Bristol Myers Squibb: From the horses mouth

Japan Approves First All-Oral, Interferon-and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen

Offers new treatment alternative for genotype 1 HCV patients in Japan who are interferon-ineligible/bigoted, or did not already react to treatment

Japanese HCV patients in dire need of consideration now have open door for cure, including more seasoned patients and those with remunerated cirrhosis

Monday, July 7, 2014 7:00 am EDT

"Japan has an one of a kind hepatitis C tolerant populace, a large number of whom are more established and have been not able to take, or react to, customary treatments, so we have a genuine feeling of direness to treat these patients now"

PRINCETON, N.J.- - (BUSINESS WIRE)- - Bristol-Myers Squibb Company (NYSE:BMY) reported today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has endorsed Daklinza® (daclatasvir), a strong, skillet genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, giving another treatment that can prompt cure for some patients in Japan who at present have no treatment alternatives. The Daklinza+Sunvepra Dual Regimen is Japan's first all-oral, interferon-and without ribavirin treatment regimen for patients with genotype 1 endless hepatitis C infection (HCV) contamination, incorporating those with repaid cirrhosis.

"Japan has an exceptional hepatitis C understanding populace, a considerable lot of whom are more seasoned and have been not able to take, or react to, customary treatments, so we have a genuine feeling of direness to treat these patients now," said a lead study agent Kazuaki Chayama of Hiroshima University in Japan. "The endorsement of the Daklinza+Sunvepra Dual Regimen offers surprisingly a treatment alternative that addresses a considerable lot of the unmet requirements for our HCV patients."

Of the 1.2 million individuals living with HCV in Japan, pretty nearly 70% have genotype 1b. Further, a critical number of patients with HCV in Japan are beyond 65 years old, prompting more infection related difficulties and a diminished probability of enduring interferon-based treatments, the chronicled standard of administer to treating HCV.

"The approbation of Daklinza+Sunvepra in Japan mirrors our vital spotlight on adding to a treatment alternative that addresses the issues of the Japanese HCV tolerant populace," said Lamberto Andreotti, CEO, Bristol-Myers Squibb. "This breakthrough underscores the organization's dedication to conveying imaginative meds to patients with the most noteworthy unmet needs, and we trust Daklinza-based regimens will assume a huge part in the advancement of HCV treatment for patients in Japan, and all around."

The Daklinza+Sunvepra Dual Regimen

The signs for Daklinza and Sunvepra in Japan are for the change of viraemia in both of the accompanying patients with unending hepatitis C genotype 1, or constant hepatitis C genotype 1 with repaid cirrhosis: (1) patients who are ineligible or prejudiced to interferon-based treatment, and (2) patients who have neglected to react to interferon-based treatment.

The endorsement is upheld by results from a Phase III study showing that the 24-week regimen of Daklinza and Sunvepra accomplished general SVR24 (managed virologic reaction 24 weeks after the end of treatment; a useful cure) among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years old or more established who were either interferon-ineligible or narrow minded, 91.9% accomplished SVR24. Further, patients with repaid cirrhosis present at standard had general SVR24 rates of 90.9%.

The regimen utilized as a part of the Phase III study brought about low rates of end (5%) because of unfriendly occasions (AEs). Also, the rate of genuine unfavorable occasions (SAEs) was low (5.9%) and few SAEs were experienced by more than one patient. Nasopharyngitis was the most widely recognized AE in the study (30.2%).

Results from the HALLMARK-Dual study, the Phase III multinational clinical trial exploring the Daklinza+Sunvepra Dual Regimen among genotype 1b HCV patients, exhibited comparable results to the Japan enlistment study and bolster filings in nations that have a high predominance of genotype 1b, for example, Korea and Taiwan.

About Bristol-Myers Squibb's HCV Portfolio

Bristol-Myers Squibb's examination endeavors are centered around progressing late-stage mixes to convey the most esteem to patients with hepatitis C. At the center of our pipeline is daclatasvir, a powerful container genotypic NS5A complex inhibitor (in vitro), which keeps on being researched in numerous treatment regimens and in individuals with co-morbidities, and is experiencing administrative survey in the U.S. what's more, Europe.

Daclatasvir is being mulled over in blend with sofosbuvir in high unmet need patients, for example, pre-and post-transplant patients, HIV/HCV co-contaminated patients, and patients with genotype 3, as a feature of the continuous Phase III ALLY Program.

In 2014, the U.S. Nourishment and Drug Administration (FDA) allowed Bristol-Myers Squibb's investigational Daclatasvir+Asunaprevir Dual Regimen Breakthrough Therapy Designation for utilization as a mix treatment in the treatment of genotype 1b HCV contamination.

In 2013, Bristol-Myers Squibb's investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) additionally got Breakthrough Therapy Designation in the U.S., which served to speed up the begin of the continuous Phase III UNITY Program. Study populaces incorporate non-cirrhotic innocent, cirrhotic gullible and beforehand treated patients. The daclatasvir 3DAA regimen is being considered as a settled dosage blend treatment with twice every day dosing.

About Hepatitis C

Internationally, there are 150 million individuals contaminated with HCV, with genotype 1 being the most common. Hepatitis C is an infection that taints the liver and is transmitted through direct contact with contaminated blood and blood items. Up to 90 percent of those tainted with hepatitis C won't suddenly clear the infection and will turn out to be chronically contaminated. As per the World Health Organization, 20 percent of individuals with perpetual hepatitis C will create cirrhosis and, of those, around 5 to 7 percent of patients may at last bite the dust of the outcomes of disease.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a worldwide biopharmaceutical organization whose mission is to find, create and convey inventive pharmaceuticals that help patients beat genuine ailments. For more data, please visit http://www.bms.com or tail us on Twitter at http://twitter.com/bmsn