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AbbVie files New Drug Submission to Health Canada for its investigational, all-oral, interferon-free therapy for the treatment of hepatitis C
  -- Submission based on the largest Phase III program in genotype 1
(GT1) hepatitis C patients conducted to date(1)
-- Health Canada grants AbbVie's request for Priority Review
May 22 2014
AbbVie filed a New Drug Submission (NDS) to Health Canada seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with cirrhosis. The NDS is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date,(1) with six Phase III studies that included more than 2,300 patients in over 25 countries.
"This latest regulatory submission is yet another significant achievement for AbbVie's HCV development program," said Felipe Pastrana, General Manager, AbbVie Canada. "Our all-oral, interferon-free regimen offers adults living with genotype 1 chronic hepatitis C a promising solution to a worldwide problem." On May 1(st), 2014, Health Canada approved AbbVie's request for Priority Evaluation for its investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1. An informal Bureau Adjudicating Committee reviewed the request and concluded that the regimen fulfilled the criteria for Priority Evaluation. This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating a drug or regimen may have substantial improvement on at least one clinically significant endpoint compared to available therapy.
"This is great news for Canadians living with hepatitis C," said Dr. Jordan Feld, of the Francis Family Liver Clinic at Toronto Western Hospital, part of the University Health Network. "We and our patients have been waiting for years to find an alternative to interferon. This new therapy leads to very high rates of cure for people with genotype 1 infection with just 12 weeks of treatment and no interferon. Access to these medications will allow us to treat and cure many more patients and prevent the devastating complications of this disease. It is truly a milestone moment."
According to the Public Health Agency of Canada, an estimated 242,500 Canadians are living with hepatitis C, but approximately 21% of those individuals don't know they are infected and remain undiagnosed(2).
About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without RBV (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.
Additional information about AbbVie's Phase III studies can be found on www.clinicaltrials.gov .
AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis. ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals ENTA -2.67% for hepatitis C virus protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.
About AbbVie Canada
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.ca . Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.
AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
(1) Comparison based on review of data from www.clinicaltrials.gov for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.
(2) Public Health Agency of Canada. Hepatitis C Quick Facts. http://www.phac-aspc.gc.ca/hepc/index-eng.php . Accessed May 9, 2014. SOURCE AbbVie
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