Novartis has formed a strategic collaboration with drug delivery specialist Lindy Biosciences to develop self-administered versions of the Swiss pharma’s innovative drugs.
For $20 million upfront, Novartis has obtained exclusive global rights to use Lindy’s Microglassifiction suspension technology to design high-concentration, self-administered drugs against multiple biologic targets, Lindy said Wednesday.
If everything goes according to plan, Lindy may receive up to $934 million in milestone payments, plus tiered single-digit royalties on potential sales.
The deal “marks a significant milestone as we take Lindy’s formulation technology into the clinic for the first time,” Lindy’s founder and CEO, Deborah Bitterfield, Ph.D., said in a statement Wednesday.
Founded in 2016, Lindy is headquartered in Morrisville, North Carolina. Its core Microglassifiction technology aims to turn traditionally intravenously infused biologics into subcutaneous injectables formulated as suspensions of solid particles.
The proprietary technique can turn monoclonal antibodies into protein microdoplets and uses common organic solvents to remove water from the solutions within seconds, according to Lindy’s website. The final product may be administered at home via pre-filled syringes or autoinjectors.
“By delivering high concentrations of biologics, this technology significantly increases the maximum dose that can be administered in a single subcutaneous injection,” Lindy said in a release Wednesday. “This has the potential to reduce healthcare costs while also improving patient comfort, convenience, and treatment compliance.”
Already, Novartis markets some self-administered injectable drugs. One presentation of the company’s blockbuster anti-inflammation antibody Cosentyx comes as an autoinjector pen dubbed Sensoready that patients can self-administer after proper training. The same device technology is also used in Novartis’ fast-growing multiple sclerosis drug Kesimpta.
Pharma companies have been keen on developing subcutaneous injectables for IV medicines. In a similar deal to the Novartis-Lindy pact, Eli Lilly in October 2023 put down $20 million upfront to leverage Elektrofi’s microparticle formulation technology exclusively on three undisclosed drug targets. The deal includes over $150 million in milestone payments per target, plus potential royalties. Lilly also retained an option to expand the agreement to cover two more targets.
Across therapeutic areas, an easier-to-use formulation can sometimes become a determinant in a drug’s commercial success. Analysts have been counting on a subcutaneous formulation to accelerate the slow launch of Eisai and Biogen’s Alzheimer’s disease drug Leqembi because of its potential to alleviate the burden on treatment centers.
After the success of Darzalex Faspro, an under-the-skin version of the multiple myeloma antibody drug Darzalex, Johnson & Johnson has teamed with drug delivery expert Halozyme to turn the big pharma company’s lung cancer bispecific drug Rybrevant into a subcutaneous version.
Because Rybrevant, used in combination with J&J’s small-molecule drug Lazcluze, will challenge AstraZeneca’s oral med Tagrisso, industry watchers view the subcutaneous formulation as an important piece in the regimen’s overall competitiveness because of its convenience and reduced side effects compared with the original intravenous infusion.
Surprisingly, subcutaneous Rybrevant also appears to be more efficacious than its IV counterpart, as shown in a phase 3 trial. Investigators theorized that the absorption of the subcutaneous drug via the lymphatic system potentially enhances immune-mediated activity.