Basel, September 15, 2005 - Novartis announced today that it has signed a global licensing agreement with NexMed, Inc (NASDAQ: NEXM) to develop new topical forms of terbinafine, the active ingredient in its popular Lamisil® (terbinafine tablets) treatment for fungal nail infections.
Novartis has acquired the exclusive rights to further develop and commercialize NexMed's NM100060 nail lacquer treatment for onychomycosis, which is commonly known as nail fungus, and for any other indications.
"Patients and doctors have said that they want a range of effective treatment options for onychomycosis. The currently available topical treatments for nail infections, while often preferred by patients, provide often poor efficacy, leading to patient frustration and poor compliance," said Joerg Reinhardt, Head of Global Development, Novartis Pharma AG. "This agreement combines Lamisil's proven track record of effectively and safely treating people with onychomycosis with the potential of meeting the needs of patients who want an effective and simple-to-use topical option for the treatment of nail infections."
NM100060 is currently in Phase I development with the active ingredient terbinafine, which is also the active ingredient in Lamisil, the most frequently prescribed treatment for fungal nail infection worldwide. Under the terms of the agreement, Novartis has acquired the exclusive worldwide rights to develop and commercialize NM100060, which incorporates NexMed's NexACT® drug delivery technology to effectively enhance penetration of terbinafine in the infected nail areas.
More about Lamisil
Lamisil oral tablets are the No. 1 prescribed treatment based on sales for fungal nail infections with a proven efficacy and safety profile. More than 17 million people have treated their infections with Lamisil in the US since 1996.
Lamisil contains the active ingredient terbinafine, which inhibits production of fungal cells by disrupting the fungal cell membranes. Terbinafine travels to the infected area under the toenail or fingernail since it is also attracted to keratin, which may also disrupt the infection. Because terbinafine accumulates and lingers in the area of the nail that is growing, it can continue to work for months even after the prescription is finished, allowing the nail to heal naturally over a period of time.
More about onychomycosis
Onychomycosis is a fungal infection affecting the toenails and/or fingernails. It is one of the most common dermatological diseases, affecting an estimated 30 million people in the US. Nail fungus can be painful, embarrassing, expensive and difficult to treat. A 1998 American Journal of Dermatology article estimated costs of monitoring and treatment of nail fungus ranged between USD 700 and USD 1,200 per patient annually.
The foregoing release contains forward-looking statements that can be identified by terminology such as "to develop and commercialize", "potentially meeting", or similar expressions, or by express or implied discussions regarding the potential development and commercialization of NM100060. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that the agreement that is subject of this release will lead to commercialization of NM100060 in any market. In particular, management's expectations regarding commercialization of NM100060 could be affected by, among other things, uncertainties relating to product development and clinical trials; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; industry, government, and general public pricing pressures; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events, or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Novartis Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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