Partnership Will Provide Pharmaceutical Grade Cannabinoid Active Ingredients to the Largest Pharmaceutical and Consumer Goods Names in the Industry

BUFFALO, N.Y., Jan. 23, 2023 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today announced filing of a U.S. Drug Master File (DMF) to the US Food & Drug Administration (FDA) for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group Company. The submission (DMF 037727) demonstrates 22nd Century Group’s absolute commitment to supplying high quality pharmaceutical grade API to the pharmaceutical industry and OTC markets.

Said James A. Mish, chief executive officer of 22nd Century, “GVB Biopharma is widely recognized for the quality and consistency of its Cannabinoid extracts and ingredients. We are now leveraging these capabilities with our DMF filing to meet the increasing regulatory demands of the supplements markets, and in parallel it expands our reach to the pharmaceutical and OTC markets, where consistently regulated high quality ingredients are a requirement. Our compliance infrastructure will ensure that our customers consistently receive API that meets the appropriate quality standards.”

Additionally, 22nd Century and GVB Biopharma have entered into an agreement with Cannabinoid API Solutions (CAS) and Transo-Pharm for global sales, marketing and distribution of GVB’s Cannabinoid APIs. With more than 35 years of industry experience as a leading global supplier of pharmaceutical grade APIs, Transo-Pharm is a well-established supplier and distributor of pharmaceutical APIs to a broad portfolio of branded and generic finished drug product manufacturers, including more than 75 current active ongoing development programs. Transo-Pharm is partnered with an extensive range of reputable multinational pharmaceutical companies, all of which will have immediate access to GVB’s cannabinoid APIs.

“The partnership with Transo-Pharm will accelerate opportunities to supply our APIs to the largest and most innovative pharmaceutical and consumer goods manufacturers in the world,” said Mish. “We estimate the Cannabinoid Derived Pharmaceutical market to be worth $1 billion in 2022 and growing, a trend we see accelerating as new entrants continue join the market. This partnership immediately provides us with the channel access and reach to support pharmaceutical programs worldwide as well as securing new opportunities in over-the-counter and consumer packaged goods spaces. Our regulated pharmaceutical grade ingredients supply chain will provide for the highest levels of quality, consistency and compliance across our entire customer base.”

About Transo-Pharm
Founded in 1987 and based in Germany and the US, Transo-Pharm has established a global reputation as a trusted supplier of active pharmaceutical ingredients (APIs). Transo-Pharm successfully connects suppliers and customers utilizing our experience, industry knowledge, marketing expertise and logistics capabilities. For more information, please visit https://www.transopharm.com/tpusa.html.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA Modified Risk Tobacco Product (MRTP) authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter, on LinkedIn, and on YouTube.

Learn more about VLN^® at tryvln.com.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 1, 2022, and in the Company’s Quarterly Report filed on August 9, 2022. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact
Darrow Associates Investor Relations
Matt Kreps
[email protected]
214-597-8200

Source: 22nd Century Group, Inc

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About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

TORONTO, Nov. 16, 2022 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, and PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, today announced that they have entered into an exclusive sales agreement. Under the sales agreement, PharmAla will be the exclusive global reseller of Mindset’s cGMP (i.e. pharmaceutical grade) psilocybin to appropriately licensed clinical researchers.

“In addition to forging new ground in next generation psychedelic drug discovery, Mindset has also developed a patent-pending, highly scalable psilocybin synthesis technology. A cost-effective supply of first generation psychedelic therapeutics is essential to the overall development of the medical psychedelic space, and Mindset is eager to help meet this increased demand for pharmaceutical grade psilocybin from researchers,” said James Lanthier, CEO of Mindset. “We have chosen PharmAla as a partner because of their track record in working with clinical researchers, and existing sales infrastructure to sell pharmaceutical grade psychedelic compounds. It’s also yet another concrete example of Mindset commercializing and creating value from its portfolio of innovations.”

Mindset has recently completed production of a large batch of cGMP psilocybin at the U.S. site of an international contract development and manufacturing company (“CDMO”) pursuant to the annual DEA quota on psilocybin.

“While we have until now focused exclusively on MDMA and its analogues, we’ve heard time and again that our clinical partners want access to other research materials. We see significant synergies in this partnership with Mindset; our sales infrastructure, as well as our Canadian pharmaceutical value chain, can create revenue opportunities for both companies,” said Nick Kadysh, CEO of PharmAla. “With the culmination of this agreement, we’re the first and only organization that is able to offer the clinical research community two of the most high-quality and in-demand APIs in Psychedelics: PharmAla’s GMP LaNeo MDMA, and Mindset’s cGMP Psilocybin.”

About PharmAla
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

For more information, visit www.PharmAla.ca.

About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic and non-psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 & 4.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

For more information, please contact:

Investor Contact:
Allison Soss
KCSA Strategic Communications
Email: [email protected]
Phone: 212-896-1267

​​
Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: [email protected]
Phone: 949-606-6585

Company Contact:
James Lanthier, CEO
Email: [email protected]

Jason Atkinson, VP, Corporate Development
Email: [email protected]
Phone: 416-479-4094

Forward-Looking Information
This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.