Viatris, Inc.

PHOENIX, July 10, 2024 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (“Creative Medical Technology” or the “Company”) (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today provided a corporate update highlighting recent developments of note. “As we enter the second half of 2024, it is an opportune time to reflect on our recent achievements,” said Timothy Warbington, Chief Executive Officer. “Many of our successes thus far in 2024 were the result of investments we have made in prior years combined with our steadfast adherence to operating a lean corporate structure, and engaging with our global partners and institutions to support the rapid translation of novel therapies into patients. “Momentum in advancing our proprietary, cell-based therapies towards commercialization is continuing to build. We believe that these novel therapies have the potential to address critical unmet medical needs, including for the treatment of Type 1 Diabetes (“T1D”) and Chronic Lower Back Pain. We have: Manufactured over six billion AlloStemTM clinical-grade cells at a cGMP facility that are being utilized for clinical trials.Developed and filed a Drug Master File with the FDA, which accelerates the Investigational New Drug (IND) filing and approval process and eliminates the need for costly and redundant regulatory filings.Received FDA clearance of two IND applications and an expanded access therapy within 30 days of filing.Received Orphan Drug Designation from the FDA for CELZ-101, or ImmCelz™ for Brittle Type 1 Diabetes.On-track to complete patient recruitment for our clinical trials over a 1 to 2-year horizon. With each new accomplishment, I am grateful for the strength of our programs, the dedication of our employees and partners, the opportunities inherent in our addressable markets and most importantly the patients who volunteer for our clinical trials.” Key Highlights Type 1 Diabetes As previously announced, the Company received clearance of the IND application for a Phase I/II clinical trial for the treatment of T1D using AlloStem™ (CELZ-201). The Company believes that CELZ-201 leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells® to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. During 2023, the Company received Institutional Review Board (IRB) approval to proceed with the trial, selected and initiated the trial site, and initiated patient recruitment. The clinical trial is registered on www.clinicaltrials.gov and actively enrolling.In Q1 2024, the Company announced the receipt of Orphan Drug Designation from the FDA for CELZ-101, or ImmCelz™. This cutting-edge therapy is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation, a significant advancement for individuals dealing with brittle T1D, a condition characterized by extreme fluctuations in blood glucose levels. The Company plans to file an IND for a Phase I/II clinical trial in the future.In Q1 2024, the Company announced that it had secured FDA authorization for an expanded access therapy using CELZ-201, its pioneering cell-based program for the use in managing abnormal glucose tolerance and preventing T1D in high-risk individuals. An important advancement in the development of personalized medicine, the Company believes that this is the first time that FDA has authorized the use of proprietary cell-based biologics for disease prevention. The program received IRB approval and has initiated patient recruitment during the first six months of 2024. Chronic Lower Back Pain During 2023, the Company received IND clearance from the FDA on a Phase I/II clinical trial of AlloStemSpine™ to treat Chronic Lower Back Pain (CELZ-201 ADAPT) using AlloStem™ (CELZ-201-DDT). This is a minimally invasive outpatient procedure with direct injection of the cell-based therapy into the patient using targeted ultrasound guidance. During the first six months of 2024 the Company received IRB approval, selected and initiated the trial site, and initiated patient recruitment. Production of Human Insulin via iPSCelz™ Program In Q2 2024, the Company announced that it had successfully generated human induced pluripotent stem cells (“iPSC”)-derived Islet Cells that produce human insulin. The iPSC clinical line that generated these insulin producing Islet Cells is part of the Company’s iPSCelz™ program, which is validated by Greenstone Biosciences Inc. (“Greenstone”). The iPSC cell line has also been utilized to derive validated mesenchymal cells and T-regulatory cells. The Company believes that this development has the potential for not only clinical translation of the human Islet Cells, but also the stand-alone human insulin which is produced by these cells. The Company is currently in strategic discussions on “next step” collaborations to further these programs. Financial Position The Company expects to report cash of approximately $7.5 million and no long-term debt as-of June 30, 2024. The Company believes it has sufficient funds to meet its anticipated operating costs and capital expenditure requirements through at least Q2 2025. Annual Meeting of Stockholders The Company’s 2024 Annual Meeting of Stockholders is scheduled to take place on July 19, 2024. The Company’s Board of Directors encourages shareholders of record as of June 3, 2024 to participate and to vote FOR each of the four Proposals to be voted on at the Annual Meeting of Stockholders. The Company specifically encourages its stockholders to vote in favor of Proposal Two, which would authorize an increase in the number of authorized shares of our common stock from 5,000,000 to 25,000,000.As of June 3, 2024, the record date for the special meeting, the Company had an aggregate of 1,348,126 shares of Common Stock outstanding, outstanding warrants to purchase 2,284,932 shares of Common Stock, and approximately 60,000 shares of Common Stock reserved for issuance under outstanding stock options and the Company’s option plans. Accordingly, at present, the Company has only 1,306,939 authorized shares of its Common Stock available for issuance. Although at present the Company has no commitments or agreements to issue additional shares of Common Stock, it desires to have additional shares available to provide additional flexibility to use its capital stock for business and financial purposes in the future. These purposes may include, among others: raising capital; establishing strategic relationships with other companies; and the acquisition of other businesses or products. Mr. Warbington concluded, “We have remained focused on maintaining a strong financial position and respecting the investment of our shareholders by allocating our resources prudently, limiting our annual cash burn, and avoiding unnecessary dilution. We will continue to concentrate on pioneering and translating new approaches to treat disease. To that end, should the need arise to raise additional capital in pursuit of this objective, we will do so in a manner that aligns with our commitment to deliver long-term shareholder value. Our current capital structure limits our ability to do this, and we therefore appreciate the support of shareholders in voting FOR Proposal Two.” Eligible stockholders may vote by contacting the Company's proxy solicitor, Okapi Partners LLC, at 844-202-7428. Please refer to the official proxy materials for further details on each proposal, this can be found at https://www.sec.gov/Archives/edgar/data/1187953/000147793224003511/celz_pre14a.htm About Creative Medical Technology Holdings, Inc.Creative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel immediately deployable FDA registered biological therapeutics in the fields of immunotherapy, endocrinology, urology, gynecology, and orthopedics and is traded on NASDAQ under the ticker symbol CELZ. For further information about the Company, please visit www.creativemedicaltechnology.com. Special Note Regarding Forward Looking StatementsNASDAQ Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov. Company ContactCreative Medical TechnologyIR@CreativeMedicalTechnology.comInvestor RelationsDevin Sullivan, Managing Director The Equity Group Inc.dsullivan@equityny.com Conor Rodriguez, Analystcrodriguez@equityny.com

The US Federal Trade Commission (FTC) released a scathing interim report on Tuesday calling out the “significant power” that pharmacy benefit managers (PBMs) have over the access and affordability of prescription drugs in the US. While the agency detailed how the six top companies handle nearly all of the country’s prescriptions — and thus have an “outsized influence” on the healthcare industry — the report did not dig into how PBMs’ alleged anticompetitive practices could be counteracted. The report stems from an investigation launched in 2022 into the impact PBMs have on drug prices and accessibility. The FTC initially requested business practice records from CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics and MedImpact Healthcare Systems, and then widened the scope of its probe last year to include group purchasing organisations (GPOs) Zinc Health Services and Ascent Health Services, also known as rebate aggregators. In its investigation update on Tuesday, the FTC noted that several PBMs have yet to provide the requested information. If they continue to delay or fail to fully comply, the agency said it can take the companies to district court to compel compliance. The interim report, which focused moreso on PBMs’ relationship with pharmacies rather than with drugmakers, laid out “how dominant pharmacy benefit managers can hike the cost of drugs… [and] squeeze independent pharmacies that many Americans — especially those in rural communities — depend on for essential care,” FTC Chair Lina Khan said in a statement. She also affirmed the agency’s commitment to use all of its “tools and authorities to scrutinise dominant players across healthcare markets and ensure that Americans can access affordable healthcare.”  Vertical integrationDecades of consolidation and ‘vertical integration’ — the process by which PBMs, insurers, pharmacies, and providers have been rolled into massive healthcare conglomerates — have granted the largest PBMs “significant control over which drugs are available, at what price, and which pharmacies patients can use to access their prescribed medications.”The FTC cited hundreds of comments from independent pharmacists, patients, clinicians, and state pharmacist associations that suggested creating conglomerates can introduce financial conflicts of interest and enable business practices that disadvantage rivals and pump up drug costs.Specifically, combining a PBM, insurer and pharmacy into a singular entity incentivizes each group to promote their sister units over potential competitors, “potentially resulting in a lessening of competition at various levels of the pharmaceutical supply chain.”Small pharmacies disadvantaged Horizontal consolidation has also allowed just a few players to dominate the prescription drug space. According to the FTC, the top six PBMs processed more than 90% of the approximately 6.6 billion prescriptions dispensed last year. Thus, smaller pharmacies often have little choice but to contract with PBMs to reach patients, giving the latter “substantial influence over independent pharmacies by imposing unfair, arbitrary, and harmful contractual terms that can impact independent pharmacies’ ability to stay in business.”The report alleges that such actions to dampen competition can push smaller pharmacies out of the market, ultimately leading to lower quality healthcare services at a higher cost. “In an opaque industry with non-disclosure and confidentiality agreements that are actively asserted on pharmacies, the combination of consolidation and vertical integration may be enabling PBM-conglomerates to squeeze unaffiliated competitors,” the FTC wrote.Generics frozen outThe report also briefly touched on “several troubling rebating practices” that PBMs and brand-name drug manufacturers may engage in to “cut off access to generic and biosimilar competitors.”The FTC said it has gathered evidence suggesting that contracts between drugmakers and PBMs may be designed to exclude lower-cost generics drugs from formularies in exchange for increased drug rebates. In addition to eliminating a patient’s ability to access lower-cost medicines, so-called “exclusionary rebates” could “deter and chill less expensive generic competitor drugs from entering the market at all.”Such rebating practices “urgently warrant further scrutiny and potential regulation,” the agency concluded.

FOCINVEZ (fosaprepitant) 150 mg/50 mL single dose vial is an anti-nausea agent for highly emetogenic and moderately emetogenic chemotherapy (HEC and MEC) Second injectable RTU product launched by Amneal in 2024 BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the launch of FOCINVEZ™, a ready-to-use injectable. Unlike other versions of fosaprepitant, this single-dose vial product is free of Polysorbate 80 and does not require reconstitution or dilution and can be administered directly from the vial using the included vial hanger. FOCINVEZ for injection is indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). “We continue to launch differentiated complex products that are clinically impactful,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “This is the second ready-to-use injectable we have launched this year that offers hospitals and oncology clinics a new presentation format that can improve pharmacy efficiency. These new 505(b)(2) injectables represent a new vector of growth for our expanding injectables portfolio.” FOCINVEZ has a unique J-Code from the Centers for Medicare & Medicaid Services (CMS) to facilitate reimbursement: J1434, Injection, fosaprepitant (focinvez), 1 mg, and is available in one vial size 150mg/50mL (3mg/mL). Adverse effects reported with FOCINVEZ include fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in extremity. For full prescribing information, see package insert located here. According to IQVIA®, U.S. annual sales for fosaprepitant for the 12 months ended April 2024 were approximately $36 million. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.