-- Announcement of BYDUREON(TM) Royalty Rate --
-- Pipeline Highlights Include New Long-Acting Olanzapine
Antipsychotic Candidate; Expanded Indications for ALKS 33, Including
Binge Eating Disorder; and Phase 2 Initiation of ALKS 37 for
of Opioid-Induced Constipation --
WALTHAM, Mass. & NEW YORK, Apr 26, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today will present an update on the
progress of its late-stage and emerging clinical product candidates from
the company's proprietary technology platforms at its Research and
Development (R&D) Day for analysts and investors in New York.
As part of the update on late-stage development programs, Alkermes will
announce the royalty rate to be received on sales of BYDUREON(TM)
(exenatide for extended-release injectable suspension). Alkermes will
also highlight key product candidates, including the announcement of a
second long-acting antipsychotic candidate to emerge from the LinkeRx(TM)
technology platform, as well as the clinical progress of phase 2 product
candidates ALKS 37 and ALKS 33. Alkermes will detail the underlying
science and drug discovery potential of the company's opioid modulator,
LinkeRx and Medifusion(TM) platforms.
"We are excited to present our diverse and value-creating R&D platforms
and clinical programs, which will provide the foundation for future
growth at Alkermes," commented Richard Pops, Chief Executive Officer of
Alkermes. "This is a particularly productive time in the company's
history, as we expect significant inflection points on most of our key
product candidates by the end of 2010."
"We are pleased with the rapid progress of our pipeline, with clinical
candidates in all stages of development," stated Elliot Ehrich, Chief
Medical Officer of Alkermes. "Our pipeline is based upon innovative
science, novel proprietary platforms and proven development experience."
R&D Day Highlights
Alkermes today will provide details on the following product programs at
its R&D day:
- Announcement of BYDUREON royalty rate.
Alkermes will provide an update on its late-stage development
programs, including the announcement of the royalty rate for
BYDUREON sales to be received by Alkermes from its partner, Amylin
Pharmaceuticals, Inc. Alkermes will receive 8% of net sales from
the first 40 million units of BYDUREON sold in any particular year
and 5.5% of net sales from units sold beyond the first 40 million
for that year. In addition, Alkermes will receive a $7 million
milestone payment upon the first commercial sale of BYDUREON in
the U.S. and an additional $7 million milestone upon the first
commercial sale in Europe.
- Growing product portfolio of long-acting antipsychotic medicines
based on LinkeRx platform.
Alkermes will unveil a long-acting olanzapine candidate, ALKS
7921, the second candidate from the LinkeRx platform.ALKS
7921 is a once-monthly, injectable, extended-release version of
olanzapine for the treatment of schizophrenia. Olanzapine is
commercially available under the trade name ZYPREXA(R).
Alkermes is engineering ALKS 7921 to prevent early, inadvertent
release of free olanzipine into systemic circulation. Based on
encouraging preclinical results, ALKS 7921 is expected to enter
the clinic in calendar 2011.
As an extended-release
medication, ALKS 7921 is designed to provide another valuable
option for patients and physicians to manage schizophrenia and be
responsive to the growing body of clinical studies that have shown
that the use of long-acting medications for the treatment of
schizophrenia can improve patient outcomes and reduce costs.ALKS
7921 builds on Alkermes' unique expertise and insight in
developing effective long-acting medications, including RISPERDAL(R)
- Advancement of two proprietary new chemical entities into phase 2
development for the treatment of opioid-induced constipation and
- Initiated phase 2 study of ALKS 37 for the treatment of
opioid-induced constipation. Alkermes will announce the
initiation of a phase 2 clinical study of ALKS 37, an orally
active, peripherally-restricted opioid antagonist with potential
to block the effects of opioid agonists on gastrointestinal
motility, commonly referred to as opioid-induced constipation
(OIC). The multicenter, randomized, double-blind,
placebo-controlled, multidose study will evaluate the efficacy,
safety and tolerability of ALKS 37 in approximately 60 patients
with OIC. According to IMS Health, over 200 million prescriptions
were written for opioids in 2007 in the U.S. Many studies indicate
that a high percentage of patients receiving opioids are likely to
experience side effects affecting gastrointestinal motility.
Alkermes expects to report preliminary results from the phase 2
study of ALKS 37 in the first quarter of calendar 2011.
- Expanded development of ALKS 33 for the treatment of reward
disorders.Alkermes will provide details on the
advancing clinical program for ALKS 33, an oral opioid modulator
for the treatment of reward disorders and impulse control
disorders. Alkermes will outline plans for the development of ALKS
33 for the treatment of binge eating disorder and as a combination
therapy with buprenorphine for the treatment of addiction and mood
disorders. Alkermes is also testing ALKS 33 in a phase 2 study in
alcohol dependent patients.
A live webcast of the company's R&D Day will begin today at 12:30 p.m.
ET and will run until approximately 3:00 p.m. ET. The webcast will be
available on the investor relations section of the company's website at www.alkermes.com.
To ensure a timely connection to the webcast, it is recommended that
users register 15 minutes prior to the scheduled webcast. This webcast
will be archived on the Alkermes website.
Alkermes, Inc. is a fully integrated biotechnology company committed to
developing innovative medicines to improve patients' lives. Alkermes
developed, manufactures and commercializes VIVITROL(R) for
alcohol dependence and manufactures RISPERDAL(R) CONSTA(R) for
schizophrenia and bipolar I disorder. Alkermes' robust pipeline includes
extended-release injectable and oral products for the treatment of
prevalent, chronic diseases, such as central nervous system disorders,
addiction and diabetes. Headquartered in Waltham, Massachusetts,
Alkermes has a research facility in Massachusetts and a commercial
manufacturing facility in Ohio.
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 the timing and success
of development activities for the company's programs, including
BYDUREON, ALKS 7921, ALKS 33 and ALKS 37 and the potential therapeutic
value of Alkermes' proprietary molecules. Although the company believes
that such statements are based on reasonable assumptions within the
bounds of its knowledge of its business and operations, the
forward-looking statements are neither promises nor guarantees and the
company's business is subject to significant risk and uncertainties and
there can be no assurance that its actual results will not differ
materially from its expectations. These risks and uncertainties include,
among others: whether the clinical trials discussed in this press
release will be completed on time or at all; potential changes in cost,
scope and duration of the clinical trials; whether the company's product
candidates will demonstrate sufficient efficacy and safety; decisions by
the U.S. Food and Drug Administration regarding such product candidates;
and whether the company's product candidates may prove difficult to
manufacture on a large scale, be uneconomical, or be precluded from
commercialization by proprietary rights of third parties. For further
information with respect to factors that could cause the company's
actual results to differ materially from expectations, reference is made
to the reports the company 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 the company disclaims any intention or responsibility
for updating predictions or financial expectations contained in this
VIVITROL(R), LinkeRx(TM) and Medifusion(TM) are trademarks of
Alkermes, Inc. RISPERDAL(R) CONSTA(R) is a trademark
of Janssen-Cilag group of companies. BYDUREON(TM) is a trademark of Amylin
Pharmaceuticals, Inc. ZYPREXA(R) is a trademark of Eli Lilly
SOURCE: Alkermes, Inc.
Rebecca Peterson, 617-899-2447
Jennifer Snyder, 617-448-0281