NuPathe Announces Second Quarter 2013 Financial Results and Recent Operational Highlights

CONSHOHOCKEN, PA--(Marketwired - Aug 8, 2013) - NuPathe Inc. (NASDAQ: PATH) today announced financial results for the quarter ended June 30, 2013, as well as recent operational highlights.

"NuPathe achieved significant progress in commercial and manufacturing preparations to support the fourth quarter launch of our first product, ZECUITY, while simultaneously advancing dialogues with potential partners to extend our reach," said Armando Anido, chief executive officer of NuPathe. "Data presented at the recent International Headache Congress, the premier headache scientific meeting, reinforced to our key audiences that ZECUITY is an easy-to-use treatment option that may benefit millions of migraine patients who frequently suffer from migraine-related nausea along with headache pain."

Quarterly and Recent Highlights

  • NuPathe accomplished a number of key commercial objectives year-to-date in preparation for the launch of ZECUITY® (sumatriptan iontophoretic transdermal system) in the fourth quarter of 2013. The Company selected its sales leadership and managed care teams as well as a third-party logistics provider and its advertising and public relations agencies of record. In addition, a recruiting plan is in place for the field sales team to support the launch.

  • The Company advanced commercial manufacturing, including the completion of almost all of the process qualification activities, the initiation of process validation for critical manufacturing operations and the finalization of delivery schedules for key assemblies and components.

  • In June, NuPathe presented new data on ZECUITY at the International Headache Congress (IHC) in Boston. A post-hoc analysis showed that ZECUITY was efficacious in treating migraine headache pain and associated symptoms regardless of the presence of nausea prior to treatment. Another post-hoc analysis showed that patients treated with a placebo patch were more likely to have treatment-emergent nausea than those treated with ZECUITY. In addition, a third data presentation showed that migraine patients could correctly and easily assemble, apply and activate ZECUITY during an attack.

  • In May, the United States Patent and Trademark Office (USPTO) issued a notice of allowance for U.S. Patent application 13/105,585 entitled "Transdermal Methods and Systems for the Delivery of Anti-Migraine Compounds." This patent, which is now issued, will provide additional protection for ZECUITY and is the fifth patent covering ZECUITY to be listed in the U.S. Food and Drug Administration's (FDA) Orange Book.

  • In April and May, the USPTO issued notices of allowance for U.S. Patent applications 12/074,101 and 11/784,526, respectively. Both patent applications are entitled "Implants for the Treatment of Dopamine Associated States." These patents, which are now issued, will provide protection for NP201, NuPathe's long-term biodegradable ropinirole implant for the treatment of Parkinson's disease, into July 2028 and October 2027, respectively.