-----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, SEA3GQbqFsQRxrgNPHD2dVowluLto7pTG45WmgPyy7P4NM9M//nPboCKgYCBU4bB PtPcwg7d1xzBfuhAIkNZ+A== 0001193125-07-134974.txt : 20070613 0001193125-07-134974.hdr.sgml : 20070613 20070613172637 ACCESSION NUMBER: 0001193125-07-134974 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070612 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070613 DATE AS OF CHANGE: 20070613 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: 07918128 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): June 12, 2007

 


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 8.01. OTHER EVENTS.

On June 12, 2007, Oscient Pharmaceuticals Corporation issued a press release announcing that the results from the successful clinical trial of its FACTIVE® tablets for the five-day treatment of community-acquired pneumonia of mild to moderate severity had been published in the July issue of the Journal of Antimicrobial Chemotherapy.

A copy of the press release is filed as Exhibit 99.1 to this report and incorporated herein by reference.

 

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

 

(d) Exhibits

 

99.1    Press Release issued by Oscient Pharmaceuticals Corporation on June 12, 2007.


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/ Philippe Maitre

Name:   Philippe Maitre
Title:  

Senior Vice President and Chief Financial

Officer

Date: June 13, 2007

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

For Immediate Release:

July Issue of Journal of Antimicrobial Chemotherapy Highlights Study of FACTIVE® Tablets for

Five-Day Treatment of Community-Acquired Pneumonia

— Article contains data from successful clinical trial comparing five-day and seven-day treatment —

Waltham, MA, June 12, 2007 – Results from the successful clinical trial of Oscient Pharmaceuticals’ (Nasdaq: OSCI) FACTIVE® (gemifloxacin mesylate) tablets for the five-day treatment of community-acquired pneumonia of mild to moderate severity (CAP) have been published in the July issue of the peer-reviewed Journal of Antimicrobial Chemotherapy, currently available in advance on-line. The data from the Phase III clinical trial comparing a five-day and seven-day course of treatment with FACTIVE for CAP formed the basis of the approval last month from the U.S. Food and Drug Administration (FDA) of FACTIVE for the five-day treatment of CAP. FACTIVE 320 mg once-daily is the only fluoroquinolone antibiotic currently approved in the U.S. for the five-day treatment of both CAP and acute bacterial exacerbations of chronic bronchitis (AECB).

“The Phase III trial of FACTIVE demonstrated the efficacy of five-day FACTIVE to treat community-acquired pneumonia,” stated Thomas File, M.D., Professor of Internal Medicine and Head of the Infectious Disease Section, Northeastern Ohio Universities College of Medicine and the lead author of the article. “The publication of these data are adding to the body of scientific evidence that demonstrates the importance of short courses of potent antibiotic therapy in treating community-acquired pneumonia, as recommended in the CAP treatment guidelines from the Infectious Diseases Society of America and the American Thoracic Society.”

“Following approval last month, we have been discussing the shortened treatment duration for FACTIVE in CAP with physicians and are planning a larger-scale campaign for this fall, in advance of the respiratory tract infection season,” stated Steven M. Rauscher, President and CEO of Oscient Pharmaceuticals. “Conducting a successful Phase III trial showing comparability between the five and seven-day treatment regimens for FACTIVE was the cornerstone of our pursuit and receipt of a shorter-course therapy of FACTIVE for CAP. This publication and recent treatment guidelines reinforce the utility of FACTIVE.”

The multicenter, double-blind study enrolled 510 patients with CAP, with 469 patients comprising the per protocol group. Clinical response at follow-up, the primary endpoint, in the per protocol group was 95% for the five-day treatment arm and 92% for the seven-day treatment arm [95% CI: -1.48, 7.42], demonstrating non-inferiority between the two groups. Further, clinical response at end of therapy in the per protocol group was 96% for the five-day group and 96% for the seven-day group [95% CI: -3.85, 3.42]. FACTIVE was well-tolerated in the study, with a low withdrawal rate due to adverse events: 1.2% for the five-day group and 2.0% for the seven-day group. There were no withdrawals due to rash and the rate of drug-related rash in both treatment groups was low: 0.4% for the five-day arm and 2.8% for the seven-day arm.

 

-more-


JAC Publication

June 12, 2007

Page 2 of 3

 

Community-acquired pneumonia is a common and serious illness in the United States with an estimated four to five million cases per year, one million of which occur in patients over the age of 65. CAP cases result in approximately 10 million physician visits and as many as one million hospitalizations annually. To date, approximately one million patients worldwide have been treated with FACTIVE.

About Oscient Pharmaceuticals

Oscient Pharmaceuticals Corporation is a commercial-stage biopharmaceutical company marketing two FDA-approved products through its national primary care sales force. ANTARA® (fenofibrate) capsules is FDA-approved for the adjunct treatment of hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia (high triglycerides) in combination with diet. FACTIVE® (gemifloxacin mesylate) tablets is an antibiotic FDA-approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Oscient also has a novel, late-stage antibiotic candidate, Ramoplanin, under investigation for the treatment of Clostridium difficile-associated disease (CDAD).

For important information regarding the safety and use of ANTARA, please see the full prescribing information available at www.antararx.com.

Important Safety Information about FACTIVE Tablets

In clinical trials, the most common (more than 2% incidence) side effects reported in patients receiving FACTIVE versus comparators were diarrhea (5.0% vs. 6.2%), rash (3.5% vs. 1.1%), nausea (3.7% vs. 4.5%), headache (4.2% vs. 5.2%), abdominal pain (2.2% vs. 2.2%), vomiting (1.6% vs. 2.0%), and dizziness (1.7% vs. 2.6%). In clinical trials, drug-related rash was reported in 2.7% of patients receiving gemifloxacin and was more commonly observed in patients less than 40 years of age, especially females. The incidence of rash increases with treatment longer than the maximum-labeled duration of 7 days. In clinical trials, the discontinuation rate due to drug-related adverse events was similar for FACTIVE tablets and comparators (2.2% versus 2.1%, respectively).

FACTIVE is contraindicated in patients with a history of hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components. Patients receiving marketed fluoroquinolones have reported serious and occasionally fatal hypersensitivity and/or anaphylactic reactions, peripheral neuropathy, antibiotic-associated colitis and tendon ruptures. FACTIVE should be discontinued immediately at the first sign of any of these events.

Fluoroquinolones may prolong the QT interval in some patients. FACTIVE should be avoided in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients receiving Class IA or Class III antiarrhythmic agents. In clinical studies with gemifloxacin, CNS effects have been reported infrequently. As with other fluoroquinolones, FACTIVE should be used with caution in patients with known or suspected CNS diseases. If CNS reactions occur, FACTIVE should be discontinued and appropriate measures instituted.

No significant drug-drug interactions were seen with theophylline, digoxin, oral contraceptives, cimetidine, omeprazole, and warfarin, although patients receiving a fluoroquinolone concomitantly with warfarin should be monitored closely. Drug-drug interactions include probenicid, sucralfate, antacids containing aluminum or magnesium, iron, multivitamins containing metal cations, and didanosine. The safety and effectiveness of FACTIVE in children, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established. For complete safety and efficacy information, please see the full prescribing information available at www.factive.com.

Forward-Looking Statement

This news release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements with regard to the importance of a short course of therapy for the treatment of CAP. Forward-looking statements represent our management’s judgment regarding future events. 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

 

-more-


JAC Publication

June 12, 2007

Page 3 of 3

 

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 (a) our ability to successfully commercialize and market ANTARA or FACTIVE due to: the limitations on our resources and experience in the commercialization of products; lack of acceptance by physicians, patients and third party payors; unanticipated safety, product liability, efficacy, or other regulatory issues; delays in recruiting and training sales personnel; problems relating to manufacturing or supply; delays in the supply of products by the third party manufacturers and suppliers on which we rely; inadequate distribution of the products by wholesalers, pharmacies, hospitals and other customers; and competition from other products; (b) whether our partners in ex-US territories will be able to obtain approval for FACTIVE and/or expand the indications for which FACTIVE is approved; (c) the delay in or inability to obtain additional regulatory approvals of our products and product candidates due to negative, inconclusive or insufficient results in ongoing or future clinical trials, the FDA requiring additional information or data, delays in the progress of ongoing clinical trials, safety concerns arising with respect to our products or product candidates and disputes with the third parties from whom we license our products or product candidate; (d) delays by the FDA; and (e) claims against us by third parties, including claims relating to our intellectual property position. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are described under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2007 and in other filings that we may make with the Securities and Exchange Commission from time to time.

 

###

-----END PRIVACY-ENHANCED MESSAGE-----