Raised $28.2 Million in Net Proceeds in a Private Placement
Received a Favorable IPR Ruling Invalidating United Therapeutics’ ‘393 Patent
Completed a Clinical Validation Study for Trevyent®
On Track to file a New Drug Application (NDA) for Trevyent for the Treatment of Pulmonary Arterial Hypertension (PAH) in Q2 2017
SAN RAMON, Calif., May 12, 2017 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today provided a corporate update and reported financial results for the first quarter ended March 31, 2017.
First Quarter 2017 and Recent Corporate Highlights Include:
- SteadyMed is on-track to file a New Drug Application (NDA) for Trevyent for the treatment of PAH by the end of the second quarter of 2017.
- In April, SteadyMed successfully raised $28.2 million in net proceeds in a private placement led by institutional healthcare investors Adage Capital, OrbiMed, Deerfield Management and Kingdon Capital Management. This additional capital is expected to fund pre-launch commercial activities, distribution network establishment and manufacture of commercial Trevyent inventory aimed at a 2018 commercial launch in the U.S. (subject to NDA approval), as well as working capital and general corporate purposes. The Company now has sufficient capital to fund operations into late 2018.
- In late March, SteadyMed received a favorable ruling from the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) in the Inter Partes Review (IPR) proceeding against United Therapeutics’ (Nasdaq: UTHR) ‘393 patent. The PTAB ruled that all 22 claims in the ‘393 patent were unpatentable and cancelled them, rendering the patent invalid. The ‘393 patent claimed a product made by a process to further purify prostacyclin derivatives, such as treprostinil. Treprostinil is the active pharmaceutical ingredient used in United Therapeutics’ Remodulin® and SteadyMed’s lead drug candidate, Trevyent, which is in development for the treatment of PAH.
- In April, SteadyMed announced the successful completion of a clinical study for Trevyent to provide clinical validation of usability over the 48 hour, per unit, intended use. This study enrolled 60 healthy adult volunteers in an in-clinic setting, and was intended to provide clinical validation of the performance of the Trevyent product. The results indicate that the PatchPump® devices performed as intended in all categories of evaluation.
