RAMM Pharma (CSE:RAMM)is pleased to announce that the Uruguayan Ministry of Public Health has approved and registered XALEX™ 10 (cannabidiol) oral solution
RAMM Pharma Corp. (including its wholly owned subsidiaries, the “Company” or “RAMM”) (CSE:RAMM), a leader in plant-derived cannabinoid pharmaceutical products, is pleased to announce that the Uruguayan Ministry of Public Health, (Ministerio de Salúd Publica or “MSP”) has approved and registered XALEX™ 10 (cannabidiol) oral solution, a prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD) free of tetrahydrocannabinol (THC), for the treatment of refractory epilepsy. RAMM has also been granted a license expansion and approval by the Instituto de Regulación y Control de Cannabis (“IRCCA”) for additional proprietary cannabis-based products and to include certain products for veterinary use, further expanding the Company’s robust portfolio of product offerings to the Latin American market.
“The approval of XALEX™ 10 is a significant accomplishment for RAMM Pharma, offering patients another federally approved pharmaceutical CBD medicine,” stated Jack Burnett, Chief Executive Officer.
XALEX™ 10 is a 10% plant-derived pharmaceutical formulation of pure CBD approved by the MSP as an anti-epileptic medication for the treatment of seizures associated with refractory epilepsy. The formulation was developed by RAMM following the success of the Company’s Epifractán™ 2% CBD pharmaceutical product (registered December 2017) and Epifractán™ 5% CBD pharmaceutical product (registered June 2018). Epifractán™ 2% and 5% are currently sold in Uruguay, Brazil, Argentina, Peru and Paraguay and are full spectrum products, which differs from XALEX™ 10 which is a pure CBD isolate free of THC. The rigorous MSP approval process includes stability testing standards which conform to international pharmaceutical requirements for registered pharmaceutical products. These same standards will eventually be required by other countries in Latin America including Brazil and Argentina. XALEX™ 10 is expected to be available in Latin America in the coming months. RAMM’s formulation and manufacturing is conducted at its state-of-the-art GMP certified facility.
Additional Treatments Under Investigation
Pharmaceutical cannabinoid medicine has progressively gained approval in a growing number of jurisdictions globally also including the United States and the European Union. CBD is being investigated for other pathologies including chronic pain, anxiety, depression, seizures associated with Tuberous Sclerosis Complex (TSC) and others.
About RAMM Pharma Corp.
Lead by renowned cannabis industry experts and backed by successful pioneers in the cannabis sector, RAMM is a leader in the field of cannabinoid pharmacology and product formulation for cannabis-based pharmaceuticals and other cannabis-based products. Founded in 1988 in Montevideo, Uruguay, the Company is a well established pharmaceutical and medical product business that has developed medically registered and approved plant-derived cannabinoid pharmaceutical products. The Company currently has multiple approved and registered products that have been authorized for sale in Uruguay and compassionate use in several Latin American countries, as well as a pipeline of new products in various stages of approval and development produced in the Company’s state of the art Good Manufacturing Practice (GMP) certified cannabis formulation facility. Further to its industry leading activities in the cannabis sector, the Company operates a successful pharmaceutical, cosmetic and nutraceutical product development and medical services business which has been servicing the local market for 30 years.
RAMM Pharma Corp. includes wholly owned subsidiaries Medic Plast SA, Yurelan SA and Ramm Pharma Holdings Corp.
Additional information about the Company is available at www.rammpharma.com.
For further information, please contact:
Chief Operating Officer
+598 92 223 131
Cautionary Note Regarding Forward-Looking Information
This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward looking statements relate, among other things, the Company’s strategies and objectives, and future expansion plans.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to materially differ from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: efficacy of the Company’s new product offerings; the expected timelines associated with the production, roll-out and availability of the Company’s new products; the ability to meet increased demand for the Company’s products, changes in prices of required commodities; the impact of COVID-19 on the Company’s workforce, suppliers, partners, customers, and other essential resources and what effect those impacts, if they occur, would have on the Company’s business and operations; future growth potential of the Company; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the Uruguayan, Latin American, and international medical and recreational cannabis markets and changing consumer habits; the ability of the Company to successfully achieve its business objectives; plans for expansion; political and social uncertainties; inability to obtain adequate insurance to cover risks and hazards; and the presence of laws and regulations that may impose restrictions on cultivation, production, distribution and sale of cannabis and cannabis related products in Uruguay or internationally; and employee relations. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.