TORONTO, April 5, 2024 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (FarmAla or the Agency) (CSE: MDMA) (OTC: MDXXF), a biotechnology company focused on the research, development and manufacturing of LaNeo™ MDMA and novel MDMA derivatives (MDXX class molecules), is pleased to announce that, for a In another Australian first, its joint venture, Cortexa Pty. Ltd. (Cortexa), is proud to have begun batch production of GMP LaNeo ® MDMA 40 mg capsules to support both clinical trials and clinical use in the of the TGA authorized prescription route.
In doing so, Cortexa reaches another significant milestone, Australian domestic production, further strengthening its position as a leader in the Australian psychedelic landscape by advancing its plan to develop a reliable local supply. This benefit will free local doctors and researchers from the costly and time-consuming burden of importation and provide seamless access to medicines.
Optima Ovest appointed Contract Manufacturer
After a comprehensive due diligence process, Cortexa is pleased to announce that it has entered into an exclusive agreement with Perth-based contract manufacturer Optima West (Great). Optima was founded in 1995 and has extensive experience manufacturing GMP clinical grade pharmaceutical products, with the ability to scale operations in line with demand.
Combined with Cortexa’s access to PharmAla’s intellectual property and manufacturing expertise, the agreement with Optima not only enables the establishment of onshore manufacturing, but ensures a secure domestic source of medicines, independent of the international supply chain.
Domestic manufacturing is a critical step in Cortexa’s growth and part of the original business plan envisioned by PharmAla and our partners at Vitura Health, said Nick Kadysh, CEO of PharmAla Biotech. I believe this is important not only because it brings us closer to our ultimate end customer, “the patient”, but because it signals our commitment to a growing Australian domestic market for LaNeo™ MDMA.
Cortexa grows the Australian market
Since its inception in May 2023, Cortexa has rapidly established itself as a leader in the emerging therapeutic area of psychedelic-assisted therapy in Australia, navigating the regulatory framework, being the first to complete importation, obtaining the supply of study products clinical and prescription authorization program and now the start of onshore manufacturing.
Additionally, Cortexa will soon launch a medical training program designed to increase awareness of psychedelic-assisted therapy in the wider adult psychiatry community and will continue its engagement with peak bodies and key customers to further expand the market in Australia.
About PharmAla
PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) is a biotechnology company focused on the research, development and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual goal: to alleviate the global backlog of clinical-grade generic MDMA to enable clinical trials and commercial sales in select jurisdictions, and to develop new drugs in the same class. PharmAla is the only company currently providing clinical grade MDMA for the treatment of patients outside of clinical trials. PharmAla’s R&D unit has completed proof-of-concept research on several intellectual property families, including ALA-002, its lead drug candidate. PharmAla is a regulatory organization, founded on the principle that true success in the psychedelic industry will only be achieved through excellent relationships with regulators.
For further information, contact: Nicholas KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email: press@PharmAla.caPhone: 1-855-444-6362Website: www.PharmAla.ca
Neither the Canadian Stock Exchange nor its regulation services provider has reviewed or accepted responsibility for the adequacy or accuracy of this release.
Cautionary statement
This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. These statements refer to future events or future performance. The use of any of the words may, intend, expect, believe, will, predicted, estimated and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current beliefs or assumptions regarding the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions made by PharmAla as of the date of the information and is subject to known and unknown risks, uncertainties and other factors that could cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption Risk Factors in PharmAla Management’s Discussion and Analysis, available on PharmAla’s profile on www.sedar.com.
This press release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any state, province, territory or jurisdiction
Source: PharmAla Biotech