Tetrahydrocannabinol

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

33 API Suppliers, 22 USDMF, 2 CEP/COS, 1 NDC API, 11 Listed Suppliers

DEVELOPMENTS

100 Drug(s) in Development

100 Drug(s) in Development

INTERMEDIATES

5 Suppliers

5 Suppliers

DOSSIERs // Finished Dosage Formulations

23 Dossiers, 19 FDA Orange Book, 2 Europe, 2 Canada

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 2.5MG, CAPSULE;ORAL - 5MG

CAPSULE;ORAL - 10MG
CAPSULE;ORAL - 2.5MG
CAPSULE;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

Suppliers, 9 BASF, 5 Actylis, 4 ACG Worldwide, 3 Lonza Capsugel, 3 Gangwal Chemicals, 2 Seqens, 2 Roquette, 2 Nomisma Healthcare, 2 Finar, 1 Qualicaps, 1 Seppic, 1 Sigachi Industries, 1 SPI Pharma, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Nanjing Well Pharmaceutical, 1 Gangwal Healthcare, 1 Kerry

EXCIPIENTS BY APPLICATIONS

9 Topical, 8 Empty Capsules, 6 Coating Systems & Additives, 6 Thickeners and Stabilizers, 6 Controlled & Modified Release, 5 Solubilizers, 5 Parenteral, 5 Film Formers & Plasticizers, 3 Fillers, Diluents & Binders, 2 Lubricants & Glidants, 2 Direct Compression, 1 Co-Processed Excipients, 1 Emulsifying Agents, 1 API Stability Enhancers, 1 Taste Masking, 1 Granulation

GLOBAL SALES INFORMATION

23 US Medicaid Prescriptions, 7 Finished Drug Prices

MARKET PLACE

8 APIs, 3 DOSSIERS // FDF, 1 EXCIPIENTS

PATENTS

4 US Patents

4 US Patents

ANALYTICAL SOLUTION(s)

2 USP Standards, 2 Other Ref. Standards

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow, 35 News

Blog

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Cannabinoids in pharmaceutical development

The development of cannabinoids in the pharmaceutical industry has exploded over the past few years. With the gradual liberation of regulations worldwide that govern cannabis and its pharmaceutical derivatives for medicinal use, this week PharmaCompass leveraged its Technology Prospector tool to develop a map of the global development landscape of these drugs. Technology Prospector is our proprietary technology. We scanned patents and journal publications, over the past five years, for cannabinoid-related content to identify the organizations which are developing products linked to the technology of interest. Click to view our Technology Prospector on Cannabinoids in Development Over the past two decades, there has been a resurgence of patient interest in using cannabis and cannabinoids to treat a variety of conditions, including chronic pain, cancer pain, depression, sleep disturbances and neurological disorders. This increased interest has resulted in a renewed scientific focus on the medical use of substances found in the cannabis plant, namely cannabinoids. The two most extensively studied ingredients in cannabis are tetrahydrocannabinol (THC) and cannabidiol (CBD). However, it is estimated that over 100 other cannabinoids and terpenoids in cannabis may also have medical uses. THC is known to produce the psychoactive effects sought by recreational users, such as euphoria, relaxation and heightened sensory experiences. There is also evidence to support the medical use of THC in controlling nausea and vomiting, stimulating appetite and reducing pain. CBD, on the other hand, may moderate the psychoactive effects of THC, while also reducing epileptic seizures. In the early 1990s, a cannabinoid system in the human brain and body was discovered that was responsible for the control of important biological functions, such as cognition, memory, pain, sleep and immune functioning. In view of this increased interest in cannabinoids, we are leveraging PharmaCompass’ Technology Prospector to provide an overview of the organizations actively involved in developing products linked to cannabinoids. Click to view our Technology Prospector on Cannabinoids in Development Cannabinoid products on market Several cannabinoid-containing medicinal products have been on the market for many years. Dronabinol (brand name: Marinol), a synthetic form of THC, got approved in 1985 for prevention of nausea and vomiting during chemotherapy and hauled in over US$ 100 million in annual sales. After the initial launch, the product also got approval for appetite and weight loss in patients with HIV/AIDS. In 1998, the product got reclassified from a Schedule II drug to a Schedule III drug by the Drug Enforcement Administration (DEA) in the US. In order to prevent drug abuse, the DEA has divided these substances into five categories (or Schedules) based on each drug’s (1) potential for abuse, (2) safety, (3) addictive potential and (4) whether or not it has any legitimate medical applications. The potential for drug abuse is the highest for Schedule I drugs and lowest for Schedule V drugs. Nabilone (brand names: Cesamet and Canemes) is a synthetic cannabinoid similar to THC. The main indication for its use is nausea and vomiting associated with chemotherapy, usually after previous treatments have failed. GW Pharmaceuticals’ Sativex, a mixture of equal quantities of THC and CBD from two cannabis extracts, is approved for sales in countries for the treatment of spasticity (muscle spasms and stiffness) related to multiple sclerosis — a disease that affects 1.3 million people worldwide, of which up to 80 percent suffer from spasticity. In 2018, the US Food and Drug Administration (FDA) approved GW Pharmaceuticals’ Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome. The drug can be taken by patients aged two years and above. Click to view our Technology Prospector on Cannabinoids in Development The battle of synthetic versus natural Cannabinoids In order to win approval for Epidiolex, GW Pharmaceuticals set up giant greenhouses in the United Kingdom where it raises cannabis plants under highly controlled conditions. The plants are then made to undergo extraction and purification to crystallize pure CBD at GW’s facilities. There are other firms which are supporting production of cannabinoids via organic synthesis rather than extraction from the cannabis plant. There are already multiple Drug Master Files (DMF) submissions to the FDA for synthetic cannabidiol, as companies bet that the future of cannabinoid production will be from organic chemistry. Firms like Noramco and Johnson Matthey, which have conventionally been active in producing controlled substances from opium like morphine, codeine etc, have focused significant resources to meet the increasing demand for large-scale production of cannabinoids. While there are multiple technical challenges associated with scaling up organic synthesis processes, once overcome, they can usually meet growing market needs faster than processes dependent on plant extraction. However, GW has claimed the superiority of cannabinoid extracts over synthesized molecules. According to GW, cannabinoid ratios in the plant generate a complex chemical fingerprint which plays a critical role in therapeutic efficacy. While Epidiolex is more than 98 percent CBD, GW’s first product — Sativex — is a mixture of CBD and THC. However, to get regulatory approvals for synthetic cannabinoids maybe easier, since they have a well characterized starting material and a more precisely defined pathway that leads to more consistent manufacturing. Click to view our Technology Prospector on Cannabinoids in Development New developments As the developments on cannabinoids evolve rapidly, PharmaCompass’ Technology Prospector found over 200 organizations across 25 countries that had either patented or published work related to cannabinoids. The United States has the maximum active organizations followed by Canada, Israel and then Germany. Unsurprisingly, GW Pharmaceutical leads the count of patents filed. However, many major pharmaceutical companies such as Roche, AbbVie, AstraZeneca and Merck are developing products targeting the cannabinoid system in the human brain and body. To deliver cannabinoids, while companies like US-based Axim Biotechnologies are working on delivering cannabinoids via chewing gums to treat nausea, Hanyi Biological in China has patents on the delivery of cannabinoids as a toothpaste and mouthwash to treat irritable bowel syndrome. Botanix Pharmaceuticals is working on new treatment options for acne, psoriasis and atopic dermatitis, using a transdermal drug delivery system. There are also new manufacturing technologies being developed at companies like US-based Teewinot Life Sciences that have developed processes to manufacture cannabinoids using biocatalysis and established players like Noramco have signed an agreement with them. Click to view our Technology Prospector on Cannabinoids in Development Our view As government controls ease on the use of cannabis for scientific and medical purposes and there is a growing understanding that CBD should not be placed under international drug control because the substance does not have psychoactive properties, with no reported cases of abuse or dependence, there is clear evidence that the field will witness a lot more development activity in the years to come. PharmaCompass’ Technology Prospector, our proprietary technology to identify organizations which are developing products linked to the technology of interest, can be applied across a variety of capabilities. Email us at support@pharmacompass.com to learn more. Click to view our Technology Prospector on Cannabinoids in Development

Impressions: 4576

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#PharmaFlow by PHARMACOMPASS

19 Dec 2019

Marijuana Based Medicines – highway to pots of gold

Legally cultivated cannabis, in some parts of the United States, resulted in a boom, which could never have been previously imagined. Just last year, there were so many growers that, in the state of Washington alone, more than 20,000 kg of marijuana (cannabis) was available, which didn’t have any takers!Last year also saw the stock market recognize the value of little known, GW Pharmaceuticals, a UK based company, focused on developing medicines from marijuana. Their product, Sativex, already approved in 27 countries is currently awaiting USFDA approval. With Wall Street valuing GW Pharmaceuticals at almost $2 billion, is there a future for marijuana based medicines? Increasing production of legal marijuanaMarijuana or cannabis, is ‘still’ classified as schedule 1 drug, which means that the Drug Enforcement Agency (DEA), believes there is no currently accepted medical use and the drug isn’t safe to use even under medical supervision. However, with all the research interest, the DEA has proposed a massive increase in the amount of marijuana production. It will hopefully allow, that the demands of the researchers will finally be met. Highly curative?There are two key active ingredients inside Marijuana, Cannabidiol (CBD) and Tetrahydrocannabinol (THC). While the potency of marijuana is linked to the amount of Tetrahydrocannabinol (THC) inside it, Cannabidiol (CBD) which isn’t responsible for the high, is the one considered to have the wider scope for medical applications. Epidiolex// treatment of epilepsy in children?An orally-administered liquid containing CBD has received orphan drug status in the US, under the brand name Epidiolex. GW Pharmaceuticals, the developer of Epidiolex is also performing their second Phase III clinical trial to demonstrate its effectiveness in the treatment of epilepsy in children. Sativex// treatment of spasticitySativex, a mixture of THC and CBD, is approved for sales in countries for the treatment of spasticity (muscle spasms and stiffness) related to multiple sclerosis; a disease that affects 1.3 million people worldwide, of which up to 80% suffer from spasticity.In addition to THC and CBD, GW Pharmaceuticals, has also developed a portfolio of products based on the other cannabinoids found in the plant. Marinol// approved in 1985GW Pharmaceuticals isn’t alone since synthetic derivatives of THC have also been on the market for years. Dronabinol (brand name: Marinol), approved in 1985 for prevention of nausea and vomiting during chemotherapy, is estimated to have current sales of almost $450 million. After the initial launch, the product also got approval for appetite and weight loss in patients with HIV/AIDS. The product got reclassified, in 1998 by the DEA, from a Schedule II drug to a Schedule III one which allowed access to a wider patient base. An open ‘high-way’ for businessInsys Therapetuics, another player in this space, who had their novel, more bio-available formulation of Dronabinol rejected by the FDA, still commands a market valuation of almost $3 billion. Plant based medicines, like Paclitaxel, Docetaxel, Morphine, Codeine have made billions for the pharmaceutical industry in the past and the market valuations of GW Pharmaceuticals and Insys Therapeutics indicates similar expectations for developing medicines from marijuana. With many other cannabinoids in the plant, raw material availability no longer as restricted as in the past, licensing opportunities on new indications available from the National Institute of Health (NIH)– it is just a matter of who hits the marijuana ‘high-way’ first?

Impressions: 2265

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#Phispers by PHARMACOMPASS

16 Jul 2015

Find PharmaFlow Article for Tetrahydrocannabinol

Tetrahydrocannabinol

Tetrahydrocannabinol

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

33 API Suppliers

22 USDMF

2 CEP/COS

1 NDC API

11 Listed Suppliers

DEVELOPMENTS

100 Drug(s) in Development

INTERMEDIATES

5 Suppliers

DOSSIERs // Finished Dosage Formulations

23 Dossiers

19 FDA Orange Book

2 Europe

2 Canada

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - 10MG

CAPSULE;ORAL - 2.5MG

CAPSULE;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

Suppliers

9 BASF

5 Actylis

4 ACG Worldwide

3 Lonza Capsugel

3 Gangwal Chemicals

2 Seqens

2 Roquette

2 Nomisma Healthcare

2 Finar

1 Qualicaps

1 Seppic

1 Sigachi Industries

1 SPI Pharma

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Nanjing Well Pharmaceutical

1 Gangwal Healthcare

1 Kerry

EXCIPIENTS BY APPLICATIONS

9 Topical

8 Empty Capsules

6 Coating Systems & Additives

6 Thickeners and Stabilizers

6 Controlled & Modified Release

5 Solubilizers

5 Parenteral

5 Film Formers & Plasticizers

3 Fillers, Diluents & Binders

2 Lubricants & Glidants

2 Direct Compression

1 Co-Processed Excipients

1 Emulsifying Agents

1 API Stability Enhancers

1 Taste Masking

1 Granulation

GLOBAL SALES INFORMATION

23 US Medicaid Prescriptions

7 Finished Drug Prices

MARKET PLACE

8 APIs

3 DOSSIERS // FDF

1 EXCIPIENTS

PATENTS

4 US Patents

ANALYTICAL SOLUTION(s)

2 USP Standards

2 Other Ref. Standards

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow

35 News

API SUPPLIERS

API REF. PRICE (USD / KG)

INTERMEDIATES

DOSSIERS // FDF

GLOBAL SALES (USD Million)