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EastPharma Unit Deva Seeks FDA Approval in 2014 for U.S. Exports

Nov. 12 (Bloomberg) -- Deva Holding AS, the Turkish drugmaker majority owned by EastPharma Ltd., will seek approval from the U.S. Food and Drug Administration in 2014 for possible exports to the U.S. beginning in 2015.

Deva obtained the so-called European good manufacturing practice certificate from Germany’s health ministry in October that will pave the way to selling products to European markets, Chief Executive Officer Philipp Haas said at a news conference in Istanbul today.

“We are aiming to complete the FDA audit test successfully just as we have done with the other audits,” Haas said. “After that realistically we could expect exports to the U.S. to start in 2015.” The U.S. is the world’s largest drug market.

The Turkish pharmaceutical industry’s exports may increase to $4 billion with the approvals from $400 million this year, Haas said. Deva’s exports were about $20 million last year, he said. Turkey’s drug imports could be as much as $5.6 billion this year, he said.

Bayer AG, GlaxoSmithKline Plc, Novartis AG, AstraZeneca Plc and more than 30 other international drugmakers operate in Turkey, a pharmaceutical market that grew 5.4 percent to $9.1 billion in 2011, according to the website of the Istanbul-based Association of Research-Based Pharmaceutical Companies.

Cancer Drugs

Amgen Inc., the world’s largest biotechnology company, bought closely held Mustafa Nevzat Pharmaceuticals in April for almost $700 million to expand in Turkey, where economic growth is boosting demand for medicines. Mustafa Nevzat is the only Turkish drugmaker with an FDA approval, Haas said.

Deva plans to focus on production of cancer drugs as well as equipment used in eye treatments and serums and infusion products, Haas said. “Every year we make an investment of about 50 million liras ($27.8 million) and so will we in 2013,” he said.

The Istanbul-based company plans “organic growth” instead of acquisitions, Haas said. Deva isn’t considering selling a stake, he said.

Deva may set up a unit in the European Union because some countries in the EU want to buy from a company in the 27-member bloc, Haas said.

Deva rose 0.5 percent to 2.06 liras at 1:58 p.m. Istanbul time. The company is 82 percent owned by Istanbul-based EastPharma, which is listed on the London Stock Exchange.

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