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Luvox CR

Posted by brooke484 on March 22, 2008, at 12:54:57

03/13/2008 | Press Release

JAZZ PHARMACEUTICALS, INC. ANNOUNCES LUVOX CR LAUNCH PLANS

PALO ALTO, Calif., March 13, 2008 -- Jazz Pharmaceuticals expects to launch once daily LUVOX® CR (fluvoxamine maleate) Extended-Release Capsules with shipments to wholesalers by the end of March. The product was approved by the U.S. Food and Drug Administration (FDA) on February 28, 2008 for the treatment of obsessive compulsive disorder (OCD) and social anxiety disorder (SAD). LUVOX CR will be priced to wholesalers at $3.25 per capsule for 100 mg and 150 mg strengths. Ex-factory sales of LUVOX CR are expected to be in the range of $40 million to $60 million during 2008.

Obsessive compulsive disorder and social anxiety disorder are two very serious and debilitating anxiety disorders that affect millions of patients in the U.S. We are excited to be near the launch of a product that has been proven safe and effective for treating both of these conditions, said Robert M. Myers, Jazz Pharmaceuticals President. A comprehensive commercialization plan, including physician education, pricing and reimbursement and manufacturing and distribution, is in place.

Jazz Pharmaceuticals sales force of approximately 200 experienced professionals has been trained and is ready to promote LUVOX CR to psychiatrists for the treatment of OCD and SAD. We look forward to a successful launch.

Jazz Pharmaceuticals sales representatives currently promote XYREM® (sodium oxybate) for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy to sleep specialists, neurologists and psychiatrists. XYREM net sales increased by 34 percent, from $29 million in 2006 to $39 million in 2007. XYREM net sales are expected to be in the range of $45 million to $55 million during 2008.

Jazz Pharmaceuticals projects sales of products in 2008 between $90 million and $120 million, with gross margin on net product sales of approximately 80 percent.

2007 was a year of strong accomplishments, with increased sales and brand awareness for XYREM and the expansion of our commercial organization in preparation for the pending launch of LUVOX CR, added Mr. Myers.


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