Ten years, two promising phase 3 trials and an FDA complete response letter later and AbbVie has decided to ditch an eye disease drug with Molecular Partners.
AbbVie has pulled out of the licensing and collaboration deal on the drug, Abicipar pegol, and will give the full worldwide development and sales rights back to Molecular Partners.
The Swiss biotech will put together a special committee to figure out next steps, Molecular Partners said Monday. The loss of support from AbbVie comes almost two months after a lackluster IPO performance from the biotech.
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“There remains a significant unmet medical need for patients living with nAMD and DME, and we remain confident in abicipar’s potential to offer these patients a differentiated treatment option over existing therapies," said Molecular Partners CEO Patrick Amstutz in a statement.
When AbbVie's Allergan signed a licensing and collaboration agreement with the Swiss biotech in 2011, Molecular Partners was in line to receive around $1.5 billion in biobucks. But that faltered last June when the FDA said the drug, Abicipar pegol, a DARPin therapy, led to too much inflammation in the eye.
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Now, Molecular Partners said improvements have been made in the manufacturing and formulation of the eye drug. Preclinical models have shown the potential to overcome those inflammatory side effects that gave the FDA qualms, the company said as part of the ended-deal announcement Monday.
The drug aims to treat patients with neovascular age-related macular degeneration and diabetic macular edema. The experimental therapy has been through two phase 3 studies that Molecular Partners labeled as positive given its quarterly dosing to maintain vision gains required less than half the number of injections as Roche's Lucentis (ranibizumab), which requires monthly treatment.
Going forward, AbbVie will still partner with Molecular Partners on their discovery collaboration to evaluate the biotech's DARPin candidates for other ophthalmic indications.
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For AbbVie, the busted deal is not the biggest setback in its ophthalmology pipeline. The company's age-related far-sightedness drug showed significant improvements in vision in a phase 3 trial, and an FDA decision is due by the end of this year.
For Molecular Partners, the AbbVie partnership is one of multiple Big Pharma collabs.
Molecular Partners is currently putting resources into its COVID-19 partnership with Novartis on an antiviral for SARS-CoV-2. The drug, ensovibep, is being studied in a phase 2 single-arm pilot in ambulatory patients in the Netherlands; a global phase 2/3 study in collaboration with Novartis; and a National Institutes of Health-sponsored global phase 3.
Though given the tough time many drugs have had in treating COVID-19, this trial remains high-risk. The biotech's shares were down more than 2% late afternoon European time on the SWX.