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):
April 7, 2004
Indevus Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 000-18728 | 04-3047911 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
One Ledgemont Center
99 Hayden Avenue
Lexington, Ma 02421-7966
(Address of principal executive offices)
Registrant’s telephone number, including area code:
(781-861-8444)
Item 5. Other Events and Regulation FD Disclosure.
On April 7, 2004, Indevus Pharmaceuticals, Inc., issued a press release announcing that it has entered into a License, Commercialization and Supply Agreement (the “Agreement”) with Odyssey Pharmaceuticals Inc., the specialty branded subsidiary of PLIVA d.d. to commercialize SANCTURA™ (trospium chloride), under review by the U.S. Food and Drug Administration (FDA) as a treatment for overactive bladder. The Press Release is attached hereto as Exhibit 99.1. The Agreement is attached hereto as Exhibit 99.2.
Item 7. Financial Statements and Exhibits.
| 99.1 | Press Release of the Registrant dated April 7, 2004. | |
| 99.2 | License, Commercialization and Supply Agreement dated April 6, 2004 between the Registrant and Odyssey Pharmaceuticals Inc. (Confidential treatment requested for a portion of this exhibit) | |
The exhibit hereto contains forward-looking statements that involve risks and uncertainties that could cause the Company’s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company’s filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under “Risk Factors” and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA; risks associated with contractual agreements; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the commercialization of SANCTURA and for the development of our other products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
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.
| INDEVUS PHARMACEUTICALS, INC. | ||||
| Dated: April 16, 2004 |
||||
| By: |
/s/ Michael W. Rogers | |||
| Michael W. Rogers | ||||
| Executive Vice President, Chief Financial Officer and Treasurer | ||||