Merck, Roche tackle the A’s and B’s of hepatitis C

Strategic agreement to focus on improving awareness, treatments of disease

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WHITEHOUSE STATION, N.J.—Merck, known as MSD outside the United States and Canada, and Roche recently announced the formation of strategic agreements, through their respective subsidiaries, for the improvement of the awareness, diagnosis and treatment of chronic hepatitis C (HCV) infection in developed and emerging markets.

Researchers associated with both Merck and Roche will collaborate to study novel combinations of marketed and investigational medicines from both companies in order to accelerate the availability of potential new treatments for HCV patients.

Per the terms of the non-exclusive agreements, Genentech, a member of the Roche Group, will promote Merck's Victrelis (boceprevir) to physicians as part of a triple-combination therapy regimen. Financial details were not disclosed, though Daniel Grotzky, spokesperson for Roche, says both companies "are contributing financial and human resources to this agreement."

The promotion will begin in the United States, and the two companies will work together to educate patients and physicians about hepatitis C. Merck and Roche are working together to expand the agreement globally to other developed and emerging markets as well.

"These agreements are consistent with both companies' goal of improving healthcare outcomes for patients with chronic hepatitis C," said Adam H. Schechter, executive vice president of Global Human Health at Merck, in a press release regarding the agreements. "Hepatitis C often goes undetected for many years. By working together, we will be able to provide physicians, nurses and patients with education about the disease, its diagnosis and treatment options including the appropriate use of Victrelis."

Currently, diagnosing chronic hepatitis often involves testing for antibody to HCV (anti-HCV), but according to the National Digestive Diseases Information Clearinghouse (NDDIC), "in 30 to 40 percent of patients, anti-HCV is not detected until two to eight weeks after onset of symptoms." Additionally, the website notes that some patients cannot produce anti-HCV due to being immunosuppressed or immunoincompetent. Having another form of liver disease, such as alcoholism or autoimmunity, can also interfere with the diagnosis in patients with anti-HCV.

The current standard therapy for the treatment of hepatitis C combines ribavirin, an antiviral drug, with peginterferon, an immune-boosting protein sold by Merck as PegIntron and Roche Holding AG as Pegasys, which received U.S. Food and Drug Administration (FDA) approval in 2001 and 2002 respectively. The therapy takes nearly a year and cures less than half of patients, according to Donald Jensen, director of the Center for Liver Diseases at the University of Chicago Medical Center. In a self-funded study, Merck found that almost half the patients receiving Victrelis saw their treatment shortened by 12 to 20 weeks. The study also showed that when combined with the current standard therapy, Victrelis cured 64 percent of chronic hepatitis C patients who hadn't responded to previous treatments, compared to 21 percent of those receiving the standard therapy, and 65 percent of treatment-naÔve patients, compared to 38 percent of those receiving the standard therapy.

"Triple combination therapy for hepatitis C marks a major change in the way this disease is treated," said Pascal Soriot, chief operating officer of Roche's Pharmaceuticals Division, in a statement about the agreements. "The use of these medicines in combination offers better treatment outcomes for patients. Roche will work with Merck to provide healthcare professionals and patients with education about the management of hepatitis C. Both companies will also collaborate to develop improved therapies for this serious disease."

"Victrelis is the first protease inhibitor approved to treat HCV, so there is an acute need to help education and training healthcare providers and patients about how to use the triple combination of Pegasys, Copegus and Victrelis," Grotzky notes. "It is important that doctors and patients are armed with the information they need to succeed in achieving improved [sustained viral response] rates with this new regimen. These agreements will help support these goals."

Roche and BMS to study combo therapy for skin cancer

BASEL, Switzerland—Roche announced June 2 that it has entered into a clinical collaboration agreement with Bristol-Myers Squibb Co. (BMS) to investigate the combination of vemurafenib with BMS' ipilimumab in patients with BRAF-mutated metastatic melanoma.

According to the companies, the agreement represents an important cross-company collaboration to explore the combined potential of two new agents in metastatic melanoma, the deadliest and most aggressive form of skin cancer.

Under the agreement, the two companies will conduct a Phase I/II study to determine the safety and efficacy of the combination. If appropriate, the companies may conduct further development of the combination.

"We have made significant progress in treating metastatic melanoma and hope to further improve outcomes by combining two agents that target this deadly disease in different ways," said Dr. Hal Barron, Roche's chief medical officer and head of global product development, in a statement. "We are entering a new era for melanoma, and are committed to studying exciting combinations with investigational medicines in our own pipeline."

Roche is pursuing a broad development program with vemurafenib, a BRAF inhibitor, which includes additional combinations as well as studies in other tumor types. Roche is also conducting a trial studying the combination of vemurafenib with another of its investigational compounds, GDC-0973, a MEK inhibitor, in patients who previously received vemurafenib alone. MEK is a protein involved in cell growth and survival. It is thought that combining a BRAF inhibitor with a MEK inhibitor could lead to improved outcomes in people with BRAF V600 mutations, which are found in about half of all metastatic melanoma cases.

People are enrolled into vemurafenib studies based on BRAF mutation status as determined by the cobas 4800 BRAF V600 Mutation Test, an investigational diagnostic from Roche.

BRAF V600 mutations are also associated with other types of tumors, including 8 percent of solid tumors.  Roche has recently begun a Phase II trial of vemurafenib to assess its efficacy and safety in people with metastatic or unresectable papillary thyroid cancer whose tumors test positive for BRAF V600 mutations and are resistant to radioactive iodine therapy. Papillary thyroid cancer is the most common type of thyroid cancer; it can spread to the lymph nodes in the neck, as well as to other parts of the body. BRAF gene mutations have been implicated in 30 to 70 percent of thyroid tumors.

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