Life Science Today 052 – AstraZeneca + Alexion, Lyell, Myovant, Foresee, GSK + Vir

Originally Published as The Niche Podcast

M&A Speed Bumps, “Normal” IPO but not approach, two updates, and FDA gives nod to menstrual bleeding, prostate cancer, and COVID19 monoclonal antibodies.

Sponsors
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Story References
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Music by Luke Goodson
https://www.soundcloud.com/lukegoodson

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, M&A Speed Bumps, “Normal” IPO but not approach, two updates, and FDA gives nod to menstrual bleeding, prostate cancer, and COVID19 monoclonal antibodies.


Massive Merger Speed Bumps

AstraZeneca and Alexion are merging for a mind-tingling $39B. This is not new news and has been announced for some time. As expected with any multi-national merger of this scale, there are significant regulatory hurdles in multiple countries. The latest is an announcement in the UK that their Competition and Market Authority (CMA) will investigate the deal for anti-competitive practices. The merger has already cleared regulatory and anti-trust hurdles in other countries, including the USA, Russia, Canada, and Brazil. These steps are probably less of a stop and more like an expected speedbump when companies of this size combine. In addition to clearing the CMA in the UK, the deal has yet to pass regulators in the EU and Japan.

Alexion has a massive portfolio of promising molecules for therapies across more than 20 indications. This will prove critical as other products like, Apellis’ pegcetagoplan (Ep 050) eat away at leading products like Soliris $4B annual cut of the complement inhibition market. While there are real concerns around competition in the rare disease space, Alexion has a wide footprint and is unlikely to be unseated quickly. This means they’ll retain value similar to their price-tag, even as markets change during the merger process.


Lyell Follows the Pattern, But Also Not

Lyell Immunopharma has filed to complete a $150M IPO. In some ways, they are exactly on brand for recent trends. In March they raked in $493M series C. Now they rapidly go public. Their valuation was something like $2B back in March. Lyell has a pipeline of genetic and epigenetic cell-reprogramming technologies to target solid tumors. With such a crowded space, this makes competition stiff. But Lyell has some unique modalities. Not just in technology either. They’ve created a 70,000 sqft manufacturing facility in Washington State. This provides them two critical if expensive opportunities. First, they can control their production pipeline which is vitally important in the cell/gene therapy spaces where high quality and reliable manufacturing capabilities are rare and expensive. Second, it may allow them to take on CMDO work and offset the capital risk within their own pipeline while they get it up and running. They have framed the $65M facility as being for their internal pipeline’s commercialization, but time will tell if they choose to pivot or draw in capital by serving other companies with less infrastructure investment. At the end of the day, this facilities gives Lyell a unique approach to building out their pipeline, while their fundraising strategy remains as “normal” as $650M in a market where $650M in 3 months is not surprising can be. Once this round is completed, we get see how they execute.

Two Story Updates

Two quick addendums to previous stories.

In Episode 050 we highlighted Apellis Pharma, who received FDA clearance to treat the rare disease PNH with pegcetagoplan (sold under EMPAVELI). Last week they released results from an additional phase III trial showing EMPAVELI is massively effective in treatment-naïve PNH patients. In combination with the results of their head-to-head study against Alexion’s Soliris, these findings give EMPAVELI major tailwinds as commercialization roles out in this rare-disease market.

Second, last week we spoke about Annovis’ exciting results in both Alzheimer’s and Parkinson’s. At the end of the story, we mentioned there was no way they had enough capital to run a phase III trial in one of these disease conditions. Rather than finding a partner quickly, they opted to raise capital. But it’s a modest $50M offering of common stock at $50/share. This move was met with market skepticism as their shares dropped to around $45.00/share at closing Friday. To try and bolster confidence and experience, they are now partnering with an outside organization to help them hunt for increased board members and new executive leaderships. All this tells me they know they need a big band-aid before they can achieve the strategic valuation and partnerships they want. If their technology pipeline is what early trials suggest it may be, it represents super-blockbuster status in a static field. But there are major obstacles and it’s clear they know they need some more bus drivers to get there. 


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.


MYFEMBREE Approved to Severe Menstrual Bleeding

An estimated 5M women in the United States suffer from major symptoms of uterine fibroids, including heavy menstrual bleeding and discomfort. While benign tumors, uterine fibroids may cause pain, heavy bleeding, miscarriage, bloating, and infertility. Heavy bleeding from uterine fibroids contributes to 1/4M hysterectomies a year. Myovant and Pfizer have been granted FDA approval for MYFEMBREE, a combination therapy to treat heavy bleeding associated with uterine fibroids. In phase III trials, MYFEMBREE reduced bleeding volume by 82%-84% compared to baseline. In addition to providing significant physical relief due to reduced blood-loss, MYFEMBREE may also serve to reduce the emotional and temporal burden associated with managing heavy menstrual bleeding. Adverse reactions were rare, occurring in just 3% of the test population.

Myovant is focused on women’s health and prostate cancer. MYFEMBREE represents their second FDA approval. Last December, Orgovyx was approved as the first oral hormone therapy for advanced prostate cancer. Myovant continues to advance a pipeline of additional women’s health products.


Advanced Prostate Cancer Therapy Approved

Speaking of Prostate Cancer, the Taiwanese company Foresee Pharma has received FDA approval to treat advanced prostate cancer with CAMCEVI. Accord BioPharma, the generics distributor, holds the license for US distribution. CAMCEVI is an injectable. What’s special is that it’s approved as a subcutaneous depot formulation. This means the therapy is injected in subcutaneous tissue where a bolus is formed and slowly absorbed over time. In this case, CAMCEVI absorbs across a 6-month time period for testosterone suppression. This makes CAMCEVI an associative therapy like to be used in combination with other oncological products in the treatment of advanced prostate cancer.


Monoclonal Antibody COVID19 Therapy Approved

GlaxoSmithKline and Vir Biotech have received FDA emergency use authorization to treat mild to severe COVID19 in people 12 years old and older with the monoclonal antibody sotrovimab. The therapy was approved early after an independent data-monitoring committee determined there was “profound clinical efficacy.” It is quite rare for an independent data-monitoring committee to suggest early trial stoppage because of positive effect. The antibody therapy demonstrated an 85% reduction in any hospitalization or death for this infected with COVID19. As vaccine role out continues around the globe, therapies will remain a critical component to care as some high-risk individuals are not eligible for vaccinations.

Adding to the ongoing needs, some countries have limited access to vaccinations while significant portions of the population remain unconvinced of the efficacy of vaccines. Sotrovimab is on track for release in Europe and may apply for full FDA approval later this year. While an exciting step in the fight against a global pandemic, the unfortunate reality is that complex and expensive monoclonal antibody treatments remain most accessible to those who also have the highest access to vaccines and other interventions.


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.