Press Release: Protext Pharma Announces South Africa’s Reclassification of Cannabis as a Schedule 4 Substance

Here’s the rest of the press release

Company Provides Update on its Cannabis License Application

BOCA RATON, FL–(Marketwired – Sep 20, 2017) – Protext Pharma, Inc. (PINKSHEETS: TXTM) (“Protext” or “the Company”), a biotech company engaged in the development of pharmaceutical botanical medicines that are formulated with highly-bioavailable plant extracts, today announced that the government of South Africa published recommended amendments to the Medical Innovation Bill that would change the status of cannabis products that do not have psychoactive properties from a Schedule 7 prohibited substance to a Schedule 4 substance. Schedule 4 drugs, which include antibiotics and corticosteroids, may be given verbally to the pharmacist by the doctor, although such instruction must be followed up by a written prescription within 7 days. Under the proposed guidelines, Cannabis sold “on the street” will remain a Schedule 7 substance and be prohibited. Protext Pharma anticipates that its Phytofare® Cannabinoid extract will be non-psychoactive and thus fall under the Schedule 4 classification.

This announcement follows the Medicines Control Council’s (MCC) proposed guidelines for growing cannabis for medicinal purposes, which was published for comment in March 2017. In last week’s Medical Innovation Bill (Cannabis guidelines) briefing of the portfolio committee on health, Dept. of Health (DoH) Deputy Director Law Enforcement, Griffith Molewa, said they would approve regulations in the next few weeks. The MCC indicated that licenses would be issued thereafter.

Roger Baylis-Duffield, Chief Executive Officer of Protext Pharma, commented, “From where we sit, the cannabis reclassification is a very positive development and it’s encouraging to see South Africa take a leading role in recognizing the potential medical benefits of cannabis and pave the way for new research. South Africa is one of only a few countries around the world to have achieved governmental support for the legalization of cannabis for medical use. There is a growing body of evidence indicating cannabis can help regulate the endocannabinoid system, which explains its perceived benefits for a host of ailments especially inflammation, depression, post-traumatic stress, muscle spasticity, chronic pain, and other neural disorders. The cannabis business is a large and emerging market anticipated to grow to $55.8 billion by 2025. Our segment of this market, cannabis based medicines, is at the cusp of what could be a new industry for decades to come.”

With regards to the much-anticipated license which would allow the company to proceed with developing a cannabis medicines platform in South Africa, Mr. Duffield stated, “Despite the licensing process taking longer than anticipated, we remain confident that the issuance of a cannabis license allowing the Company to grow cannabis for the purpose of research and producing cannabis based medicines is still on track. We believe we’re uniquely positioned to be granted this license having developed an expertise in the extraction of phytonutrients from live plants, as well as having a home base and corporate presence in South Africa for some years. On Tuesday of this week, we were notified by the DoH that our application has now moved on to the Narcotic Desk of SAPS (South African Police Service) for police clearance of all applicants to check for suitability in handling cannabis, as per the MCC guidelines published March 2017. The Company is in regular communication with senior government officials at the Ministry of Health and we expect to have the license issued once the final regulations are ratified, which, according to statements from government, should be very soon.”

Once the license is issued, the company intends to use a 10,000 square foot facility in the Mpumalanga province where plants will be grown, cloned and cultivated to ensure a consistent chemical profile. The facility will incorporate an on-site laboratory which will be designed and engineered to process live plant material and after separation and recovery of the oil-phase as a separate income stream, the final stage will be specific to the production of the Phytofare® complex containing cannabinoids, cannabinoid acids, terpenes, limonene and polyphenols. The resulting complex will be subjected to product profiling, analysis and bioavailability in order to determine efficacy and dosage. The Company will use its proprietary processing and extraction technology to commence investigations and produce a full-profile cannabis extract, one that contains both CBD and the precursor acid form of THC (THC-A and THC-B) found in live cannabis plants. The Company’s investigations will be designed to show that the extraction process, which will use live leaf and low temperatures to extract the phyto-chemicals, should leave the acid forms of THC intact, resulting in a non-psychoactive extract with full medicinal potential and having the heightened bioavailability of other Phytofare® extracts.

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