Healthcare Industry News: Takeda Pharmaceutical
News Release - September 29, 2006
TAP Enters Into Co-Promotion Agreement for Famvir(R)Co-Promotion of Genital Herpes Drug Expands Company's Product Offerings, Leverages Vast Experience in Women's Health
LAKE FOREST, Ill., Sept. 29 (HSMN NewsFeed) -- TAP Pharmaceutical Products Inc. announced today that it has entered into a co-promotion agreement with Novartis Pharmaceuticals Corporation to co-promote Famvir® (famciclovir), an oral antiviral prescription medication. Under the terms of the agreement, TAP will be responsible for promoting Famvir to the Obstetrician/Gynecology (OB/GYN) medical community.
Famvir was most recently approved for a single-day treatment in patients with recurrent genital herpes (RGH) and for a single dose treatment for recurrent herpes labialis (cold sores) in otherwise healthy patients. Famvir is the first and only oral antiviral approved to treat recurrent genital herpes with just a single day of therapy.
Famvir is also indicated for the suppression of recurrent genital herpes in otherwise healthy patients, for the treatment of recurrent herpes simplex virus infections (genital herpes and cold sores) in HIV-infected patients, and for the treatment of acute herpes zoster (shingles).
"By applying our vast experience in women's health to this innovative therapy from Novartis, we believe this will be a strong, productive partnership," said Alan MacKenzie, president of TAP. "Our specialty sales force has the expertise to further educate physicians about Famvir, continuing to establish it as an important treatment option for patients suffering from this disease."
In July, Novartis announced FDA approval of Famvir tablets as a single-day treatment for otherwise healthy patients with 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, such as pain and burning, in RGH patients by almost two days.
"The recent launch of the new single-day indication for Famvir has been very successful, and our partnership with TAP will allow more physicians and patients to benefit from this significant advance in the treatment of recurrent genital herpes," said Alex Gorsky, Chief Executive Officer, Novartis Pharmaceuticals Corporation. "TAP has a strong presence among obstetricians and gynecologists, and their expertise in this area will help us reach an important segment of physicians who are treating this disease every day."
The agreement covers the United States. Specific terms of the agreement were not disclosed.
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.
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 TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., with 3,000 employees headquartered in Lake Forest, Ill., is a joint venture that was formed in 1977 between Abbott, headquartered in Abbott Park, Ill., and Takeda Pharmaceutical Company Limited of Osaka, Japan. TAP develops and commercializes pharmaceutical products in the United States to help patients in need of important medicines. Based on sales, TAP is one of the nation's leading pharmaceutical companies and markets Prevacid® (lansoprazole) and Lupron Depot® (leuprolide acetate for depot suspension). For more information about TAP and its products, visit the company's web site at http://www.tap.com .
Source: TAP Pharmaceutical
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