Apricus Biosciences

Apricus Biosciences, Inc.

Company type	Public
Industry	Biopharmaceuticals
Predecessor	NexMed, Inc.
Founded	1995
Headquarters	San Diego , United States
Area served	North America, Europe
Key people	Richard Pascoe (CEO), Brian Dorsey (SVP & Chief Development Officer), Barbara Troupin (SVP & Chief Medical Officer)
Products	Vitaros, Fispemifene, RayVa, Femprox
Number of employees	35

Apricus Biosciences, Inc. is a biopharmaceutical firm headquartered in San Diego, specializing in the development of novel therapies for urology and rheumatology.

Its leading product, Vitaros®, has received regulatory approval in both Europe and Canada for the treatment of erectile dysfunction. The company's pipeline also includes candidates addressing conditions such as low testosterone, rheumatologic disorders, sexual dysfunction, and pain management.

History

Prior to September 10, 2010, the company operated under the name NexMed, Inc. (NASDAQ:NEXM) since its inception in 1995. Vitaros obtained Canadian market authorization on November 15, 2010, followed by European regulatory clearance on June 10, 2013.

In February 2018, the U.S. Food and Drug Administration declined to approve Vitaros for marketing in the United States for a second occasion.

Location

Apricus Biosciences maintains its corporate headquarters in San Diego, California, employing around 35 personnel across its main office and affiliated subsidiaries.

Products

Vitaros® is a topical cream designed for rapid onset (within 5–15 minutes) relief of erectile dysfunction. It contains Prostaglandin E1 combined with the proprietary permeation enhancer NexACT®, which facilitates efficient transdermal absorption into systemic circulation. The currently marketed refrigerated formulation holds approvals in Canada and Europe and is distributed in the United Kingdom (through Takeda), Germany, Sweden, and Belgium (via Sandoz), with plans for six further European market introductions anticipated during 2015.

Apricus is advancing a room temperature stable formulation of Vitaros (RTD) delivered through a customized single-use dispenser. Manufacturing has commenced to support regulatory submissions, with commercial partners aiming for a product launch in 2016.

In November 2007, Apricus divested U.S. rights for the refrigerated version of Vitaros to Warner Chilcott.

Fispemifene represents a novel chemical entity targeting male secondary hypogonadism characterized by low testosterone levels. The company intends to initiate a Phase 2b clinical study in early 2015, expecting top-line results by the end of that year. Apricus acquired U.S. rights from Forendo Pharma in late 2014 and has since progressed regulatory filings, finalized clinical protocols, arranged manufacturing capabilities, and selected trial sites.

RayVa™ is a topical therapeutic aimed at treating Raynaud's phenomenon—a circulatory condition impacting extremities such as hands and feet. Patient recruitment commenced in December 2014 for a Phase 2a trial involving 45 participants, with data anticipated in the second quarter of 2015. RayVa incorporates Prostaglandin E1 alongside NexACT to enhance systemic delivery and strives to become the first FDA-approved therapy for this disorder.

Femprox® is formulated as a topical cream intended to address female sexual interest/arousal disorder. It combines Prostaglandin E1 with NexACT to promote effective absorption into the bloodstream.

NexACT Technology

NexACT® is an exclusive water-soluble small molecule permeation enhancer that transiently modifies lipid bilayers and loosens intercellular tight junctions, thereby enabling swift systemic uptake of active pharmaceutical ingredients. This technology underpins both Vitaros and RayVa formulations and also improves drug solubility and permeability.

Leadership

Richard Pascoe – Chief Executive Officer Mr. Pascoe assumed leadership at Apricus in March 2013 following the merger of Somaxon Pharmaceuticals with Pernix. Having served as Somaxon's CEO since 2008, he guided the FDA approval process for Silenor®. His prior executive experience includes roles as Senior Vice President and COO at ARIAD Pharmaceuticals, along with senior positions at King Pharmaceuticals, Medco Research, COR Therapeutics, B. Braun Interventional, and The BOC Group. He holds board memberships at KemPharm, Cohera Medical, and the Corporate Directors Forum. Mr. Pascoe is an alumnus of West Point with a B.S. degree in Leadership and formerly served as a commissioned officer in the U.S. Army.

Brian Dorsey – Senior Vice President & Chief Development Officer With over two decades of expertise in pharmaceutical and biotechnology sectors, Mr. Dorsey has overseen drug development programs, regulatory affairs, quality control, and quality assurance from early-stage research through successful FDA approvals. His previous roles include Senior Vice President Pharmaceutical Development at Pernix Therapeutics and leadership positions at Somaxon Pharmaceuticals, Baxter Bioscience, and Pfizer Global Research & Development. He earned an M.S. in Executive Leadership and a B.A. in Chemistry from the University of San Diego.

Barbara Troupin, MD, MBA – Senior Vice President & Chief Medical Officer Dr. Troupin brings substantial senior management experience within Medical Affairs and Clinical Development from her tenure at VIVUS, Inc., where she directed the Phase 3 clinical program for Qsymia and served as lead medical reviewer during its New Drug Application submission and FDA Advisory Committee presentation. Her background also includes Medical Director roles at Profil Institute for Clinical Research and Radiant Research. She holds an M.D. from the University of Pennsylvania School of Medicine and an M.B.A. from the Wharton School of Business.