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Apotex Inc.

Drug Names(s): Melphalan, Melphalan hydrochloride

Description: Alkeran, an alkylating agent, works by three different mechanisms: 1) attachment of alkyl groups to DNA bases, resulting in the DNA being fragmented by repair enzymes in their attempts to replace the alkylated bases, preventing DNA synthesis and RNA transcription from the affected DNA, 2) DNA damage via the formation of cross-links (bonds between atoms in the DNA) which prevents DNA from being separated for synthesis or transcription, and 3) the induction of mispairing of the nucleotides leading to mutations.

Alkeran is a phenylalanine derivative of mechlorethamine, or nitrogen mustard. Alkeran is a bifunctional alkylating agent which is active against selective human neoplastic diseases. Like other alkylators, Alkeran is cell cycle phase nonspecific.

Deal Structure: GSK and Celegene
Celgene Corporation announced on April 14, 2003, that it has signed and agreement with GlaxoSmithKline to distribute an promoteALKERAN (melphalan/melphalan hydrochloride), a therapy approved by the FDAfor the palliative treatment of multiple myeloma. Under the terms of the agreement, Celgene will purchase ALKERAN tablets and ALKERAN for injection from GlaxoSmithKline and distribute the products in the United States under Celgene's label.

As of March 31, 2009, Alkeran will no longer be commercialized by Celgene as it concludes the Alkeran license agreement with GlaxoSmithKline.

GSK and Aspen
In May 2009, GSK announced that it will divest eight specialist medicines to Aspen Pharmacare Holdings, including Alkeran (excluding US), Leukeran, Myleran and Purinethol.

GSK and ApoPharma (Apotex)
In October 2010, the American Society of Hematology reported that ApoPharma (Apotex) has acquired Alkeran (melphalan) from...See full deal structure in Biomedtracker

Alkeran News

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