Category Archives: NexMed Inc. NEXM

NexMed, Inc. (NEXM) Signs Strategic Collaboration Agreement with PII

January 22, 2009

Today, Pharmaceutics International, Inc. (PII) and NexMed, Inc. announced together that they have entered a Memorandum of Understanding (MOU) for a strategic product development collaboration utilizing NexMed’s NexACT drug delivery platform.

As terms of the agreement, PII will promote the NexACT technology to its clients and will be able to independently identify new product development opportunities for this collaboration. PII will be responsible for the research and development of the new pharmaceutical products, with guidance and oversight from NexMed, as well as for clinical trial material manufacturing and commercial manufacturing of the new products.

Hem Pandya, NexMed’s COO stated, “We are very pleased to enter into this collaboration with PII. The strategic goal is to broaden the promotion of our technology and permit us access to PII’s research and development and commercial manufacturing infrastructure. We will also be able to continue with our current product development efforts at significantly reduced monthly overhead expenses.”

Steve King, PII’s Senior Vice President added, “The collaboration between the companies will offer PII’s customers opportunities for product development without having to move their compounds elsewhere. The NexACT technology fits well with PII’s Drug Delivery Solutions initiative.”

NexMed’s NexACT transdermal drug delivery technology provides a highly effective transdermal therapeutic approach to the diseases that are currently being treated by systemic (oral or intravenous injections) therapy. The patented NexACT technology utilizes new biodegradable ingredients to overcome the skin’s natural barrier properties and enable the rapid penetration of high concentrations of active drug directly through the skin and major mucous membranes, enabling the invention of new and highly effective topical and transdermal therapies.

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NexMed, Inc. (NEXM) Gets $3.5 Million from Novartis

October 27, 2008

NexMed, Inc., a New Jersey based pharmaceutical and medical technology company, will receive $3.5 million from Swiss pharmaceutical giant Novaris, for fulfilling patent and enrollment milestones as part of a product agreement originally signed in 2005. NexMed announced today that they have received a Notice of Allowance from the patent office for its patent application entitled “Antifungal Nail Coat and Method of Use”. A Notice of Allowance indicates that all the basic steps of a patent application process are completed.

The patent is for a topical application of terbinafine formulated with NexACT® for the treatment of onychomycosis, a fungal infection of fingernails or toenails. NexACT is the company’s transdermal drug delivery technology. Under the agreement, development, production, and commercialization of the new product will be handled by Novaris.

NexMed CFO, Mark Westgate, commented, “In addition to the $2 million patent milestone, NexMed will also receive $1.5 million from Novartis for the remaining 50% of the patient enrollment milestone. This $3.5 million contractual payment will significantly strengthen our cash reserves.”

NexMed, Inc. is leveraging its proprietary NexACT drug delivery technology to develop innovative topical pharmaceutical products. NexACT is NexMed’s principal product technology, designed to enhance the absorption of drugs through the skin. According to the company, the patented NexACT technology utilizes new biodegradable ingredients that are especially effective in overcoming the skin’s natural barrier properties, allowing rapid penetration of drugs directly through the skin and mucous membranes. Current products include Vitaros® for erectile dysfunction and Femprox® for female sexual arousal disorder, both considered multi-billion dollar markets.

Since the NexACT technology can be applied to a wide range of drugs, the future potential is significant. A large number of drug products are coming off patent between 2008 and 2015, and this represents a significant opportunity for converting some of those products from injectable or oral dosage forms into topical forms for better patient compliance and added therapeutic benefit.

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NexMed, Inc. (NEXM) Meets with Food and Drug Administration (FDA) for Vitaros® Product

October 20, 2008

Vitaros(R), a topical treatment for erectile dysfunction based on the NexACT(R) technology, had been denied by the Food and Drug Administration (FDA) on July 21, 2008. Several points were made in the summary of key regulatory concerns. Those were: Overall Carcinogenicity Assessment, which includes the results from its three, two-year carcinogenicity studies in mice and rats, Assessment of the transfer to the partner of NexMed’s NexACT(R) technology, Assessment of transmission of sexually transmitted diseases (STDs), and GMP (Good Manufacturing Practices) Status of NexMed’s manufacturing facility.

In the meeting with the Food and Drug Administration (FDA) on October 15, 2008, NexMed has adequately addressed the deficiencies cited in FDA’s Pre-Approval Inspection and the FDA has revised the status from “withhold” to “acceptable.”

Vivian Liu, NexMed’s Chief Executive Officer commented, “We had a very productive meeting with representatives of the FDA. We now have a well-defined roadmap as to the actions necessary for addressing the deficiencies for our Vitaros(R) NDA prior to our Class 2 resubmission.”

NexMed Management will provide an update on the Vitaros(R) action items during its third quarter conference call on November 11, 2008, details of which will be issued closer to the date of the call.

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NexMed Inc. (NEXM) – Developing Patient Friendly Drugs

September 10, 2008

NexMed Inc. (NEXM:NASDAQ) is an innovative drug developer leveraging its proprietary NexACT transdermal drug delivery technology to produce a host of new medical treatments. The company’s drugs address a variety of health conditions such as nail fungus, sexual disorders and more.

NexMed offers large pharmaceutical companies the opportunity to incorporate NexACT into their existing drugs. This allows these companies to save considerably on R&D costs while developing new patient-friendly transdermal products and extending patent lifespans and brand equity.

NexMed’s drugs incorporate NexACT drug delivery technology, which offers several competitive advantages in the treatment of various illnesses. The NexACT penetration enhancers are designed to be structurally similar to, and biologically compatible with, the skin structure; they are also non-toxic, biodegradable, and enable drug candidates to efficiently overcome skin or mucosal membrane barriers. The company’s technology has applications in transdermal dosage forms like creams, ointments, lotions, gels, and sprays.

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NexMed, Inc. (NEXM) Shares Plunge on Decision not to Submit New Drug Application for NM100060

August 29, 2008

NexMed, Inc. (NASDAQ: NEXM), an innovative drug developer that is leveraging its proprietary drug delivery technology to develop a significant pipeline of innovative pharmaceutical products to address a host of medical needs, recently announced the company’s decision not to submit a New Drug Application (NDA) for NM100060. Shares of NexMed, Inc. declined more than 80 percent earlier this week on the news.

NM100060 is a topical application of terbinafine formulated with NexACT® for the treatment of onychomycosis (nail fungus). Based on First Interpretable Results of Phase III clinical studies for NM100060, the company has decided to not submit a NDA with the FDA at this time. NexMed’s president and chief executive officer, Vivian Liu, commented in a conference call earlier this week and stated, “We do not have all of the data right now, but we know that NM100060 is safe with no adverse events.”

NexMed entered into an exclusive, worldwide agreement with Novartis in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060. Novartis is currently in the early stages of reviewing the data and may take two to three months to generate the final report. Ms. Liu concluded, “I am very surprised by this setback. It is a major detour in our growth plan, but we are still moving forward with Novartis toward the ultimate goal of getting our product commercialized.

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Dutton Associates Featured Company: NexMed, Inc. (NEXM)

July 23, 2008

NexMed, Inc. (NASDAQ: NEXM) engages in producing innovative medical treatments by utilizing their proprietary NexACT® drug delivery technology. The company works with large pharmaceutical companies offering their NexACT® drug delivery technology to be incorporated into existing drugs, allowing these companies to save enormously on research and development costs while developing new patient-friendly products which extend patent life-spans and brand equity. NexMed has partnerships with Novartis International Pharmaceutical Ltd. for licensing and marketing Onychomycosis treatment, an anti-fungal drug, and a licensing agreement with Warner Chilcott, Ltd. for exclusive rights to their topically applied treatment for erectile dysfunction (ED).

NexACT is the company’s transdermal drug delivery technology, which represents an important medical advancement that provides a more effective approach to the diseases that are currently being treated by systemic (oral or intravenous injections) therapy. By utilizing highly effective formulations that consist of new biodegradable ingredients, these drugs breakdown the skin’s natural barrier properties more naturally, which results in an increased rate of penetration carrying concentrations of active drugs directly through the skin and major mucous membranes, ultimately resulting in new and effective topical and transdermal therapies. The NexACT technology offers a wide range of applicability in the development of transdermal dosage forms such as patches, creams, gels, ointments, lotions, solutions, and intranasal sprays.

NexACT technology offers several competitive advantages in the treatment of various illness including: fast onset of action, patient-friendly route of delivery, little or no side effects, and improved clinical efficacy. It also may offer significant clinical benefits if low bioavailabilty, multiple daily dosing, liver first-pass effect, or gastrointestinal side effects are associated with oral or injection dosage forms.

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NexMed, Inc (NEXM) Appoints Dr. Jay Birnbaum to Its Scientific Advisory Board

January 4, 2008

NexMed, Inc (NEXM), a developer of innovative transdermal products, announced that Jay Birnbaum Ph.D. has joined the Company’s Scientific Advisory Board. As a result, NexMed’s board of directors has now increased to include four scientific leaders.

Dr. Birnbaum currently serves a medical research consultant, focused on ethical and OTC dermatologicals, devices, and cosmeceuticals. Prior to establishing his consulting company in 1999, Dr. Birnbaum was employed by Novartis/Sandoz Pharmaceuticals Corporation, serving most recently as Vice President of Global Project Management. During that time period, Dr. Birnbaum was responsible for oversight and management of Novartis’s dermatology projects.

Dr. Birnbaum earned his Ph.D. in Pharmacology from the University of Wisconsin and a B.S. degree in Biology from Trinity College.

Vivian Liu, Chief Executive Officer, stated, “We are pleased to welcome Jay to our Scientific Advisory Board chaired by Dr. David Tierney. Jay was involved in the development of our anti-fungal product which is now in pivotal Phase 3 trials. As part of our Scientific Advisory Board, we are delighted that Jay will now play an even more active part in the continued development and expansion of our product pipeline.”

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NexMed, Inc. (NEXM) Appoints Hem Pandya as Chief Operating Officer

November 2, 2007

NexMed, Inc. (NEXM), a developer of innovative products based on the company’s proprietary NexACT drug delivery technology, announced that Hem Pandya has been elected as the company’s Chief Operating Officer. Mr. Pandya will fill the company’s newly created position and report directly to Chief Executive Officer, Vivian Liu.

Mr. Pandya recently served as Chief Commercial Officer for Putney, Inc., a start-up veterinary pharmaceutical company. Previous to this position, Mr. Pandya served as Senior Vice President of Business Development and Strategic Alliances for Andrx Pharmaceuticals, Inc., where he was in charge of licensing and co-development opportunities with various partners.

Ms. Liu, CEO of NexMed, stated “We are very pleased to welcome Hem to NexMed’s executive team. With over 12 years of pharmaceutical industry experience in the areas of business development, alliance management, strategic planning, and commercial operations, Hem brings a wide spectrum of operational and business development experience and strong leadership skills. Together we will shape the Company’s longer range business strategies.”

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