5 Things Happening in Pharmacy Right Now

In case you missed it...

In case you missed it:

1. GSK Appoints Big Pharma’s First Female CEO1

Emma Walmsley will take over as the next CEO of GlaxoSmithKline (GSK) and become the first woman to lead a top global pharmaceutical company. She will also become one of just 7 female chief executives in the United Kingdom’s Financial Times Stock Exchange (FTSE) 100 Index, which is comprised of the top 100 UK companies.

Before joining GSK, Walmsley worked with L’Oreal for 17 years in Shanghai, Paris, London, and New York. She has been a vital member of GSK’s top executive team since 2011. She will be officially sworn in on March 31, 2017, when current CEO Andrew Witty retires.

2. More Effective Shingles Vaccine in Development

Merck’s Zostavax is currently the only shingles vaccine on the market, but GSK’s candidate, Shingrix, could arrive soon. Earlier this week, GSK shared results from phase 3 clinical trial ZOE-70, which showed 90% efficacy in patients 70 years and older and 89% efficacy in those 80 years and older for at least 4 years. These results are in line with those from previous phase 3 clinical trial ZOE-50, which showed 97% efficacy in patients 50 years and older.

Shingrix’s high efficacy is persistent across all patients 50 years and older for up to 4 years and is superior to Zostavax’s efficacy, which starts to wane off after age 60. Zostavax showed a 64% reduction in shingles in those 60 to 69 years, a 41% reduction in those 70 to 79 years, and an 18% reduction in those 80 years and older.

Shingrix also showed 89% efficacy in preventing postherpetic neuralgia (PHN), a common side effect that occurs after shingles in patients 70 years and older. For those 50 years and older, Shingrix was 91% effective in preventing PHN.

Unlike Zostavax, which is a live attenuated vaccine, Shingrix is a nonlive vaccine. Zostavax is contraindicated in immunocompromised patients, whereas Shingrix has the potential to be used in these patients. There’s ongoing study in immunocompromised patients that will be released sometime in 2017.

GSK is on track to file for Shingrix approval by the end of this year. I’m extremely excited about these results because I had shingles a few years ago and it’s one of the worst feelings I’ve ever experienced. Shingrix has the potential to not only dominate the market, but also offer superior protection to many more patients.

3. New Malaria Vaccine in the Pipeline2,3

Sanaria’s malaria vaccine candidate PfSPZ won FDA fast track designation, which will expedite its development process and get it to those who need it most as soon as possible.

PfSPZ received this designation after impressive phase 1 results showed it protected 100% of patients at 3 weeks after the last dose of the vaccine and 55% of patients at 14 months. Sanaria is planning to start a phase 3 clinical trial late next year.

PfSPZ is designed to stop transmission and eliminate Plasmodium falciparum, the deadliest malaria parasite globally and most prevalent in malaria-endemic regions like Africa.

GSK’s Mosquirix is currently the only malaria vaccine available. However, its phase 3 clinical trial results showed suboptimal efficacy, which has halted its mass implementation. Mosquirix’s efficacy in infants and young children ranged from 27% to 39%. The European Medicines Agency is requiring additional phase 4 studies from GSK to ensure safety and efficacy before releasing the vaccine to areas of need.

4. Novo Nordisk’s Newest GLP-1 Agonist Looks Dethrone Lilly’s Trulicity4

In 2010, Novo Nordisk released its blockbuster GLP-1 agonist, liraglutide (Victoza), and now it’s back at it again with semaglutide. This once-weekly drug is similar to Lilly’s dulaglutide (Trulicity), which Novo Nordisk is hoping to dethrone.

Results from semaglutide’s phase 3a clinical trial (SUSTAIN 6) showed it can cut cardiovascular problems and heart attacks by 26% and stroke risks by 39%. These results are very promising, and Novo Nordisk hopes to apply for approval later this year.

5. Tech Contest to Combat Opioid Overdose5

In 2014, almost 2 million Americans were abusing or dependent on prescription opioids. In that year alone, there were 18,893 opioid overdose deaths and 10,574 deaths related to heroin.

In light of this, the FDA has launched the Naloxone App Competition, a public contest with hopes of developing innovative technologies to curb the tide of opioid overdose.

References

  • Staton T. GSK replaces Witty with consumer chief Emma Walmsley, Big Pharma’s first woman CEO. fiercepharma.com/pharma/gsk-replaces-witty-consumer-chief-emma-walmsley-big-pharma-s-first-woman-ceo. Published September 20, 2016.
  • Sanaria PfSPZ vaccine against malaria receives FDA fast track designation. finance.yahoo.com/news/sanaria-pfspz-vaccine-against-malaria-123000756.html. Published September 22, 2016.
  • Seder RA, et al. Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Science. 2013;341(6152):1359-1365.
  • Novo Nordisk. Semaglutide reduced major cardiovascular events by 26% in adults with type 2 diabetes at high cardiovascular risk. novonordisk.com/bin/getPDF.2042547.pdf. Published September 16, 2016.
  • Felberbaum M. FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm520945.htm. Published September 19, 2016.