Horizon therapeutics winter hat11/14/2023 ![]() ![]() However, while the drug was initially expected to be a niche treatment, concerns have emerged that the medication was more widely marketed without fully disclosing all potential side effects to users and the medical community. The FDA allowed Horizon to submit Tepezza through a fast-track Orphan Drug approval process, which allowed the drug maker to introduce the injection without extensive testing, since it targeted a condition which has no other treatment available. Commonly referred to as bulging eye disease, this condition can cause blurred or double vision. Tepezza (teprotumumab-trbw) is a biologic treatment approved by the FDA in January 2020, as the first drug approved to treat thyroid eye disease, which is caused by hyperthyroidism and linked to Graves’ disease, causing inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye. Horizon’s leading drug product is Tepezza, which brought in $1.66 billion in sales in 2021. Both lawsuits seek to have the court prevent the sale of Horizon unless the undisclosed financial projections are released to Horizon’s stockholders, or, if the sale is completed, to allow investors to recover damages due to stock value loss because of the deal’s alleged violations of the Securities Exchange Act. “Absent disclosure of the foregoing material information prior to the special stockholder meeting to vote on the Proposed Transaction, Plaintiff will be unable to make a fully-informed decision regarding whether to vote in favor of the Proposed Transaction, and she is thus threatened with irreparable harm, warranting the injunctive relief sought herein,” the lawsuit states.Ī similar complaint (PDF) was filed a day later in the same court by Ryan O’Dell, another shareholder. However, it did not provide that information to shareholders. ![]() The Horizon lawsuit claims the December 30 proxy statement to shareholders is misleading because the company has provided certain non-public financial forecasts to its board and Morgan Stanley, which conducted an analysis of the company’s financial projections. ![]() However, investor Shiva Stein says the statement and proposed acquisition are based on materially incomplete and misleading representations of the state of the company. District Court for the Southern District of New York, alleging that the proposed deal violates the Securities Exchange Act.Īccording to the lawsuit, Horizon sent out a proxy statement on December 30, encouraging company stockholders to vote in favor of the deal. On January 4, a Horizon Therapeutics investor filed a complaint (PDF) against the company and its financial officers in the U.S. However, the deal has immediately raised concerns for investors on both sides, as Horizon Therapeutics faces claims that it withheld information from consumers and the medical community about the risk of irreversible hearing loss from Tepezza. On December12, Amgen agreed to pay $116.50 per share in cash to buy Horizon Therapeutics, amid mounting concerns over a growing number of Tepezza lawsuits filed by former users left with permanent hearing loss, which threatens the top selling drug, which accounts for about half of Horizon’s total sales.Īmgen officials have indicated they are buying Horizon Therapeutics in order to increase its rare disease drug portfolio, of which Tepezza figures to be the prime target of the acquisition. Following an announcement last month that the pharmaceutical giant Amgen plans to buy the biopharmaceutical company Horizon Therapeutics, which sells the blockbuster thyroid eye disease drug Tepezza, a number of investors are filing lawsuits to stop the acquisition from happening.
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