) announced that its type II diabetes drug, Forxiga, has been
approved by the Japanese Ministry of Health, Labour and Welfare
(MHLW). AstraZeneca and Japan-based Ono Pharmaceutical Co., Ltd.
will co-promote Forxiga, a sodium glucose co-transporter-2
(SGLT2) inhibitor, in Japan.
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We remind investors that the marketing application for Forxiga
was submitted to MHLW by
Bristol-Myers Squibb Company
). However, AstraZeneca acquired full rights to Forxiga from
Bristol-Myers in Feb 2014.
Forxiga is already approved in the U.S. (Jan 2014) and the EU
(Nov 2012) for type II diabetes.
We are pleased with the approval of Forxiga in Japan. According
to the company, approximately 9.5 million people are suffering
from type II diabetes in Japan. Generic competition has adversely
impacted AstraZeneca's revenues over the past few quarters - this
has put significant pressure on the company. In this context, the
recent string of approvals for Forxiga and the subsequent up-take
of the drug will give a much needed boost to the company's top
We note that
Astellas Pharma, Inc.
) Suglat, a SGLT2 inhibitor, which gained Japanese approval in
January this year, has a head start over Forxiga. Meanwhile,
Mitsubishi Tanabe Pharma's SGLT2 inhibitor, canagliflozin (U.S.
trade name: Invokana) is currently under regulatory review in
AstraZeneca, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). A better-ranked stock in the biopharma sector is
Alexion Pharmaceuticals, Inc.
). Alexion carries a Zacks Rank #1 (Strong Buy).