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GW Pharmaceuticals' Epidyolex Wins EU Positive Opinion For Seizures Disorder
Posted on Friday February 26, 2021

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for GW Pharmaceuticals Plc's (NASDAQ: GWPH) Epidyolex (cannabidiol). It is an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex (TSC) for patients two years of age and older. TSC is characterized by benign tumors that grow in the body's vital organs, including the brain, skin, heart, eyes, kidneys, and lungs, and in which epilepsy is the most common neurological feature. The condition is typically diagnosed in childhood. The EMA approved GW's cannabidiol oral solution in September 2019 as adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. Price Action: GWPH is up 0.1% at $215.05 in market trading hours on the last check Friday. See more from BenzingaClick here for options trades from BenzingaAssembly Bio/Arbutus Bio Start Testing Vebicorvir/AB-729 Triplet Therapy In HBV InfectionGlaukos' iLink Therapy Meets Primary Endpoint In Late-Stage Vision Disorder Study© 2021 Benzinga does not provide investment advice. All rights reserved.

GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX® (cannabidiol) for use as treatment of seizures associated with Tuberous Sclerosis Complex
Posted on Friday February 26, 2021

– If approved by the European Commission (EC), the label for EPIDYOLEX® will expand to include a third indication in Europe –LONDON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the Group”), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Company’s Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex (TSC), for patients two years of age and older. TSC is a condition that causes mostly benign tumours to grow in vital organs of the body, including the brain, skin, heart, eyes, kidneys and lungs, and in which epilepsy is the most common neurological feature. TSC is typically diagnosed in childhood.1 “Epilepsy is reported in more than 90% of individuals with Tuberous Sclerosis Complex (TSC), and over 60% of those with seizures associated with TSC do not respond to standard anti-epileptic medicines.2,3 Today’s positive CHMP opinion brings us one step closer to a potentially life-improving new treatment option for these patients for whom EPIDYOLEX may be appropriate,” said Justin Gover, GW’s Chief Executive Officer. “This decision represents another important step for GW as we look to expand the medicine’s label in Europe. If approved, this represents the third licensed indication for GW’s medicine, broadening patient access to this rigorously tested cannabis-based medicine.” Professor Helen Cross, Honorary Consultant in Paediatric Neurology at Great Ormond Street Hospital for Children NHS Foundation Trust, said, “This debilitating disease affects tens of thousands of patients in Europe, many of whom may benefit from alternative treatment options to achieve adequate seizure control. This decision, and the clinical data supporting the use of EPIDYOLEX in this challenging condition, offers real hope to the patients, their parents and physicians that battle this condition and the seizures it brings every day.” Carla Fladrowski and Micaela Rozenberg, Co-Chairs of the European Tuberous Sclerosis Complex Association, added, “The lives of individuals with TSC and their families are seriously impacted by drug-resistant epilepsy; TSC Associations together are therefore resolute in their search for successful therapies to help manage a condition that is so difficult to control. We are extremely hopeful of the potential benefits that this desperately needed new treatment option could bring to our community, including the positive impact it could have not only on quality of life but also the burden of the disease itself.” The CHMP’s positive opinion is based on data from a positive Phase 3 safety and efficacy study evaluating 25 mg/kg/day of GW’s cannabidiol (oral solution). The study met its primary endpoint, which was the reduction in seizure frequency compared to baseline of cannabidiol vs placebo, with seizure reduction of 49% in patients taking cannabidiol 25 mg/kg/day compared with 24% for placebo (p=0.0009). All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed was consistent with findings from previous studies, with no new safety risks identified. Dr. Volker Knappertz, GW’s Chief Medical Officer, said, “We are delighted to have been able to demonstrate the potential EPIDYOLEX has in treating seizures associated with TSC through this regulatory review and in our conversations with the CHMP. We now look forward to working with the European Commission to gain approval for this label expansion to broaden access to this medicine across the thousands of European patients who need new treatment options.” The CHMP’s recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 27 countries of the European Union (EU) alongside Norway, Iceland and Liechtenstein. The EC is expected to make a final decision on the Type II Variation Application in approximately two months. GW’s cannabidiol (oral solution) was originally approved by the EMA and received marketing authorisation in September 2019 under the trade name EPIDYOLEX® as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. ADDITIONAL INFORMATION About GW Pharmaceuticals plcGW Pharmaceuticals (GW), and U.S. subsidiary Greenwich Biosciences, is a UK-based global biopharmaceutical company that has established a world-leading position in cannabinoid science and medicine. Founded over two decades ago in response to significant unmet patient need, patients remain our key focus and improving their quality of life, our motivation. GW’s pioneering work has led to the regulatory approval of world first, potentially life improving, cannabis-based medicines. Our continued dedication has resulted in the treatment of thousands of patients with our medicines around the world. For further information, please visit About EPIDIOLEX®/EPIDYOLEX® (cannabidiol)EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and the European Commission (EC) for use in Europe, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., EPIDIOLEX® is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or Tuberous Sclerosis Complex (TSC) in patients one year of age and older. EPIDIOLEX® has received approval in the European Union under the tradename EPIDYOLEX® for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and Dravet syndrome in patients two years and older. In September 2020, EPIDYOLEX® was approved by the Australian Therapeutic Goods Administration (TGA) for use in Australia for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age and older. EPIDYOLEX® has received Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of seizures associated TSC. About Tuberous Sclerosis Complex (TSC)Tuberous Sclerosis Complex (TSC) is a rare genetic condition that has an estimated prevalence in the EU of 10 in 100,000.4 The condition causes mostly benign tumours 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.1,5 TSC often occurs in the first year of life with patients suffering from either focal seizures or infantile spasms. It is associated with an increased risk of autism and intellectual disability.1 The severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.6 EnquiriesAll investor and media GW Pharmaceuticals plc Scott Giacobello, Chief Financial Officer+1 760 795 2200 UK, EU and ex-U.S. media enquiries FTI Consulting Michael Trace / Ben Atwell+44 (0)203 727 1000 U.S. media enquiries Kristen Cardillo, Corporate Communications+1 760 579 6628 1 NIH Tuberous Sclerosis Fact Sheet. Nabbout R, Belousova E, Benedik MP, et al. Epilepsy in tuberous sclerosis complex: Findings from the TOSCA Study. Epilepsia Open. 2019 Mar; 4(1): 73–84.3 Boston Children’s Hospital. Accessed November 2020. 4 Prevalence and incidence or rare diseases: Bibliographic data. 5 TS Alliance Website. Accessed November 2020.6 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157.

The GW Pharma and Parallel Transactions: Where Does the Future of Cannabis go From Here?
Posted on Thursday February 25, 2021

This month, two groundbreaking deals in cannabis were announced — the acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals and the combination of the multi-state operator (MSO) Parallel with the special purpose acquisition company (SPAC), Ceres Acquisition Corp. The proximity of two such large deals in one month begs the question: Are the GW Pharma — Jazz and Ceres — Parallel deals an important barometer to the direction of cannabis, both in North America and abroad? In His Genes The biopharma influence on the cannabis sector started early with the drive toward adoption of current Good Manufacturing Practice (cGMP), the use of high-pressure liquid chromatography (HPLC) for testing and extraction technology for producing concentrates. David Traylor, founder and senior. managing director of Golden Eagle Partners (GEP) was well prepared for the evolution of biotechnologies in marijuana and hemp due to his previous experiences. Before he jumped into cannabis in late 2013, Traylor spent eight years in biotechnology investment banking after 15 years in operational roles in leading biotech companies based in Silicon Valley, Boulder and Berlin, and garnered inventorship on two U.S. bioprocessing patents during his work on recombinant protein production. Genomics and Cannabinoids Traylor also sees similarity to the biotech industry from over 20 years ago, "The current cannabis (both MJ and hemp) environment reminds me of working at Affymetrix — a leader in genomics — in the late 1990s. The level of opportunities available to companies developing genomic tools then and the ones driving cannabinoid innovation now are very similar — one could say almost limitless potential." With the level of opportunity in cannabis and the push for more innovation and technology, Traylor is not surprised by what these deals are suggesting — the growing importance of biotechnology, intellectual property and capital in cannabis M&A transactions. Predicting the Need for Biotech, IP and Significant Capital To begin, both of these transactions dramatically signify the continuing growing importance of biotechnology in the marijuana and hemp sectors, both in North America and internationally. Realistically, GW Pharma is more a biotech company than a cannabis company. And with the addition of two big pharma/healthcare professionals to the board of directors or the combined entity, Parallel is positioning to be more than just another MSO but a leader in life science and cannabinoid innovation. It has been said that the GW Pharma acquisition was undervalued due to the potential future growth of its products and revenues. Not including future revenues, the expectation is the transaction was more based on the depth of GW's intellectual property of 62 U.S. patents and 76 pending U.S. patent applications. With Parallel, its recent press release for its acquisition by Ceres was not short on the multiple mentions of innovation, patents and intellectual property. Biotech professionals know that creating valuable, innovative engines is expensive. The cost of patent filings, scientific salaries, expensive laboratory equipment and the sunk costs of aggressive R&D efforts aren't cheap, especially by cannabis standards. According to its most recent filings, the combined near liquid assets for GW Pharma and Jazz totaled more than $2.1 billion, and after merging with the SPAC, Parallel will have $430 million on its balance sheet. Game On? It will be interesting to see where things go from here regarding cannabis M&A transactions. However, Traylor has little doubt that these two deals have exponentially upped the competitive factor and drive for competitive advantages, something that has been sorely lacking in both the marijuana and hemp subsectors. In his final assessment, Traylor surmised, "These two transactions that focus on creating or rewarding scientific competitive advantages in cannabis are not the first, and won't be the last." Traylor spoke about consolidation today at Benzinga's Cannabis Capital Conference. With regard to how companies can best prepare for a potential acquisition, Traylor stressed the importance of focus, uniqueness and humility. He commented, "Uniqueness and consistent quality breed value," and advised, "There needs to be more humility and less arrogance to generate success and create potential interest from acquirers." Visit for more info. See more from BenzingaClick here for options trades from BenzingaBenzinga's February Cannabis Capital Conference Kicks Off With Keynote By Curaleaf's Boris Jordan"Build It And They Will Come" - North Star Holdings Unveils Cannabis Research Initiatives© 2021 Benzinga does not provide investment advice. All rights reserved.

SHAREHOLDER ALERT: WeissLaw LLP Reminds LACQ, GWPH, PRSP, and CMD Shareholders About Its Ongoing Investigations
Posted on Wednesday February 24, 2021

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