Apricus Biosciences

Last updated
Apricus Biosciences, Inc.
TypePublic
Nasdaq:  APRI
Industry Biopharmaceutical
Founded1987
Headquarters San Diego, California, United States
Key people
Richard Pascoe
(CEO)
Brian Dorsey
(iSVP & Chief Development Officer) Barbara Troupin, MD, MBA (SVP & Chief Medical Officer)
ProductsVitaros, Fispemifene, RayVa, Femprox
RevenueUS$ 7.4 million (First Nine Months 2014)
Number of employees
120 (2012)
Website

Apricus Biosciences, Inc. is a San Diego based biopharmaceutical company advancing innovative medicines in urology and rheumatology.

Contents

Apricus Biosciences' first product, Vitaros®, has been approved in Europe and Canada for the treatment of erectile dysfunction [1] Other compounds in development include: low testosterone, rheumatology, sexual dysfunction, pain, [2]

History

Until September 10, 2010, when it formally changed its name, Apricus Biosciences, Inc. (Nasdaq :  APRI) 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 and it announced European approval on June 10, 2013. [3]

In February 2018, the Food and Drug Administration issued its second denial of permission to sell Vitaros in the United States. [4]

Location

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

Products

Vitaros ® - is a rapid-onset (generally 5–15 minutes) topical cream for the treatment of erectile dysfunction. It contains Prostaglandin E1 as the active ingredient and the Company's proprietary permeation enhancer (NexACT®) which facilitates the delivery of the drug into the blood stream. The current formulation of Vitaros requires refrigeration and is delivered via a small individual dispenser. Vitaros has been approved for patient use in Canada and Europe and to date (January 24, 2015) has been launched by marketing partners in the United Kingdom (Takeda), Germany (Sandoz), Sweden (Sandoz) and Belgium (Sandoz). Six additional European territories are expected to launch Vitaros during 2015.

Apricus has developed a room temperature formulation of Vitaros which is housed and delivered in a small, custom developed, disposable dispenser or "room temperature device" (RTD). Initial production of Vitaros RTD has commenced in order to generate the required stability data required for marketing approval. The Company continues to expect its commercial partners to launch the Vitaros RTD in 2016. [5]

In November 2007 Apricus Biosciences sold the rights for the refrigerated formulation of Vitaros in the US to Warner Chilcott. [6]

Fispemifene is a new chemical entity initially being pursued for the treatment of low testosterone (secondary hypogonadism) in males. Apricus plans to begin a Phase 2b clinical trial with fispemifene in this indication in the first half of 2015, with top-line data expected to be reported by the end of 2015. Apricus in-licensed the U.S. rights to fispemifene from Forendo Pharma in Q4 2014. Since then, it has transferred the regulatory filings from Forendo, developed a Phase 2b clinical trial protocol, held a scientific advisory board meeting with experts in the field to refine its development strategy, initiated the manufacturing process for the drug, and begun the clinical trial site selection process.

RayVa ™ is a topical cream for the treatment of Raynaud's phenomenon, a circulatory disorder affecting the hands and feet. Patient enrollment commenced in December 2014 for a 45-patient Phase 2a clinical trial for RayVa which is expected to be completed and results announced in the second quarter in 2015. RayVa has the potential to be the only FDA approved treatment for this debilitating condition. RayVA contains Prostaglandin E1 as the active ingredient and Apricus' permeation enhancer (NexACT) which facilitates the delivery of the drug into the blood stream.

Femprox ® is a topical cream for the treatment of female sexual interest / arousal disorder. It contains Prostaglandin E1 as the active ingredient and a permeation enhancer (NexACT) which facilitates the delivery of the drug into the blood stream. [2] [7]

NexACT Technology

NexACT® 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. The NexACT technology is used in both Vitaros and RayVA. It can also improve the solubility of compounds resulting in enhanced drug permeation. [8]

Leadership

Richard Pascoe - CEO Mr. Pascoe joined Apricus in March 2013 following the merger of Somaxon Pharmaceuticals with Pernix. At Somaxon Mr. Pascoe was the Chief Executive Officer since August 2008 and was responsible for the FDA approval of Somaxon’s lead drug Silenor®. Prior to Somaxon, Mr. Pascoe was with ARIAD Pharmaceuticals, Inc., a specialty pharmaceutical company where he was most recently Senior Vice President and Chief Operating Officer.

Prior to joining ARIAD in 2005, Mr. Pascoe held a series of senior management roles at King Pharmaceuticals, Inc., a specialty pharmaceutical company, including senior vice president positions in both marketing and sales, as well as vice president positions in both international sales and marketing and hospital sales. Prior to King, Mr. Pascoe was in the commercial groups at Medco Research, Inc. (which was acquired by King), COR Therapeutics, Inc., B. Braun Interventional and The BOC Group. Mr. Pascoe is a member of the board of directors of KemPharm, Inc., Cohera Medical, Inc., and the Corporate Directors Forum (CDF).

Mr. Pascoe served as a Commissioned Officer with the U.S. Army 24th Infantry Division, following his graduation from the United States Military Academy at West Point where he received a B.S degree in Leadership.

Brian Dorsey - SVP, Chief Development Officer Mr. Dorsey has served in the Pharmaceutical and Biotechnology industries for over 20 years where he has provided high-level drug development, regulatory and QC/QA leadership of pharmaceutical candidates from early development to FDA approval. He has held various senior management roles with pharmaceutical companies, most recently at Pernix Therapeutics as Senior Vice President Pharmaceutical Development. Prior to this, Mr. Dorsey held managerial positions of increasing responsibility at Somaxon Pharmaceuticals, Baxter Bioscience and Pfizer Global Research and Development.

Mr. Dorsey received his Master of Science in Executive Leadership and his B.A. in Chemistry from the University of San Diego. [9]

Barbara Troupin, MD, MBA - SVP, Chief Medical Officer Dr. Troupin has held various senior management roles with VIVUS, Inc. in the areas of Medical Affairs and Clinical Development since 2006. In these roles, Dr. Troupin was the clinician lead for the Phase 3 program for Qsymia, as well as the lead contributor for all medical review of the Qsymia New Drug Application and was the lead medical presenter at the successful Qsymia FDA Advisory Committee Meeting. Prior to this, Dr. Troupin held Medical Director positions at the Profil Institute for Clinical Research and Radiant Research, both contract research organizations.

Dr. Troupin received her M.D. from the University of Pennsylvania School of Medicine and her M.B.A. from the Wharton School of Business. [10]

Related Research Articles

Erectile dysfunction (ED), also called impotence, is the type of sexual dysfunction in which the penis fails to become or stay erect during sexual activity. It is the most common sexual problem in men. Through its connection to self-image and to problems in sexual relationships, erectile dysfunction can cause psychological harm.

<span class="mw-page-title-main">Sildenafil</span> Medical drug for erectile dysfunction and pulmonary hypertension

Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is unclear if it is effective for treating sexual dysfunction in women. It is taken by mouth or by injection into a vein. Onset is typically within twenty minutes and lasts for about two hours.

<span class="mw-page-title-main">Tadalafil</span> Medication used to treat erectile dysfunction

Tadalafil, sold under the brand name Cialis among others, is a medication used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. It is taken by mouth. Onset is typically within half an hour and the duration is up to 36 hours. The effect of Tadalafil is relaxing the blood vessels muscles and increasing the blood flow into the corpus cavernosum.

<span class="mw-page-title-main">Transdermal patch</span> Adhesive patch used to deliver medication through the skin

A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. An advantage of a transdermal drug delivery route over other types of medication delivery is that the patch provides a controlled release of the medication into the patient, usually through either a porous membrane covering a reservoir of medication or through body heat melting thin layers of medication embedded in the adhesive. The main disadvantage to transdermal delivery systems stems from the fact that the skin is a very effective barrier; as a result, only medications whose molecules are small enough to penetrate the skin can be delivered by this method. The first commercially available prescription patch was approved by the U.S. Food and Drug Administration in December 1979. These patches administered scopolamine for motion sickness.

<span class="mw-page-title-main">Bremelanotide</span> Chemical compound

Bremelanotide, sold under the brand name Vyleesi, is a medication used to treat low sexual desire in women. Specifically it is used for low sexual desire which occurs before menopause and is not due to medical problems, psychiatric problems, or problems within the relationship. It is given by an injection just under the skin of the thigh or abdomen.

cGMP-specific phosphodiesterase type 5 Mammalian protein found in Homo sapiens

Cyclic guanosine monophosphate-specific phosphodiesterase type 5 is an enzyme from the phosphodiesterase class. It is found in various tissues, most prominently the corpus cavernosum and the retina. It has also been recently discovered to play a vital role in the cardiovascular system.

<span class="mw-page-title-main">Desonide</span> Chemical compound

Desonide (INN) is a low-potency topical corticosteroid anti-inflammatory that has been available since the 1970s. It is primarily used to treat atopic dermatitis (eczema), seborrheic dermatitis, contact dermatitis and psoriasis in both adults and children. It has a fairly good safety profile and is available as a cream, ointment, lotion, and as a foam under the tradename Verdeso Foam. Other trade names for creams, lotions, and ointments include Tridesilon, DesOwen, Desonate. It is a group VI corticosteroid under US classification, the second least potent group.

<span class="mw-page-title-main">Clindamycin/benzoyl peroxide</span> Type of medication

Clindamycin/benzoyl peroxide is a topical gel used for the treatment of acne. It is a fixed-dose combination of clindamycin, as the phosphate, an antibiotic, and benzoyl peroxide, an antiseptic.

Prostaglandin E<sub>1</sub> Erectile dysfunction medication

Prostaglandin E1 (PGE1), also known as alprostadil, is a naturally occurring prostaglandin which is used as a medication. In infants with congenital heart defects, it is delivered by slow injection into a vein to open the ductus arteriosus until surgery can be carried out. By injection into the penis or placement in the urethra, it is used to treat erectile dysfunction.

<span class="mw-page-title-main">Amcinonide</span> Chemical compound

Amcinonide is a topical glucocorticoid used to treat itching, redness and swelling associated with several dermatologic conditions such as atopic dermatitis and allergic contact dermatitis. Amcinonide can also be classified as a multi-functional small molecule corticosteroid, which has been approved by the FDA and is currently marketed as an ointment, lotion, or cream. It acts as both a transcription factor for responses to glucocorticoids and modulator for other transcription factors while also regulating phospholipase A2 activity.

<span class="mw-page-title-main">Avanafil</span> Chemical compound

Avanafil is a PDE5 inhibitor approved for erectile dysfunction by the FDA on April 27, 2012 and by EMA on June 21, 2013. Avanafil is sold under the brand names Stendra and Spedra. It was invented at Mitsubishi Tanabe Pharma, formerly known as Tanabe Seiyaku Co., and licensed to Vivus Inc., which partnered with Menarini Group to commercialise Spedra in over forty European countries, Australia, and New Zealand. Metuchen Pharmaceuticals obtained exclusive rights within the United States.

<span class="mw-page-title-main">Herbal viagra</span> A class of herbal products said to treat erectile dysfunction

Herbal viagra is a herbal product advertised as treating erectile dysfunction. Many different products are advertised as herbal viagra, but with varying ingredients. No clinical trials or scientific studies support the effectiveness of any of these ingredients for the treatment of erectile dysfunction and some products have been found to contain drugs and other adulterants, and have been the subject of FDA and FTC warnings and actions to remove them from the market.

<span class="mw-page-title-main">Naftifine</span> Chemical compound

Naftifine hydrochloride is an allylamine antifungal drug for the topical treatment of tinea pedis, tinea cruris, and tinea corporis.

Trimix is a prescription combination drug containing alprostadil, papaverine, and phentolamine. It is used to treat erectile dysfunction.

<span class="mw-page-title-main">Phentermine/topiramate</span> Obesity medication

Phentermine/topiramate, sold under the brand name Qsymia, is a combination drug of phentermine and topiramate used to treat obesity. It is used together with dietary changes and exercise. If less than 3% weight loss is seen after 3 months it is recommended the medication be stopped. The weight loss is modest. Effects on heart related health problems or death is unclear.

Vivus is a small pharmaceutical company headquartered in Campbell, California, working in obesity, sleep, and sexual health. Vivus is developing an erectile dysfunction drug, Avanafil, that has completed Phase 3 clinical trials. The drug has been approved for use by the FDA, and will be sold under the trademark name Stendra. Stendra is the first and only oral ED treatment approved to be taken approximately 15 minutes before sexual activity.

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, although as of now the structural formula shows an ester with decanol (C10) instead. DDAIP is typically formulated as its hydrochloride salt (DDAIP.HCl). This salt is a white crystalline solid with a melting range of 88-93 °C and is an amphiphilic molecule with a pKa of 4.87 that is soluble in water up to about 40% w/v. DDAIP is proprietary to NexMed USA, a subsidiary of Apricus Biosciences.

<span class="mw-page-title-main">Efinaconazole</span> Chemical compound

Efinaconazole, sold under the brand name Jublia among others, is a triazole antifungal medication. It is approved for use in the United States, Canada, and Japan as a 10% topical solution for the treatment of onychomycosis. Efinaconazole acts as a 14α-demethylase inhibitor.

<span class="mw-page-title-main">Tavaborole</span> Chemical compound

Tavaborole, sold under the brand name Kerydin, is a topical antifungal medication for the treatment of onychomycosis, a fungal infection of the nail and nail bed with a complete clearance rate of 6-7% and partial clearance rate of 23-24% in individuals whose “infection border does not reach the cuticle at the base of the large toenail.” Tavaborole was approved by the US FDA in July 2014. The medication inhibits an essential fungal enzyme, leucyl-tRNA synthetase, that is required for protein synthesis. The inhibition of protein synthesis leads to termination of cell growth and then cell death, eliminating the fungal infection.

<span class="mw-page-title-main">Lifitegrast</span>

Lifitegrast, sold under the brand name Xiidra, is a medication for the treatment of signs and symptoms of dry eye, a syndrome called keratoconjunctivitis sicca. Lifitegrast reduces inflammation by inhibiting inflammatory cell binding. It is often used in conjunction with ciclosporin for dry eye treatment including meibomian gland dysfunction and inflammatory dry eye.

References

  1. Bujdos, Brian. "New Topical Erectile Dysfunction Drug Vitaros Approved in Canada; Approved Topical Drug Testim Proves Helpful for Erectile Dysfunction". Archived from the original on 13 May 2011. Retrieved 7 April 2011.
  2. 1 2 "Apricus SEC Report". SEC. Retrieved 6 April 2011.
  3. Release, Press (June 10, 2013). "Apricus Biosciences Receives European Approval for Vitaros(R) for the Treatment of Erectile Dysfunction". Apricus Biosciences - Globenews. Retrieved 24 January 2015.
  4. Taylor, Phil (2018-02-16). "Apricus craters as FDA rejects erectile dysfunction cream again". Fierce Biotech. Retrieved 2022-06-08.
  5. Release, Press (2014-12-22). "Apricus Biosciences Announces Year-End 2014 Update and 2015 Plans to Advance Its Clinical Pipeline and Further Commercialize Its Erectile Dysfunction Drug Vitaros(R)". Apricus Biosciences / Globenewswire. Globenewswire. Retrieved 24 January 2015.
  6. "Form 10-Q Disclosure". www.sec.gov. SEC. Retrieved 24 January 2015.
  7. "Apricus Biosciences Inc Announces Patent Grant For Femprox In Japan". Reuters. 3 October 2010. Archived from the original on 8 September 2012. Retrieved 7 April 2011.
  8. "NexACT Transdermal Drug Delivery Technology". NexACT Transdermal Drug Delivery Technology. Archived from the original on 25 April 2011. Retrieved 6 April 2011.
  9. Release, Press. "Apricus Biosciences Appoints Brian T. Dorsey as Chief Development Officer". www.apricusbio.com. Retrieved 24 January 2015.
  10. Release, Press. "Apricus Biosciences Appoints Barbara Troupin, M.D. as Chief Medical Officer". www.apricusbio.com. Apricus Biosciences. Retrieved 24 January 2015.