Who We Are
Prometic is a biopharmaceutical corporation with two drug discovery platforms focusing on unmet medical needs in the field of fibrosis and orphan diseases. We are committed to providing patients throughout the world with hope of a healthier future and are doing this by:
- advancing our new discoveries within the lifecycle of healing through the clinical trial stages and regulatory approval process
- targeting specific unmet medical needs using our proprietary small molecule and plasma-derived drug candidates
- building a deep and rich R&D pipeline, enabled through world-class science
We are headquartered in Laval, Quebec (Canada), and have R&D facilities in Canada, the United States (“USA”) and United Kingdom (“UK”), manufacturing facilities in Canada and the Isle of Man and corporate and business development activities in Canada, the USA, Europe and Asia. These are strategic locations established to support and facilitate our growth and business activities globally.
Prometic is now focused on completing its transition from a pure R&D company into a commercially successful pharmaceutical company specialized in rare and orphan diseases with the foundations to enable significant growth over the coming years. Prometic is publicly traded on TSX (Symbol: PLI) and OTCQX (Symbol: PFSCF).
Ryplazim™ (plasminogen) is the name of our lead plasma-derived drug candidate. Plasminogen is a naturally occurring plasma protein synthesized in the liver, which is vital in wound healing and tissue remodeling. As well as patients with congenital plasminogen deficiency, Ryplazim™ (plasminogen) could treat patients with a range of acquired and acute conditions where plasminogen is known to play a key role such as acute lung injury, Idiopathic Pulmonary Fibrosis (IPF), severe burns, tympanic repair and diabetic foot ulcers.
Ryplazim™ (plasminogen) has been awarded a Rare Pediatric Disease Designation by the U.S. FDA for the treatment of patients with congenital plasminogen deficiency. Plasminogen has also been granted orphan drug designations by both the US FDA and EU regulatory authorities.
What We Do
We have the ability to pursue the clinical development of many different indications using our two drug discovery platforms. Our lead drug candidates in these platforms can work together and are well positioned to treat the full spectrum of conditions such as Idiopathic Pulmonary Fibrosis (IPF).
Small Molecule Therapeutics
Prometic’s Small Molecule Therapeutics (PSMT) operation is spearheaded by its subsidiary centred at Prometic Biosciences Inc., based in Laval.
The first drug discovery platform (small molecule therapeutics) stems from the discovery of two receptors which we believe are at the core of how the body heals: namely, promoting tissue regeneration and scar resolution as opposed to fibrosis.
Our lead drug candidate program is PBI-4050, an orally active lead drug candidate with excellent safety and efficacy profiles demonstrated in a large number of animal models of fibrosis affecting different organs, including the lung, liver, heart, kidney, and pancreas. The effects of PBI-4050 demonstrated in animal models have been replicated in Phase 2 studies in IPF, in metabolic syndrome with type 2 diabetes and in Alström syndrome. PBI-4050 is entering pivotal placebo-controlled phase 3 clinical trials for the treatment of IPF and has already started placebo-controlled phase 2 trials in metabolic syndrome and type 2 diabetes patients.
The findings of our groundbreaking studies have been presented and published at a number of international conferences. Our research and development products have been granted:
- Orphan Medicinal Product (OMP) Designations granted by the United States (US) Food and Drug Administration (FDA) and the European Commission (EC) for plasminogen (human) for the treatment of plasminogen deficiency. In addition, OMP Designation granted by US FDA for plasminogen (human) for the treatment of idiopathic pulmonary fibrosis (IPF).
- OMP Designations granted by the US FDA and EC for PBI-4050 for the treatment of Alström syndrome and IPF.
- Promising Innovative Medicine (PIM) Designations granted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for PBI-4050 for the treatment of Alström syndrome and IPF.
Plasma-Derived Protein Therapeutics
The second drug discovery and development platform (plasma-derived therapeutics) leverages Prometic’s experience in bioseparation technologies used to isolate and purify biopharmaceuticals from human plasma. The primary goal with respect to this second platform is to address unmet medical needs with therapeutic proteins not currently commercially available, such as Ryplazim™ (plasminogen). We are also leveraging this platform’s higher recovery yield potential to advance established plasma-derived therapeutics such as Intravenous Immunoglobulin (IVIG). Our operations include our own plasma purification facility in Canada where it is recovering therapeutic proteins from plasma for our own clinical trial needs and initial commercial requirements.
Prometic’s state of the art technologies and products are embedded into a successfully scaled-up manufacturing process (Plasma Protein Purification System or PPPS™) for the development, manufacturing and commercialization of best in class plasma-derived therapeutics. Prometic’s proprietary and proven affinity adsorbents are incorporated in a downstream, multi-sequential chromatographic process to extract, isolate and purify high-value proteins with superior yield and efficiency from what is currently available from the industry. The process also incorporates viral inactivation as well as prion reduction that surpass the industry alcohol based extraction process. The gentle process provides for significantly better yield and economic benefits and is easily adaptable to different protein market needs.
After years of refining, PPPS™ Prometic successfully launched it at its plasma purification facility, Prometic Bioproduction Inc., in Laval, Quebec, in late 2013. This enables Prometic to develop best-in-class plasma-derived therapeutics which will address unmet medical conditions and rare diseases in both established and emerging markets.