For Immediate Release
INSPIRE AND FAES FARMA ANNOUNCE LICENSING AGREEMENT FOR NEW ORAL
ANTIHISTAMINE TO TARGET ALLERGY MARKET IN UNITED STATES AND
CANADA
- Inspire Expands Allergy Product Portfolio
with Phase 3 Compound -
- Inspire Will Host Conference Call on November 1 at 10:00 am ET
-
DURHAM, NC -- November 1, 2006 -- Inspire
Pharmaceuticals, Inc. (NASDAQ: ISPH) and FAES Farma, S.A. (IBEX:
FAE) announced today the signing of a licensing agreement for the
U.S. and Canadian development and commercialization of bilastine, a
Phase 3 oral antihistamine compound for the treatment or prevention
of allergic rhinitis, a condition affecting approximately 40
million people in the United States.
Under the terms of the agreement, Inspire has acquired exclusive
rights to further develop and commercialize oral formulations of
bilastine in the United States and Canada, as well as the exclusive
right to develop and commercialize the ocular formulation in
various markets worldwide. The agreement provides that Inspire will
pay FAES an upfront license fee of $7 million and up to an
additional $82 million of payments, contingent upon achievement of
various development, regulatory and sales milestones. Inspire will
also pay a royalty of 14-16% on net sales of the oral formulations
of bilastine in the United States and Canada, if approved by
regulatory authorities.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented,
"Our collaboration with FAES represents an ideal strategic
opportunity for Inspire. Bilastine expands our allergy franchise
and will leverage our clinical development expertise and historical
success of our commercial team. We have the opportunity to develop
and commercialize multiple formulations of the compound for oral
and ocular uses. We expect that bilastine can generate significant
near-term revenues and bridge to the commercialization of other
compounds in our pipeline. Based on the clinical profile to date,
we believe that the oral formulations of bilastine, if approved by
regulatory authorities, could generate more than $200 million
dollars in peak sales in the $3 billion annual oral antihistamine
market in the United States."
Dr. Francisco Quintanilla, Managing Director of FAES Farma,
commented, "We are pleased to establish this partnership with
Inspire, which will enable us to leverage the global opportunity
for bilastine, an important compound that came from our internal
research and development efforts. The allergy market in the United
States represents a large and attractive revenue opportunity."
Bilastine is a new chemical entity (NCE) that is a non-sedating,
highly selective H1-antihistamine with a U.S. composition of matter
patent through 2017. FAES has assessed the efficacy, tolerability
and safety of bilastine in the once-daily oral tablet formulation
in multiple clinical trials, including two large, potentially
pivotal Phase 3 seasonal allergic rhinitis trials in Europe that
had positive outcomes. In these trials, bilastine appeared to have
an attractive tolerability profile. Nearly 4,000 subjects have been
studied in clinical trials to date. Multiple studies have been
completed in the development of this compound, including standard
toxicology, carcinogenicity, cardiac safety, and food and drug
interaction studies. FAES announced the acceptance of an
Investigational New Drug (IND) application by the U.S. Food and
Drug Administration (FDA) in April 2006 and there is currently an
ongoing thorough QT/QTc study in the United States, which is
frequently recommended by the FDA for oral antihistamines to
confirm the cardiac safety profile. The results of this study are
expected to be reported in the second quarter of 2007.
Inspire expects to request a meeting with the Pulmonary division of
the FDA to discuss various aspects of the program. Following this
meeting, Inspire plans to provide an update on requirements for
approval and target timing for a New Drug Application (NDA) filing.
Inspire anticipates conducting at least one additional trial in the
United States to broaden the experience with the compound and to
enhance the competitive position of the potential product.
Under the terms of the agreement, Inspire granted to FAES a right
of first negotiation for commercialization in Spain and Portugal of
Inspire's cystic fibrosi
