December 30, 2016
By
Mark Terry
, BioSpace.com Breaking News Staff
Hyderabad, India –
Aurobindo Pharma Limited
(
AUROPHARMA.BO
) recently
received approval
from the
U.S. Food and Drug Administration (FDA)
for two of its generic drugs.
The first was approval for a generic version of ziprasidone hydrochloride, which is marketed by Pfizer (PFE) to treat schizophrenia and acute mania.
Pfizer
markets it as Geodon in the United States.
The second is for indomethacin, which is marketed in India by
Jubilant
generics to treat fever, swelling, pain and stiffness. It is sold under the names of Indocin and Tivorbex. Indocin is not marketed in the U.S., although Tivorbex is by
Iroko Pharmaceuticals
.
On November 25, Aurobindo’s French subsidiary,
Arrow Generiques SAS
, inked a deal with Israel’s
Teva Pharmaceutical Industries
to
acquire
the right, title and interest in products Calcium and Calcium Vitamin D3, including the use of the OROCAL trademark. The acquisition allowed Arrow to increase its branded products portfolio.
This was
part of the deal
where Teva sold off some of its generics portfolio to comply with European anti-trust regulations after its $40.5 billion acquisition of
Allergan
’s generics business. Teva’s sold off around 80 products to various companies, including
Dr. Reddy’s Laboratories
,
Sagnet
,
Zydus Cadila (CADILAHC)
, Aurobindo,
Impax Laboratories
and
Perrigo
.
Aurobindo had been in
an auction
to acquire even more of Teva’s assets, but lost out to India’s
Intas Pharmaceuticals
, which acquired
Actavis Generics
in the UK and Ireland for $769 million. Aurobindo has also acquired some of Teva’s assets in the U.S.
Aurobindo Pharma
stock increased
3.38 percent to Rs 669.95 at news of the generic drug approvals. The company’s net profit, on a consolidated basis, rose 33.53 percent to Rs 605.64 crore based on 12.13 percent growth in net sales to Rs 3713.58 crore from September 2015 quarter to September 2016 quarter.
The company stock had been low since early December, when it was named in a
lawsuit
alleging collusion with other pharmaceutical companies of price fixing of two drugs in the U.S. Approximately 44 percent of the company’s sales come from its U.S. business.
The lawsuit was filed in the U.S. District Court for the District of Connecticut by 20 U.S. states. It also named Heritage Pharmaceuticals Inc., owned by India’s Emcure Pharma, as a “ring leader” of the price fixing.
The drugs in question were doxycycline hyclate, an antibiotic, andglyburide to treat diabetes. Teva,
Mylan
,
Citron Pharma
and Australia’s
Mayne Pharma
were also named in the lawsuit. Reuters noted that, “The suit comes after months of increasing scrutiny over generic drug prices in the United States, the world’s largest healthcare market. Drug pricing probes are ongoing at both the state and federal level in the country.”
Sun Pharmacy Industries (SUNPHARMA)
and Dr. Reddy’s Laboratories, both Indian companies, had previously received subpoenas by the U.S. Justice Department over generic drug prices. Aurobino, as reported by Reuters, said it was aware of the lawsuit and planned to comply with authorities.
In a filing to the Bombay Stock Exchange (BSE), Aurobindo
wrote
, “The company became aware of complaint from numerous states filed in Connecticut. It has received subpoena in March 2016 requesting non-product specific information and has not received any further requests for information or subpoenas after March 2016 subpoena.”
