Biopharmaceuticals FDA

 News Release - July 28, 2006

FDA Approves Supplemental New Drug Application for Antiviral Treatment Famvir(R)

Famvir approved to treat recurrent genital herpes outbreaks with single day of therapy

Famvir approved to treat cold sores with single dose of therapy

EAST HANOVER, N.J., July 28 (HSMN NewsFeed) -- Novartis Pharmaceuticals Corporation announced today the U.S. Food and Drug Administration (FDA) approved prescription Famvir® (famciclovir) tablets as a single-day treatment for immunocompetent patients with recurrent genital herpes (RGH), based on a supplemental new drug application (sNDA). Famvir significantly reduced the time to healing of non-aborted lesions, as well as time to resolution of studied symptoms in RGH patients with lesions by almost two days. The FDA also approved Famvir as a single-dose treatment for recurrent herpes labialis (cold sores) in immunocompetent patients.

"Famvir is the first and only antiviral approved to treat recurrent genital herpes in a single day," said Gregory Geba, MD MPH, Vice President and Therapeutic Area Head of Respiratory, Dermatology and Infectious Diseases, Novartis Pharmaceuticals Corporation. "The new data demonstrates that Famvir can minimize a recurrent genital herpes outbreak, and stop symptoms such as pain and burning, in a median of less than a day. More importantly, Famvir can also stop an outbreak from occurring altogether in many patients."

When an outbreak is triggered in the body, there is a narrow window of opportunity for treatment since the virus is replicating most actively in the first hours of an outbreak. Data shows that when patients were treated with the oral antiviral Famvir during this critical period of time, it shortened the duration of outbreaks and improved the time to resolution of symptoms. Millions of Americans live with the pain and discomfort associated with the outbreaks brought on by these conditions.

The new approved dosage of Famvir for RGH is 1,000 mg twice daily for one day. Therapy should be initiated within six hours of the first sign of prodromal symptoms, such as tingling, itching, burning or lesion appearance. Ninety-one percent of patients can identify their prodrome allowing them to initiate therapy in this narrow window of opportunity.

Similarly, the cold sore virus is most active during the first hours of an outbreak. Data shows that when a single 1,500 mg dose of Famvir therapy is initiated within one hour of the first sign of symptoms (tingling, itching or burning) of a cold sore, Famvir significantly reduced the time to healing by a median of almost two days, as well as the time to resolution of pain and tenderness by a median of one day.

"This is exciting news for the millions of people who live with these conditions," said Dr. Geba. "Treating at the first sign of symptoms, when the virus is generally most active, significantly influences the management of outbreaks."

About the Data

Recurrent Genital Herpes (RGH): Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-day Famvir (1,000 mg orally twice; n=163) with placebo (n=166) showed that when immunocompetent adult patients with RGH initiated therapy with Famvir at the first symptom/sign of an outbreak (within six hours), Famvir significantly reduced (P<0.001) the time to healing of non-aborted lesions by almost two days (median time, 4.3 vs. 6.1 days). Furthermore, the proportion of patients with aborted lesions was significantly larger (P=0.003) in the Famvir group as compared to placebo (23% vs. 13%). Famvir also significantly reduced (P<0.001) the duration of all studied symptoms consisting of burning, tingling, itching, pain, and tenderness in patients with lesions vs. placebo (median time, 3.3 vs. 5.4 days). Adverse events were of mild to moderate severity, and were similar in frequency and severity to those in the placebo group.

Cold Sores: Results from the multicenter, multinational, randomized, double-blind, placebo-controlled study comparing single-dose Famvir (1,500 mg orally once; n=152), or single-day Famvir (750 mg orally twice; n=152) with placebo (n=168) showed that when immunocompetent adult patients with cold sores initiated therapy with Famvir at the first symptom of an outbreak (within the first hour) but before the appearance of lesions, Famvir significantly reduced (P<0.001) the time to healing of primary vesicular lesions by almost two days (median time, 4.4 and 4.0 days vs. 6.2 days, respectively). There was no significant difference between treatments in the proportion of patients with aborted lesions. The study also showed that single dose Famvir (1500mg orally once; n=227) compared to placebo (n=254) also significantly reduced (P<0.001) the time to resolution of pain and tenderness in patients with lesions by one day (median time, 1.7 vs. 2.9 days, respectively). Adverse events were mild to moderate severity and were similar in frequency and severity to those in the placebo group.

About Genital Herpes

Genital herpes is one of the most common sexually transmitted diseases in the United States. Approximately one in five or about 50 million Americans are infected with genital herpes. Nearly 90 percent of people affected with genital herpes may not know they are infected. Anyone who is sexually active with an infected partner can get genital herpes; however, typically more women are diagnosed with genital herpes than men.

There is no cure for genital herpes. Oral antiviral medications such as Famvir are indicated to treat or suppress RGH. People with recurrent genital herpes can treat it suppressively, by taking medication every day, or episodically, by taking medication when each outbreak occurs. The majority of people who use prescription treatment for genital herpes manage their symptoms through episodic treatment.

About Cold Sores

Cold sores, medically known as herpes labialis, are an infection of the mouth area with the herpes simplex virus. It is estimated that cold sores affect 66 percent of American adults -- with most Americans being infected by the age of 20 years. Annually, approximately 100 million episodes of recurrent cold sores occur in the U.S. Oral antiviral medications can shorten the course of an outbreak and improve the time to resolution of symptoms (pain and tenderness) associated with cold sores. However, there is no cure for cold sores.

About Famvir

Famvir (famciclovir) tablets are indicated for the treatment or suppression of recurrent genital herpes in immunocompetent patients; the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients; the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients; and the treatment of acute herpes zoster (shingles).

In clinical trials, the most commonly reported adverse events vs. placebo were headache (zoster: 22.7% vs. 17.8%; episodic: 13.5% vs. 5.4%; suppression: 39.3% vs. 42.9%; cold sores: 9.7% vs. 6.7%); nausea (zoster: 12.5% vs. 11.6%; episodic: 2.5% vs. 3.6%; suppression: 7.2% vs. 9.5%; cold sores: 2.2% vs. 3.9%); and diarrhea (zoster: 7.7% vs. 4.8%; episodic: 4.9% vs. 1.2%; suppression: 9.0% vs. 9.5%; cold sores: 1.8% vs. 0.8%).

The efficacy of Famvir has not been established for initial-episode genital herpes infection, ophthalmic zoster, disseminated zoster, or in immunocompromised patients with herpes zoster. The safety and efficacy of Famvir for suppressive therapy has not been established beyond one year.

There is no cure for genital herpes. There is no evidence that Famvir can stop the spread of herpes to others.

Famvir is Pregnancy Category B. Famvir is contraindicated in patients with known hypersensitivity to the product, its components, or Denavir® (penciclovir cream). For more information about Famvir, see the full Prescribing Information at http://www.famvir.com.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS ), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

Forward-looking Statement

The foregoing release contains forward-looking statements that can be identified by terminology such as "committed to helping" or similar expressions, or by express or implied discussions regarding the approval of a new indication for Famvir by the FDA, or regarding the potential approval by regulatory authorities in other countries, or regarding potential future sales of Famvir. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Famvir to be materially different from any future results, performance or achievements expressed or implied by such statements. There can not be any guarantee that Famvir will reach any particular sales levels. In particular, management's expectations regarding commercialization of Famvir could be affected by, among other things, additional analysis of Famvir clinical data; new clinical data; unexpected clinical trial results; 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; increased government, industry, and general public pricing pressures; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. 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.

Source: Novartis

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