Indianapolis-based Exelead specializes in small, but it means big business. The contract development and manufacturing company makes the final formulations for drugs that treat rare and small populations; “large-scale pharmaceutical companies wouldn’t touch some of the products we manufacture, because of scale,” says Chief Executive Officer John Rigg. Demand is so high, Exelead is investing $25 million to double its capacity.
Personalized medicine is driving business for the company; unlike the traditional one-size-fits-all approach in pharmaceuticals, “hyper-specific” drugs are in high demand, “whether your operation needs batches of 1 liter or 1,000,” says Rigg. More specifically, liposomes comprise about 80 percent of Exelead’s volume. Liposomes are drug delivery systems; Rigg describes them as “spheres” which hold the active pharmaceutical ingredients to shield the drugs from detection by the body’s immune system.
“Liposomal drug products can be highly targeted, because the payloads—the active ingredients—are protected,” says Rigg. “For cancer, it could be [targeted] to the organ of choice. A lot of the active ingredients [for cancer] are toxic in nature—they also kill good cells. These liposomes allow us to put a lot less dose of the active ingredient into a patient, because you know it’s going to be targeted to the area that it needs to get to.”
Rigg describes liposomes as the next evolution in pharmaceuticals; it began with small molecules as the active ingredient, then the biotech boom delivered proteins that could be manufactured for therapeutic use, and “now things have moved on, where RNA and people’s DNA are being used to fight cancers or diseases.”
“Those RNA payloads are very fragile, meaning they’re not very stable in the body,” says Rigg. “So these liposomes not only get them to the right area within the body, but they’re also protecting them at the same time.”
Liposomal manufacturing is also an area of high interest across the U.S. for venture capital investment.
“I get a phone call once a week asking if they can buy [Exelead],” says Rigg. “It’s very, very hot in the venture capital world right now. A lot of our clients that we deal with are venture capital-backed.”
Business is booming for Exelead; Rigg says it’s working with or developing programs for “every large pharma company that you could think of.” In fact, Rigg shares that he shut down the business department during early 2019 when Exelead reached capacity; “I had to say, ‘Sorry, we’re full’ for a three-month period.”
“In 2016, we were manufacturing four different products per year, all commercial,” says Rigg. “As of today, we’re working on 22 different projects; that’s pretty complex. I’ve got a list in excess of 50 other people who we’re negotiating with right now at various stages.”
The company, which employs about 150 people, is expanding to keep pace with demand. Exelead is investing $13 million in new equipment and $12 million in infrastructure. The expansion will likely be ready for commercial production by late 2020.
Exelead says it will remain focused on small batch production, where the company’s agility is paramount. Rigg says once it transfers in a molecule, the company can deliver a formulated drug product for clinical use within four months.
As it grows internally, the company is also working to grow its brand and outreach, as well as deepen its connection with the community surrounding its Guion Road campus on the northwest side of Indianapolis. Earlier this year, Exelead donated $50,000 to Pike High School’s STEM program.
With a unique niche producing small batch drugs, an expansion underway and major pharmaceutical clients that stretch from coast to coast, Exelead says it will help companies write their future in the next chapter of pharmaceutical manufacturing.
Rigg says, unlike most pharmaceutical operations, Exelead’s philosophy is “the smaller the scale, the better.”
Rigg says Indiana’s talent pool has deep pharmaceutical expertise.