Vertex Pharmaceuticals will promote Reshma Kewalramani, its chief medical officer, to president and CEO on April 1, the company announced Thursday morning. She will succeed Jeffrey Leiden, who said he would step down as president and CEO after seven years in those roles.
Leiden, who has also served as chairman, will become executive chairman, a position he will hold through the first quarter of 2023.
Kewalramani, 46, will become the first woman to run a large biotechnology firm, a watershed moment for an industry that in 2018 had more men named “Michael” than women speak at its largest conference. Expectations are high. Under Leiden’s tenure, Vertex’s share price rose 360% and its sales doubled to $3 billion annually as the company sold $300,000-a-year medicines that have a dramatic effect on some patients with cystic fibrosis, or CF, a genetic disease that robs patients of their lung function.
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Symkevi
What is Symkevi?
Like Orkambi, which combines ivacaftor with lumacaftor, this new, dual combination therapy (brand name Symkevi) uses two drugs together in one treatment. Symkevi combines ivacaftor with new drug compound tezacaftor. The treatment has been tested on people with CF with two copies of the F508del mutation and those with one copy of F508del and another mutation that has residual function. The results have been positive.
How have studies progressed?
Two global Phase III trials have revealed that Symkevi could reduce the effects of cystic fibrosis on people with two copies of the F508del mutation and present significant improvements for those with one F508del and one ‘residual function’ mutation.
EVOLVE study
The EVOLVE study, which involves those with two copies of the F508del mutation found that the treatment was more stable than Orkambi, with similar benefits of around 4% lung function improvement and fewer side effects.
EXPAND study
The EXPAND study, which involves those with one F508del and one residual function mutation found an average absolute improvement
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Good
Pricing for drugs that were developed with public funds (NIH, charitable foundations) should be priced accordingly, not hiding under the shield of “oh these drugs cost sooooo much to develop and bring to market”.