- Biogen and AbbVie throw in the towel with daclizumab.
- Regeneron gets review to expand its anti-inflammatory drug.
- Jazz Pharmaceuticals seeks its day for a sleep drug.
Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.
Welcome to another edition of "3 Things In Biotech," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Biogen and AbbVie throw in the towel with daclizumab
Disease: Relapsing multiple sclerosis
News: BIIB and ABBV announced that they would jointly withdraw their CD25 monoclonal antibody daclizumab from the worldwide market due to concerns about the adverse event profile, which has proven too complex and dangerous to justify the risk of treatment.
Looking forward: Thus ends a saga where BIIB and ABBV were unable to make this agent stick due to safety concerns, as uptake was too slow to compete with other blockbusters in the multiple sclerosis space. As such, it comes as little surprise that the companies have opted to pull the plug. Of course, this is a sad case study on the challenges that can befall a seemingly effective drug even after it's approved.
Likely, this news won't put much of a dent into these large companies, and cutting the weight anchoring their continued growth is important for focusing their priorities.
Regeneron gets review to expand its anti-inflammatory drug
Disease: Moderate-to-severe asthma
News: REGN and SNY announced that their supplemental new drug application has been accepted for dupilumab. This application seeks to expand the marketed indication from atopic dermatitis that is not well controlled to the use as maintenance therapy for adults and adolescents with moderate-to-severe asthma. The companies guide an expected action date from the FDA of October 20, 2018.
Looking forward: Dupilumab was approved for the first time only last year, so it is not clear yet how successful this agent is going to be for REGN and SNY. However, an approval in asthma would certainly go a long way toward realizing the $3 billion in projected annual sales. As such, it's difficult not to see this move as a sign of very good things to come for REGN and SNY in 2018.
This approval alone could add serious upside to the investment theses of both companies, although this must be considered in the context of the many other drugs they market.
Jazz Pharmaceuticals seeks its day for a sleep drug
Company: Jazz Pharmaceuticals (JAZZ)
Disease: Excessive sleepiness
News: JAZZ announced that the FDA has accepted its new drug application for solriamfetol for the treatment of excessive sleepiness due to narcolepsy or obstructive sleep apnea. The application was based on findings from the TONES suite of studies investigating this agent in these patients, providing 4 trials' worth of data for the FDA to review. The action date was set for December 20, 2018.
Looking forward: Obviously JAZZ is tapping into a pretty common problem here, one for which there are not many effective options. It will be interesting to see how the FDA reviews this one, as the drug seems to be well tolerated, but its use is based on largely subjective criteria that are hard to nail down.
Overall, this looks like a cautiously optimistic move for JAZZ, although it's unclear exactly how large the market size for this agent will be.
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