Janssen Research & Development, LLC, a part of the
Johnson & Johnson
) family of companies, announced the submission of a supplemental
New Drug Application (sNDA) in the U.S. seeking approval to market
the combination of its Olysio (simeprevir) and
) Sovaldi (sofosbuvir) for treating HCV. While Olysio is an NS3/4A
protease inhibitor, Sovaldi is a nucleotide analog NS5B polymerase
Johnson & Johnson is seeking to expand Olysio's label for
treating genotype 1 chronic HCV infected treatment-naïve adults
with advanced fibrosis and null responders with all stages of liver
fibrosis. Approval for the cocktail therapy has been sought on the
basis of data from a phase II study (COSMOS), which included
treatment-naïve patients with advanced fibrosis and null-responders
with all stages of liver fibrosis.
Last month, Johnson & Johnson commenced phase III trials
(OPTIMIST) to evaluate the safety and efficacy of the combination
without interferon or ribavirin for the treatment of chronic
genotype 1 HCV infection.
Olysio is currently available in the U.S. (following approval
late last year) in combination with pegylated interferon and
ribavirin for treating chronic HCV (genotype 1) infected adults
with compensated liver disease. The drug recorded sales of $354
million in the first quarter of 2014. Sales of Olysio will pick up
in the event of its label being expanded to include use in
combination with Gilead's blockbuster HCV treatment.
Sovaldi, which was approved in the U.S. for HCV treatment in Dec
2013, performed brilliantly in the first quarter of 2014. The drug
recorded sales of $2.27 billion in its first full quarter in the
market. The product's outstanding performance in the first quarter
of 2014 should go a long way in justifying its high price tag. The
drug costs $84,000 for a 12-week treatment period in the U.S. We
remind investors that Sovaldi's high price had invited criticisms
from various quarters.
Apart from the filing, Gilead was also in the news when it
announced that its board of directors has cleared a plan to buy
back up to $5 billion of its common stock. The scheme is in
addition to the $5 billion repurchase plan which was announced in
Jan 2011. Gilead said that it is expected to be completed by Sep
2014 (currently $2.9 billion remain). The new program will expire
three years after the completion of the present repurchase program.
The authorization of the new buyback program highlights Gilead's
efforts to enhance shareholder value.
While Johnson & Johnson carries a Zacks Rank #2 (Buy),
Gilead is a Zacks Rank #1 (Strong Buy) stock. Stocks such as
) carry the same rank as Gilead.
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
ALEXION PHARMA (ALXN): Free Stock Analysis
EMERGENT BIOSOL (EBS): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
JOHNSON & JOHNS (JNJ): Free Stock Analysis
To read this article on Zacks.com click here.