Osmotica Pharmaceuticals plc Announces Agreement to Settle Patent Litigation with Adamas
Adamas to acquire global rights to OSMOLEX ER® for $7.5 million
Company to focus on maximizing commercial opportunity for Upneeq™
BRIDGEWATER, N.J., Dec. 02, 2020 (GLOBE NEWSWIRE) — Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, announced today that its subsidiary Osmotica Pharmaceutical US LLC has entered into an agreement to settle its ongoing patent litigation with Adamas Pharmaceuticals, Inc. related to OSMOLEX ER. Under the terms of the agreement, both parties will drop their respective claims relating to the patent litigation, and Adamas will acquire the global rights to OSMOLEX ER for $7.5 million. The agreement is expected to close in early 2021.
OSMOLEX ER (amantadine) extended release tablets is approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients. As part of the settlement and acquisition, the parties will enter into a supply agreement pursuant to which Osmotica will remain the sole manufacturer of OSMOLEX ER. Adamas will receive existing inventory and all rights to OSMOLEX ER. The parties are committed to working together to ensure uninterrupted product supply to patients.
“This transaction aligns with our previously stated intention of considering strategic alternatives, including the divestiture of non-core assets, so that we can focus resources on growing Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% and supporting our investigational drug arbaclofen extended-release tablets should it receive approval on its PDUFA goal date later this month. We will continue to take advantage of opportunities to monetize assets and free up resources with the goal of realizing the full potential of these two assets,” stated Brian Markison, Chief Executive Officer.
About OSMOLEX ER®
OSMOLEX ER® (amantadine) extended release tablets is FDA approved for the treatment of Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients.
For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com.
About Upneeq
Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1% is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist, which when administered to the eye, is believed to selectively target Müller muscle and elevate the upper eyelid. Upneeq is the first and only FDA-approved pharmacologic treatment indicated for the treatment of acquired blepharoptosis (ptosis, or droopy eyelid) in adults.
For more information about UPNEEQ, including the full Prescribing Information, please visit www.UPNEEQ.com.
Forward Looking Statements
This press release includes statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” The Company’s actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms “believes,” “expects,” “may,” “will,” “should,” “seeks,” “projects,” “approximately,” “intends,” “plans,” “estimates” or “anticipates,” or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, our review of strategic alternatives and efforts to maximize shareholder value, results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our business may be adversely affected by the ongoing coronavirus outbreak; our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2020, June 30, 2020 and September 30, 2020 and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.
About Osmotica Pharmaceuticals plc
Osmotica Pharmaceuticals plc (Nasdaq: OSMT) is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. The company has a diverse portfolio consisting of promoted and non-promoted products, several of which incorporate Osmotica’s proprietary Osmodex® drug delivery system. RVL Pharmaceuticals, Inc. is the Company’s ophthalmic subsidiary supporting Upneeq. Vertical Pharmaceuticals, LLC represents the Company’s diversified branded portfolio and Trigen Laboratories, LLC represents the Company’s non-promoted products, including complex generic formulations. Osmotica has operations in the United States, Argentina, and Hungary.
Investor and Media Relations for Osmotica Pharmaceuticals plc
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
