Life Science News

Optimi Health Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

Optimi Health Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, has submitted a request with Health Canada for an amendment to its Controlled Substances Dealer's Licence.

The amendment would enable the Company to synthesize, process and distribute pharmaceutical grade 3,4-Methylenedioxymethamphetamine ("MDMA"), among other substances, at its Princeton, British Columbia facility.

With the Company's main capital expenditure now completed, it will move to expand its offering to encompass a wide variety of synthetic psychedelics through its market-leading EU-GMP cultivation and analytical laboratory . The move aligns with Optimi's planned year of commercialization, allowing the Company to maximize revenue-generating opportunities through standardized psychedelic drug testing, R&D, and product development through approved clinical trials and exemption-based applications.

Ongoing large-scale studies, including Phase III clinical trials investigating MDMA conducted by the Multidisciplinary Association for Psychedelic Studies ("MAPS"), along with more recent decriminalization initiatives announced in the Province of British Columbia, have generated significant unmet demand for these substances for research purposes.

Optimi Health Chief Science Officer Justin Kirkland stated that, "Since our inception, Optimi has received a steadily increasing volume of inquiries related to the production of synthetic psychedelics from stakeholders within the sector, made all the more timely by recent developments. Our analytical laboratories were purpose-built to enable us to act as an EU-GMP compliant drug manufacturer for these interests, without in any way detracting from our primary goal of cultivating natural psilocybin."

Mr. Kirkland elevates Optimi as an industry leader utilizing his drug manufacturing expertise shown in his USPTO awarded Bromo-LSD manufacturing patent sold in 2020 for C$10M and GMP regulatory knowledge from his role as CEO at FDA registered Fristoe Pharmaceuticals.

Optimi CEO, Bill Ciprick, says the Company's EU-GMP operational footprint and throughput capacity is unmatched in North America and would likely take new entrants into the space years and millions of dollars to meet Optimi's scale and clinical efficiency.

"We have a strong idea of our position in the market and how the amendment fits with our strategic priorities," said Ciprick. "We are filing this amendment following conversations with researchers and drug developers which have led to a high volume of requests for GMP-compliant synthetic psychedelics. The positive reports from trauma sufferers, including veterans groups, for whom substances such as MDMA might make a difference, mean that safe, scalable supply is going to be more crucial than ever to the success of psychedelic medicine."

"As we continue with our planned year of commercialization, Optimi views the capacity to produce and distribute these substances as integral to our overall positioning and revenue generation within the sector's supply chain," Ciprick concluded.

The Company's amendment application to Health Canada also includes:

N,N-Dimethyltryptamine ("DMT");

3,4,5-trimethoxyphenethylamine ("Mescaline");

2-(2-chlorophenyl)-2- (methylamino)cyclohexanone ("Ketamine");

Lysergic Acid Diethylamide ("LSD");

1-(1-phenylcyclohexyl)piperidine ("Phencyclidine");

4-Hydroxybutanoic Acid ("GHB");

4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole ("Harmaline");

4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol ("Harmalol");

Salvia Divinorum, Salvinorin A; and,

4-Bromo-2,5-Dimethoxybenzeneethanamine ("2C-B").

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company's dealer's license and associated business related to Psilocybin and Psilocin and Optimi's plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bb41a009-e2a5-4d5d-bf10-082d7a8dfeb1


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

OPTI:CC
The Conversation (0)
Optimi Health Announces Closing of Strategic Non-Brokered Private Placement

Optimi Health Announces Closing of Strategic Non-Brokered Private Placement

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF U.S. SECURITIES LAWS.

Highlights:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Alberta Puts Patients First By Regulating Psychedelic Therapy: Optimi Health

Alberta Puts Patients First By Regulating Psychedelic Therapy: Optimi Health

Highlights:

  • The safe supply of psychedelic drug products manufactured at a GMP-level is critical in treating serious mental health issues. Minister of Mental Health and Addictions, the Honourable Carolyn Bennett, has publicly stated that safe drug supply is paramount to reducing overdose deaths.
  • Optimi Health is the largest cultivator of natural EU-GMP psilocybin and MDMA in North America.
  • Optimi Health is licensed by Health Canada to supply clinical trials and patients approved under the Special Access Program.

Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a leading Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is applauding the government of Alberta's decision to regulate some psychedelics for therapeutic use in the province.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada

Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada

Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is pleased to announce that in conjunction with ATMA Journey Centers ("ATMA"), the companies have confirmed their intent to proceed with a Phase I clinical trial application (CTA) that will document the safety of the Optimi's natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients.

Upon Health Canada approval, it would be the first trial to assess both safety and additional markers, such as the mystical experience questionnaire in healthy subjects that have consumed MDMA.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Optimi Health Completes Largest Legal Natural Psilocybin Harvest in Canadian History

Optimi Health Completes Largest Legal Natural Psilocybin Harvest in Canadian History

Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), is pleased to announce that it has completed what it believes to be the largest legal natural psilocybin harvest in Canadian history. The Company is licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, as well as functional mushrooms that focus on the health and wellness markets.

Building off its first official harvest on May 27 th , which produced various strains of psilocybin for lab analysis and early-stage supply agreements, the Company is pleased to report that its investment in state-of-the art environmental controls and facility cultivation operations have resulted in a commercially harvested yield of more than 150 kg of Panaeolus cyanescens and Psilocybe cubensis.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Optimi Health Signs First International Mushroom Supply Agreement with UK-based Avida Global

Optimi Health Signs First International Mushroom Supply Agreement with UK-based Avida Global

Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce natural, scalable, and accessible psychedelic and functional mushroom products for transformational human experiences, is pleased to announce that it has entered into an agreement with Avida Global ("Avida"), a privately-held UK-based producer of high-quality wellness products, including nutraceuticals and medicinal cannabis oils, for the global well-being and medical markets.

In its first large-scale international distribution agreement, Optimi will supply Avida with an extensive catalog of Optimi Life functional mushroom supplement formulations. The supplements will be available for distribution to clients and partners worldwide via Avida Labs, Avida's white-labelling and manufacturing business.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Lobe Sciences Ltd. Announces That The Drug Enforcement Administration Has Issued The Initial 2023 Quota Allowing Export Of L-130

Lobe Sciences Ltd. Announces That The Drug Enforcement Administration Has Issued The Initial 2023 Quota Allowing Export Of L-130

Dosing In Human Clinical Trial To Commence Within Weeks

lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases today announced that its exclusive commercial manufacturing partner has received their initial 2023 quota for our novel psilocin drug product (L-130) from the Drug Enforcement Administration (DEA).

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Albert Labs Validates Global Supply Chain for Controlled Substances

Albert Labs Validates Global Supply Chain for Controlled Substances

Albert Labs International Corp. (CSE: ABRT) (FSE: VB50), the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, is pleased to announce the validation of their controlled substance supply chain through the successful global distribution of its psilocybin-based KRN Active Pharmaceutical Ingredient (API).

Albert Labs Logo, Validates Global Supply Chain for Controlled Substances (CNW Group/Albert Labs International Corp.)

Albert Labs have successfully distributed their proprietary KRN API from their Health Canada licensed laboratory in Vancouver . Only very few companies have the ability to globally distribute controlled substances of this classification, Schedule 1. This now enables the API to be used as part of their pre-clinical studies at its Infarmed licensed laboratory in Porto, Portugal . This distribution follows an extensive research and development programme allowing for the production and scaling of highly potent yields of its KRN API, for which IP protection has been achieved, using bioreactor technology to ensure the efficient and economical manufacture of its mycelium derived pharmaceutical product.

The company is nearing completion of their KRN-101 pre-clinical studies, which includes full analytical profiling, in-vivo, and in-vitro studies, allowing the medicine to be used in its first, in-human studies in Melbourne, Australia due to begin in Q2 2023 .

Dr. Michael Raymont , CEO of Albert Labs : "Validating our supply chain across two of our jurisdictions, North America and Europe , marks a valuable milestone in our operational program. We have demonstrated our ability to distribute KRN-101, a schedule 1 substance, to global, licensed facilities, and this achievement advances our progress by establishing the viability of our supply chain as we prepare for our first-in-human studies."

Business of Albert Labs International Corp.

Albert Labs is a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which the needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast track clinical pathway focusing on Real World Evidence (RWE). RWE studies are an increasingly recognised clinical route, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.

Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.

The company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.

Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .

You can find more details about Albert Labs on our website here .

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs International Corp.

Dr. Michael Raymont

Chief Executive Officer, Chairman

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.

The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.

Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs International Corp.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2023/15/c5639.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Seelos Therapeutics Announces Registered Direct Offering of Common Stock and Warrants to Purchase Common Stock

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, announced today it has entered into an agreement with a life sciences-focused investment fund for the sale of 12,059,298 shares of its common stock, pre-funded warrants exercisable for an aggregate of 9,340,702 shares of common stock and common warrants exercisable for an aggregate of 26,750,000 shares of common stock. The shares of common stock and accompanying common warrants are being sold at a combined offering price of $0.525 per share, and the pre-funded warrants and accompanying common warrants are being sold at a combined offering price of $0.524 per pre-funded warrant. All of the shares of common stock, pre-funded warrants and accompanying warrants to be sold in the offering will be sold by Seelos. The pre-funded warrants will be immediately exercisable following the closing of the offering and will have an exercise price of $0.001 per share. The common warrants will not be exercisable until after the six-month anniversary of the closing of the offering, will have an exercise price of $0.60 per share and will expire on the date that is five and a half years following the closing of the offering.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

COMPASS Pathways to participate in upcoming Cowen 43rd Annual Health Care Conference, Oppenheimer 33rd Annual Healthcare Conference, and Loop Capital Investor Conference

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in three upcoming events as follows:

  • Cowen 43 rd Annual Health Care Conference: ‘Neuropsych Panel' at 12:50pm ET on March 6, 2023 and host investor meetings
  • Oppenheimer 33 rd Annual Healthcare Conference: presentation at 10:00am ET on March 13, 2023 and host investor meetings
  • Loop Capital Conference: host investor meetings on March 14, 2023

Live audio webcast of the panel and presentation will be accessible from the "Events" page of the Investors section of the COMPASS website. Each replay of the webcast will be accessible for 30 days following each event. For more information, please visit ir.compasspathways.com.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Chronic Cluster Headaches No More: The Promise Of Lobe Sciences' At-Home Psychedelic Treatments Without The Trip!

Chronic Cluster Headaches No More: The Promise Of Lobe Sciences' At-Home Psychedelic Treatments Without The Trip!

(NewsDirect)

By Richard Dal Monte

News Provided by TheNewsWire via QuoteMedia

Keep reading...Show less

COMPASS Pathways Announces Fourth Quarter and Year-End 2022 Financial Results and Business Highlights

Highlights:
  • Phase 3 pivotal program underway - important updates announced
  • Phase 3 long term follow up defined
  • Cash position at 31 December 2022 of $143.2 million
  • Conference call today at 8:00am ET (1:00pm UK)

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter and year-end 2022 and gave an update on recent progress across its business.

Kabir Nath, Chief Executive Officer, said, "During this past quarter, we commenced our COMP360 phase 3 pivotal program in treatment-resistant depression, a significant milestone for our area of science as these are the first ever phase 3 trials of psilocybin. We have also announced important updates to this program that accelerate the placebo-controlled trial pivotal data read out and streamline the long-term follow up as an integrated component of the pivotal trials. We are confident that this phase 3 program should generate the evidence to support a regulatory filing and to support broad patient access through integration into healthcare systems."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×