神隆生產Decitabine原料藥(Dacogen for myelodysplastic syndrome) ,Celgene如何穩住MDS市場?!

焦點股～神隆抗癌藥在美上市　股價奔漲停 2014年09月19日11:56台灣神隆（1789）股價早盤奔上62元的漲停價，不僅帶動健亞（4130）、和康生（1783）等新藥股攻高，拉抬生技類股指數的漲幅居早盤各類股表現之冠，也有力支撐店頭市場指數早盤持穩，不像加權指數的早盤漲幅幾乎吐光。媒體報導，神隆近期在美國推出抗癌新藥Decitabine，是神隆拿下全球第27個藥證的原料藥。神隆是全球抗癌原料藥龍頭，在全球擁有674個原料藥主檔案（DMF，原料藥藥證），在美國食品藥物管理局（FDA）登記有47張DMF，其中抗癌原料藥DMF就佔22張。不過，神隆上午發布重訊澄清，抗癌學名藥Decitabine是神隆上市的第27個產品，而非手中拿到的全球第27張藥證。（劉煥彥／台北報導）

Dr. Reddy's introduces generic version of Dacogen in US PBR Staff Writer Published 12 July 2013 India-based Dr. Reddy's Laboratories has introduced generic version of Dacogen (Decitabine for Injection) used to treat myelodysplastic syndrome in the US. Following the approval by the USFDA of Dr. Reddy's ANDA for Decitabine for Injection 50mg is available as a single dose vial. Decitabine that belongs to a class of medications called hypomethylation agents works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Myelodysplastic syndrome is a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells. The sales of Dacogen brand in the US were approximately $260m MAT for the most recent twelve months ending in July 2013, according to IMS Health data.

MGI PHARMA, Inc/ Dacogen (Decitabine) The overall response rate (CR+PR) in the ITT population was 17% in Dacogen-treated patients and 0% in the SC group (p<0.001). (See Table 3) The overall response rate was 21% (12/56) in Dacogen-treated patients considered evaluable for response (i.e., those patients with pathologically confirmed MDS at baseline who received at least 2 cycles of treatment). The median duration of response (range) for patients who responded to Dacogen was 288 days (116-388) and median time to response (range) was 93 days (55-272). All but one of the Dacogen-treated patients who responded did so by the fourth cycle. Benefit was seen in an additional 13% of Dacogen-treated patients who had hematologic improvement, defined as a response less than PR lasting at least 8 weeks, compared to 7% of SC patients. Dacogen treatment did not significantly delay the median time to AML or death versus supportive care.

l   Vidaza (Azacitidine) Injection from Celgene

l   Dacogen (Decitabine) IV from Eisai/MGI Pharma

l   Revlimid (Lenalidomide) from Celgene.