Listen to this articleThe basics:
- Novartis plans $70M radioligand therapy manufacturing facility in Winter Park, Fla.
- 35,000-sf site will mark company’s 4th US RLT facility
- Project part of Novartis’ $23B investment to expand U.S. manufacturing, R&D
- Facility will support time-sensitive cancer therapies for patients in the Southeast
Amid an effort to boost its U.S.-based manufacturing capabilities, Novartis is building a state-of-the-art radioligand therapy manufacturing facility in Florida.
The 35,000-square-foot facility in Winter Park will mark the Swiss drugmaker’s fourth such site across the country when it comes online by 2029. The site will optimize delivery of RLT medicines to patients in the Southeast, according to a Jan. 9 news release.
According to a company spokesperson, the facility will cost about $70 million.
In a statement, Novartis CEO Vas Narasimhan said, “Building this new facility in Florida marks an important step in fulfilling the promise of RLT for patients. Radioligand therapy has fundamentally changed how we approach certain cancers, and our growing US manufacturing network ensures we can continue to deliver these critical medicines with speed and reliability to patients who need them.”
Going south
The move comes as part of Novartis’ April 2024 pledge to invest $23 billion over the next five years to expand domestic manufacturing, research and technology. The company has its U.S. headquarters in East Hanover.
Novartis has said the increased capacity will enable production of 100% of its key medicines end-to-end here in the U.S. Altogether, the company expects to build seven new facilities, including a $1.1 billion biomedical research innovation hub in San Diego. After its anticipated opening between 2028 and 2029, the complex will complement Novartis’ existing research outposts in Massachusetts and Switzerland.
The company will also build four new manufacturing sites in soon-to-be-determined states. Those projects include three sites to make biologics drug substances, drug products, device assembly and packaging, as well as one to produce chemical drug substances, oral solids dosage forms and packaging, the company said.
In addition to the RLT site in Florida, Novartis plans to build another one in Texas. Novartis said it will also expand existing radioligand facilities in Millburn, Indianapolis and Carlsbad, Calif.
RLT allows radiation to be delivered directly to a tumor while minimizing harm to surrounding healthy tissue. The precision treatment pairs a tumor-targeting molecule with a therapeutic radioisotope.
Because each RLT dose is individually prepared, its delivery is highly time sensitive. Therefore, proximity to treatment facilities and transportation hubs is critical to ensure patients receive their therapy promptly and at the right location, Novartis said.
Talent search
As the sole company with two U.S. Food and Drug Administration-approved RLT treatments, and an extensive RLT pipeline across several tumors and targets, Novartis touted its expertise in the cutting-edge technology platform transforming cancer care.
Since RLT manufacturing requires specialized talent, Novartis said location is “a key factor in determining the talent for each new facility.”
Advancements in medicine
Last month, Novartis received FDA approval for Itvisma, a first-of-its-kind treatment for spinal muscular atrophy. Read more here.
“Florida has steadily invested in higher education for life sciences and technology, helping to build the next generation of leaders critical to driving for-ward advanced manufacturing for platforms like RLT. With a growing skilled workforce and a regulatory and policy environment that values pharmaceutical innovation, Florida is well positioned to become a leader in pharmaceutical manufacturing,” the company believes.
In a statement, Florida Secretary of Commerce Alex Kelly said, “Thanks to deliberate, focused, intensified investments and world class health innovation partnerships, we have led Florida to become a national and world-recognized leader for breakthroughs in cancer treatment, neurological innovations, and more.”
“Novartis’ investment in manufacturing cancer medicines here in Florida—where we’re already #2 nationally in both manufacturing for medicine and medical device technology—is an incredible opportunity to welcome world class innovators to our incredibly collaborative and impactful life sciences community,” Kelly said.
Let’s make a deal
Novartis is among more than a dozen American drugmakers to reach deals with the White House to lower prescription drug costs in exchange from an exemption from U.S. pharmaceutical tariffs.
Since calling on the industry last summer to voluntarily reduce costs, the White House has secured deals with 14 companies to cut medicine prices for the government’s Medicaid program and for cash-paying consumers.
The list includes several pharma giants with a New Jersey presence, such as Merck, Bristol Myers Squibb, Novartis, Sanofi and Novo Nordisk. These companies have also unveiled billions of dollars aimed at boosting domestic capabilities amid pressure from the Trump administration. The list includes the following commitments:
