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AbbVie Receives FDA Ranking for Hepatitis C Therapy

- By Alberto Abaterusso

A very important step has moved forward concerning the fight against the hepatitis C virus, a disease that is often asymptomatic, but if not properly treated it can become chronic and in some cases can result in more severe diseases like liver cirrhosis, liver failure and live cancer.

After a careful examination of clinical data for genotype 1 (GT1), AbbVie's "pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P)" received from the U.S. Food & Drug Administration the designation of 'Breakthrough Therapy'.

According to the FDA, the Breakthrough Therapy designation "is intended to expedite the development and review of therapies for serious or life threatening conditions."

The designation granted investigational hepatitis C virus regimen of G/P is "for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor." (PRNewswire)

Approximately 3% of the world's population (150-200 million people) is currently living with chronic hepatitis C and about 3.5 million new diagnosis of infection from hepatitis C virus are made every year.

There are different genotypes of the virus. Currently, the most widely used classification of genotypes of the virus is that one implemented by WHO and includes 11 genotypes.

In the U.S., about 70% of hepatitis C infection cases are related to genotype 1.

AbbVie Inc. (ABBV), one of the most important research-based biopharmaceutical companies worldwide, is committed to advancing hepatitis C therapies for people living with chronic hepatitis C and in April 2016, the company received the FDA's approval for VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) as a therapy in patients with uncomplicated cirrhosis due to GT1b chronic hepatitis C infection.

In first half 2016, net revenues from the sale of Viekira (approximately 6.7% of the total net revenues) was $833 million, a 35.23% increase year-over-year. The sale of Viekira declined 42% in the U.S., but increased 147.4% internationally from first half 2015 to first half 2016.

AbbVie declared its quarterly dividend of 57 cents per share on Sept. 19. The cash dividend is payable Nov. 15 to shareholders of record at the close of business on Oct. 14.

AbbVie is a member of the S&P 500.

AbbVie is trading around $63.07 per share on the New York Stock Exchange and outperformed with 0.38% the S&P 500.

The company has a market capitalization of $103.12 billion. As of the second quarter, cash and short-term investments amounted to $8 billion and total long-term debt amounted to $37.3 billion. Cash flow from operating activities was about $7.5 billion in 2015, a 114.3% increase from the previous fiscal year.

AbbVie Inc. is a pharmaceutical company that develops and markets therapies that address a range of diseases. It originated in 2013 as a spin-off of Abbott Laboratories (ABT). Approximately 61% of AbbVie's total net revenues in 2015 came from the sale of Humira, which is the company's largest product and the trade name under which adalimumab is marketed. This medication is used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, juvenile idiopathic arthritis, plaque psoriasis, hidradenitis suppurativa, uveitis and pediatric enthesitis-related arthritis (used in the European Union only).

Disclosure: I have no positions in AbbVie Inc.

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