On November 1, 2021 AstraZeneca reported that it has agreed to transfer its global rights to Eklira (aclidinium bromide), known as Tudorza in the US, and Duaklir (aclidinium bromide/formoterol) to Covis Pharma Group (Covis Pharma) (Press release, AstraZeneca, NOV 1, 2021, View Source [SID1234593984]).

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Both medicines are delivered via the Genuair device and used for the treatment of patients with chronic obstructive pulmonary disease (COPD).

The agreement will ensure continued patient access to these established medicines.

Covis Pharma previously acquired the rights to the respiratory medicines Alvesco, Omnaris and Zetonna from AstraZeneca in 2018.

Financial considerations
Covis Pharma will pay AstraZeneca $270m on completion. Covis Pharma will also cover certain ongoing development costs related to the medicines. The income arising from the upfront payment will be fully offset by a charge for derecognition of the associated intangible asset and therefore no Other Operating Income will be recognised in AstraZeneca’s financial statements. In 2020, Eklira and Duaklir generated AstraZeneca revenue of $143m in the countries covered by this agreement.

The transaction is expected to close in the fourth quarter of 2021, subject to customary closing conditions and regulatory clearances. The agreement will not impact the Company’s financial guidance for 2021.

Eklira and Duaklir
Eklira (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a long-acting muscarinic antagonist (LAMA), which is marketed in the US as Tudorza and in some countries as Bretaris. Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA). It is marketed in some countries as Brimica. Both medicines are presented as a dry powder for inhalation and are delivered via a breath-actuated multi-dose dry powder inhaler, Genuair (Pressair in the US). AstraZeneca licensed the global rights to both products from Almirall S.A. in 2014.

On November 1, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported that it will publish its third quarter financial results and corporate update for the period ended September 30, 2021 in the form of an interim management report on Thursday, November 4, 2021 (Press release, Vivoryon Therapeutics, NOV 1, 2021, View Source [SID1234593979]).

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On November 1, 2021 Kyowa Hakko Kirin reported that (Press release, Kyowa Hakko Kirin, NOV 1, 2021, View Source [SID1234593976])

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1. Consolidated Financial Results for the Nine Months Ended September 30, 2021
(1) Consolidated operating results
(2) Consolidated financial position

2. Dividends
3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2021 (from January 1, 2021 to December 31, 2021)

1. Operating Results and Financial Statements
(1) Summary of Consolidated Financial Position Assets as of September 30, 2021, were ¥856.8 billion, an increase of ¥55.5 billion compared to the end of the previous fiscal year.

 Non-current assets increased by ¥3.9 billion to ¥362.7 billion, due mainly to an increase in intangible assets associated with in-licensing of development products, despite impairment of marketing rights, a decrease from sale of investment securities, etc.
 Current assets increased by ¥51.6 billion to ¥494.1 billion, due mainly to an increase in cash and cash equivalents from the proceeds from sale of assets held for sale (shares of Hitachi Chemical Diagnostics Systems Co., Ltd.) and proceeds from upfront payment received from Amgen Inc. based on an agreement for joint development and commercialization of KHK4083, as well as an increase in inventories, despite a decrease in assets held for sale.
 Liabilities as of September 30, 2021, were ¥143.5 billion, an increase of ¥40.6 billion compared to the end of the previous fiscal year, due mainly to an increase in contract liabilities accompanying the conclusion of an agreement with Amgen Inc.
 Equity as of September 30, 2021, was ¥713.3 billion, an increase of ¥14.9 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent as well as an increase in exchange differences on translation of foreign operations resulting from the impact of exchange rates, despite a decrease due to the payment of dividends, etc. The ratio of equity attributable to owners of parent to total assets as of the end of the third quarter was 83.2%, a decrease of 3.9 percentage points compared to the end of the previous fiscal year.

(2) Summary of Consolidated Business Performance
1) Overview of results The Group now applies the International Financial Reporting Standards ("IFRS") in line with its policy of expanding business globally, and adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amountFor the nine months ended September 30, 2021 (January 1, 2021 to September 30, 2021), revenue was ¥254.0 billion (up 8.5% compared to the same period of the previous fiscal year), and core operating profit was ¥46.8 billion (down 7.6%). Profit attributable to owners of parent was ¥32.9 billion (down 12.2%).

 The increase in revenue was the result of steady growth of global strategic products in North America and EMEA and higher revenue year on year in Asia, mainly in China, despite lower revenue in Japan. The positive effect on revenue from foreign exchange was ¥4.6 billion.
 The decrease in core operating profit was the result of increases in selling, general and administrative expenses, and research and development expenses, despite an increase in gross profit due to an increase in overseas revenue. The positive effect on core operating profit from foreign exchange was ¥1.1 billion.
 Profit attributable to owners of parent decreased as a result of an increase in income tax expense in addition to a decrease in core operating profit, despite a decrease in other expenses.

On November 1, 2021 xFOREST Therapeutics Co., Ltd. (Headquarter: Kamigyoku, Kyoto, Japan, President and CEO: Shunichi Kashida, "xFOREST"), Axcelead Drug Discovery Partners Inc. (Headquarter: Fujisawa, Kanagawa, President: Yoshinori Ikeura, "Axcelead DDP"), and Kyowa Kirin Co., Ltd. (Headquarter: Chiyoda-ku, Tokyo, TSE:4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported that the three companies have entered into a joint research agreement to discover multiple drugs that target RNA structures (Press release, Kyowa Hakko Kirin, NOV 1, 2021, View Source [SID1234593975]).

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Axcelead DDP and Kyowa Kirin originally started collaboration on the development of innovative small-molecule drugs based on a novel drug discovery technology platform in October 2020. Under the terms of the agreement among three companies announced here, xFOREST participates in the research being conducted by Axcelead DDP and Kyowa Kirin on the drug discovery targeting RNA structures.

xFOREST will provide its proprietary FOREST technologies, a suite of large-scale parallel analysis platforms, to promote systematic small-molecule drug discovery research targeting RNA structures. xFOREST obtains rights to receive milestone payments and royalties on sales from Kyowa Kirin according to the progress and success of its R&D. Kyowa Kirin has exclusive rights to develop and commercialize RNA-targeted small-molecules discovered from the collaboration.

Shunichi Kashida, Ph.D., President and CEO of xFOREST commented, "xFOREST Therapeutics has been promoting the development of its proprietary FOREST technologies, aiming to realize highly effective systematic RNA-targeted drug discovery. We appreciate that we will initiate the brandnew challenge to research for discovering the RNA-targeted drug with Kyowa Kirin and Axcelead DDP and we will push forward this research collaboration to deliver new drugs to patients as soon as possible."

Yoshinori Ikeura, Ph.D., President of Axcelead DDP commented, "Since Axcelead DDP and Kyowa Kirin started collaboration in 2020, we have been striving to develop fundamental technologies that will open up a new era of small-molecule drugs together. We feel the excitement at xFOREST’s participation in our collaboration, which is sure to help us construct a novel unparalleled platform for RNA-targeted small-molecule drug discovery. We are delighted that we utilize our expertise and technologies accumulated in the pharmaceutical industry for the development of novel technology."

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin commented, "We are very delighted to initiate a collaboration with xFOREST and Axcelead DDP. We highly expect that xFOREST’s unique platform could further accelerate our efforts by integrating it with the Axcelead DDP’s extensive technology and experience of small-molecule drug discovery and our innovative drug discovery technology. We will work closely with both companies to research and develop novel drugs to answer unmet medical needs."

On November 1, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa, President and CEO: Dai Takehara, "PRISM") reported that the CREB-binding protein (CBP) / β-catenin inhibitor E7386, a medium-molecular weight compound created through collaboration research between Eisai and PRISM, has achieved the clinical POC (Proof of Concept) (Press release, Eisai, NOV 1, 2021, View Source [SID1234593967]).

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Eisai is conducting a Phase I clinical study of E7386 monotherapy for solid tumors, and a Phase Ib clinical trial of E7386 plus lenvatinib mesylate (product name: LENVIMA, "lenvatinib"), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for solid tumors including hepatocellular carcinoma. The achievement of the POC, which is defined in a collaborative research agreement between Eisai and PRISM, was confirmed based on data such as antitumor activity and changes of biomarkers in these clinical trials.

The E7386 targets, β-catenin, is considered to be one of the undruggable targets that are particularly difficult to develop into drug discovery. β-catenin, along with CBP, which is also the target of E7386, is located at the downstream of the Wnt signaling and regulates the Wnt signaling-dependent transcription activity. E7386 is a CBP / β-catenin inhibitor that inhibits CBP and β-catenin protein-protein interactions and regulates the Wnt signal-dependent gene expression. It is expected to suppress tumor growth dependent on the Wnt signaling. 1 E7386 is also expected to release the suppression of tumor-infiltrating T cells by the Wnt signaling activation, and to enhance the effect of immune checkpoint inhibitors1. The antitumor effect of E7386 alone and the combination of E7386 and anti-PD-1 antibody has been confirmed in a cancer-bearing mouse model. 1

Based on the POC achievement, Eisai has initiated a phase Ib/II clinical trial (Study 201) of E7386 in combination with anti-PD-1 therapy pembrolizumab for solid tumors in Japan.*

Dr. Takashi Owa, Senior Vice President, President of Oncology Business Group, at Eisai said, "With achieving the POC, we are confident with the prospect of offering E7386 to patients as a cancer treatment. E7386 may overcome lenvatinib and pembrolizumab treatment resistances through its combination therapy with lenvatinib or pembrolizumab. Eisai will accelerate clinical trials of E7386 in combination with lenvatinib or pembrolizumab, and do its utmost aiming to create new treatments for cancers with high unmet medical needs."

Dai Takehara, President and CEO of PRISM commented, "The approval of the clinical POC for the E7386 demonstrates that PRISM’s drug discovery platform is an effective option for novel drug targets which have been considered difficult. We are grateful to Eisai for advancing this development. We will continue to take on the challenge of targeting more novel targets, with the aim of providing new treatment to as many patients as possible."

* Study 201 is being conducted under a clinical trial collaboration and supply agreement between Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A.