RAMM Pharma Corp. Receives Federal Approval and Registration of XALEX™ 10 (cannabidiol) Oral Solution
26 März 2020 - 7:02PM
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 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
InvestigationPharmaceutical 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:
Guillermo DelmonteChief Operating Officer+598 92
223 131info@rammpharma.com
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.
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