SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): October 27, 2005
ALKERMES, INC.
(Exact Name of Registrant as Specified in its Charter)
| |
|
|
|
|
| PENNSYLVANIA
|
|
1-14131
|
|
23-2472830 |
| (State or Other Jurisdiction of
|
|
(Commission
|
|
(I.R.S. Employer |
| Incorporation)
|
|
File Number)
|
|
Identification No.) |
| |
|
|
| 88 Sidney Street |
|
|
| Cambridge, Massachusetts
|
|
02139 |
| (Address of principal executive offices)
|
|
(Zip Code) |
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 October 27, 2005, the United States District Court for the District of Massachusetts dismissed,
in its entirety and with prejudice, a purported securities class action lawsuit against Alkermes
and certain of its current and former officers and directors. The suit alleged misstatements by
Alkermes regarding a new drug application filed with the U.S. Food and Drug Administration (FDA)
for approval of RISPERDAL CONSTA®, which the FDA approved in 2003.
Last year, Alkermes and the individual defendants filed a motion seeking dismissal of the
litigation on numerous legal grounds, and the Court referred that motion to a magistrate judge for
issuance of a report and recommendation as to disposition of the motion. In early October 2005, a
federal magistrate judge recommended that the motion be granted and that the litigation be
dismissed in its entirety. After issuance of this ruling, on October 21, 2005, counsel for the
lead plaintiff filed a stipulation with the Court in which the Company and the individual
defendants joined providing for dismissal of this action, in its entirety and with prejudice. On
October 27, 2005, the Court entered an order dismissing the action with prejudice as provided in
such stipulation and terminating the case on the Court’s docket. Brian E. Pastuszenski, a senior
partner at Goodwin Procter LLP, led the litigation team in defending Alkermes and the individual
defendants in this purported securities class action lawsuit. He was assisted by Goodwin Procter
associates Alexis Shapiro and Rebecca Hayes.
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, VIVITREX® (naltrexone long-acting
injection), 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.