Shares of Celgene have been strong since it announced in early March, Celgene/NASDAQ: CELG that the Independent Data Monitoring Committee (IDMC) found the Phase III multiple myeloma (MM) trials exceeded the pre-specified value and the company stopped the trials. The IDMC found a statistically significant improvement in time-to-disease progression, the primary endpoint of these Phase III trials in patients receiving Revlimid plus dexamethasone compared to patients receiving dexamethasone alone. Celgene has initiated discussions with the FDA and international regulatory authorities regarding the submission of this data for potential approval. Treatment assignments for patients currently on the trials will be unblinded and those currently not on Revlimid will have the opportunity to add Revlimid to their dexamethasone regimen. Full data release should be available at the May 2005 ASCO meeting and the MM filing is expected in mid-2005.
Celgene’s stock should continue to be strong not only with the upcoming MM filing, but with the completion of its rolling NDA filing for Revlimid in myelodysplastic syndrome (MDS), plus the upcoming FDA review before the end of the year. At the same time, the company plans to launch two Phase III trials in 5q- and non-5q- low risk MDS to support a European approval. Revlimid should have an approval for one or both in MM and/or MDS by the end of the year or early 2006.
Both Thalomid and Revlimid will be important players in treating patients with blood cancers. Revlimid can expand the existing Thalomid sales base as it has advantages over Thalomid with a better safety-no expected teratogenicity (development of the embryo and fetus that lead to birth defects), a likely higher pricing, and an oncology label, which allows for oncology marketing and promotion. Revlimid can become the market leader for the treatment of MM, turning Celgene’s estimated $390 million MM franchise into a $1 billion franchise by 2008.
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