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Celgene goes for Gloucester
SUMMIT, N.J.—Seeking to advance its position as a developer of blood cancer therapies, Celgene Corp. announced Dec. 9 an agreement to acquire Gloucester Pharmaceuticals, a privately held biotech based in Cambridge, Mass., for $340 million in cash plus $300 million in future U.S. and international regulatory milestone payments.
Pending regulatory approval, the acquisition is expected to be complete in the first quarter of 2010. Celgene said the purchase will not impact its non-GAAP diluted earnings for 2010 and will be accretive in 2011.
Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates with the goal of advancing them through regulatory approval and commercialization. For the last four years, Gloucester has been singularly focused on the development of its first drug, ISTODAX (romidepsin), a novel histone deacetylase (HDAC) inhibitor that was approved in November 2009 by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
Although the two companies had never collaborated before this deal, Celgene was attracted to Gloucester for several reasons, says Celgene spokesman Greg Geissman.
"ISTODAX (romidepsin) is a strategic fit with our other products and further diversifies and strengthens our premier hematology/oncology product mix," Geissman says. "There is a need for better treatment options for CTCL and peripheral T-cell lymphoma (PTCL), assuming label expansion. This deal enables Celgene to maximize the clinical and commercial potential of ISTODAX through its existing infrastructure."
CTCL is a type of non-Hodgkin's lymphoma (NHL) caused by a mutation of T-cells; most types of NHL are of T-cell origin. The malignant T-cells involve the skin, causing plaques, patches, erythroderma and/or tumors and can involve other organs, including the blood, lymph nodes and viscera. According to the Cutaneous Lymphoma Foundation, this rare orphan disease has a greater frequency among men than women; the disease is more common after the age of 50.
ISTODAX has also received both orphan drug designation for the 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 the Evaluation of Medicinal Products (EMEA) has granted orphan status designation for ISTODAX for the treatment of both CTCL and PTCL. Accrual of the ISTODAX registration SPA trial for peripheral T-cell lymphoma (PTCL) is expected to be complete early next year.
Geissman says the potential market for CTCL in the United States is approximately 16,000 to 20,000 patients, with the treatable population for ISTODAX somewhere around 3,000 to 4,000 patients per year.
"For PTCL, there is a prevalence of about 40,000 to 60,000 patients in the U.S., with a treatable population for ISTODAX at around 8,000 to 10,000 per year," he adds.
Dr. Alan Colowick, CEO of Gloucester Pharmaceuticals, says Celgene's global position as a developer of innovative treatments for hematologic diseases "makes them ideally suited to bring the clinical benefits of ISTODAX to patients with CTCL."
"I wouldn't say we necessarily set out to sell the company, but our strategy was to put ourselves in a position where we had options and could control our own destiny," Colowick says. "We raised $29 million in the fall, thinking that it would give us the runway to take the drug to its initial approval, which occurred in November. Once we got it approved and removed the regulatory hurdle, we realized selling would offer an interesting path for the company. It is a very nice chapter in our story, and we're absolutely thrilled because we think it presents the best outcome possible for patients as well as our shareholders."
The companies have not yet announced what the integration will mean for Gloucester's 15 employees.