Signaling at the Astrazeneca facilities in Gaithersburg, Maryland, USA, on Monday, August 26, 2024.
Graeme Sloan | Bloomberg | Getty images
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The career to develop more convenient versions of drugs than lower cholesterol is warming up later Astrazeneca Released by encouraging new data on an experimental pill.
Astrazeneca and Merck They are the main drug manufacturers that test the oral versions of the so -called PCSK9 inhibitors, which reduce low density lipoprotein cholesterol (LDL), or what is known as “bad” cholesterol. Those medications, such as Amgen's repatha, are usually injections.
The high LDL cholesterol is the main conductor of cardiovascular events, such as heart attacks and blows. Even so, more than 70% of patients who take statins are not reaching the objective level for cholesterol, according to Mina Makar, who directs the global cardiovascular, renal and metabolism business of Astrazeneca.
He said that leads to 4 million to 5 million deaths worldwide due to high cholesterol. While PCSK9 injections have helped treatment to reach more patients, their use has still been “very limited,” Makar said. That is due to several factors, such as challenges related to cost and access and hesitation between some cardiologists and primary care doctors.
“That's why we are really excited about our oral PCSK9,” Makar said. “I think you have the opportunity to really democratize access to what these patients really need, which is something to obtain most of them” at their target cholesterol levels.
In a note last week, Goldman Sachs analysts said oral treatments could boost the growth of the PCSK9 class to around $ 12 billion in sales in 2034, compared to approximately $ 4 billion today. Analysts expect the oral PCSK9 of Astrazeneca to be “well located in the class”, and forecast the maximum sales of the medicine to be around $ 4 billion by 2037.
Now, we are going to immerse ourselves in the new mid -stage test data. It was presented at the annual scientific session of the American College of Cardiology in Chicago.
After 12 weeks, the experimental pill reduced LDL cholesterol in almost 51% when it is taken once a day in addition to a standard statin therapy, according to Astrazeneca. The pill helped 84% of patients meet the recommended cholesterol level, compared to only 13% of those who took statins alone.
The patients in the essay tolerated the pill well, and the adverse side effects were comparable between those who took the drug of Astrazeneca and the people who received a placebo.
These results are promising against Merck's treatment, although it is difficult to compare data without direct clinical trials. Merck's Oral PCSK9 is also much more advanced in development, with test data at a late stage expected this year.
Early data also suggest that Merck's medicine could be more effective than Astrazeneca's treatment, according to Goldman Sachs analysts. But they still see a “significant opportunity” for the Astrazeneca pill given the size of the market for PCSK9 and the “potential for differentiation in convenience.”
Merck's medicine is what is known as a macrocyclic peptide, which requires patients to accelerate before taking it adequate absorption. That “it could be heavy and exacerbate compliance problems in an asymptomatic disease area where there is reluctance to intensify therapy,” Goldman Sachs analysts wrote.
But Astrazeneca's pill is a small molecule drug, so it has no food restrictions or fasting requirements.
Makar said that another advantage of having a small molecule medication is that it is easy to combine with other therapies in the company's pipe. For example, Astrazeneca is considering combining it with its statin, its GLP-1 drug for weight loss or its treatment with Ezetimibe, which is a cholesterol medication for patients who cannot tolerate statins, he said.
Merck has similarly discussed the potential to combine its oral PCSK9 with other treatments, calling it a “pipe in a product.”
We will continue following the current race to develop oral PCSK9, so carry out our coverage!
Do not hesitate to send any advice, suggestion, stories ideas and data to Annika in [email protected].
The latest in Medical Care Technology: FTC says that buyer 23 Andme must “be expressly agree” to comply with privacy policies
The Federal Commerce Commission on Monday tax The Genetic Testing Company of accumulation 23Andme does not sell consumers' data unless the buyer agrees to adhere to strict standards for privacy and security security.
23Andme, which was once valued at $ 6 billion, was presented for bankruptcy protection of Chapter 11 in the Federal Court of Missouri last month. This means that its assets, including its vast genetic database, are on sale.
“Any buyer must expressly accept to be obliged and adhere to the terms of 23Andme's privacy policies and the applicable law, including the changes he later makes to those policies,” wrote the president of the FTC, Andrew Ferguson.
The company shot in the main current due to its DNA test kits in the home that gave customers an idea of their family stories and genetic profiles. The five -time company CNB Disruptor 50 was made public in 2021 through a merger with a special purpose acquisition company, but had problems generating recurring income and defending viable research and therapeutic businesses in later years.
DNA data is particularly sensitive because the sequence of each person is unique, which means that it can never be completely anonymized, according to the National Institute for Human Genome Research. If genetic data falls into the hands of bad actors, it could be used to facilitate identity theft, insurance fraud or other crimes.
23Andme has repeatedly said that it will not change how consumer data administers or protects throughout the sales process. Similarly, in a statement last week, the company said that all potential buyers must accept complying with their privacy policy and applicable law.
“To constitute a qualified offer, potential buyers must, among other requirements, accept to comply with the 23Andme consumer privacy policy and all applicable laws regarding the processing of customer data,” said 23nd me in the statement.
At this point, it is not clear who will buy the 23Andme assets. Anne Wojcicki, who resigned as CEO last month, said in an X publication that she will chase the company as an independent bidder. Wojcicki co -founded 23Andme in 2006, and has presented several failed proposals to take the company in private during the last year.
All Wojcicki offers have been rejected by the 23Andme Special Committee, which was convened in March 2024 to evaluate the company's path.
If you want to learn how you can delete your 23 Andme data, you can read more here.
Do not hesitate to send any advice, suggestion, stories ideas and data to Ashley at [email protected].