Botulism

While AbbVie's Botox dominates the medical aesthetics field, some new rivals have emerged. Public Citizen wants the FDA to change its messaging around the products. The U.S. advocacy group Public Citizen is taking aim at AbbVie’s medical and cosmetic injection Botox, as well as its new rivals, over safety and promotional issues with the shots. In a petition sent to the FDA, Public Citizen asked the FDA to “remove misleading promotional statements from the labeling of Botox and Botox Cosmetic” and to "strengthen the black box warning in the labeling of all approved Botox and related drugs.” Botox is the market leader in the medical aesthetics field, having been around for 34 years and generating around $5 billion annually for AbbVie. The Illinois-based pharma giant picked up the blockbuster drug from its buyout of Allergan in 2019. While Botox dominates the field, Public Citizen also wants the same crackdown for the med's rivals. Those are Revance Therapeutics' Daxxify, Evolus' Jeuveau, Supernus Pharmaceuticals' Myobloc, Galderma's Dysport, and Merz Therapeutics’ Xeomin. All of these products contain a form of a highly potent neurotoxin that can be used to treat cosmetic conditions, such as smoothing out wrinkle lines or, as is the case with Botox, also have medical labels, such as for migraines and incontinence. But there can be serious safety risks when using these neurotoxins, and Public Citizen wants the FDA to shore up messaging around the products. The group has a long history with Botox and originally petitioned for the drug’s black-box warning back in 2008. It argues that the current warning, which was slapped on the drug by the FDA in 2009, still does not go far enough as it “fails to explicitly mention the risk of ‘systemic iatrogenic botulism.'" This is a potential complication of Botox treatment and related drugs that can cause muscle paralysis or weakness, the group said. The advocacy group also wants the removal of “misleading promotional statements” from the labeling of Botox and Botox Cosmetic. These promotional statements are also related to potential safety risks, with Public Citizen singling out the claim that “[n]o definitive serious adverse event reports of distant spread of toxin effect” were associated with the use of recommended doses of these drugs to treat four therapeutic indications (blepharospasm, chronic migraine, severe underarm sweating, and strabismus) and certain approved cosmetic uses. It points out that regulators in other countries, including Canada and the U.K., do not use this claim, and that, when combing through the FDA’s safety database, the group said it saw that “Botox was the primary suspect when used to treat one of the four therapeutic indications listed in the misleading claims,” and that “269 (42%) included adverse reactions that were suggestive of iatrogenic botulism.”

IRVINE, Calif., Feb. 10, 2023 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, responded today to the recent ruling by the Seoul Central District Court in favor of Medytox, Inc. related to a long-standing trade secret dispute between Medytox and Daewoong Pharmaceutical Co. Ltd. AEON stated that it does not expect the ruling will affect its ongoing clinical development or planned commercialization strategy for ABP-450 (prabotulinumtoxinA) injection in target markets. As part of AEON’s global settlement with Medytox, which was entered into on June 21, 2021, all outstanding litigation relating to Medytox’s strain of C. botulinum between the two parties was fully resolved under confidential terms. The settlement contemplates that any Korean litigation between Medytox and Daewoong would not affect the supply of ABP-450 to AEON. The rights granted to AEON under the settlement include having ABP-450 manufactured and exported by Daewoong to AEON, and for AEON to continue its planned clinical development and, if approved by government regulators, commercialization of ABP-450. AEON is developing ABP-450 as a treatment for debilitating medical conditions, with an initial focus on the neurosciences market. “As previously announced, we have settled all litigation between AEON and Medytox, and we have a licensing agreement with Daewoong for ABP-450. As such, the ongoing litigation in Korea on trade secrets is between Medytox and Daewoong, and is not expected to have any impact on AEON’s clinical development and commercialization plans or timelines for ABP-450 in the U.S.,” said Marc Forth, AEON’s President and Chief Executive Officer. To learn more about AEON and the development of its uniquely positioned therapeutic neurotoxin, visit www.aeonbiopharma.com. About ABP-450 (prabotulinumtoxinA) Injection ABP-450 contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. The active part of the botulinum toxin is the 150 kDa component, and the remaining 750 kDa of the complex is made up of accessory proteins that the Company believes help with the function of the active portion of the botulinum toxin. When injected at therapeutic levels, ABP-450 blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings leading to denervation and relaxation of the muscle. AEON licenses ABP-450 from Daewoong Pharmaceutical Co., which provides AEON exclusive development and distribution rights for therapeutic indications in certain territories, including the United States, Canada and the EU, among other international territories. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. AEON recently completed a Phase 2 study of ABP-450 for the treatment of cervical dystonia and has an ongoing Phase 2 study of ABP-450 for the treatment of both chronic and episodic migraine. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, or the FDA, Health Canada and European Medicines Agency, or EMA. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The company built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. Proposed Transaction with Priveterra Acquisition Corp. On December 13, 2022, AEON and Priveterra announced entering into a definitive business combination agreement relating to a business combination that would result in AEON becoming a public company upon the closing of the proposed transaction. The Boards of Directors of both AEON and Priveterra have approved the proposed transaction, which is expected to close in the first half of 2023, subject to approval by Priveterra’s stockholders and the satisfaction or waiver of certain other customary closing conditions. In connection with the proposed transaction, Priveterra filed a registration statement on Form S-4 with the U.S. Securities and Exchange Commission (the “SEC”) on December 27, 2022. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws with respect to the proposed transaction between AEON and Priveterra, including statements regarding the benefits of the proposed transaction, the anticipated timing of the proposed transaction, the products developed by AEON and the markets in which it operates, any statements about current or planned clinical trials or related milestones, any statements of expectation or belief regarding future events, potential markets, market size, or technology developments, AEON’s projected future results, and any statements of assumptions underlying any of the items mentioned. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of Priveterra’s securities, (ii) the risk that the transaction may not be completed by Priveterra’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by Priveterra, (iii) the failure to satisfy the conditions to the consummation of the transaction, including the adoption of the agreement and plan of merger by the shareholders of Priveterra and AEON, the satisfaction of the minimum trust account amount following redemptions by Priveterra’s public shareholders and the receipt of certain governmental and regulatory approvals, (iv) the lack of a third party valuation in determining whether or not to pursue the proposed transaction, (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the business combination agreement, (vi) the effect of the announcement or pendency of the transaction on AEON’s business relationships, performance, and business generally, (vii) risks that the proposed transaction disrupts current plans of AEON and potential difficulties in AEON employee retention as a result of the proposed transaction, (viii) the outcome of any legal proceedings that may be instituted against AEON or against Priveterra related to the business combination agreement or the proposed transaction, (ix) the ability to maintain the listing of Priveterra’s securities on the NASDAQ Exchange, (x) volatility in the price of Priveterra’s securities due to a variety of factors, including changes in the competitive and highly regulated industries in which AEON plans to operate, variations in performance across competitors, changes in laws and regulations affecting AEON’s business and changes in the combined capital structure, (xi) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities, and (xii) the risk of downturns in the highly competitive pharmaceutical industry. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the registration statement on Form S-4 and proxy statement/prospectus referenced above and other documents filed by Priveterra from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and AEON and Priveterra assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Neither AEON nor Priveterra gives any assurance that either AEON or Priveterra will achieve its expectations. Contacts Investor Contact: Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Source: AEON Biopharma

The first-ever medical aesthetics partnership for the R&B superstar entertainer RALEIGH, N.C.--(BUSINESS WIRE)-- Merz Aesthetics®, the world’s largest dedicated medical aesthetics business, today announced Teyana Taylor as the latest Xeomin® (incobotulinumtoxinA) brand partner. The U.S. partnership with Taylor is a continuation of the ground-breaking ‘Beauty on Your Terms’ campaign for Xeomin® and represents the first time the entertainer has partnered with an aesthetics brand. Xeomin® (pronounced phonetically: Zeo-min) is an FDA-approved double filtered anti-wrinkle injection to temporarily improve the appearance of frown lines with only the ingredients that work and none that don’t. This press release features multimedia. View the full release here: Merz Aesthetics® announces Teyana Taylor as new Xeomin® (incobotulinumtoxinA) brand partner (Photo: Business Wire) “I always strive to understand the ingredients in any product I’m using and listen to trusted sources like my doctors when choosing what’s right for my specific skin type,” said 31-year-old Taylor. “I had never tried an aesthetic treatment before, so it was important to choose a product that gives me consistent results without any unnecessary ingredients. That’s why I chose Xeomin® for my frown lines.” Teyana Taylor is a singer-songwriter, actor, dancer and choreographer known for her melodic vocals and dynamic dance moves from the studio to the stage. On top of her three successful studio albums, Taylor most recently starred in Paramount Pictures Coming 2 America and can be seen as the main character in the upcoming A.V. Rockwell featured debut A Thousand And One. “There are still a lot of stigmas around injectable treatments, especially for women of color – thinking it is not as safe or effective for a variety of skin types,” said Dr. DiAnne Davis, board-certified dermatologist. “But, this is simply untrue. You can still celebrate who you are and embrace desired treatments for anti-aging results. Partnerships like this with Teyana and Xeomin® show that aesthetic treatments can be an option for all skin types in producing a natural-looking result.” The announcement of Taylor as the newest Xeomin® brand partner is a part of the ‘Beauty on Your Terms’ multi-channel campaign from Merz Aesthetics®, which empowers women and men to embrace beauty on their own terms. “Teyana Taylor embodies the true meaning of ‘Beauty on Your Terms’ through her music, her style and, now, her beauty treatments,” said Patrick Urban, Merz Aesthetics® President, North America. “As one of the most dynamic and talented female entertainers, we are thrilled to partner with her in furthering our mission in bringing authentic confidence to life and encouraging others to do what makes them feel most confident as well.” Follow @XeominAesthetic to stay up to speed on the latest news from Teyana Taylor. To learn more about Xeomin® and locate a provider near you, visit XeominAesthetic.com where you can access the Find a Provider tool. You can also sign up for the Xperience+ Loyalty Program at xperiencemerz.com to receive instant and future rewards on Xeomin® and additional Merz Aesthetics® treatments at your preferred practice. About Merz Aesthetics Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 110 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 52 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com. About Xeomin® (incobotulinumtoxinA) XEOMIN® (incobotulinumtoxinA) is a botulinum toxin type A approved by the U.S. Food and Drug Administration (FDA) to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. For more information, including Full Prescribing Information and Medication Guide, please visit . See below for Important Consumer Safety Information. XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION Read the Medication Guide before you start receiving XEOMIN (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more: Talk to your health care provider or pharmacist Visit to obtain the FDA-approved product labeling Call 1-866-862-1211 Uses: XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It is not known if XEOMIN is safe and effective in children under 18 years of age. Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at XeominAesthetic.com. Warnings: XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN: Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN. People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN. Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing. These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities. Do not use XEOMIN if you are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site. Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you: have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome) have had any side effect from any other botulinum toxin in the past have a breathing problem such as asthma or emphysema have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration) have bleeding problems have drooping eyelids have plans to have surgery have had surgery on your face are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN. Using XEOMIN with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past. Especially tell your doctor if you: have received any other botulinum toxin product in the last four months have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received. have recently received an antibiotic by injection take muscle relaxants take an allergy or cold medicine take a sleep medicine Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine. Possible Side Effects XEOMIN can cause serious side effects that can be life threatening including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint. See “Warnings.” The most common side effect of XEOMIN in people with frown lines include: headache These are not all the possible side effects of XEOMIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of XEOMIN Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals. Active Ingredient: botulinum toxin type A Inactive Ingredients: human albumin and sucrose Copyright © 2018 Merz North America, Inc. All rights reserved.