SUMMIT, N.J.—Seeking to advance its position as a developerof blood cancer therapies, Celgene Corp. announced Dec. 9 that it has reachedan agreement to acquire Gloucester Pharmaceuticals, a privately held biotechbased in Cambridge, Mass., for $340 million in cash plus $300 million in futureU.S. and international regulatory milestone payments.
Pending regulatory approval, the acquisition is expected tobe complete in the first quarter of 2010. Celgene said the purchase will notimpact its non-GAAP diluted earnings for 2010 and will be accretive in 2011.
Gloucester Pharmaceuticals acquires clinical-stage oncologydrug candidates with the goal of advancing them through regulatory approval andcommercialization. The company's first drug, ISTODAX (romidepsin), a novelhistone deacetylase (HDAC) inhibitor, was approved in November 2009 by the U.S.Food and Drug Administration (FDA) for the treatment of cutaneous T-celllymphoma (CTCL) in patients who have received at least one prior systemictherapy.
CTCL is a type of non-Hodgkin's lymphoma (NHL) caused by amutation of T-cells; most types of NHL are of T-cell origin. The malignantT-cells involve the skin, causing plaques, patches, erythroderma and/or tumorsand can involve other organs, including the blood, lymph nodes and viscera.According to the Cutaneous Lymphoma Foundation, this rare orphan disease has agreater frequency among men than women; the disease is more common after theage of 50.
ISTODAX has also received both orphan drug designation forthe treatment of non-Hodgkin's T-cell lymphomas, which includes CTCL and PTCL,and fast-track status in PTCL from the FDA. The European Agency for theEvaluation of Medicinal Products (EMEA) has granted orphan status designationfor ISTODAX for the treatment of both CTCL and PTCL. Accrual of the ISTODAXregistration SPA Trial for peripheral T-cell lymphoma (PTCL) is expected to becomplete early next year.
The acquisition "reflects our ongoing commitment toimproving the lives of patients worldwide through innovative medicinesdiscovered and developed both in-house and through external opportunities,"said Dr. Sol J. Barer, chairman and CEO of Celgene, in a statement. "We alsowould like to recognize the dedication, effort and leadership that Alan and histeam have demonstrated in the process of developing and delivering ISTODAX topatients living with CTCL."
Dr. Alan Colowick, CEO of Gloucester Pharmaceuticals, saidCelgene's global position as a developer of innovative treatments forhematologic diseases "makes them ideally suited to bring the clinical benefitsof ISTODAX to patients with CTCL."