- Product Sales of $90 Million to $120 Million Expected in 2008 - Initial Results from JZP-6 Phase III Clinical Trial Expected by Year End - New Data Provided on Pipeline and Early-Stage Development Portfolio
- 2008 Financial Guidance Provided
PALO ALTO, Calif., March 13 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today provided a comprehensive update on its commercial activities and near-term product development pipeline, and provided 2008 financial guidance, for investors and analysts at its Investor Day meeting in New York City.
"Jazz Pharmaceuticals' strategy combines a strong commercial presence with a rapidly advancing product development pipeline addressing important patient needs in neurological and psychiatric disorders," said Samuel R. Saks, M.D., Chief Executive Officer. "With the anticipated launch of LUVOX CR later this month, continued strong performance from our XYREM sales efforts, top-line results from our first Phase III clinical study of JZP-6 for fibromyalgia syndrome and progress across our R&D portfolio, 2008 is positioned to be a transformational year for Jazz Pharmaceuticals."
Jazz Pharmaceuticals expects to launch once daily LUVOX(R) 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(R) (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.
Development-Stage Portfolio Updates
Jazz Pharmaceuticals announced that it has achieved more than 80 percent enrollment in the first of two ongoing Phase III clinical trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia syndrome. Enrollment in the first Phase III trial is expected to be completed during the next several months. Jazz Pharmaceuticals plans to announce top-line results from this Phase III clinical trial by year end. The second Phase III clinical trial of JZP-6, with clinical sites in the U.S., Canada, Europe and South America, is approximately 30 percent enrolled. With successful results from these trials, Jazz Pharmaceuticals expects to submit a New Drug Application (NDA) to the FDA by the end of 2009. Fibromyalgia syndrome affects 6 to 12 million patients in the U.S., many of whom are treated with a polypharmacy approach and continue to look for new treatment options.
"In 2007, we made extraordinary progress in our later-stage development programs, which we have carefully selected to address significant unmet neurological and psychiatric medical needs in fibromyalgia syndrome, restless legs syndrome, recurrent acute repetitive seizures, epilepsy and bipolar disorder," said Dr. Saks. "These clinical programs are on track with our portfolio-building objectives, and we continue to add early-stage projects to expand our pipeline."
Jazz Pharmaceuticals announced that JZP-7, a proprietary transdermal gel formulation of ropinirole, is designed to provide an effective, once-a-day treatment of moderate to severe restless legs syndrome. JZP-7 has been successfully evaluated in one pharmacokinetic (PK) study, and a second PK study is near completion. Available results from both studies demonstrate that the product is well tolerated. Jazz Pharmaceuticals is currently planning to initiate a Phase III clinical trial in the fourth quarter of 2008. Restless legs syndrome affects up to 10 percent of the U.S. population.
Jazz Pharmaceuticals' product candidate for the treatment of recurrent acute repetitive seizures in patients with epilepsy, JZP-8, is designed to be a fast-acting intranasal spray providing a socially-acceptable treatment option. As previously announced, Jazz Pharmaceuticals has received orphan drug designation from the FDA for JZP-8. This novel formulation incorporates clonazepam, a widely prescribed benzodiazepine indicated for the chronic treatment of epilepsy. In December 2007, Jazz Pharmaceuticals dosed the first patient in an ongoing Phase II clinical trial of JZP-8. Assuming successful results from the Phase II trial, Jazz Pharmaceuticals expects to initiate a Phase III clinical development program for JZP-8 in the first half of 2009.
Jazz Pharmaceuticals' product candidate for once-daily treatment of epilepsy and bipolar disorder, JZP-4, incorporates a new chemical entity that inhibits both sodium and calcium channels in vitro and has shown efficacy in animal models. Two proof-of-concept clinical studies in healthy volunteers and patients demonstrated activity in well-validated epilepsy models. Jazz Pharmaceuticals plans to begin enrolling subjects in a Phase II trial of JZP-4 for the treatment of epilepsy during the third quarter of 2008.
Jazz Pharmaceuticals also disclosed three additional early-stage programs: a solid oral dosage form of sodium oxybate; a new chemical entity that is a structural analog of valproic acid for the treatment of epilepsy and bipolar disorder; and a new chemical entity that is a triple reuptake inhibitor for major depressive disorder. Both of the new chemical entities are in early feasibility studies and Jazz Pharmaceuticals has established clear targets to advance them into full development.
Jazz Pharmaceuticals provided guidance forecasting selling, general and administrative expenses during 2008 to be in the range of $130 million to $140 million, reflecting the expanded sales force, launch activities related to LUVOX CR and costs associated with being a public company. Research and development spending during 2008 is expected to be in the range of $60 million to $70 million.
Jazz Pharmaceuticals also announced that it has amended its agreement with Solvay Pharmaceuticals, Inc., to defer the payment of milestones triggered by the approval and launch of LUVOX CR.
A webcast of Jazz Pharmaceuticals' Investor Day is available on the investor relations section of Jazz Pharmaceuticals' web site at http://www.JazzPharmaceuticals.com.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information see http://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the launch of LUVOX CR, future performance from XYREM sales efforts, future progress in Jazz Pharmaceuticals' research and development portfolio, future results from clinical trials and the timing thereof, commencement of additional clinical trials and submission of applications for regulatory approval and the timing thereof, the therapeutic and commercial potential of Jazz Pharmaceuticals' product candidates in development, future financial results and financing. Words and phrases such as "will," "positioned," "projects," "plan," "expect" and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Jazz Pharmaceuticals' current expectations. Forward-looking statements involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to when or whether commercial launch of LUVOX CR will occur; Jazz Pharmaceuticals' dependence on single source suppliers and manufacturers and the need to manufacture LUVOX CR in commercial quantities; Jazz Pharmaceuticals' ability to attain market acceptance of LUVOX CR by physicians, patients and third party payors and to increase sales of XYREM; the conduct of Phase III clinical trials of JZP-6 and other product candidates and the results thereof; Jazz Pharmaceuticals' need for additional funding; regulatory requirements and competition. These and other risk factors are discussed under "Risk Factors," in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on November 9, 2007. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
|SOURCE Jazz Pharmaceuticals, Inc.|
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