Israeli-Dutch medical stage biotech firm Prilenia Therapeutics has introduced a collaboration and licensing settlement for its lead drug Pridopidine, with Spanish pharmaceutical firm Ferrer. As a part of the settlement Prilenia will obtain €125 million in rapid and near-term milestone funds and as much as €500 million total together with all milestone funds in addition to royalties if the product is improved and gross sales efficiently in the marketplace.
In alternate, Ferrer will obtain the rights to market the drug in Europe and different markets, whereas the US market will stay in Prilenia’s fingers. This can be a comparatively excessive quantity that the corporate is receiving for an settlement that also leaves it in command of the US market.
Pridopidine was dropped at Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) by Dr. Michael Hayden, who served as Teva’s director of modern R&D below CEO Dr. Jeremy Levine. With the $40 billion acquisition of Actavis and Teva’s spiralling right into a money stream disaster, the corporate determined to forgo a big a part of its growth plans, together with this drug.
Prilenia CEO Dr. Hayden bought the event rights in alternate for restricted future royalties and based Prilenia along with a workforce of Teva veterans. He additionally based different corporations that have been based mostly on Teva’s property or skills (for instance, 89bio (Nasdaq: ETNB), which already has a market cap of $1.1 billion).
Pridopidine was initially supposed to deal with Huntington’s illness. Prilenia COO Limor Ben Har says, “Following the thorough work executed at Teva, it grew to become clear that the drug’s mechanism of motion is concerned in defending nerve cells from degeneration.” This made the drug related for extra indications in which there’s early nerve cell dying, comparable to ALS.
Outcomes display potential
The corporate’s journey from its founding as a “spin-off” from Teva to the current day has not been with out disappointments, but it surely has benefitted from a number of essential occasions, which clarify the scale of the deal. In 2020, the corporate joined the Haley ALS Platform Trial, a large-scale trial carried out by the Haley Institute for ALS Analysis, a well-funded institute led by the world’s main researchers within the discipline.
As a part of the modern trial, which goals to speed up the event of ALS medication, a number of medication are being examined towards one another and towards placebo medication, with the institute itself managing and funding a big a part of the method.
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The trial outcomes have been lately acquired, displaying that Pridopidine, in addition to a number of different medication, didn’t meet the primary trial aims. Ben-Har explains, “The trial was comparatively brief – 24 weeks – and on the identical time the acceptance standards have been very liberal, permitting sufferers to be recruited as much as three years after the onset of the illness. This created a bias in favor of sufferers whose illness progresses slowly. The mixture of a brief trial and sufferers whose illness progresses slowly makes it very troublesome to show the drug’s effectiveness.
“In a retrospective evaluation we carried out, we discovered that sufferers at a comparatively early stage however with quickly progressing illness did profit from the therapy.”
Regardless of not assembly the trial’s finish factors, the corporate intends to enter a Part III trial. Transferring from a Part II trial that didn’t meet its finish factors to Part III is typically doable in uncommon and critical illnesses, if the outcomes point out potential. Ben Har provides {that a} session assembly was held with the FDA earlier than the choice was made.
Within the Huntington’s discipline, the Part IIb trial additionally yielded combined outcomes. “A number of the sufferers have been taking antidopaminergic antipsychotics, and the analysis literature from current years signifies that they might masks the impact of our drug – and that’s additionally what we noticed within the trial,” says Ben Har. “The whole trial didn’t meet its main finish level, however an extra evaluation discovered a constructive impact amongst sufferers who weren’t taking antidopaminergic medication.”
The European Medicines Company (EMA), permits uncommon illnesses to use for approval below the Totality of Proof monitor, the place even when a single trial fails, approval might be sought based mostly on all the current info, together with retrospective analyses, explains Ben Har. Prilenia has already utilized for approval below this monitor, and hopes to obtain a solution by the top of the 12 months. A constructive reply would permit the drug to succeed in the European market as early as subsequent 12 months.
Thus it’s comprehensible why the commercialization deal is concentrated totally on Europe, which can turn into the primary market through which the drug will likely be authorized, earlier than the US market.
Prilenia has 50 workers, 12 of whom are in Israel, and the proceeds from the commercialization settlement will permit it to broaden. In 2020, Prilenia raised $62.5 million led by the Forbion and with participation from Morningside Enterprise Investments, Sectoral Asset Administration, Talisman Capital Companions, and Genworks 2. In one other spherical of funding in 2021, buyers SV Well being and Sands Capital joined and so far, the corporate has raised a complete of over $100 million.
Printed by Globes, Israel enterprise information – en.globes.co.il – on April 29, 2025.
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