Pharmamar puts all the meat on the grill in lurbinetectidine, a marine compound transformed into an antitumor against small cell lung cancer and sold under the trade name of Zepzelca.
The biopharmaceutical is aware that much of its future depends on the success of the drug, once its longest-lasting antitumor in the portfolio, Yondelis, with more than 20 years in the market, has stabilized sales of over 70 million euros per year.
Aplidin still is in the early stages of moving from antitumor to possible broad-spectrum antiviral, according to the first laboratory tests of the new Pharmamar virology unit.
The drug, based on plystidine, is also its bet against the coronavirus, but the study phase prior to the marketing application is stalled two months before the date set by Pharmamar to complete the study.
Finally, his new drug, called MP14, is in initial phase of laboratory studies or small phase 1 to measure its safety in different types of solid tumors.
its affiliates Genomics Y Sylentis are not representative for the results. Genomica helped with the sale of coronavirus detection tests, but the numbers are falling due to the increase in competitors and price drops, and Sylentis is in the initial phase of studies against eye diseases.
Looking to 2025
Therefore, all hopes are pinned on Zepzelca in the case of Pharmamar and therefore has five open trials with the drug, according to the registry of Pharmamar studies compiled by the health agency of the U.S, the FDA for its acronym in English.
The most important of all is called Lagoon and is the key to mass marketing Zezpelca in the United States. The study began earlier this year and its conclusion will come in 2025.
Pharmamar will test Zepelca in 705 volunteers with small cell lung cancer in whom platinum-based first-line treatment has not been effective. Lurbinetectidine will be administered as a single agent or combined with irinotecan against comparators such as irinotecan itself or with topotecan.
If its effectiveness is confirmed, Zepzelca would become the first second-line treatment against this pathology Y Pharmamar will directly receive 150 million dollars by Jazz Pharmaceuticals after the FDA approved its sale.
Of the 1,000 million dollars that Pharmamar would receive for the license extension in the United States and Canada to Jazz would remain to be received after full approval, it is now marketed under the emergency use formula, $550 million in sales milestones and royalties.
Studies for other pathologies
Lagoon will be used by the ‘biotech’ as a registration test to start the sales application process in the European Union through your health agency, the EMA for its acronym in English.
The processes are one year late compared to the United States, so the approval would not arrive until, at least, 2026. Of course, Pharmamar will seek marketing in the Old Continent without any partner, so the income will be full for the Spanish.
The other four studies are in phase one or phase one-two, the first of three until it goes on sale, and they go through testing the efficacy of Zepzelca on advanced and solid tumors in monotherapy or combined with other drugs at higher doses than established to date or how the drug affects the kidney, because by this organ it dissolves.
Among these tests, Pharmamar points out that they have found a “highly promising activity” of Zepzelca in white tissue sarcoma and more specifically in the synovial subtype.
Roche’s way to boost revenue
For its part, Jazz Pharmaceuticals has three open trials with Zepzelca and the most promising and in which the Irish biopharmaceutical company has the most hope is the one carried out together with Roche.
Both companies will test the Zepzelca together with the Tecentriq Roche, a drug that in its latest phase three study demonstrated efficacy against lung cancer in early stages, helping to increase the life expectancy of patients.
And this is the objective of the study, that the combination of both drugs, in addition to remitting the disease, extend the life expectancy of your patients beyond the current 12-13 months.
But the essay goes a step further and the ultimate goal is for it to become a first-line medicine without the need for patients to be treated with another product and when this fails they are administered Zezpelca.
Jazz Pharmaceuticals is confident that Zepzelca will become the stronghold of its oncology unit and help with up to $1 billion in revenue to reach its global target of $5 billion by 2025.
For the moment, the drug has closed the third quarter of 2021 as the best since it began to be marketed in the United States in the same quarter a year earlier.
Jazz Pharmaceuticals entered 71.7 million dollars for the Pharmamar drug, 94 percent more than in the period from July to September 2020.