Jun 17

Apricus Biosciences Submits Response to Swissmedic for Its Vitaros(R) Market Application for Erectile Dysfunction

SAN DIEGO, June 14, 2012 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (“Apricus Bio” or “the Company”) (Nasdaq:APRI) (www.apricusbio.com) today announced that the Company has filed its response to questions received from Swissmedic, the Agency for Therapeutic Products in Switzerland, relating to its marketing application previously filed for Vitaros®, the Company’s lead product candidate for the treatment of erectile dysfunction (“ED”) in Switzerland.

The filing of the Apricus Bio response triggers a 90-day review process, after which if found acceptable, may then trigger a pre-decision by Swissmedic for the approval of Vitaros® for ED in that country. Following a subsequent approval decision and any required Company responses, Apricus Bio would then be required to supply Swissmedic with the final labeling and pricing information of Vitaros®, which could take an additional 90 days for review and acceptance before that product can be marketed in Switzerland.

“An approval in Switzerland would mark our second worldwide approval and our first European approval for Vitaros® for ED and would be an important step for us in our goal of marketing and selling this product on a worldwide basis,” said Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio. “Swissmedic is considered one of the most well-respected health regulatory agencies in the world, and their decisions influence the regulatory decisions in many other countries.”

Apricus is currently in discussions with multiple potential commercial partners for Vitaros® for ED in Switzerland.

Mar 23

NexMed signs deal for Viatros Marketing in Germany

SAN DIEGO, Feb 15, 2012 (GlobeNewswire via COMTEX) — Apricus Biosciences, Inc. (“Apricus Bio” or the “Company”) ( http://www.apricusbio.com ) announced today that its wholly-owned subsidiary NexMed(USA), Inc. has signed with Sandoz, a division of Novartis, an exclusive collaboration for Germany to market Apricus Bio’s Vitaros(R) drug for the treatment of erectile dysfunction.

Pursuant to the collaboration, Sandoz will pay Apricus Bio up to EURO21 million — divided into a fixed upfront payment and specific regulatory and commercial milestones — as well as, double digit royalties on net sales. Total upfront and milestone payments represent approximately $28 million based on today’s exchange rate.

Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio commented, “We are very excited about this major European collaboration with such an important international pharmaceutical company as Sandoz. We are happy to work again with Novartis through their division Sandoz and we look forward to expanding the reach of our Vitaros(R) product for erectile dysfunction in Germany. This is yet another important milestone in our strategy to make Vitaros(R) available worldwide and the successful continuation of the execution of our commercialization strategy of Vitaros(R).”

About Vitaros(R) and the ED Market in Europe

The ED market in Europe is presently dominated by oral PDE5 treatments. However, there is still a need for new, safe and effective treatments, especially for those patients who cannot or do not respond well to oral medication. Vitaros(R) differs from oral PDE5 drugs like Viagra(R), Cialis(R) and Levitra(R) in two ways. First, it is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically. The topical application helps to reduce side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative.

Second, Vitaros(R) operates by a different biochemical mechanism than oral ED medications, and causes erections to occur in a more localized fashion and more quickly when compared to oral treatments. Vitaros(R) contains a previously known compound, with the chemical name alprostadil. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros(R) works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED. The side effects reported were localized and transient.

Alprostadil is currently marketed as an injectable drug. Apricus Bio incorporated alprostadil with its NexACT(R) delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis. In clinical studies, Vitaros(R) worked in patients suffering from mild to severe ED, including men who did not respond to Viagra(R). Viagra(R) is a registered trademark of Pfizer, Inc.; Cialis(R) is a registered trademark of Lilly, USA; Levitra(R), is a registered trademark of Bayer A.G.; Vitaros(R) is a registered trademark in Europe held by Apricus Bio through its subsidiary NexMed International Limited, and in the U.S. held by Warner Chilcott Company.

Jan 01

Report: Medical Firm Futura Working on Erectile Dysfunction Condoms

Source: ThisIsMoney.uk

Futura makes gels and potions that work directly on the area to which they are applied.

The company has two divisions, one involved in the treatment of aches and pains and the other in sexual health. 

Futura has spent ten years researching and developing its lotions but this year should see the launch of two major products – a condom that helps maintain and even enhance erections and a spray for men suffering from occasional premature ejaculation. 

Research has shown that up to a third of men find their sexual performance is impaired when they use a condom, so many simply choose not to wear one.

Futura’s condoms should deal with this problem. 
Having developed the product, Futura has licensed it to Reckitt Benckiser, which owns Durex, the world’s biggest condom maker.

The new condoms are expected to go on sale in the next few months and Futura will receive royalty payments for each one sold. 

Futura has also signed a licensing agreement with Australian healthcare giant Ansell, which makes Mates condoms.

 

 

Nov 06

Apricus Biosciences Announces Presentation of Efficacy and Clinical Safety Data for Vitaros(R) at Upcoming Industry Conference

SAN DIEGO, Oct. 10, 2011 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (“Apricus Bio” or the “Company”) (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the submission of an abstract entitled, “Integrated Efficacy Results of Two Phase 3 Clinical Trials for Male Erectile Dysfunction using Vitaros®, a Topical Alprostadil Cream with Subgroup Analyses,” was accepted as a moderated poster (#114) at the upcoming Sexual Medicine Society of Northern America (“SMSNA”) conference taking place in Las Vegas, November 10 – 13, 2011. This is the second Apricus Bio abstract accepted by the SMSNA for presentation at this key industry conference. On October 6, 2011, Apricus Bio announced that its abstract related to the Company’s Femprox® clinical data for Female Sexual Arousal Disorder, had been accepted as a moderated poster.

Dr. Stephen Auerbach, a member of the Company’s Vitaros® Clinical Advisory Board and Medical Director, California Professional Research, Newport Beach, California, will present the poster with a short oral presentation and question and answer session on Saturday November 12, 2011 during the Medical Pharmacology session, scheduled to take place from 2:30 pm to 4:00 pm PST.

The poster presentation will discuss additional subgroup analyses on a combined dataset from two pivotal Phase 3 clinical trials in 1,732 patients suffering from erectile dysfunction (“ED”). The data further demonstrates the efficacy and safety of Vitaros® as an easy-to-administer, topical first-line treatment option for all ED patients, independent of age, body mass index (“BMI”) and risk factors, such as cardiovascular disease and diabetes.

Apricus Bio received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2010 for sales of the product in that country. In April 2011, the Company filed a marketing application in the European Union, under the Decentralized Procedure (“DCP”), for Vitaros® for the treatment of ED, with the Netherlands as its Reference Member State. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States. In July 2011, Apricus Bio filed for regulatory approval with Swissmedic, the Swiss Agency for Therapeutic Products for marketing of Vitaros® in that country.

Nov 06

Guys who can’t Fawke can still make a bang

There’s a hilarious article in The Sun:

Sexual health problems are nothing to be embarrassed about but if you go all red-faced when you speak to your GP you could try using the lingo of November 5 to get round your shyness:

My sparkler goes out too soon.

So, your erection fades prematurely. Or you can’t get one in the first place.

That’s impotence, or “erectile dysfunction” as we like to call it these days.

It may just be a temporary blip — especially if you are tired or stressed.

Or it could be a medication side-effect, or the result of overdoing the booze.

You should see your doc, though.

He’ll give you the once-over and check for other causes, such as diabetes, depression or furred-up arteries.

Then he should be able to sort out some treatment if you need it.

I can’t get my bonfire lit.

In other words, you’re just not interested in sex. Again, it’s worth getting your GP to give you a check-up.

Occasionally, lack of sex drive is a side-effect of treatment or some unsuspected illness.

And it can result from the menopause in women and, sometimes, a lack of testosterone in men. Usually, though, it’s a sign of relationship trouble. So the pair of you might need couple counselling.

 

 

Nov 06

Propecia May Increase risk of Erectile Dysfunction

Via: http://www.foxnews.com/health/2011/10/23/hair-loss-treatments-101/

 

Finasteride (Proscar/Propecia)

Finasteride is the generic name for the pill commonly marketed as Proscar or Propecia. Finasteride has been available since the late ’90s as a treatment for male pattern baldness. Finasteride works by inhibiting an enzyme that converts testosterone to dihydrotestosterone, the androgen hormone that’s responsible for shrinking hair follicle cells, leading to male pattern baldness. Although finasteride has been shown to increase hair count and appearance, it does increase the risk of sexual disorders like erectile dysfunction. So buyer beware

 

Nov 01

Apricus Biosciences Announces Issuance of Korean Patent, Expanding Its Patent Portfolio for Its Topical Cream to Treat Premature Ejaculation

Apricus Biosciences, Inc.
Press release

Apricus Biosciences Announces Issuance of Korean Patent, Expanding Its Patent
Portfolio for Its Topical Cream to Treat Premature Ejaculation

SAN DIEGO, 2011-10-19 15:30 CEST (GLOBE NEWSWIRE) --  Apricus Biosciences, Inc.
("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com)
announced today that the Korean Patent Office recently issued a Notice of
Allowance to grant a patent for the Company's development of a topical cream
utilizing vasoactive prostaglandin E to treat premature ejaculation ("PE"),
When issued, the patent, entitled, "Compositions and Methods for the Treatment
of Premature Ejaculation," will provide Korean patent protection until March
2024. It is one in a series of issued patents and pending applications that
Apricus Bio owns in the male sexual dysfunction field utilizing its proprietary
NexACT® technology, which includes its Vitaros® product to treat erectile
dysfunction ("ED"), among others in research and development. 

Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive
Officer of Apricus Bio, commented, "We are very pleased with this patent
allowance in South Korea for the use of vasoactive prostaglandin E to treat PE.
This allowed patent includes the same pharmaceutical composition as Vitaros®,
combined with a local anesthetic. We are aggressively seeking marketing
approval from various regulatory authorities and pursuing partnership
transaction applications for Vitaros® for erectile dysfunction, and are also
developing related products utilizing our NexACT® technology that may add to
the value of our existing portfolio of drugs to treat various types of sexual
dysfunction. In addition to the issuance of this new Korean patent, we are
actively seeking patent protection for this PE application in the U.S. and in
other key countries." 

Vitaros® has been approved by Health Canada for marketing and sales for
patients with ED and the Company has filed for marketing approval for the drug
for this indication in the European Union and Switzerland. Vitaros® is a
topical cream that incorporates alprostadil, a well-recognized vasodilator
currently marketed by other companies as an injectable product or an
intra-urethral insert. The drug has been studied in over 3,300 patients,
including difficult to treat populations, such as those with diabetes, cardiac
problems, sildenafil (Viagra®) failures and post prostatectomy patients.
Vitaros® has demonstrated clinical efficacy and an excellent safety profile
versus the currently approved oral therapies, and is not contraindicated for
patients taking alpha blockers or nitrate medication. Viagra® is a registered
trademark of Pfizer, Inc. 

Apricus Bio is currently studying the use of vasoactive prostaglandin E,
combined with and without local anesthetics, to develop a topical cream to
treat PE. To date, the Company has completed three clinical studies for this
application, including two single-blind studies and one double-blind study. 

The Company's PE patent portfolio currently consists of four issued patents
(Australia, Singapore, Japan and soon-to-be Korea) and eight pending
applications (the U.S., Canada, Europe, Mexico, Brazil, China, Hong Kong and
Israel). 

According to Datamonitor 2010, "Premature ejaculation is a commonly yet poorly
understood and defined male condition. Prevalence estimates vary greatly from
4% to 29% as stated by a study done by Simons and Carey (2001), according to
the different definitions used. The disorder is currently severely undertreated
and off-label prescription of selective serontonin reuptake inhibitors
("SSRIs") is the most common treatment pathway in the seven major markets." 

About Apricus Biosciences, Inc.

Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company,
has leveraged the flexibility of its clinically-validated NexACT® drug delivery
technology to enable multi-route administration of new and improved compounds
across numerous therapeutic classes. 

Revenues and growth are driven from out-licensing of this technology for the
development and commercialization of such compounds to pharmaceutical and
biotechnology companies worldwide. In addition, the Company is seeking to
monetize its existing Rx Division product pipeline, including its first
product, Vitaros®, approved in Canada for the treatment of erectile
dysfunction, which is currently expected to be available on the Canadian market
in 2011, as well as compounds in development from pre-clinical through Phase
III, currently focused on Sexual Dysfunction, Oncology, Dermatology,
Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others. 

The Company is also developing its Consumer Healthcare Division by developing a
number of drugs that utilize the Company's NexACT® technology to comply with
the FDA's over-the-counter ("OTC") requirements, can be cleared as 510(k)
topical creams that are considered to be medical devices or approved as
Abbreviated New Drug Applications ("ANDAs") as generic drugs. The Company will
also seek to market such drugs through these similar procedures in foreign
countries. 

For further information on Apricus Bio, visit http://www.apricusbio.com and for
information on its subsidiary, please visit www.nexmedusa.com. Information may
also be found at http://twitter.com/apricusbio, and

http://facebook.com/apricusbio.

Apricus Bio's Forward-Looking Statement Safe Harbor

Statements under the Private Securities Litigation Reform Act, as amended: with
the exception of the historical information contained in this release, the
matters described herein contain forward-looking statements that involve risks
and uncertainties that may individually or mutually impact the matters herein
described for a variety of reasons that are outside the control of the Company,
including, but not limited to, its ability to conduct or part with other
companies to conduct research that demonstrates the effectiveness of its
NexACT® drug delivery technology to enhance the delivery of drugs through
various routes of administration such as transdermal, transbuccal among others,
its ability to receive issued patents on its NexACT® technology and products,
develop such patented technology into product candidates such as Vitaros® for
premature ejaculation, have its Rx Division products and product candidates
approved by relevant regulatory authorities and its Consumer Healthcare
Division products either approved or cleared by relevant regulatory authorities
or be in compliance with appropriate regulatory requirements, to successfully
manufacture and commercialize such Rx Division products along with its Consumer
Healthcare Division products and product candidates and to achieve its other
development, commercialization and financial goals. Readers are cautioned not
to place undue reliance on these forward-looking statements as actual results
could differ materially from the forward-looking statements contained herein.
Readers are urged to read the risk factors set forth in the Company's most
recent annual report on Form 10-K, subsequent quarterly reports filed on Form
10-Q and other filings made with the SEC. Copies of these reports are available
from the SEC's website or without charge from the Company. 

         Apricus Biosciences, Inc.
         Edward Cox, V.P.
         Corporate Development & Investor Relations, Apricus Bio, Inc.
         (858) 848-4249
         ecox@apricusbio.com

         Apricus Bio Investor Relations
         Paula Schwartz
         Rx Communications Group, LLC
         (917) 322-2216
         pschwartz@rxir.com

Oct 31

Food Addiction and Erectile Dysfunction

Be sure to check out this inspiring story about one man’s struggle with food addiction:

On top of Karen’s ailments, Shauntae was missing school due to bacterial infections and daily problems with irritable bowel syndrome. She had always been resistant to eating vegetables. Later on, I noticed that she was on her way to either being bulimic or anorexic. Her whole diet—she ate very little—consisted primarily of grain and sweets, with hardly any fruits or vegetables. I intervened, and while she struggled with readjusting her diet, she understood the importance of what she was doing. She experienced a tough period of withdrawals, as did the rest of us. (Mine were very intense and scary, but I’ll get to that.)

Coby had problems with attention deficit hyperactivity disorder and weight gain. Jonathan seemed to have problems with anxiety, weight gain and lethargy.

I had an even longer list of problems stemming from my food addiction: obesity, bad gas, bloating, constipation, low confidence, acne, dandruff, anxiety disorders, erectile dysfunction, tooth decay and general weakness. Throughout my relationship with Karen, I was the one who wasted money and time smoking cigarettes, drinking alcohol and periodically overdosing on pharmaceuticals. We ate what we thought were healthy meals: cereal for breakfast, soup and a sandwich for lunch, and a seemingly well-rounded dinner of some kind of lean meat and vegetables with a couple slices of bread,

 

 

Oct 29

BioSante Rising as Female Libido Drug Moves Foward

BioSante Pharmaceuticals (BPAX) CEO Stephen Simes has heard the critics and he maintains that the dysfunction is very real. Simes hopes to prove the skeptics wrong sometime this quarter when BioSante discloses detailed study data that shows its experimental product LibiGel increases sexual desire in menopausal women. Last week, the company noted its trials to show the drug’s effectiveness were wrapping up. Today, the company said ongoing research showed the product was safe.

The company’s shares traded up on both bits of news. The stock rose 2% to $2.38 in midday trading and is up 46% this year. Since its public debut in early 2000, the company’s shares have lost almost three-fourths of their value.

It’s indeed been a long journey for Simes, who hopes to apply for US approval for LibiGel in about a year. He’s seen potential competitors drop out of the race. A year ago, German drug maker Boehringer Ingelheim announced it was scrapping plans to develop its female libido drug because of safety concerns. Procter & Gamble (PG) ran into similar government concerns last decade over its testosterone patch.

LibiGel has been nicknamed the female Viagra but it works much differently than the blockbuster erectile dysfunction drug. Pfizer’s (PFE) Viagra is a pill that increases blood flow to the penis. Like the P&G patch, LibiGel is testosterone in cream form. There’s no US approved use for testosterone in treating low sexual desire in women but there’s believed to be considerable “off-label” use to perk up female sex drives. According to BioSante, there were 4 million testosterone prescriptions written for women with low sex drives. The company predicts it would capture 90% of those prescriptions, converting patients to LibiGel.

Source: http://www.minyanville.com/businessmarkets/articles/biosante-libigel-hypoactive-sexual-disorder-female/10/11/2011/id/37330

 

Oct 16

ED: A Possible Diabetes Warning Sign?

There’s a a must-read article on nj.com about the warning signs of Diabetes:

Are you in your 30s or 40s and eating or drinking — or both — like you did when you were younger? Do you order super-portioned dinners and sugar-loaded mixed drinks at restaurants and eat at fast food joints more than twice a week? My husband David and I did just that from May 2010 to June 2011, and now we’re paying the price.

If this sounds anything like you, be warned. Why? Because after all that carelessness, we were diagnosed with a disease that is creeping up on many people, and if you change your ways now, you may be able to prevent it.

We’re not talking about high cholesterol, heart disease or even high blood pressure. We’re talking about diabetes, specifically Type 2 diabetes, the sneaky and silent adult onset disease.

Age does creep up on us… doesn’t it.

You may be familiar with some of the complications of diabetes – but Erectile Dyscfuntion is another possible complication. If you are being treated for ED, ask your doctor for a blood sugar check as well, just in case.

 

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