Jazz Pharmaceuticals, Inc. provided a comprehensive update on its commercial activities and near-term product development pipeline, and provided 2008 financial guidance 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 CR (fluvoxamine maleate) extended-release capsules with shipments to wholesalers by the end of March. The product was approved by the US 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 US. 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, president, Jazz Pharmaceuticals. "A comprehensive commercialisation 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' Xyrem (sodium oxybate), for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, net sales increased by 34 per cent, 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 per cent.
"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 Myers.
Jazz Pharmaceuticals announced that it has achieved more than 80 per cent enrolment in the first of two ongoing phase III clinical trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia syndrome. Enrolment in the first phase III trial is expected to be completed during the next several months. It also 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 US, Canada, Europe and South America, is approximately 30 per cent 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 US, 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 programmes 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 per cent of the US 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 programme 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.
The company 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.