BANGALORE (Dow Jones)--Dr. Reddy's Laboratories Ltd. (500124.BY) said Wednesday it has received U.S. regulatory approval to launch a copy of GlaxoSmithKline PLC's (GSK) anticlotting Arixtra injection, which is expected to boost the Indian generic-drug maker's profit.

The Food and Drug Administration has given Dr. Reddy's approval to sell four doses--2.5 milligram per 0.5 milliliter, 5.0 mg per 0.4 ml, 7.5 mg per 0.6 ml and 10 mg per 0.8 ml--of the drug, fondaparinux sodium, in pre-filled, single-dose syringes, it said in a joint statement with Australia-based partner Alchemia Ltd. (ACL.AU).

Mumbai- and New York-listed Dr. Reddy's will manufacture fondaparinux under license using a patented process developed by Alchemia.

Shares of Dr. Reddy's jumped more than 5.0% to a one-month high of INR1,628 on the Bombay Stock Exchange in early trade, in anticipation of the drug-approval announcement. They were trading 3.2% up at INR1,593.10 compared with the benchmark Sensex that was 0.7% higher at 0825 GMT.

Alchemia shares jumped 30% to A$0.80 on the Australian Stock Exchange.

The launch will add to Dr. Reddy's portfolio of products on which the company enjoys high margins because of limited competition from other generic drug makers in the key U.S. market.

"Given that this is a complex generic molecule, which is difficult to manufacture at scale, competition is likely to be limited for the foreseeable future," Chief Executive G.V. Prasad said in a statement.

The U.S. patents on Arixtra expired in 2002 and Alchemia is the only company that so far has developed a process to manufacture a generic version of the blood thinner, which prevents the formation of harmful blood clots in patients recovering from surgery. Clots that form in the blood vessels of the legs can travel and cause events like a sudden blockage of an artery.

The Arixtra brand had U.S. sales of about $340 million for the 12 months ended May 2011, Dr. Reddy's said, citing IMS market research data.

Surajit Pal, a pharmaceuticals analyst at Elara Securities (India) Pvt. Ltd., said he is factoring in an addition of INR11 on a net-present-value basis to Dr. Reddy's earnings per share from now to the fiscal year ending March 2013 because of the fondaparinux launch.

Pal estimates Dr. Reddy's EPS for the next fiscal year at INR83.50, excluding the contribution from fondaparinux sales.

Pinc Reserch's pharma analyst Sushant Dalmia said while Dr. Reddy's will be able to sustain high margins on the sales of fondaparinux over a long period because of the absence of any generic competitors, it would have to split the profits with Alchemia.

Alchemia and Dr. Reddy's have to share profits equally, with Alchemia's share increasing to 60% if sales of fondaparinux exceed a certain level, according to analysts.

Alchemia signed an agreement to make Dr. Reddy's its U.S. marketing partner for fondaparinux in 2007, when the Australian company transferred manufacturing rights to generic fondaparinux to Dr. Reddy's.

Alchemia's process for the synthesis of fondaparinux is covered by a patent estate with two issued patents and two pending applications in the U.S., Wednesday's statement said.

Alchemia and Dr. Reddy's last year expanded their agreement on generic fondaparinux to all markets.

"This approval is a major milestone for Alchemia, fondaparinux representing a significant source of potential future income for the company," Alchemia Chief Executive Pete Smith said in the statement.

--By Rumman Ahmed, Dow Jones Newswires; 91-9845104173; rumman.ahmed@dowjones.com

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