Teva will have to wait more than a decade to launch its proposed generic version of Amicus Therapeutics’ ultra-rare genetic disorder treatment Galafold (migalastat) 123mg capsules, after reaching a settlement agreement with the originator in US patent-litigation proceedings.
Under the terms of a deal that terminates all ongoing Hatch-Waxman litigation between Amicus and Teva regarding Galafold patents pending in the US District Court for the District of Delaware, Teva will be able to launch its generic version of the Fabry disease treatment beginning on 30 January 2037.
According to the US Food and Drug Administration’s Orange Book, Galafold is shielded currently by dozens of patents, including 40 that expire in 2038 and five the following year. Patent protection on that database runs as far as 2042.
Fabry disease is a rare genetic condition which causes a person not to produce enough healthy versions of the enzyme alpha-galactosidase A, causing harmful levels of the lipid sphingolipids to build up in blood vesselsand tissues.
Galafold was approved by the FDA for patients with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on anin vitrotest in August 2018, more than a decade after Sanofi’s Genzyme unit established the market for a Fabry treatment with the launch of Fabrazyme(agalsidase beta) – an enzyme replacement therapy administered intravenously every two weeks.
Galafold was thus the first oral monotherapy for people living with Fabry disease who have amenable genetic variants.
To date, no generic versions of either Galafold or Fabrazyme have received a final approval from the FDA, meaning that with Teva’s settlement, a small but vastly expensive market can open up to cheaper generic competition. Amicus prices Galafold at around $315,000 per year, and sales of the drug reached $230m in the first six months of 2024, up from $180m in H1 2023.
Teva was sued for patent infringement by Amicus in late 2022, at the same time as the originator also slapped further abbreviated new drug application sponsors Lupin and Aurobindo with lawsuits – four in total against the three generics manufacturers – for allegedly infringing Galafold’s intellectual property.
Following the Teva settlement, Amicus noted that litigation would continue against Aurobindoas the remaining active party, while a litigation stay ordered towards the end of last year would remain in place for Lupin.
Lupin in April this year announced tentative FDA approval for its generic Galafold product, though this does not show currently on the FDA’s database of approved drugs. The Indian firm plans to manufacture its product at its facility in Goa.
Commenting on Teva’s settlement deal, Bank of America Securities, which holds a ‘buy’ rating on Amicus stock, said it was encouraged by the first agreed upon settlement date, which comes only a year before Galafold’s composition-of-matter patents expire in 2038.
Meanwhile, the equity analyst also feels that the deal will “likely set the tone” for other ongoing negotiations involving Aurobindo and Lupin. “We now model a more gradual decline from US peak sales in 2030, noting despite the long patent life we could see impacts from competitors entering the space (gene therapies),” Bank of America stated, forecasting peak annual Galafold sales at around $680m.
Leerink Partners, which holds an ‘outperform’ rating on the originator’s stock, described Teva’s settlement an “encouraging step forward” for the broader Galafold litigation, “and suggests that other parties may also settle.”
“Considering some Galafold patents expire in the late 2020s and the risk of a skinny label approval, we believe this settlement in the late 2030s is a near best-case outcome for [Amicus]. This potentially provides the company with another 10+ years of exclusivity in the US for Galafold, which continues to launch well and is on track for >$450M in sales this year.”
