Isosceles Pharmaceuticals, Inc., a preclinical stage pharmaceutical company ("Isosceles", or the "Company") engaged in the development of synthetic cannabidiol for the treatment of pain has announced the execution of a non-binding letter of intent with a strategic partner for the phase 1 development of the Company's intravenous product, IPI 201. The non-binding letter of intent ("LOI") provides Isosceles with a strategic partner that will accelerate the use of the Company's cannabidiol intravenous product, IPI 201, in humans. This proposed partnership will provide Isosceles with a proven CRO partner for IPI 201 and the opportunity to dose humans in 2023.
"This agreement is another step forward for Isosceles as we pursue novel and non-opioid options for the treatment of pain," said Brett Lanier, President of Isosceles. "Further, the opportunity to partner with an established Contract Research Organization as part of our Phase 1 trials is a significant milestone for IPI 201 and will help us validate our proprietary non-opioid offering for the treatment of pain."
About Isosceles Pharmaceuticals
Using novel parenteral delivery systems, Isosceles Pharmaceuticals is developing a platform of proprietary options to treat acute pain. Parenteral delivery reduces hepatic exposure by avoiding first-pass metabolism and maximizes bioavailability by direct systemic delivery. With nearly 80 million inpatient and outpatient surgical procedures performed in the U.S. annually, the treatment of acute postoperative pain remains an unmet need particularly with the current opioid crisis. Effective treatment of postoperative pain is important to hospitals, doctors, and their patients. Unrelieved pain can produce adverse effects on the cardiovascular system, pulmonary function, sleep, mood stability, normal physical function, and the potential for deleterious effects on the immune system, which can transition to chronic pain.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of U.S. federal securities laws. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue" and similar expressions are intended to identify such forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to the LOI. Statements regarding the LOI are non-binding until such time that a definitive agreement is entered into and closed. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results and, consequently, you should not rely on these forward-looking statements as predictions of future events. These risks and uncertainties include, among others, the fact that a definitive agreement may not be entered into or consummated. Isosceles cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Isosceles undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Corporate Communications:
IR@isoscelespharma.com
Media Contact:
Brett Lanier
910.520.3071
Isosceles Pharmaceuticals welcomed two new team members – Herbert Neuman, MD, MBA, and Thomas L. Harrison LH.D – to their award-winning mission. The early-stage venture launched two years ago, setting out to formulate and commercialize products that effectively and safely treat post-operative acute pain. Using synthetic cannabidiol manufactured under an FDA drug master file – along with novel parenteral delivery systems – Isosceles Pharmaceuticals is developing a platform of proprietary, non-opioid options. Neuman has joined the company as chief medical officer, while Harrison will serve as a strategic advisor.
"Both Herb and Tom bring a level of industry and non-opioid pain expertise that enhances our efforts," said Bill Humphries, Chief Executive Officer of Isosceles Pharmaceuticals. "We believe patients deserve better treatments for acute pain. Our nation's growing opioid crisis is proof positive that something's got to change. This is what drives our company every day, and we're confident Herb and Tom will help us make great strides in rewriting the healthcare narrative."
Neuman comes to Isosceles with more than 20 years' experience in the pharmaceutical industry. Specifically, his focuses include medical affairs, new product development, launch strategies, pharmacovigilance, and business development. Board-certified in Internal Medicine, he continues to practice medicine on a parttime basis. During the course of Neuman's pharmaceutical career, he's held a variety of senior executive positions, including vice president of global regulatory affairs, vice president of medical affairs and chief medical officer for a Fortune 500 global healthcare company.
Harrison currently is Chairman Emeritus of Diversified Agency Services (DAS), the world's largest group of marketing services companies. DAS is a division of Omnicom Group, which Harrison joined in 1992 when his healthcare advertising and medical education agencies were acquired by Omnicom Group. Over the years, Harrison's leadership helped grow DAS from Omnicom's smallest division to its largest, accounting for over 50 percent of the parent company's total revenues. Harrison began his career at Pfizer Laboratories starting as a pharmaceutical sales representative and later joining Pfizer's marketing department as a product marketing director with responsibility for several of Pfizer's in-line brands. Harrison worked closely with medical advertising agencies and became aware of their role in helping to develop and guide brand strategy and communications. He'd subsequently leave Pfizer to join a mid-sized healthcare advertising agency before co-founding his own medical advertising agency, Harrison and Star.
"The acumen and knowledge that Tom and Herb bring to Isosceles is arriving at the perfect time," Humphries said. "We have made significant strides these last months on our portfolio, strategy and plan to develop synthetic cannabidiol in various innovative patent protected forms to serve key physician and patient channels. Adding Tom and Herb into these important discussions and our Series A meetings will create incremental value."
Isosceles Pharmaceuticals Inc. a biotechnology company dedicated to developing, commercializing, and marketing innovative non-opioid products for the treatment of mild to moderate pain and inflammatory diseases, today announced the appointment of William D. Humphries as its Chief Executive Officer. Mr. Humphries is a highly accomplished executive leader in the pharmaceutical industry with a proven track record leading several global pharmaceutical companies.
"We are excited to welcome Bill for the role of Chief Executive Officer," said Tim Wright, Chairman of Isosceles Board of Directors. "His extensive background in the pharmaceutical industry will provide invaluable leadership as Isosceles achieves its strategic growth milestones."
Most recently, Mr. Humphries served as President of Ortho Dermatologics, a subsidiary of Bausch Health Companies. He has also held global executive leadership positions at Merz North America, GlaxoSmithKline, Stiefel, and Allergan.
"I would like to thank Tim and the Isosceles team for welcoming me to company," said Mr. Humphries, Chief Executive Officer of Isosceles. "I was attracted to Isosceles by their focus on the pursuit of innovative solutions for safe, novel non-opioid pain relief and the passion the team has for delivering these important products to the market. I look forward to leveraging my experience to accelerate the company's development plans and lead Isosceles as it unlocks its full potential."
Mr. Humphries currently serves as Chairman of the Board at Clearside Biomedical, Chairman of the North Carolina State University Global Luxury Management Board, is a member of the Board at Aclaris Therapeutics, and a member of the Board at Strata Skin Sciences. He received his MBA from Pepperdine University and completed his undergraduate studies at Bucknell University.
SOURCE: GREATER WILMINGTON BUSINESS JOURNAL
BY JENNY CALLISON
BIOTECH | ISOSCELES PHARMACEUTICALS INC. BRETT LANIER, PRESIDENT | YEAR FOUNDED: 2019 | EMPLOYEES: 7 (Photo by Terah Wilson)
Early-stage venture Isosceles Pharmaceuticals is working on developing non-opioid pain relief alternatives to opium-derived drugs such as Oxycodone. Working with a group of medical doctors and pharmaceutical Ph.D.s, the young company wants to formulate products that will be effective in treating post-operative acute pain safely, using synthetic cannabidiol manufactured under an FDA drug master file.
Patients would be administered the drug intravenously or through a skin patch.
“Our cannabidiol, or CBD, is created in a laboratory under lab conditions, so it’s synthetic and not hemp derived,” said founder and President Brett Lanier, a medicinal chemist with more than a decade of experience in the pharmaceutical industry. “As a comparison, aspirin originally came from the bark of willow trees, but we no longer grow willow trees to make aspirin; we synthesize it. There are too many impurities in an agricultural product; the FDA would not approve it.”
“Isosceles has a team of medical doctors and pharmaceutical Ph.D.s with a proven track record of drug development and FDA approval for pain products and transdermal pain patches,” the company’s nomination form stated. “They have a combined 130 years of pharmaceutical experience and multiple FDA drug approvals. Isosceles is leveraging that experience to develop a completely new type of pain product through the clinical trial process.”
There is a large market for non-opioid drugs that address acute, post-operative pain, Lanier said.
If the venture is successful, its products would aim to reduce the amount of opioids prescribed after surgery, and, Lanier noted, could reduce pediatric exposure to opioids.
He believes that CBD’s strong endorsement from the FDA means that Isosceles’ products will be approved for use with children as well as adults.
“Research shows that children initially got exposed to opioids through dental surgery, such as extraction of wisdom teeth,” he said.
Isosceles Pharmaceuticals has received some early-stage funding, according to Lanier. In May, the company was the winner of the inaugural NC BIONEER Venture Challenge, a competition aimed at enhancing life sciences and biotechnology business ventures in the region.
Its award consisted of a $20,000 investment and a one-year tenancy at the University of North Carolina Wilmington’s Center for Innovation and Entrepreneurship.
“Isosceles Pharmaceuticals is fortunate to have the crucial mix of a great idea that meets an existing market need, a strong team headed by an exceptional entrepreneurial leader, an impressive rollout and growth plan and attractiveness for raising equity capital,” said Randall Johnson, executive director of the N.C. Biotechnology Center Southeastern Office in Wilmington. “Brett Lanier possesses a flexible, go-getter attitude and unceasing drive that bode well for the success of the venture and were on full display when he recently participated in and won the NC BIONEER Venture Challenge.”
Isosceles Pharmaceuticals recently won a 2020 Coastal Entrepreneur Award (CEA) for the Biotechnology category. The industry accolades – presented by the Greater Wilmington Business Journal and The Center for Innovation and Entrepreneurship (CIE) at the University of North Carolina Wilmington – celebrate rising ventures in the Cape Fear region.
“Our entire team is honored to be among this great group of visionary businesses and leaders,” said Brett Lanier, president of Isosceles Pharmaceuticals. "As an innovator in non-opioid pain relief, Isosceles is focused on the large, unmet need for alternatives to addictive pain therapeutics to stem the opioid crisis in our country – especially in Wilmington. Isosceles is capitalizing on the availability of an FDA-approved drug master file for synthetic Cannabidiol and is pursuing FDA approval for several delivery methods that will improve bioavailability and mitigate liver toxicity associated with oral delivery.”
This marks the 12th annual CEA, with Isosceles Pharmaceuticals receiving the honor in its first year. Winners are selected not only by their fast growth, but potential to make a significant regional impact, according to a press release issued by organizers.
Isosceles Pharmaceuticals was featured – along with other winners – in a special section of the Greater Wilmington Business Journal. A celebratory event will take place later in 2020. Isosceles Pharmaceuticals currently is developing the delivery of synthetic CBD through an IV and a transdermal skin patch for pain relief. It’s designed to provide healthcare with a safer, non-addictive and effective alternative to opioid treatment.
"We look forward to FDA responses to our regulatory filings,” Lanier said. “While we are confident that our products will make a significant impact at global level, it’s an absolute thrill to be recognized for this effort right here in our own backyard of North Carolina.”
Article from WilmingtonBiz.com.
A Wilmington company developing non-opioid solutions for pain relief is the first-place winner of the inaugural NC BIONEER Venture Challenge, according to an announcement Tuesday.
Isosceles Pharmaceuticals Inc. took the top award of the challenge that aims to enhance life sciences and biotechnology business ventures in the region.
Isosceles Pharmaceuticals is a company that is developing the delivery of synthetic CBD through an IV and a skin patch for pain relief. It solves the problem for the need of a safer, non-addictive and effective alternative to opioid treatment, according to the release.
The company will receive a $20,000 investment and a one-year tenancy at the University of North Carolina Wilmington Center for Innovation and Entrepreneurship, which will help the venture’s development of the opioid substitute.
“The venture applications for this inaugural challenge were exceptional and showed a broad range of biotech-related commercialization activities and opportunities in Southeastern North Carolina,” said Randall Johnson, executive director of the N.C. Biotechnology Center Southeastern Office, in the release.
“This initiative showcases and strengthens the region's impressive community of innovators and entrepreneurs and helps young companies progress toward attracting investment to boost commercialization of biotech innovations and create high-paying jobs across our region.”
Other winners, all Wilmington-based, include AccuGenomics, the second award winner, which will receive a $10,000 investment to market kits for sequencing gene expression tests that accurately diagnose, monitor and guide cancer treatments, according to the release.
Third and fourth award winners are Electronic Lab Logs and IndiOmics; both will receive $5,000 to help boost their commercialization efforts.
Electronic Lab Logs, which was announced last week as a recipient of the NC IDEA SEED Grant, uses a software platform for biotech lab management, and IndiOmics has developed a testing kit for environmental health assessments.
The four finalists went through a two-month process of mentoring and other assistance that ended with the entrepreneurial pitch judging session held Monday. Entrepreneurs pitched their ventures to a panel of judges that included investors, entrepreneurial support organizations, biotech company leaders and technology innovators.
The competition was launched earlier this year by N.C. Biotechnology Center Southeastern Office and UNCW's CIE, in a partnership that seeks to raise the profile, increase the volume and enhance the success of regional life science innovation, commercialization, entrepreneurs and companies, according to the release.
Isosceles Pharmaceuticals is led by president and founding member Brett Lanier, who is a medicinal chemist with over a decade of experience in the pharmaceutical industry, according to the company’s website.
"The CIE is excited to have this opportunity to provide additional support to entrepreneurs in this important sector. We are pleased to help them with the expertise and resources we have on campus,” said Diane Durance, director at the UNCW CIE, in the release. “The emerging biotechnology ventures participating in this challenge will make great contributions to our regional economy as they grow."
