Upcoming AWS Coverage on Impax Laboratories Post-Earnings Results

LONDON, UK / ACCESSWIRE / April 21, 2017 / Active Wall St. blog coverage looks at the headline from AbbVie Inc. (NYSE: ABBV) as the Company announced on April 20, 2017, that its Phase 3 EXPEDITION-1 study demonstrated that 99% of chronic hepatitis C virus (HCV) infected patients achieved sustained virologic response at 12 weeks' post-treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of AbbVie's competitors within the Drug Manufacturers - Major space, Impax Laboratories, Inc. (NASDAQ: IPXL), announced on April 06, 2017, that it will release its Q1 2017 financial results on Wednesday, May 10, 2017, prior to the open of the US financial markets. The Company will host a conference call and live webcast with the investment community at 8:30 a.m., ET on May 10, 2017. AWS will be initiating a research report on Impax Labs in the coming days.

Today, AWS is promoting its blog coverage on ABBV; touching on IPXL. Get all of our free blog coverage and more by clicking on the link below: http://www.activewallst.com/register/.

The EXPEDITION Study

AbbVie's EXPEDITION-1 is a single arm, multicenter, open-label study evaluating the efficacy and safety of 12 weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic HCV infection and compensated cirrhosis (Child-Pugh A) in 146 patients, including those new to treatment or had prior treatment experience with IFN-based treatments. The primary endpoint was the percentage of patients achieving SVR12. SVR12 was achieved by 145/146 patients, with one GT1a-infected patient experiencing relapse.

These high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin. Patients with specific virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study.

"We have already seen great progress in the treatment of HCV patients with compensated cirrhosis. However, treatment challenges remain related to the use of ribavirin," said Xavier Forns, M.D., head of hepatitis unit, Hospital Clinic de Barcelona, Spain, "The positive findings from the EXPEDITION-1 study, along with previously reported data, show that G/P has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes."

In the EXPEDITION-1 study, the majority of adverse events (AEs) were mild and no patients discontinued treatment due to an AE. The most common AEs were fatigue and headache. No patients experienced ALT elevations equal to or above Grade 3. Of the 11 patients who experienced serious AEs, none were considered treatment-related.

AbbVie's HCV Clinical Development Program

Approximately 130 to 150 million people worldwide are living with chronic HCV, for whom the risk of cirrhosis of the liver is between 15-30% within 20 years. Treatment guidelines around the world recommend that all patients with cirrhosis should be considered for treatment, yet the treatment of specific patients with HCV and compensated cirrhosis is still challenging.

AbbVie's glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), which make up the majority of HCV patients.

AbbVie's G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.

Authorization applications for G/P are currently under review by regulatory authorities around the world. G/P has been granted accelerated assessment by the European Medicines Agency (EMA), and priority review designations by the US Food and Drug Administration (FDA), and Japanese Ministry of Health, Labor and Welfare (MHLW).

Stock Performance

On Thursday, April 20, 2017, the stock closed the trading session at $63.78, slightly up 0.52% from its previous closing price of $63.45. A total volume of 5.70 million shares have exchanged hands. AbbVie's stock price advanced 4.94% in the last three months, 5.71% in the past six months, and 9.53% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 3.90%. The stock is trading at a PE ratio of 17.47 and has a dividend yield of 4.01%.

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SOURCE: Active Wall Street