-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, H46XKGQl2PrG4v1Nyzv5s21pQ0pvcKftjYdRDqycsHMkKdE9WASQsna5/nbyQWpe 0mrlizdzj3wQR1E5hzqCog== 0001104659-11-007540.txt : 20110215 0001104659-11-007540.hdr.sgml : 20110215 20110215083037 ACCESSION NUMBER: 0001104659-11-007540 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20110215 ITEM INFORMATION: Other Events FILED AS OF DATE: 20110215 DATE AS OF CHANGE: 20110215 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DEPOMED INC CENTRAL INDEX KEY: 0001005201 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943229046 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13111 FILM NUMBER: 11612434 BUSINESS ADDRESS: STREET 1: 1360 O'BRIEN DRIVE CITY: MENLO PARK STATE: CA ZIP: 94025 BUSINESS PHONE: 6504625900 MAIL ADDRESS: STREET 1: 1360 O'BRIEN DRIVE CITY: MENLO PARK STATE: CA ZIP: 94025 8-K 1 a10-23642_38k.htm 8-K

 

 

UNITED STATES

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): February 15, 2011

 

DEPOMED, INC.

(Exact name of registrant as specified in its charter)

 

001-13111

(Commission File Number)

 

California

 

94-3229046

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation)

 

 

 

1360 O’Brien Drive, Menlo Park, California 94025

(Address of principal executive offices, with zip code)

 

(650) 462-5900

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

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))

 

 

 


 

Item 8.01  Other Events

 

On February 15, 2011, Carl Pelzel, the President and CEO of Depomed, Inc. (the “Company”), is presenting at the 13th Annual BIO CEO & Investor Conference in New York City at 8:30 am EST.  The presentation is available on the Company’s website (http://www.depomed.com).

 

The presentation includes additional disclosure related to the Orphan Drug designation of GRALISETM (gabapentin) tablets.  Gralise is a once-daily formulation of gabapentin for the management of postherpetic neuralgia developed by the Company and licensed to Abbott Products, Inc. in the U.S., Canada and Mexico.  As previously disclosed, FDA has granted GRALISE Orphan Drug designation for the management of PHN, based on the size of the PHN population and the reduced incidence of adverse events observed in DM-1796 clinical trials relative to the incidence of adverse events reported in the package insert for immediate release gabapentin.

 

Subsequent to the FDA’s approval of Gralise, the Company was informed that additional submissions or evidence to demonstrate the clinical superiority of GRALISE based on improved safety will be required to be provided to the FDA to obtain a seven year period of market exclusivity in PHN as a result of the Orphan Drug designation.  If obtained, the market exclusivity period will run from January 28, 2011, the date FDA approved the GRALISE New Drug Application.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

DEPOMED, INC.

 

 

 

 

 

 

Date: February 15, 2011

By:

/s/ Matthew M. Gosling

 

 

Matthew M. Gosling

 

 

Vice President and General Counsel

 

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