Lutetium Dotatate LU-177

In an effort to protect the patent rights for radiation ligand therapy, Novartis has filed a lawsuit against Eli Lilly and its partner Lantheus, alleging infringement of the patent rights for the prostate cancer drug Pluvicto. As Novartis expands into radiopharmaceuticals, the Swiss pharmaceutical giant has stepped up its legal offensive against rivals. In a series of lawsuits filed during the year, Novartis accused several competitors of infringing patents for its radiation ligand therapies, Pluvicto and Lutathera. The lawsuits involve Eli Lilly, its recently acquired Point Biopharma and its partner Lantheus, as well as Curium Pharma in Europe. Novartis is working to increase Pluvicto's market share in prostate cancer treatment and Lutathera's market share in neuroendocrine tumor treatment. Pluvicto achieved sales of $1.04 billion in the first three quarters of 2024, successfully surpassing major sales milestones. Lutathera's sales continued to grow at a double-digit rate, which could be attributed to increased adoption of its first-line applications. In a lawsuit filed in the U.S. District Court for the Southern District of Indiana, Novartis, in conjunction with Purdue Research Foundation, alleges that Point's PNT2002 infringes U.S. Patent No. 10,624,970. The patent, which relates to PSMA binding couplings and related pharmaceutical preparations and methods for the treatment of prostate cancer, was granted to Purdue in 2020 and subsequently to Endocyte, a subsidiary of Novartis. Both PNT2002 and Pluvicto target PSMA positive prostate cancer and will compete directly with each other. PNT2002 is a key asset in Lilly's $1.4 billion acquisition of Point last year and part of a potentially $2 billion strategic partnership between Point and Lantheus two years ago.

Radiopharmaceuticals consist of radioactive isotopes that are chemically attached to small molecules, peptides or protein drugs such as antibodies. These treatments are rapidly gaining traction in the treatment of cancer for their ability to zap tumors with deadly targeted radiation, and they depend on the scalable production of medical isotopes including Copper-67 (Cu-67) and Actinium-255 (Ac-225). However, the complexities of radiopharmaceuticals in addition to the expertise and facilities required to develop them means that biopharma companies “don’t have the specialized skills or processes necessary to deliver these medicines, particularly when they are still in clinical trials,” said Frank Scholz, president and CEO of NorthStar in a public statement, adding that the companies “understand that it is not realistic or financially viable to do it themselves.” NorthStar’s new 52,000 square-foot (4,830 square-meter) facility is intended to address the growing demand for these radioisotopes by guiding the development of radiopharmaceutical drugs for its client pharma and biopharma companies and letting NorthStar add more services to its offerings. NorthStar was founded in 2006 and has raised more than $117 million in grants and equity financing, according to ​ Crunchbase ​. The company specializes in the production of  radioisotopes including Ac-225, Lu-177, Cu-64, Cu-67, and In-111 and has developed electron accelerator processes for Cu-67 and Ac-225 that scalably produce the goods at a commercial scale. googletag.cmd.push(function () { googletag.display('text-ad1'); }); With the new facility in place, NorthStar touts itself as the only U.S. company to have “co-located, commercial scale multi-radioisotope production and radiopharmaceutical manufacturing.” The increasing integration of medical radioisotopes with diagnostic and molecular imaging as well as the rise of personalized medicine is spurring the growth of the global market for these products, which was valued at $5.1 billion in 2022 ​ and is expected to soar by 8.8% per year to $11.4 billion by 2032. NorthStar’s peers in the field include Nordion, Isotopen Technologien München (ITM) and Curium. Radiopharmaceuticals in particular are attracting major big pharma interest with recent deals including the acquisition of Fusion Pharmaceuticals by AstraZeneca for up to $2.4 billion and Novartis snapping up Mariana Oncology for up to $1.75 billion. The opening of NorthStar’s facility occurs in the same week that another CDMO, Nucleus RadioPharma expanded two sites in the U.S. to triple its production capacity and add 100 jobs to its roster. Meanwhile, the firm SpectronRx is set to build a production facility in Belgium after striking a partnership with the Belgian Nuclear Research Center.