Month: August 2022

Incannex has appointed a former Pfizer and now Novo Nordisk A/S executive to its board to help steer regulatory approvals for its key cannabinoid and psychedelic medicinal therapies.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has appointed international pharmaceutical regulatory heavyweight Robert B. Clark to its board as a non-executive director.

Clark is a senior-level strategic regulatory affairs expert with more than 38 years of US and global regulatory experience in a move the company believes is a vote of confidence in their business.

He worked with global pharmaceutical giant Pfizer (NYSE:PFE) for more than 20 years and was vice president of worldwide regulatory strategy and US regulatory affairs at the company.

Clark led a team of up to 150 regional regulatory professionals supporting drug development.

At Pfizer he led or supported US Food and Drug Administration (FDA) approval of many new medicines and represented the company at critical interactions with FDA, and other global health authorities, including key project milestone meetings.

Clark joined Danish multinational pharmaceutical powerhouse Novo Nordisk A/S (NYSE:NVO, CPH:NOVO-B) in 2012, where he is currently vice president, US regulatory affairs.

Novo Nordisk has a market cap of ~US$185 billion, and is one of the world’s biggest companies.

Clark is an internationally recognised expert on FDA and the European Medicines Agency (EMA) liaison interactions, US pharmaceutical advertising practices and regulatory aspects related to healthcare professionals and sales force activities.

At Novo Nordisk, Clark provides strategic leadership to more than 50 regulatory staff and scientists in the development of new medicines. He advises the global executive team on matters related to drug development programs, FDA liaison strategies, managing FDA-related compliance issues, and monitoring emerging US regulatory trends and opportunities.

He and his team manage all interactions with FDA on behalf of Novo Nordisk and have secured FDA approvals for 12 significant new drugs since he started at the company a decade ago.

Proven track record to be applied to ‘medcan’ and psychedelics

Clark has senior level experience in managing regulatory aspects of large-scale pharmaceutical acquisitions, significant compliance matters and business development due diligence.

He has documented success with FDA accelerated approval programs including fast-track, orphan drug, breakthrough therapy designations, and priority reviews, which are areas of interest for IHL management due to the nature of its drug candidate mix.

Clark’s appointment follows IHL’s landmark acquisition of leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx), which further strengthens its global position in the cannabinoid and psychedelic sectors.

Independent validation from a pharmaceutical superstar

IHL CEO and managing director Joel Latham describe Clarke as among the best credentialed regulatory affairs experts globally and said his appointment to the board of directors is a strong vote of confidence in its drug candidates and development strategy.

“He brings to Incannex deep knowledge of the US regulatory environment and decades of experience at the highest level of large pharmaceutical organisations,” Latham said.

“His experience will be invaluable to us now that our interactions with FDA have become more frequent whilst we pursue our mission to bring cannabinoid and psychedelic pharmacological solutions to patients with unmet medical needs.”

Clark said he was looking forward to being a part of the burgeoning cannabinoid and psychedelic medicines sector through his IHL appointment.

“I look forward to working with the board and the management team, and I am excited about the broad Incannex portfolio of products to treat patients who have few or no other available treatments,” he said.

“Cannabinoid and psychedelic pharmacotherapies represent a growing area of research and hold the potential to treat various conditions for which effective options are limited.”

This article was developed in collaboration with Incannex Healthcare,a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

The post Power move: Incannex attracts global regulatory affairs expert, Novo Nordisk exec to board appeared first on Stockhead.

Incannex will move into the lucrative treatment of drug addictions following its takeover of APIRX.

Clinical-stage pharmaceutical company Incannex Healthcare (ASX:IHL) will work to tackle addiction disorders following the acquisition of leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx).

IHL said APRIx has multiple patents for cannabinoid-based drug candidates designed for treatment of addiction to different drug classes.

Opioid addiction

APIRx’s CanQuit O to treat patients withopioid addiction is a patented chewing gum that combines cannabinoids including CBD with opioid agonists and/or antagonists.

It’s designed in the form of a medicated chewing gum to potentially suppress an addict’s craving for the highly addictive drug in a sustained release format.

The act of mastication (chewing) also has an analgesic and anti-anxiety effect, which is thought to also assist to suppress opioid cravings.

The prescription product is aimed at combating opioid addiction for which the annual market size in the US alone is expected to reach US$64 billion by 2028.

The costs to society include healthcare, lost productivity, addiction treatment, and criminal justice involvement and governments are crying out for solutions for people who have become lost in the system

Cannabis addiction

APIRx’s CheWell for Cannabis Dependence is a patented CBD chewable tablet with high bioavailability that can be used in the treatment of marijuana addiction.

The company said marijuana dependence is predicted to be the fastest growing segment of the drug dependence market.

Preliminary data suggest a possible beneficial impact of CBD on mitigating the craving effect of cannabis, while a case report has shown positive outcomes for one patient treated with CBD during the withdrawal and relapse phase of cannabis dependence.

Pre-IND with FDA is pending.

Help to quit smoking

IHL said more effective and cost-effective cannabinoid plus nicotine gum may disrupt the incumbent global nicotine gum market, which had sales of US$5.2 billion in 2020.

By combining cannabinoids with reducing doses of nicotine, APIRx’s patented CanQuit – Nicotine Addiction is a chewing gum designed to better assist addicted smokers quit smoking.

APIRx’s over the counter (OTC) product will be trialled for effectiveness against nicotine medicated chewing gums.

Opportunity for growth

IHL’s takeover of APIRx which was announced last week strengthens its global leadership in the cannabinoid and psychedelic sectors.

It marks possibly the most significant corporate transaction in the medicinal cannabis sector since the takeover of GW Pharmaceuticals (developer of CBD-based Epidiolex) by Jazz Pharmaceuticals for US$7.2B that was first announced in May 2021.

An additional 22 clinical and  pre-clinical  research  and  development  projects have  been transferred  to  IHL, which it says represents  aggregate  addressable  markets  of  ~US$400 billion annually.

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

The post Incannex powers into addiction treatment following APIRx deal to takeover novel patented treatments appeared first on Stockhead.

Incannex has completed a landmark acquisition which strengthens its global leadership in the cannabinoid and psychedelic sectors.

Clinical-stage pharmaceutical company Incannex Healthcare (ASX:IHL) has announced it  has finalised the acquisition of leading cannabinoid biotech company APIRx Pharmaceuticals (APIRx).

IHL announced in March it was buying APIRx in a deal that has now supercharged its technical and drug development capability.

The completion of the APRIx acquisition marks possibly the most significant corporate transaction in the medicinal cannabis sector since the takeover of GW Pharmaceuticals (developer of CBD-based Epidiolex) by Jazz Pharmaceuticals for US$7.2B that was first announced in May 2021.

In a statement to the ASX today Incannex said APIRx stakeholders (sellers) have been issued 218,169,497 new shares in IHL at a notional price per share of $0.573, representing share consideration agreed between the sellers of APIRx and Incannex in March 2022.

APIRx founders Dr George Anastassov and Lekhram Changoer have joined the Incannex team as non-executive director and chief technology officer respectively. The APIRIx sellers have entered a voluntary escrow deed over their shares for 12 months.

More projects and more patents

IHL CEO and managing director Joel Latham said the acquisition of APIRx follows a solid relationship with Dr Anastassov and Changoer that first began in 2018 when Incannex transitioned its business towards development of pharmaceutical cannabinoids.

“After extensive due diligence and corporate strategy assessments of the APIRx assets, we are excited and ready to commence development activities over our newly acquired portfolio of drug candidates,” Latham said.

Following the deal, 22 additional clinical and  pre-clinical  research  and  development  projects have  been transferred  to  Incannex, which it says represents  aggregate  addressable  markets  of  ~US$400 billion annually.

These projects are underpinned by an intellectual property portfolio that includes 19 granted patents and 23 pending patents.

In conjunction with patent applications derived through development of its combination cannabinoid  drug  candidates, Incannex now has  the  world’s  largest portfolio  of  patented  medicinal cannabinoid drug formulations and psychedelic treatment protocols.

Initial high-priority drug candidates resulting from the acquisition are:

• MedChew Dronabinol for chemotherapy induced nausea and vomiting
• MedChew Rx for pain and spasticity in patients with multiple sclerosis
• CanQuit and CanQuitO –chewables that combine nicotine and cannabinoids and cannabinoids and opioid antagonists for smoking cessation and opioid addiction, respectively
• CheWell –high-bioavailability chewable tablet to be implemented in adolescent drug addiction studies, among other indications
• CanChew –patented high-bioavailability and  long-acting CBD  chewing  gum  for  the  over-the-counter market.

Earlier this week IHL announced it had engaged Curia Global (Curia) to further develop and manufacture its proprietary inhaled drug product IHL-216A for the treatment of concussion and traumatic brain injury (TBI).

Incannex is also listed on the Nasdaq under IXHL listed as American Depositary Shares (ADS).

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

The post Incannex completes landmark deal, positioning as a global leader in medicinal cannabis and psychedelics appeared first on Stockhead.