Bayer Says Failed NAVIGATE Trial Won’t Affect Xarelto Sales Projections
- Last Updated: August 4th, 2023
Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.
Legally Reviewed
This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.
Fact-Checked
TruLaw does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.
Bayer Says Failed NAVIGATE Trial Won’t Affect Xarelto Sales Projections
Bayer and J&J subsidiary Janssen Pharmaceuticals decided to end the phase 3 NAVIGATE ESUS study of Xarelto after they got some bad news – the anticoagulant was no more effective than aspirin in preventing stroke and systemic embolism, and came with a much higher risk of uncontrollable bleeding.
The disappointing results came at a decidedly bad time for Bayer.
Last year, Bayer was flying high on $3.4 billion annual sales of Xarelto, and told analysts to expect the drug’s sales to peak at more than $5.3 billion a year.
But when the trial was stopped for lack of efficacy, Bayer was quick to promise that the setback would not affect its sales forecasts for Xarelto.
To compound matters, Bayer has been trying to play financial catch up with rival Bristol-Myers Squibb (BMS), whose novel oral anticoagulant Eliquis currently holds a commanding lead in sales over Xarelto.
Despite the fact that sales of Xarelto were up 18.6 percent in the second quarter of 2017 over Q2 of 2016, the sales of Eliquis increased 51 percent to nearly $1.2 billion, and Bayer could be in danger of failing to reach peak sales forecasts of $5 billion.
Another blockbuster blood thinner, Pradaxa, is holding firmly in third place with $1.5 in sales last year.
The bleeding risk connected with Xarelto is well documented, and Bayer and J&J are facing more than 18,000 lawsuits over bleeding injuries in state and federal courts.
Portola is working on AndexXa, a bleeding-reversal agent for Xarelto, but the process stalled last year when the company received a letter from the U.S. Food and Drug Administration citing manufacturing problems and other issues.
To address the FDA’s concerns, Portola took out $50 million in loans from partners BMS and Pfizer, and in August, Portola announced that the FDA had accepted its resubmitted application for approval.
A decision is expected by February 2018.
Table of Contents
Experienced Attorney & Legal SaaS CEO
With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three. She spent the first decade of her career working as an international tax attorney at Deloitte.
In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.
In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!
Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
Would you like our help?
At TruLaw, we fiercely combat corporations that endanger individuals’ well-being. If you’ve suffered injuries and believe these well-funded entities should be held accountable, we’re here for you.
With TruLaw, you gain access to successful and seasoned lawyers who maximize your chances of success. Our lawyers invest in you—they do not receive a dime until your lawsuit reaches a successful resolution!
Do you believe you’re entitled to compensation?
Use our Instant Case Evaluator to find out in as little as 60 seconds!
AFFF Lawsuit claims are being filed against manufacturers of aqueous film-forming foam (AFFF), commonly used in firefighting.
Claims allege that companies such as 3M, DuPont, and Tyco Fire Products failed to adequately warn users about the potential dangers of AFFF exposure — including increased risks of various cancers and diseases.
Suboxone Tooth Decay Lawsuit claims are being filed against Indivior, the manufacturer of Suboxone, a medication used to treat opioid addiction.
Claims allege that Indivior failed to adequately warn users about the potential dangers of severe tooth decay and dental injuries associated with Suboxone’s sublingual film version.
Social Media Harm Lawsuits are being filed against social media companies for allegedly causing mental health issues in children and teens.
Claims allege that companies like Meta, Google, ByteDance, and Snap designed addictive platforms that led to anxiety, depression, and other mental health issues without adequately warning users or parents.
Transvaginal Mesh Lawsuits are being filed against manufacturers of transvaginal mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Claims allege that companies like Ethicon, C.R. Bard, and Boston Scientific failed to adequately warn about potential dangers — including erosion, pain, and infection.
Bair Hugger Warming Blanket Lawsuits involve claims against 3M — alleging their surgical warming blankets caused severe infections and complications (particularly in hip and knee replacement surgeries).
Plaintiffs claim 3M failed to warn about potential risks — despite knowing about increased risk of deep joint infections since 2011.
Baby Formula NEC Lawsuit claims are being filed against manufacturers of cow’s milk-based baby formula products.
Claims allege that companies like Abbott Laboratories (Similac) and Mead Johnson & Company (Enfamil) failed to warn about the increased risk of necrotizing enterocolitis (NEC) in premature infants.
Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
Would you like our help?
