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From: Paul Lee12/19/2014 8:29:30 AM
   of 240
 
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)
   of 240
 
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 Lee10/5/2015 11:05:13 AM
   of 240
 
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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From: Paul Lee10/22/2015 11:09:06 AM
   of 240
 
The Neostigmine Shortage: A Clinical Conundrum with Few Drug Alternatives

by Steven Greenberg, MD, FCCP; Sorin J. Brull, MD, FCARCSI (Hon); Pavan Rao, MD, MBA; Robert L. Barkin, MBA, PharmD, FCP, DAAPM, DACFM; Jeff Thiel, MS, PharmD; Joseph Szokol, MD, MBA, JD; and Richard C. Prielipp, MD, MBA, FCCM



Nationwide drug shortages affect anesthesia professionals every day.1 In 2012, a survey generated by the American Society of Anesthesiologists (ASA), and accessible on the ASA website, suggested that 97.6% of anesthesiologists experienced a drug shortage in their practices. There have been several documented reasons for drug shortages, which include raw material shortages, manufacturing quality control issues, industry consolidation, and manufacturer discontinuation. Despite governmental and provider organization support to reduce drug shortages, they appear to be on the rise.1 At the present time, no governmental agency or other entity has the accountability, authority, or responsibility to mandate a corporation or manufacturer to continue production, maintain levels of inventory and/or set prices of any drug. Drug manufacturing is a market-driven process, and pharmaceutical companies­—like all corporations­­­—must balance the needs of customers (physicians and patients), the marketplace, and shareholders. When drugs are in short supply, suspended, prohibitively expensive, or eliminated, anesthesia providers respond by searching for alternative options. However, when a drug with few alternatives becomes the focus of a drug shortage, it may significantly alter practice patterns and ultimately, patient safety.

In the previously cited ASA survey, as well as in a 2013 Survey conducted by the AANA, and accessible on the AANA website, neostigmine was one of the drugs most commonly associated with drug shortages. This shortage was in part, and interestingly, due to new U.S. Food and Drug Administration (FDA) rules. In 2011, the FDA issued revised guidance on marketed, unapproved drugs: “Compliance Policy Guide Sec 440.100, Marketed New Drugs Without Approved NDAs or ANDAs (CPG440.100).”a The FDA guidance established “an orderly approach for removing unapproved drugs from the market.” In 2013, Eclat Pharmaceuticals, the only makers of “FDA-approved” neostigmine (Bloxiverz)b sent a letter calling on the FDA to stop all 5 of its competitors (Cardinal Health, West-Ward Pharmaceuticals, Fresenius Kabi USA, American Regent and General Injectables & Vaccines) from selling the “FDA-unapproved” generic neostigmine.c In this letter to the FDA, Eclat Pharmaceuticals also claimed that the manufacturers of unapproved neostigmine “lack complete labeling and pose a potential safety hazard.” Flamel Technologies, which acquired Eclat Pharmaceuticals in 2012, significantly raised the price of Bloxiverz, the only available neostigmine preparation.d In the current marketplace in 2015, neostigmine is only manufactured by 2 companies (Fresenius Kabi and Eclat Pharmaceuticals),e which significantly increased the cost of the drug. More importantly, the shortage created a clinical conundrum for anesthesia providers because alternatives to neostigmine are quite limited. Institutions and providers across the United States may need to decide between the following choices to provide effective perioperative clinical care:

  1. Continue using neostigmine at a much higher cost
  2. Minimize "waste" of neostigmine by using prefilled syringes with fixed volumes/doses
  3. Consider an alternative like edrophonium (with premixed atropine), called “Enlon Plus”.
  4. Minimize or eliminate use of NMB drugs, and thus nullify the need for reversal agents altogether.
These choices, however, may be associated with substantial unintended consequences. The unexpected increase in neostigmine pricing may create considerable financial pressure on the OR pharmacy and anesthesiology budgets. Perhaps a better alternative is to minimize the waste of neostigmine by placing it in prefilled syringes, which facilitates a more cost conscious utilization of the drug. The high cost of the reversal agent may also promote more conservative use of neuromuscular blocking agents (NMBAs) in the perioperative period. However, it may also raise the danger of an increase in residual neuromuscular blockade in the PACU because providers might inadvertently under-dose patients during the reversal process in an attempt to save on the cost of neostigmine.

Changing to the only available alternative product, edrophonium plus atropine (“Enlon Plus” in its premixed fashion) also may have unintended consequences. Many anesthesia providers may be unfamiliar with the dosing, pharmacokinetics ,and side effects of this combination reversal alternative. For instance, there may be an increase in the incidence of central anticholinergic syndrome with the addition of atropine to edrophonium. Moreover, patients with comorbidities (specifically cardiac) may be more susceptible to the drug-induced effects of secondary tachycardia or bradycardia sometimes observed with this pre-mixed product. Additional education is certainly required to avoid drug errors and enhance clinician awareness of the potential adverse effects of this combination drug.

The difference in onset and offset of edrophonium (peak effect of 2–4 minutes) vs. neostigmine (peak effect of 6–10 minutes) must also be reviewed by anesthesia providers, and the administration should be timed appropriately. The recommended dose of Enlon Plus is 0.5–1 mg/kg edrophonium and 0.007–0.014 mg/kg atropine given intravenously over a minimum of 45–60 seconds.2 The anticholinesterase effect of edrophonium lasts approximately 70 minutes (assuming normal renal function), and therefore, it is unlikely to result in reappearance of neuromuscular block (“re-curarization”) with the intermediate acting modern muscle relaxants.2 To make it easier for clinicians, the solution is 10 mg/mL of edrophonium, and the dose range is from 0.05–0.1 mL/kg. Therefore, a 70-kg patient would typically receive 3.5–7 mL of the Enlon-Plus mixture. Lastly, the long-term availability of edrophonium is not entirely clear, particularly if the prices of “FDA-approved” neostigmine preparations start decreasing.

Edrophonium is not as effective as a reversal agent as neostigmine, because the bonds it forms to acetylcholinesterases are mostly ionic, rather than the more resistant covalent bonding of neostigmine. Thus, if edrophonium is used for reversal of neuromuscular block, the clinician should wait for sufficient spontaneous recovery (Train-Of-Four (TOF) count of 2–3) prior to reversal. Once this level of recovery is attained, the full dose of 1 mg/kg edrophonium should be administered over at least 3–5 minutes. It should be recognized that the faster the administration, the greater the peak plasma concentration of edrophonium/atropine, so the greater the potential for side effects. In patients at risk of bradycardia (elderly, pediatrics, patients on beta-blockers, etc.), the clinician should consider giving some additional atropine upfront. If TOF count is 4, and there appears to be no fade to TOF stimulation assessed subjectively, only 25%–50% of the full dose should be administered again, over at least 3–5 min.3

A final strategy to avoid the high cost of neostigmine is to refrain from using reversal agents altogether—the obvious concern with this choice is the high likelihood of residual neuromuscular blockade and its associated negative effects.4 A preferred alternative would be to monitor neuromuscular function objectively (by using an accelerograph or the integrated kinetomyograph) or at least with the use of a nerve stimulator in the TOF mode. Then, choose an appropriate reversal dose based on the degree of neuromuscular recovery.

While the dilemma of neostigmine shortage and high pricing highlights the impact of drug shortages on practice patterns, it will not be the last one. In the 2015 February issue of the APSF Newsletter, Orlovich and Kelly wrote a concise review on the drug shortage issue as it relates to anesthesia providers. They offered several factors and potential solutions to proactively prevent the ever-increasing anesthesia drug shortage epidemic.5 It is up to anesthesia organizations, business leaders, hospital administrators, and government officials to rethink viable solutions to this ever growing problem, so that our patients do not assume unnecessary perioperative risk. Lastly, but perhaps most importantly, Hsia et al. recently suggested that a clear majority of patients (60.9%) want to be informed of a drug shortage even if it made little difference to patient outcomes.6 On the other hand, informing patients of the shortages may increase their fear and anxiety unnecessarily, just prior to surgery, and therefore this disclosure needs to be reviewed carefully and critically. However, it may allow us, as providers, to stop and appreciate that our patients are becoming more concerned and knowledgeable about their care and the ever-escalating problem of drug shortages. This may be the right time to enhance our alliance with our patients and help lobby for effective changes to curb this recurring problem. Meanwhile, we must continue to prioritize patient safety and value-based care.

_______

a. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm270834.htm. Accessed Aug 7, 2015.
b. http://bloxiverz.com. Accessed August 8, 2015.
c. http://www.fdanews.com/ext/resources/newsletters/Sample-PDFs/WDL091613web.pdf
d. http://www.bloomberg.com/article/2015-01-15/aRDS4F8u8pEs.html
e. http://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=1150



Dr. Greenberg is Assistant Editor of the APSF Newsletter, Clinical Associate Professor in the Department of Anesthesiology/Critical Care at the University of Chicago Pritzker School of Medicine, and Director of Critical Care Services at Evanston Hospital, NorthShore University HealthSystems

Dr. Brull is the Patient Safety Section Editor, Anesthesia & Analgesia, Executive Committee Member of the APSF, and Professor of Anesthesiology at the Mayo Clinic, Jacksonville, FL.
Dr. Rao is an Anesthesiology Resident at the University of Chicago, Pritzker School of Medicine


Dr. Barkin is Professor of Anesthesiology, Pharmacology and Family Medicine at Rush Medical College in Chicago, IL. He is also a Clinical Pharmacologist at North Shore University Health System at Skokie and Evanston Pain Centers.

Dr. Thiel is Assistant Vice President, Pharmacy Services at NorthShore University HealthSystem.

Dr. Szokol is Vice Chairperson, Department of Anesthesiology, NorthShore University HealthSystem and Clinical Professor in the Department of Anesthesiology/Critical Care at the University of Chicago Pritzker School of Medicine

Dr. Prielipp is Chairperson of the APSF Committee on Education and Training, Executive Committee Member of the APSF, and Professor of Anesthesiology at the University of Minnesota.

Editorial Note: In a 2013 survey conducted by the AANA, 48.6% of respondents reported a neostigmine shortage as well.



References

  1. De Oliveira GS, Jr, Theilken LS, McCarthy RJ. Shortage of perioperative drugs: implications for anesthesia practice and patient safety. Anesth Analg 2011;113: 1429-35.
  2. Cronnelly R, Morris RB, Miller RD: Edrophonium: Duration of action and atropine requirement in humans during halothane anesthesia. Anesthesiology 1982; 57: 261-6.
  3. Thilen SR, Hansen BE, Ramaiah R, Kent CD, Treggiari MM, Bhanaker SM. Intraoperative neuromuscular monitoring site and residual paralysis. Anesthesiology 2012;117: 964-72.
  4. Murphy GS, Brull S. Residual neuromuscular block: Lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg 2011;111: 120-8.
  5. Orlovich DS, Kelly RJ. Drug shortages in the US - A balanced perspective. APSF Newsletter 2015;29: 49-50.
  6. Hsia IKH, Dexter F, Logvinov I, et al. Survey of national drug shortage effect on anesthesia and patient safety: A patient perspective. Anesth Analg 2015;121: 502-6.









©Copyright 2015 Anesthesia Patient Safety Foundation



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From: Paul Lee1/8/2016 9:33:36 AM
   of 240
 
Flamel Technologies Provides Update on Corporate Progress Clinical Programs Continue to Move Forward; Outlines Full Year 2016 Revenue Guidance

LYON, FRANCE--(Marketwired - Jan 8, 2016) - Flamel Technologies (NASDAQ: FLML) today announced an update on the Company's corporate progress as it relates to a number of initiatives, including ongoing clinical programs and 2016 revenue guidance.

Highlights include:

Micropump™ sodium oxybate on track to begin Phase 3 pivotal trial Recent independent study confirms the robust abuse-deterrent capabilities of Trigger Lock™ Two LiquiTime™ products to move into pivotal studies in 2016 Positive interim results of a first-in-man clinical trial with Medusa™ 2016 revenues expected to be in the range of $100 to $120 million, including the launch of Éclat #3
  • Strong cash flow and liquidity to continue in 2016

  • Mike Anderson, Chief Executive Officer of Flamel, remarked, "The Company has made excellent progress during 2015 at advancing its proprietary pipeline, using Flamel's best-in-class drug delivery platforms to create patent protected products that are expected to offer substantial benefits to healthcare consumers. We continued to generate significant operating profit and cash flow with Bloxiverz® and Vazculep®, enabling us to invest in our pipeline."

    Micropump Sodium Oxybate (FT218)
    The Company, after consultation with the FDA, will be submitting a Special Protocol Assessment (SPA) for once-nightly Micropump sodium oxybate in the first quarter of 2016 and upon approval will commence patient recruitment in the second quarter. SPAs serve as a way to reduce the risks associated with clinical studies, as the acceptance represents general agreement by the FDA of a pivotal trial's design, endpoints and analyses.

    The pivotal trial of Flamel's Micropump technology applied to sodium oxybate for the treatment of narcolepsy is expected to run through early 2017. It is expected to be a placebo-controlled efficacy study of approximately 200-300 patients and will be conducted at between 50 and 60 clinical sites in North America and Europe.

    Mr. Anderson continued, "For the past several months, we have had numerous contacts with potential investigators in order to accelerate enrollment procedures once the SPA is approved. We expect to file for Investigational Medicinal Product Dossier (IMPD) approval in the EU in conjunction with the SPA in the US. Any additional studies, such as pivotal pharmacokinetic (PK) studies, needed for a New Drug Application (NDA) approval will be run simultaneously, and the target for trial completion remains mid-2017. Ultimately, we believe we will be able to demonstrate improved efficacy, improved safety and improved patient satisfaction over the standard of care, JAZZ's Xyrem®, a twice nightly sodium oxybate formulation, which is expected to generate at least $950 million in revenues in 2015. Micropump sodium oxybate is our most important development project and our entire organization is dedicated to moving it forward efficiently and completely."

    Trigger Lock Hydromorphone (FT227)
    In the second quarter of 2015, Flamel announced positive results from two pilot PK studies in healthy volunteers of FT227, an abuse-deterrent, extended-release, oral hydromorphone product using its proprietary Trigger Lock drug delivery platform. In addition, a recently completed independent study has confirmed the robust abuse-deterrent capabilities of FT227, duplicating the Company's previous internal work. The independent study of FT227 demonstrated better resistance in extraction/recovery studies in different media and under several different conditions than both Exalgo and Oxycontin, and was shown to resist both chemical and physical manipulation in concert with the FDA's 2015 Guidance. Flamel has requested a meeting with FDA in the first quarter of 2016 to discuss continued development of FT227 and expects to initiate licensing discussions for the technology in early 2016.

    LiquiTime
    In October 2015, Flamel licensed its LiquiTime technology for the Over-the-Counter (OTC) market to Perrigo. Included with the licensing arrangement were LiquiTime ibuprofen and guaifenesin, and a minimum of five additional products. Flamel plans to move the first two LiquiTime products, ibuprofen and guaifenesin, into pivotal testing in 2016. Ultimately, LiquiTime ibuprofen and guaifenesin will be filed for OTC approval via the 505(b)2 pathway.

    Flamel expects commercialization of a minimum of seven OTC LiquiTime products with royalties in the mid-single digits and a minimum of $50 million in product launch and milestone payments.

    Mr. Anderson commented, "The licensing of LiquiTime technology to Perrigo for the U.S. OTC market was strong validation of our technology, and we expect to see meaningful revenues from these products following their launch. Even though the remaining five products have not been finally identified, the U.S. cough/cold market is estimated to be $6.5 billion, representing a significant financial opportunity for the Company. Additionally, the Company is pursuing licensing options for OTC use of LiquiTime in Europe. Furthermore, we are engaged in several feasibility studies for additional LiquiTime prescription products, which we plan to identify in 2016. The use of LiquiTime for the Rx market is a meaningful opportunity for the Company."

    Medusa Exenatide (FT228)
    In December 2015, Flamel announced positive results of a Phase 1a study using its propriety Medusa technology applied to exenatide, a GLP1 analog used to treat patients suffering from Type 2 Diabetes Mellitus. Flamel's once weekly subcutaneous injection formulation of exenatide achieved all safety and pharmacokinetic (PK) assessment objectives. As such, the Company plans on moving into a multiple dose Phase 1b study with diabetic patients in early 2016. At the conclusion of the study, the Company will assess next steps. The Company does not anticipate moving beyond the Phase 1b trials on its own.

    Marketed Products Revenue Outlook & Corporate Initiatives
    Mr. Anderson continued, "We expect 2015 revenue to be at the lower end of our 2015 guidance of $170 to $185 million, and are providing product revenue guidance for 2016 in the range of $100 to $120 million in 2016. The year over year decline in revenue is primarily attributed to the declining Bloxiverz business that we anticipate will be impacted by the launch of a third FDA approved neostigmine methylsulfate. We remain excited about the expected FDA approval and launch of Éclat #3 by midyear. We fully expect that our UMD products will continue to produce meaningful cash flow in the coming years, allowing for the autonomous development of Flamel's proprietary product pipeline."

    The Company's full year 2016 revenue guidance is based on the following assumptions:

  • On December 28, 2015, the FDA announced approval of a generic version of neostigmine to be marketed by West-Ward Pharmaceuticals, creating a market of three approved providers. While Flamel garnered a majority share of the neostigmine market of between 55 - 60% throughout 2015, expectations for market share in 2016 are in the range of 30 - 40% of a total market estimated to be approximately 4.5 million vials per year, with a reduction in net-price in the range of 20 - 30%. The decrease in total market size from approximately 5 million vials per year to 4.5 million vials per year is a result of Merck's December 2015 approval of Bridion® (sugammadex), a neostigmine alternative, which is expected to reduce the overall neostigmine market by approximately 10%.

  • Vazculep, which is marketed in three vial sizes, 1mL, 5mL and 10mL, continues to increase its share of the phenylephrine market. Flamel supplies 100% of the 5mL and 10mL vials, and currently holds a combined share of 40% for all three vial sizes. The Company expects the entrance of a generic phenylephrine to the market in mid-2016, which would likely impact its share and pricing.

  • The Company's third UMD (Éclat #3) is expected to receive FDA approval on its PDUFA date of April 30, 2016. Following launch of Éclat #3 in mid-year 2016, Flamel expects its market share to be in the range of 20 - 30%, and to increase substantially in 2017. Flamel closely monitors market conditions as it relates to its portfolio of UMD products, and while the market size of its third UMD was initially estimated in the range of $70 - 80 million, recent developments have made this asset more attractive than initially anticipated with the potential to earn an attractive return on investment for shareholders.

    During 2016, the Company expects to increase its R&D expenditures to a range of $35-50 million. The increase over 2015 is a result of additional investments for the sodium oxybate trial, the LiquiTime trials, and other projects.

    Mr. Anderson concluded, "We will continue to pursue a number of other initiatives to increase shareholder value in 2016. Among the initiatives are the development of at least one additional UMD, the pursuit of inorganic growth through potential acquisitions, and the optimization of our effective tax rate. Our strong cash flow, substantial cash position and lack of debt allow us the financial flexibility to pursue inorganic growth opportunities and continue to fund our R&D pipeline, enabling us to continue our mission to become a premier and diversified specialty pharmaceutical company."

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    From: Paul Lee6/2/2016 11:00:23 AM
       of 240
     


    Jazz Makes Deal In Xyrem IP Fight With Ranbaxy, Sun, Ohm By Kevin Penton


    Law360, New York (May 13, 2016, 9:52 PM ET) -- Jazz Pharmaceuticals Inc. has agreed to drop its claims against generic-drug makers Ranbaxy, Sun and Ohm in a patent infringement case involving the narcolepsy drug Xyrem after the companies resolved their differences and struck a licensing agreement, the company told a New Jersey federal judge Thursday.

    Ranbaxy Inc., Sun Pharmaceutical Industries Ltd. and Ohm Laboratories Inc. stipulated as part of the proposed order sent to U.S. District Judge Esther Salas that the abbreviated new drug applications they filed for a proposed generic version of Xyrem was a technical act of infringement of each of the asserted patents in the case and that their manufacturing and sales of the proposed generic would also infringe. The filing did not give details of the agreement.

    Other than what the May 9 licensing deal allows, Ranbaxy, Sun and Ohm agreed not to manufacture or to sell the generic drug during the life of the patents, according to the letter.

    Counsel for the parties could not be reached for comment on Friday.

    Jazz began suing Ranbaxy and other drugmakers in 2013, alleging that their planned generic versions of Xyrem would infringe several of its patents, including those covering the composition of the drug and the method of distributing it. Other defendants include Amneal Pharmaceuticals, Par Pharmaceutical Inc. and Watson Laboratories Inc.

    The suits came in response to ANDAs filed by each of the defendants seeking approval to commercially market a generic version of Xyrem before the expiration of various patents held by Jazz concerning the drug, which is used to treat daytime sleepiness and muscle weakness in narcolepsy patients.

    The active ingredient in Xyrem is GHB, an intoxicant that the U.S. Drug Enforcement Agency has labeled a date-rape drug. Because of the risk of abuse, Xyrem is only available through one central pharmacy to patients who undergo special training on how to use it.

    Several of the generics makers have alleged that the patents are invalid, saying they claim only the abstract idea of controlling access to a prescription drug to guard against potential abuse.

    U.S. Magistrate Judge Joseph A. Dickson consolidated five related complaints in January.

    Jazz is represented by Charles M. Lizza, William C. Baton and Sarah A. Sullivan of Saul Ewing LLP and Frank C. Calvosa, Brian J. Forsatz and Catherine T. Mattes of Quinn Emmanuel Urquhart & Sullivan LLP.

    Ranbaxy, Sun and Ohm are represented by Karen A. Confoy, Christopher R. Kinkade and Kai W. Marshall-Otto of Fox Rothschild LLP and William Zimmerman, Carol Pitzel Cruz, Ben Anger, Karen Cassidy, and Christie Matthaei of Knobbe Martens Olson & Bear LLP.

    The case is Jazz Pharmaceuticals Inc. v. Amneal Pharmaceuticals LLC et al., case number 2:13-cv-00391, in the U.S. District Court for the District of New Jersey.

    --Additional reporting by Alex Wolf. Editing by Brian Baresch.
    All Content © 2003-2016, Portfolio Media, Inc.


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    To: Paul Lee who wrote (234)6/2/2016 11:01:59 AM
    From: Paul Lee
       of 240
     
    Jazz Makes Deal In Xyrem IP Fight With Ranbaxy, Sun, Ohm By Kevin Penton


    Law360, New York (May 13, 2016, 9:52 PM ET) -- Jazz Pharmaceuticals Inc. has agreed to drop its claims against generic-drug makers Ranbaxy, Sun and Ohm in a patent infringement case involving the narcolepsy drug Xyrem after the companies resolved their differences and struck a licensing agreement, the company told a New Jersey federal judge Thursday.

    Ranbaxy Inc., Sun Pharmaceutical Industries Ltd. and Ohm Laboratories Inc. stipulated as part of the proposed order sent to U.S. District Judge Esther Salas that the abbreviated new drug applications they filed for a proposed generic version of Xyrem was a technical act of infringement of each of the asserted patents in the case and that their manufacturing and sales of the proposed generic would also infringe. The filing did not give details of the agreement.

    Other than what the May 9 licensing deal allows, Ranbaxy, Sun and Ohm agreed not to manufacture or to sell the generic drug during the life of the patents, according to the letter.

    Counsel for the parties could not be reached for comment on Friday.

    Jazz began suing Ranbaxy and other drugmakers in 2013, alleging that their planned generic versions of Xyrem would infringe several of its patents, including those covering the composition of the drug and the method of distributing it. Other defendants include Amneal Pharmaceuticals, Par Pharmaceutical Inc. and Watson Laboratories Inc.

    The suits came in response to ANDAs filed by each of the defendants seeking approval to commercially market a generic version of Xyrem before the expiration of various patents held by Jazz concerning the drug, which is used to treat daytime sleepiness and muscle weakness in narcolepsy patients.

    The active ingredient in Xyrem is GHB, an intoxicant that the U.S. Drug Enforcement Agency has labeled a date-rape drug. Because of the risk of abuse, Xyrem is only available through one central pharmacy to patients who undergo special training on how to use it.

    Several of the generics makers have alleged that the patents are invalid, saying they claim only the abstract idea of controlling access to a prescription drug to guard against potential abuse.

    U.S. Magistrate Judge Joseph A. Dickson consolidated five related complaints in January.

    Jazz is represented by Charles M. Lizza, William C. Baton and Sarah A. Sullivan of Saul Ewing LLP and Frank C. Calvosa, Brian J. Forsatz and Catherine T. Mattes of Quinn Emmanuel Urquhart & Sullivan LLP.

    Ranbaxy, Sun and Ohm are represented by Karen A. Confoy, Christopher R. Kinkade and Kai W. Marshall-Otto of Fox Rothschild LLP and William Zimmerman, Carol Pitzel Cruz, Ben Anger, Karen Cassidy, and Christie Matthaei of Knobbe Martens Olson & Bear LLP.

    The case is Jazz Pharmaceuticals Inc. v. Amneal Pharmaceuticals LLC et al., case number 2:13-cv-00391, in the U.S. District Court for the District of New Jersey.

    --Additional reporting by Alex Wolf. Editing by Brian Baresch.
    All Content © 2003-2016, Portfolio Media, Inc.

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    From: Paul Lee10/6/2016 7:37:28 AM
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    Flamel Technologies Reaches Agreement With FDA on Protocol for Phase III Pivotal Trial of FT218



    October 6, 2016

    LYON, FRANCE--(Marketwired - Oct 6, 2016) - Flamel Technologies ( NASDAQ : FLML ) today announced that its Irish subsidiary, Flamel Ireland Holdings, has reached agreement with the U.S. Food and Drug Administration (FDA) for the design and planned analysis of a Phase III clinical trial of FT218, a once nightly formulation of sodium oxybate utilizing the Company's proprietary drug delivery platform, Micropump®. The agreement was reached through the Special Protocol Assessment (SPA) process.

    A SPA is an acknowledgement by FDA that the design and planned analysis of the Company's pivotal clinical trial of FT218 adequately addresses the objectives necessary to support a regulatory submission. The Phase III trial, titled "A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy," recently commenced patient enrollment in Canada, with sites in Europe and the U.S. to be initiated near-term.

    Mike Anderson, Chief Executive Officer of Flamel, remarked, "We are thrilled to announce that we have come to a much anticipated agreement with FDA on our SPA for a pivotal study of FT218, Micropump® sodium oxybate. This is a major milestone for the trial, as we move forward with site initiation in Europe and subsequently, the United States. We believe our once nightly formulation of sodium oxybate has the potential to offer significant improvements over the current standard of care, in addition to meaningful improvement in overall quality of life for patients suffering from narcolepsy."

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    From: Paul Lee12/16/2016 8:18:14 AM
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    Flamel Technologies Doses First Patient in REST-ON Phase III Trial of FT218 for Excessive Daytime Sleepiness & Cataplexy



    MarketwiredDecember 16, 2016

    LYON, FRANCE--(Marketwired - Dec 16, 2016) - Flamel Technologies SA ( NASDAQ : FLML ) today announced that the first patient has been dosed in its Rest-On Phase III clinical trial of FT218, a once-nightly formulation of sodium oxybate utilizing the Company's proprietary Micropump® technology, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.

    Mike Anderson, Flamel's Chief Executive Officer, remarked, "This is an exciting milestone for Flamel. FT218 is our most important asset and has the potential to provide a number of benefits to narcoleptic patients, who suffer from debilitating quality of life issues. We are seeing significant interest in this trial from both physicians and patients alike, and are excited to continue the screening and enrollment process as more sites are initiated throughout Europe, Canada and the U.S."

    REST-ON is a 264 patient, double-blind, randomized, placebo controlled Phase III clinical trial to assess the efficacy and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The study will be conducted across 50 -- 60 clinical sites throughout the U.S., Europe and Canada.

    About Sodium Oxybate
    Sodium Oxybate is the sodium salt of gamma hydroxybutyrate, an endogenous compound and metabolite of the neurotransmitter gamma-aminobutyric acid (GABA). It has been described as a therapeutic agent with high medical value; in Europe and the United States it is currently approved in a twice nightly formulation indicated for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy at doses up to 9g/night.

    About Micropump®
    Micropump® is a microparticulate system that allows the development of modified and/or controlled release of solid, oral dosage formulations of drugs. Micropump allows the achievement of extremely precise pharmacokinetic profiles of single or combination of drugs, in a variety of formats (such as tablets, capsules, sachet, or liquids (LiquiTime®), while preserving the targeted release rate over the shelf-life of the product.

    About Flamel Technologies
    Flamel Technologies SA ( NASDAQ : FLML ) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs

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    From: Paul Lee10/5/2017 7:52:58 AM
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    Avadel Pharmaceuticals Announces Data Presentation for Noctiva™ at The American Urogynecologic Society’s Annual Scientific Meeting
    DUBLIN, Ireland, Oct. 05, 2017 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc ( AVDL), announced that data for the clinical evaluation of Noctiva (previously “SER120”) for the treatment of patients with nocturia due to nocturnal polyuria with concomitant overactive bladder (OAB) will be presented in an oral poster presentation at Pelvic Floor Disorders (PFD) Week 2017, the American Urogynecologic Society’s annual scientific meeting.

    Douglas Van Drie, M.D., who specializes in urogynecology and reconstructive pelvic surgery, will present oral poster 127, “Evaluation of SER120 for the Treatment of Patients with Nocturia due to Nocturnal Polyuria with Concomitant Overactive Bladder,” authored by Van Drie, D., Lepor, H., Nitti, V., Cheng, M., Cheng, L., Fein, S., on Friday, Oct. 6 at 5:11 p.m. EST at the Rhode Island Convention Center in Providence, R.I.

    “Nocturia is a medical condition that affects approximately 40 million people in the United States and represents an unmet medical need among my urogynecological patients,” commented Van Drie. “The condition results in frequent nighttime urination, which prevents patients from experiencing a normal, restful sleep cycle and can lead to a number of complex and costly co-morbidities and health-related consequences, such as nighttime falls and fractures, impaired daytime functioning and productivity, and compromised quality of life.”

    In an subset analysis of Noctiva’s Phase III pivotal studies, 207 patients suffering from nocturia due to nocturnal polyuria with concomitant overactive bladder were evaluated. Patients on Noctiva demonstrated both a significant reduction in mean number of nocturic episodes, a significant improvement to their overall quality of life and a substantial increase in the time from bedtime to first nocturic void compared to placebo.

    Noctiva at doses of 1.66 and 0.83 mcg is effective for the treatment of patients with nocturia due to nocturnal polyuria with concomitant OAB. Highlights of Dr. Van Drie’s presentation at Friday’s event will include:

    • The reduction in mean nocturic episodes/night for the 1.66 mcg dose was 2 times that of placebo (P=.0010) and almost 2 times that of placebo for the 0.83 mcg dose (P=.0076)

    • The percentage of patients who achieved =50% reduction in mean nocturic nocturic episodes/night for the 1.66 mcg dose was more than 3 times greater than placebo (P=.0007) and 0.83 mcg dose was >2.5 times that of placebo (P=.0096)

    • The validated QoL Questionnaire (INTU) completed by the patients demonstrated an almost 6 times greater improvement in the QoL for the 1.66 mcg dose and approximately 5 times greater improvement for the 0.83 mcg dose compared to placebo. These results documented that decreasing nocturic episodes correlated with clinically meaningful improvements in how these patients felt and functioned

    • The length of time from bedtime to first nocturic void was 2.4 times greater than placebo for the 1.66 mcg dose (P=.0136) and 2.8 times great than placebo for the 0.83 mcg dose (P=.0036)

    <p class="canvas-atom canvas-text Mb(1.0em) Mb(0)--sm Mt(0.8em)--sm" type="text" content="About Noctiva™
    Noctiva is the first and only formulation of desmopressin acetate, a vasopressin analog, approved by the FDA for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. It is a proprietary low-dose formulation of desmopressin acetate administered through a patent-protected preservative-free intranasal delivery system. Its nasal administration provides targeted absorption, a consistent pharmacokinetic profile and excellent bioavailability.* Noctiva is dosed as a single spray in one nostril 30 minutes before bedtime, and is approved in two dosage forms of 0.83 mcg and 1.66 mcg. Noctiva is expected to become available to patients in the second quarter of 2018. (Full Prescribing Information available&nbsp; here)." data-reactid="20" style="margin: 0px 0px 1em; color: rgb(38, 40, 42); font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 15px; background-color: rgb(255, 255, 255);">About Noctiva™
    Noctiva is the first and only formulation of desmopressin acetate, a vasopressin analog, approved by the FDA for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. It is a proprietary low-dose formulation of desmopressin acetate administered through a patent-protected preservative-free intranasal delivery system. Its nasal administration provides targeted absorption, a consistent pharmacokinetic profile and excellent bioavailability.* Noctiva is dosed as a single spray in one nostril 30 minutes before bedtime, and is approved in two dosage forms of 0.83 mcg and 1.66 mcg. Noctiva is expected to become available to patients in the second quarter of 2018. (Full Prescribing Information available here).

    Important Safety Information and Indication for Noctiva (desmopressin acetate)

    *Data on file

    WARNING: HYPONATREMIA
    Call 1-877-622-2320 for a complete list of warnings.

    NOCTIVA can cause hyponatremia, which is a condition that occurs when you do not have enough sodium in your blood.

    Your doctor should monitor the sodium levels in your blood before you start and while you are using NOCTIVA. Mild cases of hyponatremia may not have any symptoms, but signs can include nausea, vomiting, fatigue, dizziness, headache, confusion, muscle cramps, feeling restless, and in severe cases, seizures and coma. It may be life-threatening if severe.

    Some people should not take NOCTIVA because of a higher risk of severe hyponatremia. You should not take NOCTIVA if you have a lot of fluid intake, have an illness that can cause fluid or electrolyte imbalances, or use loop diuretics (water pills like bumetanide or ethacrynic acid) or systemic or inhaled glucocorticoids (steroids like cortisone or prednisone).

    You may need to temporarily or permanently stop taking NOCTIVA if you get hyponatremia.

    What is NOCTIVA used for?
    NOCTIVA is a prescription medicine nasal (nose) spray used in adults who wake up two or more times during the night to urinate due to a condition called nocturnal polyuria. Nocturnal polyuria is a condition where your body makes too much urine at night. There are other conditions that could cause you to wake up during the night to urinate. NOCTIVA is only approved for the treatment of nocturnal polyuria. Your doctor should have you measure your urine and the times that you urinate for 24 hours to determine if you have nocturnal polyuria if you have not already done this.

    NOCTIVA is not intended for use in children. It has not been studied in adults less than 50 years old, so it is unknown whether NOCTIVA is safe or effective in people below this age.

    Who should not take NOCTIVA?
    You should not take NOCTIVA if you:

    • have or have had low salt levels in your blood

    • are thirsty much of the time and drink large amounts of fluids (polydipsia)

    • wet the bed while sleeping at night

    • are taking a type of water-pill called a loop-diuretic

    • are taking a glucocorticoid (steroid) medicine, including an inhaled glucocorticoid (steroid) medicine

    • have moderate to severe kidney problems

    • have or may have a condition called syndrome of inappropriate antidiuretic hormone (SIADH) secretion

    • have an illness that can cause you to have low levels of fluid or electrolytes in your blood, such as vomiting, diarrhea, an infection, or a kidney problem that causes you to lose too much salt

    • have symptoms from a heart problem called congestive heart failure

    • have high blood pressure that is not controlled

    Ask your doctor if you are not sure you have any of these conditions or take any of the types of medicines listed.

    What is the most important information you should know about NOCTIVA?

    NOCTIVA can cause hyponatremia (low levels of sodium in the blood). Severe cases can lead to seizures, coma, or death. It can cause fluid retention (water weight gain), which can be a particular problem for people with congestive heart failure or uncontrolled high blood pressure.

    Call your doctor if you have any of the following symptoms of low salt levels in your blood:

    • headache

    • nausea or vomiting

    • drowsiness

    • dizziness

    • muscle cramps

    • feeling restless

    • fatigue

    • change in your mental condition, such as confusion, or decreased awareness or alertness

    Low salt levels in the blood happen more often in people treated with NOCTIVA who are 65 years old or older than in people treated with NOCTIVA who are younger than 65 years old. Your doctor should check the salt levels in your blood before you start or re-start taking NOCTIVA, during treatment with NOCTIVA, and before increasing your dose.

    Ask your doctor if you should temporarily discontinue NOCTIVA if you have allergies or a cold that makes your nose runny or stuffed up, as having such symptoms could affect how your body absorbs the medicine in NOCTIVA.

    What should you tell your health care provider?

    Before using NOCTIVA, tell your health care provider about all of your medical conditions, including if you:

    • have vomiting, diarrhea, fever, or infection

    • have kidney or heart problems

    • have diabetes mellitus

    • have had a head injury

    • have a heart problem called congestive heart failure

    • have a history of not being able to empty your bladder all of the way (urinary retention)

    • have any nose problems, such as blockage, stuffy nose, runny nose, or drainage

    • are pregnant or plan to become pregnant. It is not known if NOCTIVA can harm your unborn baby.

    • Are breastfeeding or plan to breastfeed. Desmopressin, and ingredient in NOCTIVA, passes into breast milk. Talk to your doctor about the best way to feed your baby if you use NOCTIVA.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using NOCTIVA with certain other medicines may cause serious side effects. Do not start taking any new medicines until you talk to your doctor.

    Especially tell your doctor if you take a:

    • water pill (diuretic)

    • glucocorticoid (steroid) medicine, including an inhaled glucocorticoid (steroid) medicine

    Your doctor should stop your treatment with NOCTIVA for a period of time while you are taking and after you stop taking an oral or inhaled glucocorticoid (steroid) medicine.• medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI)

    • medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine

    • medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine

    • non-steroidal anti-inflammatory medicine (NSAID)

    • medicine that you use in your nose

    There have not been any studies done to see if other medicines might interact with NOCTIVA. Ask your doctor or pharmacist if you are not sure if your medicine is one of the types listed above, or if you are unsure whether any of the medicines you already take might put you at increased risk of side effects.

    How should you take NOCTIVA?
    You should use NOCTIVA exactly as instructed by your health care professional. Your doctor has prescribed the strength that is best for you, and you should not use more than 1 spray of the prescribed dose at a time, even if you missed a prior dose.

    What are the side effects of NOCTIVA?
    NOCTIVA may cause serious side effects, including hyponatremia, which may lead to serious or life-threatening conditons, including seizure, coma, trouble breathing, or death if not treated early. NOCTIVA may also cause your body to hold too much water (fluid retention).
    The most common side effects of NOCTIVA include:

    • nose discomfort

    • pain or swelling (inflammation) in your nose or throat

    • stuffy nose

    • sneezing

    • high blood pressure

    • back pain

    • nosebleed

    • inflammation of the lining of the bronchial tubes that carry air to and from your lungs that causes a cough (bronchitis)

    • dizziness

    These are not all of the possible side effects of NOCTIVA. You are encouraged to call your doctor for medical advice about side effects, and you can also report them to the FDA.

    To report SUSPECTED SIDE EFFECTS, contact Avadel Specialty Pharmaceuticals, LLC, at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please be aware that this is not a complete listing of all safety information associated with NOCTIVA. For more information, call 1-877-622-2320

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