Significant for Celgene:
Among retail, there has always been an aura that Thalidomide is untouchable in that no generic would want to get involved due to the history, and that the STEPS program for prescribing Thal safely would ward off the generics.
Clearly the generics could care less.
I've babbled about celgene being priced for perfection (while the price goes up!), and I think this simply reiterates that point. Celgene's recent growth on thalidomide has been primarily due to pricing increases. Now with Revlimid coming in at a high price off the bat, the loss of thalidomide sales could be a significant blow that they won't be able to combat with Revlimid price increases.
Revlimid is looking good in hematological malignancies so far, but solid tumour penetration is looking as unlikely as it was for thalidomide. Two melanoma studies have already failed.
Celgene Notified of ANDA Filing for Thalidomide
Wednesday December 13, 9:32 am ET
SUMMIT, N.J., Dec. 13 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG - News) announced that the Company has been notified of an Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA), with a Paragraph IV certification, by Barr Pharmaceuticals, Inc. This applicant is seeking authorization to market a generic version of thalidomide 200 mg tablets in the United States for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Celgene Corporation markets thalidomide under the brand name THALOMID® and has approval to market as a treatment in combination with dexamethasone for newly diagnosed multiple myeloma, as well as for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
Celgene intends to file a complaint alleging infringement of Celgene patents, within the required forty-five day response period. By bringing suit, Celgene is entitled to up to a 30-month injunction against the applicant's marketing of generic thalidomide. Celgene has seven issued patents in the Orange Book with expiration dates of 2018 and 2020, which cover methods of more safely administering pharmaceutical products, including thalidomide through S.T.E.P.S.®, an integral part of the FDA approved THALOMID labeling. Furthermore, Celgene holds additional broad patents protecting methods of using thalidomide in the treatment of hematological and solid tumor cancers.
Celgene intends to vigorously protect and defend its intellectual property rights against infringement. Marketing of an FDA-approved generic thalidomide may not commence until FDA approval of the generic and either a decision favorable to the ANDA applicant is rendered or until after the 30 months (two and a half years) injunction has lapsed, whichever comes first.
AI
