SteadyMed and Cardiome Partner To Commercialize PAH Therapy Trevyent Outside The U.S.

SteadyMed Ltd., a pharmaceutical company developing therapies for both high value and orphan diseases with unmet parenteral delivery needs, and Cardiome Pharma Corp. have recently announced an exclusive agreement for Cardiome to market Trevyent in specific markets outside the United States if Trevyent receives approval to treat pulmonary arterial hypertension (PAH) in those regions. The license agreement stipulates that SteadyMed will receive $12.25 million linked to regulatory and sales milestones, and will include a $3 million upfront payment. In addition, Cardiome will pay royalties on future sales of Trevyent to SteadyMed. This exclusive partnership includes Canada, Europe and the Middle East.

“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,” noted Jonathan Rigby, who is the President and CEO of SteadyMed.

William Hunter, Cardiome’s CEO, added in a press release: “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.”

Trevyent is a small, discreet, single-use (2 day) PatchPump that delivers Treprostinil, the only parenteral treatment for PAH that is approved by the FDA for both intravenous (IV) and subcutaneous (SC) administration. Trevyent is designed to improve the delivery of Treprostinil through the PatchPump technology, which features pre-filled, pre-programed doses and sensors to provide patients audible and visual feedback on successful delivery and end of dosing.

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The Mayo Clinic in Florida has been named as a Pulmonary Hypertension Care Center by the Pulmonary Hypertension Association. This designation is only awarded to centers that can provide early diagnosis, specialized care options and therapies for pulmonary hypertension, as well as follow-up capacities and clinical research projects. The Mayo Clinic now joins the 26 Pulmonary Hypertension Care Centers throughout the country and is the only in the Southeast.