Big Pharmas Are Developing New Treatments To Prevent Blood Clots For A $55 Billion Prize
Bristol, J&J, Bayer, and other big pharmas are developing new treatments to prevent blood clots to lessen the possibility of unintentional bleeding.
According to estimates, blood clots account for around 1 in 4 fatalities globally, and the most popular medications for treating them are the main blood thinners. The medications are referred to as Factor Xa inhibitors for the enzyme they block in the body's normal clotting process and are sold under the trade names Eliquis and Xarelto.
However, occasionally, turning off Factor Xa can have unforeseen repercussions, such as internal bleeding that poses a life-threatening risk or easy bruising, which restricts who can take the medications. Now, pharmaceutical companies are developing substitutes that significantly lower those dangers by acting on a different enzyme.
According to Andrew Baum, an analyst at Citigroup Inc., if the new treatments are found to be safe and effective, they will enable pharmaceutical companies to target the roughly eight applications where Eliquis and Xarelto are ineffective, including, critically, preventing strokes in people who have already experienced one.
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Any of them won't be accessible for a few more years: Three of the controversial experimental medications are currently undergoing late-stage testing. They come from Bayer, Bristol-Myers Squibb and its collaborator Johnson & Johnson, and Novartis spinoff Anthos Therapeutics.
And none would see significant sales until after Eliquis and Xarelto lose their patent protection in 2028, according to Baum. Long-term potential, however, is enormous. By roughly 2035, he predicts that the new medications might reach a $55 billion market.
Eliquis and Xarelto are significant moneymakers even with a limited number of usage cases: For Bristol-Myers Squibb Co., Eliquis generated about $11 billion in sales last year, while Xarelto sales from J&J and Bayer AG totaled more than $8 billion.
Atrial fibrillation, which causes an erratic heartbeat that can cause clots and is thought to impact 37 million people worldwide, is one of the disorders they can treat. Leslie Lake, co-founder and managing director of New York City-based Invus Financial Advisors, and president of the National Blood Clot Alliance, a nonprofit advocacy group, agree that if the drugs function as well as the available treatments without the risk of bleeding.
That would be a game changer. That’s a really, really big deal.- Leslie Lake
Clots block oxygen-rich blood from reaching vital organs by acting like a dam in a blood artery. The so-called coagulation cascade, which the body uses to stop blood from gushing out when you scrape your arm or cut yourself while shaving, is what gives rise to them.
Blood thinners have been the subject of research by scientists for more than a century; early successes included the development of the still-in-use medications heparin and warfarin.
The most focused methods created to date are factor Xa inhibitors, which were approved roughly ten years ago. Blocking the Factor Xa enzyme, however, is dangerous because doing so opens a spigot and raises the likelihood that the flow might not stop.
Doctors consider a patient's potential benefit from the blood thinner in comparison to the potential risk that the side effects could pose before administering Eliquis or Xarelto. According to University of Tennessee Health Science Center cardiologist John Jefferies, a lumberjack or a sushi chef with atrial fibrillation wouldn't be a good option because one mistake at work could cause them to bleed out.
Anything you can do to put someone on a blood-thinning medication without the risk of bleeding is huge.- Dr. John Jefferies
The discovery of Factor XIa as a different blood-clotting enzyme to target has been made possible through genetics. Even if they bleed a little bit more than usual, those without the enzyme do not bleed as much as people with other types of hemophilia.
Researchers found that these persons had a lower risk of stroke, which gave pharmaceutical companies the confidence to try to duplicate the phenomena. It has taken decades for the drugs to reach their final stages of development.
Bristol began its initial research in 1999, and it took 10 years to perfect the chemistry to produce a powerful tablet. Bristol and J&J are now testing the milvexian chemical on people. Results from a few midstage trials were presented by the firms over the previous year.
In April, Bayer raised excitement when a study of their own Factor XIa-targeting chemical, asundexian, revealed that it caused 67% less bleeding than Eliquis.
Most recently, data from research evaluating if milvexian could help people who had previously experienced a stroke avoid having another one was shared by Bristol and J&J.
Executives noted a 30% reduction in stroke risk without a concerning danger of bleeding, which provided the businesses enough confidence to send milvexian to the last phase of tests despite the trial's failure to achieve its primary objective.
Asundexian from Bayer also fell short of its main goal, but the company indicated it will continue nevertheless. Patients are now being enrolled in late-stage trials for the monoclonal antibody abelacimab from Anthos Therapeutics Inc. since May.
Geoffrey Barnes, a heart and blood artery specialist at the University of Michigan, notes that it's significant that the results show the new medications are living up to their promise of being safer than the current treatments.
But I do think we all need to tamper down some of the enthusiasm in case they’re not able to be quite as efficacious as hoped, and we won’t know that until we conduct large Phase III studies.- Geoffrey Barnes, a consultant for Bristol, J&J, and Pfizer Inc.
According to Lake, 58, who has been on Xarelto since physicians discovered several blood clots in her lungs in 2018, patients are pulling for all the medications in the pipeline. Her doctors advised her to give up pastimes like riding horses and cycling across Manhattan due to the possibility of unintentional bleeding. She asserts that "This could change the way people live their lives."
The impending loss of Eliquis' exclusivity is a significant factor, according to Bristol CEO Giovanni Caforio, but the company's need for a safer blood-clot medication has always been urgent, “The sense of urgency has always been there to develop milvexian rapidly because we know that there are patients that are waiting.”
In light of big pharmas are developing new treatments to prevent blood clots, the final tests that the corporations must do to demonstrate that the medications are effective won't be finished for years. It will be a huge task to monitor and recruit thousands of people all around the world.