SteadyMed Therapeutics, a pharmaceutical company focused on developing drugs to treat underserved medical needs in orphan and high value disease states, recently announced a development and manufacturing agreement with Bespak Europe, a Consort Medical company and supplier of drug delivery devices for injectable and inhaled products. The two companies will join efforts to produce SteadyMed’s lead Pulmonary Arterial Hypertension drug Trevyent.
SteadyMed and Bespak already work together in the development of the novel PatchPump device, which is used for the parenteral delivery of treprostinil. The new agreement will allow for the continuation of the development process as well as the final commercial manufacturing phase. SteadyMed expects that with this step, Trevyent’s development capabilities will significantly expand.
“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,” said President and Chief Executive Officer of SteadyMed, Jonathan M.N. Rigby.
Trevyent is a late development stage drug that uses SteadyMed’s PatchPump to administer treprostinil, a vasodilatory prostacyclin analogue to treat Pulmonary Arterial Hypertension. The drug product has not been approved for sale by the U.S. Food and Drug Administration, and SteadyMed aspires to be able to deliver the New Drug Application during the second half of 2015.
The current focus is now on the development of the delivery process, as Trevyent is being produced to come to the patients already pre-programmed with the correct dosage — an approach that current technologies cannot provide. It will also be already pre-filled with sterile drug inside the PatchPump device, which the company promises to be small, discreet, disposable, and water resistant.
“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,” stated Bespak’s Managing Director, Keyvan Djamarani.
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