dilluns, 6 de juliol del 2015

SteadyMed inks deal for EU, Canada, Middle East

SteadyMed inks deal for EU, Canada, Middle East

SteadyMed Therapeutics (NSDQ:STDY) said last week that it inked an exclusive deal with Cardiome for commercialization of its Treyvant product in regions outside the U.S., hinging on its regulatory approval in those regions.

Cardiome will have exclusive rights to the territories of the European Union, Canada and the Middle East, SteadyMed said.

SteadyMed is a developer of hypertension and pain treatments given with a discrete, patented drug-delivery device called the PatchPump. The company is focusing on development and approval of Treyvant, a drug to treat pulmonary arterial hypertension.

“SteadyMed has been searching for the ideal partner for ex-U.S. commercialization of Trevyent that has a track record of selling parenteral therapeutics to cardiologists, an excellent regulatory infrastructure, a commercial organization with operations in major European markets and a passion to sell – we found this in Cardiome. In addition, Cardiome has an extensive network of specialty pharmaceutical product distributors in many global markets that will be key contributors to the future success of Trevyent, which if approved is an exciting new potential treatment for PAH. We believe this agreement will help to ensure that Trevyent, if approved, will be available to the patients who need a ready to use and easier to administer alternative product to treat this serious and debilitating condition,” SteadyMed CEO Jonathan Rigby said in a press release.

Cardiome is slated to pay $12.25 million in up-front and milestone payments, with $3 million payable within 7 business days of the effective date, $7.25 million payable upon achievement of “regulatory milestones” by SteadyMed and $2 million payable in connection with “the achievement of a sales milestone by Cardiome,” according to an SEC filing.

Cardiome will also pay SteadyMed a transfer price on finished goods and a scaling royalty ranging from the low-teens to mid-20% on future Trevyent sales by Cardiome, according to the SEC filing.

“We believe that Trevyent will complement our current portfolio of cardiovascular products and will broaden our franchise of specialty products into additional treatment centers and physician specialties. We look forward to working with SteadyMed as we jointly prepare for submission of the request for regulatory approvals for Trevyent beginning in 2016. We are thrilled to have the opportunity to promote this new and exciting product candidate,” Cardiome CEO William Hunter said in a prepared statement.

SteadyMed closed a $40 million initial public offering in March, floating 4.7 million shares at $8.50 per share.

The Israel- and California-based company said it hoped to bring in $55 million from the offering initially, planning to float 4.25 million shares at $12 to $14 apiece.

The post SteadyMed inks deal for EU, Canada, Middle East appeared first on MassDevice.



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