Flamel Technologies: An Interesting Long-Term Investment
Fri, Jan. 8, 11:55 AM
- Thinly traded micro cap Flamel Technologies (FLML -15.7%) is down on a 4x surge in volume in response to its update today on its progress and financial guidance.
- The downer is its revenue guidance of $100M - 120M, significantly below what the company should post in 2015, which stood at $129.8M through Q3. Final results for Q4 and the full year will be released in mid-to-late Q1.
- Shares have slumped almost 30% since New Year's eve on the news of FDA clearance of a competitor to BLOXIVERZ.
- Previously: Flamel Tech slumps 16% on FDA clearance of competitive neostigmine methylsulfate (Dec. 31, 2015)
Dec. 31, 2015, 4:12 PM
- Thinly traded micro cap Flamel Technologies (FLML -15.8%) slumps on a 6x surge in volume in what appears to be a delayed response to the FDA's approval of a rival neostigmine methylsulfate, the active ingredient in the company's BLOXIVERZ.
- According to the FDA's website, it cleared a generic version from Eurohealth International Sarl's U.S. representative West-Ward Pharmaceuticals on December 28. The product will be sold in 5 mg/10 mL and 10 mg/10mL multi-dose vials.
- BLOXIVERZ is sold in in the same strengths and same size multi-dose vials. In Q3, it accounted for 87% of Flamel's revenues ($41.2M/47.3M).
- Neostigmine methylsulfate is a reversal agent of certain kinds of muscle relaxants used in surgery.
Dec. 31, 2015, 12:40 PM
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- In a letter to shareholders, Flamel Technologies (FLML -47.5%) says that it is "in discussions" with regulatory and legal counsel to devise a plan to minimize the encroachment of a new competitor to its lead product Bloxiverz.
- The FDA just approved Fresenius Kabi's New Drug Application (NDA) for its version of neostigmine methylsulfate.
Jan. 14, 2015, 12:43 PM
Jan. 14, 2015, 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.
Dec. 3, 2014, 3:51 PM
- Small cap Flamel Technologies (FLML +7.7%) clears the $16 resistance level on a 3x surge in volume. Shares are up more than 50% since the October 31 low of $11.12. The company recently sold one of its manufacturing sites to a Swedish CDMO.
- Previously: Flamel sells development & manufacturing facility to Swedish firm
Nov. 13, 2014, 12:48 PM
Jun. 20, 2014, 1:16 PM
- Shares of Flamel Technologies (FLML +15.7%) pop on a 5x surge in volume representing a tidy 450% gain from the December 2012 low of $2.85. The fuel for the uptrend is the expectation that the FDA will issue a ruling that will favor Flamel's Bloxiverz (neostigmine methysulfate injection).
- Neostigmine was first synthesized in 1931, making it eligible for grandfathering when the FDA was established. No company had an approved NDA for the product until Flamel's in July 2013. The regulator typically removes unapproved products within one year after it clears an NDA. Bloxiverz will enjoy a period of exclusivity as a result. Approximately 5M vials of neostigmine are sold in the U.S. each year.
Flamel Technologies SA is a specialty pharmaceutical company with drug delivery and formulation expertise. It engages in the development, manufacture, and marketing of pharmaceutical products. The company operates under the following trademarks: Bloxiverz, DeliVax, Flamel Technologies,... More
Industry: Drug Delivery & Accessories
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