APT Acquires Exclusive
Worldwide Rights to Develop and Commercialize Inhalable Cyclosporine
to Prevent Lung Transplant Rejection
Such a Product
Should Increase Survival Odds for 1,500 Lung Transplant Patients
Annually if Drug is Approved by the FDA
FOSTER CITY,
CA – JUNE 5, 2007
APT, a specialty drug development company
focused on effective treatments for significant unmet medical
needs, announced today that it has entered into an exclusive
licensing agreement with Novartis Pharma AG for the worldwide
rights to develop and commercialize an inhalable form of cyclosporine
for the prevention and treatment of lung transplant rejection.
Cyclosporine, marketed as Neoral®, 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 Licenses 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. “inhalable 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 1500 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 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 inhalable Cyclosporine
A long-term study of inhalable 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 inhalable
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: www.aptbio.com.
CONTACT:
Ted Rossman/Lisa Kelaita
New Venture Communications
(650) 343-2735
trossman@newventurecom.com
lkelaita@newventurecom.com
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