Novartis received a clinical data boost which could aid the company’s ambition of $2B in peak sales.
Pluvicto proved to be beneficial for patients who had previously been treated for PMSA-positive mCRPC (metastatic castration-resistant prostate cancer). It helped these patients live longer without the progression of the radiographic disease. The improvement was observed on an androgen-receptor inhibitor like Xtandi (Pfizer) and Astellas. According to the company, the improvement was meaningful.
The results were from a PSMAfore phase III trial which had all the patients that had received an androgen-receptor inhibitor prior to the study but had not received taxane-based chemotherapy. According to Vas Narasimhan, CEO of Novartis, a positive outcome in the pre-texane setting would increase the possible number of patients that the drug could target by up to fourfold.
The PSMAfore data will be discussed with the FDA when Novartis will seek potential approval in the coming year. The complete results will be shared in a medical meeting in the future.
The company is very optimistic about Pluvicto, which is why the peak sales are projected over $2B. This estimate depends on positive readouts from PSMAfore along with PSMAaddition, which is another phase III scheduled to report metastatic hormone-sensitive prostate cancer data in 2023.
Novartis has recently started to expand its production due to the expectation of Pluvicto’s success and foreseen growth along with the company’s entire radiotherapy presence. Capacity is being increased in the company’s Millburn, New Jersey site following a temporary stop in production after a manufacturing glitch. The company is also expecting the Indianapolis’ Purdue Research Park plant to be functional by mid-2023, according to Narasimhan’s conference call with investors in October.
Narasimhan also said that Novartis will be in a good position to expand and also cater to the demand for the chemo-naïve mCRPC indication after the facility in New Jersey sees through the expansion. The company would get two manufacturing plants on the Indianapolis site as the European facilities’ efforts will be aimed at Europe and other markets outside of the States. This will also help in Novartis’ goal of adding more capacity in Asia.
The CEO said that as of now, the company is capable of supplying the post-chemo indication to over 120 designated selection centers, however, the aim is to ultimately reach up to 400 centers. He also claims that the prescribed volume of the therapy would be even more if Novartis removes the limit on the number of centers. Novartis’ Pluvicto had third-quarter sales of $80M, and it was the drug’s first complete quarter on the market.
Pluvicto is just one of the eight products that Novartis markets and each of them have the potential to have multibillion-dollar sales. The company’s highest-selling heart drug, Entresto, is getting close to its patent. Novartis is also working on expanding its generic line, Sandoz, to more innovative medications. Regarding therapeutic areas and technology platforms, Novartis is focusing on solid tumors and radioligand therapy.