Takeda blood pressure drug tops rivals in studies

* Takeda drug lowers BP more than Diovan, Benicar

* Takeda’s azilsartan awaiting FDA approval decision

* Analysts see azilsartan sales of $733 mln in 2014

By Bill Berkrot

NEW YORK, May 3 (BestGrowthStock) – An experimental hypertension
drug being developed by Japan’s Takeda Pharmaceutical
Co(4502.T: ) lowered blood pressure more than two rival medicines
from the same class in a pair of late-stage studies.

The Takeda drug, azilsartan medoxomil, which belongs to a
class of blood pressure medicines called angiotensin receptor
blockers, or ARBs, was tested against the highest doses of
Diovan, a big seller for Novartis (NOVN.VX: ), and Benicar, sold
by Daiichi Sankyo (4568.T: ).

Data from the Phase III studies, which were being presented
on Monday at the American Society of Hypertension meeting in
New York, is part of the package under review by the U.S. Food
and Drug Administration. Takeda filed its submission seeking
U.S. approval of azilsartan last week.

Analysts polled by Thomson Reuters expect the Takeda drug
to reach annual sales of $733 million in 2014 if approved.

One six-week study of 1,291 patients compared the Takeda
drug at 40 milligrams or 80 mg with a 40 mg dose of Benicar,
known chemically as olmesartan medoxomil, or 320 mg of Diovan,
known chemically as valsartan.

The studies evaluated 24-hour mean systolic blood pressure
by ambulatory blood pressure monitoring. Systolic is the first,
or upper number, in a blood pressure reading.

Azilsartan at 80 mg lowered systolic blood pressure by 14.5
mmHg, while the 40 mg dose took the number down by 13.4 mmHg.
Diovan patients saw an average reduction of 10.2 mmHg, while
Benicar led to a 12 mmHg reduction.

The difference in reduction between the high dose
azilsartan and both rival medicines was considered to be
statistically significant, researchers said.

The other six-week study of 1,272 patients tested
azilsartan at three doses — 20 mg, 40 mg and 80 mg — against
40 mg of Benicar.

The 80 mg dose of the Takeda drug lowered systolic blood
pressure by 13.2 mmHg, while it went down by 12.1 points at 40
mg and 10.8 at 20 mg. That compared to a reduction of 11.2 seen
with Benicar.

Once again, the difference between the highest dose of
azilsartan and Benicar was considered statistically
significant, researchers said.

There was also a statistically significant difference in
reduction between 80 mg of azilsartan and 40 mg of Benicar when
measuring sitting blood pressure in the clinic — 8.6 mmHg
versus 7.1 mmHg, Takeda said.

The most commonly reported adverse side effects from
azilsartan were dizziness, increased blood creatine
phosphokinase and diarrhea, the company said.

Takeda is hoping the data will not only convince the FDA to
approve the drug, but help to differentiate azilsartan in a
crowded field of blood pressure lowering medicines.

“We were encouraged at the results demonstrating azilsartan
medoxomil achieved greater reductions in 24-hour mean systolic
blood pressure when compared to two other commonly used ARBs at
their respective maximum doses,” Stuart Kupfer, executive
medical director for Takeda clinical science, said in a
statement.

Failure to control blood pressure increases the risk of
heart attack, stroke and heart failure.

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(Reporting by Bill Berkrot; Editing by Bernard Orr)

Takeda blood pressure drug tops rivals in studies