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Avadel spikes as Oppenheimer says selloff is overdone
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Avadel Pharmaceuticals Announces Submission of New Drug Application for FT218 to the FDA
DUBLIN, Ireland, December 16, 2020 -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.
“The submission of our NDA represents a significant milestone for the Company. We look forward to working with the FDA during the NDA review process in order to get once-nightly FT218 approved and commercially available to patients with narcolepsy who suffer from excessive daytime sleepiness and cataplexy,” said Greg Divis, Chief Executive Officer of Avadel. “If approved, we believe once-nightly FT218 has the potential to provide a valuable treatment option for sodium oxybate eligible narcolepsy patients, including those who are not satisfied with the current twice-nightly treatment, which requires waking up in the middle of the night to take a second dose.”
About FT218
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.
Kid looks like he is about 18 but he is spot on with his analysis
Hard to look at his face but just listen to him, he has all the facts and hopes correct
Avadel Pharmaceuticals Completes the REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
GlobeNewswire GlobeNewswire•March 25, 2020
Topline data from the REST-ON study expected in Q2 2020
DUBLIN, Ireland, March 25, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed the REST-ON Phase 3 clinical trial for FT218. The REST-ON study enrolled a total of 212 patients, and the last patient last visit occurred earlier this week. The Company currently expects to announce topline data from the study in the second quarter of 2020.
“We’re excited to complete our pivotal Phase 3 REST-ON study of FT218 and look forward to announcing the topline data from the study as we move closer toward potentially bringing this new drug to narcolepsy patients. I want to thank our investigators, study staff and patients for their participation in this study, as well as the Avadel team for their continued dedication,” stated Dr. Jordan Dubow, Chief Medical Officer of Avadel.
The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of FT218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump™ technology for extended-release oral suspension, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The REST-ON study is under a Special Protocol Assessment agreement with FDA.
Based on the Company’s industry research, it believes FT218, if approved by the FDA, has the potential to provide a valuable advancement in the treatment of both excessive daytime sleepiness and cataplexy for patients with narcolepsy. Currently, the twice-nightly sodium oxybate market is valued at an estimated annualized rate of $1.7 billion1.
Avadel Pharmaceuticals Receives U.S. FDA Approval for Nouress™ (AV001), a Cysteine Hydrochloride Injection for Treating Neonate Patients Requiring Total Parental Nutrition (TPN)
PDF Version
USPTO issues Orange Book-listed patent for Nouress
DUBLIN, Ireland, Dec. 16, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced today that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition (TPN).
In addition, Avadel announced today that the United States Patent and Trademark Office (USPTO) recently issued United States Patent No. 10,493,051 covering cysteine solutions, including the approved Nouress product. This patent is listed in the Orange Book for Nouress and is set to expire in March of 2039. Avadel has additional U.S. patent applications pending for Nouress.
“We are pleased to receive FDA approval for Nouress, which validates our strategy of developing innovative medicines for patients,” said Greg Divis, Chief Executive Officer of Avadel. “Nouress is the fourth FDA approved product in our sterile injectable hospital business. The cash flow generated by this legacy business is supporting the clinical development costs from our lead program, FT218, which is currently expected to announce topline data from the pivotal Phase 3 REST-ON trial in the second quarter of 2020. We believe that as a once-nightly formulated sodium oxybate, FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxybate market, which is currently valued at an estimated annualized rate of $1.7 billion1.”
Avadel is currently evaluating the timing and process for a commercial launch of Nouress in the United States. In this regard, a competitor received FDA approval earlier this year for its cysteine hydrochloride injection and more recently was granted a U.S. patent, which Avadel is assessing along with other market factors.
Due to a historical lack of reliable supply, U.S. markets previously imported cysteine hydrochloride injection from Canada under special FDA rules allowing shortage drugs to be sourced abroad if no domestic supplies are available. With FDA approvals of Nouress and another U.S. company’s cysteine hydrochloride injection earlier this year, Avadel expects domestic supply of cysteine hydrochloride injection will be sufficient to support the entire U.S. market, which, under FDA regulations, should preclude further import or U.S. marketing of unapproved cysteine hydrochloride injection products. Under these potential market conditions, the U.S. annual market for cysteine hydrochloride could be greater than $50 million.
Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial of FT218 for Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy
GlobeNewswire GlobeNewswire•November 25, 2019
205 patients enrolled; additional patients currently in screening will be allowed to enroll if eligible
Topline data from the REST-ON study expected in Q2 2020
DUBLIN, Ireland, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for its once-nightly sodium oxybate, FT218. Additional patients currently in the screening process will also be allowed to enroll in the study if they meet eligibility criteria. The last patient’s last visit is expected to occur by the end of the first quarter of 2020, with topline data expected in the second quarter of 2020.
“Achieving the patient enrollment target in the pivotal REST-ON study marks an important milestone in our development efforts for our lead asset, FT218. We expect to announce topline data from the study in the second quarter of 2020, as we continue to advance this program towards submission for regulatory approval,” stated Dr. Jordan Dubow, Chief Medical Officer. “Being able to accelerate this achievement by up to 12 months is a testament to the hard work of the study investigators, staff, and patients, as well as the Avadel team.”
Based on the Company’s industry research, it believes FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxybate market. Currently, this market is valued at an estimated annualized rate of $1.7 billion1.
The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel’s proprietary Micropump™ technology for extended-release oral suspension, in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The REST-ON study is under a Special Protocol Assessment agreement with FDA.
About FT218
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to a twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.
Footnote:
1. Annualized Xyrem revenues from Jazz Pharmaceuticals Q3 2019 earnings press release, November 5, 2019
Drugmaker Avadel Gets Boost From Parent In Del. Ch. 11
By Jeff Montgomery
Law360 (February 8, 2019, 7:00 PM EST) -- Bankrupt, one-product drug company Avadel Specialty Pharmaceuticals LLC cleared initial Chapter 11 hurdles Friday, helped along by what a Delaware judge said was a notably responsible nondebtor parent.
The company, forced into Chapter 11 on Wednesday by slow physician and insurer adoption of its Noctiva medication for excessive nighttime urination, received what Judge Christopher S. Sontchi described as a "strange," albeit supportive, debtor-in-possession loan from parent Avadel U.S. Holdings.
The $2.7 million maximum borrowing 13-week agreement calls for a 5 percent annual rate, rising to 7.5 percent in the event of a default, without fees or administrative expenses and having a status equivalent to other third-party, prepetition unsecured claims. DIP loans with significantly higher rates and repayment priorities and more punitive default terms have not been uncommon in recent years.
"My initial view of this entire bankruptcy is the parent is acting very responsibly as a corporate citizen," Judge Sontchi said before approving the loan and terms. "I hope you find a soft landing for the business."
Paul J. Keenan Jr. of Greenberg Traurig PA, counsel to the debtors, told Judge Sontchi "growth has been slower than anticipated" for the business, which contracts out production of the medication in order to focus on marketing, sales and distribution.
Current plans call for a sale of assets and wind-down of the business.
The company has operated at a deficit since its launch, with the U.S. parent sinking more than $152 million into the venture before a search for a buyer began, followed by the bankruptcy filing. Virtually all of Avadel Specialty's debt is held by the parent company, although third-party vendors and other unsecured creditors are owed $1.7 million
The drug was approved by the U.S. Food and Drug Administration in March 2017, but there has been "minimal market demand," with medications for other conditions, such as prostate or bladder problems, complicating efforts to drum up interest in Noctiva.
An additional monitoring consideration for users and past side effects with "older formulations of the same active ingredient" have caused some physician hesitation to adopt Noctiva, the company said in its initial declaration.
Restrictions for use by patients in managed care programs and other health benefits restricted use of the drug, with more than half of all prescriptions dispensed for free.
During the company's initial hearing Friday, Judge Sontchi approved routine motions to continue the company's payment of employees and product-handling contractors.
Avadel's payroll dropped significantly on Thursday, however, with the company's remaining workforce cut from 34 to 14 employees, according to a summary issued during the hearing.
The approvals in Delaware came the same day the debtor's indirect parent, Ireland-based Avadel Pharmaceuticals PLC, announced its own plan to restructure and refocus efforts on more promising specialty drugs.
"Noctiva's performance since launch has been highly disappointing despite a substantial investment of resources," the parent company said in a statement issued Friday. "It no longer warrants such a level of support, and Avadel will be better positioned for the future by exiting the business entirely."
The same statement said the global parent's workforce will be reduced by about half, with the remaining company focusing on a promising new drug for excessive daytime sleepiness and sudden muscle weakness or immobility in patients suffering from narcolepsy.
Keenan told Judge Sontchi that although the Irish parent company is restructuring, there are no current court proceedings scheduled in the United States or overseas.
Avadel is represented by Dennis A. Meloro, Paul J. Keenan Jr., John R. Dodd, Sara A. Hoffman and Reginald Sainvil of Greenberg Traurig LLP.
The case is In re: Avadel Specialty Pharmaceuticals LLC, case number 19-10248, in the U.S. Bankruptcy Court for the District of Delaware.
--Additional reporting by Rick Archer. Editing by Stephen Berg.
For a Reprint of this article, please contact reprints@law360.com.
Drugmaker Files Ch. 11, Blames Low-Selling Urination Drug
By Rick Archer
Law360 (February 6, 2019, 10:10 PM EST) -- Specialty drugmaker Avadel Specialty Pharmaceuticals filed for Chapter 11 in Delaware bankruptcy court Wednesday, saying slow sales growth for its nighttime urination drug caused its parent company to cut off funding after investing $152 million with minimal returns.
In the company's Chapter 11 declaration, Avadel said its corporate parent and sole funding source, Avadel Group member Avadel U.S. Holdings Inc., has invested $152 million since September in their attempt to launch Noctiva, its sole commercial product, but that the drug so far has less than $3 million in net sales.
"In light of the Avadel Group's broader restructuring, and as a result of its own ongoing financial and capital constraints, AUSH determined that it could no longer continue to fund ASP," Avadel president Gregory Divis said in the declaration.
The declaration said the company is part of the Dublin, Ireland-based Avadel Group, which is itself undergoing out-of-court restructuring.
The company has no other secured or unsecured debt, except for about $1.7 million in unsecured claims from vendors and other third parties, the declaration said.
The declaration said the company's sole commercial product is Noctiva, a nasal spray that treats nocturnal polyuria, a condition that causes the body to make too much urine at night.
The drug was approved by the U.S. Food and Drug Administration in March 2017, but there has been "minimal market demand" for the drug, with physicians unwilling to prescribe it, the declaration said. Managed care companies have also placed restrictions on the drug, resulting in more than half of all prescriptions so far being dispensed for free, it said.
"Making matters worse, sales projections based on the current growth trend illustrate a substantially longer period of operating losses than originally assumed," Divis said.
The declaration said the company will pursue an asset sale followed by a wind-down and liquidation of any unsold operations and assets.
Representatives of Avadel did not immediately respond to requests for comment late Wednesday.
Avadel is represented by Dennis A. Meloro, Paul J. Keenan Jr., John R. Dodd and Sara A. Hoffman of Greenberg Traurig LLP.
The case is In re: Avadel Specialty Pharmaceuticals LLC, case number 19-10248, in the U.S. Bankruptcy Court for the District of Delaware.
Avadel Launches NOCTIVA™, the First and Only FDA-Approved Treatment for Nocturia Due to Nocturnal Polyuria
GlobeNewswire•May 1, 2018
DUBLIN, Ireland, May 01, 2018 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (AVDL) today announced the launch of NOCTIVA™ (desmopressin acetate), an emulsified microdose Nasal Spray. NOCTIVA is the first and only FDA-approved treatment proven to help adults with nocturia due to nocturnal polyuria, a condition which causes the kidneys to overproduce urine at night.1 NOCTIVA safely and effectively treats a condition that causes more than 40 million Americans2 to wake two or more times per night to use the bathroom, and prevents them from getting a good night’s sleep.
NOCTIVA’s innovative formulation works in the kidneys to lessen nighttime urine production. The nasal spray is a proprietary emulsified microdose of desmopressin combined with a permeation enhancer that increases the transport of NOCTIVA across the nasal mucosa. Delivered via a unique spray pattern, NOCTIVA’s breakthrough formulation substantially increases the bioavailability of the active drug, allowing for microdosing, rapid absorption and consistency from dose to dose.
NOCTIVA was studied in two clinical trials in patients who experienced on average two or more nighttime awakenings to urinate. Study patients received either 1.66 mcg or 0.83 mcg of NOCTIVA or a placebo for 12 weeks. Those using NOCTIVA were able to stay in bed an average of four hours or more before having to wake up to urinate (on average, an improvement greater than 50% relative to placebo vs 2.4-hour baseline). In fact, NOCTIVA responders using 1.66 mcg were able to stay in bed more than five hours before experiencing a nocturic episode.3
“Having a safe, effective medication to treat my patients suffering from nocturia due to nocturnal polyuria is a game changer for their quality of life,” said Dr. Steven A. Kaplan, Professor of Urology at the Icahn School of Medicine at Mount Sinai and Director of the Benign Urologic Diseases and Men’s Health Program at Mount Sinai Health System. “Nocturia is not only highly bothersome, but has been underreported and understudied in terms of its long- and short-term health consequences, including increased risk of falls, fractures and depression.”
As part of the clinical development of NOCTIVA, a novel instrument was developed in collaboration with the FDA to evaluate the daytime and nighttime impacts of nocturia. Patients’ quality of life was assessed in one of the two clinical trials using the “Impact of Nighttime Urination (INTU)” Questionnaire, which evaluated 10 daytime and nighttime consequences of nocturia. Patients rated their bother in terms of concentration, tiredness, irritability and insufficient sleep using a 0-100 scale. The higher the score, the greater the impact. At the end of the clinical trial, patients taking 1.66 mcg of NOCTIVA demonstrated a 45% improvement in their quality of life score when compared to their baseline measure.
“We’re committed to getting patients the help they need to improve their quality of life,” Avadel CEO Michael Anderson said. “We’re working with specialists to provide a safe and effective treatment option to patients who suffer from nocturia due to nocturnal polyuria.”
Avadel is committed to making this innovative, patient-focused product widely accessible and affordable to those diagnosed with nocturia due to nocturnal polyuria. With the NOCTIVA Care+ program available at launch, patients will pay no more than $40 for the prescription.4
Please see Important Safety Information below and Full Prescribing Information at www.Noctiva.com.
Avadel Pharmaceuticals Announces Divestiture of Pediatric Business
GlobeNewswire•February 12, 2018
Cerecor to acquire Avadel’s pediatric assets
Enters into license agreement to develop four LiquiTime™ or Micropump® products
DUBLIN, Ireland, Feb. 12, 2018 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (AVDL) (“Avadel” or “the Company”) today announced that it has entered into an asset purchase agreement with Cerecor, Inc (“Cerecor”) whereby Cerecor will acquire the Avadel pediatric portfolio. In connection with this transaction, Avadel and Cerecor will enter into a license and development agreement pursuant to which Avadel will develop up to four product formulations for Cerecor using Avadel’s LiquiTime™ and Micropump® technologies. Under the asset purchase agreement, Cerecor will acquire the Company’s four commercial pediatric products, Karbinal™ ER, Cefaclor for Oral Suspension, Flexichamber™ and AcipHex® Sprinkle™, and Cerecor will assume Avadel’s remaining payment obligations to Deerfield CSF, LLC, including a $15 million note due in 2021 and its related interest payments, as well as a 15% annual royalty on net sales of the four pediatric products. The Company expects the deal to be accretive to EPS in 2018.
Mike Anderson, Avadel’s Chief Executive Officer commented, “We made significant progress developing our pediatric business over the last two years. The script growth and revenue numbers were up substantially in 2017, particularly for Karbinal ER. However, after strategically evaluating our business objectives, we have made the decision to focus our efforts on expanding our urology, sleep and hospital based products. Our pediatric products align with Cerecor’s objective to become a leading U.S. pediatric pharmaceutical company and with the addition of our sales team will expand their commercial footprint.”
Mr. Anderson continued, “We will also enter into a license and development agreement to provide four new pediatric-focused product formulations using our Micropump and LiquiTime technologies to be selected by Cerecor. We believe they will be an excellent commercial partner and our team looks forward to working together during the development process.”
Under the development agreement, Avadel expects to complete the initial bioequivalence studies within 18 months. Cerecor will reimburse Avadel for any costs associated with the development of the four products in excess of $1 million and, upon transfer of the product formulations, will assume all remaining development costs and responsibilities associated with regulatory approval and marketing. If any products receive approval, Cerecor will pay Avadel quarterly royalties based on a percentage of net sales in the mid-single digits.
Avadel expects the transaction to close before February 28, 2018, subject to the satisfaction of certain closing conditions including the delivery of certain third-party guarantees and consents.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (AVDL) is a branded specialty pharmaceutical company that seeks to develop differentiated pharmaceutical products that are safe, effective and easy to take through formulation development, in-licensing / acquiring new products and by utilizing its drug delivery technology; ultimately, helping patients adhere to their prescribed medical treatment and see better results. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri, United States and Lyon, France. For more information, please visit www.avadel.com.
Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for FT 218 for the Treatment of Narcolepsy
GlobeNewswire•January 10, 2018
DUBLIN, Ireland, Jan. 10, 2018 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (AVDL), “Avadel” or “the Company,” today announced that FT 218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. FT 218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump® technology, is currently undergoing testing in a Phase III clinical trial for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. The designation has been granted on the plausible hypothesis that FT 218 may be clinically superior to the same drug already approved for the same indication because FT 218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.
Mike Anderson, Avadel’s Chief Executive Officer, said, “Receipt of Orphan Drug Designation for FT 218 is meaningful for both Avadel and patients suffering from Narcolepsy. Narcolepsy is a debilitating and rare sleep disorder for which limited treatment options exist. We look forward to completing our REST-ON Phase III trial this year and are hopeful that FT 218 can provide meaningful benefit to patients and their quality of life over other standards of care.”
Orphan Drug status is intended to advance drug development for rare diseases. The FDA provides Orphan Drug Designation to drugs and biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions that affect fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design and an exemption from FDA user fees.
About REST-ON Phase III Clinical Trial
REST-ON is a double-blind, randomized, placebo controlled study of 264 patients 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. For more information, please visit www.rethinknarcolepsy.com.
https://finance.yahoo.com/news/top-cheap-stocks-week-130223440.html
Avadel Pharmaceuticals plc (NASDAQ:AVDL)
Avadel Pharmaceuticals PLC identifies, develops, and commercializes pharmaceutical products for primary care and sterile injectable markets in the United States, France, and Ireland. Founded in 1990, and headed by CEO Michael Anderson, the company size now stands at 179 people and with the company’s market capitalisation at USD $334.00M, we can put it in the small-cap stocks category.
AVDL’s stock is currently hovering at around -76% under its true value of $36.9, at a price of $8.68, based on its expected future cash flows. The difference between value and price signals a potential opportunity to buy AVDL shares at a discount. Moreover, AVDL’s PE ratio is currently around 4.4x relative to its pharmaceuticals peer level of 24.2x, implying that relative to its comparable company group, AVDL’s shares can be purchased for a lower price. AVDL is also in great financial shape, with near-term assets able to cover upcoming and long-term liabilities. AVDL also has a miniscule amount of debt on its balance sheet, which gives it headroom to grow and financial flexibility.
NasdaqGM:AVDL PE PEG Gauge Dec 17th 17
NasdaqGM:AVDL PE PEG Gauge Dec 17th 17
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