FDA Oks Horizon Pharma's Time-Release Painkiller

FDA Oks Horizon Pharma's Time-Release Painkiller [Chicago Tribune]

From Chicago Tribune (IL) (July 27, 2012)

July 26--The Food and Drug Administration on Thursday gave the suburban biotech company Horizon Pharma Inc. the thumbs up on a new anti-inflammatory drug, the second the company will bring to market.

Deerfield-based Horizon won approval to sell Rayos, a delayed-release version of the corticosteroid drug prednisone, which is sold in Europe under the brand name Lodotra by Horizon’s Swiss-based partner Mundipharma.

Although Horizon sought FDA approval for rheumatoid arthritis, the FDA’s ruling allows the drug to be sold for treatment of a broad range of indications.

"This is a huge milestone for the company, with two launches in one year," said Timothy Walbert, president and chief executive officer. "Not many big companies can get two products approved in a year."

Rayos was designed for patients to take before they go to bed. The drug’s proprietary outer layer dissolves slowly in the digestive system, releasing the common pain-relieving steroid prednisone after four hours when patients need it most. Patients with rheumatoid arthritis often experience pain in the overnight hours and stiffness in the morning.

Horizon gained FDA approval for its other drug, the pain reliever Duexis, last year.

Sales, however, have been slow. Horizon, which has yet to turn a profit, said it lost $23.7 million, or 98 cents a share, in its most recent quarter on just $2.5 million in sales.

Walbert, a former Abbott Laboratories vice president who helped bring the blockbuster drug Humira to market, said Duexis is showing promise, with sales increasing each week. He also said a pact signed last month with Mallinckrodt, the Hazelwood, Mo.-based pharmaceutical arm of Covidien PLC, will help the drug gain widespread exposure among doctors, who drive sales.

Under terms of the deal, Mallinckrodt will begin marketing Duexis starting in August, effectively doubling Horizon’s U.S. sales force to 150, Walbert said.

Walbert, who took over as Horizon’s chief executive in 2008, has raised more than $250 million for the company to help acquire the two drugs and usher each through late-stage trials. Horizon, which was formed in April 2010 after a merger between Horizon Therapeutics Inc. and Nitec Pharma A.G., a Swiss firm, now has about 200 employees, including about 80 in its corporate headquarters in Deerfield. That’s up from about 20 when it issued its IPO last July.

Walbert said he’ll continue to look for "these types of deals to broaden the company," noting that Horizon is particularly interested in seeking mergers or acquisitions with other small companies that have near-market products.

Cowen & Co., which maintains an "outperform" rating for the company, has praised Horizon for making "impressive progress" with Duexis since its commercial launch in December.

Cowen analysts Edward Nash and Yun Zhong warned in a May research note that the market for both of Horizon’s drugs is crowded with stronger competitors with deeper pockets.

But they’re still bullish on the firm. "Horizon has a strong management team that distinguishes itself by having worked on developing and launching (pain relief drugs) for most of their careers," the analysts said. "We believe this is key to the overall successful launch of the products and therefore the success of Horizon."

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(c)2012 the Chicago Tribune

Visit the Chicago Tribune at www.chicagotribune.com

Distributed by MCT Information Services

FDA OKs Horizon Pharma's time-release painkiller [Chicago Tribune]

From Chicago Tribune (IL) (July 27, 2012)

July 26--The Food and Drug Administration on Thursday gave the suburban biotech company Horizon Pharma Inc. the thumbs up on a new anti-inflammatory drug, the second the company will bring to market.

Deerfield-based Horizon won approval to sell Rayos, a delayed-release version of the corticosteroid drug prednisone, which is sold in Europe under the brand name Lodotra by Horizon’s Swiss-based partner Mundipharma.

Although Horizon sought FDA approval for rheumatoid arthritis, the FDA’s ruling allows the drug to be sold for treatment of a broad range of indications.

"This is a huge milestone for the company, with two launches in one year," said Timothy Walbert, president and chief executive officer. "Not many big companies can get two products approved in a year."

Rayos was designed for patients to take before they go to bed. The drug’s proprietary outer layer dissolves slowly in the digestive system, releasing the common pain-relieving steroid prednisone after four hours when patients need it most. Patients with rheumatoid arthritis often experience pain in the overnight hours and stiffness in the morning.

Horizon gained FDA approval for its other drug, the pain reliever Duexis, last year.

Sales, however, have been slow. Horizon, which has yet to turn a profit, said it lost $23.7 million, or 98 cents a share, in its most recent quarter on just $2.5 million in sales.

Walbert, a former Abbott Laboratories vice president who helped bring the blockbuster drug Humira to market, said Duexis is showing promise, with sales increasing each week. He also said a pact signed last month with Mallinckrodt, the Hazelwood, Mo.-based pharmaceutical arm of Covidien PLC, will help the drug gain widespread exposure among doctors, who drive sales.

Under terms of the deal, Mallinckrodt will begin marketing Duexis starting in August, effectively doubling Horizon’s U.S. sales force to 150, Walbert said.

Walbert, who took over as Horizon’s chief executive in 2008, has raised more than $250 million for the company to help acquire the two drugs and usher each through late-stage trials. Horizon, which was formed in April 2010 after a merger between Horizon Therapeutics Inc. and Nitec Pharma A.G., a Swiss firm, now has about 200 employees, including about 80 in its corporate headquarters in Deerfield. That’s up from about 20 when it issued its IPO last July.

Walbert said he’ll continue to look for "these types of deals to broaden the company," noting that Horizon is particularly interested in seeking mergers or acquisitions with other small companies that have near-market products.

Cowen & Co., which maintains an "outperform" rating for the company, has praised Horizon for making "impressive progress" with Duexis since its commercial launch in December.

Cowen analysts Edward Nash and Yun Zhong warned in a May research note that the market for both of Horizon’s drugs is crowded with stronger competitors with deeper pockets.

But they’re still bullish on the firm. "Horizon has a strong management team that distinguishes itself by having worked on developing and launching (pain relief drugs) for most of their careers," the analysts said. "We believe this is key to the overall successful launch of the products and therefore the success of Horizon."

------

(c)2012 the Chicago Tribune

Visit the Chicago Tribune at www.chicagotribune.com

Distributed by MCT Information Services


 

Posted: July 2012


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