Novartis announces new organizational structure to accelerate growth, strengthen pipeline and increase productivity

On April 4, 2022 Novartis reported the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade (Press release, Novartis, APR 4, 2022, View Source [SID1234611382]).

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"The simpler organizational model we are unveiling today is central to our growth strategy as it will make us more agile and competitive, enhance patient and customer orientation, unlock significant potential in our R&D pipeline and drive value-creation through operational efficiencies," said Vas Narasimhan, CEO Novartis. "With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term."

Integrating Pharmaceuticals and Oncology business units
Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus—Innovative Medicines US and Innovative Medicines International. The two units will have full P&L responsibility across all therapeutic areas and ownership of customer experience, marketing and sales, and market access for their respective markets. The elevation and establishment of an independent US commercial organization strengthens Novartis’s ability to achieve its goal of becoming a top-five company in the US in terms of sales while maintaining and growing its leadership position internationally. The new model will also help Novartis bring increased focus and commitment to its core therapeutic areas of Cardiovascular, Hematology, Solid Tumors, Immunology and Neuroscience.

Marie-France Tschudin, currently President, Novartis Pharmaceuticals, will become President, Innovative Medicines International and Chief Commercial Officer. In her capacity as Chief Commercial Officer, Marie-France Tschudin will oversee global marketing, medical affairs and value and access across all therapeutic areas. Victor Bulto, currently Head of US Pharmaceuticals, will become President, Innovative Medicines US. They will both report to Vas Narasimhan effective immediately.

New Strategy & Growth Function
Novartis will create a new Strategy & Growth function combining corporate strategy, R&D portfolio strategy and business development. This function will help drive the company’s growth strategy end-to-end and will look across internal and external opportunities to strengthen Novartis’s pipeline with medicines that are both transformational and can make significant contributions to growth. This new function will be led by a Chief Strategy & Growth Officer who will become a member of the ECN and report to the CEO. The search is currently underway for this new leader, and in the interim the function will be led by Lutz Hegemann, M.D., Ph.D., President, Global Health.

Integrated Operations and Global Functions
Novartis will also combine its Technical Operations and Customer & Technology Solutions units to create a new Operations unit. This new unit will provide a stronger and simpler operational backbone that can accelerate multiple technology transformation initiatives more efficiently, create novel digital solutions at scale and increase productivity, while maintaining industry-leading quality and service levels. Effective immediately, Steffen Lang, currently Global Head of Novartis Technical Operations, will become President, Operations reporting to Vas Narasimhan. In addition, all G&A functions—Finance, People & Organization, Ethics, Risk & Compliance, Legal, and Communications & Engagement—will be integrated on global and country levels.

Change in Global Drug Development (GDD) Leadership
Novartis has appointed Shreeram Aradhye, M.D., as President, Global Drug Development and Chief Medical Officer effective May 16th, 2022. Dr. Aradhye, who is returning to Novartis, was most recently Executive Vice President and Chief Medical Officer at Dicerna Pharmaceuticals where he led the development of multiple clinical stage RNAi assets. Previously, he was Chief Development Officer at Axcella Health. Dr. Aradhye has dedicated his entire professional career to improving patient lives, first as an academic clinician and then as a drug developer and business leader. He brings significant experience in global clinical development of innovative medicines across several therapeutic areas and has played a key leadership role in the development of multiple innovative therapeutics. During his 20-year tenure at Novartis, he held several global leadership roles including as development head for the company’s Neuroscience franchise and Global Head of Medical Affairs for the Pharmaceuticals business unit. Dr. Aradhye will report to Vas Narasimhan and join the ECN. With the changes in organizational structure and operating model, John Tsai, M.D., has decided to pursue opportunities outside Novartis effective May 15th, 2022.

"I would like to extend my deep gratitude to Susanne, Robert and John for their invaluable contributions to the company. Susanne has been an inspiring and dedicated leader at the company for 25 years, and she has played a pivotal role in strengthening our global Oncology business. Over the last four years, Robert has led a successful transformation of our business services and technology operations and helped create a strong Customer & Technology Solutions unit. Since taking over as Head of GDD in May 2018, John has played a key leadership role in advancing our mid-stage pipeline and delivering 18 major drug approvals to patients around the world. I wish them the very best in their future endeavors," added Vas Narasimhan, CEO Novartis. "I would like to congratulate Marie-France, Shreeram, Steffen and Victor on their new roles, and extend a warm welcome back to Shreeram. I look forward to working closely with them as we embark on this new phase of our journey to reimagine medicine together."

Kuraray Included in New ESG Index

On April 4, 2022 Kuraray Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President: Hitoshi Kawahara; hereinafter "Kuraray" or the "Company") reported that it has been included in the FTSE Blossom Japan Sector Relative Index designed by the global index provider FTSE Russell (Press release, Kuraray, APR 4, 2022, View Source [SID1234611379]).

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Kuraray has been included on a continuous basis in the following ESG (environmental, social and governance) investment indexes: the FTSE4Good Index Series and FTSE Blossom Japan Index designed by FTSE Russell; the MSCI Japan ESG Select Leaders Index and MSCI Japan Empowering Women Index (WIN) developed by U.S. company, MSCI Inc.; and the S&P/JPX Carbon Efficient Index. Kuraray has now also been included in the FTSE Blossom Japan Sector Relative Index, making it a constituent of all of the ESG investment indexes for Japanese stocks adopted by Japan’s Government Pension Investment Fund (GPIF).

In line with its corporate mission statement, "For people and the planet—to achieve what no one else can," the Kuraray Group will remain committed to strengthening corporate governance while also working to solve social issues and help improve natural and living environments through its business activities.

The five ESG Indexes for Japanese stocks employed by the Government Pension Investment Fund (GPIF):
1. FTSE Blossom Japan Index
An investment index designed by FTSE Russell, a wholly owned subsidiary of London Stock Exchange Group. This index comprises Japanese corporations that meet high ESG performance standards.
View Source

2. FTSE Blossom Japan Sector Relative Index
An investment index designed by FTSE Russell, a wholly owned subsidiary of the London Stock Exchange Group. This index reflects the performance of Japanese corporations that demonstrate strong Environmental, Social and Governance (ESG) practices relative to their sector. In addition, to encourage the transition to a low-carbon economy, for companies with especially high greenhouse gas emissions, only companies whose improvement initiatives have been evaluated using TPI Management Quality Score are included.
View Source

3. MSCI Japan ESG Select Leaders Index
An index comprising companies in each sector that achieve high ESG ratings selected from constituents of the underlying MSCI Japan IMI Top 700 Index.
View Source

4. MSCI Japan Empowering Women Index (WIN)
An index comprising companies drawn from the MSCI Japan IMI Top 700 Index that exhibit high gender diversity within their sector. Constituent selection is based on a gender diversity scoring system developed by MSCI.
View Source

5. S&P/JPX Carbon Efficient Index
An index with S&P Dow Jones Indices’ TOPIX (Tokyo Stock Price Index) as its universe, that weights constituents according to environmental information disclosure status and carbon efficiency standards.
View Source

JW Therapeutics Announces Receipt of Breakthrough Therapy Designation for Carteyva® in Mantle Cell Lymphoma in China

On April 3, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) in patients with mantle cell lymphoma (MCL) (Press release, JW Therapeutics, APR 3, 2022, View Source [SID1234611376]). Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics.

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The Breakthrough Therapy Designation was supported by the results from the clinical study of Carteyva in relapsed or refractory MCL (r/r MCL), which aimed to assess the efficacy and safety of Carteyva in adults with r/r MCL in China. This is the first clinical result obtained in Chinese patients.

MCL is a non-Hodgkin lymphoma, which is highly aggressive and can’t be cured by the currently approved therapies1. About 80% to 90% of MCL patients were diagnosed at the advanced stage and with poor prognoses2. Despite a few novel mechanism-of-action drugs such as Bruton tyrosine kinase inhibitors (BTKi) have improved outcomes for patients living with this disease, subsets of patients with aggressive disease biology or multiply relapsed disease continue to experience relatively poor outcomes with these currently available therapies. There are still urgent unmet medical needs to develop additional active therapeutic agents for the treatment of r/r MCL.

References

1. The consensus of the diagnosis and treatment of mantle cell lymphoma in China (2016 version) .Chin J Hematol.2016, 37(9):735-741.

2. Herrmann A, Hoster E, Zwingers T, et al. Improvement of Overall Survival in Advanced Stage Mantle Cell Lymphoma[J]. Journal of Clinical Oncology, 2009, 27(4):511-518.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About JWCAR029-005 Study (NCT04718883)

This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva in adults with r/r MCL in China. This is the first clinical study to evaluate such novel therapy in Chinese MCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients.

This study will enroll a total of 59 r/r MCL patients either relapsed or refractory to second-line or more line regimens. Prior therapies must include an anti-CD20 monoclonal antibody, anthracycline- or bendamustine-containing chemotherapy, and BTK inhibitor therapy. These patients will be followed up for long-term survival in 2 years or above.

The study is currently ongoing. Preliminary clinical data found Carteyva providing outstanding efficacy and good safety profile for r/r MCL patients. In particular, Carteyva provided clear therapeutic benefits to patient refractory or relapsed to BTK inhibitor therapy.

Kintor Pharma Announces Two Upcoming Poster Presentations at AACR 2022

On April 3, 2022 Kintor Pharmaceutical Limited (Kintor Pharma, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, reported two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, including proxalutamide to treat COVID-19 and a c-Myc Degrader to treat blood cancer and small cell lung cancers (SCLC) (Press release, Suzhou Kintor Pharmaceuticals, APR 3, 2022, View Source [SID1234611375]). This year’s AACR (Free AACR Whitepaper) annual meeting will be held in the city of New Orleans, United States, on April 8-13, 2022.

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E-Poster
Mechanisms of action (MOA) for proxalutamide, an androgen receptor (AR) antagonist, for the treatment of mild, moderate and severe COVID-19 patients

Abstract#: 5274

Session Title: COVID-19 and Cancer

Session Time: April 8, 2022, 12:00 PM – 1:00 PM

Abstract Link: View Source!/10517/presentation/18533

Discovery and evaluation of GT19630, a c-Myc/GSPT1 cereblon E3 ligase modulator(CELMoD) , for targeting Myc-driven blood cancers and small cell lung cancers(SCLC)

Abstract#: 5479

Session Title: Small Molecule Therapeutic Agents

Session Time: April 8, 2022, 12:00 PM – 1:00 PM

Abstract Link: View Source!/10517/presentation/18624

Please refer to the website of AACR (Free AACR Whitepaper) for more details.

Epsilogen raises £30.8M series B to support testing IgE antibody against ovarian cancer

On April 2, 2022 Epsilogen Ltd. reported that it has raised £30.8 million (US$41.5 million) in an oversubscribed series B, after its lead immunoglobulin E (IgE) program delivered positive results in a phase I in advanced solid tumors (Press release, Epsilogen, APR 2, 2022, View Source [SID1234611331]). The money is to fund a phase Ib trial of the product, Mov18 IgE – the first and only IgE antibody to have made it to the clinic – in platinum-resistant ovarian cancer.

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