PALO ALTO, Calif., March 13 JazzPharmaceuticals, Inc. (Nasdaq: JAZZ) today provided a comprehensive update onits commercial activities and near-term product development pipeline, andprovided 2008 financial guidance, for investors and analysts at its InvestorDay meeting in New York City.
"Jazz Pharmaceuticals' strategy combines a strong commercial presence witha rapidly advancing product development pipeline addressing important patientneeds in neurological and psychiatric disorders," said Samuel R. Saks, M.D.,Chief Executive Officer. "With the anticipated launch of LUVOX CR later thismonth, continued strong performance from our XYREM sales efforts, top-lineresults from our first Phase III clinical study of JZP-6 for fibromyalgiasyndrome and progress across our R&D portfolio, 2008 is positioned to be atransformational year for Jazz Pharmaceuticals."
Jazz Pharmaceuticals expects to launch once daily LUVOX(R) CR (fluvoxaminemaleate) Extended-Release Capsules with shipments to wholesalers by the end ofMarch. 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 towholesalers at $3.25 per capsule for 100 mg and 150 mg strengths. Ex-factorysales of LUVOX CR are expected to be in the range of $40 million to $60million during 2008.
"Obsessive compulsive disorder and social anxiety disorder are two veryserious and debilitating anxiety disorders that affect millions of patients inthe U.S. We are excited to be near the launch of a product that has beenproven safe and effective for treating both of these conditions," said RobertM. Myers, Jazz Pharmaceuticals' President. "A comprehensive commercializationplan, including physician education, pricing and reimbursement andmanufacturing and distribution, is in place. Jazz Pharmaceuticals' salesforce of approximately 200 experienced professionals has been trained and isready 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(R)(sodium oxybate) for the treatment of excessive daytime sleepiness andcataplexy in patients with narcolepsy to sleep specialists, neurologists andpsychiatrists. XYREM net sales increased by 34 percent, from $29 million in2006 to $39 million in 2007. XYREM net sales are expected to be in the rangeof $45 million to $55 million during 2008.
Jazz Pharmaceuticals projects sales of products in 2008 between $90million and $120 million, with gross margin on net product sales ofapproximately 80 percent.
"2007 was a year of strong accomplishments, with increased sales and brandawareness for XYREM and the expansion of our commercial organization inpreparation for the pending launch of LUVOX CR," added Mr. Myers.
Development-Stage Portfolio Updates
Jazz Pharmaceuticals announced that it has achieved more than 80 percentenrollment in the first of two ongoing Phase III clinical trials of JZP-6(sodium oxybate) for the treatment of fibromyalgia syndrome. Enrollment inthe first Phase III trial is expected to be completed during the next severalmonths. Jazz Pharmaceuticals plans to announce top-line results from thisPhase III clinical trial by year end. The second Phase III clinical trial ofJZP-6, with clinical sites in the U.S., Canada, Europe and South America, isapproximately 30 percent enrolled. With successful results from these trials,Jazz Pharmaceuticals expects to submit a New Drug Application (NDA) to the FDAby the end of 2009. Fibromyalgia syndrome affects 6 to 12 million patients inthe U.S., many of whom are treated with a polypharmacy approach and continueto look for new treatment options.
"In 2007, we made extraordinary pro