On February 4, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "the Company" ) reported the status and the completion of acquisition of its own shares based on the resolution of the Board of Directors’ meeting held on October 31, 2019, pursuant to the Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act (Press release, Astellas, FEB 4, 2020, View Source [SID1234553798]).

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The Company also announced the number of shares to be canceled on February 14, 2020 pursuant to Article 178 of the Companies Act has been finalized.

Particulars

1. Status of acquisition of own shares
(1) Class of shares acquired: Common stock of the Company
(2) Total number of shares acquired: 7,009,900 shares
(3) Total amount of acquisition cost: 13,133,509,050 yen
(4) Period of acquisition: From January 1, 2020 to January 31, 2020
(5) Method of acquisition: Purchased on the Tokyo Stock Exchange

2. Details of the cancellation of treasury stock
(1) Class of shares to be cancelled: Common stock of the Company
(2) Number of shares to be cancelled: 27,036,100 shares
(Ratio to the total number of shares outstanding [excluding treasury stock]:
1.45 %)
(3) Cancellation date: February 14, 2020

2
(Reference)
1. Details of the resolution at the meeting of the Board of Directors on October 31,
2019

(1) Class of shares to be acquired: Common stock of the Company
(2) Total number of shares to be acquired: Up to 32 million shares
(Ratio to the total number of shares outstanding [excluding treasury stock):
1.70%]
(3) Total amount of acquisition cost: Up to 50 billion yen

(4) Period of acquisition: From November 1, 2019 to January 31, 2020
2. Accumulated Company’s own shares acquired pursuant to the above board resolution
(1) Total number of shares acquired: 27,036,100 shares
(2) Total amount of acquisition cost: 49,999,815,550 yen
(Ratio to the total number of shares outstanding [excluding treasury stock]:
1.45 %)

3. Details of the decided cancellation of treasury stock (October 31, 2019)

(1) Class of shares to be cancelled: Common stock of the Company
(2) Total number of shares to be cancelled: All of the shares repurchased
as stated in 2 above
(3) Scheduled cancellation date: February 14, 2020

4. Status of shares after cancellation
(1) Number of shares issued: 1,861,787,075 shares (expected)
(2) Number of the Company’s treasury stock: 3,381,929shares (expected)
[Estimated numbers of shares described above (1) and (2) were calculated on the basis of the issued shares and the Company’s treasury stock as of January 31, 2020, respectively.]

On February 4, 2020 Celsion Corporation (NASDAQ: CLSN), an oncology drug-development company, reported Prof. Riccardo Lencioni, M.D., FSIR, EBIR delivered a presentation titled "Thermally-Sensitive Ablation Enhancers: Where Do We Stand?" at the SPECTRUM 2020 Interventional Oncology Conference held in Miami , FLA last month (Press release, Celsion, FEB 4, 2020, View Source [SID1234553840]). Dr. Lencioni is a professor in the Department of Radiology at the University of Pisa School of Medicine in Italy and is an Honorary Research Professor of Interventional Oncology at the Miami Cancer Institute. He was the lead principal investigator in Europe for the Company’s completed Phase III HEAT Study in hepatocellular carcinoma (HCC), or primary liver cancer, using radiofrequency ablation (RFA) plus ThermoDox, the Company’s lead product.

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The SPECTRUM Conference is the only interventional oncology conference endorsed by The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). In his talk, Prof. Lencioni focused on the HEAT Study subgroup analysis showing the duration of RFA heating time per tumor volume of 45 minutes or longer plus ThermoDox was key to overall survival benefit in this patient population. He noted that in early-stage HCC, nearly 50% of patients with a solitary lesion of less than 5 cm on imaging have microsatellites on histology. While RFA and other energy sources are not able to treat these microsatellites, a thermosensitive drug carrier such as ThermoDox would deposit increased amounts of doxorubicin in the margins of a tumor given increased ablation time.

"The significant attention ThermoDox is receiving among key opinion leaders at important medical conferences has helped build awareness of our drug in combination with RFA for treating HCC," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We are grateful to Prof. Lencioni for helping Celsion create the training video on RFA heating time for lesion sizes from 3 cm to 7 cm that is being used by all investigators in our current Phase III OPTIMA Study."

The Company’s OPTIMA Study was based on the prospective analysis of the HEAT Study subgroup of patients who received 45 minutes or more of RFA energy. The OPTIMA Study was fully enrolled in August 2018 with 556 subjects from 65 clinical sites in 14 countries. At its first interim analysis in November 2019 following 128 patient events, or deaths, the independent Data Monitoring Committee (iDMC) unanimously recommended the OPTIMA Study continue according to protocol based on safety and data integrity.

The Company re-affirms its projection that its second pre-planned interim efficacy analysis will occur during the second quarter of 2020, following 158 patient events, or deaths. The hazard ratio for success at 158 events is 0.70, which is below the hazard ratio of 0.65 observed for the 285 patients in the HEAT Study subgroup of patients treated with RFA of 45 minutes or longer.

Mr. Tardugno added, "We were pleased that the HCC part of the SPECTRUM program featured invited faculty with ties to Celsion, such as Dr. Josep Llovet, Founder and Director of the Liver Cancer Program and Full Professor of Medicine at the Mount Sinai School of Medicine in New York, who is chair of the OPTIMA iDMC, and Dr. Ghassan Abou-Alfa of Memorial Sloan Kettering Cancer Center and Professor, Weill Medical College at Cornell University, both in New York City, who was a member of the HEAT Study DMC. The medical community’s independent assessment, along with the National Institutes of Health’s published confirmation of the hypothesis supporting the potential for ThermoDox as a curative treatment for the largest unmet need in oncology is gratifying indeed."

On February 4, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that the United States Patent and Trademark Office (USPTO) has granted the Company a new patent for methods of screening for anti-PVRIG antibodies that inhibit the binding of PVRIG with PVRL2 (Press release, Compugen, FEB 4, 2020, View Source [SID1234553856]).

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U.S. Patent No. 10,550,173, titled "PVRIG Polypeptides and Methods of Treatment," covers a method of screening for any anti-PVRIG antibody that inhibits the binding of PVRIG with PVRL2, which can be used, for example, for determining the effect of candidate antibody agents on various T cell activation.

The patent is expected to expire in the United States no earlier than February 2036.

About COM701 and PVRIG

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint target candidate discovered by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. In addition, COM701 combined with antagonist anti-PD-1 antibodies has demonstrated synergistic effects in enhancing human T cell stimulation and inhibiting tumor growth in murine models, indicating an intersection of the PVRIG and PD-1 inhibitory pathways and the potential of these combinations to further enhance immune response against tumors.

PVRIG and TIGIT constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. Preclinical data for COM701 suggest that PVRIG may be a dominant checkpoint pathway in diverse patient populations with tumors that express elevated PVRL2, the ligand of PVRIG, as compared to expression of PVR, the ligand of TIGIT. This includes patients with breast, endometrial, and ovarian cancers. In addition, expression studies show that PVRIG, TIGIT, and their respective ligands, are expressed in a broad variety of tumor types, such as those noted above, as well as lung, kidney, and head & neck cancers. In these tumors the blockade of both TIGIT and PVRIG may be required to sufficiently stimulate an anti-tumor immune response, with or without additional PD-1 pathway blockade.

COM701 is in Phase 1 clinical trials in patients with advanced solid tumors, to evaluate monotherapy and combination therapy with a PD-1 inhibitor.

On February 4, 2020 Nippon Kayaku reported Financial Results For the Third Quarter of the Fiscal Year Ending March 31, 2020 (Press release, Nippon Kayaku, FEB 4, 2020, View Source net/doc/4272/ir_material_for_fiscal_ym8/76321/00.pdf [SID1234553800]).

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1. Consolidated Business Results for the First Three Quarters of the Fiscal Year Ending March 31, 2020 (April 1, 2019–December 31, 2019)

(1) Significant changes in subsidiaries during the first three quarters (changes in designated subsidiaries that result in changes in scope of consolidation): None

(2) Adoption of special accounting methods for presenting the quarterly consolidated financial statements: None

(3) Changes to accounting policies and estimates and restatements

[1] Changes to accounting policies associated with revision of accounting standards or similar items: None
[2] Changes other than
[1]: None
[3] Changes to accounting estimates: None
[4] Restatements: None (4) Number of shares issued (common stock)

[1] Number of shares issued at end of the fiscal period (including treasury stock) As of December 31, 2019: 177,503,570 shares As of March 31, 2019: 182,503,570 shares
[2] Number of treasury stock at end of the fiscal period As of December 31, 2019: 5,275,358 shares As of March 31, 2019: 9,358,749 shares
[3] Average number of shares during the fiscal period (cumulative) First three quarters of fiscal year ending March 31, 2020: 173,012,317 shares First three quarters of fiscal year ended March 31, 2019: 173,145,466 shares *Quarterly summary financial statements are not subject to audit by a certified public accountant or audit firm. *Analysis related to appropriate use of the business results forecasts, and other notes The information in this report constitutes forward-looking statements regarding future events and performance.

This information is based on the beliefs and assumptions of management in light of information currently available to it at the time of announcement and subject to a number of uncertainties that may affect future results. Actual business results may differ substantially from the forecasts herein due to various factors.

For matters pertaining to business forecasts, please refer to "(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts" on page 3 of the Supplementary Information

1. Qualitative Information Concerning Results for the First Three Quarters

(1) Analysis of Operating Results In the first three quarters of this consolidated fiscal year (April 1, 2019 to December 31, 2019), the global economy as a whole saw continued slow growth. This was mainly due to the deceleration of external demand in the manufacturing industry, while consumer spending remained steady on the back of an improved employment and income environment in the U.S. and Europe. The trend of deceleration in economic growth persisted in China, owing to the impact from trade friction between the U.S. and China, among other factors. The Japanese economy showed signs of a gradual rebound despite weak exports. This resulted mainly from moderate growth in capital investment and a resurgence in consumer spending. Amid these conditions, the Nippon Kayaku Group worked to implement the key themes and resolve the midand long-term key issues outlined in "KAYAKU Next Stage," the mid-term business plan launched this fiscal year.

We worked to cut costs further to reinforce our profit structure, in addition to focusing on strengthening R&D, optimal allocation of business resources into core businesses, and expanding our overseas business. Owing to these actions, net sales for the first three quarters of this consolidated fiscal year outperformed the same period of the previous fiscal year in the functional chemicals business, the pharmaceuticals business, and the safety systems business, resulting in total net sales of 131,825 million yen, an increase of 2,924 million yen (2.3%) yearon-year. Operating income totaled 14,231 million yen, a decrease of 331 million yen (2.3%) year-on-year. Ordinary income totaled 14,682 million yen, a decrease of 1,307 million yen (8.2%) year-on-year due to an increase in exchange losses. Profit attributable to owners of parent was 11,302 million yen, an increase of 721 million yen (6.8%) year-onyear due to a decrease in income taxes-deferred. Performance by business segment is as described below. [Functional Chemicals Business] Sales stood at 53,260 million yen, an increase of 1,892 million yen (3.7%) year-on-year. The functional materials business recorded growth in sales over the same period of the previous fiscal year. This growth was resulted from strong sales of epoxy resins for 5G base stations, which more than covered for the deceleration in demand from the semiconductor market. The color materials business outperformed the same period of the previous fiscal year, boosted by strong sales of colorants for inkjet printers for industrial applications and materials for thermal paper, despite the negative impact from deceleration of the Chinese market. The catalyst business outperformed the same period of the previous fiscal year. In the Polatechno Group, sales of components for X-ray analysis systems were strong, but sluggish sales of dyetype polarizing films resulted in underperformance of the Polatechno Group as a whole, compared with the same period of the previous fiscal year. Segment profit was 4,537 million yen, a decrease of 1,011 million yen (18.2%) year-on-year. [Pharmaceuticals Business] Sales stood at 36,327 million yen, an increase of 831 million yen (2.3%) year-on-year. Pharmaceuticals in Japan were impacted by drug price revisions accompanying the increase in the consumption tax rate, but the segment outperformed the same period of the previous fiscal year as growth in sales for the antibody biosimilar, INFLIXIMAB BS for I.V. Infusion, and for TRASTUZUMAB BS for I.V. Infusion contributed to performance along with growth in generic anti-cancer drugs as the switch to generic drugs continued. Although exports and diagnostic agents underperformed the same period of the previous fiscal year, sales of active pharmaceutical ingredients and contract production for the Japanese domestic market outperformed the same period of the previous fiscal year. Segment profit totaled 3,947 million yen, an increase of 991 million yen (33.5%) year-on-year. [Safety Systems Business] Sales stood at 36,182 million yen, an increase of 797 million yen (2.3%) year-on-year. Business in Japan outperformed the same period of the previous fiscal year due to firm sales of both airbag inflators and micro gas generators for seatbelt pretensioners. The overseas business overall saw sales decline from the same period of the previous year as the deceleration of Chinese market growth caused sales of air bag inflators and squibs to underperform year-on-year. While sales of micro gas generators for seatbelt pretensioners outperformed the same period of the previous fiscal year due to the increase in the automotive safety component installation rate, this did not compensate for the above decline. Nippon Kayaku Co., Ltd.

Summary of Consolidated Financial Results [Japanese GAAP] For the Third Quarter of the Fiscal Year Ending March 31, 2020

I. First three quarters of the fiscal year ended March 31, 2019 (April 1, 2018– December 31, 2018)

2. Information concerning impairment losses on non-current assets, goodwill, etc. by reportable segment (Material change in the amount of goodwill) The business combination with RaySpec Limited which was implemented on December 26, 2017, was subject to provisional accounting in fiscal year ended March 31, 2018 and confirmed during the previous consolidated fiscal year. This has resulted in a decrease in the amount of goodwill in the functional chemicals business segment. (Business Combinations, etc.) (Regarding the Acquisition of Shares via Tender Offer and the Demand for the Sale of Shares) Nippon Kayaku decided to acquire the consolidated subsidiary POLATECHNO CO., LTD. (hereafter, "Polatechno") via tender offer (hereafter, "this tender offer"), based on the Financial Instruments & Exchange Act. The resolution was approved at the Board of Directors meeting held on August 27, 2019.

This tender offer was executed and the acquisition was completed on October 10, 2019. A Demand for the Sale of Shares was subsequently exercised based on Article 179, Paragraph 1 of the Companies Act, and Nippon Kayaku made Polatechno a wholly owned subsidiary on November 12, 2019.

1. Summary of Business Combination (1) Name and business description of the business to be combined Name of company: POLATECHNO CO., LTD. Business description: Manufacture and sale of components for LCD displays, components for LCD projectors, etc.

(2) Dates of business combination Acquisition via tender offer: October 18, 2019 (deemed acquisition date: October 1, 2019) Acquisition via the Demand for the Sale of Shares: November 12, 2019 (deemed acquisition date: October 1, 2019)

(3) Legal form of business combination Acquisition of shares for cash

(4) Name of company after combination No change.

(5) Percentage of subsidiary shares held after additional acquisition: Percentage of shares held prior to business combination: 66.45% Percentage of shares held after tender offer: 99.20% Percentage of shares held after the Demand for the Sale of Shares: 100.00% 2.

Breakdown of the cost of acquiring additional shares of the subsidiary and type of payment (including the shares Nippon Kayaku intends to acquire via the Demand for the Sale of Shares) Acquisition for cash: 13,808 million yen Acquisition cost: 13,808 million yen 3.

Overview of Accounting Method Implemented These transactions qualify as transactions under common control specified in the Revised Accounting Standard for Business Combinations (ASBJ Statement No.21, September 13, 2013) and Revised Guidance on Accounting Standard for Business Combinations and Accounting Standard for Business Divestitures (ASBJ Guidance No.10, September 13, 2013) and Nippon Kayaku is handling these as transactions under common control.

On February 4, 2020 PharmaCyte Biotech (OTCQB: PMCB) is reported to embark upon a planned U.S. FDA Phase 2b clinical trial to treat locally advanced, inoperable pancreatic cancer (LAPC) at trial sites all over the United States, and with that journey comes the need to keep its signature technology, Cell-in-a-Box, protected should it one day receive marketing approval from drug regulatory agencies in the U.S. and Europe (Press release, PharmaCyte Biotech, FEB 4, 2020, View Source [SID1234553841]). PharmaCyte’s Cell-in-a-Box technology for the treatment of pancreatic cancer is certainly protected well into the future if/when it does receive the coveted marketing approval it’s striving for upon the completion of clinical trials.

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Currently, PharmaCyte is revamping its provisional patent application and its strategy related to full patent protection. The idea is to present the United States Patent and Trademark Office (USPTO) with an acceptable provisional patent application that protects its therapy to treat cancerous tumors, including the therapy that will be used in its upcoming clinical trial in LAPC.

Provisional patent applications are a way to establish and protect a "date of invention" or "priority filing date" for one year. The provisional patent application was created to provide inventors with a way to begin protecting their inventions, and an approved provisional patent application will provide PharmaCyte 12 months to prepare a full patent application. This approach will offer the company an opportunity to establish an early effective filing date for a patent.

A provisional patent—and eventually a full patent—would give PharmaCyte a fresh 20 years of patent protection; however, even without it, PharmaCyte has protections in place to protect its technology that are in line with any biotechnology/pharmaceutical company developing treatments after many years. In most cases, the 20-year patent protection that biotechnology/pharmaceutical companies have in place while developing drugs/treatments, have their 20-year time frame cut in half to 10 years by the time the drug hits the marketplace.

Patents are typically awarded within a few years after the patent application submission, but a common misconception is that the patent begins only after the drug hits the market, so with this in mind, PharmaCyte will actually have longer protections in place than most biotechnology/pharmaceutical companies have upon marketing approval after years of development.

How is this possible? Well, actually PharmaCyte has two protections in place that will keep its technology protected—and unlike 20-year patent protection where the clock is ticking throughout development, these protections don’t begin until the therapy is approved. First, PharmaCyte is developing a "biologic" therapy, which offers protections under the Affordable Care Act, and second, PharmaCyte’s therapy for pancreatic cancer was granted Orphan Drug Designation from both the U.S. FDA and in the European Union by the European Medicines Agency (EMA).

PharmaCyte’s pancreatic cancer therapy was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the U.S. FDA on December 17, 2014. This orphan drug status assures marketing exclusivity for PharmaCyte’s pancreatic cancer therapy in the U.S. for 7 years after market approval by the FDA. Also, PharmaCyte has orphan drug status in the European Union (EU) for its pancreatic cancer therapy. This designation provides 10 years of marketing exclusivity in all countries in the EU following approval by the European Medicines Agency (EMA).

In addition, the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010, establishes a period of 12 years of "data exclusivity" for reference products to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in a biosimilar application. PharmaCyte’s 12-year exclusivity doesn’t begin until the FDA approves the company’s pancreatic cancer therapy.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the protections for the company’s pancreatic cancer therapy, "If our pancreatic cancer therapy receives FDA approval, the orphan drug designation in the U.S. and the EU, together with the BPCIA data exclusivity, will give us substantial marketing exclusivity for our pancreatic cancer therapy. Any new patent application, while it does include our pancreatic cancer therapy, should really be viewed as an opportunity to dramatically broaden PharmaCyte’s ability to protect our therapy for all malignant tumors for the next 20 years."