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Sunday, December 4, 2011

Ranbaxy Laboratories falls on payment concerns to Teva Pharmaceuticals, delay in settlment with FDA

NEW DELHI/MUMBAI: A day after Ranbaxy Laboratories launched its low-cost version of the world's best selling drug Lipitor in the US, its share price fell 1.66% due to concerns about payment to Teva Pharmaceuticals and delay in settlement with US authorities.

A Teva spokesman on Friday clarified that his company was not supplying ingredients to Ranbaxy for making the Lipitor clone, resulting in some analysts criticising the Indian drug maker for its profit sharing agreement with the Israeli company.

"Teva is getting the money for the security they assured, but without any services,'' said Centrum Broking's Ranjit Kapadia. But a Citigroup report said 'the disquiet over profit sharing to Teva is overdone'. "We believe Ranbaxy's agreement with Teva was an insurance policy to safeguard against the uncertainty surrounding Ranbaxy's generic Lipitor ANDA approval," said the report.

A similar point was made by Kotak Securities who in a note on Thursday said Ranbaxy had allied with Teva as a backup in case it approvals were held back because of its manufacturing issued with the US Food and Drug Administration. Some analysts had reduced their estimates about how much Ranbaxy would make from the drug on assumptions that it may have to pay as much as $130 million to Teva.

" But the amount will be quite small compared to what is being speculated because Ranbaxy is not using Teva's services," an industry analyst said. Analysts are disappointed that a comrehensive settlement on all of Ranbaxy's outstanding issues with the drug regulator had not come through.

"We expected clarity on the settlement along with the generic Lipitor approval. That would have allowed Ranbaxy to resume selling drugs from its two Indian plants," said Kapadia In 2008, the FDA banned 30 drugs and halted approval of new ones from two Indian plants after it found the Daiichi Sankyo-owned firm guilty of violating US drug manufacturing rules.

This had threatened the company's ability to get regulatory approval for manufacturing atorvastatin (chemical name for Lipitor), as the ban included the plant where it had originally planned to manufacture the drug. The Gurgaon-based firm closed at. 436.75 on Friday at the BSE. Meanwhile, the aggressive marketing tactics of Lipitor's original drug maker Pfizer Inc have come under the scanner of some US senators.

Three senate members have sought details of the deal between Pfizer, Pharma Benefit Companies and Insurance Companies, who had asked pharmacies not to sell generic versions. "By working with manufacturers to push brand-name drugs, PBM may be abusing Medicare to boost their profits and denying generic alternatives to patients," said Max Baucus chairman Senate Finance Committee in a press statement.

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