Sun Pharmaceutical Industries Ltd. (SUNP), controlled by Indian billionaire Dilip Shanghvi, rose the most in 14 months after the U.S. approved the company’s generic version of Johnson & Johnson (JNJ)’s cancer drug Doxil.
The U.S. Food & Drug Administration allowed sales of Sun Pharma’s version of the drug to treat patients with ovarian cancer that has progressed or recurred, to ease a shortage of the treatment, according to a statement from the agency. Doxil generated $402 million of revenue for J&J in 2011, according to data compiled by Bloomberg.
“It’s a very important approval for Sun Pharma,” said Hitesh Mahida, an analyst at Fortune Equity Brokers (India) Ltd. in Mumbai. “It’s the first generic player to get an approval for this drug, and we are expecting it to enjoy exclusivity for the next nine months to one year.”
Sun Pharma, which reported revenue of 80.2 billion rupees ($1.5 billion) in the year ended March 31, will earn $53 million from sales of the medicine in the 12 months beginning April 1, Mahida estimates.
Sun Pharma’s shares rose 49 percent last year making it the second-best performing stock in the 26-company Bloomberg Asia Pacific Pharmaceuticals Index. (BPRPHRM) Shanghvi, who controls about 68 percent of the drugmaker, has assets valued at $9.3 billion, according to Bloomberg Billionaires Index.
Sun Pharma’s generic, doxorubicin hydrochloride liposome injection, will help resolve a shortage of the drug, the FDA said in a statement yesterday.
J&J alerted doctors in June 2011 about the Doxil shortage. The drug is produced by a contract manufacturer that signaled it would be getting out of the business over the next several years, according to Doxil’s website.
In February 2012, the FDA said it would exercise enforcement discretion for temporary, controlled import of Lipodox, the alternative to Doxil made by Sun Pharma, to address a shortage of the drug in the U.S.
To contact the reporter on this story: Ketaki Gokhale in Mumbai at email@example.com
To contact the editor responsible for this story: Jason Gale at firstname.lastname@example.org