FDA Approval of Aurobindo's Two Drugs Sends Stock Up

Published: Jan 03, 2017

FDA Approval of Aurobindo Pharma's Two Drugs Sends Stock Up 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.”

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