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Otsuka Acquires Rights to Dacogen® from Eisai

Mon, 03/31/2014 - 8:17am

 

Otsuka Pharmaceutical Co., Ltd.has announced an agreement with Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd. to acquire rights to the hematological cancer treatment Dacogen ® and to an enzyme inhibitor, E7727.

 

Rights Acquired From Eisai

 

1.

 

Exclusive rights to the development and sale of DNA methylation inhibitor Dacogen ®, an intravenous formulation of decitabine (generic name), in the U.S., Canada, and Japan in addition to the licensing rights worldwide excluding Mexico. Eisai will retain the rights in Mexico. Janssen Pharmaceutical Companies will retain its worldwide development and commercialization rights (excluding the U.S., Canada, Mexico and Japan).

2.

 

Patent rights to metabolic enzyme inhibitor E7727, currently in pre-clinical development by Otsuka's U.S. subsidiary Astex Pharmaceuticals, Inc. E7727 is in development together with decitabine to form the combination product ASTX727 (an oral hypomethylating agent), which if approved would become the first oral formulation of decitabine.

 

 

Otsuka Pharmaceutical’s In-Line Products and Development Projects For Hematological Malignancies

 

 

 

 

 

Type of Leukemia

 

 

Myelodysplastic
Syndrome (MDS)

 

Acute Myeloid Leukemia
(AML)

 

Chronic Myeloid
Leukemia (CML)

 

Acute Lymphoblastic
Leukemia (ALL)

Products
Currently
Marketed

 

Dacogen®
(for MDS in U.S.; Janssen is marketing in E.U. for
AML and in specified other countries for AML and/or
MDS)

 

Sprycel ®
(co-promotion with Bristol-Myers Squibb of their drug
for CML and Philadelphia chromosome-positive ALL)

 

IV Busulfex ®

Products in
Clinical
Development

 

SGI-110 (Phase II)

 

 

ASTX727 (Pre-clinical)

 

 

           

 

                     

Purpose and Significance of the Agreement

Otsuka's activities in the area of hematological malignancies began in March 2008 with the promotion of IV Busulfex ®, a conditioning agent used prior to hematopoietic stem cell transplantation in patients with chronic myeloid leukemia. Since 2010, Otsuka has co-promoted Sprycel ® in a joint venture with Bristol-Myers Squibb for treatment of patients in Japan, the U.S. and Europe with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Otsuka also has in phase II clinical trials a prodrug subcutaneous injection of decitabine, SGI-110. With Dacogen ®, and potentially in the future with SGI-110 and ASTX727, Otsuka aims to further improve the quality of treatments available to patients with hematological malignancies.

About Dacogen®

Dacogen ® was developed by SuperGen, Inc., (now Astex Pharmaceuticals, Inc.) as a therapeutic agent for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) possessing cell differentiation-inducing activity through the inhibition of DNA methylation. U.S.-based MGI Pharma, (acquired by Eisai Inc. in 2008) acquired worldwide rights to develop and market Dacogen ® from SuperGen, Inc. and sublicensed worldwide rights (except for the U.S., Canada, Japan and Mexico) to Janssen Pharmaceutical Companies. Dacogen ® was approved for sale in the U.S. and is currently indicated for treatment for myelodysplactic syndromes (MDS) including previously treated and untreated de novo and secondary MDS of all FAB (French-American-British) hematological subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and for intermediate-1, imtermediate-2, and high-risk International Prognostic Scoring System groups.

Janssen is responsible for R&D and commercialization of Dacogen ® in the EU (where it is approved for acute myeloid leukemia (AML)) and in other specified countries (where it is approved for AML and/or MDS).

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