Tue, Nov. 10, 9:13 AM
Wed, Jan. 14, 11:51 AM
- Flamel Technologies (FLML -25%) drops on a 6x surge in volume in apparent response a favorable ruling from the USPTO for Jazz Pharmaceuticals (JAZZ +3.1%) and against the petitions from Par Pharmaceuticals, Roxane Labs and Amneal Pharmaceuticals. The decision reaffirmed the validity of four patents related to Xyrem (#'s 7,895,059, 8,457,988, 7,668,730, 8,589,182).
- In October, Canaccord Genuity analyst John Newman published a research report reiterating his Buy recommendation on Jazz Pharmaceuticals (JAZZ +3.8%) with a $163 price target based on his view that Flamel's NDA for its once-daily version of Xyrem (sodium oxybate), to be filed under the 505(NYSE:B)(2) paragraph IV pathway, will reference Jazz's orange book-listed patents. This will trigger a lawsuit and and an automatic 30-month stay of approval.
- The delay will give Jazz more time to develop its once-daily version, JZP-386, which should enter Phase 2 this year.
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.
Aug. 19, 2014, 5:37 PM
May 9, 2014, 9:17 AM
May 8, 2014, 5:49 PM
Mar. 28, 2014, 7:35 AM
- Shares of Aria Pharmaceuticals (ARIA) are up 7% in premarket trading on rumors that Jazz Pharmaceuticals (JAZZ) is mulling a buyout for as much as $20/share versus yesterday's close of $7.60. This would value the acquisition at ~$3.6B.
- Consensus 2014 and 2015 revenue estimates for ARIA are $87.9M and $158.4M, respectively.
- 287 mutual funds own ARIA, down from 505 a year earlier.
Feb. 26, 2014, 9:16 AM
Feb. 25, 2014, 4:33 PM
- Along with its Q4 results, Jazz Pharma (JAZZ) announces CFO Kathryn Falberg is resigning, effective March 9, to "pursue other interests." Corporate development SVP Matthew Young is replacing Falberg.
- Jazz expects 2014 revenue of $1.1B-$1.16B and EPS of $8-$8.25 vs. a consensus of $1.08B and $8.07. Xyrem net sales are expected to total $755M-775M, and Erwinaze/Erwinase net sales $185M-$200M.
- Xyrem net sales +45% Y/Y in Q4 to $164.2M, Erwinaze/Erwinase net sales +26% to $43.5M. Opex +25% to $75.5M.
- Q4 results, PR.
Jan. 14, 2014, 3:51 PM
- Jazz Pharmaceuticals (JAZZ -1.3%) has acquired the narcolepsy treatment ADX-N05 from Aerial BioPharma.
- JAZZ is paying $125M upfront and Aerial, as well as SK Biopharmaceuticals (which has commercial rights in certain Asian countries) are eligible for milestone payments and tiered royalties on any eventual sales.
- JAZZ CEO Bruce Cozadd calls the drug "a strong fit with [the company's] specialty focus." (PR)
Dec. 20, 2013, 9:47 AM
- "The complex nature of [Defitelio] could make it difficult to copy, so we believe it possible that generic competition might not emerge," FBR's William Tanner says, regarding Jazz Pharmaceuticals' (JAZZ +7.6%) acquisition of Gentium (GENT +2.5%) and its sVOD treatment.
- "There may be additional growth opportunities that could be tapped," Tanner adds, noting that "sale of the drug in Europe is expected to be accomplished using the Erwinaze sales force as the call point is the same."
- JAZZ remains a top pick at FBR.
- Also out positive on JAZZ is Brean's Gene Mack who lifts the price target on the shares to $171 noting that "JAZZ is already marketing Erwinaze [in] Europe to hematologists and we believe having both products in the portfolio will allow [them] to increase their physician base."
- For more, see here and here.
Dec. 20, 2013, 9:11 AM
Dec. 20, 2013, 8:28 AM
- Shares of Jazz Pharmaceuticals (JAZZ) are 7% higher in thin premarket trading on the heels of the company's Gentium (GENT) acquisition.
- The deal gives the company Defitelio — the sVOD treatment that also has an Orphan designation in the EU for GvHD — which JAZZ says "is highly complementary to [the company's] experience in and focus on orphan diseases in the area of hematology/oncology."
- JAZZ expects the deal to be immediately accretive. (PR)
Dec. 19, 2013, 5:38 PM
Nov. 5, 2013, 4:18 PM
Oct. 8, 2013, 5:33 PM
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