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

September 13, 2012 (September 11, 2012)

Date of Report (date of earliest event reported)

 

 

TRANSCEPT PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   000-51967   33-0960223

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

1003 W. Cutting Blvd., Suite #110

Point Richmond, California 94804

(Address of principal executive offices)

(510) 215-3500

(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):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ 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 July 11, 2012, Transcept Pharmaceuticals, Inc. (“Transcept”) announced that the website of the U.S. Food and Drug Administration (“FDA”) indicated that an Abbreviated New Drug Application (“ANDA”) for a generic version of Intermezzo® (zolpidem tartrate) sublingual tablet C-IV had been submitted, but that Transcept had not received a Paragraph IV notice letter with respect to this filing. On July 19, 2012, Transcept announced that it had received two Paragraph IV notice letters with respect to Intermezzo. On August 3, 2012, Transcept announced that it had received a third Paragraph IV notice letter with respect to Intermezzo. On August 28, 2012 and September 11, 2012, Transcept announced that it joined actions filed by Purdue Pharmaceutical Products L.P., its U.S. commercialization partner with respect to Intermezzo, in response to such Paragraph IV notice letters.

On September 11, 2012, Transcept received new Paragraph IV notice letters from each of Par Pharmaceutical, Inc. and Par Formulations Private Ltd. (together, “Par”) advising Transcept that Par has filed ANDAs with the FDA for generic versions of the 1.75mg and 3.5mg strengths of Intermezzo. These Paragraph IV notice letters allege that Transcept’s U.S. Patent Nos. 7,658,945, 7,682,628, 8,242,131 and 8,252,809 are invalid, unenforceable and/or will not be infringed by Par’s manufacture, use, importation, sale or offer for sale of the products for which Par’s ANDAs were submitted.

For additional information relating to Transcept’s prior announcements regarding ANDA filings and related actions, see the Current Reports on Form 8-K filed on July 11, 2012, July 19, 2012, August 3, 2012, August 28, 2012 and September 11, 2012. For more information on the risks associated with Transcept’s efforts to secure and maintain intellectual property protection for Intermezzo, please see the Risk Factors section of Transcept’s Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 13, 2012. The information contained herein is intended to be considered in the context of more complete information included in Transcept’s filings with the SEC and other public announcements that Transcept has made and may make from time to time by press release or otherwise. Transcept undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.


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.

 

    TRANSCEPT PHARMACEUTICALS, INC.
Date: September 13, 2012    
  By:  

  /s/ Leone D. Patterson

    Name: Leone D. Patterson
    Title:   Vice President, Chief Financial Officer