On September 22, 2022 Novartis executives are meeting investors and industry analysts in Basel , reported that sharing insights into the updated company strategy at the annual Meet Novartis Management event (Press release, Novartis, SEP 22, 2022, View Source [SID1234621362]). The meeting will allow participants to learn more about Novartis journey to unite technology leadership in Research and Development with novel access approaches, helping to alleviate some of society’s greatest disease burdens.

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"Novartis is transforming into a ‘pure-play’ Innovative Medicines company. Our strategy is focused on five core attractive therapeutic areas, key technology platforms, and the US market, with the aim to increase value per new molecular entity from our deep pipeline", said Vas Narasimhan, CEO of Novartis. "We will continue to deliver improved financials with +4% sales CAGR through 2027 and a Core Op Inc margin ~40%+ in the mid – long term. Our disciplined capital allocation will balance continued investment in the business and returning capital to our shareholders".

Novartis is implementing this strategy with a clear focus on five therapeutic areas for investment – cardiovascular, immunology, neuroscience, solid tumors and hematology. Novartis has multiple significant in-market and pipeline assets in each of these areas, which represent significant disease burden and have the largest growth potential in the USD 1 Tn innovatives medicines market. Eight current in-market brands, Cosentyx, Entresto, Zolgensma, Kisqali, Kesimpta, Leqvio, Pluvicto and Scemblix, each hold multi-billion dollar peak sales potential.

Focus on US and other priority geographies including China, Germany, Japan
These eight brands are underpinning growth across all key geographies, supporting Novartis aspiration to improve competitive positioning and organically build its US business to become a top-five player in the US by 2027. A ‘US-first’ mindset, increasing share of US patients in clinical trials and building capability and talent, among other actions, will enable Novartis to acheive this objective. Novartis also aims to be a top-three player in China, a key growth market for the next decade, while maintaining leading positions in Germany and Japan.

Establishing Leadership across Key Technology Platforms
The Novartis portfolio of medicines is shifting toward biologics and technology platforms – recognizing their increasing power in tackling disease. In addition to two established platforms in chemistry and biotherapeutics, three newer platforms – gene & cell therapy, radioligand therapy, and ‘xRNA’ – are being prioritized for continued investment into new R&D capabilities and manufacturing scale. With over 50 projects in exploratory to early clinical development, Novartis is well positioned to lead the industry in developing these platforms and expand our business presence.

Rich Development Pipeline shifting to High-Value NMEs
Management outlined its approach to prioritization of Novartis rich pipeline. Increasing commercial focus in five core therapy areas, as well as renewed attention to high-value assets that have the potential to drive growth in the US, were highlighted. The company showcased a number of catalysts set to drive newsflow in the mid & near-term:

Kisqali (ribociclib);data from the NATALEE trial in adjuvant HER2-negative breast cancer in both high- and intermediate-risk patients with breast cancer in 2023.
Iptacopan; first phase 3 trial results in patients with paroxysmal nocturnal hemoglobinuria later this year with more data readouts in other indications in 2023.
Pluvicto; phase 3 data from the PSMAfore trial in metastatic castration-resistant prostate cancer late 2022/early 2023.
Remibrutinib; phase 3 data from two trials in chronic spontaneous urticaria in 2024 and from two phase 3 trials in relapsing multiple sclerosis in 2025.
Scemblix (asciminib);data from the CML-CP trial in first line CML in 2024.
The high value late stage development pipeline is also expected to deliver a large number data readouts in the 2024-25 timeframe. Focused on driving operational excellence, Novartis shared insights into selected early clinical programs where strengthening integration within R&D will help accelerate development and release operational efficiency.

Continuing to deliver improved financials
The growing business, with sales expected to improve +4% CAGR 2021-2027, coupled with announced strategic moves, will enable improving financial performance in the coming years. Core operating income margin is expected to increase to ~40+% in the mid – long term, including the absorption of corporate costs. This improved profitability is set to drive improved Free Cash Flow and Return on Invested Capital (ROIC).
Management outlined Novartis disciplined shareholder-focused approach to capital allocation, highlighting USD 53bn distributed to shareholders from 2017-2021. Substantial cash generation will continue to allow us to balance returning capital to shareholders with investing in the business.

Separation of Sandoz, via 100% spin-off, is in the best interests of shareholders
The Sandoz spin-off transaction is expected to be completed in H2 2023, supporting Novartis ambitions in becoming a fully focused medicines company. Sandoz is planned to be incorporated in Switzerland and to be listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the US, and expected to become the publicly traded #1 European generics company1 and a global leader in biosimilars based in Switzerland.

Strengthening foundations – ESG
Aiming to continue strengthening the foundations of its business including improving broad access to innovation for patients, Novartis outlined key elements of its approach to ESG. These include ensuring access strategies are incorporated in all new product launches and increasing the diversity of patients in clinical trials, as well as ensuring innovative medicines reach more patients in low and middle income countries faster; neglected tropical diseases remain a focus for innovation. Novartis will continue to prioritize its leading position in third-party ESG ratings and confirmed that its innovative sustainability linked bond targets are on track.

On September 22, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that data published in the Journal of the National Cancer Institute demonstrate that the company’s Decipher Prostate Genomic Classifier may help identify African American men with early, localized prostate cancer who are most likely to harbor more aggressive disease (Press release, Veracyte, SEP 22, 2022, View Source [SID1234621361]). The data, from the prospective, multi-site VANDAAM Phase 2 clinical study, suggest that the genomic test may offer a robust improvement over clinical factors alone in risk-stratifying prostate cancer among African American men, which may help reduce disparities in prostate cancer outcomes.

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"While African American men have both higher incidence and mortality associated with prostate cancer, few prospective studies maximize recruitment of these men to provide an unbiased assessment of the genomic processes that underlie these disparities," said Kosj Yamoah, MD, Ph.D., chair, Department of Radiation Oncology, Moffitt Cancer Center, and lead author on the published paper. "We very intentionally recruited a balanced sample of men into this study, but prioritized recruitment of African American men first in order to ensure we had a representative sample of this population, which historically has been underserved in prostate cancer clinical trials. The integration of the Decipher classifier with traditional clinical risk factors was shown to improve identification of the subset of African American men with more aggressive disease. This information could help guide targeted interventions and treatment strategies to improve outcomes in this population."

The Decipher Prostate Genomic Classifier is a 22-gene prognostic biomarker that provides a low, intermediate or high score indicating the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment.

The VANDAAM trial enrolled men with low- or intermediate-risk prostate cancer as classified by the National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer. For the current analysis, researchers identified a clinically balanced cohort of 226 men (113 African American men and 113 non-African American men) from the study and performed genomic analysis using the Decipher Prostate classifier to generate Decipher risk scores.

Results show that a higher proportion of African American men with NCCN low and favorable intermediate risk prostate cancer (18% and 37.8%, respectively) had higher Decipher scores as compared to non-African American men. Men who self-identified as African American were more than twice as likely as non-African American men to have their cancer re-classified from NCCN low or intermediate risk based on a high Decipher score (known as genomic risk of reclassification or GrR; relative risk = 2.23; 95% CI). In addition, the data show that younger African American men had higher Decipher scores, whereas in non-African American men, higher risk of metastasis scores were observed in older men.

"This study demonstrates that prostate cancer risk classification using clinical factors alone may be suboptimal and may underestimate African American men’s risk of harboring aggressive disease," said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. "We commend the study team for undertaking the first prospective trial to utilize genomic classifiers as part of the trial design, as well as for their efforts to help close the clinical disparity gap by improving risk stratification among African American men with prostate cancer."

On September 22, 2022 The University of Pennsylvania reported that it has received a $55 million gift for the study and treatment of hereditary cancers. The gift, from Penn alumni Mindy and Jon Gray, will be used to establish the Basser Cancer Interception Institute, at the Basser Center for BRCA , part of Penn’s Abramson Cancer Center (Press release, The Gray Foundation, SEP 22, 2022, View Source [SID1234621360]).

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The goal of the Institute is to move up the timeline of cancer treatment, "intercepting" various forms of the disease when abnormal BRCA1/2 cells develop — rather than relying on standard treatments like surgery, radiation or chemotherapy after a cancer has been detected. In its announcement, the university said, "the Basser team will pioneer efforts ranging from drugs and immune-based approaches to intercept BRCA-related cancers to new methods of detecting cancer cells with biomarkers and artificial intelligence."

According to the National Cancer Institute, BRCA1 and BRCA2 are tumor suppressor genes that play a role in controlling or preventing cancer. An error or mutation in a BRCA1 or BRCA2 gene increases an individual’s cancer risks. The mutation can also be inherited by an individual’s children who then face increased cancer risks in adulthood.

On September 22, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration’s ("FDA") Oncologic Drugs Advisory Committee ("ODAC") met to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, SEP 22, 2022, View Source [SID1234621359]). The committee voted 9-4 that the current benefits of poziotinib did not outweigh its risks.

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"We are disappointed by the outcome of the ODAC meeting, as patients with NSCLC HER2 exon 20 insertion mutations are in need of additional effective and safe therapies," stated Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We plan to carefully evaluate our options for this program as we approach the November 24, 2022, PDUFA date. We would like to thank lung cancer patients and their families, as well as investigators and their staff, for their support."

ODAC is an independent panel of experts that reviews and evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer. The committee makes appropriate recommendations to the FDA, but these recommendations are not binding and the final decision regarding product approval will be made solely by the FDA.

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4, which, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC. There is no approved therapy for either treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. Spectrum Pharmaceuticals holds an exclusive license from Hanmi Pharmaceutical ("Hamni") to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the Company and Hanmi in several mid-stage trials in multiple solid tumor indications.

On September 22, 2022 Servier and Oncodesign Precision Medicine (OPM) reported a collaborative research agreement, named ‘STarT Pancreas’, to identify and validate new therapeutic targets in Pancreatic Ductal Adenocarcinoma (Press release, Servier, SEP 22, 2022, View Source [SID1234621358]).

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The three-year agreement between Oncodesign Precision Medicine (OPM) and Servier includes two steps: Co-construction of an AI analytical platform based on data generated in the OncoSNIPE clinical trial and identification of targets with this platform; then experimental validation of the pre-selected targets.

Dr. Walid S. Kamoun, Servier’s Director of R&D Oncology: "We are delighted to initiate this collaboration with OPM, and to contribute to the development of an AI-based data analysis solution that could enable us to identify new therapeutic targets in pancreatic ductal adenocarcinoma, a dreaded cancer increasing in industrialized countries. This partnership is in line with the Group’s strategy of making the fight against cancer one of its strategic priorities, targeting hard-to-treat cancers for which treatment options are limited."

Pancreatic cancer is considered as one of the most difficult cancers to treat, due to its insidious symptoms and high degree of malignancy leading to a high mortality rate.