On August 1, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that Pilot, Inc. (HQ: Kobe, Japan; CEO: Kazuo Maeda), a software firm, has become a wholly-owned subsidiary through the acquisition of outstanding shares and that the company name has changed to Sysmex Pilot Co., Ltd (Press release, Sysmex, AUG 1, 2022, View Source [SID1234617168]). Going forward, the companies aim to improve the speed of development by reinforcing software design and development capabilities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Pilot has high technical capabilities in control system software development and has established a strong track record in system development for ships, robots, medical equipment and others since its establishment. Pilot started collaborating with Sysmex in 2004 on software design and development for hematology products and transportation systems, thereby contributing to greater efficiency in clinical testing laboratories through automation and acceleration.

With the aim of improving Sysmex’s software design and development capabilities; quality and safety; and product development speed, and also of delivering further synergies, Pilot has become a wholly-owned subsidiary through the acquisition of outstanding shares.

By maximizing the synergies between the two companies and accelerating the software development speed for next-term products, the companies will contribute to the development of healthcare and the healthy lives of people.

On August 1, 2022 Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported that G-Lasta Subcutaneous Injection 3.6 mg BodyPod ("the product"), which is an automated injection device of G-Lasta [KRN125, generic name: pegfilgrastim (genetical recombination), long-acting Granulocyte Colony-Stimulating Factor*1 (G-CSF) preparation], was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for decreasing the incidence of febrile neutropenia*2 in patients receiving cancer chemotherapy on July 28 (Press release, Kyowa Hakko Kirin, AUG 1, 2022, View Source [SID1234617167]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

G-Lasta is a long-acting G-CSF preparation, which has been licensed from Amgen K-A Inc. to Kyowa Kirin. It has been marketed in Japan since 2014 with the indication of decreasing the incidence of febrile neutropenia in patients receiving cancer chemotherapy. It is typically administered by medical staff at least one day after chemotherapy. This automated injection device works by delivering a dose of GLasta into the body one day after it is attached to the patient. By attaching it to patients on the day of chemotherapy, an additional outpatient visit required for administration of G-Lasta on the following day can be omitted. With the product, it is expected that burden on both patients and medical staff can be reduced.

"We are very pleased with the approval of G-Lasta Subcutaneous Injection 3.6 mg BodyPod. We believe the product will deliver new value to patients, caregivers, and medical staff who are involved in cancer chemotherapy," said Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. "We will continue to make further effort to launch the product with Terumo Corporation."

The product had been co-developed with Terumo Corporation (TSE:4543). Kyowa Kirin submitted the NDA of the product based on the result of safety data from the phase 1 clinical study conducted by Kyowa Kirin in August 2021.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

*1: About Granulocyte Colony-Stimulating Factor (G-CSF) G-CSF is a protein produced by gene recombination technology. G-CSF selectively stimulates production of neutrophils and also enhances the neutrophil function. Based on this mechanism, G-CSF accelerates recovery from chemotherapy-induced neutropenia and reduces various risks associated with neutropenia.

*2: About febrile neutropenia Myelosuppressive chemotherapy causes low neutrophil count, i.e., neutropenia, which can raise risk of infections. Neutropenia with fever, known as febrile neutropenia, can be a sign of a serious infection and patients’ needs to be given appropriate treatments.

On August 1, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) and Marengo Therapeutics, Inc. reported a strategic partnership to advance two of Marengo’s preclinical STAR platform-generated candidates into the clinic (Press release, Ipsen, AUG 1, 2022, View Source [SID1234617166]). The collaboration will leverage Marengo’s proprietary R&D expertise of a novel mechanism of T cell activation with Ipsen’s global oncology footprint for clinical development and commercialization.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Ipsen will make an upfront payment of $45 million, together with potential payments up to a total of $1.592 billion if all milestones are met in addition to tiered sales royalty payments. Marengo will lead the preclinical development efforts and will expense related costs until the submission of an Investigational New Drug (IND) application to the U.S. FDA. Ipsen will assume responsibilities for clinical development and commercialization.

Collectively, the Ipsen and Marengo teams have a proven track record of successful oncology-medicine development and commercialization to maximize the potential of candidates across a large range of cancer indications.

"Marengo’s foundational discovery of activation of T cell subsets via TCR Vβ is unprecedented and highly differentiated from the current immuno-oncology technologies we have seen," said Howard Mayer, M.D., Executive Vice President and Head of R&D at Ipsen. "This partnership with Marengo provides a strong foundation for a productive and successful collaboration as we embark on a journey to develop novel and durable therapies that will strengthen our oncology pipeline and further enhance our commitment to people living with cancer".

"Our strategic partnership with Ipsen underscores our shared ambition to develop transformative medicines for people fighting cancer," said Zhen Su, M.D., MBA, CEO of Marengo Therapeutics. "Marengo brings a precision medicine approach to the field of Immuno-oncology with a focus on T cell activation and this collaboration is an important validation of our STAR platform beyond our lead candidate. Together this partnership is a demonstration of the strong progress and promise of our innovative scientific platform."

On August 1, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first three months (April 1, 2022 – June 30, 2022) of the fiscal year 2022 ending March 31, 2023 (FY2022) (Press release, Astellas, AUG 1, 2022, View Source [SID1234617165]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

1. Qualitative information on consolidated financial results for the first three months of FY2022 Business performance

Consolidated financial results (core basis) in the first three months of FY2022 are shown in the table below. While revenue increased, core operating profit and core profit decreased.

Revenue
-Sales of XTANDI for the treatment of prostate cancer and XOSPATA for the treatment of acute myeloid leukemia continued to grow.
-PADCEV for the treatment of urothelial cancer contributed to revenue growth due to significant expanding of sales in the United States and Japan as well as an increase in the number of countries in which the product was launched in Europe.
-Additionally, the expansion of sales of Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") and the immunosuppressant agent Prograf as well as the growth of sales of EVENITY for the treatment of osteoporosis in Japan contributed to revenue growth.

Core operating profit / Core profit-Gross profit increased by 11.0% year-on-year to ¥292.9 billion. The cost-torevenue ratio increased by 4.2 percentage points year-on-year to 23.3%, mainly due to the foreign exchange rate impact from the elimination of unrealized profit in intra-group transactions (increase of ¥12.3 billion year-on-year).-Selling, general and administrative expenses increased by 11.9% year-on-year to ¥153.4 billion.

Although expenses decreased as a result of global optimization of personnel aligned with transformation of product portfolio (decrease of approximately ¥3.0 billion year-on-year) and reduction of mature products-related costs (decrease of approximately ¥2.0 billion year-on-year), the total amount increased due to foreign exchange rate impact (increase of ¥16.7 billion year-onyear) and an increase in investment for new product launch readiness (increase of approximately ¥2.0 billion year-on-year). Selling, general and administrative expenses, excluding co-promotion fees of XTANDI in the United States, increased by 7.4% year-on-year to ¥110.3 billion.

-Research and development (R&D) expenses increased by 26.9% year-on-year to ¥74.0 billion. The total amount increased due to foreign exchange rate impact (increase of ¥7.5 billion year-on-year) in addition to one-time expenses recorded during this period, which was included in the full-year forecast.-Amortisation of intangible assets increased by 80.2% year-on-year to ¥10.7 billion.As a result of the above, core operating profit decreased by 12.0% year-on-year to ¥55.3 billion, and core profit decreased by 6.9% year-on-year to ¥45.8 billion.

On August 1, 2022 Medical and Biological Laboratories Co., Ltd. ("MBL"), a JSR Life Sciences Company, reported that MEBGEN BRAF Kit, an in vitro diagnostic reagent, was approved for detection of BRAF gene mutations (V600E or V600K) by the Ministry of Health, Labour and Welfare (MHLW) for production and marketing in Japan on July 7, 2022 (Press release, JSR, AUG 1, 2022, View Source [SID1234617164]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

MEBGEN BRAF Kit was developed as a companion diagnostic for multiple anti-cancer agents in melanoma. The MEBGEN BRAF Kit is expected to be an important clinical diagnostic in guiding personalized medicine for patients with melanoma.