{"id":14914,"date":"2013-08-01T11:58:39","date_gmt":"2013-08-01T15:58:39","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=14914"},"modified":"2014-01-10T11:00:38","modified_gmt":"2014-01-10T16:00:38","slug":"actelion-to-acquire-developer-of-rare-cancer-treatment","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=14914","title":{"rendered":"Actelion to Acquire Developer of Rare Cancer Treatment"},"content":{"rendered":"
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T Cell, in blue, a key component in the body’s immune system (Lawrence Berkeley National Lab)<\/figcaption><\/figure>\n

Actelion Ltd<\/a>, a biopharmaceutical company based in Switzerland, acquired Ceptaris Therapeutics Inc.<\/a>, a specialty pharmaceutical developer in Malvern, Pennsylvania, in a deal with a potential value of at least $250 million. The acquisition, however, depends on the U.S. Food and Drug Administration approving Ceptaris’s only current product, a topical treatment for symptoms from a rare form of non-Hodgkin’s lymphoma.<\/p>\n

Ceptaris Therapeutics develops a gel form of topical mechlorethamine to treat mycosis fungoides<\/a>, a rare form of non-Hodgkin’s lymphoma known as cutaneous T-cell lymphoma, in its early stages. Cutaneous T-cell lymphomas occur when T cells, white blood cells vital to the operation of the immune system, become cancerous. The cancerous T cells affect the skin, causing various skin lesions, although skin cells themselves do not become cancerous.<\/p>\n

Mechlorethamine is a compound usually given as an injection during chemotherapy<\/a> to treat Hodgkin’s disease and some types of non-Hodgkin’s lymphoma. Topical forms of mechlorethamine are the current standard of care for early stages of cutaneous T-cell lymphoma, but the only items of this kind available are\u00a0non-standardized preparations compounded by pharmacies.<\/p>\n

A clinical trial<\/a> tested Ceptaris’s mechlorethamine gel, given the brand name Valchlor, to determine if it worked as well as a pharmacy-compounded mechlorethamine ointment, called a non-inferiority trial. The study involved 260 patients with early stage mycosis fungoides at 13 locations in the U.S. The company reports Valchlor worked at least as well as the pharmacy-compounded ointment in reducing the severity of the lesions caused by mycosis fungoides. Skin irritations, mainly dermititis, caused about 1 in 5 patients — both Valchlor- and ointment-treated — to withdraw from the trial.<\/p>\n

Ceptaris first submitten a new drug application to the FDA for its mechlorethamine gel<\/a> in 2011, and was granted fast-track and orphan-drug status by the agency. If approved by the FDA, it will be the first standardized topical mechlorethamine product to treat early-stage mycosis fungoides. Ceptaris says FDA set a target date of 27 August to complete its review.<\/p>\n

That FDA approval is a key contingency of the acquisition. Under the deal, Actelion paid $25 million on signing, but will pay the remaining $225 million only when FDA approval of Valchlor and other closing conditions are met. Ceptaris shareholders will also be eligible for future commercialization milestone payments and sales royalties.<\/p>\n

Actelion develops biologic therapies<\/a> to treat pulmonary arterial hypertension and Gaucher’s disease, also a rare disorder. The publicly-traded company operates in 30 countries and has nearly 2,400 employees.<\/p>\n

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