StelaraTreatment for Psoriasis
Update: Stelara (ustekinumab) Now FDA Approved - September 25, 2009
Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
PRINCETON, N.J., December 07, 2007 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced that it will receive an undisclosed milestone payment from its licensing partner, Centocor, Inc., for the submission of regulatory applications requesting approval of ustekinumab (CNTO 1275) in the United States and in Europe for the treatment of chronic moderate to severe plaque psoriasis by Centocor.
Ustekinumab is a human monoclonal antibody that binds to the cytokines IL-12 and IL-23 and was generated using Medarex's UltiMAb(R) technology. Medarex may receive future milestone payments and royalties should this product candidate progress to commercialization and achieve commercial sales.
"News of a first regulatory filing for approval for an antibody developed from Medarex technology is an important milestone for Medarex and marks a major achievement in translating the technology developed by our head of research, Dr. Nils Lonberg, into innovative and potentially significant treatments for many unmet medical needs," said Howard H. Pien, President and CEO of Medarex. "We believe that the ongoing development progress of ustekinumab and other antibody programs generated from Medarex's UltiMAb platform will continue to highlight the therapeutic importance and value creation opportunities of antibodies and our technology."
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 30 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 III clinical trials. 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 website at 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"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with product development, unforeseen safety issues resulting from the administration of antibody products in humans, uncertainties concerning Centocor's activities under its agreement with Medarex, 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, 2006 and its quarterly reports on Form 10-Q. There can be no assurance that future milestone payments will be paid, whether the product development efforts will succeed, or whether 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.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.
CONTACT: Investor Relations, Laura S. Choi, +1-609-430-2880, x2216, orCorporate Communications (media), Jean Mantuano, +1-609-430-2880, x2221,both of Medarex, Inc.
Web site: http://www.medarex.com/
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Ticker Symbol: (NASDAQ-NMS:MEDX)
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Posted: December 2007
- FDA Approves Stelara (ustekinumab) to Treat Psoriasis - September 25, 2009
- FDA Extends Review Timeline for Stelara (ustekinumab) Biologic License Application by Three Months - May 27, 2009
- FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application - December 19, 2008
- FDA Extends Review Timeline for Ustekinumab Biologic License Application Three Months - August 8, 2008
- FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis - June 18, 2008
- Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA - February 4, 2008
- Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis - December 4, 2007