Life Science Today 053 – All About FDA Approvals

Originally Published as The Niche Podcast

Pending FDA approvals, expanded FDA approvals, new FDA approvals, and a lawsuit about FDA approvals.

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Music by Luke Goodson
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Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.

Transcript

Introduction

Welcome to The Niche Podcast – Your weekly rundown of the biotech, pharma, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, pending FDA approvals, expanded FDA approvals, new FDA approvals, and a lawsuit about FDA approvals.

Aducanumab Is Coming

In the show Game of Thrones, house Stark is famous for the phrase “winter is coming.” These words mark their preparedness for change and certainty that the way things are today will not last. Biogen’s potential blockbuster Alzheimer’s therapy, Aducanumab, seems to align with the statement “Aducanumab’s fate is coming.” After nearly a year of punts, delays, and renegotiations with the FDA, a date with destiny is set for June 7th (the day this airs). We will report the changes that occur in the market after this pivotal decision next week, but what is clear is that the market must change. Tens of billions of dollars in development have yielded zero new Alzheimer’s therapeutics in 20 years. In some ways, a failure would allow the market to fully reset, but would likely negatively impact current developmental pipelines from other companies in the space. Conversely, a success could spur the whole market forward, but it’s not clear that it would be in the right direction. On top of that, Biogen itself will also probably face major restructuring efforts regardless of the ruling. Any outcome will be complex and far reaching. What is clear? Aducanumab’s fate is coming.


Novartis Expands on $4B drug

Novartis has been granted expanded FDA approval to treat pediatric patients 6+ y/o, suffering from plaque psoriasis with their leading therapy Cosentyx. 75 mg or 150 mg of Cosentyx may now be given as a subcutaneous injection every four weeks to the 1% of children who suffer from potentially debilitating plaque psoriasis. This approval not only expands the growing market that saw nearly $4B in revenue last year, but demonstrate a good safety profile for the human biologic, even in those who are quite young. Cosentyx works by inhibiting interleukin-17A, a key inflammatory regulator in a variety of conditions. Robust clinical trial and real-world data continue to support a broad base for expanding Novartis’ reach into applicable markets moving forward. Last year, Cosentyx sales increased 13%. That trend will likely  continue, for the near-term at least, as they engage broader global markets and gain expanded approvals.
 

Regeneron Expands COVID19 Treatment Range

Regeneron has received expanded FDA approval for their COVID19 antibody cocktail REGEN-COV. Specifically, they have received EAU to give REGEN-COV to adults and children 12+, but at half the dose or 1200 mg, compared to original EAU of 2400 mg.. The therapy has shown significant impact and was rapidly moved to market. Utilizing REGEN-COV at half the dose expands their reach and supply chains around the globe, while likely providing a slightly decreased risk in some patients of adverse reactions. As previously noted on this show, Regeneron has been on a role fiscally and this will certainly not hurt them. If revenue trends continue, expect acquisitions in the near future.


Sponsor

Developing a new product in the biopharma space is incredibly challenging. There are design barriers, capital to raise, and regulatory hurdles. The Scope Method provides consultative solutions to navigate industry specific challenges. We’ve helped companies pivot into new therapeutic spaces, designed and run decentralized clinical trials, and empowered CEOs with tools that turns their data into stories that raise capital. Find out more at thescopemethod.com.
 

Taking on Mental Illness, without Weight Gain

Side effects can often drive adoption of, and passion against, certain drugs. This is absolutely the case for the decades old schizophrenia and bipolar medication Olanzapine, which is known to cause significant weight gain. Last week, Alkermes received approval to treat Schizophrenia and Bipolar Type I with an oral mixture of Olanzapine and samidorphan. The therapy not only significantly impacts the diseases, through Olanzapine, but showed a significant reduction in the portion of the population to gain 10% or more body weight. A perfect solution? No, but an improvement over Olzanzapine alone.
 

Wegovy Set to Combat Obesity Epidemic

Speaking of weight gain, a new weight loss therapy has been approved. Novo Nordisk has received FDA approval to treat adults with a 2.4 mg once weekly injection of semaglutid, sold as Wegovy, to treat obesity. With staggering obesity rates around the world, effective therapeutics to treat the disease state are a serious unmet need. Obesity alone is such an integral risk factor to so many human diseases that therapeutic interventions are an absolute must for the future of global health. Patients on the Gucagon-like pedtide-1 receptor antagonist , Wegovy, saw significant improvements with an average of 14.9% weight-loss when on an exercise and caloric controlled diet, compared 2.4% loss for placebo control group under the same conditions. With more than 42% of the American population obese, and evidence emerging about the resistance of the disease to dietary treatment alone, Wegovy may tilt the scales in the right direction.


Big Approval for Smallpox

Chimerix has developed a smallpox therapy in a partnership with BARDA. Why would a smallpox free world need an FDA approved smallpox therapy? The partnership is based on defense initiatives that consider the risk of intentional re-infection with smallpox by human actors. The therapy was approved based on studies in extant animal models, which is the only way to ethically study diseases like smallpox at this time. Chimerix is calling the drug TEMPEXA and will try to sell it through a partnership with US defense stockpilers. In a post-COVID19 world with rumors about the origins of COVID19 circulating, they’ll likely have a receptive Department of Defense.


BMS Lawsuit for Getting FDA Approval

Chicanery and shenanigans happen in every business. It should come as no surprise that this applies to the pharmaceutical business as well. One of the most common forms of woopsie-but-maybe-on-purpose-and-now-we’re-in-a-lawsuit has occurred to BMS based on the Celgene merger. To catch you up, in 2019 BMS took over Celgene for a stunning $74B. As part of this deal there was a contingent value right (CVR). CVRs stipulate that shareholders of the acquired company (Celgene), will receive a specific benefit if the acquiring company (BMS) meets certain deadlines. In this case, BMS has stipulated that if three drugs were approved by certain deadlines, then the CVR note holders would get $9/share. Not a big deal. Except there are 715M CVR notes, giving it a $6.4B price-tag. So did BMS miss a deadline? Technically yes. The cancer drug Liso-cel was approved in February of this year, but that missed the CVR note deadline of December 31, 2020. Liso-cel was on track for approval on time. But allegedly, COVID19 related delays of FDA inspections of production facilities caused the delayed approval, missing the deadline. A new lawsuit says, “hold on BMS, you’re telling me you’re going to forego a payment of $6.4B owed to investors because ‘dang it, we were just 6 weeks late?’” It seems unlikely that BMS will successfully fend off the payout, even with COVID19 as an excuse. But they probably knew this and are likely gunning for a settlement that saves them a few billion dollars, even after a lot of exorbitant lawyer  fees. Alternatively, the revenue on an investment of $6.4B while lawyers haggle it out  is probably worth more than the cost of council. BMS has technically followed the rules, but it is pretty hard for a broader public audience to see a move like this as ethical.


Closing Credits

Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.