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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (1392)	2/25/2003 8:08:50 AM
From: Icebrg	Respond to of 3044

EMEA Accepts Marketing Authorization Application For Bortezomib (VELCADE(TM)) 3.5mg Powder For Solution For Injection Tuesday February 25, 7:59 am ET -- Clinical development of bortezomib (VELCADE) one of the fastest; well under the industry average of seven years -- CAMBRIDGE, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) announced today that the Agency for the Evaluation of Medicinal Products (EMEA) has accepted for review the Company's Marketing Authorization Application (MAA) for bortezomib (VELCADE) for the treatment of relapsed and refractory multiple myeloma. This announcement comes approximately three weeks after the Company submitted marketing applications in both the European Union (EU) and the United States. Bortezomib (VELCADE) received fast track status from the U.S. Food and Drug Administration (FDA) in June 2002, and Millennium filed the New Drug Application (NDA) under the provision of Subpart H Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses on January 21, 2003. The MAA was submitted to the EMEA a week later. "We are very pleased that the EMEA has accepted this MAA for review," said Barry Greene, general manager, oncology at Millennium. "Having taken just over four years to go from the dosing of the first patient to the recent global filings, bortezomib (VELCADE) represents one of the industry's fastest clinically developed drug candidates. We look forward to continuing to work closely with the global regulatory authorities to help get this important medicine to multiple myeloma patients." The global filings for bortezomib (VELCADE) in the EU and the U.S. were based primarily upon the results of the phase II SUMMIT trial, a multi-center study of 202 patients with relapsed and refractory multiple myeloma which were presented in full at the December 2002 meeting of the American Society of Hematology (ASH). The key findings from the study showed that the overall response rate among evaluable patients was 35 percent and that even among this critically ill group of patients, nearly one out of 10 experienced a complete remission. The most commonly reported adverse events were gastrointestinal- related, including nausea, diarrhea, constipation, and vomiting, as well as thrombocytopenia, peripheral neuropathy, neutropenia, fatigue, anorexia, pyrexia and anemia. The data were submitted in the common technical document (CTD) format, which allowed for nearly simultaneous filings in the EU and the U.S.

To: Icebrg who wrote (1392)	3/10/2003 11:08:45 AM
From: Icebrg	Read Replies (1) \| Respond to of 3044

FDA Accepts for Review NDA Filing and Grants Priority Review for VELCADE(TM) (bortezomib) for Injection Monday March 10, 11:03 am ET # CAMBRIDGE, Mass., March 10 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the U.S. Food and Drug Administration (FDA) accepted for review and granted Priority Review designation of the Company's New Drug Application (NDA) for VELCADE for the treatment of relapsed and refractory multiple myeloma. Priority Review is granted by the FDA to an NDA for a new treatment that addresses an unmet medical need. The FDA expedites the approval process for such an NDA by reducing the target review period for the application from 10 months to six months. Acceptance of the filing means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.(Photo: "We believe that the acceptance of our NDA for review is another step in our ongoing commitment of working to get this important medicine to multiple myeloma patients," said Barry Greene, general manager, oncology at Millennium. "The Agency's decision to grant the application Priority Review status underscores the potential therapeutic benefit of VELCADE and represents a significant step toward the Company's global mission of developing novel treatments in areas of significant unmet medical need." The acceptance of this filing comes approximately six weeks after the Company filed marketing applications in both the U.S. and the European Union (EU). VELCADE was granted fast track status by the FDA in June 2002, and Millennium filed the NDA under the provisions of Subpart H Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses on January 21, 2003. The Agency for the Evaluation of Medicinal Products (EMEA) accepted the Marketing Authorization Application (MAA) for review on February 24, 2003. The NDA submission was based primarily upon the results of the phase II SUMMIT trial, a multi-center study of 202 patents with relapsed and refractory multiple myeloma which were presented in full at the December 2002 meeting of the American Society of Hematology (ASH). The data were submitted electronically as well as in the common technical document (CTD) format, which allowed for nearly simultaneous filings in the U.S. and the EU.