24 January 2022
Notice of Allowance of Patent Application for a Non-Steroidal Anti-Inflammatory, Diclofenac Potassium, Strengthens Proprietary Position in U.S. until 2039
Geneva, Switzerland, January 24, 2022 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), has received a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for Patent Application No. 16/713,052 entitled, “Ready to Use Diclofenac Packs.”
Diclofenac potassium is an off-patent, potent non-steroidal anti-inflammatory drug (“NSAID”) widely used therapeutically for inflammatory conditions and pain management. By applying the patented dynamic buffering technology (“DBT”), APR developed the first, and still the only, NSAID ever approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of acute migraine attacks in adults -- currently marketed as CAMBIA by Assertio Therapeutics Inc. in the U.S. and Miravo Healthcare (formerly Nuvo Pharmaceuticals Inc.) in Canada, under an exclusive, royalty bearing license agreement with APR.
DBT and CAMBIA are currently protected by a family of four patents listed in the FDA Orange Book, all expiring in 2026. CAMBIA is currently available in the form of a dry powder packed into a single dose sachet to be poured and dissolved in water before administration. APR, in order to offer a potential life cycle management option to its current commercial partners, has developed a liquid version of the same product packed into a portable stick pack in order to offer improved convenience to migraine patients; and this new dosage form is the subject matter of the new patent application just allowed by the USPTO.
The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. The allowed claims are for a (i) single dose, ready to use oral solutions provided as liquid formulations in a stick pack containing diclofenac or a salt thereof, and (ii) methods of treating pain or migraine in a patient in need thereof comprising administering to said patient a therapeutically effective amount of the various diclofenac formulations. Once issued, the patent will have an expiration date of December 13, 2039.
“The receipt of this Notice of Allowance from the USPTO is another confirmation of our drug development and reformulation expertise,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “The new, user friendly, ready to use, liquid portable stick packs to deliver CAMBIA should improve patient compliance. We look forward to continue to identify, develop and commercialize innovative therapies for patients with niche and rare diseases.”
Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19 through Relief’s collaboration partner in the U.S., NeuroRx, Inc. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. Finally, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.
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This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding SA. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether and when the new patent will issue, (ii) whether the new patent will be upheld, if challenged, (iii) the scope of the protection ultimately afforded by the new patent, and (iv) those risks discussed in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.