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Xeris Biopharma Announces Notice of Allowance From U.S. Patent and Trademark Office for New Patent Covering KEVEYIS®

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Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that today the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance with respect to U.S. Patent Application No. 17/151,405, entitled “Compositions and Methods of Use.” The allowed claims in this application cover the use of the company’s KEVEYIS® (dichlorphenamide) product. The Notice of Allowance indicates that the USPTO has determined that the application meets the requirements for patentability and is expected to issue as a U.S. patent following the completion of standard administrative steps. Following this issuance, the Company will submit the patent to the U.S. Food and Drug Administration (FDA) for listing in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the Orange Book. Assuming that all necessary actions are taken and all maintenance fees are paid, this new patent will provide intellectual property protection for KEVEYIS through 2039.

“KEVEYIS is the first FDA-approved therapy for primary periodic paralysis, a rare and debilitating condition, and this Notice of Allowance reflects our long-standing commitment to this highly underserved patient community who depend on it,” said John Shannon, CEO of Xeris. “What we do matters. We fight for patients every day, and protecting and strengthening the intellectual property around KEVEYIS ensures we can continue to deliver this important therapy and comprehensive support for the primary periodic paralysis community for years to come.”

KEVEYIS® (dichlorphenamide) is an FDA-approved treatment for primary periodic paralysis (PPP). KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. PPP is a rare genetic condition that affects muscles and causes episodes of muscle weakness and/or temporary paralysis that can be progressive and debilitating. KEVEYIS has been shown to reduce the number, severity, and duration of PPP attacks. For full prescribing information, including Important Safety Information, please visit www.keveyis.com.

Important Safety Information

  • Contraindications

    • Hypersensitivity to dichlorphenamide or other sulfonamides

    • Concomitant use of KEVEYIS and high-dose aspirin

    • Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS

    • Hepatic insufficiency: KEVEYIS may aggravate hepatic encephalopathy

  • Warnings and Precautions

    • Hypersensitivity/Anaphylaxis/Idiosyncratic Reactions

      • Fatalities associated with the administration of sulfonamides have occurred due to adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias.

      • Pulmonary involvement can occur in isolation or as part of a systemic reaction.

      • Discontinue KEVEYIS at the first appearance of skin rash or any sign of immune-mediated or other life-threatening adverse reaction.

  • Concomitant Use of Aspirin or Other Salicylates

    • Carbonic anhydrous inhibitors, including KEVEYIS, can cause metabolic acidosis, which can increase the risk of salicylate toxicity.

    • Anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin.

    • Concomitant use of KEVEYIS and high-dose aspirin is contraindicated. Use with caution and carefully monitor in patients receiving low-dose aspirin.

  • Hypokalemia

    • KEVEYIS increases potassium excretion and can cause hypokalemia.

    • The risk of hypokalemia is greater when KEVEYIS is used in patients with conditions associated with hypokalemia (e.g., adrenocortical excess, renal tubular acidosis type 1 and 2), and in patients receiving other drugs that may cause hypokalemia (e.g., loop diuretics, thiazide diuretics, laxatives, antifungals, penicillin, and theophylline).

    • Baseline and periodic measurements of serum potassium are recommended.

    • If hypokalemia develops or persists, consider reducing the dose or discontinuing KEVEYIS and correction of potassium levels.

  • Metabolic Acidosis

    • KEVEYIS can cause hyperchloremic non-anion gap metabolic acidosis.

    • Concomitant use of KEVEYIS with other drugs that cause metabolic acidosis may increase the severity of acidosis.

    • Concomitant use of KEVEYIS in compensated patients with respiratory acidosis, such as in advanced lung diseases, may lead to respiratory decompensation.

    • Baseline and periodic measurements of serum bicarbonate during KEVEYIS treatment are recommended.

    • If metabolic acidosis develops or persists, consider reducing the dose or discontinuing KEVEYIS.

  • Falls

    • KEVEYIS increases the risk of falls; risk is greater in the elderly and with higher doses.

    • Consider dose reduction or discontinuation of KEVEYIS in patients who experience falls while treated with KEVEYIS.

  • Pregnancy and Lactation

    • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known in humans whether dichlorphenamide is excreted in human milk; exercise caution when administered to a nursing woman.

  • Adverse Reactions

    • The most common adverse reactions seen in clinical trials (incidence ≥ 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state.

  • Please see Full Prescribing Information.

About Xeris

Xeris (Nasdaq: XERS) is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: RECORLEV®, for the treatment of endogenous Cushing’s syndrome; GVOKE®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; and KEVEYIS®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners.

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram.

Forward-Looking Statements

Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans, opportunities, and prospects for Xeris Biopharma Holdings, Inc., including statements regarding, the expected grant and scope of the U.S. patent for Keveyis, the company’s intention to submit the patent for listing in the FDA’s Orange Book, the term of intellectual property protection for Keveyis, the company’s intention to protect and strengthen its intellectual property rights relating to KEVEYIS®, commitment to protecting the long-term value of its assets, the growth potential of its drug products, including KEVEYIS®, the market and therapeutic potential of its products and product candidates, and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its collaborators’ ability to protect its intellectual property and proprietary technology, and general macroeconomic and geopolitical conditions, including the possibility of an economic downturn, changes in governmental priorities and resources, announced or implemented tariffs, and market volatility. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Annual Report on Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to management, as of the date of this communication and, while the Company believes its assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, the Company does not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.

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