|By Marketwired .||
|June 19, 2014 11:49 AM EDT||
SAN RAMON, CA -- (Marketwired) -- 06/19/14 -- SteadyMed Therapeutics Inc., a Specialty Pharmaceutical company focused on the use of its platform technology to develop drug products to treat underserved medical needs in orphan and high value disease states, today announced that the company has entered into an agreement with Bespak Europe Ltd ("Bespak") for the development and manufacture of the device elements of SteadyMed's lead drug product Trevyent.
Trevyent is a late development-stage drug product that uses SteadyMed's PatchPump® to administer treprostinil, to treat the orphan disease Pulmonary Arterial Hypertension. Unlike the current infusion systems used to deliver treprostinil, Trevyent will come to the patient pre-programmed with the correct dose delivery rate and pre-filled with sterile drug in a small, discreet, disposable and water resistant wearable device.
Bespak's Cambridge, UK, based Innovation Team has been working with SteadyMed to develop its novel PatchPump device, for the parenteral delivery of treprostinil. This new agreement between Bespak and SteadyMed provides for the further development of the device and its final commercial manufacturing process. The agreement helps to significantly advance SteadyMed's Trevyent development program for which a New Drug Application is planned to be filed with the U.S. Food and Drug Administration during the second half of 2015.
Jonathan M.N. Rigby, SteadyMed's President and Chief Executive Officer, commented, "As a company rapidly approaching final design for industrialization of our Trevyent product and significant regulatory milestones, it is critical that we select the very best contract manufacturing partners in the industry. That is why we chose Bespak. We are very pleased to be working with them in this partnership."
Keyvan Djamarani, Bespak's Managing Director, commented: "We are delighted to have entered into this agreement with SteadyMed. This collaboration takes Bespak into an interesting therapeutic area and parenteral drug delivery technology, and we are pleased with the latest success of our Innovation Team. This program further strengthens our presence in the growing Injectable therapeutics sector."
SteadyMed Ltd., with offices in San Ramon, CA and Rehovot, Israel, is a private, venture funded Specialty Pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. These drug products will be approved via the 505(b)(2) regulatory pathway, leading to commercialization by a targeted SteadyMed sales and marketing infrastructure.
Trevyent is not approved for sale by the FDA; it is a development stage drug product that uses SteadyMed's PatchPump to administer treprostinil, a vasodilatory prostacyclin analogue to treat Pulmonary Arterial Hypertension. Unlike the current infusion systems used to deliver treprostinil, Trevyent will come to the patient pre-programmed with the correct dose delivery rate and pre-filled with sterile drug in a small, discreet, disposable and water resistant PatchPump.
PatchPump is not approved for sale by the FDA; it is a novel, compact, prefilled, preprogrammed, disposable, parenteral drug delivery platform.
Bespak, a Consort Medical company, is a leading global supplier of drug delivery devices for injectable and inhaled products. Bespak has contributed to the design, development and industrialization of some of the world's leading medical devices. Headquartered in the UK and with representation in a number of key territories, Bespak employs over 600 people and manufactures more than 500 million medical devices each year, supporting device programs from pilot-scale to commercial supply.
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