Life Science Today 005 – Vaccines Reach Warp Speed, Merck, and Tecartus Approved
Originally Published as The Niche Podcast
Introduction
Welcome to The Niche Podcast – Your weekly 5-minute rundown of the biotech, clinical research, and applied science industries. I’m your host, Dr. Noah Goodson. This week, we review a few of the big winners from operation Warp Speed, Merck continues to be quietly successful, and a new CAR T treatment, Tecartus, gets FDA approval.
Operation Warp Speed Accelerates
Scotty, or the Federal government’s equivalent, finally engaged the hyperdrive on Operation Warp Speed this week. Initiated earlier this year, the effort by the federal government to accelerate the development of a COVID-19 vaccine by the end of 2020 has made a number of collaborations, but more were finalized this week.
Let’s review what has happened so far: March 30th, $456 million were put into Johnson and Johnson to move toward a phase 1 trial, April 16th Moderna got its first $483 million, and on May 21 AstraZeneca got $1.2 billion. In July the numbers have picked up with Novavax getting a $1.6 billion deal. Last Saturday Pfizer and their partner BioNTech locked down a $2 billion deal for 100 million vaccines. Moderna got another $472 million in the middle of the week. And finally, on Friday a partnership between Sanofi and GSK signed a $2.1 billion deal with the US. These are just the agreements with the US, other arrangements with Japan and UK were announced this week as well.
What does this all mean for the industry? We can expect Pfizer and GSK to try and win major international market shares, but it’s not obvious at this time that their candidates will prove safe and effective in a larger population. The nod from the federal government to long standing players suggests companies like Moderna with their newer technology pipelines may have an even greater challenge in developing a sustainable company out of this pandemic unless they win. Each of these companies face three big challenges; 1) be the first to market 2) have the best product, and 3) create a supply chain that will meet the demand. Best case you get all three, but I think most would settle for doing two really well and the other one good enough. This diversified funding also signals that the federal government is making the same bets as the stock market: taking an educated guess, creating a diverse portfolio, and hoping they win on average. Let’s just hope with all this investment in going Warp Speed we can land this US Enterprise at the end.
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Merck Continues Steadily
Merck has been relatively quiet as a company through the COVID-19 hustle and bustle. They have pushed some vaccine collaborations through IAVA, purchased collaboration rights on an antiviral treatment from Ridgeback Bio, and secured a measles-based vaccine pipeline through the acquisition of Themis. On the surface, this gets them preclinical COVID-19 vaccines and their foot in the door for a drug treatment. However, I think it is more likely they are eyeing the acquisition of Themis and their measles-based pipeline for other long-term uses. They may see it as supplemental to their animal and human vaccine portfolio, or as a mechanism to develop oncology therapies, or both. My guess is it really weights heavily towards oncology.
In general, Merck’s Q2 earnings report seems to underemphasize COVID-19 related efforts with some tame language about being “conscious of our abiding responsibility to help advance vaccine and antiviral efforts.” This doing-the-socially-responsible-thing seems to contrast with the rest of the report, where the money is not coming from COVID-19, but from their core oncology treatment Keytruda. Global sales of this keystone drug rose 29% to $3.4 billion in Q2. Despite a decrease in sales of almost every other major pharmaceutical, Merck has increased their revenue estimates by about 2.4% and their earnings per share by more than 10% for 2020. Merck seems to be comfortable playing the long game. Yes, they have their eye on the COVID-19 market, but they seem more interested in fueling their pipeline and enjoying the profits of Keytruda
Tecartus Get FDA Approval
In 2017, Gilead inked an $11.9 billion deal to acquire Kite Pharma. At the time, Yescarta was the only clear CAR T cell therapy Kite had, and while the product has done well, its sales were south of half a billion in 2019. This is no chump-change, but 20+ years to clear a profit is indeed a long-term investment. However, the FDA approved a new therapy from Kite this week. Tecartus is a CAR T cell therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma. This form of non-hodgekins lymphoma carries pretty significant risks, and while there are a suite of potential chemotherapy treatments available this is the first CAR T cell therapy. The clinical trial leading to FDA approval yielded a remarkable response rate of nearly 90%, with 62% of patients achieving a complete response to treatment. Tecartus is not without risk and includes a specific mitigation program to train healthcare providers prior to providing the care. Despite the challenges present in CAR T cell therapy, a one-time infusion for the treatment of a refractory and deadly cancer is a step in the right direction. The price tag of $373,000/dose suggests the Kite investment may indeed prove worthwhile for Gilead.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly 5-minute summary of top news in the biotech, clinical trials, and applied science industries. You can find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends in the industry. 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.
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Story References
https://s21.q4cdn.com/488056881/files/doc_financials/2020/q2/Merck-2Q20-Earnings-News-Release.pdf
https://www.hhs.gov/about/news/index.html
Music by Luke Goodson