Apricus Biosciences

Apricus Biosciences
Type Public
Traded as NASDAQAPRI
Industry Biopharmaceutical
Founded 1987
Headquarters San Diego, California, United States
Key people Bassam Damaj, Ph.D
(President, CEO, & Chairman of Board of Directors)
Edward Cox
(VP of Corporate Development & Investor Relations)
Steve Martin
(Senior Vice President & Chief Financial Officer)
Randy Berholtz
(Executive Vice President & General Counsel & Secretary)
Products DDAIP, Vitaros, Femprox, MycoVa, PrevOnco, RayVa, Nupen, PsoriaVa
Revenue US$ 5 million (2010)
Employees 35 (2011)
Website www.apricusbio.com

Apricus Biosciences (NASDAQAPRI) is a San Diego based pharmaceutical company which develops products utilizing a permeation enhancer, the NexACT drug delivery technology (DDAIP) to enable multi-route administration of compounds across numerous therapeutic classes.

Apricus Biosciences' first product, Vitaros, was approved in Canada for the treatment of erectile dysfunction[1] and is expected to be available on the Canadian market by the second half of 2011. Other compounds in development from pre-clinical through phase III include: sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes and cosmeceuticals.[2]

Contents

History

On September 10, 2010 NexMed, Inc formally changed its name to Apricus Biosciences, Inc. and symbol (NASDAQAPRI). The company had been operating in the pharmaceutical industry since 1995 under the name NexMed, Inc NASDAQ:NEXM. On November 15, 2010 Apricus Bio received Canadian approval for its topical ED treatment Vitaros, the first drug approval in the company's history. On December 22, 2010 Apricus Bio announced it had signed its first partnership, since becoming Apricus Biosciences, with Bracco SpA licensing Vitaros for the Italian Market.[2]

Location

Apricus Biosciences is headquartered in San Diego, CA. The company has approximately 35 employees.

Permeation Enhancer

DDAIP is a proprietary water-soluble small molecule permeation enhancer which temporarily changes the permeation dynamics of the lipid bi-layer and transiently loosens the tight junctions between the cells so that active drug molecules can be rapidly absorbed into systemic circulation. It can also improve the solubility of compounds resulting in enhanced drug permeation.[3]

Products

Vitaros Vitaros an approved topical cream for the treatment of erectile dysfunction. It contains Prostaglandin E1 as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream. Two Phase III studies have been completed for Vitaros, and approval has been granted in Canada. Apricus Biosciences is currently seeking regulatory approval in Europe, Asia,[4] South America, the Middle East,[5][6] and other territories.[7] Apricus Biosciences sold the rights for Vitaros in the US to Warner Chilcott.[8][2]

Femprox Femprox is a topical cream for the treatment of female sexual arousal disorder"Apricus Biosciences Announces Formation Of Clinical Advisory Board As Part Of Its Plans To Further The Clinical Development Of Femprox(R)". The Street. http://www.thestreet.com/story/11045421/1/apricus-biosciences-announces-formation-of-clinical-advisory-board-as-part-of-its-plans-to-further-the-clinical-development-of-femproxr.html. Retrieved 7 April 2011. </ref> It contains Prostaglandin E1 as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2][9]

MycoVa MycoVa is a medicinal nail lacquer for the treatment of onychomycosis. It contains terbinafine as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the nail bed where the fungus resides.[2]

PrevOnco PrevOnco is lansoprazole and DDAIP in combination with doxorubicin for the treatment of hepatocellular carcinoma.[10] It is currently in negotiations for a FDA Special Protocol Assessment Phase III trial.[2][11]

RayVa RayVa is a topical cream for the treatment of Raynaud's phenomenon. It contains Prostaglandin E1 as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Nupen is a topical G-CSF cream for Post-chemotherapy Recovery of Neutrophil Counts entering human Phase I clinical trials. It contains Filgrastim as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

PsoriaVa PsoriaVa is a topical cream for the treatment of Psoriasis. It contains Calcipotriol and Betamethasone as the active ingredients and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Drug Candidates

5-FU Apricus Biosciences Drug Candidate: 5-FU is a topical cream for actinic (solar) keratoses. It contains Fluorouracil or 5-FU as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Rituximab Apricus Biosciences Drug Candidate: Rituximab is a Subcutaneous and topical treatment for non-Hodgkin lymphoma. It contains Rituximab as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Paclitaxel Apricus Biosciences Drug Candidate: Paclitaxel is a topical cream for Squamous-cell carcinoma. It contains Paclitaxel as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Insulin Apricus Biosciences Drug Candidate: Insulin is a Subcutaneous Subcutaneous long-acting treatment for diabetes. It contains insulin as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Lidocaine Apricus Biosciences Drug Candidate: Lidocaine is a topical cream for localized pain . It contains lidocaine as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Collagen Apricus Biosciences Drug Candidate: Collagen is a topical cream for cosmeceutical use. It contains collagen as the active ingredient and a permeation enhancer DDAIP which facilitates the delivery of the drug into the blood stream.[2]

Leadership

Bassam Damaj, Ph.D. - Dr. Damaj was appointed to serve as President and Chief Executive Officer and as a member of the Board in December 2009 and was elected as Chairman of the Board in October 2010. Dr. Damaj is the co-founder and former Chief Scientific Officer of Bio-Quant, and served in that capacity since its inception in 1999. Prior to Bio-Quant, Dr. Damaj served as President & Chief Executive Officer of BioSignature Diagnostics, Inc. He also served as the Group Leader for the Office of New Target Intelligence and a Group Leader for immunological and inflammatory disease programs at Tanabe Research Laboratories, U.S.A., Inc. Previous appointments included Pharmacopeia Inc., a New Jersey based company where Dr. Damaj served as a senior scientist and a member of the senior staff board of the drug discovery department. He was also a visiting scientist at Genentech, Inc., Pfizer Inc. and the NIH (NIAID). Dr. Damaj is the founder of Celltek Biotechnology, Mina Holdings, BioSignature Diagnostics and R&D Healthcare Inc. He holds numerous patents in this field and authored numerous peer reviewed scientific publications, and is the author of the Immunological Reagents and Solutions reference book. Dr. Damaj served on several scientific advisory boards of biopharmaceuticals including Celltek, Virocell and Microislet, Inc. He is the holder of the U.S. Congress Award for the development of the first Anthrax Diagnostic Blood Test for the United States in 2003. He also represented the State of California on the Congressional Scientific Liaison Committee in 2002. Dr. Damaj holds a Ph.D. in Immunology/Microbiology, a postdoctoral fellowship in Molecular Oncology and an MBA in Healthcare. He has been involved with over seven drug candidates currently in clinical trials for a variety of diseases.

Steve Martin - Mr. Martin is a certified public accountant, currently working as the Chief Financial Officer for Apricus Biosciences. Since 2008, Mr. Martin served as Senior Vice President and Chief Financial Officer of BakBone Software, a publicly-traded software company. Mr. Martin also served as Interim CEO over the final 10 months with BakBone and through the successful sale of the company that was completed in January 2011. From 2005 to 2007, Mr. Martin served as Chief Financial Officer of Stratagene Corporation, a publicly-traded company specializing in the development, manufacture, and marketing of specialized research and clinical diagnostic products. Mr. Martin's experience also includes the position of Controller with publicly-traded Gen-Probe Incorporated, a life sciences company, as well as 10 years with the public accounting firm of Deloitte & Touche.

Mr. Martin holds a B.S. in Accounting from San Diego State University. He is also the former President and a member of the Board of Directors of the Financial Executives International San Diego Chapter.

Edward Cox - Mr. Cox was named Vice President Corporate Development & Investor Relations in December 2009, having previously served as President and a member of the Board of Directors of Bio-Quant since January 2007. He has broad experience in finance and strategic business planning for pre-IPO companies. Mr. Cox has served as an Officer and/or Director of several early-stage companies and was a Business Strategist for companies in the areas of Healthcare, Life Science, Technology and Resources. Mr. Cox holds a Masters of Science in Business from the University of Florida.

Randy Berholtz - Randy Berholtz was named the Executive Vice President, General Counsel and Secretary in May 2011. From 2004 to 2010, he was the Vice President, General Counsel and Secretary of ACON Laboratories, Inc., a diagnostics company based in San Diego and Hangzhou, China. He was the Chief Operating Officer and General Counsel of Inglewood Ventures, LP, a life sciences venture capital firm form 2003 to 2004. Mr. Berholtz was the Acting General Counsel and Secretary and earlier the Senior Corporate Counsel of Nanogen, Inc., a Nasdaq-listed genomics company from 2000 to 2003. He was an attorney with the law firms of Heller Ehrman, LLP and Cooley Godward, LLP in San Diego, with Cravath, Swaine and Moore in New York City and Kirkpatrick & Lockhart (now K&L Gates) in Pittsburgh, Pennsylvania. Mr. Berholtz holds a bachelor's degree from Cornell University, a master's degree from Oxford University where he was a Rhodes Scholar and a law degree from the Yale Law School.

References

  1. ^ Bujdos, Brian. "New Topical Erectile Dysfunction Drug Vitaros Approved in Canada; Approved Topical Drug Testim Proves Helpful for Erectile Dysfunction". http://www.accessrx.com/blog/current-health-news/vitaros-testim-topical-drugs-treat-erectile-dysfunction-a1115. Retrieved 7 April 2011. 
  2. ^ a b c d e f g h i j k l m n o "Apricus SEC Report". SEC. http://www.sec.gov/Archives/edgar/data/1017491/000114420411014080/v214147_10k.htm. Retrieved 6 April 2011. 
  3. ^ "NexACT Trasdermal Drug Delivery Technology". NexACT Trasdermal Drug Delivery Technology. http://www.apricusbio.com/tech6.html. Retrieved 6 April 2011. 
  4. ^ "Apricus Bio Announces Expansion Of Patent Portfolio For Topical Cream To Treat Premature Ejaculation With Issuance Of Japanese Patent". Traders Huddle. 14 January 2011. http://www.tradershuddle.com/20110114148012/globenewswire/Apricus-Bio-Announces-Expansion-of-Patent-Portfolio-for-Topical-Cream-to-Treat-Premature-Ejaculation-With-Issuance-of-Japanese-Patent.html. Retrieved 7 April 2011. 
  5. ^ Chapman, Kim (10 January 2011). "Apricus Biosciences and Elis Pharma Sign License Agreement for VitarosĀ® in the Gulf and Part of the Middle East". http://www.iewy.com/13599-apricus-biosciences-and-elis-pharma-sign-license-agreement-for-vitaros%C2%AE-in-the-gulf-and-part-of-the-middle-east.html. Retrieved 7 April 2011. 
  6. ^ "Apricus Biosciences And Neopharm Group Sign Licensing Agreement For Vitaros(R) In Israel For Up To $4.35 Million, Plus Royalties". The Street. 14 February 2011. http://www.thestreet.com/story/11007437/1/apricus-biosciences-and-neopharm-group-sign-licensing-agreement-for-vitarosr-in-israel-for-up-to-435-million-plus-royalties.html. Retrieved 7 April 2011. 
  7. ^ "Apricus Biosciences Expands Patent Coverage In Mexico For Its Erectile Dysfunction Drug, Vitaros". Trader's Huddle. 31 March 2011. http://www.tradershuddle.com/20110331194294/globenewswire/Apricus-Biosciences-Expands-Patent-Coverage-in-Mexico-for-Its-Erectile-Dysfunction-Drug-VitarosR.html. Retrieved 7 April 2011. 
  8. ^ "Apricus Biosciences' Chief Executive Officer is Interviewed on CDTV.net". 26 January 2011. http://seekingalpha.com/news-article/474326-apricus-biosciences-chief-executive-officer-is-interviewed-on-cdtv-net. Retrieved 7 April 2011. 
  9. ^ "Apricus Biosciences Inc Announces Patent Grant For Femprox In Japan". Reuters. 3 October 2010. http://www.reuters.com/finance/stocks/keyDevelopments?rpc=66&symbol=APRI.O&timestamp=20100428224700. Retrieved 7 April 2011. 
  10. ^ "Apricus Biosciences Announces Poster Presentations On Progress Of PrevOnco(TM) In Combination With NexACT(R) Technology At The American Association For Cancer Research 2011 Annual Meeting". The Street. 22 March 2011. http://www.thestreet.com/story/11054774/1/apricus-biosciences-announces-poster-presentations-on-progress-of-prevoncotm-in-combination-with-nexactr-technology-at-the-american-association-for-cancer-research-2011-annual-meeting.html. Retrieved 7 April 2011. 
  11. ^ "Apricus Biosciences And FDA Initiate PrevOnco(TM) SPA Phase III Clinical Protocol Discussion". The Street. 17 February 2011. http://www.thestreet.com/story/11013949/1/apricus-biosciences-and-fda-initiate-prevoncotm-spa-phase-iii-clinical-protocol-discussion.html. Retrieved 7 April 2011.