APT Acquires Exclusive Worldwide Rights to Develop and Commercialize Inhalable Cyclosporine to Prevent Lung Transplant Rejection
Cyclosporine, marketed as Neoral(R), is an immunosuppressant developed by Novartis for the prevention of organ rejection following kidney, liver or heart transplantation. In late 2004, Chiron Corporation (now Novartis Vaccines and Diagnostics, Inc.) submitted a new drug application for an aerosolizable form of cyclosporine to the Food and Drug Administration. The FDA issued an approvable letter in June 2005, opening the door for eventual approval of inhalable cyclosporine.
APT specializes in re-purposing existing drugs, with particular interest in developing new treatments for rare diseases and unmet medical needs. If inhalable cyclosporine is approved by the FDA, it is eligible to receive orphan drug designation, giving APT seven years of exclusivity to market the drug.
"We are delighted to add inhalable cyclosporine to our development portfolio," said Dr. Stephen Dilly, President and CEO of APT and formerly Chief Medical Officer of Chiron BioPharmaceuticals. "Inhaled cyclosporine is an excellent fit with our mission to develop effective treatments to address significant unmet medical needs. Furthermore, as cyclosporine has been used in other transplant indications for 20 years, it is well aligned with our focus on improving well-characterized drugs."
Under the terms of the Agreement, Novartis has licensed patent, know-how and regulatory cross-referral rights to APT for inhalable cyclosporine.
About Lung Transplantation
About 1,500 lung transplants are performed in the United States each year. Recipients of lung transplants have a five-year survival rate of about 47%, compared to five-year survival rates approaching 85% for heart, kidney and liver transplants. Obliterative bronchiolitis is reported as a cause of death over the long term in about 30% of lung transplant recipients. This condition is related to chronic rejection from within the airway of the transplanted lung.
Obliterative bronchiolitis often cannot be completely controlled with conventional systemic immunosuppressive therapy as drug levels achieved in the airway are too low and doses are limited by renal and hepatic toxicity. By delivering cyclosporine by inhalation, higher drug levels can be achieved in the airway without significantly increasing circulating drug levels.
About the Promise of Inhaled Cyclosporine
A long-term study of inhaled cyclosporine was conducted in 56 lung transplant recipients at the University of Pittsburgh Medical Center, a nationally recognized transplant center, and published in the New England Journal of Medicine in 2006. Patients that received inhalable cyclosporine in addition to their standard immunosuppressive treatment showed a 78% reduction in mortality compared to those in the control group, who received conventional immunosuppressive treatments.
"An inhaled form of cyclosporine is a product that the University of Pittsburgh has worked on for several years and we believe that it provides significant benefit to lung transplant patients," said Dr. Joseph Pilewski, Medical Director of the Lung transplant Program at the University of Pittsburgh Medical Center. "We are very excited that APT is dedicating the majority of its focus to develop a well-tolerated and user-friendly form of this important and effective immunosuppressant."
About APT Pharmaceuticals, Inc.
APT Pharmaceuticals, Inc. is a drug development company based in Foster City, California. APT is backed by several leading venture capital firms, including Charter Life Sciences, VIVO Ventures and Research Corporation Technologies. For more information, please visit www.aptbio.com.
Posted: June 2007