SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of report (Date of earliest event reported): March 7, 2006
ALKERMES, INC.
(Exact Name of Registrant as Specified in its Charter)
| |
|
|
|
|
| PENNSYLVANIA
|
|
1-14131
|
|
23-2472830 |
| (State or Other Jurisdiction
|
|
(Commission
|
|
(I.R.S. Employer |
| of Incorporation)
|
|
File Number)
|
|
Identification No.) |
| |
|
|
|
|
| |
|
|
| 88 Sidney Street |
|
02139 |
| Cambridge, Massachusetts
|
|
(Zip Code) |
| (Address of principal executive offices)
|
|
|
Registrant’s telephone number, including area code: (617) 494-0171
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
| |
|
|
| o |
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
|
| o |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
|
| o |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
| |
|
|
| o |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 7.01. Regulation FD Disclosure.
On
March 1, 2006, Alkermes, Inc., received notification from the
U.S. Food and Drug Administration (FDA) regarding the Company’s
response to the approvable letter for the VIVITROL™ (naltrexone for extended-release injectable
suspension) New Drug Application (NDA) issued by the FDA in December 2005. The FDA considers the
response, received on February 16, 2006, to be a complete, Class I response. Under the Prescription
Drug User Fee Act (PDUFA), the FDA has set a targeted response date of April 16, 2006.
In March 2005, Alkermes submitted an NDA for VIVITROL. In June 2005, Alkermes and Cephalon, Inc.
entered into a collaboration agreement to develop and commercialize VIVITROL in the United States
for the treatment of alcohol dependence.
About Alkermes, Inc.
Alkermes, Inc. is a pharmaceutical company that develops products based on sophisticated drug
delivery technologies to enhance therapeutic outcomes in major diseases. The Company’s lead
commercial product, RISPERDAL® CONSTA® [(risperidone) long-acting injection],
is the first and only long-acting atypical antipsychotic medication approved for use in
schizophrenia, and is marketed worldwide by Janssen-Cilag (Janssen), a wholly owned division of
Johnson & Johnson. The Company’s lead proprietary product candidate, VIVITROLTM
(naltrexone for extended-release injectable suspension), is being developed as a once-monthly
injection for the treatment of alcohol dependence. The Company has a pipeline of extended-release
injectable products and pulmonary drug products based on its proprietary technology and expertise.
Alkermes’ product development strategy is twofold: the Company partners its proprietary technology
systems and drug delivery expertise with several of the world’s finest pharmaceutical companies and
it also develops novel, proprietary drug candidates for its own account. The Company’s headquarters
are in Cambridge, Massachusetts, and it operates research and manufacturing facilities in
Massachusetts and Ohio.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the
discovery, development and marketing of innovative products in four core therapeutic areas: central
nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people
in the United States and Europe. U.S. sites include the company’s headquarters in Frazer,
Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania,
Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company currently markets four
proprietary products in the United States: PROVIGIL® (modafinil) [C-IV],
GABITRIL® (tiagabine hydrochloride), ACTIQ® (oral transmucosal fentanyl
citrate) [C-II] and TRISENOX® (arsenic trioxide) injection, and numerous products
internationally.
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 related to attaining final regulatory approval of VIVITROL. Although both Alkermes
and Cephalon believe that such statements are based on reasonable assumptions within the bounds of
their respective knowledge, the forward-looking statements are neither promises nor guarantees, and
both the Alkermes and Cephalon businesses are subject to significant risk and uncertainties. As
such, there can be no assurance that either or both of Alkermes’ or Cephalon’s actual results will
not differ materially from their respective expectations. Such expectations are subject to risks,
including, among others; whether VIVITROL will ultimately receive marketing approval from the FDA
in a timely fashion or at all, and, if approved, whether it will be launched and commercialized
successfully by Cephalon and Alkermes; whether Alkermes can successfully scale up and manufacture
VIVITROL at a commercial scale; decisions by the FDA regarding VIVITROL, which may be based on
interpretations of data that differ from Alkermes’ interpretations; and whether VIVITROL in
commercial use, may have unintended side effects, adverse reactions or incidents of misuse that
could cause the FDA or other health authorities to require post approval studies or require removal
of the product from the market. For further information with respect to specific risks,
uncertainties and factors that could cause actual results to differ from expectations, reference is
made to the reports on Forms 8-K, 10-Q and 10-K that Alkermes and Cephalon 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 Cephalon disclaim any intention or responsibility for updating such statements, except
as may be required by law.