Niraparib Tosylate

AstraZeneca also has a new PARP inhibitor in early trials that could help boost future lagging sales from Lynparza when it starts to lose patent protection in 2028. AstraZeneca and Merck & Co. were the first to grab an FDA approval for their PARP inhibitor Lynparza, and, despite growing competition, the drug is set to remain top dog in the PARP space. That’s according to a new report out by analysts at GlobalData, which predicts $4 billion in global sales for Lynparza by 2027, boosted by new licenses. Lynparza (olaparib) was first approved for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who had already been given three lines or more of chemo back in 2014. Since then, it has racked up supplemental U.S. nods in various cancers, including in certain breast, prostate, pancreatic and ovarian tumors. GlobalData sees the drug’s revenues in these indications to reach “over 68% of the global PARP inhibitors market by 2027,” helping bring in that $4 billion. Most of Lynparza's sales come from ovarian and HER2-negative breast cancer treatment, the analysts said in their latest report. It doesn’t have the market to itself, however, with GSK’s PARP inhibitor Zejula (niraparib) holding the second position, with more than $1.6 billion in sales and 28% of the market share. The drug, which was originally developed by Tesaro before being bought out by GSK, saw its first approval in 2017 for ovarian cancer. It has since added several new licenses within that disease space. It’s not all been positive for Lynparza and PARPs, however. AZ and Merck back in the fall of 2022 voluntarily pulled the drug from treating heavily pretreated ovarian cancer patients, after seeing a potential “detrimental effect” on patient survival from a confirmatory phase 3 trial. GSK and Clovis Oncology, for its drug Rubraca, had also pulled their drugs in the same patient population. Rubraca has seen the hardest path, with Clovis a year back selling off the PARP drug in a bankruptcy sale to a Swiss pharma. The drug never really picked up after its approval in 2016 and has been the weak link in the PARP market. For Lynparza and Zejula, however, the withdrawals did not cause much of a sales impact, given that the drugs have largely moved into earlier treatment settings. And, while Lynparza will be making strong blockbuster sales in 2027, patent protection in the U.S. falls off in 2028. From then on, “there is an anticipated downshift in sales post-patent expiry through generic erosion,” said  Biswajit Podder, Ph.D., oncology and hematology analyst at GlobalData. But there is hope on the horizon. Lynparza currently has 123 ongoing phase clinical trials across a multitude of cancer types and combos, which GlobalData says “signifies its pivotal role in oncology.” AZ is also working on an experimental selective PARP1 inhibitor, saruparib, which has shown some early promise in phase 1/2 trials for homologous recombination repair (HRR)-deficient advanced breast cancers. “If approved, saruparib would further strengthen AstraZeneca’s lead in the PARP inhibitor market,” Podder said.

LUND, SWEDEN / ACCESSWIRE / April 24, 2024 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F) Spago Nanomedical AB (publ) announced today data from a non-clinical study exploring 177Lu-SN201 in a model for triple-negative breast cancer. In the model, 177Lu-SN201 demonstrates superior anti-tumor effect compared to standard cancer drugs with a low and acceptable level of radiotoxicity observed. Spago Nanomedical's leading candidate drug within the radiopharmaceutical program Tumorad, 177Lu-SN201, is progressing in clinical development. In parallel to the ongoing phase I/IIa clinical trial in patients with advanced cancer, an extensive non-clinical study is underway to explore 177Lu-SN201 as monotherapy and combination therapy in a 4T1 orthotopic triple-negative breast cancer model. "Triple-negative breast cancer is a very aggressive disease with poor prognosis. The current observations are therefore very promising and support further studies of 177Lu-SN201, especially in combination therapy as is planned in the next step." said Mats Hansen, CEO of Spago Nanomedical. Data from the initial part of the study with 177Lu-SN201 as monotherapy demonstrates statistically significant anti-tumor effect compared to standard cancer drugs including anti PD-1 and anti-CTLA-4 (immune checkpoint inhibitors), Niraparib (PARP-inhibitor), Paclitaxel (taxanes), and Carboplatin (platinum-based chemotherapy). 177Lu-SN201 reduces tumor growth and significantly increases survival rate compared to animals treated with standard cancer drugs. A low and acceptable level of radiotoxicity was observed based on body weight and general appearance. " The current results are very encouraging and we are looking forward to learn more about how 177Lu-SN201 may work synergistically with other drugs. " said Oskar Axelsson, CSO of Spago Nanomedical. Spago Nanomedical intends to publish results from these studies in recognized scientific journals. For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se Spago Nanomedical AB is a Swedish company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise treatment and diagnosis of cancer and other debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see FNCA Sweden AB is the Certified Adviser of the company. Attachments Spago Nanomedical reports favorable data in breast cancer model with Tumorad SOURCE: Spago Nanomedical View the original press release on accesswire.com