Pharmala Biotech is dedicated towards the development, manufacture and sales of MDMA and MDXX class molecules in service of the clinical community. The company’s business consists of 2 business lines with 1 being a developer of novel chemical entities and the other 1 being a commercial-stage supplier of API’s.
DRUG PROGRAMS TARGET:
SUBSTANCE FOCUS: MDMA, MDXX
OWNERSHIP:
Restora – 50/50 JV with Aluvaris
Cortexa – 50/50 JV with Vitura Health
NEWS & PARTNERSHIPS:
2022
The company entered into an exclusive sales agreement with Mindset Pharma where PharmAla will be the exclusive global reseller of Mindset’s cGMP psilocybin to appropriately licensed clinical researchers.
The company contracted Clerkenwell Health to assist PharmAla in regulatory proceedings with both the US Food and Drug Administration and the UK Medicines and Health Regulatory Authority (MHRA). PharmAla intends to bring ALA-002, its leading Novel Chemical Entity, to both jurisdictions. Clerkenwell will provide regulatory support for ALA-002 in both the UK and USA. The agreement also countenances the potential to drive more molecules through the pharmaceutical regulatory approval’s pathway. PharmAla continues to develop additional molecules, including its ABA series of non-controlled MDMA analogues, and further NCEs still under development.
The company was selected as the MDMA manufacturing partner for a human MDMA trial at a campus of the University of California. The University of California system encompasses 10 campuses across the State of California. This is the first US-based Clinical Trial to utilize PharmAla’s LaNeo MDMA. The University of California has requested that PharmAla maintain confidentiality regarding both the Campus and Principal Investigator of the trial to allow for unbiased patient recruitment.
The company became the first publicly traded company to produce GMP-MDMA at scale.
The company signed an agreement with SABI Mind which will allow for its GMP MDMA to be administered to patients at SABI Mind’s Healing Centres. PharmAla will provide GMP, clinical-grade MDMA to SABI Mind and PharmAla will have a right to access anonymized patient data collected during treatment by SABI Mind.
The company signed a supply agreement with Global Wellness Strategies for the supply of GMP MDMA for Shanti Therapeutics’ upcoming clinical trial.
The company initiated preclinical research on its patented novel chemical entities at the laboratory of Dr. William Fantegrossi at the University of Arkansas for Medical Sciences.
The company initiated preclinical research on a new class of patented novel chemical entities with InterVivo Solutions to validate novel MDMA analogs.
The company was selected by Mind Medicine Australia as the company’s MDMA manufacturing partner.
The company signed an agreement with CCrest Laboratories, allowing for its GMP MDMA to be delivered to customers in Canada and around the world. The company will make use of the numerous services that CCrest offers from its state-of-the-art facilities located in Montreal such as the capability to perform extensive chemistry and microbiology testing, stability studies, method development and validation, consulting services and regulatory support.
The company was selected as the MDMA manufacturing partner for a major Australian Research institute’s Phase 3 clinical trial.
The company was selected as the MDMA manufacturing partner for the University of Sydney’s upcoming Phase 2 Clinical Trial.
2023
The company provided its GMP LaNeo MDMA capsules to the Orygen Institute, affiliated with the University of Melbourne in support of a clinical trial registered by the Orygen Institute.
The company completed the first shipment of the first batch of psychedelic molecules explicitly for the Authorized Prescriber Scheme, batches of MDMA and psilocybin both as an API and finished drug capsules to Cortexa in Australia.
The company, the University of Calgary and Heroic Hearts Canada announced a letter of intent and received initial Ethics Board Approval, to initiate an Observational Trial on patients treated with MDMA through Health Canada’s Special Access Program. PharmaAla will supply the trial with the compound, and The University of Calgary, under the direction of Dr Leah Mayo, Parker Research Chair in Psychedelics, will assess the data. The goal of the trial is to gather data on the efficacy of treatment for patients who are already qualified for treatment under the Special Access Program and the company will get access to voluntary data.
The company entered into a clinical development agreement with the University of Sydney, under the leadership of Dr. Adam Guastella, the Michael Crouch Chair in Child and Youth Mental Health at the University.
The company was awarded a research grant by Ontario Centre for Innovation for Innovation in conjunction with the University of Windsor. The OCI will support Pharmala’s In-Silico Modeling Partnership with the University of Windsor.
The company and Shaman Pharma were granted the first ever authorization to provide a number of its LaNeo MDMA capsules to a Canadian physician for treatment of a patient under Health Canada’s Special Access Program. PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the first company to make available to researchers 2 clinical-grade Psychedelic APIs: LaNeo MDMA and GMP-Psilocybin manufactured by Mindset Pharma. Shaman Pharma will be distributing all Special Access Program requests for PharmAla.
The company announced the establishment of a 50/50 joint venture called Cortexa with Australian-based Vitura Health. Supported by exceptional domestic distribution provided by the Vitura group, Cortexa will be able to provide MDMA and Psilocybin products for clinical use to be prescribed by authorized prescribers and for use in clinical trials undertaken by academic and commercial researchers. Any sale orders for the products received by PharmAla from the date of signing the letter of intent in February have been transferred to Cortexa, ensuring that the joint venture will generate revenues from the outset. Cortexa will pay PharmAla a licensing fee for the terms of the license to PharmAla’s manufacturing technology and IP, of 250,000 CAD every year, for 3 years on and from the date the joint venture is unconditional. Cortexa will also pay PharmAla a royalty equal to 5% of the net profit generated by Cortexa.
The company received a purchase order for GMP LaNeo MDMA and Psilocybin by Incannex.
The company was selected as the MDMA manufacturing partner for the Clinical Psychedelic Lab at Monash University’s upcoming Phase 2 Clinical Trial.
The company was named the exclusive MDMA supplier to Awakn.
The company completed an agreement to sell a shipment of its GMP LaNeo MDMA to Emyria.
The company was granted an export permit for 300 grams of LaNeo MDMA to a client in the UK for use in research and development, for a proposed commercial purpose.
2024
The company launched its Prescribers Portal for medical practitioners with prescribing power to learn more about MDMA, its effects, and the potential ability to access the molecule for their patients.
Cortexa, the company’s JV started producing GMP LaNeo MDMA 40mg capsules to support both clinical trials and clinical use under the TGA’s Authorised Prescriber pathway. Cortexa entered an exclusive arrangement with Optima Ovest as its appointed contract manufacturer.
The company signed a sale agreement with Numinus to provide its GMP LaNeo MDMA for a prospective clinical trial.
The company announced that data from its computational drug discovery program, in conjunction with the University of Waterloo will be published in the scientific journal ACS Chemical Neuroscience in the article: “Uncovering Structure-Activity Relationships of Phenethylamines: Paving the Way for Innovative Mental Health Treatments”.
The company was accepted as a client of Intellectual Property Ontario and granted 35,000 CAD in grants with a further total grant of 100,000 CAD available in subsequent funding calls.
Cortexa supplied the first GMP psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme for TRD, establishing the company as the only Australian company able to immediately supply and deliver both GMP MDMA and Psilocybin for both clinical trials and prescriptions via the TGA’s Authorised Prescriber Scheme.
The company entered into a consulting relationship with Red Light Holland to consult on the development of clinical-grade psilocybin drug product extracted from Red Light Holland’s mushroom portfolio. PharmAla’s manufacturing experts have been retained by Red Light to consult and provide their expertise to Red Light in an all-cash consulting contract for 1 year, with the goal of developing GMP and regulatory documentation of Red Light’s Psilocybin capsule products. The agreement also includes the provision that, upon completion of the Drug Product to specification, PharmAla and Red Light may enter into a sales agreement, where PharmAla would sell the products or provide them to its affiliates in global markets as Red Light’s exclusive sales agent.”
The company announced that it was granted a Controlled Drugs & Substances Dealer’s License by Health Canada, Canada’s federal health regulator. The CDSL allows PharmAla to offer for sale both 3,4 Methylenedioxymethamphetamine (MDMA) and Psilocybin to those authorized to legally hold these materials.
The company partnered with Harvard’s Maclean Hospital for the supply of its LaNeo MDMA for a clinical trial.
The company was selected as a supplier for a clinical trial at the University of Texas, San Antonio which will be focused on testing a novel dosage form of PharmAla’s proprietary LaNeo MDMA as well as provide already developed 40mg MDMA capsules.
The company secured a contract to supply MDMA for a clinical trial conducted by Johns Hopkins Medicine.
The company’s partnership with Red Light Holland ended on the 3rd of September.
The company was contracted as a supplier of its GMP LaNeo MDMA to a clinical trial at Mt. Sinai Health System.
The company was contracted as a supplier of its GMP LaNeo MDMA and novel derivatives of MDMA to a clinical trial at Yale University.
The company signed a letter of intent with a research institution to provide its LaNeo MDMA in exchange for a full and perpetual license to the efficacy and safety data generated by the trial.
2025
The company announced the advancement of its contract with the University of Texas Health Science Center at San Antonio to provide LaNeo MDMA for a Department of Defense-funded clinical trial.The study, conducted by the STRONG STAR Consortium, will evaluate MDMA-Assisted Therapy specifically for active-duty military personnel suffering from PTSD. To support this research, PharmAla will develop a new 20mg dose of its clinical drug product, providing practitioners with greater dosing flexibility and marking a significant step toward expanding treatment options for military members and veterans.
The company completed an international shipment of LaNeo MDMA to the University of Washington, USA.
The company signed a distribution agreement with Duchefa Farma of Haarlem, Netherlands, to act as exclusive distribution agent for its LaNeo MDMA in the Netherlands market. The distribution agreement includes an annual purchase minimum as well as restrictions on re-export and price controls. It also includes an escalator provision which would significantly increase the minimum purchase amounts in the 24 months following regulatory changes which allow for use of MDMA in the healthcare system. Duchefa will also act as Importer of Record as well as providing Qualified Person Release of PharmAla’s products; under EU regulations, QP release is necessary prior to use of a drug product in either commercial use or in clinical trial.
The company launched its Phenesafe AI platform, an AI technology stack specifically designed to derive novel substituted phenethylamine molecules for patent and subsequent development.
The company warned about products that are not theirs being labeled under their brand.
The company warned about retailing a nasal spray online that is not theirs but labeled under their brand.
The company completed customs clearance and delivery of over 500 capsules of the company’s LaNeo 40mg MDMA to Merhavim Mental Health Centre of Beer Yaakov, Israel
The company signed a distribution agreement with Veridion Group, giving them exclusive distribution rights for its LaNeo MDMA in New Zealand. The distribution agreement includes an annual purchase minimum which is waived for the first year, as well as restrictions on re export. PharmAla anticipates shipping to New Zealand from existing inventory allocated for its Australian operations.
The company launched NEXUS, its new and updated tool to bring together and connect Prescribers, Therapists and Clinic managers. NEXUS is designed to be a key tool in connecting the total chain of care for MDMA practitioners, as well as an important mechanism to deliver and share knowledge on the latest advances to regulatory processes, scientific evidence, and best-in-class patient care.
The company completed release testing of its first Australian-made batch of LaNeo MDMA 40mg capsules.
PharmAla Biotech Australia contracted a UK-based CDMO to execute manufacture of its ALA-002 drug substance.
2026
The company was selected as the supplier of LaNeo MDMA to Østfold Hospital Trust.
The company executed a binding supply agreement with Amsterdam University Medical Center in the Netherlands for the provision of LaNeo 40mg MDMA capsules for use in a proposed clinical trial. The agreement sees PharmAla supply its LaNeo 40mg capsule dosage, repackaged in a new single capsule packaging format and it also includes a 3-year stability testing program for the single-capsule dosage form, which will generate new stability data that PharmAla expects to leverage in the development of commercial-grade blister packaging for its LaNeo MDMA product line.
The company executed an agreement with Spaulding Rehabilitation, a member of the Mass General Brigham healthcare system, for the provision of MDMA for use in a clinical trial investigating MDMA-assisted therapy for the treatment of fibromyalgia. Under the agreement, PharmAla will provide its LaNeo MDMA at no charge to Spaulding Rehabilitation for use in a study entitled “Hyperscan Neuroimaging to Reveal the Brain Mechanisms Supporting Analgesia Following MDMA-Assisted Therapy in Fibromyalgia” in exchange for a license to the study results.
The company executed a Supply & Data Agreement with Nautilus Sanctuary of Brooklyn, New York, for the provision of MDMA for use in a Phase 2 clinical trial in the United States by the name of “An Open Label Study to Treat Post-Traumatic Stress in Frontline Healthcare Workers and First Responders Using MDMA-Assisted Therapy”. The company will in turn be granted a perpetual, non-exclusive license to the clinical trial data, which includes pseudonymized and de-identified raw data sets as well as Nautilus Sanctuary’s analysis of the safety and efficacy of the intervention. The license permits PharmAla to use the data for regulatory approvals and any commercial purpose in any jurisdiction globally.
The company executed a definitive special purpose vehicle, shareholder and license agreement with Aluvaris and Diteba. The agreement established a jointly-owned special purpose vehicle called Restora Neurosciences to lead the clinical and regulatory development of APA-01, the company’s patented novel MDXX molecule, with the explicit objective of filing a first Investigational New Drug application with the US Food and Drug Administration. PharmAla retains ownership of the underlying intellectual property and a continuing economic interest in any product commercialized by the SPV through equity, license fee, royalty and sublicense participation, while Restora’s operating cash needs are met by capital raised by Aluvaris. Diteba was appointed as Restora’s principal provider of bioanalytical and scientific project-management services for the duration of the IND development program. Aluvaris is given an exclusive, worldwide, royalty bearing license under the PharmAla intellectual property to research, develop, manufacture and commercialize licensed products in all therapeutic fields of human use, with the right to grant sublicenses subject to PharmAla consent. The SPV will pay a one-time license fee of 500K to PharmAla and PharmAla retains a 3% of net sales royalty. PharmAla’s ownership percentage in Restora will not drop below 25%.
The company entered into a term sheet under which PharmAla would grant Jupiter Neurosciences exclusive, perpetual United States licensing rights to ALA-002 with PharmAla retaining all rights to ALA-002 in territories outside of the US.
Due to the agreement with Jupiter Neurosciences, granting them exclusive US rights to ALA-002, the company exercised its option to cancel a pending licensing deal with Restora Neurosciences for its APA-01 compound, which it now retains full ownership of.
The USPTO issued US Patent No. 12,679,817 to PharmAla, covering scalable, enantioselective manufacturing processes for the direct production of single (R)- and (S)-enantiomers of MDMA and MBDB. This process-level patent addresses historical cost and yield barriers, supporting the economical creation of R-MDMA and PharmAla’s lead non-racemic drug candidate, ALA-002.