Ensysce Biosciences Announces Key Additions to Executive Team Ahead of Financing

Ensysce Biosciences Inc | April 16, 2019

Ensysce Biosciences Announces Key Additions to Executive Team Ahead of Financing
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.”

Spotlight

Pharmaceutical or biotechnology companies looking to outsource their API production are planning for success by looking at the entire development cycle. The growing desire to select one API partner to work with throughout the drug development process, and to potentially also synthesize commercial quantities, put an increased importance on the selection process.

Related News

PCI Pharma Services Announces Global Clinical Footprint With Creation COE in Western Europe

PCI Pharma Services | July 28, 2020

PCI Pharma Services, a leading pharmaceutical and biopharmaceutical global outsourcing solutions provider, today announced a significant milestone in its global clinical footprint with the creation of a new Clinical Center of Excellence (COE) in Western Europe at its Berlin location, a major investment that will represent a new flagship site for customers. This is part of PCI’s global strategy to expand its clinical supply-chain network into continental Europe to complement offerings available at its UK and Ireland sites. The COE is expected to be completed in January 2021. “With this expansion, our Berlin Clinical Center of Excellence will address the needs of European and global clients,” said Brian Keesee, vice president and general manager, Global Clinical Operations and Supply, PCI Pharma Services. “Berlin is an excellent logistical hub that will serve as a proactive solution to Brexit, ensuring there are no gaps in the supply chain and our clients conducting clinical trials in all parts of Europe continue to be served.”

Read More

RESEARCH

Eli Lilly wins FDA's emergency nod for COVID-19 antibody—but, thanks to mixed data, it's limited

Eli Lilly | November 11, 2020

The U.S. just had another COVID-19 drug authorized for emergency use. But the approval is limited—and, with at least one vaccine launch on the horizon, industry watchers wonder whether drugs to treat the illness have any staying power. The FDA authorized Eli Lilly’s bamlanivimab for emergency use on Monday, making it the first antibody therapy to win that distinction. Dubbed LY-CoV555, it's an anti-SARS-CoV-2 antibody therapy the Indianapolis pharma is co-developing with AbCellera. The OK comes with some caveats: It's limited to patients 12 years and older who aren't hospitalized but who are at high risk of developing severe illness, including elderly people and those with certain underlying conditions. And Lilly is advising infusion within 10 days of symptom onset.

Read More

PHARMA TECH

MyMD Pharmaceuticals Announces Issuance of U.S. Patent Covering Lead Drug Candidate MYMD-1 in a Method of Extending Lifespan

MyMD | November 24, 2021

MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced that the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent 11,179,382 B2, titled “Methods of Reversing Normal Aging Process and Extending Lifespan.” The allowed claims protect the use of MYMD-1 in a method designed to extend the lifespan of an individual. “This patent is a timely addition to our IP portfolio as we advance toward the launch of our fully funded Phase 2 trial of MYMD-1 for aging. After a comprehensive review by USPTO, we are pleased with the broad scope of the granted claims which offer further protection for our lead drug candidate, which we believe has the potential to become the first and only FDA-approved therapeutic solution for delaying aging and prolonging healthy lifespan,” Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD “Our primary focus for MYMD-1 is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan,” Dr. Chapman added. “It’s also important to note that MYMD-1 shows promise in pre-clinical studies as a treatment for immune diseases including rheumatoid arthritis, multiple sclerosis, and Hashimoto’s thyroiditis, and as an anti-fibrotic and anti-proliferation therapeutic.” The latest patent adds to MyMD’s intellectual property portfolio of 14 granted patents (12 U.S. and two foreign) covering MYMD-1 in methods of treating chronic inflammation, autoimmune disorders, diabetes, multiple sclerosis, viral infections, addictions, fibrosis, asthma, and other disorders. MyMD also holds two patents for its synthetic cannabidiol (CBD) derivative Supera-CBD. An additional 30 patent applications are pending worldwide. About MYMD-1 Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions. MYMD-1 is also showing promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic. MYMD-1 has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. About MyMD Pharmaceuticals, Inc. MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.

Read More

Spotlight

Pharmaceutical or biotechnology companies looking to outsource their API production are planning for success by looking at the entire development cycle. The growing desire to select one API partner to work with throughout the drug development process, and to potentially also synthesize commercial quantities, put an increased importance on the selection process.