Lexicon Pharmaceuticals spent years jumping and often falling over regulatory hurdles for its new heart drug Inpefa, but, after finally getting an FDA approval this year, it’s now turning to Tom Garner to help shore up the drug’s launch.
Garner has some real heart disease and pharma sales chops, having most recently been at Bristol Myers Squibb as its senior vice president and head of the company's U.S. Cardiovascular & Established Brands business unit. That included working on heart drug Eliquis, the most prescribed oral, branded medicine in the U.S., as well as Camzyos, a newly approved therapy for obstructive hypertrophic cardiomyopathy. He’s been at BMS for a mighty 21 years, having served stints at Boehringer Ingelheim and Eli Lilly before that stretch.
His role at Lexicon will initially center on Inpefa, the once-daily pill that back in May became the first SGLT1/SGLT2 inhibitor to reach the market after getting an FDA green light. The med is now licensed to reduce the risk of heart failure in adults who have had the condition or have Type 2 diabetes, chronic kidney disease or other cardiovascular risk factors.
It has been a winding and sometimes dark path for the drug to reach the finish line. In 2019, following an 8-8 vote from an advisory committee, what was then just known as sotagliflozin was rejected by the FDA to treat Type 1 diabetes patients who can’t control their blood sugar with insulin.
A year later, when Lexicon appealed the decision, the regulator swatted it back again, citing the risk of diabetes ketoacidosis.
In between the FDA rejections, regulators in Europe approved sotagliflozin as Zynquista for Type 1 diabetes patients. Last year, however, the holders of Zynquista’s marketing rights in Europe, Guidehouse Germany GmbH, withdrew the marketing authorization, saying it did not wish to commercialize the product.
Then, as Lexicon approached its bid to treat heart failure in Type 2 patients in 2022, the company yanked its application to work through what it termed “technical issues,” though these were ultimately resolved.
Inpefa joins a strong field of SGLT2 inhibitors, including another that was approved earlier this year—TheracosBio’s Brenzavvy. Blockbusters that rule the market are Boehringer Ingelheim and Eli Lilly’s Jardiance, which generated sales of $6.1 billion in 2021, and AstraZeneca’s Farxiga, which rung up $4.4 billion in revenue last year.
It will be a tough market battle, but one that Lexicon believes Garner can take on.
“His overall breadth and depth of commercial and general management experience, with notable success in the cardiovascular space and leading launches, makes him a particularly valuable addition to our management team as we continue to drive the launch of Inpefa (sotagliflozin) for the treatment of heart failure,” said Lonnel Coats, Lexicon’s CEO, in a press release.“As the leader of our commercial organization, Mr. Garner will have a critical role in ensuring we are effectively executing on our launch strategy for Inpefa and delivering against the promise we believe this differentiated brand can have for patients."
"I am very enthusiastic about joining the Lexicon leadership team and leading the commercial organization,” said Garner, adding that he is “particularly excited to leverage my expertise for the ongoing launch of Inpefa.” He is also eyeing the “potential opportunity” to bring Lexicon’s late-stage pipeline drug LX9211 to market for diabetic peripheral neuropathic pain. He said that the med “is what attracted me to Lexicon, and I cannot wait to step into this role and get started.”