-----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, B/wWK+0RgnZAcONiLt1PEUN2U6h+iaQC8dNWEWGJKVpfXFPFW6xHb+/UWgvCrOY7 BqAcUlIknZiYRPmuS/7WUA== 0001193125-06-023085.txt : 20060208 0001193125-06-023085.hdr.sgml : 20060208 20060208083824 ACCESSION NUMBER: 0001193125-06-023085 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060203 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060208 DATE AS OF CHANGE: 20060208 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSCIENT PHARMACEUTICALS CORP CENTRAL INDEX KEY: 0000356830 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 042297484 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-10824 FILM NUMBER: 06587183 BUSINESS ADDRESS: STREET 1: 1000 WINTER STREET STREET 2: SUITE 2200 CITY: WALTHAM STATE: MA ZIP: 02451 BUSINESS PHONE: 7813982300 MAIL ADDRESS: STREET 1: 1000 WINTER STREET STREET 2: SUITE 2200 CITY: WALTHAM STATE: MA ZIP: 02451 FORMER COMPANY: FORMER CONFORMED NAME: GENOME THERAPEUTICS CORP DATE OF NAME CHANGE: 19941215 FORMER COMPANY: FORMER CONFORMED NAME: COLLABORATIVE RESEARCH INC DATE OF NAME CHANGE: 19920703 8-K 1 d8k.htm FORM 8-K Form 8-K

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 3, 2006

 


 

OSCIENT PHARMACEUTICALS CORPORATION

(Exact name of registrant as specified in its charter)

 


 

Massachusetts   0-10824   04-2297484

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(I.R.S. Employer

Identification Number)

 

1000 Winter Street, Suite 2200

Waltham, Massachusetts 02451

(Address of principal executive offices, including zip code)

 

(781) 398-2300

(Registrant’s telephone number, including area code)

 


 

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 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.

 

On February 3, 2006, Oscient Pharmaceuticals Corporation (“Oscient”) entered into an agreement (the “Agreement”) with Vicuron Pharmaceuticals, Inc. (“Vicuron”), a wholly owned subsidiary of Pfizer Inc. (“Pfizer”), whereby Oscient, which previously licensed Ramoplanin from Vicuron for the U.S. and Canada, acquired worldwide rights and assumed full control of Ramoplanin manufacturing, development and commercialization. Ramoplanin is currently under development for the potential treatment of Clostridium difficile-associated disease (CDAD).

 

The Agreement supersedes the earlier License and Supply Agreement signed by the parties on October 8, 2001, as amended on August 8, 2002 and October 22, 2002.

 

In exchange for the assignment of the rights it received under the Agreement, Oscient has made a one-time, up-front payment to Pfizer and will make additional milestone payments for regulatory filings and approvals in various countries. Under the terms of the Agreement, Oscient will also pay mid-single-digit to low double-digit royalties to Pfizer for net sales of Ramoplanin dependent upon the territory.

 

Pursuant to the Agreement, Oscient assumed all responsibility for manufacture of Ramoplanin and Pfizer will assist Oscient in the transfer of technological know-how related to its manufacture. Oscient is currently in discussions with potential third-party manufacturers for Ramoplanin in order to secure long term product supply.

 

The Agreement provides that royalty obligations to Pfizer expire on a country by country basis ten years after the first commercial sale of product in such country.

 

On February 8, 2006, the Company issued a press release announcing the entering into of the Agreement. A copy of that press release is furnished with this Current Report on Form 8-K as Exhibit 99.1.

 

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

 

(d) Exhibits

 

  99.1 Press Release issued by Oscient Pharmaceuticals Corporation on February 8, 2006.


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.

 

OSCIENT PHARMACEUTICALS CORPORATION

By:

 

/s/    STEPHEN COHEN


    Name:   Stephen Cohen
    Title:   Senior Vice President and Chief Financial Officer

 

Date: February 8, 2006


EXHIBIT INDEX

 

Exhibit Number

 

Description


99.1   Press Release issued by Oscient Pharmaceuticals Corporation on February 8, 2006.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

Investor Contact:

Christopher Taylor

781-398-2466

 

Media Contact:

Sarah Emond

781-398-2544

 

Oscient Pharmaceuticals Acquires Expanded Worldwide Rights to

Lead Clinical Candidate Ramoplanin

— Key milestone for commencing Phase III program —

 

Waltham, Mass., February 8, 2006 – Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) and Pfizer Inc. subsidiary Vicuron Pharmaceuticals Inc., have restructured the business relationship for Oscient’s lead clinical candidate, Ramoplanin, currently in development for the potential treatment of Clostridium difficile-associated disease (CDAD). As part of the new arrangement, Oscient, which previously licensed Ramoplanin from Vicuron for the U.S. and Canada only, acquired worldwide rights and assumes full control of Ramoplanin manufacturing, development and commercialization on a global basis. Oscient recently agreed on a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration for the Phase III program of Ramoplanin.

 

“Acquiring worldwide rights to Ramoplanin is a major milestone for Oscient,” stated Steven M. Rauscher, President and Chief Executive Officer of Oscient Pharmaceuticals. “With full ownership of Ramoplanin, we have significantly strengthened our asset portfolio and, after securing a long-term source of product supply, will be poised to advance the product candidate into Phase III development.”

 

As announced previously, the SPA from the FDA calls for two pivotal Phase III trials to study Ramoplanin in CDAD. The two non-inferiority studies will enroll, in each trial, approximately 490 patients diagnosed with CDAD, from centers in the United States, Canada and other parts of the world. Each patient will be randomly assigned to one of two treatment arms, in a double-blind regimen: Ramoplanin 200 mg orally twice daily or vancomycin 125 mg orally four times daily for ten days. The primary endpoint will be the response rate at end of therapy.

 

In exchange for the expanded worldwide rights, Oscient has made a one-time, up-front payment to Pfizer, and will make additional payments upon the achievement of specified regulatory milestones and for royalties on net sales. Additionally, Oscient has assumed all responsibility for drug manufacture and is currently in discussions with potential third-party manufacturers for Ramoplanin. Royalty obligations to Vicuron have been adjusted to reflect the elimination of Vicuron’s manufacturing responsibility. Pfizer has agreed to transfer the technological know-how related to the manufacture of Ramoplanin.

 

About C. difficile-Associated Disease

 

C. difficile is a spore-forming bacterium known to cause diarrhea and colitis. In the past, C. difficile-associated disease has been mainly a concern in patients who have had recent antibiotic therapy and/or are hospitalized. In recent years, the incidence and severity of CDAD has increased and anecdotal cases are being reported where no antibiotic therapy or exposure to


hospitals has occurred. Many countries across the globe have reported rising numbers of CDAD cases, including Australia, Canada and the United Kingdom. Currently, it is estimated that 400,000-500,000 cases of CDAD occur each year in the U.S. The disease generates an estimated $1.1 billion in hospital health care costs annually in the U.S., and can prolong hospital stays by one to three days. Presently, vancomycin and metronidazole are used to treat CDAD, although only vancomycin is FDA-approved for such use.

 

About Ramoplanin

 

Oscient Pharmaceuticals’ Ramoplanin is an investigational new drug being studied for the treatment of Clostridium difficile-associated disease (CDAD). Ramoplanin has been shown to be bactericidal in vitro against Clostridium difficile. Because it is not absorbed systemically from the gastrointestinal (GI) tract following oral dosing and exerts its bactericidal activity in the GI tract, Ramoplanin represents a potential new method for managing certain pathogens commonly found in the hospital.

 

About Oscient Pharmaceuticals

 

Oscient Pharmaceuticals Corporation is a biopharmaceutical company committed to the clinical development and commercialization of novel therapeutics to address unmet medical needs. The Company is marketing FACTIVE® (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. In addition to the oral tablet form, Oscient is developing an investigational FACTIVE intravenous formulation for use in hospitalized patients. The Company is also promoting Auxilium Pharmaceuticals’ TESTIM® 1% testosterone gel to primary care physicians in the U.S.

 

Forward-Looking Statement

 

This press release may contain forward-looking statements, as defined by the Private Securities Litigation Reform Act of 1995, including statements regarding (i) Ramoplanin’s potential to be an effective therapeutic alternative for treatment of CDAD and (ii) the advancement of Ramoplanin’s clinical development. These statements represent, among other things, the expectations, beliefs, plans and objectives of management and/or assumptions underlying or judgments concerning matters discussed in this document. Forward-looking statements typically are identified by use of terms such as “may,” “will,” “should,” “plan,” “expect,” “intend,” “anticipate,” “estimate,” and similar words, although some forward-looking statements are expressed differently. We do not plan to update these forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of risks affecting our business. These risks include, but are not limited to, the delay in or inability to obtain additional regulatory approvals for Ramoplanin due to negative, inconclusive or insufficient results in ongoing or future clinical trials, our inability to enroll sufficient numbers of patients in Ramoplanin clinical trials, the FDA requiring additional information or data, delays in the progress of the anticipated Phase III clinical trial, safety concerns, and problems relating to manufacturing and supply. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement are described under the heading “Factors Affecting Future Operating Results” in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2005 and in other filings that we may make with the Securities and Exchange Commission from time to time.

 

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