BIAL-Portela & Cia SA

Neurocrine has ongoing partnerships with the likes of Takeda, Idorsia, Voyager and Xenon, and has often been viewed as a hot M&A target. Soon, the firm will have a new CEO. Neurocrine Biosciences’ dealmaking prospects may soon get another round of attention with the installment of a new CEO.  More than three decades after founding Neurocrine in 1992, Kevin Gorman, Ph.D., will retire as the neuroscience specialist’s CEO, the company said Tuesday. Effective October 11, the biotech’s current chief business development and strategy officer, Kyle Gano, Ph.D., will take over the reins as the new CEO. Gorman, who has been Neurocrine’s CEO since 2008, worked the company to the commercial stage in 2017 with the FDA approval of Ingrezza. With indications in tardive dyskinesia and involuntary movements in Huntington’s disease, Ingrezza is today a fast-growing blockbuster with sales expected to surpass $2 billion this year. The paucity of commercial-stage neuroscience biotechs has made Neurocrine a regular name on Wall Street’s M&A watch lists. The revenue stream from Igrezza means Neurocrine has the firepower to buy things for itself, and a fast-growing product would give any larger buyer an immediate top-line boost. An IPO in 1996 helped Neurocrine raise $34 million, and today, the California biotech carries a market value of about $13.5 billion. The closest Neurocrine has come to being bought out likely happened in 2019. That year, Michel Vounatsos, then CEO at fellow neuroscience giant Biogen, planned to take over Neurocrine to ease the potential risk of what would later become the ill-fated Alzheimer’s disease drug Aduhelm, Stat reported earlier. Vounatsos rallied support from the entire Biogen exec team, but the plan was shot down by the company’s board. Biogen likely isn’t targeting any major neuroscience purchases these days, as new CEO Chris Viehbacher focuses more on immunology rather than the risky field of neurology. Neurocrine actually partnered up on its second commercial product, endometriosis therapy Orilissa, which it licensed to AbbVie in 2010. The following year, Gano, who originally joined in 2001 in a market research and analytics capacity, became Neurocrine’s chief business development officer. Business development has yielded success at Neurocrine but also brought the company’s most dramatic setback. Back in 2006, Neurocrine’s stock price crashed below its IPO price after Pfizer walked out on a partnership following an FDA rejection of the former partners’ investigational insomnia drug, indiplon. Last year, Neurocrine returned the North American rights to the struggling Parkinson’s disease med Ongentys to its licenser, Portuguese company Bial. Neurocrine paid $30 million upfront for the COMT inhibitor in 2017. And after an approval in April 2020, the drug couldn’t attract enough traction. Today, partnerships remain a key element in Neurocrine’s business. The company has a multi-candidate collaboration with Takeda. One of the programs failed in a phase 2 trial last year in patients with anhedonia in major depressive disorder (MDD), while another recently delivered a positive mid-stage trial readout in adjunctive MDD. Other than that, Neurocrine has tapped Mitsubishi Tanabe Pharma to run Ingrezza in Japan. It also boasts a sodium channel inhibitor pact with Xenon Pharmaceuticals and a gene therapy collaboration with Voyager Therapeutics. Further, the company bought a calcium channel blocker from Idorsia. Neurocrine is also working with Nxera Pharma, previously known as Sosei Heptares, to develop muscarinic receptor agonists for a range of neurological disorders. As Gorman put it in a Tuesday statement, now is “the right time to initiate this well-planned leadership transition.” He praised Gano for being instrumental in Neurocrine’s success and an “exceptional leader” of the organization. Gano is the lead inventor on the patent to the valbenazine molecule that forms Ingrezza. Besides the licensing deals mentioned above, Gano also oversaw the 2022 acquisition of Diurnal Group, which gave Neurocrine a pipeline targeting chronic endocrine conditions and a presence in Europe. A top priority at Neurocrine these days is crinecerfont, for which the company recently completed FDA submissions for the treatment of pediatric and adult patients with classic congenital adrenal hyperplasia. The company has already started building a commercial team around the drug, even though it expects the FDA will ask for an advisory committee meeting. Gorman will continue to serve on Neuroncrine’s board, on which Gano has been named a new member. 

AC Immune SA Appoints New Chief Medical Officer Nuno Mendonça, MD appointed new Chief Medical Officer and Executive Committee member Lausanne, Switzerland, July 26, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced the appointment of Nuno Mendonça, MD. He will join the Company on October 1st, as Chief Medical Officer and be appointed to the Executive Committee. Johannes Streffer, MD, currently Chief Medical Officer, will leave at the end of September to pursue a new role. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “It is with great pleasure that we welcome Dr Mendonça to our Executive Committee and the position of Chief Medical Officer at AC Immune SA. He has outstanding international industry experience in the clinical development of investigational therapeutics for neurodegenerative diseases, including in senior roles at leading global pharmaceutical companies. With his strong track record of product development, we look forward to his leadership of the Clinical Development group at AC Immune and effective delivery of the Company’s ambitious clinical development plans. Our clinical-stage programs, such as ACI-24 and ACI-7104, have made tremendous advances and we are looking forward to sharing results from our ongoing trials in the coming months. Dr Pfeifer continued: “I also want to sincerely thank Dr Streffer for his contributions in the past few years, particularly his work in establishing innovative, adaptive, biomarker-based clinical trials for some of our key programs. We wish him every future success.” Nuno Mendonça, MD commented: “I am delighted to be joining AC Immune SA at such an important time in its development, with its cutting-edge technology platforms and broad, diverse pipeline of candidates addressing neurodegenerative diseases, many in advanced clinical development. It is my ambition to bring my experience to bear to ensure we deliver on our groundbreaking programs and secure high value-creating progress across our clinical assets for the patients we aim to serve. Background on Nuno Mendonça, MD Prior to joining AC Immune SA Dr Mendonça was the Senior Vice-President, Chief Medical Officer of Bial (Portugal) where he led early and late-stage development programs across neuroscience and Orphan diseases. He has further managed medical affairs and clinical operations in North America and Europe. Dr Mendonça’s work in industry began with roles specializing in Neuroscience at AbbVie in Germany. With increasingly senior roles he led the Clinical Strategy Team focusing on early and late-stage Alzheimer’s disease programs. He continued this work as Medical Director and Chair of the Clinical Strategy Team in Neuroscience at AbbVie based in the USA where he was responsible for overall tau antibody development in Alzheimer’s and Progressive Supranuclear Palsy. Following this he also led the late-stage clinical development in the EMEA of Zolgensma for spinal muscular atrophy with Novartis Gene Therapies as Senior Medical Director. Dr Mendonça, a certified Neurologist, obtained his MD from the University of Coimbra in Portugal. His medical residency at the University Hospital of Coimbra led to an appointment as Neurology Consultant at the Centro Hospitalar de Lisboa Central in Lisbon (Portugal). He also completed a Clinical Scholars Research Training program at Harvard Medical School (USA). About AC Immune SA AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features ten therapeutic and three diagnostic candidates, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments. SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and US. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU. The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release. For further information, please contact: Head of Investor Relations & Corporate CommunicationsGary Waanders, Ph.D., MBAAC ImmunePhone: +41 21 345 91 91Email: gary.waanders@acimmune.comU.S. InvestorsCorey Davis, Ph.D.LifeSci AdvisorsPhone: +1 212 915 2577 Email: cdavis@lifesciadvisors.comInternational MediaChris MaggosCohesion BureauPhone: +41 79 367 6254Email: chris.maggos@cohesionbureau.com Forward looking statementsThis press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement. Attachment 20230726_ACIU_Senior Management Change_FINAL

PORTO, Portugal, May 25, 2023 /PRNewswire/ -- BIAL - R&D Investments S.A (BIAL R&D), a subsidiary of BIAL Holding, S.A., today announced the dosing of the first patient in its Phase 2 clinical trial (ACTIVATE study) to evaluate the efficacy, safety, and tolerability of BIA 28-6156. BIA 28-6156 is an allosteric activator of the enzyme beta-glucocerebrosidase (GCase) for the treatment of patients with Parkinson's disease (PD) who have a mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD). Parkinson's disease is the second most common neurodegenerative disorder and the GBA1 gene mutations are identified as the most common genetic risk factor of the disease. "Dosing of the first patient in our Phase 2 clinical trial represents a major milestone in the clinical development of BIA 28-6156 for the treatment of Parkinson's disease patients with a genetic validated risk factor as GBA1 gene mutation. Activation of GCase enzymatic activity via allosteric modulation with BIA 28-6156 offers a novel potential treatment for patients with GBA-PD as well as a promising new approach to delay clinical motor progression. Data from nonclinical settings, including data from human cells, suggest that activation of GCase enzymatic activity could provide therapeutic benefit to patients with PD who carry a GBA-PD risk-associated variant in the GBA1 gene.1", commented Nuno Mendonça, Chief Medical Officer of BIAL The ACTIVATE study is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of two fixed dose levels of BIA 28-6156 (10mg and 60mg/day). The trial will randomize approximately 237 genetically confirmed GBA-PD subjects to one of the three treatment arms, either 10mg, 60mg or placebo. This is a time to event study to assess the delay of meaningful clinical progression as assessed by the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and Part III up to 78 weeks of double-blind treatment period. The trial will enrol subjects with PD diagnosed between 1 to 7 years before genetic screening, a modified Hoehn and Yahr score ≤2.5, and a score of ≥22 on the Montreal Cognitive Assessment. Subjects must be receiving a stable dose of PD medication and will continue to receive it throughout the study. The ACTIVATE study is currently screening patients across sites in North America and planned to start in Q3.2023 in EU. For more information regarding the trial design, please see (identifier: NCT05819359). About BIA 28-6156 BIA 28-6156 (formerly called LTI-291 or LTI-00291) is a novel allosteric activator of beta-glucocerebrosidase (GCase) that is being developed by BIAL R&D for the proposed indication of treatment of Parkinson's disease (PD) in patients with a mutation in the glucocerebrosidase 1 (GBA1) gene (GBA-PD). BIA 28-6156 is a small molecule, for oral administration, once-daily that has been designed to have a low toxicity profile with the ability to cross the blood brain barrier, features that were validated in vitro and in vivo experiences and extensive toxicology studies. About BIAL R&D BIAL - R&D Investments S.A. (BIAL R&D), a Portuguese Company, is a subsidiary of BIAL Holding, S.A. and part of the BIAL Group (BIAL), dedicated to the conduction and management of research projects with the objective of discovering new drugs for human use. BIAL - R&D is also the owner of intellectual property relating to proprietary pharmaceutical compounds for neurodegenerative diseases, namely Parkinson's disease, at various stages of clinical development, such as, a small molecule activator of GCase enzyme referred to internally as BIA 28-6156; BIAL - R&D, as part of BIAL, benefits from the BIAL expertise, knowledge, and long experience, namely, in discovery, development and clinical activities. About BIAL BIAL is an innovation-driven pharmaceutical company aiming to improve people's lives worldwide. With 99 years of experience, BIAL is strongly committed to therapeutic innovation, consistently investing over 20% of its annual turnover in R&D, in which neurosciences is its major area of research. Based on its own innovative medicines and with a consistent partnering program, BIAL has extended its presence worldwide. The company has ten affiliates in three different continents – Europe, America and Africa – and its products are present in fifty countries, fulfilling its purpose of making a real difference in the lives of people all over the world. For more information about BIA28-6156, please click here For more information about BIAL, please visit: 1 BIAL R&D (data on file) Logo: SOURCE Bial