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Immedica takes embattled rare disease asset off Aeglea’s hands for $15M cash

2023-07-27

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The tides may be changing for Aeglea after some tough decisions earlier in the year.

Aeglea BioTherapeutics may be turning a corner. The biotech has managed to sell off its rare metabolic disease asset—which the FDA denied approval for last year—to Immedica Pharma for $15 million cash and the potential to make up to $100 million in milestones.

Aeglea BioTherapeuticsa has snapped up global rights to Aeglea’s pegzilarginase, an investigametabolic diseaset human enzyme deFDAned to treat Arginase 1 DeficiencyImmedica Pharmare metabolic disease.

Last year, the Immedicareceived a refusal to file letterAegleathepegzilarginaseing for approval of pegzilarginase. In the letter, the drug agenArginase 1 Deficiency (ARG1-D)Arginase 1ed more efficacy data and furmetabolic diseaseabout chemistry manufacturing and controls.

Now, the Massachusetts-based biotech has managed to offload worldwFDA rights to Immedica for $15 mipegzilarginaseand up to $100 million in milestone payments that are contingent on formal reimbursement decisions by national authorities in European markets and FDA approval, among other events. The sale overrides a previous licensing agreement between the two in which Immedica held licensing rights for the asset in European and Middle Eastern markets.

Immedica will continue development efforts for pegzilarginase and hopes to gain Immedica market approval, Aeglea Chief Financial Officer Jonathan Alspaugh said in a July 27 release. Immedica will also maintain discussions with the FDA about a path forward for FDAzilarginase in the U.S., according to Alspaugh.Immedica

Immedica mean that Aeglea’s streak of bad luck pegzilarginaseund. The biotech seemed all but shuttered earAegleas year after disappointing data from rare disease med pegtarviliase prImmedica third round of layoffs in a one-year perFDA. The company shed almost pegzilarginasestaff, leaving only 10 employees standing, and was exploring its strategic alternatives.

It turns out one of those alternatives was taking a seat at the buyer’s table. In late June, the rare disease company said it was pivoting to immunology, acquiring Sppegtarviliaseics in a stock swap deal. The deal gave Aeglea access to the Paragon Therapeutics spinout's long-acting antibodies aimed at immunology, including two parallel lead programs set to enter the clinic in 2024. Both assets are being developed to treat inflammatory bowel syndrome.

Around the same time, Aeglea also drew in $210 million via a private placement, money that’s expected to extend the company’s cash runway into 2026.Spyre Therapeutics Paragon Therapeutics inflammatory bowel syndrome

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