Xeris scores first FDA nod with shelf-stable glucagon injector, syringe

FDA Building 2
The FDA approved Xeris Pharmaceuticals' shelf-stable glucagon injector pen Tuesday. (FDA)

Diabetes drugmaker Xeris Pharmaceuticals made a $75 million bet last summer when it went public to back an FDA submission for its shelf-stable glucagon injector pen. Now, more than a year later, Xeris is ready to reap the rewards from that gambit.

Tuesday, the FDA approved Chicago-based Xeris’ Gvoke pen to treat severe hypoglycemia in pediatric and adult diabetes patients over the age of two, the company said.

Gvoke is a first-of-its-kind shelf-stable glucagon pen that comes in a prefilled syringe application or an auto-injector, adding a convenience factor to the standard-of-care treatments that require syringe filling prior to use.

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The FDA’s approval was based on data from three phase 3 clinical trials showing Gvoke’s 100% and 99% success rates in treating children and adult patients, respectively, the company said. Xeris said in a release its “usability research” showed a nearly 100% success rate in administering a full dose of glucagon in a two-step administration process.

RELATED: Xeris files $75M IPO to fund shelf-stable glucagon rescue injector

On the heels of Tuesday’s news, Xeris’ share price dropped from a market-open high of $11.61 to a low of $9.58.

In a call to investors Tuesday morning, Chairman and CEO Paul Edick said the company expected to launch the prefilled syringe application within four to six weeks with the auto-injector manufacturing scale-up starting immediately.

Analysts were a bit put off by the news that the autoinjector would launch after the syringe application, sometime in 2020. 

SVB Leerink analyst Ami Fadia said the wait for the autoinjector could put Xeris at at a disadvantage against Eli Lilly's glucagon nasal powder Baqsimi, which the FDA approved in July. 

"We view the autoinjector form as a competitive product to Baqsimi but the relative inconvenience of (pre-filled syringes) could put Xeris in an uphill battle against the large pharma competitor, at least during the first couple of quarters of launch," Fadia wrote in a note to investors.

RBC Capital Markets analyst Randall Stanicky said the wait on the autoinjector was only a "modest surprise" and projected peak sales for Gvoke at $248 million per year in 2024. 

Edick said both applications, as well as the two available doses for each, will be listed at the same price and will be competitive with Baqsimi. 

With the Gvoke prefilled syringe fast approaching the market, Edick said 60 sales reps would come online in the next few weeks on conditional offers, with the pen expected to have robust market access in major pharmacies and door-to-door deliveries.

Edick said Xeris’ market research indicated the company would see strong physician and patient uptake right away on the product.

“We believe there is a great deal of anticipation in the market,” he said. “Our market research suggests that there are patients who really do want a better solution and are not filling these current prescriptions because the kit that is available is just too difficult and too scary.”

Also Tuesday, Xeris announced it had expanded its line of credit with Oxford Finance and Silicon Valley Bank from $45 million to $85 million in preparation for Gvoke’s commercial launch.

Under the terms of its debt facility, Xeris will draw $60 million at the initial funding date with additional withdrawals of $15 million and $10 million available before March 31, 2021, and June 30, 2021. The new debt plan replaces an original $45 million debt facility, of which Xeris had already drawn down $35 million.

Edick called the restructured debt deal a “no-brainer” for the company, with more favorable terms than the original agreement.

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