Noctiva is the only FDA-approved product indicated for the treatment of nocturia
DUBLIN, Ireland I September 05, 2017 I Avadel Pharmaceuticals plc (NASDAQ:AVDL) (“Avadel”), today announced that it has entered into a license agreement with Serenity Pharmaceuticals, LLC (“Serenity”). The agreement grants Avadel the sole right to commercialize and further develop Noctiva in the United States and Canada. Noctiva is a proprietary low-dose formulation of desmopressin acetate administered through a patent-protected intranasal delivery system. It is the first and only product approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of nocturia due to nocturnal polyuria.
Key Highlights:
- Deal Includes $50 million upfront payment; funded by cash on hand, and a near term expected improvement in the Company’s effective tax rate.
- Current nocturia-treated patient pool estimated at over $2B with no FDA approved treatment options until now, and market growth potential1.
- Long-term growth opportunity with current intellectual property through mid-2030, and potential opportunities to extend patent life.
- Balance sheet remains strong with no bank debt, and adequate cash to fund ongoing operations, including completion of the Company’s REST-ON Phase III trial.
Nocturia is a medical condition that affects approximately 40 million2 people in the United States, and represents a high unmet medical need. Nocturia results in frequent nighttime urination, which may prevent patients from experiencing a normal, restful sleep cycle. Nocturia is associated with a number of co-morbidities and health-related consequences, including an increase in the risk of nighttime falls and fractures, loss of sleep, decreased work productivity, impaired daytime functioning and compromised quality of life3.
Mike Anderson, Avadel’s Chief Executive Officer, said, “Licensing Noctiva is an important step in our strategic growth plan and positions Avadel as a fully-integrated specialty pharmaceutical company, with a profitable base and a significant ongoing Phase III trial. Noctiva is the first and only FDA approved product to treat nocturia due to nocturnal polyuria, and aligns with our mission of offering patients unique and differentiated branded products. Noctiva has the potential to deliver significant value to Avadel, the large, underserved patient population who suffer from nocturia and our shareholders.”
Dr. Samuel Herschkowitz, Chief Executive Officer of Serenity, said, “Approximately $200 million has been invested in order to develop and gain FDA approval for Noctiva, which is the first drug therapy shown to be safe and effective for the treatment of nocturia. The clinical program for Noctiva included four Phase 3 studies and two long-term safety trials and demonstrated significant reductions in the mean number of nocturic episodes, and improved quality of life4. We believe Avadel is the right partner with the experience, capability and commitment to bring Noctiva to market for the benefit of patients, providers and payors.”
Terms of the final agreement, which can be found in detail on Avadel’s 8-K filed with the S.E.C. on September 5, 2017, include an upfront payment of $50 million, $20 million due at the earlier of full scale commercial launch or June 30, 2018, performance-based milestones tied to specific Noctiva net sales thresholds and a tiered royalty rate structure based upon achievement of annual net sales. As a result of the licensing agreement, the Company expects an improvement in its effective tax rate, as expenses associated with the launch will partially offset U.S. taxable income. Avadel’s strong balance sheet, with $173 million in cash and marketable securities and no bank debt at June 30, 2017, means the Company is able to self-fund the licensing acquisition of Noctiva and subsequent near-term commercialization plans.
The transaction is set to close upon expiration of any applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. T.R. Winston & Company, LLC, served as financial and strategic advisor to Serenity.
Conference Call:
Avadel will host a conference call and live audio webcast on Wednesday, September 6, 2017 at 8:30 am EDT to discuss this transaction. Interested parties may access the conference call by dialing (844) 388-0559 (U.S. & Canada) or (216) 562-0393 (International) and entering Conference ID# 79911607. The live audio webcast and slide presentation may be accessed via the Investors section of the Avadel Pharmaceuticals website at www.avadel.com. A replay of the webcast will be available on the website for 90 days.
1 Data on file.
2 Sources: (1) US census data 2016 estimates (2) Lee, L. K., et al. “Potential benefits of diagnosis and treatment…” International journal of clinical practice 70.1 (2016): 66-81.
3 Data on file.
4 New Drug Application for Noctiva. Data on file.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a specialty pharmaceutical company that seeks to commercialize differentiated pharmaceutical products that are safe, effective and easy to take through formulation development, by utilizing its proprietary drug delivery technology and in-licensing / acquiring new products; 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 and Lyon, France. For more information, please visit www.avadel.com.
About Noctiva™:
Noctiva is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Noctiva™ is a preservative-free intranasal formulation of desmopressin, administered 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. (Full Prescribing Information available here).
SOURCE: Avadel Pharmaceuticals
Post Views: 124
Noctiva is the only FDA-approved product indicated for the treatment of nocturia
DUBLIN, Ireland I September 05, 2017 I Avadel Pharmaceuticals plc (NASDAQ:AVDL) (“Avadel”), today announced that it has entered into a license agreement with Serenity Pharmaceuticals, LLC (“Serenity”). The agreement grants Avadel the sole right to commercialize and further develop Noctiva in the United States and Canada. Noctiva is a proprietary low-dose formulation of desmopressin acetate administered through a patent-protected intranasal delivery system. It is the first and only product approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of nocturia due to nocturnal polyuria.
Key Highlights:
- Deal Includes $50 million upfront payment; funded by cash on hand, and a near term expected improvement in the Company’s effective tax rate.
- Current nocturia-treated patient pool estimated at over $2B with no FDA approved treatment options until now, and market growth potential1.
- Long-term growth opportunity with current intellectual property through mid-2030, and potential opportunities to extend patent life.
- Balance sheet remains strong with no bank debt, and adequate cash to fund ongoing operations, including completion of the Company’s REST-ON Phase III trial.
Nocturia is a medical condition that affects approximately 40 million2 people in the United States, and represents a high unmet medical need. Nocturia results in frequent nighttime urination, which may prevent patients from experiencing a normal, restful sleep cycle. Nocturia is associated with a number of co-morbidities and health-related consequences, including an increase in the risk of nighttime falls and fractures, loss of sleep, decreased work productivity, impaired daytime functioning and compromised quality of life3.
Mike Anderson, Avadel’s Chief Executive Officer, said, “Licensing Noctiva is an important step in our strategic growth plan and positions Avadel as a fully-integrated specialty pharmaceutical company, with a profitable base and a significant ongoing Phase III trial. Noctiva is the first and only FDA approved product to treat nocturia due to nocturnal polyuria, and aligns with our mission of offering patients unique and differentiated branded products. Noctiva has the potential to deliver significant value to Avadel, the large, underserved patient population who suffer from nocturia and our shareholders.”
Dr. Samuel Herschkowitz, Chief Executive Officer of Serenity, said, “Approximately $200 million has been invested in order to develop and gain FDA approval for Noctiva, which is the first drug therapy shown to be safe and effective for the treatment of nocturia. The clinical program for Noctiva included four Phase 3 studies and two long-term safety trials and demonstrated significant reductions in the mean number of nocturic episodes, and improved quality of life4. We believe Avadel is the right partner with the experience, capability and commitment to bring Noctiva to market for the benefit of patients, providers and payors.”
Terms of the final agreement, which can be found in detail on Avadel’s 8-K filed with the S.E.C. on September 5, 2017, include an upfront payment of $50 million, $20 million due at the earlier of full scale commercial launch or June 30, 2018, performance-based milestones tied to specific Noctiva net sales thresholds and a tiered royalty rate structure based upon achievement of annual net sales. As a result of the licensing agreement, the Company expects an improvement in its effective tax rate, as expenses associated with the launch will partially offset U.S. taxable income. Avadel’s strong balance sheet, with $173 million in cash and marketable securities and no bank debt at June 30, 2017, means the Company is able to self-fund the licensing acquisition of Noctiva and subsequent near-term commercialization plans.
The transaction is set to close upon expiration of any applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. T.R. Winston & Company, LLC, served as financial and strategic advisor to Serenity.
Conference Call:
Avadel will host a conference call and live audio webcast on Wednesday, September 6, 2017 at 8:30 am EDT to discuss this transaction. Interested parties may access the conference call by dialing (844) 388-0559 (U.S. & Canada) or (216) 562-0393 (International) and entering Conference ID# 79911607. The live audio webcast and slide presentation may be accessed via the Investors section of the Avadel Pharmaceuticals website at www.avadel.com. A replay of the webcast will be available on the website for 90 days.
1 Data on file.
2 Sources: (1) US census data 2016 estimates (2) Lee, L. K., et al. “Potential benefits of diagnosis and treatment…” International journal of clinical practice 70.1 (2016): 66-81.
3 Data on file.
4 New Drug Application for Noctiva. Data on file.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a specialty pharmaceutical company that seeks to commercialize differentiated pharmaceutical products that are safe, effective and easy to take through formulation development, by utilizing its proprietary drug delivery technology and in-licensing / acquiring new products; 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 and Lyon, France. For more information, please visit www.avadel.com.
About Noctiva™:
Noctiva is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Noctiva™ is a preservative-free intranasal formulation of desmopressin, administered 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. (Full Prescribing Information available here).
SOURCE: Avadel Pharmaceuticals
Post Views: 124
