After a disappointing combo announcement that knocked nearly 16% off of shares, AstraZeneca’s immuno-oncology portfolio needed a boost—and it got one Monday.
The FDA handed the battered company a breakthrough designation for its PD-L1 med, Imfinzi, as a maintenance therapy in surgery-ineligible non-small cell lung cancer patients. And now, AstraZeneca hopes “to bring it to patients as soon as possible,” R&D chief Sean Bohen said in a statement.
If it can, it’ll go where no other PD-1/PDL-1 med has gone before, and as the fifth-to-market medication in its class, for Imfinzi, that’s a big deal. Right now, the drug’s only approval is in bladder cancer, where rivals Keytruda from Merck, Opdivo from Bristol-Myers Squibb, Bavencio from Pfizer and Merck KGaA, and Tecentriq from Roche also have clearances.
“When investors count the major I-O manufacturers, AZ is invariably last,” Bernstein’s Tim Anderson wrote to clients the day the British drugmaker touted its maintenance results. “Not any longer—this was a shrewd investment decision … AstraZeneca deserves a tip of the hat.”
With lung cancer affecting such a mammoth population, even the maintenance green light AstraZeneca is chasing represents a hefty opportunity. If the company can rack up regulatory go-aheads around the world, the patient pool will number 47,000 patients, Anderson said. And while that’s a smaller market than the 60,000-patient, second-line NSCLC population in the U.S., it’s about equal to the sum of the U.S. market for all other immuno-oncology indications.
Needless to say, an approval would be even more welcome by AstraZeneca after last week’s crushing news on the lung-cancer combo front. A miss from a pairing of Imfinzi and unapproved CTLA4 med tremelimumab—a duo that couldn’t outperform solo Imfinzi or chemo at improving progression-free survival—cast major doubt on the combo’s overall survival prospects in that population, and on PD-1/PD-L1 and CTLA4 marriages on the whole.
It also dealt a big blow to AstraZeneca’s sales ambitions, which looked questionable even before the flop. The company is under pressure to hit a massive top-line target its CEO, Pascal Soriot, offered up in the face of a Pfizer buyout threat, and even he has since said it’s a bit of a stretch.
By Carly Helfand
Source: FiercePharma
Five years ago, GSK made headlines when it hired Emma Walmsley to become the first woman to run a major pharmaceutical company. Now the Big Pharma has brought in another woman to control the company’s finances. Julie Brown will be GSK’s next chief financial officer. Brown, currently the chief operating and financial officer at fashion and beauty brand Burberry Group, is set to replace Iain Mackay.
Moderna created a new role responsible for “building out the company’s organization to support its growing pipeline.” Starting first thing 2023, Juan Andres, Moderna’s manufacturing head, will step into this new role under the title president of strategic partnerships and enterprise expansion, the company said Thursday.
The latest takeover is anticipated to boost the presence of Torrent in the dermatology segment. Indian company Torrent Pharmaceuticals has signed a definitive agreement for the complete acquisition of Curatio Healthcare for $245.16m (Rs20bn).
