Apricus Biosciences
Encyclopedia
Apricus Biosciences is a San Diego based pharmaceutical company which develops products utilizing a permeation enhancer, the NexACT drug delivery technology (DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

) 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
Erectile dysfunction
Erectile dysfunction is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance....

  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
Sexual dysfunction
Sexual dysfunction or sexual malfunction refers to a difficulty experienced by an individual or a couple during any stage of a normal sexual activity, including desire, arousal or orgasm....

, oncology
Oncology
Oncology is a branch of medicine that deals with cancer...

, dermatology
Dermatology
Dermatology is the branch of medicine dealing with the skin and its diseases, a unique specialty with both medical and surgical aspects. A dermatologist takes care of diseases, in the widest sense, and some cosmetic problems of the skin, scalp, hair, and nails....

, autoimmune, pain
Pain
Pain is an unpleasant sensation often caused by intense or damaging stimuli such as stubbing a toe, burning a finger, putting iodine on a cut, and bumping the "funny bone."...

, anti-infectives, diabetes and cosmeceuticals.

History

On September 10, 2010 NexMed, Inc formally changed its name to Apricus Biosciences, Inc. and symbol . 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.

Location

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

Permeation Enhancer

DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

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.

Products

Vitaros
Vitaros an approved topical cream for the treatment of erectile dysfunction
Erectile dysfunction
Erectile dysfunction is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance....

. It contains Prostaglandin E1
Prostaglandin E1
Prostaglandin E1 , known pharmaceutically as alprostadil, is a prostaglandin. It is a drug used in the treatment of erectile dysfunction and has vasodilatory properties.-Sexual dysfunction:...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 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 , South America, the Middle East , and other territories . Apricus Biosciences sold the rights for Vitaros in the US to Warner Chilcott .

Femprox
Femprox is a topical cream for the treatment of female sexual arousal disorder
Female sexual arousal disorder
Female sexual arousal disorder , commonly referred to as frigidity, is a disorder characterized by a persistent or recurrent inability to attain sexual arousal or to maintain arousal until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling...

. It contains Prostaglandin E1
Prostaglandin E1
Prostaglandin E1 , known pharmaceutically as alprostadil, is a prostaglandin. It is a drug used in the treatment of erectile dysfunction and has vasodilatory properties.-Sexual dysfunction:...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

MycoVa
MycoVa is a medicinal nail lacquer for the treatment of onychomycosis
Onychomycosis
Onychomycosis means fungal infection of the nail. It is the most common disease of the nails and constitutes about a half of all nail abnormalities....

. It contains terbinafine
Terbinafine
Terbinafine hydrochloride is a...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the nail bed where the fungus resides.

PrevOnco
PrevOnco is lansoprazole
Lansoprazole
Lansoprazole is a proton-pump inhibitor which prevents the stomach from producing gastric acid. It is manufactured by a number of companies worldwide under several brand names . It was first approved by the U.S...

 and DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 in combination with doxorubicin
Doxorubicin
Doxorubicin INN is a drug used in cancer chemotherapy. It is an anthracycline antibiotic, closely related to the natural product daunomycin, and like all anthracyclines, it works by intercalating DNA....

  for the treatment of hepatocellular carcinoma
Hepatocellular carcinoma
Hepatocellular carcinoma is the most common type of liver cancer. Most cases of HCC are secondary to either a viral hepatitide infection or cirrhosis .Compared to other cancers, HCC is quite a rare tumor in the United States...

 . It is currently in negotiations for a FDA Special Protocol Assessment
FDA Special Protocol Assessment
A Special Protocol Assessment is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval....

 Phase III trial.

RayVa
RayVa is a topical cream for the treatment of Raynaud's phenomenon
Raynaud's phenomenon
In medicine, Raynaud's phenomenon is a vasospastic disorder causing discoloration of the fingers, toes, and occasionally other areas. This condition can also cause nails to become brittle with longitudinal ridges. Named for French physician Maurice Raynaud , the phenomenon is believed to be the...

. It contains Prostaglandin E1
Prostaglandin E1
Prostaglandin E1 , known pharmaceutically as alprostadil, is a prostaglandin. It is a drug used in the treatment of erectile dysfunction and has vasodilatory properties.-Sexual dysfunction:...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

Nupen is a topical G-CSF cream for Post-chemotherapy Recovery of Neutrophil Counts entering human Phase I clinical trials. It contains Filgrastim
Filgrastim
Filgrastim is a granulocyte colony-stimulating factor analog used to stimulate the proliferation and differentiation of granulocytes. It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. ...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

PsoriaVa
PsoriaVa is a topical cream for the treatment of Psoriasis
Psoriasis
Psoriasis is an autoimmune disease that appears on the skin. It occurs when the immune system mistakes the skin cells as a pathogen, and sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is not contagious. However, psoriasis has been linked to an increased risk of...

. It contains Calcipotriol
Calcipotriol
Calcipotriol or calcipotriene is a synthetic derivative of calcitriol or vitamin D. It is used in the treatment of psoriasis, marketed under the trade name Dovonex or Daivonex.-Mechanism:...

 and Betamethasone
Betamethasone
Betamethasone is a potent glucocorticoid steroid with anti-inflammatory and immunosuppressive properties. Unlike other drugs with these effects, betamethasone does not cause water retention. It is applied as a topical cream, ointment, foam, lotion or gel to treat itching...

 as the active ingredients and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

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
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

Rituximab
Rituximab
Rituximab, sold under the trade names Rituxan and MabThera, is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of B cells...


Apricus Biosciences Drug Candidate: Rituximab is a Subcutaneous
Subcutaneous injection
A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, collectively referred to as the...

 and topical treatment for non-Hodgkin lymphoma
Non-Hodgkin lymphoma
The non-Hodgkin lymphomas are a diverse group of blood cancers that include any kind of lymphoma except Hodgkin's lymphomas. Types of NHL vary significantly in their severity, from indolent to very aggressive....

. It contains Rituximab
Rituximab
Rituximab, sold under the trade names Rituxan and MabThera, is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of B cells...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

Paclitaxel
Paclitaxel
Paclitaxel is a mitotic inhibitor used in cancer chemotherapy. It was discovered in a U.S. National Cancer Institute program at the Research Triangle Institute in 1967 when Monroe E. Wall and Mansukh C. Wani isolated it from the bark of the Pacific yew tree, Taxus brevifolia and named it taxol...


Apricus Biosciences Drug Candidate: Paclitaxel is a topical cream for Squamous-cell carcinoma. It contains Paclitaxel
Paclitaxel
Paclitaxel is a mitotic inhibitor used in cancer chemotherapy. It was discovered in a U.S. National Cancer Institute program at the Research Triangle Institute in 1967 when Monroe E. Wall and Mansukh C. Wani isolated it from the bark of the Pacific yew tree, Taxus brevifolia and named it taxol...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

Insulin
Insulin
Insulin is a hormone central to regulating carbohydrate and fat metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle....


Apricus Biosciences Drug Candidate: Insulin is a Subcutaneous Subcutaneous
Subcutaneous injection
A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, collectively referred to as the...

 long-acting treatment for diabetes. It contains insulin
Insulin
Insulin is a hormone central to regulating carbohydrate and fat metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle....

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

Lidocaine
Lidocaine
Lidocaine , Xylocaine, or lignocaine is a common local anesthetic and antiarrhythmic drug. Lidocaine is used topically to relieve itching, burning and pain from skin inflammations, injected as a dental anesthetic or as a local anesthetic for minor surgery.- History :Lidocaine, the first amino...


Apricus Biosciences Drug Candidate: Lidocaine is a topical cream for localized pain . It contains lidocaine
Lidocaine
Lidocaine , Xylocaine, or lignocaine is a common local anesthetic and antiarrhythmic drug. Lidocaine is used topically to relieve itching, burning and pain from skin inflammations, injected as a dental anesthetic or as a local anesthetic for minor surgery.- History :Lidocaine, the first amino...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

 which facilitates the delivery of the drug into the blood stream.

Collagen
Collagen
Collagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...


Apricus Biosciences Drug Candidate: Collagen is a topical cream for cosmeceutical use. It contains collagen
Collagen
Collagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...

 as the active ingredient and a permeation enhancer DDAIP
DDAIP
DDAIP is a pharmaceutical ingredient added to topical products to increase penetration through the skin. Chemically, DDAIP is an ester of N,N-dimethylalanine and dodecanol. DDAIP is typically formulated as its hydrochloride salt...

which facilitates the delivery of the drug into the blood stream.

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 of 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.
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