Medical cannabis company Impression Healthcare (ASX: IHL) has continued its top-tier recruitment drive with the addition of yet another pharmaceutical industry expert into its ranks.
Former Roche (market cap: US$256 billion) executive John Michailidis has been installed as chief executive officer of Impression’s drug discovery division Incannex, with a key focus of advancing the company’s expanded clinical program that includes four clinical trials into obstructive sleep apnoea (OSA), Traumatic Brain Injury (TBI), TMJ dysfunction (TMD) and periodontitis (gum disease).
A recipient of an executive MBA from Harvard Business School, Mr Michailidis wields business leadership skills developed over three decades of management, chief executive officer and managing director roles in the pharmaceutical industry.
To ensure Impression succeeds in developing effective medicinal cannabis treatments in all of its focus areas, the company has brought in a host of top-tier personnel over the past six months including Dr Sud Agarwal as chief medical officer, Drs Ron Jithoo, Simon Hinckfuss, David Cunnington and Professor Michael Stubbs, who have joined its medical advisory board.
With Mr Michailidis on the team, Impression is confident it now has all the personnel in place to complete its clinical trial program and commercialise an entire range of sophisticated medicinal cannabis products, as outlined in Dr Agarwal’s presentation broadcast by Small Caps last month.
Furthermore, Impression said that the appointment also means it will soon have in-human observations for three patent-protected products with its medical advisory board participants representing “instrumental” components in product development and prescriptions under Australia’s special access scheme.
Operational boost
Mr Michailidis is an experienced pharmaceutical executive with an extensive and successful career in developing novel drugs. He’s seen through over 10 drug discovery commercialisation successes and product launches over his career.
Prior to joining Impression, Mr Michailidis served as managing director of Teva Pharmaceuticals where he established a significant commercial operation in 2014. His track record includes the closing of several multi-million-dollar licencing and partnering deals and increasing total sales beyond $100 million by 2017.
Possibly most important, and what may prove to be crucial to Impression’s commercial aspirations is Mr Michailidis’ background in the Australian medicinal cannabis sector.
During his time at Teva, he was responsible for organising multifaceted partnerships between state and federal government regulators, establishing registration and commercialisation pathways for cannabinoid medicines and enacting licence deals with several Israeli cannabis companies.
One of his most high-profile achievements was advancing Roche Holding as global business director and as chief executive officer of Roche Korea in 2006. At Roche, Mr Michailidis successfully launched key new treatments into the Korean market and tripled sales in a two-year period.
Mr Michailidis’ appointment is considered as part and parcel of the “continued and significant strengthening” of Impression’s drug development team, created to commercialise novel patented cannabinoid drugs.
The company said that Mr Michailidis brings with him real-world experience in all facets of pharmaceutical development, including strategic planning and execution of pre-clinical and in-human clinical trials, IP protection and successful product launch acumen.
“John brings enthusiasm, vigour and maturity into our drug discovery processes. He has demonstrated solid commercial acumen over his long and successful tenure in the pharmaceutical sector,” said Dr Sud Agarwal, chief medical officer and director of Impression.
Supplementary research services
Today’s announcement of the appointment of Incannex’s new chief executive officer coincides with the formalisation of a research services agreement with Cannvalate, Australia’s largest network of medical cannabis clinics.
According to Impression, the agreement is supplementary to the initial clinical trial services agreement first announced in March this year and provides a framework for the requisite pre-clinical assessments and phase 1 clinical trials for TBI, OSA and TMJ dysfunction.
“The supplementary agreement facilitates a long-term partnership between the two parties and fast tracks Impression’s transition to a pharmaceutical drug development company whereby global sales are achievable post successful product registrations,” the company said.
The program now facilitates a pathway to creating unique globally significant products for which registration post the clinical trial process (pre-clin, P1, P2, P3) will be sought from Australia’s TGA, the FDA in the US, Europe’s EMA and other regulatory bodies.
Over the life of the supplementary agreement, Cannvalate will receive up to $2.5 million in performance-based fees, for managing the extensive program that will take four drug prospects up to the completion of phase 2 clinical trials. These activities are funded courtesy of Impression’s $5 million institutional/HNW capital raising at 7.8c that was completed in late October 2019.
Impression’s next steps are to finalise all patent filings, set all initial product formulations and to commence in-human observations under the special access scheme under the guidance of the relevant medical advisory board appointee who will then report their initial findings.
Furthermore, Impression confirmed that it has already filed a patent application for IHL-216A for TBI and is now busy formulating the product for in-human observations. Patents are also set to be filed for IHL-42X for OSA and IHL-493C for TMJ Dysfunction.
“I’m delighted to join a company that is committed to a proper, scientifically principled and sound commercialisation strategy. Dr Sud Agarwal and I are excited to fully develop a world-class medicinal cannabis company to commercialise our novel cannabinoid drugs”, said Mr Michailidis, newly appointed chief executive officer of Incannex.
