Jazz Pharmaceuticals (JAZZ) - Jazz it UP!!!

About Jazz Pharmaceuticals Inc.
JAZZ is a Palo Alto-based (California) specialty pharmaceutical company engaged in identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. The firm's objective is to build a expansive portfolio of products through a combination of internal development and acquisition/in-licensing activities and to utilize its specialty sales resources to promote products in target markets. Jazz Pharmaceuticals applies novel formulations and drug delivery technologies to pre-approved drug compounds, and compounds with the same mechanism of action or similar chemical structure as marketed products, to enhance patient care by improving efficacy, minimizing adverse side effects or increasing patient compliance relative to existing therapies.


Trading Catalyst
FDA Advisory Panel Meeting - August 20, 2010
PDUFA Date - October 11, 2010

What is sodium oxybate?
Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM (sodium oxybate) oral solution, approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

What is fibromyalgia?
Fibromyalgia is a chronic condition characterized by widespread pain. Fibromyalgia is believed to be a central nervous system condition, resulting from neurological changes in how the brain perceives and responds to pain. In addition to pain, the main symptoms are fatigue, disturbed sleep and morning stiffness. The exact causes of fibromyalgia are unknown. It may be triggered by physical trauma, emotional stress, chronic pain or infection. Genetics, neurochemicals that affect pain modulation, neurohormones and sleep physiology abnormalities are thought to play a role. Research also has suggested a relationship between sleep and pain. Fibromyalgia patients experience a high prevalence of sleep problems, including a reduction in non-restorative or deep sleep.

Drug in Spotlight - JZP-6 (sodium oxybate)
The U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

Clinical Data
On Dec. 15, 2009, JAZZ submitted an New Drug Application (NDA) for JZP-6 based on a comprehensive clinical development program for the drug, including results from two Phase III clinical trials.

In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change (in activity limitations, symptoms, emotions, and overall quality of life), and sleep quality. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

Recent Stock Trend

An upward momentum is apparent in advance of the catalyst date of Aug 20. JAZZ closed at $8.74 today on a volume of 658,701 (avg 557,000). It appears that $8.75 may be the current resistance as the stock price touched and retracted from this level on many occasions in the past 10 days. If this resistance is broken, we'll be in for a wild ride up before Aug. 20 arrives. Given that the price is at a 'transient peak' as of today, I do think that the entry point should be aimed lower at around $8.40-8.50.