| To: rkrw who wrote (224) | 12/18/2009 12:18:33 PM | | From: Arthur Radley | | | | | My guess is that they figured this would be the quickest venue to get another drug approved.......guess they didn't remember the result of Coreg and the huge market they garnered for that one. Appears that FLML and ELN are both working on this method of drug delivery......leaving me to question why I still own shares in these two. I still believe that reformulation for existing drugs will eventually be successful.....but when???? (:<) |
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| From: Arthur Radley | 12/3/2014 10:51:56 AM | | | | | | | Has been a long haul on this one! Took transforming the company to get here, but hit a new high today on increasing volume. Niche market players can make money---and it appears FLML has hit on how to do it! Glad I kept a few shares in the lock-box--maybe I can now afford to buy that grandkid a Christmas gift! |
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| From: Paul Lee | 12/19/2014 8:29:30 AM | | | | | | Flamel Technologies Announces Positive Results of a Second Clinical Trial With Micropump(R) Sodium Oxybate Results Confirm Elimination of the "Middle-of-the-Night Dose" Achieved in Previous Study Meeting With FDA Will Be Requested in the First Quarter of 2015
LYON, FRANCE--(Marketwired - Dec 19, 2014) - Flamel Technologies (NASDAQ: FLML) today announced that its second clinical study in healthy volunteers using its proprietary Micropump® technology applied to sodium oxybate has achieved the objective of one single dose before bedtime for patients suffering from narcolepsy, confirming the results of a previous, first-in-man, study. The current dosing regimen for the standard of care, Xyrem® (sodium oxybate), in the United States is two equal, divided doses: the first dose at bedtime and the second dose 2.5 to 4 hours later. The elimination of the second dose for narcolepsy patients would not only provide more convenience, but may improve the benefit sodium oxybate provides as there will be no disruption to nighttime sleep. The potential for additional benefits, including improved safety, will be studied.
The trial was designed as a 2-arm study with 12 patients in each arm evaluating two different formulations of Micropump® sodium oxybate at a nightly dose of 4.5g, 6g and 7.5g. Each subject consumed a standard meal two hours prior to dosing. Subjects were instructed to maintain a consistent meal time and dosing schedule throughout the study. One subject dropped out of the study prior to the completion of the 7.5g dosing portion for reasons unrelated to drug. The data for both formulations at the 4.5g and 6g doses were consistent with the data seen in the previous study which showed:
- Onset of action similar to Xyrem
- Cmax lower than Xyrem
- Mean blood concentration (ug/ml) at hours 7 and 8 similar to Xyrem
The data at the 7.5g dose for both formulations were consistent with expectations given the data generated at the lower doses. While both formulations were successful, Flamel has chosen to move forward with the optimal formulation.
To date, Micropump® sodium oxybate has been tested in 40 healthy subjects across three doses among three different formulations with no safety or tolerability issues.
Flamel plans to meet with the U.S. Food and Drug Administration (FDA) before the middle of 2015. Based on current expectations, the Company plans to begin registration studies prior to the end of 2015.
Flamel's Micropump technology is protected by intellectual property through at least 2025 in the United States. Micropump is a proven drug delivery platform for the oral delivery of small molecules.
Narcolepsy is a sleep disorder involving irregular patterns in Rapid Eye Movement (REM) sleep and significant disruptions of the normal sleep/wake cycle. People with narcolepsy experience excessive daytime sleepiness, sleep attacks, cataplexy, sleep paralysis, hallucinations and disrupted nighttime sleep.
Xyrem® is sold in the United States by Jazz Pharmaceuticals plc, in Canada by Valeant Canada Limited (via license from Jazz) and in twenty-two EU countries and Mexico by UCB Pharma Limited (via license from Jazz).
About Flamel Technologies - Flamel Technologies SA's (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The Company markets Bloxiverz® (neostigmine methylsulfate) and Vazculep™ (phenylephrine hydrochloride) in the US and licenses the Micropump-based microparticles technology to Recipharm AB for application to the manufacturing under FDA-audited GMP guidelines of Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its pipeline includes chemical and biological drugs formulated with its Micropump® (and its applications to the development of liquid formulations LiquiTime® and of abuse-deterrent formulations Trigger Lock™) and Medusa™ proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and Dublin, Ireland. Additional information may be found at www.flamel.com. |
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| To: Arthur Radley who wrote (228) | 12/19/2014 3:01:13 PM | | From: SI Ron (Crazy Soup Man) | | | | We'd like to have a logo on this board as part of our site modernization and to increase your board's visibility. We are over 600 logos on active message boards. Can you please find an appropriate image and upload it to the board? I can upload it to your board if you don't know how.
Thanks
Ron |
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| From: Paul Lee | 10/5/2015 11:05:13 AM | | | | | | Flamel Ireland Limited Licenses LiquiTime(R) Technology to Perrigo for U.S. Over-the-Counter Market
Related Quotes LYON, FRANCE--(Marketwired - Oct 5, 2015) - Flamel Technologies (NASDAQ: FLML) announced today that the Company's Irish subsidiary, Flamel Ireland Limited, has licensed exclusive U.S. rights to the LiquiTime® drug delivery platform to Perrigo's Irish subsidiary, Elan Pharma International Limited, for the U.S. Over-the-Counter (OTC) drug market. LiquiTime® is Flamel's drug delivery platform for modified, extended and controlled release of liquid oral drugs.
Flamel has entered into a multi-product agreement for extended release liquid OTC products in the U.S. market whereby Flamel will receive an upfront payment of $6.0 million and will be eligible for at least $50 million in approval and launch milestones for a minimum of seven products. In addition, Flamel will receive mid-single digit royalties on net sales. The exclusive license includes Flamel's LiquiTime® Ibuprofen and LiquiTime® Guaifenesin oral suspensions.
Flamel and Perrigo believe there is a large market opportunity for other OTC extended release liquid drug formulations, including products containing active ingredient combinations for the US cough/cold market, which analysts have estimated at $6.5 billion annually.
"We are very pleased to partner with Perrigo, one of the premier companies in the US Over-the-Counter consumer goods market. Flamel's LiquiTime® platform meets the unmet medical need for patients who are seeking the convenience of extended release liquid OTC medications. In addition, our LiquiTime® drug delivery platform is patent protected through September 2025 in the US and we will have the ability to apply for product-specific patents to extend those periods of patent protection," said Michael S. Anderson, Chief Executive Officer.
"This licensing agreement with Perrigo is another important validation of the quality and differentiation of Flamel's drug delivery platform technology. Moreover, we are pleased to accomplish one of our major commitments to investors in 2015 by putting these products into the hands of a leading OTC consumer products company that may result in an attractive set of milestone and royalty payments to our Company over time. |
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