Editors' (re)View: A new radioisotope facility; FTC comes for pharma

June 16, 2023
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of June 12

Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.

Right on target

Earlier this week we reported that radiopharmaceutical specialist ITM Isotope Technologies opened a new production facility for therapeutic radionuclides near Munich, Germany. According to ITM, its new facility will offer the world’s largest production site of lutetium-177.

With a market estimated to exceed $13 billion by 2030, therapeutic radiopharmaceuticals have become a rising sector of the pharma industry. And any discussion about the feasibility of these targeted cancer killers must consider the supply of medical isotopes — the source of the therapy's tumor-destroying power.

While there are thousands of known radioisotopes, only a short list are suited for therapeutics. Most radioisotopes used in therapeutics today are produced using neutron activation in nuclear reactors. Radioisotope suppliers source their isotopes from a few nuclear reactors around the world. According to the World Nuclear Association, most of these reactors are over 50 years old, which means there is an ongoing risk that they could break down and temporarily be taken offline.

The growing popularity of certain isotopes combined with the limited number of nuclear reactors, as well as the ultra-rare input materials and complex purification processes needed to make radioisotopes, means that isotope supply has been and remains top of mind.

Lutetium-177 currently has the lion’s share of presence in clinical trials. Both of Novartis’ approved drugs, Lutathera and Pluvicto, also rely on lutetium.

But the current supply and demand situation for 177Lu is not entirely transparent, which is a big part of the manufacturing challenge. Given its effectiveness against prostate cancer, the potential demand is extensive. (Prostate cancer is the second most common cancer among men, with an estimated 1.4 million people diagnosed globally each year.)

To that end, ITM says once the new NOVA production facility is fully operational, the company will increase its capacity to supply clinics, pharma partners and its own drug pipeline tenfold — which is fantastic news for the future of 177Lu-based radiopharma drugs.

— Karen Langhauser

FTC comes for pharma 

In response to growing consolidation in the biopharma industry, the Federal Trade Commission introduced a new working group in 2021, consisting of antitrust enforcers from various countries, dedicated to adopting a proactive stance in addressing anticompetitive pharmaceutical mergers. The initiative, vowing to more closely evaluate pharma mergers in light of concerns about anticompetitive behavior and drug pricing, has done precisely that. 

Earlier this week, we reported that Pfizer will be refiling its merger notification with the FTC for its proposed $43 billion acquisition of Seagen — the largest biopharma deal announced this year.

In a note to customers made available to media sources, Andrew Berens, an analyst at SVB Securities, said that the refiling could be an opportunity to add more context and prevent further issues. “This pull-and-refile strategy was likely utilized to provide the FTC with slightly more information to address antitrust concerns and give the agency 30 additional days to review, without having to pay a second filing fee and without triggering the need for a ‘second request.”

And it's not just Pfizer, but every other pharma jauggernaut trying to make moves this year is facing FTC scrutiny, with both Sanofi and Amgen having to provide further details about their acquisitions. 

Just last month, the FTC filed a lawsuit to block Amgen’s $28.7 billion Horizon purchase, saying that the deal would allow Amgen to use rebates on its existing blockbuster drugs to pressure insurance companies to favor Horizon’s drugs. 

“Rampant consolidation in the pharmaceutical industry has given powerful companies a pass to exorbitantly hike prescription drug prices, deny patients access to more affordable generics, and hamstring innovation in life-saving markets,” said FTC Bureau of Competition Director Holly Vedova, about Amgen's lawsuit. “Today’s action– the FTC’s first challenge to a pharmaceutical merger in recent memory – sends a clear signal to the market: The FTC won't hesitate to challenge mergers that enable pharmaceutical conglomerates to entrench their monopolies at the expense of consumers and fair competition.”

Sanofi was in a similar position back in April, having to withdraw and refile its pre-merger notification and report form in connection with its pending $2.9 billion acquisition of Provention Bio in order to provide the FTC with additional time for a closer review. 

But despite the FTC's efforts to slow the transactions, Amgen, Sanofi and Pfizer have stated they expect the sales to close this year or early 2024. 

— Andrea Corona