Sepracor, Arrow sign license, development pact

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MARLBOROUGH, Mass.—Sepracor Inc. announced it signed a technology license and development agreement with Arrow International Ltd. for know-how and intellectual property rights related to stable sterile steroid suspension formulations as well as other applicable nebule technology for use in developing ciclesonide, a corticosteroid, in an inhalation solution.
The agreement facilitates enhanced development of Sepracor's ciclesonide stand-alone product for the treatment of asthma as well as a planned ciclesonide/ Brovana brand arformoterol tartrate inhalation solution combination product for the treatment of COPD, and includes Arrow's "U-Bend" packaging technology, which allows increased accuracy in dosing through a novel U-Bend ampule design.

"The identification of technology to enable the successful development of a stable sterile ciclesonide suspension for nebulization has been a priority for Sepracor for our newly attained ciclesonide franchise since only a limited number of approaches can be used," says Dr. Mark H.N. Corrigan, EVP, research and development at Sepracor.
"Arrow and its affiliates have significant experience and success in the development of inhalation solution products, particularly with corticosteroids, and we are excited to have in-licensed this technology that should assist us in moving forward two important clinical development programs in our respiratory portfolio, which could provide a significant number of patients with COPD with greater convenience in treating their disease."

Under the terms of the agreement, Arrow is entitled to receive $250,000 upon execution of the agreement and future payments of up to $22.5 million in support of the ciclesonide stand-alone product. In addition, Arrow is also entitled to receive $250,000 upon execution of the agreement and future milestones of up to $25 million in support of Sepracor's planned ciclesonide/Brovana combination product. Arrow will also receive a low-single-digit royalty on Sepracor's sales of these products.

Sepracor will fully fund all product development activities and manage the development program, including all interactions with the U.S. Food and Drug Administration and other regulatory bodies. Sepracor will oversee the development program and is responsible for all commercial activities associated with the product in the U.S. Arrow will be responsible for formulation development.

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