Transcept Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of proprietary products to address therapeutic needs in neuroscience, and Shin Nippon Biomedical Laboratories (SNBL) have entered into an exclusive worldwide licensing agreement for a novel, rapidly absorbed treatment for acute migraine incorporating dihydroergotamine (DHE) as the active drug. 

Transcept will have global development and commercialization rights to the product candidate, designated TO-2070, which is expected to offer a new and potentially improved approach to the treatment of acute migraine. 

Preclinical data suggest TO-2070 may offer significant migraine treatment benefits beyond those provided by less convenient and more invasive DHE drug delivery methods, such as injection, liquid nasal sprays or pulmonary inhalation. TO-2070 is designed to provide these benefits at a relatively low cost via a proprietary nasal powder drug delivery system that can be easily self-administered by patients.

Transcept has agreed to pay SNBL an upfront technology license fee of $1 million, development milestones totaling $6.5 million and commercialization milestones up to $35 million. Additionally, Transcept will pay tiered, low double-digit royalties on annual net sales. The companies anticipate entering into further agreements under which SNBL would supply Transcept with nasal powder delivery devices and would provide certain preclinical and clinical services to support development.

Glenn A. Oclassen, president and CEO of Transcept, said, “There are approximately 30 million migraine cases each year in the U.S. alone, and we estimate that the worldwide therapeutic market is over $3 billion. TO-2070 will offer these advantages in a DHE treatment system that does not have the problems associated with intranasal liquid, injectable or pulmonary delivery, that can be conveniently self-administered, and that has a relatively low manufacturing cost.” 

DHE is a well-established acute migraine treatment, especially among migraine specialists, and has been approved for use in the U.S. since 1946. However, it has poor oral bioavailability and is not available in an oral dosage form. Instead, DHE is generally administered via subcutaneous (SC), intramuscular (IM) or intravenous (IV) injection. It is also available as a liquid nasal spray; however, the performance of that product is limited by an administration regimen, slow onset of relief, inconsistent absorption, post-nasal drip and bitter taste. A DHE product that is delivered via pulmonary inhalation is under review by the FDA.

TO-2070 is based on a novel nasal powder drug delivery technology created by SNBL that combines a muco-adhesive drug carrier with a proprietary nasal powder drug delivery device.  The SNBL system is able to consistently deliver drug into the nasal cavity with each administration and hold it in place on the nasal mucosa to enable enhanced absorption into the bloodstream.