Wed, Jan. 14, 11:13 AM
- At JPM15, Jazz Pharmaceuticals (JAZZ +4.5%) Chairman and CEO Bruce Cozadd said that he expects 2014 revenues to come in at the upper range of previously-reported guidance of $1.15B - 1.17B.
- Also, he sees Xyrem sales at the upper end of $765M - 780M and Erwinaze/Erwinase at the upper end of $190M - 200M.
Dec. 19, 2014, 1:13 PM
- Thinly-traded small cap Flamel Technologies (FLML +12%) heads north in response to its announcement that it achieved its objective of a single before-bedtime dose of sodium oxybate using its proprietary Micropump technology. A single dose option for sufferers of narcolepsy would eliminate a second dose 2.5 to 4 hours later that is necessary with the current standard of care, Jazz Pharmaceuticals' (JAZZ -0.9%) Xyrem (sodium oxybate). This would be more convenient and would eliminate the disruption in sleep.
- Flamel plans to meet with the FDA before mid-2015 to clarify a regulatory path.
Dec. 12, 2014, 1:28 PM
- Jazz Pharmaceuticals (JAZZ -3.4%) initiates its rolling submission of its New Drug Application (NDA) to the FDA for Fast Track-designated defibrotide for the treatment of severe hepatic veno-occlusive disease (VOD). The company expects to complete its filing in the first half of next year.
- The Fast Track process allows for a company to submit individual sections of its NDA in order to expedite regulatory review. The FDA has also tagged defibrotide an Orphan Drug for VOD so it will have a seven-year period of market exclusivity if approved.
- Jazz obtained the U.S. rights to defibrotide from Sigma-Tau Pharmaceuticals that obtained the rights from Gentium S.p.A. Jazz acquired Gentium a year ago.
- Previously: Jazz to acquire Gentium in $1B deal (Dec. 19, 2013)
Dec. 2, 2014, 4:50 PM
- Jazz Pharmaceuticals (NASDAQ:JAZZ) enrolls the first patients in a Phase 3 clinical trial evaluating the safety and efficacy of Xyrem (sodium oxybate) in young patients aged seven to 17 who have narcolepsy with cataplexy.
- Xyrem is currently approved for use in adults with the same condition.
- The 52-week randomized, double-blind study will enroll up to 100 pediatric patients at sites in the U.S. and several countries in Europe. The press release also states that the trial is open label (both patients and investigators know what is being administered) which is impossible if it is double-blind (neither know).
- The primary efficacy endpoint is the change in cataplexy attacks over two weeks (double-blind). Safety will be measured over 52 weeks in what may be the open label portion.
Nov. 4, 2014, 4:22 PM
Nov. 3, 2014, 5:35 PM
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Aug. 19, 2014, 5:37 PM
Aug. 5, 2014, 5:55 PM
- Jazz Pharmaceuticals (JAZZ -1.5%) Q2 results: Total revenues: $291.2M (+39.8%); Operating Expenses: $216.9M (+65.3%); Operating Income: $74.3M (-3.6%); Net Income: $43.6M (+3.3%); EPS: $0.70 (+1.4%); Quick Assets: $268.3M (-57.8%).
- Product sales: Xyrem: $191.4M (+43.2%); Erwinaze/Erwinase: $47.9M (+6.7%); Defitelio/defibrotide: $20.2M.
- 2014 Guidance: Revenues: $1,125M - 1,165M; net product sales: $1,125M - 1,165M; Xyrem sales: $765M - 780M; GAAP EPS: $0.47 - 0.90; non-GAAP EPS: $8.00 - 8.25.
Aug. 5, 2014, 4:11 PM
Aug. 4, 2014, 5:35 PM
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Jul. 28, 2014, 8:35 AM
- CANbridge Life Sciences enters into an exclusive partnership with Jazz Pharmaceuticals' (NASDAQ:JAZZ) EUSA Pharma to commercialize Caphosol in China.
- Caphosol is an oral electrolyte solution designed to moisten, lubricate and clean the oral cavity. It is indicated for dryness of the mouth or throat regardless of the cause or whether the condition is temporary or permanent.
- Financial terms are not disclosed.
Jul. 2, 2014, 8:43 AM
- Jazz Pharmaceuticals (JAZZ) acquires the rights to defibrotide from Sigma-Tau Pharmaceuticals for the U.S. and all other countries in the Americas. Sigma-Tau held the rights on the basis of an agreement with Gentium S.p.A (GENTY) which Jazz acquired in December 2013.
- Jazz markets Defibrotide in Europe under the brand name Defitelio for the treatment of severe hepatic veno-occlusive disease (VOD) in patients over one month of age undergoing hematopoietic stem cell transplantation therapy. The company is working with the FDA on a regulatory pathway for defibrotide as a treatment for severe VOD.
- Under the terms of the agreement, Sigma-Tau receives an upfront payment of $75M when the transaction closes, $25M in milestone payments upon the FDA's acceptance of the NDA for VOD and up to $150M based on the timing of FDA clearance. Jazz expects to fund the deal with cash on hand. The transaction will close in Q3.
Jun. 2, 2014, 3:41 PM
- Jazz Pharmaceuticals' (JAZZ +0.1%) JZP-110 (formerly ADX-NO5), an investigational drug for the treatment of the symptoms of excessive daytime sleepiness in adults with narcolepsy, meets all primary and secondary endpoints in a Phase 2b clinical trial. The company plans to proceed with a Phase 3 trial after regulatory approval.
- In the 12-week Phase 2b study, 93 narcolepsy patients were randomized between placebo and a regimen of JZP-110 of 150 mg/day for four weeks followed by 300 mg/day for eight weeks.
- Sleep onset latency (SOL) was 1.4 minutes for placebo compared 9.5 minutes for JZP-110 at 4 weeks and 2.1 minutes for placebo compared to 12.8 minutes at 12 weeks. Clinical global impression change (symptoms "much improved" or "very much improved") was 51% for placebo compared to 80% at 4 weeks and 38% for placebo compared to 86% at 12 weeks. Epworth sleepiness scale (decrease in overall sleepiness) improved at 4 weeks (-5.6 vs -2.4 (placebo) and 8 weeks (-8.5 vs -2.5 (placebo).
- Jazz acquired the rights to the drug from Aerial BioPharma in early 2014.
May 19, 2014, 3:26 PM
May 9, 2014, 9:17 AM
May 8, 2014, 5:49 PM
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