New American Therapeutics Acquires Antiviral Drug Denavir®
New American Therapeutics, Inc. announced today that it acquired all US rights to manufacture, market and sell the antiviral topical drug Denavir® owned by Novartis. Denavir (1% penciclovir cream) is a highly selective and potent topical antiviral treatment indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older. The topical antiviral cream market in the US is valued at approximately $100 million annually.
Novartis has agreed to provide limited transitional services to New American Therapeutics to allow for a smooth transition of the business to New American Therapeutics.
“Denavir offers patients a proven therapy for the treatment of herpes labialis. Likewise, the established revenue stream will provide New American Therapeutics with the capital required to expand our growing infrastructure and product line,” stated Alan L. Rubino, CEO and President of New American Therapeutics. “We are enthusiastic about advancing the commercial efforts of this important asset.”
Denavir 1% penciclovir topical cream is a safe and effective medicine when used as directed. Patients should read the package directions before using Denavir. Possible side effects include headache or irritation at the site of application. Patients should contact their doctor if they experience these symptoms as a result of using Denavir. Patients should consult their doctor before using 1% penciclovir topical cream if they are allergic to penciclovir or acyclovir (Zovirax®), or any other drugs, or are pregnant or nursing.
Please see below for Important Safety Information about Denavir.
New American Therapeutics, Inc. is a privately-held, specialty pharmaceutical company based in Cranford, NJ that acquires, markets and develops products in select therapeutic areas.
Contact:Alan L. Rubino
CEO and President
New American Therapeutics
arubino@natxcorp.com
Denavir® (penciclovir cream, 1%) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.
IMPORTANT SAFETY INFORMATION
Denavir should not be used in patients with known hypersensitivity to the product or any of its ingredients.
There are no adequate and well‐controlled Denavir studies in pregnant women; therefore, Denavir should be used during pregnancy only if clearly needed. There is no information on whether Denavir is excreted in human milk after topical administration; a decision whether to discontinue Denavir should take into account the importance of the drug to the mother. The effect of Denavir has not been established in immunocompromised patients. Denavir does not cure cold sores.
In clinical studies, the most common adverse reaction with Denavir was headache, which occurred in 5.3% of patients who received Denavir and 5.8% of patients who received placebo. Other adverse reactions with Denavir occurred in less than 2% of patients and included application site reaction, decreased sensitivity to touch/local anesthesia, taste perversion, and rash.
Other reported adverse reactions have included swelling of the mouth or throat, pain, alterations in sense of smell, abnormal touch sensation, itching, skin discoloration, and hives.
Denavir is available by prescription only. Please see the Full Prescribing Information.