[gpt3]rewrite this title and make it good for SEOPrilenia signs deal for former Teva ALS drug worth up to 500m[/gpt3]

Israeli-Dutch clinical stage biotech company Prilenia Therapeutics has announced a collaboration and licensing agreement for its lead drug Pridopidine, with Spanish pharmaceutical company Ferrer. As part of the agreement Prilenia will receive €125 million in immediate and near-term milestone payments and up to €500 million overall including all milestone payments as well as royalties if the product is improved and sales successfully on the market.

In exchange, Ferrer will receive the rights to market the drug in Europe and other markets, while the US market will remain in Prilenia’s hands. This is a relatively high amount that the company is receiving for an agreement that still leaves it in control of the US market.

Pridopidine was brought to Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) by Dr. Michael Hayden, who served as Teva’s director of innovative R&D under CEO Dr. Jeremy Levine. With the $40 billion acquisition of Actavis and Teva’s spiralling into a cash flow crisis, the company decided to forgo a large part of its development plans, including this drug.

Prilenia CEO Dr. Hayden purchased the development rights in exchange for limited future royalties and founded Prilenia together with a team of Teva veterans. He also founded other companies that were based on Teva’s assets or talents (for example, 89bio (Nasdaq: ETNB), which already has a market cap of $1.1 billion).

Pridopidine was initially intended to treat Huntington’s disease. Prilenia COO Limor Ben Har says, “Following the thorough work done at Teva, it became clear that the drug’s mechanism of action is involved in protecting nerve cells from degeneration.” This made the drug relevant for additional indications in which there is early nerve cell death, such as ALS.

Results demonstrate potential

The company’s journey from its founding as a “spin-off” from Teva to the present day has not been without disappointments, but it has benefitted from several crucial events, which explain the size of the deal. In 2020, the company joined the Haley ALS Platform Trial, a large-scale trial conducted by the Haley Institute for ALS Research, a well-funded institute led by the world’s leading researchers in the field.

As part of the innovative trial, which aims to accelerate the development of ALS drugs, several drugs are being tested against each other and against placebo drugs, with the institute itself managing and funding a large part of the process.

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The trial results were recently received, showing that Pridopidine, as well as several other drugs, did not meet the main trial objectives. Ben-Har explains, “The trial was relatively short – 24 weeks – and at the same time the acceptance criteria were very liberal, allowing patients to be recruited up to three years after the onset of the disease. This created a bias in favor of patients whose disease progresses slowly. The combination of a short trial and patients whose disease progresses slowly makes it very difficult to prove the drug’s effectiveness.

“In a retrospective analysis we conducted, we found that patients at a relatively early stage but with rapidly progressing disease did benefit from the treatment.”

Despite not meeting the trial’s end points, the company intends to enter a Phase III trial. Moving from a Phase II trial that did not meet its end points to Phase III is sometimes possible in rare and serious diseases, if the results indicate potential. Ben Har adds that a consultation meeting was held with the FDA before the decision was made.

In the Huntington’s field, the Phase IIb trial also yielded mixed results. “Some of the patients were taking antidopaminergic antipsychotics, and the research literature from recent years indicates that they may mask the effect of our drug – and that is also what we saw in the trial,” says Ben Har. “The entire trial did not meet its primary end point, but a further analysis found a positive effect among patients who were not taking antidopaminergic drugs.”

The European Medicines Agency (EMA), allows rare diseases to apply for approval under the Totality of Evidence track, where even if a single trial fails, approval can be sought based on all of the existing information, including retrospective analyses, explains Ben Har. Prilenia has already applied for approval under this track, and hopes to receive an answer by the end of the year. A positive answer would allow the drug to reach the European market as early as next year.

Thus it is understandable why the commercialization deal is focused primarily on Europe, which may become the first market in which the drug will be approved, before the US market.

Prilenia has 50 employees, 12 of whom are in Israel, and the proceeds from the commercialization agreement will allow it to expand. In 2020, Prilenia raised $62.5 million led by the Forbion and with participation from Morningside Venture Investments, Sectoral Asset Management, Talisman Capital Partners, and Genworks 2. In another round of funding in 2021, investors SV Health and Sands Capital joined and to date, the company has raised a total of over $100 million.

Published by Globes, Israel business news – en.globes.co.il – on April 29, 2025.

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