Lexicon Pharmaceuticals has faced numerous challenges in its journey to gain regulatory approval for its groundbreaking heart drug, Inpefa. After securing FDA approval this year, Lexicon is enlisting the expertise of Tom Garner to ensure a successful launch of the drug. Garner brings a wealth of experience in both heart disease and pharmaceutical sales, having recently served as the Senior Vice President and head of the US Cardiovascular & Established Brands business unit at Bristol Myers Squibb.
During his impressive 21-year tenure at BMS, he contributed to the success of heart drug Eliquis, the most widely prescribed oral branded medicine in the US, and the newly approved therapy for obstructive hypertrophic cardiomyopathy, Camzyos. Prior to BMS, Garner held positions at Boehringer Ingelheim and Eli Lilly.
At Lexicon, Garner’s primary focus will be on Inpefa, a once-daily pill that made history in May as the first SGLT1/SGLT2 inhibitor to receive FDA approval. This medication is now licensed to reduce the risk of heart failure in adults who have previously experienced the condition or have Type 2 diabetes, chronic kidney disease, or other cardiovascular risk factors.
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Inpefa’s path to approval has been marked by twists and turns. In 2019, it faced an initial FDA rejection for treating Type 1 diabetes patients who couldn’t control their blood sugar with insulin, following an 8-8 vote from an advisory committee. A subsequent appeal by Lexicon was also denied, citing concerns about diabetes ketoacidosis. Despite these setbacks, European regulators approved sotagliflozin as Zynquista for Type 1 diabetes patients. However, the product’s marketing rights in Europe were later withdrawn by Guidehouse Germany GmbH, citing a lack of interest in commercializing the drug.
As Lexicon moved towards seeking approval for heart failure treatment in Type 2 patients in 2022, the company temporarily withdrew its application due to what it referred to as “technical issues,” which were ultimately resolved.
Inpefa enters a competitive market of SGLT2 inhibitors, including TheracosBio’s Brenzavvy, which received approval earlier this year. Leading the market are Boehringer Ingelheim and Eli Lilly’s Jardiance, with $6.1 billion in sales in 2021, and AstraZeneca’s Farxiga, generating $4.4 billion in revenue last year.
“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. 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.”
– Lonnel Coats, Lexicon’s CEO
“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.”