Sun Pharma gets US nod for 2 generic drugs

Sun Pharma gets US nod for 2 generic drugs

Bangalore: Shares in Sun Pharmaceutical Industries rose more than 3% on Wednesday after the Indian drugmaker got the US regulator’s approval to launch two generics, including a version of Sanofi-Aventis’ cancer drug Eloxatin.

The company also received US Food and Drug Administration’s okay to launch sumatriptan succinate tablets, the generic version of GlaxoSmithKline’s Imitrex tablets to treat migraine, Sun said in a statement to the stock exchanges.

Sun Pharma, India’s largest drugmaker by market value, said oxaliplatin injections, a copycat version of Eloxatin, is used to treat colon and rectal cancer and has annual sales of about $2.3 billion in the United States.

Sun will share a 180-day marketing exclusivity for oxaliplatin with three to four other generic makers, a spokesman said, but he declined to set a timeframe for the launch of oxaliplatin and sumatriptan.

Teva Pharmaceutical Industries Ltd and Hospira Inc on Tuesday announced the launch of oxaliplatin injections after receiving the approval from the US regulator.

Nomura Financial said in a report if Sun Pharma were to launch oxaliplatin during the exclusivity period, the product could generate revenues of $75 million and net profit of $64 million.

It, however, said the launch would be “at risk" since Sanofi-Aventis had appealed in the appellate court against the New Jersey US District Court’s judgement against the French firm in patent litigation over Eloxatin.

“If Sun launches at risk, our conservative assumptions suggest Sun could easily generate about $50 million in profits during the exclusivity window," Macquarie analysts Abhishek Singhal and Gautam Duggad wrote in a report.

Sanofi-Aventis said on Wednesday it was considering options, including asking the appellate court to enforce the stay and was not issuing a revised 2009 earnings guidance following generic entry of Eloxatin in the United States.

Shares in Sun Pharma, which has a market value of $5.2 billion, were trading up 3% at Rs1,242 by 0733 GMT, after having risen as much as 3.7% to their highest level in two weeks, in a weak Mumbai market that was down 2.3%.

Analysts said the regulatory approval for the two generics came as a boost to Sun whose earnings had been weighed down by the recent seizure of its unit’s medicines by the US health regulator on manufacturing violations.

In June, US authorities seized all medicines produced by generic drugmaker Caraco Pharmaceutical Laboratories, a unit of Sun Pharma, at Michigan facilities following, in what health officials said were repeated violations of manufacturing standards.

The drugs included generic versions of heart, pain and psychiatric medicines.