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
Though Galapagos has undergone plenty of staff shake-ups and strategy revamps in recent years, the company is sticking strong to the CAR-T pivot first unveiled by CEO Paul Stoffels, M.D., following his arrival at the biotech from Johnson & Johnson in early 2022.
The new investment is expected to create more than 500 jobs and significantly strengthen France’s ability to control the production of essential medicines from start to finish, the company stated. According to Sanofi, this plan increases the amount Sanofi has committed to major projects in France since the Covid-19 pandemic to over €3.5 billion.
A tough biotech funding environment and a downturn in COVID-related contracts has weighed heavily on CDMOs of all stripes in recent years. Now, with a new CEO waiting in the wings, Swiss manufacturing juggernaut Lonza is attempting to reassure the market that an industry stabilization is on the horizon.
