Life Science Today 002 - Aducanumab, PPD, and Gilead
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. Today on The Niche, Biogen has submitted their Alzheimer’s drug aducanumab to the FDA, we take a look at the fate of PPD since their February IPO, and explore Gilead’s not-a-claim claims on their COVID-19 treatment.
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Biogen and the FDA
Biogen submitted paperwork to the FDA on July 8th for approval of the critical Alzheimer’s treatment Aducanumab. The treatment is a monoclonal human antibody which reportedly binds to Aβ aggregates and may disrupt the progression of the disease. There is significant doubt if the FDA will approve the treatment which has limited functional effects. However, the lack of any new Alzheimer’s drugs in the last 14 years may provide enough pressure to gain approval. If approved, Aducanumab will be extremely profitable, and Biogen has significant investment in the drug’s success. An answer may be available from the FDA in Q1 of 2021.
The Fate of PPD
Pharmaceutical Product Development Inc (PPD), is a contract research organization (CRO) founded in 1985, and based in Wilmington, North Carolina since 1986. The company has passed through various iterations over the years. It was first listed on the Nasdaq in 1996 as PPDI but was sold to private equity in 2011 for $3.9 billion. In February of 2020, the company went through a second IPO with 60 million shares listed at $27 each, for a company valuation north of $9 billion. At the time, it received significant press as the largest IPO in Q1.
Disruptions in the stock market this year caused a major loss to PPD, plummeting from a February 11th high of $32.87/share to a March 18th low of just $14.00/share. However, PPD was not taken out for good and has climbed steadily to $29.09/share at closing on Friday. In fact, PPD has outperformed some of its competitors like IQVIA, Syneos Health, and Paraxel, who all sit far below their February highs. Does this mean PPD is in a better position? That is hard to say.
Every clinical trial has been affected by COVID-19. Most trials involve regular and, at times, lengthy office visits. One of the primary obstacles in all trials is recruitment. For many sites, COVID-19 has delayed interactions, disrupted office visits, and placed a major constriction on recruitment pipelines. PPD, like other CROs, has scrambled to implement digital technologies, modify where needed, and maintain their current trials while attempting to obtain new business. It is unclear if the shifting landscape in the pharmaceutical industry will drive the CRO business space or inhibit it. Cost/trial and expertise requirements will probably increase with COVID constraints, but a net industry contraction could decrease products moving to trial. Which of these forces will win the day is yet to be seen.
With all this uncertainty, why has PPD outperformed their competition? PPD worked very hard to get their ducks in a row for a February IPO and our best guess is this placed them in a stronger business position when the pandemic storm hit. Are they subject to the same market fluctuations as other CROs? Yes. However, they may have just been the most accurately valuated CRO on the market in February when things went south. Unless there are major challenges behind the scenes at the company, I suspect they will likely match the overall market and slightly outpace their competitors heading into 2021.
Gilead and Remdesivir
Gilead presented additional information on the impact of its antiviral drug Remdesivir on July 10th. Rather than a complete report or paper detailing all findings, Gilead has been leaving a trail of breadcrumbs with incomplete but compelling data on the protective effects of the drug. After examining the results of a phase 3 trial cross-compared with a retrospective cohort of COVID-19 patients, they claim that Remdesivir reduced patient mortality 62%. Remdesivir is currently only approved for emergency use in severe COVID-19 cases. Gilead’s piecemeal data-release reports are equivalent to claims not-a-claim. Yes, in a comparison between a retrospective and clinical trial their drug did better. Should we approve it for use within a wider population? Who are we to say, we just make the thing. Gilead’s shares rose on Friday.
Closing Credits
Thanks for joining me on The Niche Podcast. Our goal is to keep you informed so you can engage your colleagues. Join us weekly for a 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. Once again, I’m Dr. Noah Goodson, I’ll see you next week.
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Story References
https://doi.org/10.1016/j.cct.2018.01.003
https://www.ppd.com/
https://www.businesswire.com/news/home/20200514005477/en/PPD-Honored-Quality-Capabilities-CRO-Leadership-Awards
https://www.clinicaltrialsarena.com/comment/biogen-aducanumab-fda-approval-alzheimers/
https://www.fiercebiotech.com/biotech/a-test-for-hahn-s-fda-biogen-submits-controversial-alzheimer-s-drug-aducanumab
https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/gilead-presents-additional-data-on-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19
Music by Luke Goodson