Poisoning

BERKELEY, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- HOPO Therapeutics, Inc. announced today that it has been awarded a contract valued at up to $226 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. The funds will be used to advance development of the drug candidate HOPO-101 through registrational studies as a medical countermeasure against radiological threats, including planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The initial award of approximately $9.4 million will fund toxicology and pharmacology studies, manufacturing activities, and nonclinical research in other types of heavy metal poisoning, with approximately $216 million in additional funding available for later-stage development upon agreement between BARDA and HOPO. The ongoing Phase 1 clinical study of HOPO-101 (NCT05628961), as well as earlier nonclinical work, has been funded by the National Institute of Allergy and Infectious Diseases. There are no approved oral therapies to treat individuals exposed to radioactive heavy metals like plutonium, americium, and curium. In the event of a radiological or nuclear disaster, treatment with a decorporation agent – a drug designed to bind and accelerate the clearance of heavy metals from the body – is the only practical means to mitigate the risk of radiation poisoning. HOPO Therapeutics is developing decorporation agents that can be taken orally, with the aim of providing rapid access to treatment for an exposed population. This BARDA funding will also be used to study HOPO-101 as a possible treatment for lead poisoning. As recently highlighted by several leading global health organizations including the U.S. Agency for International Development (USAID), lead poisoning kills an estimated 1.5 million people each year, more than malaria and HIV combined. Most of these deaths, and the over 800 million children currently suffering from lead poisoning, are in low- and middle-income communities. “We are thrilled to partner with BARDA on the development of a new oral decorporation agent for radiological threat preparedness,” said Dr. Julian Rees, HOPO’s Chief Executive Officer and co-founder. “We believe that HOPO-101 can fill an important gap in the world’s ability to respond to a nuclear or radiological disaster, a scenario made ever more likely by ongoing conflicts around the world, and that it could also help to address one of the most significant unmet needs in global health. Nonclinical studies indicate that HOPO-101 would be a substantial improvement over the existing standard of care, and we are delighted to have BARDA’s support in exploring its dual-use capability as both a medical countermeasure and a potential treatment for lead poisoning in adults and children.” Funding for this award was received under contract through BARDA’s Broad Agency Announcement. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50124C00062. About HOPO Therapeutics HOPO Therapeutics is a privately-held, clinical-stage pharmaceutical company developing treatments for heavy metal poisoning and pioneering novel methods for directed radioisotope delivery. Leveraging world-class expertise in the chemistry and biochemistry of heavy metals and technology licensed from Lawrence Berkeley National Laboratory, HOPO’s mission is to safeguard all people throughout the world from the harmful effects of heavy metal contamination while utilizing the power of metals in medicine to cure disease and improve lives. For more information, please visit www.hopotx.com.

HOPO Therapeutics scored a government contract for up to $226 million to develop an oral countermeasure against radiological threats and heavy metal poisoning. The funding from the Biomedical Advanced Research and Development Authority (BARDA) will go toward investigating HOPO-101 in registrational studies, including a planned submission to the FDA, as a treatment for radiological threats as well as studies in other heavy metals like lead. According to the company, HOPO-101 would be the first oral treatment for people exposed to radioactive heavy metals like plutonium, americium and curium. In the event of a radiological or nuclear disaster, the company said treatment with a drug like HOPO-101 is the only “practical means to mitigate the risk of radiation poisoning.” The drug works as a chelating agent; it binds to heavy metals and then can be excreted by the body. The current standard of care for radioactive poisoning is a slow IV infusion treatment. “The job of the chelating agent is really to vastly accelerate how quickly the body will clear these heavy metals,” HOPO CEO and co-founder Julian Rees said in an interview. In a disaster scenario, the standard of care is “extremely burdensome,” he noted. While HOPO-101 is already in a Phase 1 trial in healthy volunteers that is separately funded by the National Institute of Allergy and Infectious Diseases, BARDA’s funding is expected to get the drug through early-stage and pivotal studies in heavy metal poisoning. The pivotal studies will be done in animal models instead of humans, though HOPO will also go through the pharmacology and safety studies in healthy volunteers. The initial award is $9.4 million. “The specific targets of what we will look at and what we believe we can address — this is something that that initial tranche of funding is designed to help us tackle — is to really understand what is the full scope of capability of this product, particularly on the non-radioactive side,” Rees told Endpoints News . That will include investigating whether the pill could also work in poisonings with lead, mercury, cadmium and arsenic, all of which are heavy metals that are already in the environment. “Many of them don’t have good treatments, so that’s part of what that initial award is designed to address,” Rees added.

— Third Quarter Revenues of $378.1 Million — — Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year — — GAAP Net Income from Continuing Operations of $92.8 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.56 — — Company Reiterates 2024 Financial Expectations — DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2024. "Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value. We plan to manage the business to deliver significant profitability and cash flow while investing in these strategic initiatives," said Richard Pops, Chief Executive Officer of Alkermes. "2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2, and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development and we believe a significant opportunity for Alkermes and our shareholders." Key Financial Highlights *As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the nine months ended September 30, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods. Revenue Highlights LYBALVI Revenues for the quarter were $74.7 million. Revenues and total prescriptions for the quarter grew 47% and 37%, respectively, compared to the third quarter of 2023. ARISTADAi Revenues for the quarter were $84.7 million. VIVITROL Revenues for the quarter were $113.7 million. Revenues for the quarter grew 14% compared to the third quarter of 2023, driven by the alcohol dependence indication. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $58.4 million. VUMERITY® manufacturing and royalty revenues for the quarter were $32.6 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At Sept. 30, 2024, the company recorded cash, cash equivalents and total investments of $927.8 million, compared to $962.5 million at June 30, 2024. The company's total debt outstanding as of Sept. 30, 2024 was $288.8 million. Share Repurchase Program During the third quarter of 2024, the company repurchased approximately 4.4 million of the company's ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $115.6 million. As of Sept. 30, 2024, the company had $200 million (exclusive of any fees, commissions or other related expenses) remaining under the program. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), and discussed the study design for its ongoing phase 2 studies in NT1 and NT2. The company also announced its plans to initiate a phase 2 study in patients with IH in 2025. In September 2024, the company presented positive clinical data from its phase 1b study of ALKS 2680 in patients with NT2 and IH at the European Sleep Research Society's 27th Congress, Sleep Europe 2024. In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with NT2. In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes' website. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, Oct. 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including drivers of shareholder value and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations, including those related to profitability; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. 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