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Epidiolex delivers positive results for a third rare condition called TSC

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Epidiolex reports positive results for its drug when treating tuberous sclerosis complex (TSC) a rare genetic condition. The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs and is a leading cause of genetic epilepsy.

Epidiolex was the leading medical marijuana drug originally produced by GW Pharmaceuticals to treat the rare pediatric epilepsy diseases – Dravat Syndrome and Lennox Gastaut. GW Pharmaceuticals was later acquired by Jazz Pharmaceuticals (NASDAQ: JAZZ). Epidiolex was the first medical non-synthetic marijuana drug to go through the highly regulated FDA study trials. It has been instrumental in reducing the stigma of medical marijuana by demonstrating significant reductions in seizures for children with these diseases.

Real-world data

“Our real-world data presentations at AES 2024, including novel findings from the BECOME-LTC, BECOME-TSC and EpiCom studies, demonstrate the meaningful impact of Epidiolex in the treatment of patients with rare epilepsies,” said Sarah Akerman, MD, head of neuroscience global medical and scientific affairs of Jazz Pharmaceuticals. “These findings increase our understanding of Epidiolex’s benefits beyond seizure control, addressing unmet needs across a range of epilepsy syndromes for people living with rare epilepsies and demonstrating reproducibility and consistency of effect across different populations.” BECOME-TSC refers to BEhavior, COgnition, and More with the Epidiolex caregiver survey.

The company will present the results at the American Epilepsy Society (AES) 2024 Annual Meeting, which will be held this week in Los Angeles, California. The company reported some of the findings as follows:

  • A three-month study demonstrated improvements after an Epidiolex treatment in the severity of behavioral problems in patients with TSC as reported by the TAND Self-Report Quantified Checklist and Aberrant Behavior Checklist.

  • Two updated analyses showed that, of 55 caregivers who completed the survey, 89% planned to continue Epidiolex treatment for their loved one. The most important reasons for continuing Epidiolex included seizure and non-seizure benefits such as reduced seizure frequency and severity/duration and TAND-related improvements in cognition and language/communication.

  • Results from the BECOME-LTC (BEhavior, COgnition, and More with Epidiolex in the Long-Term Care Setting) survey found that, among 102 nurses surveyed, 85% reported a reduction in the overall frequency of any seizure type after Epidiolexinitiation, with 49% reporting a greater than 50% reduction.

  • Results from CARE-EpiC (Caregiver Analysis of Real-world Epidiolex in Epilepsy Context), a cross-sectional caregiver survey, demonstrated reduced caregivers’ need for additional support of their dependents’ physical, emotional, and behavioral care after Epidiolex initiation and characterized improvements in their dependents’ well-being as well as caregivers’ experiences.

  • In the TSC group, Epidiolex was associated with a median reduction from baseline of 51%–87% in focal seizures and 44%–87% in total seizures. In the non-TSC group, Epidiolex was also associated with a median reduction from baseline of 46%–75% in focal and 46%–74% in total seizures.

Epidiolex success

Green Market Report wrote in November that Epidiolex, accounted for $251.5 million in revenue for the company’s third quarter, up from $213.7 million the same quarter a year ago. For the past nine months ending in September, Epidiolex has generated $697 million in sales – an increase of 15% over the previous year. Epidiolex, which is now available in 35 countries, was second in sales only to Xywav, Jazz’s sleep aid drug, which sold $388.4 million in the quarter.

The company has been facing patent lawsuits from other medical marijuana companies including Teva Pharmaceuticals, Inc. and Ascent Pharmaceuticals. Some of the original claims to create a generic version of the drug dating back to 2022 were dismissed but others were allowed to move forward. Jazz managed to reach settlements with some parties, but then new cases were filed. A trial is scheduled for September 2025.

Separately, On November 20, 2024, Jazz Pharmaceuticals announced that the FDA accelerated approval of its Ziihera (zanidatamab-hrii) 50mg/mL for injection for IV for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). The FDA granted accelerated approval for this indication based on overall response rate and duration of response.



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Massachusetts regulators order single-lab testing to combat cannabis lab shopping

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Massachusetts regulators will require cannabis businesses to use a single laboratory for all compliance testing in an effort to prevent companies from shopping around for favorable test results.

The state’s Cannabis Control Commission voted 3-0 to require licensed businesses submit testing samples to one independent laboratory starting April 1, 2025, according to an administrative order advanced Thursday. The new rule is meant to close loopholes that some say have allowed companies to shop around for labs to juice their numbers for market share.

“This administrative order continues our mission of being a strong regulator,” Acting Executive Director Debbie Hilton-Creek said in a statement.

Under current rules, companies can split testing among multiple labs. The practice has led some facilities to report suspiciously high THC levels or overlook contamination to attract business.

The commission’s enforcement team said the changes would reduce risks of noncompliant products reaching consumers and improve audit capabilities. The move follows a November listening session in which testing concerns were raised, according to the announcement.

If an original testing lab needs to subcontract work, they must first obtain commission approval and demonstrate they are “incapable of performing certain required tests due to a hardship.” Labs also can only subcontract with one other facility at a time.

“The commission shall only approve subcontracting agreements when the Originating Independent Testing Laboratory is incapable of performing certain required tests due to a hardship relative to its facilities, instrumentation, personnel, or required consumable materials or in the event of an actual or potential conflict of interest,” according to the order.

Results must be uploaded to the state’s tracking system within 72 hours, with all certificates of analysis containing the complete testing results, including any subcontracted work, it said.

The commission will also begin publishing THC test results on its public data platform and establishing regular meetings with licensed laboratories to improve oversight.

The commission thus far has struggled to implement effective testing oversight. Earlier this year, the agency contracted with a private lab for a “secret shopper” program to verify retail products’ test results, Green Market Report previously reported. Unlike other major cannabis markets such as California and Colorado, Massachusetts lacks a state reference lab to independently verify commercial lab results.

Analysis of testing data by MCR Labs found that across multiple states, laboratories reporting higher THC concentrations tend to increase their market share while those reporting average failure rates lose business, according to Chemical & Engineering News.



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Cansortium completes merger with RIV Capital, plans to scale up in New York

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Florida-based Cansortium (CSE: TIUM.U) (OTCQB: CNTMF), which does business as Fluent, has finalized its megamerger with New York-based RIV Capital, (CSE: RIV) (OTC: CNPOF), creating a new multistate operator that has a footprint in four states with 42 operational dispensaries.

The move gives Cansortium immediate access to New York, one of the fastest-growing legal marijuana markets in the nation, along with its existing portfolio of cannabis shops and grows in its home state, Pennsylvania and Texas. The company now owns eight total cultivation and processing facilities, which it said in a press release would allow it to bolster the Fluent brand even more going forward.

The company reportedly has $33 million in the bank with which to finance further acquisitions, it said in a Thursday announcement.

Another major winner in the deal is Scotts Miracle-Gro, which has a sizable stake in RIV Capital through its subsidiary The Hawthorne Collective. Existing shares will be converted into 1.245 shares of the newly formed Fluent, eliminating $160 million in company debt.

Shareholders of Cansortium will own 51.25% of the new Fluent, while shareholders of RIV Capital will own 48.75%, the company said. The company will continue trading under Cansortium’s existing ticker symbols on the Canadian Securities Exchange and the Over-The-Counter markets.

Cansortium CEO Robert Beasley will continue to lead the new company, and RIV Capital interim CEO David Vautrin will serve as the new company’s chief commercial officer.

Beasley said in the release that Fluent intends to scale up wholesale operations in New York to boost its Moods brand of marijuana products and “gain additional shelf space in dispensaries across the state,” which he said has “immense potential.”

The merger could prove key to the long-term prospects for both Cansortium and RIV Capital. Cansortium posted an $11.7 million net loss for the third quarter of 2024, and RIV Capital reported a $63.4 million net loss for the same period.

“Looking ahead, we remain focused on sustainable, long-term growth and will continue to drive efficiencies across all areas of the business to achieve our profitability and cash generation goals,” Beasley said.



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The Daily Hit: December 19, 2024

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News from: US Farm Bill, Fluent Cannabis, Massachusetts and more.

The Daily Hit is a recap of the top financial news stories for Thursday, December 19, 2024.

On the Site

Farm Bill extension leaves hemp industry rules intact for now, including intoxicating products

The farm bill extension would run through March 2025.

Read more here.

Cansortium completes merger with RIV Capital, plans to scale up in New York

Scotts Miracle-Gro, which is a major investor in RIV, also benefits from the deal.

Read more here.

Massachusetts regulators order single-lab testing to combat cannabis lab shopping

The rule change follows growing evidence of inconsistent testing practices in the state’s $7 billion cannabis industry.

Read more here.

Nine New York social equity retailers ask to join lawsuit halting cannabis licensing for 3rd time

A court filing argued that the group of CAURDs are in danger of bankruptcy if the injunction is not removed soon.

Read more here.

In Other News

Greenway Greenhouse Cannabis Corp.

Greenway Greenhouse Cannabis Corp. entered into an asset purchase agreement to acquire all of Choice Growers’ consumer packaged goods brands, SKUs and listings of the brands, trademarks, goodwill and other associated intellectual property. This acquisition encompasses all of Choice Growers’ brands, including Grapefruit God Bud (also known as Grape God), The Jeffrey, Watermelon Pebbles, Pink Lemonade, Duke Nukem, Tangerine Dream and Blackberry Cheesecake.

Read more here.

Innocan Pharma Corp.

Innocan Pharma Corp. intends to complete a non-brokered private placement of up to 3.5 million units of the company at a price of C$0.20 per unit for gross proceeds up to C$700,000 plus 15% overallotment options. The offering is expected to close on or around Dec. 31.

Read more here.



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