For many biopharmas, it takes years of hard work to transition from being a clinical-stage drugmaker to a commercial one. Companies rarely want to make the shift back. But after a years-long uphill battle for Lexicon Pharmaceuticals and its insulin adjunct prospect Zynquista (sotagliflozin), the drugmaker is doing exactly that.
Lexicon will move forward with no commercial sales team and no further promotional efforts for its Inpefa, a heart failure version of sotagliflozin approved by the FDA in 2023. The company will still manufacture the drug and provide it to patients and existing prescribers, Lexicon said in a Friday release.
The pivot will prompt a 60% reduction of the company's workforce, effective December 31st. Lexicon expects to cut full-year operating costs by $100 million with the plan. Already in August, the company slashed 50% of its field force in a bid to save $40 million annually.
"While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," CEO Mike Exton, Ph.D., said in the company’s release. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact.”
Lexicon’s pipeline includes a phase 3 study of Inpefa in hypertrophic cardiomyopathy, plus a phase 2 trial of its diabetic peripheral neuropathic pain candidate that should read out in early 2025. The company is also studying a non-incretin oral prospect for obesity and other cardiometabolic disorders.
The strategy shift comes after the company’s attempts to market insulin adjunct prospect Zynquista have crashed and burned yet again. This time, the FDA issued a definitive notice of deficiencies in response to the company's drug application.
Lexicon had recently refiled its Zynquista application with the FDA in hopes to bring the drug to patients with type 1 diabetes and chronic kidney disease as an add-on to insulin for glycemic control five years after the agency's initial rejection. The company made its case to an FDA advisory committee again late last month, but the panel wasn’t convinced that the benefits of the treatment outweigh its risks.
The agency was meant to decide on an approval by December 20, but instead hit Lexicon with a notice that it wouldn't be completing the review because of the application's "deficiencies."
Zynquista had first faced an advisory committee back in 2019 amid an approval bid for a broader population, which ended in an 8-8 vote and resulted in a safety-related complete response letter from the FDA. Since then, Lexicon's prior partner Sanofi jumped ship after initially hopping on with a high-dollar licensing deal. Sanofi ended up having to pay $260 million to exit the partnership after Lexicon claimed breach of contract.
Lexicon tried again to appeal the decision shortly after its first rejection but had no success. Even in Europe the struggles continued, with marketing partner Guidehouse Germany withdrawing a marketing authorization despite a regulatory approval in the type 1 diabetes indication.
While Inpefa eventually ended up receiving the regulator’s blessing, sales have been slow, with only $1.7 million coming in during this year’s third quarter. Last year, the company pulled in 2023 revenues of just $1.2 million and tacked up losses of $175.6 million.