Aralez Pharmaceuticals Canada, Inc.

TORONTO, Sept. 20, 2022 /PRNewswire/ - Xpira Pharmaceuticals ("Xpira" or "the Company"), a leading developer of next-generation psychedelic medicines for the treatment of eating disorders, is pleased to announce has obtained approval from the United States Food and Drug Administration ("FDA") for its first Investigational New Drug ("IND") application. The Company will initiate a Phase 2a clinical trial which will study the efficacy of psilocybin-assisted therapeutic protocols in patients suffering from Anorexia Nervosa ("AN"). Anorexia nervosa is among the deadliest mental illnesses known to psychiatric medicine, for which there is currently no approved treatment regimen, neither pharmacologic nor psychotherapeutic. With this trial, Xpira aims to contribute to the successful outcome of treatment for patients with AN, including enhancing patients' quality of life by furthering the development of its innovative psilocybin-assisted treatment. "Throughout my career as a psychiatrist, I have participated in many high-profile pharmacological trials in AN, all of which failed to meet their objectives," said Dr. Allan Kaplan, Xpira's Vice President of Clinical Development. Because of what we now know of its neurobiology, and the mechanism of action of psilocybin on brain circuitry, I believe that AN could be potentially successfully treated with psilocybin, when utilized and overseen properly within the parameters of psychedelic-assisted psychotherapy. With clear clinical endpoints and a robust study design, and taking into full account the vulnerability of AN patients, we hope to move closer to a treatment that will both improve the prognosis of sufferers and bring us closer to a more complete understanding of this pervasive and difficult to treat condition," Dr. Kaplan added. This critical regulatory approval from the FDA reinforces Xpira's commitment towards improved clinical outcomes for patients suffering from eating disorders. Since its inception, Xpira has worked to ensure a safe and effective trial design, leading to a higher standard of care for patients while providing value for its shareholders. With this trial progressing, Xpira has moved to establish a clear differentiation for itself through its clinical expertise and pursuit of specific indications in both the growing market for psychedelic therapeutics and the landscape of pharmaceutical companies committed to the development of treatments for eating disorders. About Xpira Xpira Pharmaceuticals Inc ("Xpira") is positioned to be a global leader in development, production and marketing of psychedelic-based medicines with clinically proven efficacy. Our mission is to have a meaningful impact on the lives of patients suffering from mental conditions by developing high quality proprietary therapeutic treatments with a special focus on Eating Disorders. Xpira's team is composed of industry leaders in North America and the Netherlands, with substantial experience in eating disorders, drug development, intellectual property ("IP"), registration, product commercialization and Specialty Pharma. Dr. Allan Kaplan — Vice President, Clinical Development In addition to his work with Xpira, Dr. Kaplan is a Senior Clinician at the Center for Addiction and Mental Health in Toronto, as well as a Professor in the Department of Psychiatry at the University of Toronto's Temerty Faculty of Medicine. He has worked in the field of eating disorders for 35 years, has lectured widely on various topics in the field, published 200 peer reviewed articles, two books, 60 book chapters and over 200 abstracts. He has held the position of President for both the Academy for Eating Disorders, the largest organization of eating disorder professionals in the world, and the International Eating Disorder Research Society. CEO and Director — Vanesa Fernandez, Ph.D Vanesa Fernandez has over 20 years of experience in various C-level positions and is co-founder of several companies in Europe and North America in the pharma and consumer products sectors. Ms. Fernandez provides Xpira with profound knowledge in product development, clinical programs, regulatory affairs, as well as expertise in licensing, patents, external financing and working in a complex governance structure. Ms. Fernandez is the former CEO of Echo Pharmaceuticals BV ("Echo"), a pioneering firm in the regulated cannabis industry that under her lead grew from a start-up to a mature business, securing Series B investment and raised over EUR 10M of non-dilutive funds. Ms. Fernandez has a Ph.D. in chemistry, is the author of several scientific publications and is the named inventor of more than 10 patents for novel formulations. President and Director — Nick Wong Nick Wong is an IP lawyer with over 20 years of experience in the pharmaceutical industry, in the areas of legal, regulatory and scientific R&D. Mr. Wong was selected by his peers for inclusion in the 2022 and 2023 Edition of The Best Lawyers of the Year in Canada for his expertise in IP law and biotechnology law. He has also been recognized internationally in IAM Patent 1000 as a leading lawyer in IP transactions. His existing legal practice combines extensive experience in strategic IP portfolio development and IP litigation, with an expertise in business development (drug development and life cycle-management) and negotiating product development agreements for clients in the areas of pharmaceuticals and other health sciences. Board of Directors Xpira's Board of Directors is a experienced group of healthcare entrepreneurs and executives including; Jaiveer Singh, CEO of Mint Pharmaceuticals; Steve Ottaway, CEO of Hyperion Capital Inc. and former Head of Healthcare at GMP Securities L.P. ("GMP"); Dr. Par Nijhawan, Chief Executive Officer of Edesa Biotech Inc. and the former founder and CEO of Medical Futures Inc.; Gregory Gubitz, founding Chief Executive Officer of HLS Therapeutics Inc. and the former Senior Vice President, Corporate Development and General Counsel of Biovail Corporation. SOURCE Xpira Pharmaceuticals

SAN DIEGO and MILTON, Ontario, Jan. 3, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI - News) ( ) and Stellar Pharmaceuticals Inc. ("Stellar Pharma") (OTCQB:SLXCF.PK - News) (OTCBB:SLXCF.PK - News) (Pink Sheets:SLXCF), a Canadian public company, announced today the signing of an exclusive license agreement. Under the agreement, Stellar Pharma has the exclusive right to sell Apricus Bio's MycoVa(TM) product for the treatment of onychomycosis (nail fungus) in Canada, following receipt of Canadian regulatory approval for such product. The exclusive license agreement provides for an upfront payment, regulatory approval milestone, sales achievement milestones and royalty payments during the term of the agreement. Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. According to the Merck Manual, the worldwide incidence rate of onychomycosis is approximately 10%. As described by Iorizzo and Piraccini (2007), the incidence has been increasing due to diabetes, immunosuppression and an aging population. While occurring in approximately 2.6% of children younger than 18 years, it occurs in as much as 90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma had stated that the worldwide market was approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014. The advantage of Apricus Bio's MycoVa(TM) product is that it is easy to apply, and is therefore believed to improve patient compliance. MycoVa(TM) is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure. Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio commented, "We are very pleased with our exclusive license agreement with Stellar Pharma and we look forward to the future commercialization in the Canadian market of MycoVa(TM), our second major product utilizing our proprietary NexACT(R) technology. We are very impressed with the experience of Rob Harris and his team at Stellar Pharma, and we are very excited about this first potential launch of this important drug in that market. We also hope that our partnership with Stellar Pharma will produce additional collaborations among multiple NexACT(R) products in the future." Rob Harris, President and Chief Executive Officer of Stellar Pharma stated, "We are excited about this opportunity and are very pleased to be able to strengthen our dermatology portfolio in Canada. I would like to thank Bassam and his excellent team at Apricus Bio for providing us with this opportunity to launch MycoVa(TM) in the Canadian market. We will be assisting Apricus Bio in the filing of a New Drug Submission for MycoVa(TM) for onychomycosis and look forward to its commercial launch in Canada following Canadian regulatory approval." About MycoVa(TM) MycoVa(TM) combines an existing, approved drug for nail fungus, terbinafine, with the NexACT(R) technology that enhances the absorption of the drug through the skin. In January 2011, the Company announced that an additional analysis showed that MycoVa(TM) is as effective for the treatment of nail fungus as the current European standard of care for topical therapy, Loceryl(R) (an ointment made by Galderma). In June 2011, the Company announced that based on a reanalysis of its Phase III trials for its MycoVa(TM) product for treating onychomycosis (nail fungus), it is revisiting its regulatory strategy for the drug and will seek guidance from regulatory authorities in the U.S., Canada and Europe. A combined post-hoc analysis of two randomized, double-blind, vehicle controlled, multicenter, parallel group Phase III studies to assess the efficacy, safety and tolerability of MycoVa(TM) demonstrated statistically significant results in primary and secondary efficacy endpoints in favor of active treatment in patients who did not present with comorbid tinea pedis (athlete's foot), as these patients are considered at higher risk of reinfection. About Apricus Biosciences, Inc. Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes. Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT(R) technology. Apricus Bio's current pipeline includes Vitaros(R), approved in Canada for the treatment of erectile dysfunction, Totect(R) the only drug approved in the US for the treatment of anthracycline extravasation, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare. The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide. For further information on Apricus Bio, visit and for information on its subsidiary please visit You can also receive information at and About Stellar Pharmaceuticals Inc. Stellar Pharma and its subsidiary, Tribute Pharmaceuticals, is an emerging Canadian specialty pharmaceutical company focused on the acquisition, licensing, development and management of pharmaceutical and healthcare products with its primary focus on the Canadian market. Stellar Pharma currently competes in the dermatology market in Canada with its promotion of Soriatane(R)* (acitretin). Stellar Pharma also markets Bezalip(R)* SR (bezafibrate), NeoVisc(R) (1.0% sodium hyaluronate solution) and Uracyst(R) (sodium chondroitin sulfate solution 2%) in the Canadian market place and is awaiting regulatory approval for Cambia(R)** (diclofenac potassium for oral solution) in Canada. Additionally, NeoVisc(R) and Uracyst(R) are commercially available in 58 countries and are sold globally through various international partnerships. Stellar Pharma is currently in negotiations to license both NeoVisc(R) and Uracyst(R) in the US and other international markets. For further information on Stellar Pharma, visit and for information on its subsidiary please visit Apricus Bio's Forward-Looking Statement Safe Harbor Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to receive issued patents on its NexACT(R) technology and products, develop such patented technology into product candidates, have its Rx Division products and product candidates such as Vitaros(R) and MycoVa(TM) approved by relevant regulatory authorities and its Consumer Healthcare Division products either approved or cleared by relevant regulatory authorities or be in compliance with appropriate regulatory requirements, to successfully manufacture and commercialize such Rx Division products as Totect(R) for the treatment of anthracycline extravasation, Vitaros(R) for erectile dysfunction and MycoVa(TM) for onychomycosis in the U.S., Canada, and in other countries along with its Consumer Healthcare Division products and product candidates and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company. Stellar Pharmaceuticals' Forward Looking Statement This press release contains certain forward-looking statements about Stellar Pharma as defined in the Private Securities Litigation Reform Act of 1995, which statements can be identified by the use of forward-looking terminology, such as "may", "will", "expect", "intend", "anticipate", "estimate", "predict", "plan" or "continue" or the negative thereof or other variations thereon or comparable terminology referring to future events or results. Forward-looking statements, by their nature, are subject to risks and uncertainties, Stellar Pharma's actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including general economic conditions, the ability of Stellar Pharma to successfully integrate operations, and the timing of expenditures and expansion opportunities, any of which could cause actual results to vary materially from current results or anticipated future results. See Stellar Pharma's reports filed with the Canadian Securities Regulatory Authorities and the U.S. Securities and Exchange Commission from time to time for cautionary statements identifying important factors with respect to such forward-looking statements, including certain risks and uncertainties, that could cause actual results to differ materially from results referred to in forward-looking statements. Stellar Pharma assumes no obligation to update the information contained in this press release to update forward-looking statements to reflect changed assumptions, the occurrence of anticipated events or changes in future operating results, financial condition or business over time. *Soriatane and Bezalip are registered trademarks and under license from Actavis Group PTC ehf **Cambia is a registered trademark and under license from Nautilus Neurosciences, Inc. Contact: Apricus Biosciences, Inc.Edward Cox, V.P.Corporate Development & Investor Relations, Apricus Bio, Inc.(858) 848-4249ecox@apricusbio.comApricus Bio Investor RelationsPaula SchwartzRx Communications Group, LLC(917) 322-2216pschwartz@rxir.comStellar Pharmaceuticals Inc.Attention: Scott LangilleCFO(519) 434-1540scott.langille@stellarpharma.comAttention: Arnold TenneyChairman705-445-9505