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Novartis/Idenix Launch Free Telbivudine HBV Drug Program for HBV Therapy
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Novartis and Idenix today announced a Six-Month Money-Back Commitment Program for eligible self-paying individuals who have been prescribed Tyzeka (telbivudine), the most recently approved treatment for chronic hepatitis B. Current guidelines recommend that people with chronic hepatitis B get their blood tested every six months and sometimes more frequently. Through this program, which is the first of its kind in hepatitis B, if an individual's virus levels are still detectable after treatment with Tyzeka for six months, Idenix and Novartis will reimburse the person for out-of-pocket drug costs.
Chronic hepatitis is a serious public health problem in the United States and over 1.25 million Americans are infected. High hepatitis B virus levels increase the risk of disease complications, including liver cancer, cirrhosis, or death.
Please find attached a press release explaining the Six-Month Money-Back Commitment Program in additional detail. Also, I am happy to coordinate an interview with Dr. Calvin Q. Pan, MD, Director, Clinical Research/Hepatology, Mount Sinai Services at Elmhurst Hospital in New York City if you are interested in learning more.
Novartis launches Six-Month Money-Back Commitment for eligible individuals taking Tyzeka for chronic hepatitis B
- 1.25 million Americans are infected with chronic hepatitis B1
- Eligible patients reimbursed for out-of-pocket Tyzeka drug costs if viral levels are detectable
- First of its kind program in hepatitis B
East Hanover, NJ, August 7, 2007 - Novartis today announced a Six-Month Money-Back Commitment Program for eligible self-paying individuals who have been prescribed Tyzeka (telbivudine) tablets, for the treatment of chronic hepatitis B in adults with evidence of viral replication and active liver disease. Idenix Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation are co-promoting Tyzeka for the treatment of chronic hepatitis B in the United States.
Current guidelines recommend that people with chronic hepatitis B get their blood tested every six months and sometimes more frequently2,3. Through the Money-Back Commitment Program, if an individual's virus level is detectable after treatment with Tyzeka for six months, Idenix and Novartis will reimburse the person for out-of-pocket Tyzeka drug costs, subject to the program's terms, conditions, and limitations.
"Chronic hepatitis B is a serious public-health problem in the United States," said Dr. Calvin Q. Pan, MD, Director, Clinical Research/Hepatology, Mount Sinai Services at Elmhurst Hospital in New York City. "One of the primary treatment goals is to reduce the amount of virus in the body to undetectable levels. If a patient has no detectable virus in their blood after six months of therapy, they are more likely to have improved treatment responses at one year than those who do have detectable virus."
In a large clinical study, Tyzeka reduced the hepatitis B virus to undetectable levels at six months in 44% of hepatitis B e-antigen positive patients and 80% of hepatitis B e-antigen negative patients. This was not the primary measure of response in the study.
Participation and Enrollment Start with Patient Starter Kit
Eligible self-paying individuals who have been prescribed Tyzeka can participate in the Six-Month Money-Back Commitment Program by completing the Patient Support Enrollment Card, which is available as part of a Tyzeka Patient Starter Kit Plus through their physicians. These materials will be provided to patients in English, Spanish, Vietnamese, Chinese and Korean.
"The Money-Back Commitment Program is the first of its kind in hepatitis B and is tangible evidence of the Idenix/Novartis Alliance's confidence in Tyzeka and commitment to patients," said Dr. Gillian Zeldin, Director of Medical Affairs Infectious Disease and Transplant Immunology, Novartis Pharmaceuticals Corporation. "This is one of several programs that has been developed by the Alliance to provide information to physicians and support to patients."
For more information about the Money Back Commitment Program and other patient support programs offered by the Idenix/Novartis Alliance please call 1-877-8-TYZEKA.
Indication
Tyzeka is indicated for the treatment of chronic hepatitis B in adults with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside treatment-naive adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease.
Important safety information
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.
Severe acute exacerbations of hepatitis B have been reported in people who have discontinued anti-hepatitis B therapy, including Tyzeka. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
- Cases of myopathy have been reported with Tyzeka use several weeks to months after starting therapy. Myopathy has also been reported with some other drugs in this class. Physicians considering concomitant treatment with agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor and advise patients to report any signs or symptoms of unexplained muscle pain, tenderness or weakness, particularly during periods of upward dosage titration. Tyzeka therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is diagnosed.
- Because Tyzeka is eliminated primarily by renal excretion, coadministration of Tyzeka with drugs that affect renal function may alter plasma concentrations of Tyzeka and/or the coadministered drug. Dose-interval adjustment is required in patients with creatinine clearance <50mL/min, including those on hemodialysis. Tyzeka should be administered after hemodialysis.
- There are no adequate and well-controlled studies for Tyzeka treatment of patients with established lamivudine-resistant or adefovir-resistant hepatitis B virus infection.
- The safety and efficacy of Tyzeka in liver transplant recipients are unknown. If Tyzeka treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function should be monitored both before and during treatment with Tyzeka.
- Patients should be advised that treatment with Tyzeka has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
- Safety and effectiveness of Tyzeka in pediatric patients under the age of 16 years have not been established.
- Most common adverse events (5%) in clinical studies, regardless of attributability to Tyzeka, were upper respiratory tract infection (14%), fatigue and malaise (12%), abdominal pain (12%), nasopharyngitis (11%), headache (11%), blood CPK increased (9%), cough (7%), nausea and vomiting (7%), influenza and influenza-like symptoms (7%), post-procedural pain (7%), diarrhea and loose stools (7%), and pharyngolaryngeal pain (5%).
- Creatine kinase (CK) elevations were more frequent among subjects on Tyzeka treatment. Grade 3/4 CK elevations occurred in 9 percent of Tyzeka-treated patients.
- The relationship of initial treatment response to outcomes such as hepatocellular carcinoma and decompensated cirrhosis is unknown.
About Chronic Hepatitis B
More than 1.25 million Americans are infected with chronic hepatitis B1. Asian-Americans make up more than half of this number and, in fact, the incidence of hepatitis B constitutes the greatest health disparity between Asian-Americans and the general U.S. population4. One in 10 Asian-Americans have chronic hepatitis B, compared with one in 1,000 for the general U.S. population4.
Idenix/Novartis collaboration
Idenix and Novartis Pharmaceuticals Corporation are co-promoting Tyzeka for the treatment of chronic hepatitis B in the United States. Marketed as Sebivo outside of the U.S., it is co-promoted by Idenix and Novartis Pharma AG in France, Germany, Italy, Spain and the UK. Novartis has the exclusive right to commercialize Sebivo in the rest of the world.
Novartis is committed to infectious diseases and is developing a portfolio of products with complementary mechanisms of action in the treatment of hepatitis B and C, while working to bring innovation to the treatment of serious hospital infections.
Forward-looking statements
This release contains certain "forward-looking statements" relating to the Group's business, which can be identified by the use of forward-looking terminology such as "will," "committed," "confidence," "should," "developing," "working," or similar expressions, or by express or implied discussions regarding the potential approval of potential future approvals of additional products under development, or potential future revenues from Tyzeka or from such other products. Such forward-looking statements reflect the current views of Novartis regarding future events and 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 any of the additional development compounds referred to in this release will be approved for sale in any markets, or that Tyzeka, or any of these development compounds will reach any particular levels of revenue. Management's expectations regarding such products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; uncertainties relating to clinical trials, including new clinical data and additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the Company's ability to obtain or maintain patent or other proprietary intellectual property protection; Idenix's dependence on its collaboration with Novartis Pharma AG; Idenix's ability to obtain additional funding required to conduct its research, development and commercialization activities; as well as other risks and factors referred to in Novartis' 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.
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, cure 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. 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. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.pharma.us.novartis.com.
References
1. Centers for Disease Control and Prevention. Hepatitis B frequently asked questions. Available at www.cdc.gov/ncidod/diseases/hepatitis/b/faqb.htm.
2. Lok AS, McMahon BJ. American Association for the Study of Liver Diseases Practice Guidelines: Chronic Hepatitis B. Hepatology 2007; 45(2): 507-537.
3. Keeffe EB, Dieterich D, Han S, et al. A Treatment Algorithm for the Management of Chronic Hepatitis B Virus Infection in the United States: An Update. Clinical Gastroenterology and Hepatology 2006; (4):936-62.
4. Asian Liver Center at Stanford University/Centers for Disease Control and Prevention. HBV a Silent Killer. Available at http://liver.stanford.edu/files/2005Handbook.pdf.
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Novartis Media Relations
Amy Hunter
Novartis Infectious Disease and Transplant Immunology
+1 862-778-6309 (direct)
+1 917-535-2602 (mobile)
amy.hunter@novartis.com
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