Prothena Corp. Plc

Roche is actively looking at deals across all therapeutic areas, its pharma chief Teresa Graham said.\n Roche has about $10 billion in M&A firepower it can deploy every year, but it’s “not just going to spend money,” the company’s pharma CEO Teresa Graham said at the J.P. Morgan Healthcare Conference.Roche is fully ready to deploy the money “if and when we find transformative assets that are either complementary to our portfolio or, again, change the game in important diseases outside of those focus areas,” Graham said Monday.The Swiss pharma didn’t spend that much on business development last year, J.P. Morgan analyst Richard Vosser noted during the Q&A session of Graham’s presentation.Last fall, Roche unveiled a new pharma strategy, placing a focus on the five therapeutic areas of neurology, oncology/hematology, immunology, ophthalmology and CVRM (cardiovascular renal metabolic).Some of Roche’s recent deals in these focus areas include an antibody-drug conjugate pact with Innovent Biologics, the $1.5 billion acquisition of off-the-shelf CAR-T partner Poseida Therapeutics, the purchase of Wnt signaling-focused biotech AntlerA Therapeutics and the $850 million upfront licensing of a portfolio of CDK inhibitors from China’s Regor Pharmaceuticals. As Graham noted Monday, Roche has had a strong presence in China and will continue to look for assets in the country.Roche wants to get in on differentiated assets with the potential to help a large number of patients around the world, Graham added. Roche recently took a hard look at its internal pipeline, a process that led the company to discontinue about 30% of its pipeline so far, according to Graham. Still, the company expects its R&D spending to remain flat in 2025; while Roche will “continue to be very disciplined” in resource allocation, it will also make sure to maintain sufficient investments in its research programs, the exec said.“As we’ve culled so many things out of our portfolio, we have freed up a lot of oxygen to actually invest in new programs that may be internal or external,” the Roche exec said.According to Graham, Roche\'s late-stage program will look “materially different” in 2026 than it is today; about 18 programs may enter late-stage testing or graduate from that phase in the next 18 months.But, as is always the reality with drug development, not all Roche candidates, including those in-licensed, may succeed as planned. During Monday’s presentation, Graham said Roche is not giving up on its Prothena-partnered prasinezumab in Parkinson’s disease despite a phase 2b flop disclosed in December. While the PAVODA trial missed its primary endpoint of time to confirmed motor progression, Roche has noted a more pronounced effect for the anti-alpha-synuclein antibody in levodopa-pretreated patients.“Given the high level of unmet need for these patients, we decided that the important thing to do is to let the [open-label extension] data mature a little bit longer before we actually take a decision on where we wanted to head” with prasinezumab, Graham said during her presentation.Roche wants to thoroughly evaluate the results and make a data-driven decision. The company will be able to share more later this year, Graham said.

DUBLIN--(BUSINESS WIRE)-- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced that Oleg Nodelman will step down from Prothena’s Board of Directors to create time to focus on existing and new endeavors. During his five-year tenure, Mr. Nodelman played a pivotal role in which he made significant contributions to the Company’s current strategy. “I would like to thank Oleg for his contributions during the past five years. As a veteran biotechnology investor and advisor with deep roots in the biotechnology and scientific communities, Oleg shares Prothena’s mission to deliver life-saving therapies for unmet medical needs caused by diseases of protein dysregulation,” said Daniel G. Welch, Chair of Prothena’s Board of Directors. “The entire board of directors recognizes and appreciates Oleg’s strategic impact since joining the board in 2019.” “As a long-standing investor in Prothena, I leave the board knowing the company is in good hands. I look forward to the multiple clinical readouts across the portfolio in 2025,” said Nodelman. “I have enjoyed working alongside the other directors and leadership team who have contributed to an industry leading R&D pipeline and a mission to develop transformative medicines for patients and their families.” About Prothena Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp. Forward-Looking Statements This press release contains forward-looking statements. These statements relate to, among other things, expected milestones in 2025; and the expected timing of reporting data from clinical trials. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations. Media Michael Bachner, Senior Director, Corporate Communications 609-664-7308, michael.bachner@prothena.com Investors Mark Johnson, CFA, Vice President, Investor Relations 650-417-1974, mark.johnson@prothena.com

DUBLIN, Ireland I December 19, 2024 I Prothena Corporation plc (NASDAQ:PRTA), today announced results from the Phase IIb PADOVA study conducted by partner Roche investigating prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical effect in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01] and p=0.0657. The effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99] and nominal p=0.0431. Pre-specified supplementary covariate-adjusted* analyses of these endpoints demonstrated nominally significant effects on the primary endpoint (HR=0.81 [0.67-0.98]; nominal p=0.0334) and in the levodopa subgroup (HR=0.76 [0.61-0.95]; nominal p=0.0175). Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. The Phase IIb PADOVA results along with prior clinical study results will inform future clinical development, including study design, statistical analysis, and appropriate evaluation of patient sub-groups, of prasinezumab as a potential first-in-class disease-modifying treatment for patients with Parkinson’s disease. “The results from the Phase 2b PADOVA study are a significant step forward to potentially bring the first disease-modifying treatment option to the millions of individuals living with Parkinson’s disease and their families,” stated Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. “As pioneers in developing the first anti-alpha synuclein targeting antibody, we look forward to Roche presenting the results from the PADOVA study at an upcoming medical conference and sharing with health authorities to determine the most appropriate path forward.” The Phase II PASADENA and Phase IIb PADOVA open-label extension studies will continue in order to explore the observed effects in both studies. Roche will continue to evaluate the data and work together with health authorities to determine next steps. Full results from the PADOVA study will be presented at an upcoming medical meeting. About prasinezumab Prasinezumab is an investigational monoclonal antibody designed to selectively bind aggregated α-syn and reduce neuronal toxicity. By targeting the build-up of α-syn protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, thereby slowing down the progression of the disease. The evidence supporting targeting α-syn aggregates as a mechanism of action in Parkinson’s disease is based on a wide range of scientific evidence in the field. Prasinezumab is currently being assessed in ongoing open-label extensions of the Phase II PASADENA and Phase IIb PADOVA studies. Four-year data from the PASADENA study showed potential evidence of sustained slowing of motor progression compared to a matched PPMI natural history study cohort, published in the October 2024 edition of Nature Medicine. The PASADENA delayed-start (n = 94) and early-start (n = 177) groups showed a slower decline (a smaller increase in score) in MDS–UPDRS Part III scores in the OFF state (delayed start, −51%; early start, −65%) than did the PPMI external comparator (n = 303). The safety database for prasinezumab consists of data from more than 900 Parkinson’s disease study participants that have been treated with the investigational medicine, including more than 500 who were treated over 1.5-5 years. Roche entered into a Licensing, Development, and Commercialization agreement with Prothena in December 2013 to develop and commercialize monoclonal antibodies targeting α-syn, such as prasinezumab, for the potential treatment of Parkinson’s disease. About the PADOVA study PADOVA is a Phase IIb multicenter, randomized, double-blind trial evaluating the efficacy and safety of prasinezumab compared with placebo in 586 randomized patients with early-stage Parkinson’s disease who were on stable symptomatic treatment (stable doses of levodopa or monoamine oxidase-B inhibitor as monotherapy for more than three months at baseline). Patients receive monthly intravenous doses of prasinezumab 1500 mg or placebo every four weeks for at least 76 weeks. This is followed by a two-year open-label extension phase in which all participants receive active treatment, which is currently ongoing. The primary endpoint of PADOVA is the time to confirmed motor progression of Parkinson’s disease (≥5-point increase in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale [MDS-UPDRS] Part III score assessed in OFF medication state). A 5-point increase in MDS-UPDRS Part III represents a clinically meaningful motor progression event (Trundell et al., in press). About Parkinson’s disease Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease that has a devastating impact on patients and families. Parkinson’s disease is characterized by the gradual loss of neurons that make dopamine and other nerve cells, and the development of motor and non-motor symptoms that may appear years before diagnosis. Symptoms can vary widely between individuals and disease progression is not predictable, in which symptoms can develop gradually over time or suddenly. Clinical diagnosis of Parkinson’s disease is late in the disease course and currently based only on motor symptoms, with non-motor symptoms often preceding diagnosis by up to 20 years. About Prothena Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp. SOURCE: Prothena