Vertex receives FDA approval for INCIVEK to treat hepatitis C

May 23 2011

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK (in-SEE-veck) is approved for people who are new to treatment, and for people who were treated previously but who did not achieve a viral cure (relapsers, partial responders and null responders). INCIVEK is given for 12 weeks in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks - half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. INCIVEK will arrive in pharmacies this week.

“Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them”

The approval of INCIVEK was based on data from three Phase 3 studies, which showed that people who received INCIVEK combination treatment achieved significantly higher rates of sustained viral response (SVR, or viral cure) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:

INCIVEK (750 mg) is given as two 375-mg tablets three times daily. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses.

Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.

"Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College and principal investigator for a Phase 3 study of INCIVEK. "With INCIVEK, 79 percent of people new to treatment achieved a viral cure."

"Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. "The approval of INCIVEK was only possible thanks to more than 4,000 people who volunteered for our clinical studies, the doctors, nurses and coordinators who managed the studies, and our own pioneering scientists who have worked for more than 15 years to bring this new medicine to people with hepatitis C."

Vertex has 200 field-based employees across the United States, including a 115-person sales team, who are ready to support the introduction of INCIVEK. The sales team has an average of more than 14 years of experience bringing medicines to people who need them, including eight years of direct experience with antiviral medicines for diseases such as hepatitis C.

Helping People with Hepatitis C Get INCIVEK

The people who work at Vertex understand that medicines can only help patients who can get them. With that in mind, the company introduced a comprehensive financial assistance and patient support program to help people get INCIVEK who might not otherwise be able to afford it. The program will help people with hepatitis C learn about insurance benefits for their medicines, give INCIVEK for free to eligible patients who do not have insurance and provide coverage for co-pay or co-insurance costs associated with INCIVEK for people who meet certain program criteria. Additionally, patients will have access to nurses through a 24-7 hotline by which they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to people with hepatitis C before, during and after the treatment process.

For eligible patients, the program includes the following:

• Insurance Benefits Research and Support: Vertex case managers will research patients' insurance benefits for INCIVEK combination treatment, assist people with insurance appeals and help guide them to other forms of financial support, including Vertex's free medicine and co-pay programs;
• Free Medicine Program: Vertex will give INCIVEK for free to people who do not have insurance and have an annual household income of $100,000 or less; and
• Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit Patient Access Network Foundation, which has a fund to provide co-pay support to people taking hepatitis C medicines.

Source: http://www.vrtx.com/