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By Bari Faye Siegel

Many people don't know that female sexual dysfunction is a very real health problem for one in four women in the U.S., according to the Mayo Clinic.

Vivian Liu, president and CEO of NexMed, says her company's "story" is only beginning

Talk about "don't ask, don't tell!" But NexMed, an innovative East Windsor, N.J.-based drug developer, is not only asking. The company is already talking—to the FDA, to investors and to potential large pharmaceutical partners.

NexMed (NEXM-Nasdaq) is hoping that its proprietary NexACT® drug delivery technology will be approved to treat not only female sexual dysfunction, but the male variety, as well. The patient-friendly technology can be used in a wide range of applications such as creams and lacquers.

In September of 2005, the company announced a global agreement with Novartis International Pharmaceutical Ltd., for the licensing and marketing of its terbinafine product, or a topical Lamisil® for treating onychomycosis, commonly known as nail fungus. In July of 2007, Novartis announced that it had completed patient enrollment for the ongoing Phase 3 clinical trials for the NexMed product.

Other leading treatments under development include innovative topical treatments for male and female sexual dysfunction.

NexACT - A New Drug Delivery Platform

What in the world, you may ask, is the connection between sexual dysfunction and nail fungus?

Both problems, explained Vivian Liu, president and chief executive officer of NexMed, require local solutions. "There are many health issues where a topical treatment makes a lot of sense. If you think about the Digger commercials, you know where the fungus resides so a topical treatment for this condition is the way to go. The challenge, of course, is being able to deliver the drug through the nail and into the nail bed in order to kill the fungus, and eliminate the undesirable systemic side effects. Our studies have shown that NexACT can do this and now Novartis is trying to prove the efficacy of our product in the ongoing Phase 3 trials in the U.S. and Europe."

Liu said that NexACT provides a highly effective transdermal therapeutic approach to medical conditions that are currently being treated by oral medications or intravenous injections. The patented NexACT technology utilizes highly effective formulations containing new biodegradable ingredients to overcome the skin's natural barrier properties and enables the rapid penetration of high concentrations of active drug directly through the skin and major mucous membranes.

"This platform technology is compatible with different drug compounds," she continued. "And for drugs with a narrow therapeutic index, NexACT technology may provide a controlled rate of administration which is a significant advantage for maintaining efficacy while reducing toxicity."

Commercial Potential

NexMed believes that large pharmaceutical companies should and are (the company is in active negotiations) taking the opportunity to incorporate NexACT into their existing drugs. Liu said the NexACT platform technology can be applied to dramatically improve the absorption of active therapeutic ingredients and/or to develop new patient-friendlier routes of administration. Incorporating older drugs with the NexACT proprietary delivery system can create new products that not only provide patients with added therapeutic benefits, but also extend the product life under the multiple patent protection of the NexACT technology. A good example is Novartis' decision to extend the life of Lamisil® in a topical format.

From now to 2015, many more blockbuster drugs products will lose their patent protection. This represents a significant opportunity for converting some of those products from injectable or oral dosage forms into topical forms for better patient compliance or for added therapeutic benefit. ,

The NexACT technology offers several competitive advantages in the treatment of various illnesses including: fast onset of action, patient friendly route of delivery, little or no side effects and improved clinical efficacy. NexACT penetration enhancers are designed to be structurally similar to and biologically compatible with the skin's structure, are non-toxic, biodegradable, and enable drug candidates to efficiently overcome the skin or mucosal membranes.

"There are unmet medical needs in the market because some patients are really locked out-they are not able to take oral medications. Many of these medical conditions are age related. And, of course, as we age we take more medicines to treat a variety of conditions," Liu pointed out. "Doctors are concerned about the drug's safety profile and how it interacts with the other medication that the patient may be taking.

"For example, Viagra®, Cialis® and Levitra® are great products, but if a patient is on nitrate medications, and many older people are, he can't take any of the oral products. So currently, for many aging men who want to maintain their lifestyles, the only viable options are injection or insertion of a pellet into the penis or a vacuum device. If they had a patient-friendly topical cream, wouldn't it make more sense for them to use it?"

NexMed's Pipeline

NexMed has a robust pipeline of early and late stage products. They recently filed a New Drug Application with the FDA, seeking approval to commercialize its topical erectile dysfunction (ED) product. ED is described as the inability to attain and maintain an erection sufficient for sexual intercourse. In essence, the penis has insufficient or inadequate blood supply and the causes may be due to physiological impairment, psychological factors, or a combination of the two.

Conservative estimates suggest that 31 million men in the U.S., and more than 140 million men worldwide, are affected by ED. The worldwide ED treatment market is currently at about $3 billion and is projected to expand to $5 billion by the year 2013.

On the other side of the equation, the problem of treating female sexual arousal disorder (FSAD) has been largely ignored. However, approximately 47 million American women are estimated to suffer with sexual dysfunction, with symptoms that include the inability to experience sexual arousal or orgasm. The FSAD treatment market is projected to be a multibillion-dollar business opportunity, comparable in size, if not larger than the ED market. Currently there is no pharmaceutical product approved for treating FSAD.

NexMed is among the front-runners in the race to develop a viable treatment for FSAD. "We are a pioneer in this area. We have taken this product into phase 2 in the U.S. However, the regulatory path here is not well defined and evolving. We want to partner with a company that has the resources and infrastructure to guide Femprox's® development. "

In addition to completing a U.S. Phase 2 study, positive results were obtained from a 400-patient Femprox study conducted in China. The study was double-blind, placebo-controlled and randomized, and designed to test the efficacy and safety of Femprox cream in women diagnosed with FSAD. Femprox is topically applied and also incorporates alprostadil with the NexACT permeation enhancer. "This is a very exciting time for us. We reached a major milestone when we filed the NDA for our ED product. Given the size of our staff (20 full time), it was a major accomplishment" Liu said.

"So, investors are asking 'What's next for NexMed?' We have a robust pipeline of products under development including an exciting approach to treating psoriasis. Our intention is to use the revenues from partnered products to fund the early stage products. I am very excited about the future ahead of us and can't wait to share more information as data becomes available. The NexMed story is only beginning."