On June 8, 2023 Sandoz reported to host the first of two Capital Markets Days (CMDs) for investors, in New York City, to set out its plans for growth and success as a standalone company, following the proposed 100% spin-off from Novartis (Press release, Novartis, JUN 8, 2023, View Source [SID1234632568]).

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Sandoz reported sales of USD 9.1 bn in 2022, with a record of six consecutive quarters of single-digit growth. At the CMD today, the company will forecast mid-single digit net sales growth for 2023 as well as for the mid term (2024 to 2028). The core EBITDA margin is expected to expand to 24–26% in the mid term, from a forecast 18-19% in 2023, with the initial decrease from 21.2% in 2022 driven by ongoing inflation and investments required to stand up Sandoz as a separate company.

Free cash flow is expected to more than double by 2028, from a reported USD 0.8 bn in 2022. This should enable Sandoz, with a targeted investment grade credit profile and a prudent capital structure, to pay shareholders a full-year dividend of 20-30% of FY 2023 core net income, increasing to 30-40% in the mid term.

"I am honored to have the opportunity to lead Sandoz into its exciting new future and believe this company will have the Board, Executive team and key capabilities it needs to succeed as a standalone company", said Gilbert Ghostine, Chairman-designate of the proposed new company, who will open the event later today. "Sandoz is an established European champion and global leader in generics and biosimilars with an impressive scientific heritage, a powerful purpose-driven strategy and one of the strongest brands in the industry. I am confident that our new company represents a compelling opportunity for both equity and debt investors."

Sandoz CEO Richard Saynor said: "In recent years, we have reshaped our business for the future, driven by a strong leadership team with clear alignment on our vision. We are focused on sales execution, while significantly expanding our pipeline, investing in targeted build-up of capabilities and developing strategic partnerships. Looking forward, six strategic levers will drive long-term investor value: attractive market fundamentals, leadership and scale, multiple growth drivers, margin improvement, accelerated cash generation, and a compelling sustainability story. The proposed spin-off would enable us to deliver our full potential, with an attractive and sustainable financial outlook including an expected shareholder dividend."

The expanding Sandoz product pipeline is expected to contribute an additional USD 3 billion in potential net sales over the next five years, with the mix shifting increasingly towards high-value biosimilars and complex generics. The biosimilar pipeline has trebled in size over recent years, now with 24 products, on top of a core generic pipeline of more than 400 products.

Concluding, Saynor said: "We actively pioneer access for patients by shaping the global healthcare environment, strengthening healthcare systems worldwide by delivering over USD 17 billion in annual savings in Europe and the US alone, reaching 500 million patients a year in over 100 countries, and generating a total social impact estimated in the hundreds of billions of dollars".

Sandoz will host a second CMD, in London on June 12, where investors and analysts will have another opportunity to meet Sandoz leadership.

Both events will also be webcast; to register online for access, visit the Investor Relations section of the Novartis website at www.novartis.com, or click directly below:
Capital Markets Day – New York (media-server.com)
Capital Markets Day – London (media-server.com)

Additional Transaction Details

The proposed 100% spin-off of Sandoz is expected to occur in the second half of 2023. Completion of the proposed spin-off is subject to satisfaction of certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, receipt of favorable tax rulings and opinions, final endorsement by the Board of Directors of Novartis AG and shareholder approval. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed. Further details of the proposed spin-off will be provided at a later date.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On June 8, 2023 Sandoz reported to host the first of two Capital Markets Days (CMDs) for investors, in New York City, to set out its plans for growth and success as a standalone company, following the proposed 100% spin-off from Novartis (Press release, Novartis, JUN 8, 2023, View Source [SID1234632568]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Sandoz reported sales of USD 9.1 bn in 2022, with a record of six consecutive quarters of single-digit growth. At the CMD today, the company will forecast mid-single digit net sales growth for 2023 as well as for the mid term (2024 to 2028). The core EBITDA margin is expected to expand to 24–26% in the mid term, from a forecast 18-19% in 2023, with the initial decrease from 21.2% in 2022 driven by ongoing inflation and investments required to stand up Sandoz as a separate company.

Free cash flow is expected to more than double by 2028, from a reported USD 0.8 bn in 2022. This should enable Sandoz, with a targeted investment grade credit profile and a prudent capital structure, to pay shareholders a full-year dividend of 20-30% of FY 2023 core net income, increasing to 30-40% in the mid term.

"I am honored to have the opportunity to lead Sandoz into its exciting new future and believe this company will have the Board, Executive team and key capabilities it needs to succeed as a standalone company", said Gilbert Ghostine, Chairman-designate of the proposed new company, who will open the event later today. "Sandoz is an established European champion and global leader in generics and biosimilars with an impressive scientific heritage, a powerful purpose-driven strategy and one of the strongest brands in the industry. I am confident that our new company represents a compelling opportunity for both equity and debt investors."

Sandoz CEO Richard Saynor said: "In recent years, we have reshaped our business for the future, driven by a strong leadership team with clear alignment on our vision. We are focused on sales execution, while significantly expanding our pipeline, investing in targeted build-up of capabilities and developing strategic partnerships. Looking forward, six strategic levers will drive long-term investor value: attractive market fundamentals, leadership and scale, multiple growth drivers, margin improvement, accelerated cash generation, and a compelling sustainability story. The proposed spin-off would enable us to deliver our full potential, with an attractive and sustainable financial outlook including an expected shareholder dividend."

The expanding Sandoz product pipeline is expected to contribute an additional USD 3 billion in potential net sales over the next five years, with the mix shifting increasingly towards high-value biosimilars and complex generics. The biosimilar pipeline has trebled in size over recent years, now with 24 products, on top of a core generic pipeline of more than 400 products.

Concluding, Saynor said: "We actively pioneer access for patients by shaping the global healthcare environment, strengthening healthcare systems worldwide by delivering over USD 17 billion in annual savings in Europe and the US alone, reaching 500 million patients a year in over 100 countries, and generating a total social impact estimated in the hundreds of billions of dollars".

Sandoz will host a second CMD, in London on June 12, where investors and analysts will have another opportunity to meet Sandoz leadership.

Both events will also be webcast; to register online for access, visit the Investor Relations section of the Novartis website at www.novartis.com, or click directly below:
Capital Markets Day – New York (media-server.com)
Capital Markets Day – London (media-server.com)

Additional Transaction Details

The proposed 100% spin-off of Sandoz is expected to occur in the second half of 2023. Completion of the proposed spin-off is subject to satisfaction of certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, receipt of favorable tax rulings and opinions, final endorsement by the Board of Directors of Novartis AG and shareholder approval. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed. Further details of the proposed spin-off will be provided at a later date.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On June 7, 2023 ITabMed Ltd., a clinical-stage biotech company in China, reported the IND approval from China National Medical Products Administration (NMPA) for A-337, a CD3-activating bi-specific antibody targeting EpCAM. This is a "Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of A-337 in patients with advanced solid tumors" (Press release, ITabMed, JUN 7, 2023, View Source [SID1234632575]). EpCAM is one of the earliest identified tumor-associated antigens (TAA) and up-regulated and over-expressed in many solid tumors.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A-337 is the second immune oncology product generated by the immunotherapy antibody (iTab) platform to enter clinical development in China. iTab is a T cell engager (TCE) platform for human CD3-activating bi- and tri-specific antibodies targeting tumor associated antigens (TAA). A-337 was designed with two EpCAM targeting fragments (EpCAM x EpCAM x CD3) with significantly enhanced biological properties and improved safety profile compared to the competitor’s products including EpCAM x CD3 TCE, EpCAM x CD3 bispecific antibodies. In preclinical studies, A-337 demonstrated potent anti-tumor activity, favorable pharmacokinetics, and a significantly improved safety window.

Dr. Xiao Qiang Yan, Chairman and CEO of ITabMed Ltd commented "A-337 is our second immunotherapeutic antibody entering clinical development in China. A-337 has the similar structural design as A-319 which is in phase I development to treat liquid tumors. Two phase I studies of A-319 are being conducted in patients with relapsed and refractory B cell acute lymphoblastic leukemia (r/r-B-ALL) and in patients with relapsed and refractory non-Hodgkin’s lymphoma (r/r-NHL). The preliminary results of the two phase I studies have demonstrated an excellent safety profile and promising anti-tumor responses of A-319 during dose-escalation. Likewise, we believe that A-337 has enormous potential to treat metastatic solid tumors due to its improved safety profile and its unique format design. The IND approval demonstrates our continued effort in "innovating for life" and to cure many cancer patients with our innovative medicines".

About iTab platform

ITabMed has been developing the iTAb (immunotherapy antibody) platform for more than a decade. iTAb generates bi- and tri-specific antibodies that bind to the CD3 molecule on human T cells, and simultaneously bind to TAAs or TSA on a tumor cell. The formation of a synapse between the tumor cell and the T cell linked by the antibody leads to the activation of the T cells, and the release of mediators lysing the tumor cells. These T cell engaging bi- and tri-specific antibodies can drive the expansion of T cells, rendering T cells as serial killers of tumor cells. The iTAb antibodies are very potent and are manufactured in CHO cells in serum-free conditions. The iTAb drug products are very stable in liquid formulation with extra-long stability profile.

On June 7, 2023 Real-world data and expert perspectives on state-of-the-art clinical practice for the management of infection in patients with CLL will be showcased during the Octapharma Update-in-Hematology session at the EHA (Free EHA Whitepaper) Hybrid Congress on June 9, 2023, in Frankfurt, Germany (Press release, Octapharma, JUN 7, 2023, View Source [SID1234632574]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Secondary immunodeficiency (SID) is a common complication in patients with haematological malignancies such as CLL. Up to 85% of patients with CLL develop hypogammaglobulinemia, either due to the underlying disease or as a side effect of treatment.1 Patients with hypogammaglobulinemia are more likely to develop infections, which are a major cause of morbidity and account for up to 60% of deaths in patients with CLL.2 The use of immunoglobulin therapy (intravenous and subcutaneous) is well established as secondary prophylaxis once patients experience a severe/repeated infection. Furthermore, primary prophylaxis with immunoglobulin therapy has been suggested to decrease infection rates but more robust data are needed to evaluate the safety and efficacy of this strategy.3-5

Octapharma’s interactive Update-in-Hematology session "Chronic Lymphocytic Leukemia (CLL) and Beyond: Management of the Infection Burden" will begin with a spotlight on the risk of infections in patients with CLL using a data-driven and machine learning approach by Dr Caspar da Cunha-Bang, Rigshospitalet, Copenhagen, Denmark. This will be followed by a discussion on the risk factors for infections and the importance of guideline recommendations in choosing the right treatment to reduce the severity of these infections by Professor Hartmut Link, Haematology Oncology Kaiserslautern, Kaiserslautern, Germany. Finally, Professor Livio Trentin, University of Padua, Italy, will speak about his experience using subcutaneous immunoglobulin therapy for infection prophylaxis in patients with CLL. In addition, he will share his first-hand experience with ongoing research into this area, including the PRO-SID clinical trial and its potential for primary infection prophylaxis. The session will round off with an exciting panel discussion bringing together the audience and experts to exchange views on challenging cases of infections associated with CLL.

Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Centre in Ulm, Germany, will chair the session. He stated, "The COVID-19 pandemic has vividly reminded us about the impact of infections on patients. Therefore, novel perspectives in approaching prophylaxis in CLL are highly valued – I am very much looking forward to discussing some of these exciting advances in the field with the international panel of speakers and audience at this session."

Octapharma has a longstanding commitment to improving the management of patients with SID, and in 2020 launched PRO-SID (NCT04502030), a Phase III clinical trial investigating primary infection prophylaxis with panzyga, a human immunoglobulin for intravenous administration, in patients with CLL and SID. Over 240 adult patients with CLL and hypogammaglobulinemia (IgG levels < 5 g/L) who are receiving antineoplastic treatment will be enrolled to investigate the efficacy and safety of panzyga compared with placebo. The primary outcome is the occurrence of at least one major infection over 52 weeks. With this trial, Octapharma aims to gather robust clinical data on the efficacy of primary prophylaxis in managing infection risk in patients with SID and expand the treatment options in these patients.

Livio Trentin, Professor of Haematology and Director of the Haematology Unit at Padua University, is supervising one site of the PRO-SID trial. He commented: "There remains a significant need to establish the most effective approach to managing patients with haematological malignancies and secondary immunodeficiency. Proactive management of infections in these patients using primary prophylaxis with intravenous immunoglobulin has great potential but it is important that we gather robust evidence on the efficacy and safety of this treatment option through trials such as PRO-SID."

Olaf Walter, Board Member at Octapharma, added: "Octapharma is delighted to support this Update-in-Hematology session, and we look forward to facilitating expert perspectives and audience interaction to improve the care of patients with CLL. We are also proud to support the PRO-SID study which will provide important data to understand how to improve and potentially save the lives of these patients."

In addition to this Update-in-Hematology session, the strong commitment of Octapharma to the field of SID will be illustrated by the presentation of a subgroup analysis of patients with SID in a non-interventional safety study conducted in Germany. The results of this analysis on 3,846 SID patients will be displayed and commented during the poster session of the Congress on June 9, 2023:

P1505: "Tolerability and safety of intravenous immunoglobulins (5% and 10%) for the treatment of patients with secondary immunodeficiencies – Final subgroup results of a non-interventional safety study," presented by Octapharma.
We look forward to seeing you soon at EHA (Free EHA Whitepaper) 2023 – drop by the Octapharma booth on-site in Frankfurt for more information.

About panzyga

Panzyga is a 10% human normal immunoglobulin solution ready for intravenous administration. Panzyga is approved for use in treatment of primary immunodeficiency, idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP) in the USA, Europe and Canada. It is also approved for secondary immunodeficiencies and Guillain Barré syndrome in Europe and Canada and for Kawasaki disease, and multifocal motor neuropathy (MMN) in Europe.

On June 7, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported its second broad provisional patent application covering the composition of matter for a new telomere-targeting molecule (Press release, MAIA Biotechnology, JUN 7, 2023, View Source [SID1234632573]). MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell – intrinsic telomerase activity – and thus cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules.

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MAIA has nominated a new molecular entity candidate (designated as MAIA-2021- 029) for further advancement into preclinical GLP-toxicity and other studies, and may advance this candidate into human clinical trials upon completion of the required preclinical evaluations. The patent titled "TUMOR REDOX-ACTIVATED 6-THIOPURINE CONTAINING DIMER COMPOUNDS" further adds to MAIA’s Telomere-Targeting Molecule Program, which includes THIO, the lead therapeutic candidate currently being evaluated in a Phase 2 clinical trial, and follow-on compounds MAIA-2021-020 and MAIA-2022-012, patented in the fourth quarter of 2022.

"The discovery and preclinical advancements of these new telomere-targeting compounds represent another significant chapter for MAIA. We have observed impressive single-agent activity in several different tumor types for the new candidates, as well as in combination with immune checkpoint inhibitors," said Sergei Gryaznov, Ph.D., MAIA Chief Scientific Officer. "The observed anti-cancer activity in vitro and in vivo is quite remarkable, often leading to complete tumor eliminations. We are working diligently to advance these candidates toward clinical development."

"The development of proprietary new molecular entity candidates is a key component to MAIA’s strategy and greatly increases the chances to bring a highly efficacious telomere-targeting therapy to market. Our molecules can be used in the treatment of multiple cancer indications, and with the excellent preliminary results observed in our ongoing Phase II trial evaluating THIO in patients with Non-Small Cell Lung Cancer, we look forward to announcing further developments of MAIA’s proprietary new molecular entity candidates," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.