Navigation Links
Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of Ipilimumab
Date:4/25/2008

PRINCETON, N.J., April 25 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that, after meeting with the U.S. Food and Drug Administration (FDA), the companies will delay the Biologics License Application (BLA) submission for ipilimumab, an investigational immunotherapy for patients with advanced metastatic melanoma. The FDA has requested additional overall survival (OS) data to further demonstrate the benefit of ipilimumab. Revised timelines are under development, but a BLA for ipilimumab will not be submitted to the FDA in 2008.

The randomized Phase 3 trial evaluating the efficacy of ipilimumab in combination with dacarbazine versus dacarbazine alone in patients with untreated unresectable Stage III or Stage IV melanoma is ongoing under Special Protocol Assessment (SPA). The companies are engaged in discussions with the FDA to change the primary endpoint in this trial from progression free survival (PFS) to OS. A potential submission for melanoma would include survival data from patients in the Phase 2 second-line studies and the randomized Phase 3 first-line trial currently ongoing.

Bristol-Myers Squibb and Medarex remain committed to the development of ipilimumab. The companies also have ongoing Phase 2 studies in hormone-refractory prostate cancer and lung cancer as well as a Phase 3 study, to be initiated shortly, in adjuvant melanoma.

Twelve abstracts evaluating ipilimumab in melanoma will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting this year. These include data from the three Phase 2 trials evaluating ipilimumab in patients with advanced Stage III or Stage IV metastatic melanoma (Abstract #9010, 9021 and 9025).

Ipilimumab is being developed through a joint partnership between Bristol-Myers Squibb and Medarex. Based on nonclinical and clinical studies showing that antibody blockade of CTLA-4 plays an important role in sustaining an active immune response to fight cancer, the companies are pursuing a broad clinical development program with ipilimumab. More than 2,000 patients have been treated in clinical trials with ipilimumab as a monotherapy or in combination with other agents.

For further information about ipilimumab clinical trials, please visit http://www.clinicaltrials.gov.

About Ipilimumab

Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. The absence or presence of CTLA-4 can augment or suppress the immune system's T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells.

About Medarex

Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. More than 40 of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with seven of the most advanced product candidates currently in Phase 3 clinical trials or the subject of regulatory applications for marketing authorization. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its Web site at http://www.medarex.com.

Medarex Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "expect"; "could"; "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. These risks and uncertainties include whether the development of ipilimumab will be successful, whether the clinical studies described in this release will support the filing of a BLA with the FDA, or whether, if a BLA is filed with the FDA, it will be filed in the timeframe developed by the parties or will receive regulatory approval, as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and its quarterly reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical and related health care products company whose mission is to extend and enhance human life.

Bristol-Myers Squibb Statement on Cautionary Factors

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the development of biological products and the submission of applications to market such products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the development of the product described in this release will be successful or that the clinical studies described in this release will support the filing of a Biological License Application (BLA) with the U.S. Food and Drug Administration (FDA). Furthermore, there can be no assurances that if a BLA is filed with the FDA, that it will be filed in the timeframe described in this release or that the BLA for the product described in this release will receive regulatory approval. There can be no assurances that if approved, the product described in this release will be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2007, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.


'/>"/>
SOURCE Medarex, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Medarex Announces 2007 Fourth Quarter and Year End Financial Results
2. Medarex to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference
3. Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
4. PharmAthene and Medarex Announce Additional $0.8 Million U.S. Government Appropriation for Continued Development of Anthrax Therapeutic Valortim(TM)
5. Medarex to Present at the JPMorgan Small/Mid Cap Conference
6. Ono and Medarex Announce Allowance of Investigational New Drug Application for Fully Human Anti-PD1 Antibody
7. Former Bristol-Myers Squibb Senior Vice President Indicted for Lying to the Federal Government About Popular Blood-Thinning Drug
8. Bristol-Myers Squibb to Announce Results for the First Quarter of 2008 on April 24
9. Bristol-Myers Squibb to Present at Healthcare Conferences
10. Bristol-Myers Squibb Company Reports Financial Results for the Fourth Quarter and Twelve Months of 2007
11. Avista Capital Partners Completes Acquisition of Bristol-Myers Squibb Medical Imaging
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... ... January 20, 2017 , ... Michael and Betsy Brauser celebrated 5 years ... Betsy, the clinical trial has been life-saving as she has been on the ... Betsy Brauser was diagnosed with ovarian cancer in 2009. She underwent standard chemotherapy but ...
(Date:1/20/2017)... ... ... Magdalene: Grace is Greater than Sin”: a unique and memorable piece of literature ... Grace is Greater than Sin” is the creation of published author, Brenda Roberts, a ... had little knowledge of the female characters portrayed in the Holy Bible. , ...
(Date:1/20/2017)... ... January 20, 2017 , ... “I Forgive You”: a fine examination of how ... You” is the creation of published author, Stephen Miller, who, for over ten long years ... given to him. Born in Trinidad and Tobago, he has been serving the Lord for ...
(Date:1/20/2017)... ... ... Christmas:” a beautiful and enchanting tale that teaches children the true meaning of Christmas. “Journey ... Oklahoma City, and a devoted woman of faith. , “Becoming a parent changes you. ... of my mind for years, but actually doing it might have been a while in ...
(Date:1/20/2017)... ... , ... “God's Miracle Man: Against All Odds”: an inspiring affirmation of ... Keith C. A. Tucker, son of Minister Delores Pinnock and a Jamaican native who ... Hardy , “While sitting up in bed, I felt a pounding headache. It was ...
Breaking Medicine News(10 mins):
(Date:1/20/2017)... 20, 2017 Research and Markets has ... (by Devices, Implant Types, OTC Amplifiers, Diagnostic Instruments), Sales Volume, ... offering. ... Global Hearing Aids Market Sales Volume, Company Analysis and Forecast ... hearing aid industry. The growing prevalence of hearing ...
(Date:1/20/2017)... 20, 2017  Palladian Health, a leading provider ... launch of an opioid management program which assists ... and helps stem the growing tide of dependence ... treat chronic non-cancer pain (back pain, neck pain, ... lack of evidence regarding long-term effectiveness. ...
(Date:1/19/2017)... Germany Cataract Surgery Devices Market Outlook ... Cataract Surgery Devices Market Outlook to 2022", provides key ... The report provides value, in millions of US dollars, ... segements - Phacoemulsification Equipment and Ophthalmic Viscoelastic Devices (OVD). ... shares data for each of these market segements, and ...
Breaking Medicine Technology: