-- Companies Report Phase 1 Study Results --
CAMBRIDGE, Mass. & LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 4,
2007--Alkermes, Inc. (Nasdaq: ALKS) and Indevus Pharmaceuticals, Inc.
(Nasdaq: IDEV) today announced that they have entered into a joint
collaboration for the development of ALKS 27, an inhaled formulation
of trospium chloride for the treatment of chronic obstructive
pulmonary disease (COPD). The announcement of this collaboration
follows the completion of extensive feasibility work, preclinical
studies and a phase 1 study in healthy volunteers. Preliminary results
from the phase 1 study showed that ALKS 27 was well tolerated over a
wide dose range, with no dose-limiting effects observed.
The phase 1 randomized, double-blind, placebo-controlled study was
designed to assess the safety, tolerability, and pharmacokinetics of
ALKS 27 in 20 healthy, non-smoking adults. Subjects were given single
escalating inhaled administrations of ALKS 27 at dose levels ranging
from 50 mcg to 800 mcg. The study results showed that ALKS 27 was well
tolerated over a wide dose range, with no dose-limiting effects
observed. Evaluation of the pharmacokinetic data indicated that
exposure was dose-related.
"We are encouraged by the early data on ALKS 27 and are pleased to
be working with Indevus to develop a new product candidate for the
treatment of COPD, a serious and underserved disease," stated Richard
Pops, chief executive officer of Alkermes. "ALKS 27 combines our
proprietary AIR technology with Indevus' trospium chloride, a molecule
with a known safety profile and proven efficacy in certain spasmodic
indications. In addition, there exists an established regulatory path
for inhaled COPD medications that serves as a basis for advancing the
ALKS 27 program in the clinic."
"We believe that these phase 1 results support the rationale for
the ALKS 27 program, which combines Alkermes' AIR pulmonary drug
delivery technology and the unique properties of our compound to
create a new approach for the treatment of COPD," stated Glenn L.
Cooper, M.D., chairman, and chief executive officer of Indevus. "We
very much look forward to continuing to collaborate with Alkermes
through phase 2a, and working together to secure a partner to bring
forward an exciting new therapy in the COPD market."
Alkermes and Indevus plan to initiate a phase 2a clinical study in
the first half of 2007 designed to evaluate the clinical efficacy of
ALKS 27, administered once-daily, in subjects with COPD. Pending
results of the phase 2a study, the companies plan to engage a partner
for future development and commercialization of ALKS 27.
Under the joint collaboration, Alkermes and Indevus have shared
and continue to share equally all costs of development and commercial
returns on a worldwide basis. Alkermes will perform all formulation
work and manufacturing. Indevus will conduct the clinical development
program. Additional terms of the agreement were not disclosed.
ALKS 27 is an inhaled formulation of trospium chloride, a
muscarinic receptor antagonist that relaxes smooth muscle tissue and
has the potential to improve airflow in patients with COPD. Trospium
chloride is the active ingredient in SANCTURA(R), Indevus' currently
marketed product for overactive bladder. The formulation under
development for ALKS 27 is specifically designed for inhalation
utilizing Alkermes' proprietary AIR(R) pulmonary delivery system.
Chronic obstructive pulmonary disease (COPD), characterized by
airflow obstruction and loss of expiratory force, comprises mostly
smoking-related diseases such as emphysema and chronic bronchitis.
COPD is the fourth largest cause of death in the U.S. and is projected
to be the third leading cause of death for both males and females by
2020. It is estimated that over 12 million adults have been diagnosed
with COPD and approximately 24 million adults have evidence of
impaired lung function, indicating COPD is significantly
under-diagnosed. There is no known cure at the present time. In the
U.S., estimated direct healthcare costs are in excess of $20 billion
and surveys indicate a severe quality of life impact to COPD patients.
The total U.S. market for COPD product sales is over $3 billion.(1)
About Alkermes, Inc.
Alkermes, Inc. is a biotechnology company that develops innovative
medicines designed to yield better therapeutic outcomes and improve
the lives of patients with serious disease. Alkermes currently has two
commercial products: RISPERDAL(R) CONSTA(R) ((risperidone) long-acting
injection), the first and only long-acting atypical antipsychotic
medication approved for use in schizophrenia, and marketed worldwide
by Janssen-Cilag (Janssen), a wholly owned division of Johnson &
Johnson; and VIVITROL(R) (naltrexone for extended-release injectable
suspension) the first and only once-monthly injectable medication
approved for the treatment of alcohol dependence and marketed in the
U.S. primarily by Cephalon, Inc. Alkermes' pipeline includes
extended-release injectable, pulmonary, and oral products for the
treatment of prevalent, chronic diseases such as central nervous
system disorders, addiction and diabetes. Alkermes' headquarters are
in Cambridge, Massachusetts, and it operates research and
manufacturing facilities in Massachusetts and Ohio.
About Indevus Pharmaceuticals, Inc.
Indevus is a biopharmaceutical company engaged in the acquisition,
development and commercialization of products to treat urological,
gynecological and men's health conditions. The Company's marketed
products include SANCTURA(R) for overactive bladder and DELATESTRYL(R)
to treat male hypogonadism. The compounds in development include
SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO(R) for
male hypogonadism, PRO 2000 for the prevention of infection by HIV and
other sexually-transmitted pathogens, pagoclone for stuttering, and
aminocandin for serious fungal infections, for which the Company
recently licensed worldwide rights to Novexel S.A.
Certain statements set forth above may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements relating
to: development activities for ALKS 27 and the therapeutic potential
of ALKS 27 in COPD and other spasmodic indications. Although both
Alkermes and Indevus believe that such statements are based on
reasonable assumptions within the bounds of their respective knowledge
of their businesses and operations, the forward-looking statements are
neither promises nor guarantees and both the Alkermes' and Indevus'
businesses are subject to significant risk and uncertainties. As such,
there can be no assurance that either or both of Alkermes' and
Indevus' actual results will not differ materially from their
respective expectations. These risks and uncertainties include, among
others: whether Alkermes and Indevus can successfully develop ALKS 27
for the treatment of COPD; potential changes in cost, scope and
duration of the clinical trial; whether ALKS 27 will demonstrate
sufficient efficacy and safety in subsequent trials; whether Alkermes
can successfully manufacture ALKS 27 for clinical use; whether the
companies can engage a partner for future development and
commercialization of ALKS 27; and decisions by the FDA regarding the
companies' product candidates. For further information with respect to
specific risks, uncertainties and factors that could cause the
companies' actual results to differ materially from expectations,
reference is made to the reports that Alkermes and Indevus each filed
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended. The forward-looking statements made
in this release are made only as of the date hereof and both Alkermes
and Indevus disclaim any intention or responsibility for updating such
statements, except as may be required by law.
AIR(R) is a registered trademark of Alkermes, Inc; VIVITROL(R) is
a registered trademark of Cephalon, Inc.; SANCTURA(R) is a registered
trademark of Indevus Pharmaceuticals, Inc. (as assigned in the U.S. to
Esprit Pharma, Inc.); DELATESTRYL(R) is a registered trademark of
Indevus Pharmaceuticals, Inc.; and RISPERDAL(R) CONSTA(R) is a
registered trademark of Johnson & Johnson Corporation.
(1) U.S. Department of Health and Human Services, National
Institutes of Health, National Heart, Lung, and Blood Institute, Data
Fact Sheet; IMS Data.
CONTACT: For Alkermes
Rebecca Peterson, 617-583-6378
Vice President, Corporate Communications
Brooke D. Wagner, 781-402-3410
Vice President, Corporate Communications
SOURCE: Alkermes, Inc.