FOSTER CITY,
CA – JUNE 5, 2007
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
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,
please visit www.aptbio.com.
Media Contacts
/Lisa Kelaita
New Venture Communications
lkelaita@newventurecom.com
(650) 343-2735
Ted Rossman
New Venture Communications
trossman@newventurecom.com
(914) 432-7083
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