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AstraZeneca Faces Lawsuit from Puma Biotech over Alleged Patent Infringement; Acquires Fusion Pharmaceuticals; Caps Inhaler Costs; Fusion Pharmaceuticals Downgraded by Morgan Stanley; Boehringer to Lay Off Salespeople as Humira Biosimilar Sales Lag; AstraZeneca to Withdraw Covid Vaccine; Pfizer Sued in Kansas over COVID-19 Vaccine

2024-06-18 18:59:40.726000

AstraZeneca, the pharmaceutical giant, is facing a lawsuit from Puma Biotechnology over alleged patent infringement. The dispute revolves around Puma Biotech's claim that AstraZeneca's cancer drug, Tagrisso®, infringes on two patents held by Puma Biotech. The court has denied AstraZeneca's motions to prove the patents invalid and for summary judgment of non-infringement. However, the court ruled in AstraZeneca's favor regarding pre-issuance damages. Despite being dismissed as a plaintiff due to lack of constitutional standing, Puma Biotech still retains its contractual rights to seek monetary damages. The case is set to proceed to a jury trial scheduled for May 13, 2024. [84309098]

In addition to the lawsuit, AstraZeneca has recently made headlines for its acquisition of Fusion Pharmaceuticals, a Canadian company specializing in innovative cancer treatments. The deal, valued at £1.9 billion, will enable AstraZeneca to expand its portfolio of next-generation therapies. Fusion Pharmaceuticals is known for its groundbreaking drug for prostate cancer, which utilizes "next-generation radioconjugates" to target cancer cells more accurately than traditional treatments like chemotherapy and radiotherapy. AstraZeneca sees this acquisition as a significant step forward in its mission to revolutionize cancer treatment. The agreement includes an upfront payment of £1.6 billion, with an additional £315 million contingent upon meeting certain conditions. This strategic move aligns with AstraZeneca's commitment to advancing healthcare and improving patient outcomes. [e8062129]

Furthermore, AstraZeneca has announced that it will cap out-of-pocket costs for inhalers and related medication at $35 per month, starting June 1. This initiative aims to assist vulnerable patients with asthma or chronic obstructive pulmonary disease (COPD), particularly those without health insurance. The decision comes in response to a request from the Senate Committee on Health, Education, Labor and Pensions to lower prices for inhalers. AstraZeneca's CEO, Pascal Soriot, stated that the expanded savings programs are designed to address barriers to access and affordability for patients with respiratory diseases. This cost-reduction strategy follows a similar move by Boehringer Ingelheim, a rival in the medical device sector. While AstraZeneca's initiative has been applauded by Senator Bernie Sanders, GlaxoSmithKline and Teva have not agreed to a price cap. The Asthma and Allergy Foundation of America has welcomed the efforts to make asthma drugs more affordable and has called on all stakeholders in the healthcare industry to reduce costs. [ef416291]

Morgan Stanley, a prominent financial institution, has downgraded Fusion Pharmaceuticals from Overweight to Equalweight. However, they have raised the price target for Fusion Pharmaceuticals to $21 from $10. This adjustment comes as Fusion Pharmaceuticals is set to be acquired by AstraZeneca for $21 per share at closing, with a contingent value right (CVR) that could bring the total contingent value to a maximum of $2.4 billion. The market has responded to this news, with Fusion's stock price adjusting to match the acquisition price. Morgan Stanley's revised price target of $21 aligns with the acquisition price, indicating limited upside beyond the agreed terms. [edd19c49]

Boehringer Ingelheim plans to lay off some of its salesforce due to poor U.S. sales of its biosimilar version of AbbVie's arthritis treatment Humira. The German drugmaker will reduce its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30. The decision is largely due to pharmacy benefit managers (PBMs) keeping branded Humira on their reimbursement lists, resulting in less uptake of biosimilar versions. Boehringer did not provide details on the number of layoffs. AbbVie has held onto over 98% of the Humira market despite the launch of nine biosimilars in the U.S. last year. Boehringer's biosimilar, Cyltezo, has only sold 1,487 prescriptions since its launch in July 2023, compared to almost 2.8 million Humira prescriptions during the same period. The layoff decision comes as Humira's annual sales have been surpassed by Merck & Co's cancer drug Keytruda. Boehringer priced its branded and unbranded versions of the drug at a 5% and 81% discount to Humira's 2023 list price of $6,922 per month. Boehringer's Humira biosimilar was the first to be designated interchangeable by the U.S. FDA. UnitedHealth Group's Optum Rx and Cigna's Express Scripts included Cyltezo on their insurance reimbursement lists last year alongside Humira and other biosimilars. [b1c469d8]

AstraZeneca has announced its decision to withdraw its Covid vaccine. The company made this decision after facing criticism and concerns over rare cases of blood clots linked to the vaccine. The European Medicines Agency (EMA) conducted a review of the vaccine and concluded that the benefits of the vaccine outweigh the risks. However, several countries have suspended the use of the AstraZeneca vaccine as a precautionary measure. AstraZeneca has stated that it will continue to work with regulatory authorities to address any concerns and provide necessary information. The company's decision to withdraw the vaccine will impact the global vaccination efforts and may lead to delays in vaccine distribution. AstraZeneca's vaccine has been a key component of many countries' vaccination strategies, and its withdrawal will create challenges in meeting vaccination targets. The company has emphasized that it remains committed to global vaccine supply and will continue to work on improving the safety profile of its vaccine. [e3717f94]

Pfizer, another pharmaceutical company, is facing a lawsuit in Kansas over its COVID-19 vaccine. The state of Kansas has filed a lawsuit against Pfizer, alleging that the company misled the public about the effectiveness of its COVID-19 vaccine. The lawsuit claims that Pfizer violated the Kansas Consumer Protection Act by making false statements about the vaccine's effectiveness, including its ability to protect against mutated forms of the virus and prevent illness and transmission. Kansas is seeking unspecified monetary damages. This lawsuit follows a similar one filed by Texas Attorney General Ken Paxton against Pfizer over its marketing practices for the COVID-19 vaccine. [20d54877]

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