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Can a Big Pharma Ever Be Worth $1 Trillion?
The Wall Street Journal reported:
There are five tech companies valued at over $1 trillion. In healthcare, the closest contender is Eli Lilly. This year it became the first big pharmaceutical to surpass a market capitalization of $500 billion thanks to the popularity of its obesity and diabetes medications and, to a lesser extent, its experimental Alzheimer’s drug. But hanging over Lilly and rival Novo Nordisk is a reality that puts the brakes on big pharma’s ascent: the patent cliff.
There are several reasons why there isn’t a big pharma company in the trillion-dollar club, but the boom-and-bust nature of drug development is high on the list. Unlike Apple, which hypothetically can make huge margins off the iPhone for perpetuity, U.S. drug companies have a limited period from which to profit from their innovation. As their patents expire and generic competitors enter the market, sales plunge. Pharma executives, overly focused on short-term growth, don’t often prepare their companies for that.
As Lilly soars into the pharma stratosphere, a big question is whether it can avoid the fate that has befallen its competitors (and itself in the past). The company’s chief scientific and medical officer, Daniel Skovronsky, says he wants to avoid a key error much of the industry tends to make.
“When a company has a mega-blockbuster drug that is doing really well, every investment on the margin goes towards that instead of towards something that’s untested and unproven,” he says in an interview. “And that drug overshadows the rest of the portfolio and everything else is starved for people, money and attention.” Once the big blockbuster runs out, he added, “they find out their cupboard is bare, and there’s nothing else coming.”
Bristol Myers Pours $100 Million Into RNA Drugs for Cardiovascular Diseases
Bristol Myers Squibb has agreed to spend at least $100 million to expand a partnership aimed at creating RNA-based medicines for cardiovascular diseases.
The deal, announced Tuesday, shows Bristol Myers is willing to bet more on drugmaking technology developed by Avidity Biosciences. Founded in 2012, Avidity is trying to combine elements from two kinds of medicines — monoclonal antibodies and oligonucleotide therapies — to make new treatments that are both precise and target the root cause of diseases.
The most advanced of Avidity’s so-called AOCs, or antibody oligonucleotide conjugates, are in early-stage human trials, where researchers are evaluating their ability to treat three kinds of rare, muscle-eroding diseases. The company has other experimental therapies in preclinical testing, and is partnered with Eli Lilly on AOCs for immune system disorders and “other select indications.”
Merck Strides Onto Pfizer’s Turf, Posting Pivotal Vaccine Data and Heading to Regulators
Merck & Co. has revealed data from a phase 3 trial designed to knock Pfizer’s pneumococcal vaccine off its perch. The vaccine candidate matched Prevnar 20 for shared serotypes and performed better for 10 of its 11 unique serotypes, positioning Merck to file for approvals around the world.
Pfizer is the dominant force in the adult U.S. pneumococcal vaccine market, with Prevnar 20 holding a 95% share in the third quarter, but Merck believes its V116 candidate provides broader protection than the competition. The drugmaker shared top-line data from a phase 3 trial of V116 in July and followed up Tuesday with a closer look at the results at the World Vaccine Congress West Coast.
Manufacturers Need to Be More Open About a Dangerous Alzheimer’s Drug Side Effect
Since the FDA’s approval of lecanemab (marketed as Leqembi) and Medicare’s recent decision to cover the drug, I have met with Alzheimer’s patients and their loved ones who are anxious to know whether they may benefit from this new treatment. They come in the hope that this new medication may slow the progression of a cruel memory-robbing and personality-eroding disease.
It is therefore concerning to me that while the modest benefit of Leqembi in slowing the progression of Alzheimer’s has been highlighted both in medical journals and the media, relatively less attention has been paid to common side effects of the drug: brain swelling and bleeding that are together called amyloid-related imaging abnormalities, or ARIA, which have been found in all three drugs designated as “breakthrough treatments” by the Food and Drug Administration: lecanemab, aducanumab, and donanemab. I am especially worried about drugmakers’ lack of transparency in fully reporting all details of clinical outcomes related to ARIA.
Each of the three new Alzheimer’s drugs has also been linked with patient deaths in clinical trials — four with aducanumab and three each with lecanemab and donanemab. Some of these patients may have experienced catastrophic brain bleeding related to ARIA because they were either already on blood thinners for other conditions such as to prevent stroke due to atrial fibrillation or may have received a clot-busting drug when they experienced symptoms of a stroke. So far, only one of these cases has been published in a peer-reviewed scientific journal; it was authored by independent researchers not affiliated with the drug manufacturers.
In most other instances, information on these unfortunate deaths has come to light mainly through the work of investigative journalists, including at STAT, sometimes requiring the filing of a Freedom of Information Act (FOIA) request with the FDA.
After Cyfendus’ Full Approval, Emergent Clinches $75 Million Anthrax Vaccine Supply Pact in U.S.
Armed with full FDA approval after four years of supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the United States.
The nation’s Biomedical Advanced Research and Development Authority (BARDA) is laying out $75 million to exercise an option on an existing deal for additional doses of Emergent’s two-dose anthrax shot Cyfendus, according to a securities filing.
The FDA signed off on Emergent’s vaccine — formerly known as AV7909 — in July. Prior to the shot’s formal green light, Emergent had been furnishing the U.S. Department of Health and Human Services with the product since 2019.
The immunization includes anthrax vaccine absorbed (AVA) and an adjuvant and is administered in two doses over 14 days. It’s intended for post-exposure prophylaxis in adults 18 to 65.
White House Plans Next Year’s RSV Immunization Campaign Following Shortages
The Biden administration on Monday met with the manufacturers of RSV immunizations to discuss making the medications available through the private market and preparing for next year as demand for the products far exceeded what drugmakers anticipated this season.
A readout from the White House said on Tuesday that officials met with drugmakers to discuss “manufacturing, distribution, and accessibility of RSV immunizations through the private market.”
This year marked the first time that immunizations against the common respiratory virus RSV would be available for infants and seniors with the approval of the monoclonal antibody Beyfortus from Sanofi and AstraZeneca as well as the vaccine Arexvy GlaxoSmithKline.
Beyfortus is recommended for infants younger than 8 months of age who are born during or are just entering their first RSV season, which typically starts in the fall and peaks during the winter. Infants aged between 8 and 19 months who are at an increased risk for severe RSV disease may also get the shot if they are entering their second RSV season.
Pharma’s Q3 Growth Rankings: GLP-1 Drugs From Eli Lilly, Novo Nordisk Were Once Again the Big Story
Eli Lilly’s fortunes have turned quickly. Two quarters after posting an 11% revenue decrease in Q1 — due largely to a decrease in sales of COVID antibodies — the Indianapolis company enjoyed the largest revenue gain in the industry at 38% in the third quarter.
It’s no secret that Lilly’s booming sales have been fueled by type 2 diabetes drug Mounjaro, which generated $1.4 billion in just its fifth full quarter on the market. But the spike has even surprised analysts, who came up 12% short in their estimate of Mounjaro’s sales for the period.
It was the second straight quarter where the overwhelming success of blood sugar-regulating treatments was the dominant story in the biopharma industry. The only other company rivaling Lilly’s revenue increase in the quarter was Novo Nordisk, with a 29% boost year over year, bolstered by the skyrocketing sales of its semaglutide products Ozempic and Wegovy.
Expecting the trend to continue through the rest of this decade are analysts at TD Cowen. In a report released last week and titled “Will GLP-1s Eat the World?” Cowen projects the type 2 diabetes and obesity market to mushroom to $102 billion by 2030. It’s a huge increase from the $30 billion market Cowen envisioned last year for 2030.
These People Experienced Complications From Weight-Loss Drugs. Here’s What It’s Like.
Weight-loss drugs have exploded in popularity over the last year, with people filling social media with their success stories. But these medications come with potential risks — and some are more serious than others.
As drugs like Ozempic, Wegovy and Zepbound become household names, there is an increasing number of testimonies from former patients about a range of complications they’ve experienced while taking the medications. Stomach paralysis, gastrointestinal illness and suicidal thoughts are just a few of the problems patients have dealt with.
Joanie Knight told CNN that she was diagnosed with severe gastroparesis, aka stomach paralysis, after taking Ozempic. (Gastroparesis is a condition that slows or even stops the movement of food from your stomach to your small intestine, leading to symptoms such as abdominal pain and vomiting, according to the National Institute of Diabetes and Digestive and Kidney Diseases).
Australian dad Roy Webster said his wife, Trish, died after taking Ozempic along with weight-loss drug Saxenda to lose weight for their daughter’s wedding. Webster told “60 Minutes” that, while his wife lost weight, she was also sick a lot.
