Ensysce Biosciences Announces Key Additions to Executive Team Ahead of Financing

Ensysce Biosciences Inc | April 16, 2019

a clinical phase drug development company with innovative technologies to curb prescription drug abuse and overdose, today announced two appointments to its senior management team. Kurt Schmidt has been appointed as the Company’s Chief Financial Officer. Mr. Schmidt is coming on board just as the company is rapidly progressing its lead TAAP TM product, PF614 through clinical development to help stem the opioid crisis that is facing America. Geoff Birkett is joining as the Chief Commercial Officer to position the company’s therapeutic pipeline in the marketplace. Mr. Schmidt has over 30 years of experience in helping build early stage companies as they progress from development to commercialization. He has lived and worked in both the US and Europe and recently held positions at healthcare companies MDxHealth and Agendia where he was CFO. He will be responsible for finance strategy and business expansion at Ensysce. “I look forward to working with the team to bring solutions to our healthcare system,” said Mr. Schmidt. “My near-term focus will be on raising capital to support our ongoing clinical trials. I am especially encouraged by the support of our programs by the FDA with Fast-Track designation and the recent award from the NIH through the National Institute on Drug Abuse, which shows the importance placed on our work by the government.” Mr. Birkett has over 25 years of experience in the pharmaceutical industry with a focus on CNS, oncology, pain and addiction. He is the former SVP of Global development and Marketing for CNS/Oncology products at AstraZeneca and has launched such brands as Nicorette, Prozac, Seroquel and Zomig. Most recently he has acted as consultant with several pharmaceutical companies on development strategy and marketing. “Ensysce is leading the challenge of entering the opioid space when the political and regulatory climate is looking for new answers for analgesia. Opioid products are necessary for many indications, and Ensysce is providing an option for both patients and prescribers that can reduce abuse and stem overdose from these prescription products. Kurt and Geoff recognize the opportunities to contribute to this effort and are coming on board to aid our financing goals and commercial activities for the coming years,” said Dr. Kirkpatrick, CEO of Ensysce Biosciences. “Our TAAP TM oral prodrug technology and MPAR TM overdose protection, both unique to the industry, have already demonstrated exceptional clinical results. We look forward to rapidly progressing these through clinical development so the public can benefit from these safer alternatives.”

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MedinCell’s Partner Teva Announces Successful Launch of UZEDY™

Businesswire | August 03, 2023

MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI). About UZEDY Richard Francis said1 “We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.” “The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.” UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales. About LAI olanzapine (mdc-TJK), initiated in January 2023 Eric Hughes said1 “Our Olanzapine Phase 3 study is actually enrolling very quickly.” “Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.” Richard Francis, said1 “With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.” mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales. About MedinCell MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.

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PAN-TB Collaboration Announces the Start of a Phase 2 Clinical Trial to Evaluate Two Novel Tuberculosis Treatment Regimens

PRNewswire | August 10, 2023

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration announced today the start of a phase 2b/c clinical trial, sponsored by the Bill & Melinda Gates Medical Research Institute (Gates MRI). The trial will evaluate whether novel regimens that combine registered products and new chemical entities have the potential to effectively treat drug-sensitive TB (DS-TB) and inform the development of a "pan-TB" regimen capable of treating all forms of active pulmonary TB. The regimens under evaluation are designed to explore shorter treatment durations compared to existing drug regimens, without the need for accompanying drug-resistance testing for individuals. The goal is to identify a candidate regimen suitable for phase 3 development. Trial sites are being hosted in countries with a high burden of TB. The trial has started in South Africa with the first participant screened in the last week of July. 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PRNewswire | August 09, 2023

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