Maze lands new partner for Pompe drug, after Sanofi pact came apart

Dive Brief:

• Biotechnology startup Maze Therapeutics has licensed a Pompe disease drug to Shionogi, five months after a challenge from the Federal Trade Commission caused Sanofi to back out of a similar deal for the same medicine.
• Per deal terms announced Friday, Shionogi will pay Maze $150 million upfront, and possibly more later, for global rights to a drug called MZE001. The medicine is in Phase 1 testing, with results expected later this year. It could become the first oral therapy for Pompe, a rare inherited disease that causes progressive muscle weakness.
• The deal has already been cleared by U.S. antitrust authorities and is complete, freeing Maze to receive the upfront payment. According to a spokesperson, the startup never got any money from its terminated collaboration with Sanofi, which had promised Maze $150 million initially through a deal struck last May.

Dive Insight:

Partnerships with pharmaceutical companies are vital for young biotechs. Alliances enable startups to defray the sizable costs of developing a medicine, pursue research they may not otherwise have and gain credibility with future investors.

The FTC’s decision to challenge Maze’s licensing deal with Sanofi in December therefore rang alarm bells across the sector. In its complaint, the FTC argued the deal would “eliminate a nascent competitor poised to challenge Sanofi’s monopoly in the Pompe disease therapy market,” while reducing the incentive to develop new therapies for the condition. Sanofi already sells multiple drugs for Pompe disease.

Rather than fight the FTC, Sanofi canceled the partnership, costing Maze financially — the deal involved up to $750 million in potential payouts — and slowing the drug’s development.

While the regulator has taken a more aggressive stance against M&A in pharma, its complaint against the Maze deal was a “troubling” sign for drug startups, CEO Jason Coloma said in an interview earlier this year.

Vijay Pande, a general partner at Andreessen Horowitz, which invests in Maze, warned at the time that the regulator’s action “could have a chilling effect” on dealmaking. 

Yet even though the FTC continues to zero in on drugmakers, it hasn’t challenged other licensing deals. Now Maze, only five months later, has found a partner, Shionogi, that doesn’t sell any medicines for Pompe.

“Shionogi is committed to advancing and commercializing MZE001 because they understand the potential this therapy has for patients and the unmet medical needs it could address,” said Coloma, in a statement.

MZE001 blocks an enzyme involved in glycogen production, lowering the amount that accumulates in the muscles of people with Pompe. The drug has the potential to be used on its own or alongside standard enzyme replacement therapies, though it remains in early testing. A Phase 2 study could begin early next year, according to a spokesperson.