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GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX® (cannabidiol) for use as treatment of seizures associated with Tuberous Sclerosis Complex

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) […]

The post GW Pharmaceuticals receives positive CHMP opinion for EPIDYOLEX® (cannabidiol) for use as treatment of seizures associated with Tuberous Sclerosis Complex appeared first on Technical420.

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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 plc
GW 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 visitwww.gwpharm.co.uk

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. 1The severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications. 6

Enquiries
All investor and media enquiries publicrelations@gwpharm.com
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. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet .
2 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. https://www.childrenshospital.org/conditions-and-treatments/conditions/t/tuberous-sclerosis-tsc/symptoms-and-causes . Accessed November 2020.
4 Prevalence and incidence or rare diseases: Bibliographic data.https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf
5 TS Alliance Website. https://www.tsalliance.org/ . 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.


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How to open a cannabis dispensary in New Mexico

The post How to open a cannabis dispensary in New Mexico appeared first on Cannabis Industry Lawyer – Tom Howard.

Republished by Plato

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How to Open a Cannabis Dispensary in New Mexico

Open a cannabis dispensary in New Mexico

The New Mexico Legislature recently voted to legalize recreational cannabis through the House Bill 2 that was recently passed by two House committees. 

The bill, sponsored by Reps. Javier Martinez, Andrea Romero, and Deborah A. Armstrong passed the House Health and Human Services Committee on Feb. 15 and passed the House of Taxation and Revenue Committee on Feb 24. Now, on March 31, it passed the Senate on a 22-15 vote. 

It then returned to the House, which had approved it 38–32 earlier in the day, for consideration of Senate changes. That vote passed by a voice vote.

Legal retail sales are scheduled to begin by April 1, 2022

Opening a Cannabis Dispensary in New Mexico

Although there have been some delays in signing the bill, and the road to recreational sales in early 2021 is anything but clear, recreational sales are expected to take up to six months to reach the market.

With the revenue generated by cannabis dispensaries in the billions of dollars and rising, these developments present a very lucrative opportunity. However, opening and running a dispensary is a challenging business venture:

  • Opening a dispensary requires a lot of considerations, compliance with numerous regulations and a significant amount of capital.
  • Costs to open your doors could run from $500,000 upwards of millions depending on real estate costsand the size of the operation.
  • Many cannabis dispensaries are selling millions of dollars of product a month
  • Competition for new dispensaries tends to be fierce.

It’s important to mention that the first dispensaries that will sell recreational cannabis will be existing medical marijuana dispensaries, and although the application window isn’t open just yet, it is generally a good idea to be prepared ahead of time for the application process.

Timeframe for the licensing process

The Cannabis Control Division is going to start accepting and processing New Mexico Cannabis license applications in accordance with the following schedule:

  • September 1, 2021: Cannabis producers; cannabis producers microbusinesses and any other person properly licensed and in good standing as a licensed cannabis producer pursuant to the Lynn and Erin Compassionate Use Act.
  • January, 2022: All other licenses.

The Cannabis Control Division (CCC) is scheduled to develop a plan to encourage racial, ethnic, gender and geographic diversity among licensees by no later than January 1, 2022. 

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Obtain a New Mexico Cannabis License

You can check out the details on how to obtain a New Mexico cannabis license here. Obtaining a cannabis license can be incredibly difficult and costly. Further, there usually are strict requirements for prospective dispensary owners.

There is information pending regarding the licensing process. However, according to the current recreational cannabis bill:

Apart from direct cannabis knowledge, your team must be knowledgeable in a wide range of topics. This is because there are multiple topics considered essential to running a cannabis company, and any information gaps will jeopardize long-term success.

Also, your team should prepare various business plans, which should include:

  • Financial Plan
  • Manufacturing Plan
  • Inventory Control Plan
  • Security Plan
  • Recordkeeping Plan
  • Community Benefits Plan

A revenue forecast is conducted by estimating how much product you think you will sell production costs, retail price and complementary costs (payroll, rent, transport, etc.). You may also include a break-even analysis, with an estimated timeline until profitability.

  • New Mexico-specific Requirements – You may include details of covering your security systems, secure product transport, product tracking, waste plans and other state requirements. Note that these may be included in your application.
  • Investor Proposal – Involves how you will value your shares if you present your plan to investors. Consult with a CPA to ensure you are compliant with state and federal regulations

The prospect of booming business

With the new law set to take effect soon it is only a matter of time before the cannabis industry develops into a multi-billion industry. Residents can take advantage of the various licenses set to be issued out for growers and dispensary owners. Going by the stipulations in the new bill it is a very real prospect that New Yorkcould soon become a cannabis haven and there is no telling what new opportunities may crop up in the process.

Conclusion

With the right motivation and access to necessary resources, our office can help you successfully start a profitable cannabis dispensary in New Mexico. Although it is important to note that this process takes time even when you have the resources.

Given the licensure steps, finding a suitable location and developing your storefront to meet the state requirements, it may take well over a year from application to selling.

Remember: the cannabis industry is heavily regulated and getting help from industry, and business experts is recommendable.

And lastly, don’t miss out on our Marijuana Legalization Map where you can browse the current status of laws in every state in the United States and see all our posts on each of them.

Check Out:

Interested in coming on as a guest? Email our producer at [email protected]

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Source: https://www.cannabisindustrylawyer.com/how-to-open-a-cannabis-dispensary-in-new-mexico/

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How to open a dispensary in New Jersey

The post How to open a dispensary in New Jersey appeared first on Cannabis Industry Lawyer – Tom Howard.

Republished by Plato

Published

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How to Open a Dispensary in New Jersey

How to get a dispensary license in New JerseyHow to get a dispensary license in New Jersey? That’s the question you should ask yourself if you’re thinking about opening a dispensary in New Jersey. In order to obtain a dispensary license, you’d need to comply with requirements established by the new law on the matter and be awarded a license – a rigorous process.

Medical marijuana businesses became legal in New Jersey in 2010 –although heavily regulated- just to give some perspective on this: even though the state has a population of 8.8 million, there are only 13 medical cannabis dispensaries

Since November 2020, recreational marijuana businesses have been legalized, thanks to a ballot initiative. According to this initiative, The Cannabis Regulatory Commission (CRC) will oversee the state’s marijuana program and the issuance of associated licenses, and among them, the dispensary licenses. However, the county and city where the business will be located may also determine whether you can start a business within their borders or not.

With some sources stating that the market size of legal marijuana is expected to reach $23 billion by 2025, the one thing that’s certain about this state is that there’s good money to be made in legal Cannabis in New Jersey –once you decide you’re willing to overcome all the bureaucracy and some stiff competition.  

Medical marijuana dispensary licenses in New Jersey

Unfortunately, 22 August 2019 was the last date to apply for a medical marijuana dispensary license in New Jersey and since then, there hasn’t been another period to apply for it. However, this doesn’t mean that it won’t open anytime soon. What’s even more: with the approval of adult-use marijuana, there’ll be an opening for businesses to get a dispensary license soon. 

So, now is the time when you need to know what to do, what to expect, and how much everything is going to cost, so you can get ahead of your competition. 

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Opening a Cannabis Dispensary New Jersey

Although there have been some delays in signing the bill, and the road to recreational sales in early 2021 is anything but clear, recreational sales are expected to take up to six months to reach the market.

With the revenue generated by cannabis dispensaries in the billions of dollars and rising, these developments present a very lucrative opportunity. However, opening and running a dispensary is a challenging business venture:

  • Opening a dispensary requires a lot of considerations, compliance with numerous regulations and a significant amount of capital. 
  • Costs to open your doors could run from $500,000 upwards of millions depending on real estate costs and the size of the operation.
  • Many cannabis dispensaries are selling millions of dollars of product a month
  • Competition for new dispensaries tends to be fierce.

It’s important to mention that the first dispensaries that will sell recreational cannabis will be existing medical marijuana dispensaries, and although the application window isn’t open just yet, it is generally a good idea to be prepared ahead of time for the application process.

Obtain a New Jersey Dispensary License

You can check out the details on how to obtain a cannabis dispensary license here. Obtaining a cannabis license can be incredibly difficult and costly. Further, there usually are strict requirements for prospective dispensary owners.

There is information pending regarding the licensing process. However, according to the current recreational cannabis bill:

“Each license application shall be scored and reviewed based upon a point scale with the commission determining the amount of points, the point categories, and the system of point distribution by regulation. The commission shall assign points and rank [all] applicants [, from the most to the least points,] according to the point system.”

This “point system” approach is similar to what we’ve seen in other states that have recently legalized adult-use cannabis. Your application will be scored using a point system that considers your and your team’s experience, skills, and qualifications on a wide range of topics. Here’s a sample of some of the topics you may be assessed on:

  • Environmental impact plan
  • Safety and security procedures
  • Cybersecurity plan
  • Emergency management plan
  • Diversion prevention
  • Sanitation practices plan
  • Procedures reporting adverse events
  • Proof of financial competence to carry out plans

As you can see, apart from direct cannabis knowledge, you must be knowledgeable in a wide range of topics. This is because each of the above topics is essential to running a cannabis company, and any information gaps will jeopardize long-term success.

Also, your team should prepare a business plan, which should include:

  • Financing plan
  • Quality control and quality assurance plan
  • Dispensary/operations plan 
  • Labor compliance plan
  • Workforce and job creation plan
  • Security plan 
  • Environmental impact plan
  • Anything else you think would help you stand out and attract investors

A revenue forecast is conducted by estimating how much product you think you will sell production costs, retail price and complementary costs (payroll, rent, transport, etc.). You may also include a break-even analysis, with an estimated timeline until profitability.

  • New Jersey-specific Requirements – You may include details of covering your security systems, secure product transport, product tracking, waste plans and other state requirements. Note that these may be included in your application.
  • Investor Proposal – Involves how you will value your shares if you present your plan to investors. Consult with a CPA to ensure you are compliant with state and federal regulations

The prospect of booming business

With the new law set to take effect soon it is only a matter of time before the cannabis industry develops into a multi-billion industry. Residents can take advantage of the various licenses set to be issued out for growers and dispensary owners. Going by the stipulations in the new bill it is a very real prospect that New Yorkcould soon become a cannabis haven and there is no telling what new opportunities may crop up in the process.

Conclusion

With the right motivation and access to necessary resources, our office can help you successfully start a profitable cannabis dispensary in New Jersey. Although it is important to note that this process takes time even when you have the resources.

Given the licensure steps, finding a suitable location and developing your storefront to meet the state requirements, it may take well over a year from application to selling.

Remember: the cannabis industry is heavily regulated and getting help from industry, and business experts is recommendable.

And lastly, don’t miss out on our Marijuana Legalization Map where you can browse the current status of laws in every state in the United States and see all our posts on each of them.

Check Out:

Interested in coming on as a guest? Email our producer at [email protected]

How to open a dispensary in New York

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Source: https://www.cannabisindustrylawyer.com/how-to-open-a-dispensary-in-new-jersey/

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How to open a dispensary in New York

The post How to open a dispensary in New York appeared first on Cannabis Industry Lawyer – Tom Howard.

Republished by Plato

Published

on

Connecticut Cannabis Establishment License

Do you want to open a dispensary in New York but don’t know where to start? This page will keep you informed of the latest news and updates about starting a cannabis company in New York.

New York became the 15th state to legalize recreational cannabis on March 31st. This means that one of the most promising cannabis markets has opened up.

Opening a Cannabis Dispensary in New York

New York will issue retail licenses to applicants, although we don’t know the timeframe in which the application process is going to start, it is expected that retail sales would start in 2022.

With the revenue generated by cannabis dispensaries in the billions of dollars and rising, these developments present a very lucrative opportunity. However, opening and running a dispensary is a challenging business venture:

  • Opening a dispensary requires a lot of considerations, compliance with numerous regulations and a significant amount of capital. 
  • Costs to open your doors could run from $500,000 upwards of millions depending on real estate costs and the size of the operation.
  • Many cannabis dispensaries are selling millions of dollars of product a month
  • Competition for new dispensaries tends to be fierce.

Prepare a Business Plan

You will need a business plan if you seek to open a dispensary in New York. There are several aspects that your business plan should cover. These are explained in detail below:

  • Product/Service Description – This entails how you plan to run the dispensary and the unique aspects about it. Try to be as specific as possible. Include details of the strains of flower you will dispense and where you will source them.
  • Market Research – This section includes the methods you used to identify your target customers and how this data will affect your marketing, operations and pricing. Always use concrete numbers (ideally verified by a third party) rather than estimates.
  • Competitors – Includes details on other businesses that you will compete with, either directly or indirectly. What are their strengths and weakness, and how do you plan to differentiate your business.
  • Leadership Team – This section includes a summary of your qualifications and those of your management team. You may include business development experience in other sectors, leadership skills or customer service.
  • Financials – This section can be quite daunting. It involves formulating a clear and concise budget. You should include a long-term (say 5 years) financial forecast that includes operational expenses, net profit and projected annual revenue.

A revenue forecast is conducted by estimating how much product you think you will sell production costs, retail price and complementary costs (payroll, rent, transport, etc.). You may also include a break-even analysis, with an estimated timeline until profitability.

  • New York-specific Requirements – You may include details of covering your security systems, secure product transport, product tracking, waste plans and other state requirements.
  • Investor Proposal – Involves how you will value your shares if you present your plan to investors. Consult with a CPA to ensure you are compliant with state and federal regulations

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Obtain a Cannabis Dispensary License

You can check out the details on how to obtain a cannabis dispensary license here. Obtaining a cannabis license can be incredibly difficult and costly. Further, there usually are strict requirements for prospective dispensary owners.

The prospect of booming business

With the new law set to take effect soon it is only a matter of time before the cannabis industry develops into a multi-billion industry. Residents can take advantage of the various licenses set to be issued out for growers and dispensary owners. Going by the stipulations in the new bill it is a very real prospect that New Yorkcould soon become a cannabis haven and there is no telling what new opportunities may crop up in the process.

Business plans you will need to open a dispensary in New York

There are a lot of things to consider as you prepare to make your application as a cannabis dispensary. If you are looking to apply for the license then you will probably need the following business plans;

  • Financial plan
  • Marketing plan
  • Security plan
  • Suitability of proposed facility
  • Staffing plan
  • Plan with which to educate patients
  • Inventory control

Conclusion

With the right motivation and access to necessary resources, our office can help you successfully start a profitable cannabis dispensary in New York. Although it is important to note that this process takes time even when you have the resources.

Given the licensure steps, finding a suitable location and developing your storefront to meet the state requirements, it may take well over a year from application to selling.

Remember: the cannabis industry is heavily regulated and getting help from industry, and business experts is recommendable.

And lastly, don’t miss out on our Marijuana Legalization Map where you can browse the current status of laws in every state in the United States and see all our posts on each of them.

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How to open a marijuana dispensary in Maine Are you wondering how to open a marijuana dispensary in Maine? This page will keep you up to date with the latest news and information relevant to opening a marijuana store in Maine. Although adult-use marijuana was…

Massachusetts Marijuana Retailer License Application

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Source: https://www.cannabisindustrylawyer.com/how-to-open-a-dispensary-in-new-york/

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