On July 30, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first three months (April 1, 2021 – June 30, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, JUL 30, 2021, View Source [SID1234585456]).

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1. Qualitative information on consolidated financial results for the first three months of FY2021 (1) Business performance Consolidated financial results (core basis) in the first three months of FY2021 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 Strategic products XOSPATA for the treatment of acute myeloid leukemia, PADCEV for the treatment of urothelial cancer and Evrenzo for the treatment of renal anemia increased as expected.

-Moreover, factors for the increase in sales in the first three months of FY2021 included the growth of sales of Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB"), and the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic level which decreased mainly in the corresponding period of the previous fiscal year because of the impact of the spread of COVID-19.

-The sales growth of the products above offset the sales decrease mainly due to the termination of sales promotion activities for Celecox for the treatment of inflammation and pain, the transfer of manufacturing rights of Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.

As a result of the above, revenue in the first three months of FY2021 increased by 6.2% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥326.1 billion. Core operating profit/ Core profit-Gross profit increased by 6.7% year-on-year to ¥263.9 billion. The cost-to-revenue ratio fell by 0.4 percentage points year-on-year to 19.1%, mainly due to changes in product mix.-Selling, general and administrative expenses increased by 13.5% year-on-year to ¥137.1 billion.

The total amount increased due to the up-front investment to support CSP2021 initiatives (increase of Approx. ¥3.0 billion year-on-year), the increase of co-promotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥3.0 billion year-on-year), the impact of the exchange rate (increase of ¥4.4 billion year-on-year), and moreover there was a one-off increase factor from the decrease of expenses for sales promotion activities and travel expenses due to the impact of the spread of COVID-19 in the corresponding period of the previous fiscal year (increase of Approx. ¥6.0 billion year-on-year). Excluding co-promotion fees associated with the growth of sales of XTANDI in the United States, selling, general and administrative expenses increased by 15.0% year-on-year to ¥102.6 billion.

-Research and development (R&D) expenses increased by 1.8% year-on-year to ¥58.3 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for 3 Primary Focus, such as genetic regulation, cell therapy and immuno-oncology.-Amortisation of intangible assets increased by 1.8% year-on-year to ¥6.0 billion.

As a result of the above, core operating profit decreased by 0.9% year-on-year to ¥62.8 billion, and core profit decreased by 5.3% year-on-year to ¥49.2 billion. Impact of exchange rate on financial results The exchange rates for the yen in the first three months of FY2021 are shown in the table below. The resulting impacts were a ¥13.6 billion increase in revenue and a ¥6.1 billion increase in core operating profit compared with if the exchange rates of the first three months of FY2020 were applied.

On July 30, 2021 Minovia Therapeutics, Ltd. (CEO; Natalie Yivgi-Ohana, Ph.D., "Minovia") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported a worldwide strategic collaboration and license agreement for the research, development, and commercialization of novel cell therapy programs for diseases caused by mitochondrial dysfunction (Press release, Astellas, JUL 30, 2021, View Source [SID1234585455]).

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Through this strategic collaboration, Astellas and Minovia aim to accelerate the creation of allogeneic mitochondrial cell therapy programs. The two companies will jointly research cell therapy program candidates comprised of cells derived from Astellas’ proprietary genetically-engineered, induced pluripotent stem cells and augmented with Minovia’s proprietary MAT platform technology. The goal of these programs will be to treat diseases caused by mitochondrial dysfunction, through the transfer of healthy mitochondria to restore the patients’ tissues.

Minovia is a leading company in the field of mitochondrial cell therapy that utilizes mitochondrial transfer to deliver healthy mitochondria to a patient’s diseased cells. Minovia has a unique technology platform called Mitochondrial Augmentation Therapy (MAT), where the patient’s own cells are isolated, loaded with healthy mitochondria obtained from a healthy donor, and then re-infused back into the patient. Minovia is currently conducting research, development and clinical studies with MAT in mitochondrial diseases.

Astellas is engaged through its US subsidiary companies, Astellas Institute for Regenerative Medicine (AIRM) and Universal Cells Inc., to advance allogeneic, off-the-shelf, differentiated cell therapy programs derived from pluripotent stem cells1. The new collaboration with Minovia extends Astellas’ capabilities in mitochondrial biology, and follow its recent acquisition of Mitobridge, Inc. and Nanna Therapeutics Limited2,3.

"We are excited and honored to collaborate with Astellas," stated Minovia’s Co-founder and Chief Executive Officer, Natalie Yivgi-Ohana, Ph.D. "We share with Astellas both their passion for mitochondrial science and their commitment to patients in need of new therapies. As Minovia continues the development of Mitochondrial Augmentation Therapy, we believe this partnership is critical to accelerate the development of off-the-shelf, allogeneic cell therapy programs for the many patients living with mitochondrial diseases caused by mitochondrial dysfunction."

Naoki Okamura, Representative Director, Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, at Astellas said, "We, at Astellas, have positioned mitochondrial biology as one of the Primary Focuses of our research and development strategy to develop therapies for patients with unmet medical needs. One of the aspirations of this Primary Focus is to establish a mitochondrial cell therapy platform. Minovia is pioneering mitochondrial cell therapy and has unique technologies for enhancing delivery of healthy mitochondria to the patients’ cells. This strategic collaboration with Minovia will accelerate and expand our pipeline of treatment options for patients with diseases with underlying mitochodrial dysfunction."

Under the terms of the agreement, Minovia receives an upfront cash payment of $20M USD. Through the joint research program with Minovia, if Astellas develops and commercializes product candidates for diseases caused by mitochondrial dysfunction, Minovia is eligible to receive up to $420M USD per product in future development, regulatory and commercial milestone payments from Astellas.

On July 30, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that Craig Granowitz, M.D., Ph.D. will join the company as senior vice president and chief medical officer, effective August 2, 2021 (Press release, Lexicon Pharmaceuticals, JUL 30, 2021, View Source [SID1234585454]).

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Dr. Granowitz joins Lexicon with deep and successful leadership experience in the pharmaceutical industry, having previously built global medical organizations at three separate companies. Before joining Lexicon, Dr. Granowitz served as chief medical officer at Amarin Corporation plc, where he was a key leader on the company’s clinical development programs and held a number of other medical, safety and communications responsibilities. Prior to joining Amarin, Dr. Granowitz was senior vice president and head of global medical affairs, global human health at Merck & Co., Inc., where he developed and implemented an entirely new global medical affairs organization following Merck’s merger with Schering-Plough Corporation. Prior to the merger, he held a variety of medical and commercial management positions with Schering-Plough, including group vice president, head of global medical affairs.

"We are very pleased to have Dr. Granowitz join Lexicon as our chief medical officer," said Lonnel Coats, Lexicon’s president and chief executive officer. "He will be instrumental in building out our medical affairs organization and overseeing development of our pipeline. His experience as a physician, scientist and medical affairs leader with notable success in cardiovascular medicine makes him a particularly valuable addition to our management team as we prepare to file a new drug application for sotagliflozin as a therapy for people suffering from heart failure and living with type 2 diabetes."

"I am very excited to join the Lexicon team as we continue to advance sotagliflozin toward filing for regulatory approval," said Craig Granowitz, M.D., Ph.D. "The SOLOIST and SCORED studies clearly demonstrate the potential for sotagliflozin to improve the care of people living with type 2 diabetes and heart failure, particularly those with normal, or "preserved," left ventricular ejection fraction (≥ 50%). I look forward to the opportunity to build on the evolving science around sotagliflozin’s unique mechanism of action and the compelling scientific platform that forms the foundation for Lexicon’s drug discovery and development pipeline"

Dr. Granowitz earned his M.D. from the College of Physicians and Surgeons at Columbia University and his Ph.D. from the Graduate School of Arts and Sciences at Columbia University. He is a recognized expert in cardiovascular health and author of more than 30 peer-reviewed abstracts and manuscripts in respected journals and publications, including: The Journal of the American College of Cardiology, American Association of Clinical Endocrinologist, Academy of Managed Care Pharmacy, American Diabetes Association, American Heart Association, American Society for Preventative Cardiology, European Society of Cardiology, International Society for Pharmacoeconomics and Outcomes Research, National Kidney Foundation, the National Lipid Association and the New England Journal of Medicine.

On July 29, 2021 Luye Pharma Group reported that Boyounuo (Bevacizumab Injection), an oncology biologic developed in-house by its subsidiary Boan Biotech, has been approved by China’s National Medical Products Administration for the treatment of recurrent glioblastoma (Press release, Luye Pharma, JUL 29, 2021, View Source [SID1234595074]). It is the third indication approved for Boyounuo in China, the first two being advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer. The approval of this new indication will enable the product serve a broader patient population.

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Glioblastoma is the most common malignant primary brain tumor, representing approximately 57% of all gliomas and 48% of all primary malignant central nervous system (CNS) tumors1. Characterized by high morbidity, high recurrence rate, high mortality rate and low cure rate, glioblastoma is regarded as one of the most difficult tumors to treat in the field of neurosurgery. Bevacizumab is one of the most important therapeutic agents in the treatment of glioblastoma after temozolomide, and has been listed as a recommended therapy for recurrent glioblastoma in multiple authoritative guidelines and consensus in China and around the world.

Boyounuo is an anti-VEGF humanized monoclonal antibody injection developed in-house by Boan Biotech. It is a biosimilar to Avastin. Comparative clinical studies have shown that Boyounuo is highly similar to Avastin in terms of PK characteristics, clinical efficacy, safety and immunogenicity. According to the Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars, all indications for Avastin approved in China can also be gradually applied to Boyounuo.

A signature anti-angiogenic oncology drug, bevacizumab is one of the standard therapies in the treatment of malignant tumors. Avastin has been approved worldwide for the treatment of non-small cell lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer and other solid tumors, while in China it has been approved for treating advanced, metastatic or recurrent non-small cell lung cancer , metastatic colorectal cancer, recurrent glioblastoma and hepatocellular carcinoma.

Dr. Dou Changlin, R&D President and COO of Boan Biotech, said, "We are delighted to see the approval of the third indication for Boyounuo within three months of the Group’s announcement of marketing authorization for the product on May 7. Bevacizumab injection is the gold standard for the treatment of several malignant tumors. Its efficacy and safety have been widely recognized by doctors and patients in clinical applications. Given the large unmet treatment needs in these disease areas, we hope that Boyounuo will bring benefits to more patients, helping them live longer lives while improving their quality of life."

Boan Biotech is accelerating growth in core market coverage via its own business team, commercial resources and networks to improve the accessibility of Boyounuo. Meanwhile, the company has granted AstraZeneca exclusive promotional rights in county markets across 21 provinces, municipalities and autonomous regions of China’s mainland to serve a broader patient base.

On July 29, 2021 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that it will report the company’s second quarter 2021 financial results on Thursday, August 5, 2021 after the close of U.S. financial markets (Press release, Aligos Therapeutics, JUL 29, 2021, View Source [SID1234591813]).

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