solution has been accepted by the Food and Drug Administration for priority review.   The firm is seeking an indication that will allow the pharmaceutical brand Pulminiq to be used, in combination with standard immunosuppressive therapy, to increase survival and prevent chronic rejection in patients who have received allogeneic lung transplants. Immunosuppressant cyclosporine is already approved as the standard treatment for chronic rejection of kidney, liver and heart allogeneic transplants, but Pulminiq would be the first immunosuppressant approved for this lung rejection indication.   Chiron noted that survival after lung transplantation has not appreciably improved in the last 10 to 15 years when compared with other types of organ transplants.   The NDA contains data from a double-blind trial of Pulminiq among patients who underwent single-lung or double-lung transplants and were receiving standard immunosuppressive treatment. For this randomized, placebo-controlled trial, the subjects were exposed to Pulminiq for at least two years.   Results showed a 79 percent decrease in the risk of death for patients who received Pulminiq as compared with those who received placebo. Moreover, 60 percent of the participants who received placebo had histologically proven bronchiolitis obliterans (chronic rejection) or death versus only 19 percent of the Pulminiq-treated patients.   Pulminiq, which contains 300 mg/4.8 mL of cyclosporine, delivers the drug directly to the lungs, thus achieving greater drug concentration at the rejection site than intravenous or oral cyclosporine, Chiron said.

Friday, September 17, 2004

PROTEIN DESIGN, ROCHE TO COLLABORATE ON DEVELOPMENT OF ZENAPAX FOR ASTHMA

Protein Design Labs Inc. and Roche Holding AG entered into a worldwide agreement to jointly develop and commercialize Zenapax (daclizumab) for the treatment of asthma and related respiratory diseases.   PDL will receive a $17.5 million upfront payment from Roche as well as up to $187.5 million in development and commercialization milestone payments. The firms will share development expenses and co-promote the product, if approved, in the United States. PDL will receive royalties on sales of the drug outside the United States.   In 1989, Roche acquired from PDL worldwide rights to Zenapax, which received Food and Drug Administration approval in 1997 for use in combination with cyclosporine and corticosteroids to prevent acute organ rejection in kidney transplant recipients. In 2003, PDL reacquired from Roche all rights to the drug for uses other than transplantation.   Earlier this year, PDL approached Roche regarding a collaboration in asthma after Phase II study results suggested Zenapax is effective in treating patients with moderate to severe asthma. William Burns, global head of Roche's pharmaceuticals division, said the firm believes Zenapax will offer patients a significant improvement over current therapies.   Ron Ellis, a Leerink Swann drug analyst, projected Zenapax could post peak annual sales of $500 million for asthma, according to Reuters. He said PDL would likely split sales with Roche in the United States and receive a 10 percent royalty on sales elsewhere.   Ellis, however, added that the pharmaceutical brand name drug Zenapax is not likely to receive approval for the asthma indication before late 2007.