RESEARCH

Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defense

Gilead | November 21, 2020

Gilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas about the drug’s worth.

At clear odds with the FDA’s approval, the WHO has for now recommended against the use of remdesivir in any hospitalized patients—regardless of disease severity—after an expert panel said it had found no evidence that remdesivir has any meaningful effect on saving lives and other important outcomes for patients, the international body said Thursday.

A “disappointed” Gilead immediately fought back. It pointed to remdesivir’s inclusion in several other organizations’ guidelines based on data from a phase 3 trial by the National Institute of Allergy and Infectious Diseases (NIAID), which showed the drug’s use could lead to faster recovery.

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BUSINESS INSIGHTS, PHARMACY MARKET

AEON Biopharma to Become Publicly Listed via Merger with Priveterra Acquisition Corp.; Accelerating Clinical Development of ABP-450

AEON Biopharma | December 14, 2022

AEON Biopharma, Inc. a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 injection for therapeutic indications, and Priveterra Acquisition Corp. a special purpose acquisition company announced that they have entered into a definitive business combination agreement. Upon closing of the proposed transaction, the combined company will operate as AEON Biopharma, Inc. and is expected to list on Nasdaq under the ticker symbol AEON Uniquely Positioned to Capitalize on Global Therapeutic Neurotoxin Opportunity Since its founding in 2019, AEON Biopharma has been led by Marc Forth, an Allergan plc veteran of 16 years and a former head of the BOTOX® Therapeutic franchise in the United States. AEON has assembled a seasoned team with expertise in neuroscience research, development, regulatory affairs, operations, manufacturing, and commercialization. Its executive team is comprised of industry leaders who have led new drug FDA approvals including multiple indications across multiple neurotoxin products. The global therapeutic neurotoxin market is currently estimated to be $3.0 billion, of which the U.S. represents approximately 84%, and projected to grow to approximately $4.4 billion in 2027. BOTOX®, marketed by Abbvie, Inc., currently holds approximately 95% U.S. market share for therapeutic indications in the neurotoxin space.1 Other neurotoxin competitors have had success with aesthetic indications in the cash-pay consumer-driven market but have been unable to acquire meaningful market share for therapeutic indications due to the indirect influence of pricing dynamics for aesthetic indications that results in a minimal value proposition for both payors and providers. AEON intends to file a unique BLA for therapeutic indications that would be free of any effects on reimbursement that exist for all other toxin competitors that have both therapeutic and aesthetic indications approved under a single BLA. Lead product candidate, ABP-450, is the same botulinum toxin approved and marketed for an aesthetic indication. Its 900 kDa molecular weight, similar to the market leader, will enable providers with a seamless transition to ABP-450 for therapeutic uses. Similar to the approved neurotoxins currently in the market, ABP-450’s commercial success does not depend upon patent protection, creating the possibility for an annuity-like construct of continued revenue generation, should ABP-450 be FDA approved. AEON’s therapeutic-only focus also provides a differentiated business model designed to deliver enhanced value to payors and providers by permitting a traditional pharma pricing model that is not currently available to competitors that also market their products for aesthetic uses approved under a single BLA. The sole focus on therapeutics allows AEON to pursue an original BLA filing that would allow a unique commercial strategy that cannot be employed by other competitors. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets. The Company is dedicated to innovation in the rapidly expanding therapeutic botulinum toxin market and believes its therapeutic-only focus will allow AEON to advance safe and effective treatment options to patients, while delivering differentiated economics to payors and physicians. The Company continues to evaluate additional therapeutic indications for development based on a comprehensive product assessment process designed to identify those indications where it believes ABP-450 can attain clinical, regulatory, and commercial success. About Priveterra Acquisition Corp. Priveterra Acquisition Corp. is a blank-check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in life sciences. Priveterra is sponsored by Robert Palmisano and Priveterra Capital, LLC.

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PHARMACY MARKET, PHARMA TECH

Prescryptive Health Partners with Lilly on First-to-Market Value-Based Program to Stabilize Insulin Pricing

Prescryptive Health | December 16, 2022

Prescryptive Health, a healthcare technology company on a mission to rewrite the script for the U.S. pharmaceutical market, today announced a partnership with Eli Lilly and Company on a new and first-to-market subscription model to help lower costs for people who pay for their Lilly insulin through their employer-sponsored benefits. Through a flat, per-member, per-month subscription fee, employers can offer insulin to their employees with predictable, affordable, and transparent costs. This unique value-based program is designed to create price stability related to insulin utilization, with Lilly refunding a portion of the subscription fee if an employer's total medical spend increases over time for their employees who live with diabetes. "We are proud to partner with Lilly on this unique and first-to-market value-based program. This solution challenges the traditional drug pricing model and reduces the burden on employers who sponsor pharmacy benefits. The result is that it insulates employers against increased drug prices and aligns interests to focus on patient access and health outcomes." Chris Blackley, Prescryptive Health CEO This new program can help address controversial rebates in the pharmacy benefit manager pricing model and will be available through Prescryptive free of any margin or price mark-up, further reducing the cost to employers, health plans, and ultimately healthcare consumers. Additionally, the program offers opportunities for employers to supply insulin at lower costs, or at no cost, to their employees. Added benefits for employers participating in the program include the Prescryptive mobile experience that supports patient engagement and adherence for diabetes care. "In the U.S., more than 34 million people have diabetes, and some people who have employer-based insurance still need affordability solutions to ensure they don't pay too much out-of-pocket for their insulin," said Mike Mason, President, Lilly Diabetes. "At Lilly, we strive to provide new solutions to help lower costs at the pharmacy, including partnering with Prescryptive Health to ensure people with diabetes have access to affordable options to help them reach their treatment goals." According to the American Diabetes Association people with diagnosed diabetes spend about 2.3 times more on medical costs than those without diabetes, which impacts not only every individual patient and plan member, but also employers who sponsor their benefits coverage. Additionally, costs related to the condition include $3.3 billion in increased absenteeism. About Prescryptive Health Prescryptive Health is a healthcare technology company delivering solutions that empower consumers. Prescryptive's secure, mobile-first products connect consumers, pharmacists, and employers, ultimately providing people with the information they need to make informed decisions and take control of their health.

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PHARMA TECH

Additional US$ 4 Million Received for Next Development Steps of MedinCell's 6-Month Active Injectable Bioresorbable Subcutaneous Contraceptive

MedinCell | December 01, 2022

MedinCell has received an additional US$ 4 million payment from the Bill & Melinda Gates Foundation This amount is intended to finance the next steps of MedinCell’s program mdc-WWM in readiness to initiate the first clinical trial end of 2023 It follows US$ 11,8 million already received as part of the two successive grants for a total of up to US$ 22,5 million from the Bill & Melinda Gates Foundation to finance the development of the program up to phase 1 completion The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide About MedinCell MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.

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