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):June 23, 2006
Penwest Pharmaceuticals Co.
(Exact Name of Registrant as Specified in Charter)
| | | | | |
Washington
(State or Other Juris-
diction of Incorporation | | 000-23467
(Commission
File Number) | | 91-1513032
(IRS Employer
Identification No.) |
| | | |
39 Old Ridgebury Road, Suite 11
Danbury, Connecticut
(Address of Principal Executive Offices) | |
06810-5120
(Zip Code) |
Registrant’s telephone number, including area code:(877) 736-9378
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 (seeGeneral 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)) |
TABLE OF CONTENTS
Item 8.01. Other Events
On June 23, 2006, Penwest Pharmaceuticals Co. announced in a press release that Endo Pharmaceuticals Inc., Penwest’s collaborator in the development and commercialization of oxymorphone extended-release tablets, announced that the U.S. Food and Drug Administration granted final approval of Endo’s New Drug Application for an extended-release formulation of oxymorphone hydrochloride. This product will now be known under the trade name Opana® ER tablets. Opana® ER uses Penwest’s proprietary time release technology, TIMERx®. Endo said that Opana® ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around the clock opioid treatment for an extended period of time and not intended to be used on an as-needed basis.
The press release issued by Penwest is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits
| | | |
| (c) | | Exhibits |
| | | |
| | | See Exhibit Index attached hereto. |
SIGNATURE
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.
| | | | | |
| | PENWEST PHARMACEUTICALS CO.
| |
| Date: June 28, 2006 | By: | /s/ Jennifer L. Good | |
| | | Jennifer L. Good | |
| | | President and Chief Executive Officer | |
EXHIBIT INDEX
| | | |
Exhibit No. | | Description |
| | | |
| 99.1 | | Press release dated June 23, 2006 |
