On October 12, 2022 Amgen (NASDAQ:AMGN) reported the 9th edition of its Biosimilar Trends Report, which examines the current and future state of the U.S. marketplace with biosimilars (Press release, Amgen, OCT 12, 2022, View Source [SID1234621937]). This year, in addition to examining important trends in the U.S., the Report also highlights key considerations and learnings from the global marketplace with biosimilars. To access the full Report, visit View Source

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"Our 2022 Biosimilar Trends Report found that the marketplace with biosimilars is well established, and the U.S. is poised to see continued growth in biosimilar approvals. This is good news for patients, physicians and payers, as the successful adoption of biosimilars has increased competition and generally lowered treatment costs associated with biologic medicines," said Jen Norton, vice president and head of U.S. Value & Access at Amgen.

New data from the Report confirm that biosimilar uptake in the U.S. continues to increase over time, resulting in significant market share in most therapeutic areas where biosimilars have been introduced. In fact, for therapeutic areas that have had biosimilars launch in the last three years, the average biosimilar share was 75 percent compared to 39 percent in the preceding three years.1

"The trends highlighted in the Report underscore that it’s an exciting time for the marketplace with biosimilars. As biosimilars become more widely available in the U.S., they have the potential to help to control costs for patients, payers and health systems," said Chelsee Jensen, pharmaceutical formulary manager at the Mayo Clinic.

The Report also discusses biosimilars’ potential to expand access to treatment options that may lower healthcare costs.2 In particular, the Report found:

Trends show an increase in savings per quarter, and in Q2 alone, savings in drug spend due to biosimilar availability are estimated to be $3.2 billion.3
Biosimilars primarily covered under the medical benefit have typically launched at a wholesale acquisition cost (WAC) that is generally 10% to 57% lower than that of the reference product.4
There are currently seven FDA-approved biosimilars for the reference product HUMIRA, with the possibility of seven or more launches in 2023. The entry of biosimilars is expected to lead to price declines across all products within the class.5
"Biosimilars are another potential treatment option for the millions of Americans living with inflammatory-bowel disease (IBD)," said Laura Wingate, executive vice president, Education, Support & Advocacy, Crohn’s & Colitis Foundation. "We are excited about the potential expansion of biosimilars in the U.S. as we know how important it is for patients to have a variety of options."

On October 12, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported that BRUKINSA (zanubrutinib) achieved superior Progression-Free Survival (PFS) versus IMBRUVICA (ibrutinib) in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee (IRC) and investigator (Press release, BeiGene, OCT 12, 2022, View Source [SID1234621933]). BRUKINSA was generally well tolerated; safety findings at the final PFS analysis were consistent with prior reports.

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"This positive result adds to the growing body of evidence underpinning our belief in the potential for BRUKINSA to provide new hope for CLL patients facing this intractable disease. With this final PFS analysis, BRUKINSA has achieved superior progression free survival, as well as superiority in overall response rate versus ibrutinib," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "We look forward to sharing the full results with the medical and patient communities and will submit for presentation at a medical congress and for publication."

BeiGene’s supplemental New Drug Application for BRUKINSA for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL) is currently under review with the FDA, with a target action date of January 20, 2023.

About ALPINE

ALPINE is a randomized, global Phase 3 trial (NCT03734016) comparing BRUKINSA against ibrutinib in previously treated patients with relapsed or refractory CLL or SLL. In the trial, a total of 652 patients across Europe (60%), the United States (17%), China (14%), New Zealand and Australia (9%) were randomized into two arms, with the first receiving BRUKINSA (160 mg orally twice daily) and the second receiving ibrutinib (420 mg orally once daily) until disease progression or unacceptable toxicity.

The primary endpoint of overall response rate (ORR), defined by pre-specified non-inferiority of BRUKINSA versus ibrutinib, was assessed by investigator and IRC using the modified 2008 iwCLL guidelines, with modification for treatment-related lymphocytosis for patients with CLL, and per Lugano Classification for non-Hodgkin’s lymphoma for patients with SLL. There was pre-specified hierarchical testing of non-inferiority followed by superiority in ORR as assessed by investigator and IRC. Key secondary endpoints include PFS and event rate of atrial fibrillation or flutter; other secondary endpoints include duration of response, overall survival, and incidence of adverse events. In April 2022, BeiGene announced results from the final response analysis showing BRUKINSA demonstrated superiority versus ibrutinib in ORR as assessed by an IRC.

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program, which includes more than 4,500 subjects in 35 trials across 28 markets. To date, BRUKINSA has received approvals covering more than 55 countries and regions, including the United States, China, the EU, Great Britain, Switzerland, Canada, Australia, and additional international markets.

On October 12, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported the approval, as of October 7, 2022, of an application for a partial change to the manufacturing and marketing approval in Japan of its gene amplification reagent LYNOAMP CK19 marketed as a lymph node metastasis test reagent for breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, expanding its amplification to cervical cancer and endometrial cancer (Press release, Sysmex, OCT 12, 2022, View Source [SID1234621932]).

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Whether lymph node metastasis has occurred is an indicator of cancer progression during treatment for cervical cancer and endometrial cancer. Lymph node metastasis testing plays an important role in forming a medical treatment plan such as operating procedures and post-operative adjuvant therapy.

This testing is typically performed during or after surgery when a pathologist prepares samples from surgically removed lymph nodes, and then views the samples under a microscope to determine whether the cancer cells have metastasized. However, the test places a heavy workload on pathologists. Combined with a shortage of pathologists, this type of testing presents problems in medical settings.

Sysmex has employed its proprietary technology, the OSNA method,1 in rapidly detecting cancer lymph node metastasis, using its a gene amplification detector RD-100i and the reagent LYNOAMP BC, and has marketed them in in Japan since 2008. After gaining manufacturing and marketing approval for breast cancer in the same year, Sysmex strove to expand the system to further cancer types. In 2018, Sysmex launched the gene amplification detector RD-200 and the reagent LYNOAMP CK19, which shortens the testing process while increasing the number of samples that can be tested simultaneously. This has been approved by the national health insurance in Japan as the only lymph node metastasis testing system that adopts a molecular biological technique.

The system automates and simplifies cancer lymph node metastasis testing, and provides objective test results without relying on the examiner’s proficiency. This reduces the workload on pathologists and contributes to the equalization of medical care2 and the formulation of medical treatment plans, taking into account the burden on patients and their QOL.

Sysmex has now gained approval for a partial change to expand the application of LYNOAMP CK19, currently used as a lymph node metastasis test reagent for breast cancer, colorectal cancer, gastric cancer and non-small cell lung cancer, to cervical cancer and endometrial cancer. Through the provision of rapid and accurate results in lymph node metastasis testing, the system is expected to contribute to the formulation of appropriate medical treatment plans for patients with cervical or endometrial cancer.

Sysmex will continue working toward the further rollout of testing of lymph node metastasis using the OSNA method, contributing to the standardization of healthcare and improvement of patients’ QOL.

On October 12, 2022 NEC Corporation ("NEC") reported the status of a repurchase of shares of its own common stock, pursuant to Article 459, Paragraph 1 of the Companies Act of Japan and NEC’s Articles of Incorporation, which was approved at the Board of Directors meeting held on August 29, 2022, as follows (Press release, NEC, OCT 12, 2022, View Source [SID1234621931]):

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(1)Type of shares repurchased:
Common stock
(2)Total number of shares repurchased:
1,505,800 shares
(3)Aggregate value of shares repurchased:
7,455,282,000 yen
(4)Repurchase period:
September 1, 2022 – September 30, 2022
(5)Method of repurchase:
Open market purchase through the Tokyo Stock Exchange based on a discretionary trading contract
(For Reference)
1. Details of Matters Relating to the Repurchase (as announced on August 29, 2022)

(1)Type of shares to be repurchased:
Common stock
(2)Total number of shares to be repurchased:
Up to 6.7 million shares
(2.46% of total shares outstanding excluding treasury stock)
(3)Aggregate repurchase price:
30 billion yen (maximum limit)
(4)Repurchase period:
August 30, 2022 – March 31, 2023
(5)Method of repurchase:
Open market purchase through the Tokyo Stock Exchange based on a discretionary trading contract
Depending on market trends and other factors, all or part of the planned repurchase may not be completed.

2. Total number and aggregate value of shares repurchased pursuant to the resolution approved at the above-mentioned Board of Directors meeting (as of September 30, 2022)

Total number of shares repurchased:
1,786,100 shares
Aggregate value of shares repurchased:
8,879,015,000 yen

On October 12, 2022 Australian diagnostics company Minomic International Ltd (Minomic) reported that their lead product, MiCheck Prostate,1 has recorded its initial commercial sales in the US, the world’s largest healthcare market (Press release, Minomic, OCT 12, 2022, View Source [SID1234621930]).

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Each year, two million American men2 undergo highly invasive prostate biopsies to diagnose prostate cancer after an elevated Prostate-Specific Antigen (PSA) test result. Prostate biopsies can result in side effects such as bleeding, infections and difficulty urinating.3 A significant proportion of these biopsies are unnecessary,4 as the patient does not have cancer or has a low-grade cancer that requires monitoring rather than intervention.

MiCheck Prostate is a blood test that can be quickly measured and reported providing an easy-to-understand graphical result. Urologists who have patients with elevated PSA can order the test and receive a report with the percentage risk of aggressive prostate cancer, helping avoid unnecessary biopsies.

The MiCheck Prostate test is run at Minomic Inc’s CLIA Certified "High Complexity" Laboratory located in Gaithersburg, Maryland. The test has become available following CLIA Laboratory registration and internal validation of MiCheck Prostate in 2022. The first tests have already been ordered by Las Vegas Urology, a large urology practice based in Nevada.

Each year, there are 1.2 million American men returning an elevated PSA result and a further 3 million under active surveillance due to an already elevated PSA, who would benefit from the use of MiCheck Prostate.

Importantly, MiCheck Prostate will be reimbursed through Medicare increasing access for a significant number of men. The most affected cohort are men over the age 65 with the majority (65%) covered by Medicare. Reimbursement also provides a direct pathway to commercial revenues for Minomic.

Dr Brad Walsh, Minomic CEO, said: "We are very excited to have completed the journey, bringing MiCheck Prostate to commercial reality in the key US market. The high negative predictive value of the test and its superior specificity can better inform urologists and uro-oncologists about the patient’s risk of aggressive prostate cancer."

Dr Vijay Goli, Urologist at Las Vegas Urology, said: "I really like the test, I can make a decision whether to biopsy in seconds using the graph in the MiCheck Prostate report. The report is much easier than other tests which take more time to work out the pathway and are very complicated."

Prostate cancer is the most commonly diagnosed cancer in Australia,5 with one in seven men affected. In the US, one in eight men will face this disease in their lifetime.6

Minomic is currently expanding their sales and marketing teams to reach more urology practices across the US, so that more men can benefit from this revolutionary test.

MiCheck Prostate is available through Minomic’s US laboratory and will soon be available for patients at selected Sonic pathology laboratories in Australia.