On April 28, 2022 Incyte (NASDAQ:INCY) and Maruho Co., Ltd. reported that the companies have entered into a Strategic Alliance Agreement for the development, manufacturing and exclusive commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK2 inhibitor ruxolitinib, for treatment of autoimmune and inflammatory dermatology indications in Japan (Press release, Incyte, APR 28, 2022, View Source [SID1234613234]).

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"Having successfully launched Opzelura (ruxolitinib cream) in atopic dermatitis in the United States, and with a regulatory decision for ruxolitinib cream in the U.S. and regulatory feedback in Europe expected this year for vitiligo, we are eager to begin our collaboration with Maruho, a company specialized in dermatology in Japan"

Under the terms of the agreement, Maruho will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development, regulatory and commercial milestones and royalties on net sales of the licensed product in Japan.

Maruho will receive the rights to develop, manufacture and exclusively commercialize ruxolitinib cream, and other potential future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatologic diseases, including vitiligo and atopic dermatitis, in Japan.

"Having successfully launched Opzelura (ruxolitinib cream) in atopic dermatitis in the United States, and with a regulatory decision for ruxolitinib cream in the U.S. and regulatory feedback in Europe expected this year for vitiligo, we are eager to begin our collaboration with Maruho, a company specialized in dermatology in Japan," said Hervé Hoppenot, Chief Executive Officer, Incyte. "There remains a significant unmet need among patients living with immune-mediated dermatologic diseases and we believe Maruho’s expertise makes them an outstanding partner to support the development of ruxolitinib cream and, if approved, help patients and healthcare providers in Japan access this innovative therapy."　

Maruho President and CEO, Atsushi Sugita said, "Incyte has successfully launched ruxolitinib cream in the U.S. and provided a new treatment for patients suffering from atopic dermatitis. As a specialty pharmaceutical company in dermatology aimed at improving the lives of patients, supporting the development of ruxolitinib cream has great significance for Maruho. Leveraging our strengths, we will support the development of ruxolitinib cream in Japan and work to provide a new treatment option to patients suffering from immune mediated dermatologic diseases beginning with atopic dermatitis as soon as possible."

The transaction is effective immediately upon the execution of the Strategic Alliance Agreement.

About Ruxolitinib Cream (Opzelura)

Ruxolitinib cream (Opzelura), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States, indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In October 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥12 years) with non-segmental vitiligo with facial involvement. Additionally, in December 2021, Incyte announced the acceptance and priority review of the supplemental New Drug Application (sNDA) for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥12 years) with vitiligo.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Opzelura is a trademark of Incyte.

About Incyte Dermatology

Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

Currently, Incyte is exploring the potential of JAK inhibition for additional immune-mediated dermatologic conditions with a high unmet medical need, including hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

On April 28, 2022 Aadi Bioscience, Inc. (Nasdaq: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that it will report results for the first quarter 2022 before market open on Thursday, May 12, 2022 (Press release, Aadi Bioscience, APR 28, 2022, View Source [SID1234614203]). Aadi management will then host a conference call and webcast at 8:30 am EDT (5:30 am PDT) to discuss the results as well as provide a corporate update.

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Individuals may join the webcast online by clicking here or may participate in the live call via telephone by dialing (877) 407-9716 (domestic) or (201) 493-6779 (international) and using conference ID 13729259. A replay of the call will also be available through Aadi’s website within the "Investors & News/Event Calendar" section.

On April 28, 2022 NEC reported (Press release, NEC, APR 28, 2022, View Source [SID1234613084])

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1. Consolidated Financial Results for the Year ended March 31, 2022 (April 1, 2021 – March 31, 2022)
(1) Consolidated Operating Results
(2) Consolidated Financial Position
(3) Consolidated Cash Flows

2. Dividends
3. Consolidated Financial Results Forecast for the Fiscal Year Ending March 31, 2023 (April 1, 2022 – March 31, 2023)

1. Non-consolidated Financial Results for the Year Ended March 31, 2022 (April 1, 2021 – March 31, 2022)
(1) Non-consolidated Operating Results
(2) Non-consolidated Financial Position

*This consolidated financial results falls outside the scope of audit to be performed by certified public accountants or an audit firm.

*Explanation concerning the appropriate use of the financial results forecast and other special matters (Adjusted profit (loss)) "Adjusted operating profit (loss)" is an indicator for measuring underlying profitability in order to clarify the contribution of acquired companies to the NEC Group’s overall earnings. It is measured by deducting amortization of intangible assets recognized as a result of M&A and expenses for acquisition of companies (financial advisory fees and other fees) from operating profit (loss). Also, "Adjusted net profit (loss) attributable to owners of the parent" is an indicator for measuring underlying profitability attributable to owners of the parent. It is measured by deducting adjustment items of operating profit (loss) and corresponding amounts of tax and non-controlling interests from net profit (loss) attributable to owners of the parent. (Cautionary statement with respect to forward-looking statements) The forward-looking statements such as operating results forecast contained in this statements summary are based on the information currently available to NEC Corporation ("the Company") and certain assumptions considered reasonable. Actual operating results may differ significantly from these forecasts due to various factors.

For details, please refer to "3. Cautionary Statement with Respect to Forward-Looking Statements" on page 16. (How to obtain supplementary financial materials and information on the financial results briefing) On April 28, 2022, the Company will hold a financial results briefing for the institutional investors and analysts. Presentation materials will be posted on the company website after the release of financial results, and the presentation video and Q&A summary will be also posted on the company website promptly after the financial results briefing. In addition to the above, the Company periodically holds briefings on business and operating results for the individual investors. Presentation materials and Q&A summary will be posted on the company website promptly after the briefing. For the schedule and details, please check the company website.

On April 28, 2022 XBiotech (NASDAQ: XBIT) reported that the French National Agency for the Safety of Medicines and Health Products [L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)] approved the launch of a multicenter randomized clinical study for XBiotech’s candidate cancer treatment Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer (Press release, XBiotech, APR 28, 2022, View Source [SID1234613124]). The French National Cancer Institute (INCA) has also awarded a grant to fund all clinical costs for the study.

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Investigators will combine Natrunix and trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer in subjects that have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. The study will randomize patients to receive the Natrunix plus chemotherapy or placebo plus chemotherapy and is designed to seamlessly proceed to a Phase III study based on achievement of certain early efficacy milestones.

Headed by Dr. François Ghiringhelli and Dr. Come Lepage, the clinical program will include over 20 participating clinical centers and enroll at least 160 subjects. Dr. François Ghiringhelli is Professor in Medical Oncology and Director of the INSERM research team at the Georges-Francois Leclerc Cancer Centre, and Dr. Come Lepage, Prof. Department Gastroenterology and Digestive Oncology, University Hospital Dijon, Dijon, France. The study design was developed by the lead investigators in collaboration with XBiotech.

The first portion of the study will be an open label, dose escalation (3:3). The Phase II portion will be a multicenter, randomized, double blind, placebo-controlled, non-comparative trial that will enroll 160 subjects. The main objective of the phase II study is to evaluate the efficacy of Natrunix + trifluridine/tipiracil in comparison with placebo + trifluridine/tipiracil with respect to 6-month overall survival in patients with refractory metastatic colorectal cancer. Secondary efficacy measures in the phase 2 portion will include progression free survival, median overall survival, tolerance, quality of life, serum markers of inflammatory cytokines, and tumor markers by immunohistochemistry. With successful completion of the primary endpoint in the Phase II portion, the study will continue into a phase III trial with the number of additional patients enrolled based upon results from the Phase II.

Natrunix is a therapeutic monoclonal antibody discovered, manufactured and undergoing clinical development by XBiotech. The antibody blocks the activity of interleukin-1 alpha (IL-1α). Malignant tumors "trick" the body into producing IL-1α, which has multiple roles in supporting tumor growth and spread. IL-1α expression is also induced by cytotoxic chemotherapy. IL-1α is a potent activator of new blood vessel formation (upregulating VEGF and tumor neoangiogenesis); it mediates breakdown of connective tissue through stimulating matrix metalloproteinase production; facilitates metastasis (enhancing adhesion and migration across blood vessels); and mediates systemic illness (fatigue, anorexia, and anxiety) through activating the hypothalamic-pituitary-adrenal axis. Using Natrunix to block IL-1α in combination therapy could inhibit tumor growth and spread, reduce unwanted effects of chemotherapy, and improve outcomes.

Colorectal cancer is one of the most common forms of cancer in Europe and the United States, with the American Cancer Society’s estimating over 151,000 new cases and over 52,000 deaths in the United States alone.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

On April 28, 2022 The Board of Directors of PerkinElmer, Inc. (NYSE: PKI) reported a regular quarterly dividend of $0.07 per share of common stock (Press release, PerkinElmer, APR 28, 2022, View Source [SID1234613142]). This dividend is payable on August 12, 2022 to all shareholders of record at the close of business on July 22, 2022.

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