SteadyMed raises $32m

SteadyMed Therapeutics (NASDAQ:STDY) today announced a new $32 million round of funding through a 2-tranche private placement.

The round was led by new investor OrbiMed and joined by existing investors including Federated Investors and Deerfield Management, according to the San Ramon, Calif.-based company.

“This financing is exciting news for our Company, strengthens our balance sheet and enables us to execute on our development and pre-commercialization plans for our lead product candidate Trevyent for the treatment of Pulmonary Arterial Hypertension. We remain on track with our overall goal of a commercial launch of Trevyent in the U.S. in late 2017. We are focused on our New Drug Application for Trevyent, which we expect to submit to the Food and Drug Administration in Q1 2017, and plan to deprioritize our At Home Patient Analgesia Products to allow for this,” CEO Jonathan Rigby said in a press release.

JMP Securities acted as lead placement agent for the offering, with H.C. Wainwright & Co and Ladenburg Thalmann as co-placement agents.

“We believe SteadyMed is well positioned for regulatory and commercial success based on our positive conversations with the FDA, the institution of our Inter Partes Review by the US Patent and Trademarks Office against a patent held by United Therapeutics, and Trevyent’s orphan drug designation, which we believe would provide us with 7 years of market exclusivity. We look forward to the opportunity to bring to market a much needed improvement in the treatment of PAH, and appreciate the confidence in SteadyMed that has been demonstrated by our existing and new investors,” CEO Rigby said in prepared remarks.

In April, SteadyMed said the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office initiated an inter partes review against a United Therapeutics patent.

The patent in question, No. 8,497,393, is related to a process to purify prostacyclin derivatives, such as treprostinil, which is used in United Therapeutics’ Remodulin and SteadyMed’s drug candidate Trevyent, designed to treat pulmonary arterial hypertension.

San Ramon, Calif.-based Steadymed said that IPR reports from 2012-2015 indicated that 74% of reviews were resolved by finding all claims unpatentable, cancelling claims and rendering patents invalid. Only 14% of cases were resolved by finding some claims unpatentable and cancelling those, and 12% were resolved by finding all claims patentable.

The post SteadyMed raises $32m appeared first on MassDevice.

from MassDevice http://ift.tt/2aMJy4Y