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
August 3, 2012 (July 31, 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 certification with respect to this filing. On July 19, 2012, Transcept announced that it had received two Paragraph IV certifications with respect to Intermezzo.
On July 31, 2012, Transcept received a new Paragraph IV certification from Novel Laboratories, Inc. (“Novel”) advising Transcept that it has filed an ANDA with the FDA for generic versions of the 1.75mg and 3.5mg strengths of Intermezzo. This Paragraph IV certification alleges that Transcept’s U.S. Patent Nos. 7,658,945 and 7,682,628 are invalid, unenforceable and/or will not be infringed by Novel’s manufacture, use, importation, sale or offer for sale of the products for which Novel’s ANDA was submitted.
For additional information relating to Transcept’s prior announcements regarding ANDA filings, see the Current Reports on Form 8-K filed on July 11, 2012 and July 19, 2012. For more information on the risks associated with the Company’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 May 15, 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: August 3, 2012 | ||||||
| By: | /s/ Leone D. Patterson | |||||
| Name: Leone D. Patterson | ||||||
| Title: Vice President, Chief Financial Officer | ||||||