Celgene Announces End of FTC Waiting Period....!!!!!! - 500 Beiträge pro Seite

[MSolver]

zur info:


Celgene Announces End of FTC Waiting Period; d-Methylphenidate License Agreement with Novartis Now Effective
Milestone Triggers $10 Million Payment to Celgene
WARREN, N.J., June 12 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) announced today that its exclusive worldwide (except Canada) license agreement with Novartis Pharma AG for the development and marketing of d-methylphenidate, its chirally pure version of Ritalin®, has become effective with the expiration of the 30-day waiting period required under the Hart-Scott-Rodino (HSR) Pre-Merger Notification Act on June 10, 2000.

``With the HSR waiting period behind us, we will quickly establish the joint Novartis-Celgene development committee that will oversee the further development and commercialization of this compound. This milestone triggers a $10 million payment under the agreement. Our next major objective is to submit our New Drug Application (NDA) in the third quarter of this year,`` said Sol Barer, Ph.D., President and Chief Operating Officer of Celgene.

Under the terms of the agreement, Celgene granted its intellectual property rights to the chirally pure version of Ritalin and to a long acting formulation of Ritalin. This formulation will eliminate the mid-day dose, which has been identified by physicians, parents and school staff as a significant unmet medical and market need.

Under the license agreement, Novartis is to fund all remaining development required for the regulatory approval process and to cover expenses associated with the commercialization of the product. A joint development committee will direct the commercialization and regulatory strategies regarding the new drug including the continuation of marketing trials to amplify its safety and efficacy profile. As previously announced, Celgene will receive substantial milestone payments upon submission and approval of the d-methylphenidate products as well as royalties on all formulations of the Ritalin product line.

Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company engaged in the discovery, development and commercialization of small molecule drugs for cancer and immunological diseases. Please feel free to visit the Company`s website at http://www.celgene.com .

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.

SOURCE: Celgene Corporation

[biozocker]

endlich mal wieder gute nachrichten !!
jetzt kann es ja,wenn das umfeld positiv ist,wieder in richtung allzeithoch gehen!!