Following this week’s announcement by GW Pharmaceuticals plc (NASDAQ:GWPH) that the drug Epidiolex was accepted for filing with Priority Review by the U.S. Food and Drug Administration, comes news that the company submitted a Marketing Authorisation Application to the European Medicines Agency. In a statement released Friday GW noted that they have already received the EMA’s Orphan Designations for the drug for the treatment of LGS, Dravet syndrome, West syndrome, and Tuberous Sclerosis Complex. Data from three Phase 3 safety and efficacy studies preceded the application, each of which met their primary endpoint.
GW’s lead cannabinoid product candidate, Epidiolex is a pharmaceutical formulation of purified cannabidiol. The company hopes to receive approval to market the drug for the treatment of several rare childhood-onset epilepsy disorders. Earlier this month, GW Pharma announced the end of their licensing agreement with Otsuka Pharmaceutical Co., Ltd. over another drug Sativex.
“This MAA submission marks another major milestone for the Epidiolex program and is an important next step toward providing this potential new treatment option globally,” remarked GW Pharmaceuticals CEO Justin Gover. “GW is committed to making Epidiolex available to patients in Europe that struggle with the burden of living with LGS and Dravet syndrome, both very difficult to treat and devastating conditions. We continue to build a commercial infrastructure in Europe in anticipation of future approval and launch.”
Progress from Epidiolex sparked immense growth in GW stock this year, as the company saw their prices rise 28 percent, from a 52-week low of $92.65 to $140.52.
Privateer Lands Goodship
You're supposed to end with "Argh!"... The Goodship brand edibles set sail with private equity firm Privateer Holdings this week. The cannabis edibles brand plans to use the deal to expand its offerings across North America. Located in Washington State, Goodship is known for their cookies, brownies, and other pastries, popularized under the tagline “damn fine edibles.”
Privateer touts itself as “the world’s first and leading private equity firm to invest exclusively in legal cannabis.” With investments in seven U.S. states and seven more countries, the firm has $150 million put up in over 500 cannabis brands. CEO Brendan Kennedy praised the deal with Goodship, stating the company ups the standard for cannabis edibles in the market.
“We are proud to welcome The Goodship to the Privateer Holdings family. Jody and her team have created something truly special: a purpose-driven brand with unrivaled products, unmistakable packaging, and a thriving entrepreneurial culture.” said Kennedy in a statement. “This is an exciting time to be in the cannabis industry, and we’re looking forward to working together to develop innovative products and bring Goodship to new legal markets across North America.”
Pivot’s German Connection
Ich bin ein Berliner… Pivot Pharmaceuticals Inc. (CSE:PVOT) (OTCQB:PVOTF) announced on Friday that along with German technology partner, SolMic GmbH, they have begun to develop a pure, natural and water-soluble oral cannabidiol solution called PGS-N001. In a release, the company claims the product has the highest bioavailability with no THC. Hopes are for the drug to treat a variety of ailments, include nausea and vomiting in cancer patients caused by chemotherapy.
Based in Duesseldorf, Germany, SolMic Research GmbH is a privately-owned life sciences company that develops, manufactures and markets various nutraceutical products in Europe. Pivot Green Stream Health Solutions Inc., Pivot’s wholly-owned medical cannabis products division performs research on cannabinoid-based nutraceuticals and pharmaceuticals. Previously, Pivot announced the licensing of worldwide rights for SolMic cannabinoid-focused Technology.
“I am very pleased to continue to work with the Pivot Pharmaceuticals team to develop novel cannabinoid products and therapies using our proprietary SolMic formulation technology,” said Dr. Wolfgang Schoenfeld, SolMic CEO. “Our technology strongly enhances bioavailability of cannabinoids and improves product attributes such as stability and masks unpleasant tastes and odours, thus making it a better product experience for patients and consumers.”
Financing And Partnerships
If Francoise Sagan hadn't written a book called A Chateau in Sweden, I would certainly write a short story called A Chateau in Puerto Rico. And I may yet… Veritas Pharma Inc. (CSE:VRT) (OTC:VRTHF) was back in the news on Friday as the company announced its completion of a pre-study visit of the Fundación de Investigación facilities in San Juan, Puerto Rico. The site will house subsidiary Cannevert Therapeutics Ltd.’s research into CTL-X, a cannabis strain for pain management. According to a release put out by Veritas, a human study on the strain will occur in two stages.
“I recently traveled to Puerto Rico and visited the FDI clinical trial facility. I was very impressed by their Phase I and Phase II-III clinical trial units,” said Veritas’s CEO Lui Franciosi.
I’ve had to live with some hard promises… On Friday MYM Nutraceuticals Inc., (CSE:MYM) (OTC:MYMMF) adopted an automatic securities disposition plan as allowed per Canadian legislation. According to a statement, MYM insiders will not exercise discretion over how dispositions will occur under the plan, and conversely, the broker administering the plan is not allowed to consult with MYM insiders. The purpose of the plan is to sell shares of MYM on the open market.
News and Notes
Effective immediately, your license to kill is revoked… Speaking of Veritas, Marapharm Ventures Inc. (OTCQB:MRPHF) announced on Friday that Veritas received a dealer's license from Health Canada to its subsidiary. They can now produce cannabis liquid extracts and ship them throughout the world. Marapharm owns 6.1 million common shares of Veritas, which represents approximately 15 percent of the share capital of the issuer.
Art is making something out of nothing and selling it… Quadron Cannatech Corporation (CSE:QCC) announced on Thursday the completion of the first sale of its BOSS CO2 Extraction System to a United States-based client.
Closed for business (part II)... Following the shutdown of Namaste Technologies yesterday, the IIROC halted trading today for Canopy Growth (TSX:WEED) and Aphria Inc. (TSX:APH), citing a Single-Stock Circuit Breaker as the reason for both.
Until next year...