AbbVie Prices Hepatitis C Drug 12% Below Gilead Rival

AbbVie Inc. and Enanta Pharmaceuticals Inc.’s hepatitis C combination drug will be about 12 percent cheaper than its rival from Gilead Sciences Inc., setting the stage for fierce competition for patients of the liver virus.

The cocktail of pills, which will be sold under the name Viekira Pak, will cost $83,319 for a 12-week course of treatment, AbbVie said today. The Food and Drug Administration cleared Viekira Pak for sale to patients with the U.S.’s most common strain of the virus, genotype 1, according to a statement from the agency.

The price “reflects the value we believe Viekira Pak brings to hepatitis C patients and the health-care system,” said Morry Smulevitz, a spokesman for AbbVie.

Viekira Pak could generate $2.9 billion in sales next year, according to the average of three analysts’ estimates compiled by Bloomberg. The revenue will help North Chicago, Illinois-based AbbVie expand its sources of revenue beyond best-seller Humira, the rheumatoid arthritis treatment that is projected by analysts to bring in $12.6 billion this year.

Like Gilead’s combination treatment Harvoni, which was approved in October at $94,500 for a 12-week course, Viekira Pak is an all-oral medication that doesn’t require immune system-boosting shots that can have flu-like side effects and are used with older treatments.

AbbVie’s combination will require most patients to take four to six pills a day for 12 weeks, compared with one pill a day for Gilead’s drug. If patients have a subtype called genotype 1a and cirrhosis, a condition that scars the liver and affects functioning, they may have to take the drug for 24 weeks, according to an FDA update.

Drug prices have attracted the ire of U.S. lawmakers and insurers since Gilead priced its hepatitis C drug Sovaldi at $84,000 for a 12-week regimen. Sovaldi was approved about a year ago and is part of the combination drug Harvoni.

3.2 Million Americans

“This is an area we’re committed to and expect to be in for a long time,” Michael Severino, AbbVie’s executive vice president of research and development, said in an interview before the FDA decision.

AbbVie’s and Gilead’s drugs offer new promise for about 3.2 million Americans who have hepatitis C, according to the U.S. Centers for Disease Control and Prevention. The virus infects the liver and can lead to scarring, cancer and organ failure -- eventually necessitating a costly liver transplant. Hepatitis C is transmitted through infected needle sharing and sexual contact. Others with the infection got it through blood transfusions or organ transplants done before 1992, when the U.S. began screening the blood supply for the virus.

Clinical Trials

AbbVie plans to focus on Viekira Pak’s high cure rate, including in hard-to-treat patients, such as those who also have HIV, instead of the higher number of pills it will require daily, Severino said.

“We believe the performance of our product speaks for itself,” he said.

In six clinical trials testing Viekira Pak, 91 percent to 100 percent of patients, including those considered difficult to treat, were cured. Common side effects include tiredness, itching, nausea and trouble sleeping, the FDA said.

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease” Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”

Drug Cocktail

The drugs in the Viekira Pak cocktail include paritaprevir, ombitasvir, dasabuvir and ritonavir. Some patients will also be told to take ribavirin, which is part of older hepatitis C regimens. Foster City, California-based Gilead’s Harvoni, which is estimated to generate $12 billion in sales next year, combines two medicines into one pill taken once a day for genotype 1 patients.

Three clinical trials on Harvoni showed at least 94 percent of patients who took the drug were cured in eight or 12 weeks, the FDA said when it approved the medicine Oct. 10. Harvoni combines Gilead’s Sovaldi, largely considered to be the backbone of future combination treatments, and a drug called ledipasvir.

Olysio, from New Brunswick, New Jersey-based Johnson & Johnson and Medivir AB, was approved in November in combination with Sovaldi once daily for patients with genotype 1. A 12-week treatment of Olysio is $66,000, bringing the cost when combined with Sovaldi to $150,000.

European Decision

The European Committee for Medicinal Products for Human Use gave AbbVie’s hepatitis C combination treatment, called Viekirax there, a positive opinion Nov. 21. The European Commission is expected to make a final decision in the first quarter of 2015 on whether AbbVie can sell its drug there, the company said in a statement.

Enanta, the Watertown, Massachusetts-based biotechnology company that worked with AbbVie to develop Viekira Pak, is entitled to receive payments for regulatory and reimbursement approval milestones as well as tiered royalties, according to a statement from Enanta.

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