In addition to meeting the demanding criteria for a CMO, Endoceutics has the following distinctive advantages that will optimize and facilitate the approval process for clinical trials with the United States Food and Drug Administration (“FDA”):
– Company with state-of-the-art facilities and a solid worldwide reputation in the formulation and manufacture of pharmaceutical products, with several American and European multinationals as clients.
– Extensive knowledge of regulations and manufacturing processes related to clinical trials with the FDA, as well as in the commercialization of products. The company has namely successfully completed a Phase 3 clinical trial with the FDA for its Intrarosa® product, which is sold in several countries.
– Licensed to distribute steroids (or androgens) and recognized as one of the best companies in the world in this regard. This is very important to Triple Hair, as finasteride, a component of TH07, is a steroid.
– Local Canadian company located in Mont-St-Hilaire, Québec, which is an important advantage with respect to the proximity of Triple Hair’s operations, particularly in the context of the situation surrounding COVID-19.
– In addition to all the above, it is more advantageous in terms of costs to use a Canadian company than a US company (CAN$ vs US$).
“We are very pleased to have retained Endoceutics, a company with state-of-the art facilities and proven expertise that is extremely relevant to our TH07 prescription product, and a key element in advancing our product towards clinical trials,” said Jean-Philippe Gravel, President and CEO of Triple Hair. “Endoceutics will support us in the development and subsequent initiation of a Phase 3 clinical trial for TH07, which will be key to filing an NDA application with the FDA for approval of a new topical hair growth prescription product, the first since the approval of Rogaine in 1988.”
“Endoceutics ticks all the boxes in my criteria list for a CMO and more,” said Dr. Satish Asotra, Chief Scientific Officer of Triple Hair. “The fact that Endoceutics has successfully completed a Phase 3 clinical trial with the FDA is a real advantage for us, as they can share their experience to optimize the chances of success of our own clinical trial. In particular, Endoceutics will be responsible for the compilation of the CMC section, formulation and manufacturing of the clinical trial batches, which will be planned and designed for eventual commercial production, as well as the labelling and packaging of the batches according to the FDA’s rigorous criteria. All of these factors strongly support our decision and we look forward to beginning our relationship with Endoceutics.”
Despite the current context surrounding COVID-19, our Triple Hair team is focused on achieving its objectives. In the coming months, Triple Hair will undertake product development activities with the goal of generating CMC (chemistry, manufacturing and control) data and manufacturing clinical trial batches at Endoceutics in preparation for the TH07 Phase 3 clinical trial.
Endoceutics is a private pharmaceutical company actively committed to advancing basic science, clinical research and development, world-class manufacturing, and product commercialization worldwide. The company successfully completed a Phase 3 clinical trial with the FDA for its Intrarosa® product, which is sold in several countries.
Endoceutics’ facility is designed and built to exceed the most up-to-date cGMP compliance requirements for worldwide delivery. Its fully enclosed, automated state-of-the-art manufacturing and packaging equipment offers full redundancy and is integrated up to the packing level.
Triple Hair is developing the next generation topical hair growth therapies that will disrupt the US$8.5 billion global hair loss market. Triple Hair is the only company to develop effective topical products for both the prescription product market and the over-the-counter market. The company is in the process of conducting a Phase 3 clinical trial for its hair growth prescription product TH07 under FDA Section 505(2)(b).