Catherine Sohn Elected To Jazz Pharmaceuticals Board Of Directors

Jazz Pharmaceuticals plc JAZZ -0.93% today announced the election of Catherine Angell Sohn, Pharm.D., CLP, to its board of directors at the company's annual meeting of shareholders held on July 27, 2012. 

"Cathy has extensive product and business development experience and brings a strong patient-focused perspective to our board," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "As we strengthen our operations in both the United States and Europe, continue to optimize our commercial activities and evaluate product development strategies for the future, Cathy will add tremendous value." 

Catherine Angell Sohn, Pharm.D., CLP, is the founder of Sohn Health Strategies where she consults for pharmaceutical, biotechnology, medical device, and consumer healthcare companies in the areas of business strategy, business development and strategic product development. She currently serves on the boards of Ariel Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, and The Dohmen Company, a privately held provider of business services to life science companies. She also serves on the Dean's Advisory Council for Drexel University School of Public Health, the Ben Franklin Technology Partners Investment Advisory Committee, Ernst & Young's global Life Science Advisory Board, Springboard Enterprises Life Science Council and the global advisory board of the Healthcare Businesswomen's Association. 

From 1982 to 2010, Dr. Sohn was with GlaxoSmithKline plc (and with SmithKline Beecham plc before its merger with GlaxoWellcome plc), where she served most recently as senior vice president, worldwide business development and strategic alliances in the GSK Consumer Healthcare division. Previously, she held a series of positions in medical affairs, pharmaceutical business development, U.S. product marketing, and global strategic product development in the pharmaceutical division. She also previously served on the boards of multiple non-profit organizations, including two terms on the Health Advisory Board for the Johns Hopkins University Bloomberg School of Public Health and as vice chair of the Corporate Executive Board of the Philadelphia Museum of Art. 

Dr. Sohn started her career as Assistant Professor of Clinical Pharmacy at the University of the Sciences in Philadelphia, where she currently holds the position of Dean's Professor. She received a Pharm.D. from the University of California, San Francisco, School of Pharmacy. She also received a Certificate of Professional Development from The Wharton School at the University of Pennsylvania.

Jazz Pharmaceuticals Announces Fourth Quarter and Full Year 2010 Results

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the fourth quarter and full year ended December 31, 2010. Total revenues for the fourth quarter of 2010 were $53.4 million, compared to $38.3 million for the fourth quarter of 2009. Full year 2010 revenues were $173.8 million, up 35 percent compared to revenues of $128.4 million for 2009. GAAP net income for the fourth quarter of 2010 was $24.5 million, or $0.56 per diluted share, compared to $5.7 million, or $0.17 per diluted share, for the fourth quarter of 2009. GAAP net income for 2010 was $32.8 million, or $0.83 per diluted share, compared to a 2009 GAAP net loss of $6.8 million, or $0.23 per diluted share. Adjusted net income for the fourth quarter of 2010 was $27.2 million, or $0.63 per diluted share, compared to $10.8 million, or $0.33 per diluted share, for the fourth quarter of 2009. Adjusted net income for 2010 was $61.0 million, or $1.55 per diluted share, compared to a 2009 adjusted net loss of $1.5 million, or $0.05 per diluted share. A reconciliation of GAAP net income (loss) to adjusted net income (loss) and the related per diluted share amounts is included with this press release.Net sales of Xyrem® (sodium oxybate) oral solution increased 36 percent to $42.9 million for the fourth quarter of 2010, compared to net sales of $31.6 million for the fourth quarter of 2009. Xyrem net sales for 2010 increased 47 percent to $142.6 million, compared to $96.8 million in net sales for 2009. Net sales of once-daily Luvox CR® (fluvoxamine maleate) increased to $9.4 million for the fourth quarter of 2010, compared to $5.7 million for the fourth quarter of 2009. Luvox CR net sales for 2010 increased to $27.4 million, compared to 2009 net sales of $18.3 million. Both fourth quarter and full year 2010 net sales of Luvox CR include $2.0 million of revenue recorded as a result of a change in the timing of when revenue is recognized; the company now records Luvox CR sales upon shipment to distributors net of estimated returns. The profit associated with this change has been excluded from the company's fourth quarter and full year 2010 adjusted net income."In 2010, our first full year of profitability, our progress included strengthening our balance sheet, enhancing our commercial business management team, significantly increasing Xyrem sales, and broadening our patent protection for sodium oxybate," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We look forward to improving our performance in 2011, as we continue to grow and protect our Xyrem business and advance our intranasal clonazepam product candidate for acute repetitive seizures in epilepsy patients."Research and development expenses for the fourth quarter of 2010 were $4.1 million, compared to $6.3 million for the fourth quarter of 2009. Research and development expenses in 2010 were $25.6 million, compared to $36.6 million for 2009. Selling, general and administrative expenses for the fourth quarter of 2010 were $17.1 million, compared to $15.7 million for the fourth quarter of 2009. In 2010, selling, general and administrative expenses were $69.0 million, compared to $58.7 million for 2009. Interest expense for the fourth quarter of 2010 was $1.1 million, compared to $5.8 million for the prior year period. Interest expense in 2010 was $12.7 million, compared to $22.8 million in 2009. As of December 31, 2010, cash and cash equivalents were $44.8 million, an increase from $22.9 million at September 30, 2010.

Jazz Pharmaceuticals to Present at the J.P. Morgan Healthcare Conference in San Francisco on January 12

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the company will make a presentation at the J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 12, 2011 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time. Bruce Cozadd, the company's chairman and chief executive officer, will provide a business and financial update.

Jazz Pharmaceuticals Announces New Patent Issued for Sodium Oxybate

Jazz Pharmaceuticals Inc. announced in a press release that the United States Patent and Trademark Office (USPTO) has issued a patent related to Xyrem(R) (sodium oxybate) oral solution titled "Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy." The new patent, number 7,851,506, is also listed in the FDA's Approved Drug Products List (the Orange Book).

In addition to the newly issued patent, Xyrem is protected by seven other patents related to the product's formulation and Jazz Pharmaceuticals' distribution system. Six issued patents are now listed in the Orange Book. These patents expire from 2019 to 2024.

"Enhancing and enforcing the intellectual property coverage for Xyrem is an important strategic priority for our company," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.

Jazz Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry.

Jazz Pharmaceuticals Announces New Patent Issued for Sodium Oxybate

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that the United States Patent and Trademark Office (USPTO) has issued a patent related to Xyrem® (sodium oxybate) oral solution titled "Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy." The new patent, number 7,851,506, is also listed in the FDA's Approved Drug Products List (the Orange Book).

In addition to the newly issued patent, Xyrem is protected by seven other patents related to the product's formulation and Jazz Pharmaceuticals' distribution system. Six issued patents are now listed in the Orange Book. These patents expire from 2019 to 2024.

"Enhancing and enforcing the intellectual property coverage for Xyrem is an important strategic priority for our company," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.

Jazz Pharmaceuticals Swings To Q3 Profit; Boosts 2010 Outlook; Shares Up 13%

Specialty pharmaceutical company Jazz Pharmaceuticals, Inc. reported Thursday a profit for the third quarter compared to a loss last year, boosted by strong sales growth across both its products, Xyrem and Luvox. Both adjusted earnings per share and quarterly revenues came in above analysts' expectations.

The company's stock was up 13% in after-hours trading after it significantly raised earnings and product sales forecast for the full-year 2010, citing higher projected sales of Xyrem and lower expected expenses.

The Palo Alto, California-based company reported net income of $13.24 million or $0.32 per share for the third quarter, compared to a net loss of $1.67 million or $0.05 per share for the prior-year quarter.

Excluding items, adjusted net income for the third quarter climbed to $17.25 million or $0.41 per share from $2.11 million or $0.06 per share in the prior year quarter.

On average, four analysts polled by Thomson Reuters expected the company to earn $0.34 per share for the third quarter. Analysts' estimates typically exclude special items.

Total revenues for the quarter increased 45% to $44.75 million from $30.81 million in the same quarter last year, and topped four Wall Street analysts' consensus estimate of $42.63 million.

Net product sales for the third quarter surged 46% to a record $43.84 million from $30.0 million in the prior-year quarter.

Jazz Pharma Loses Fibromyalgia Drug Approval, Still on our Top Pharmaceutical Stocks List

Drug maker Jazz Pharmaceuticals Inc. (NASDAQ: JAZZ) said it failed to get an FDA nod for its JZP-6 (sodium oxybate), a potential treatment for fibromyalgia. The U.S. health regulator, in its complete response letter, informed the Palo Alto, Calif.-based company that additional clinical studies of JZP-6 would be required and that the agency wanted more information on the appropriate fibromyalgia patient population, methods to ensure the drug’s safe use, dosage and a risk management plan.

Monday’s news did not come as a great surprise given that a joint advisory committee in August voted against the approval of JZP-6 amid risks of drug abuse and accidental overdose. JZP-6 is a close relative of gamma-hydroxybutyric acid (GHB), which has been used as a club drug.

Since 2002, Jazz has been selling JZP-6 as a treatment for sleep disorders under the brand name Xyrem. It also markets Luvox CR (fluvoxamine maleate) for the treatment of both obsessive-compulsive disorder and social anxiety disorder.

Jazz is focused on the development and commercialization of pharmaceutical products to meet unmet medical needs in neurology and psychiatry. Expanding its market to include fibromyalgia would be a significant growth opportunity for the drug maker. Fibromyalgia, one of the most common chronic pain conditions, affects an estimated 10 million people in the United States and an estimated 3-6% of the world population, according to the National Fibromyalgia Association.

Following Monday’s negative FDA decision, the company said it has requested a meeting with the FDA in order to discuss and clarify the contents of the complete response letter and will then evaluate its next steps for JZP-6.

“We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA,” Bruce Cozadd, chairman and CEO of Jazz stated in a press release.

So far JAZZ has reached a 52-week low and high of $6.01 and $13.95, respectively. It has a consensus recommendation of Outperform.

FDA Rejects GHB for Fibromyalgia

The FDA has told Jazz Pharmaceutical it can't approve sodium oxybate (JZP-6), also known as GHB, in its current form for treating fibromyalgia.

The FDA listed a number of reasons for the decision, including the need for additional clinical studies, and the need for methods to ensure its "safe use," according to a company press release.

In August an FDA advisory panel voted 20-2 against approval of the drug for a fibromyalgia indication.

The Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee felt the potential for widespread abuse of the "date rape" drug was too great to warrant expanding the indication to a condition that affects an estimated 2% of the U.S. population.

Sodium oxybate, currently approved as Xyrem at a 500 mg/ml dose for narcolepsy-associated cataplexy and excessive daytime sleepiness, is a central nervous system depressant and carries a boxed warning against its use in combination with other similar drugs.

The label information also warns that sodium oxybate is a drug known to be abused. Sodium oxibate is a sodium salt of y-hydroxybutyrate, or GHB.

The committee examined the company's two randomized, double-blind, phase III trials testing sodium oxybate versus placebo.

In FDA documents released in advance of the August panel meeting, FDA reviewers said there was "no question" the drug was effective, but advisory committee members weren't so sure.

Also, panelists were concerned about the drug's odd dosing mechanism, as was the FDA. The drug has an extremely short half-life, so patients must take one dose of a self-mixed solution at bedtime, and set their alarm clocks to wake up and take a second dose four hours later.

Patients taking the drug pass out almost immediately, with no time to even "send an e-mail" as another patient put it.

The dosing apparatus also has the potential for confusion, panelists pointed out. Patients must empty a solution into a small cup and mix it with water. Several people in the study accidentally took a double dose.

GHB was sold without a prescription in health food stores until 1990 when it was classified as a controlled substance by the FDA.

Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals, said his company has requested a meeting with the FDA to discuss the agency's denial.

"We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA," Cozadd said in the press release.

FDA panel say risks of Jazz Pharmaceutical drug outweigh benefits for fibromyalgia

Federal health experts said Friday the risks of a sleep drug from Jazz Pharmaceuticals outweigh its benefits for treating the chronic pain disorder fibroymalgia.

The Food and Drug Administration's panel of outside advisers voted 20-2 against recommending approval of the company's application to market sodium oxybate for fibromyalgia, according to an agency spokeswoman. Fibromyalgia is a little-understood condition characterized by muscle pain and fatigue.

The FDA gives weight to the panel's recommendations, but is not required to follow them. The agency is scheduled to make its final ruling on the drug by Oct. 11.

Stock Alert for Jazz Pharmaceuticals Inc. Issued by MicroStockProfit

MicroStockProfit.com announces an investment report featuring Jazz Pharmaceuticals Inc.The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.ent "JAZZ recently announced financial results for the second quarter ended June 30, 2010, and updated financial guidance for 2010. The Company's updated financial guidance reflects higher expected sales of XYREM(R) (sodium oxybate) and the effects of recent financing activities. Total revenues for the quarter ended June 30, 2010, were $40.5 million, compared to $37.3 million for the quarter ended June 30, 2009. Total revenues included net product sales, royalties and contract revenues.

"JAZZ recently announced that it has prepaid the remaining $63.5 million principal amount of its 15% senior secured notes. The prepayment was made using a combination of borrowings under a new term loan and revolving credit facility with Silicon Valley Bank that closed on June 30, 2010, and cash on hand. The $50 million term loan will amortize in twelve equal quarterly installments of $4.2 million."

Jazz Pharmaceuticals to Present at Two Upcoming Investor Conferences

PALO ALTO, Calif., Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that company management will present a corporate overview at two upcoming investor conferences.

Robert M. Myers, President of Jazz Pharmaceuticals, will speak at the Rodman & Renshaw Annual Global Investment Conference on Thursday, September 10, 2009 at 3:15 p.m. EDT at the Palace Hotel in New York City.

Bruce C. Cozadd, Chairman and CEO of Jazz Pharmaceuticals, will speak at the NewsMakers in the Biotech Industry Conference on Wednesday, September 16, 2009 at 9:00 a.m. EDT, at the Millennium Broadway Hotel in New York City.

EOD Leaders NASDAQ - Jazz Pharmaceuticals

Jazz Pharmaceuticals, Inc.,JAZZ

Jazz Pharmaceuticals, Inc., a specialty pharmaceutical company, develops and commercializes products for neurology and psychiatry primarily in the United States. The company's marketed products include Xyrem for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy; and Luvox CR for obsessive compulsive disorder and social anxiety disorder. Its product candidate in Phase III clinical trials comprise JZP-6 for the treatment of fibromyalgia.

Last Trade: 3.16

Day's Range: 1.68 - 5.10

52wk Range: 0.52 - 8.95

Jazz Pharmaceuticals, Inc. Announces First Quarter 2009 Financial Results

PALO ALTO, Calif., Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the quarter ended March 31, 2009. Total revenues for the first quarter of 2009 were $22.1 million, compared to $14.6 million for the first quarter of 2008. Xyrem(R) (sodium oxybate) oral solution net sales for the first quarter of 2009 were $17.7 million, an increase of 56% over net sales of $11.3 million for the first quarter of 2008. This increase reflects the effect of significant price increases over the past twelve months and sales volume growth. Net sales of once-daily Luvox CR(R) (fluvoxamine maleate) Extended Release Capsules were $3.6 million for the first quarter of 2009.

Jazz Pharmaceuticals' cash and cash equivalents as of March 31, 2009 were $17.0 million. On March 31, 2009, Jazz Pharmaceuticals did not pay $5.1 million in interest due to the holders of the $119.5 million principal amount of its senior secured notes due June 2011, and Jazz Pharmaceuticals remains in default on the notes. The total overdue interest due on the notes through March 31, 2009 is $9.6 million.

"Our focus for the remainder of 2009 will be on increasing sales of our commercial products for their approved indications and submitting the NDA (New Drug Application) for JZP-6, our sodium oxybate product currently in Phase III clinical trials for the treatment of fibromyalgia," said Bruce Cozadd, Chairman and Chief Executive Officer. "We are pleased to report that we have completed the second pivotal trial for JZP-6 and expect to announce the results in mid-2009. We remain on track to submit our NDA for JZP-6 by the end of the year," he continued.

Research and development expenses for the first quarter of 2009 were $11.4 million, compared to $21.2 million for the first quarter of 2008. Reduced expenses in the first quarter of 2009 reflect Jazz Pharmaceuticals' decision that its JZP-4, JZP7, and JZP-8 programs will continue to the next phase of development only upon partnering or other funding for the programs.

Selling, general and administrative expenses for the first quarter of 2009 were $14.2 million, compared to $32.8 million for the first quarter of 2008. The decrease in the first quarter of 2009 reflects a decrease in spending on Luvox CR and the 2008 reductions in force.

Jazz Pharmaceuticals' net loss for the first quarter of 2009 was $13.0 million, compared to a net loss of $46.7 million for the first quarter of 2008.