EISAI FILES MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER’S DISEASE IN SOUTH KOREA

by codm | Jun 8, 2023 | Newsletter

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TOKYO and CAMBRIDGE, Mass., June 8, 2023 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI^®), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain, to the Ministry of Food and Drug Safety (MFDS) in South Korea. This application is the first application for lecanemab in Asia outside of Japan and China. Eisai plans to submit additional applications in other Asian countries.

The application is based on the results of the confirmatory Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds to and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

*   Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.¹

¹  Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab – Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics (2022). https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9, 2023

Contacts:

[Notes to editors]
1.    About Lecanemab
Lecanemab (Brand Name in the U.S.: LEQEMBI^®) is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

In the U.S., LEQEMBI was launched after being granted accelerated approval by the U.S. Food and Drug Administration (FDA) in January, 2023. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. The accelerated approval is based on Phase II data which demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of clinical benefit in a confirmatory trial. The FDA determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of LEQEMBI. Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway in January, 2023. The FDA accepted Eisai’s sBLA granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application on June 9, 2023.

Please see full Prescribing Information in the United States.

Eisai has also submitted applications for approval in Japan, Europe, China, Canada, and Great Britain. In Japan and China, the applications have been designated for priority review, and in Great Britain, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.

Eisai has completed the lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD OLE.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium (ACTC) that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. The Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has been ongoing since January 2022.

2.    About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

3.    About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.

4.    About Eisai Co., Ltd.
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter, LinkedIn and Facebook.

5.    About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

Notification of Ransomware Incident

by codm | Jun 6, 2023 | Newsletter

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Company Name: Eisai Co., Ltd.
Representative: Haruo Naito
Representative Corporate Officer and CEO
(Code 4523 Tokyo Stock Exchange Prime Market)
Inquiries: Sayoko Sasaki
Vice President,
Corporate Communications
Phone +81-3-3817-5120

Eisai Co., Ltd. announced today that the Eisai Group became aware of a ransomware incident that encrypted some of the Group’s servers. In response to this case, Eisai Group immediately established a company-wide task force, and is working on recovery efforts with the advice of external experts and undertaking measures to understand the scope of the incident. Additionally, Eisai Group has consulted with law enforcement.

Whilst it is expected to take some time to gauge the full extent of the incident, the information below further details what is known at this time. We deeply apologize for any inconvenience and worry this may have caused to our partners and stakeholders.

1. Background
A ransomware incident that encrypted some of Eisai Group’s servers was detected late night on Saturday, June 3, Japan time. We immediately implemented our incident response plan and launched an investigation with the aid of our cybersecurity partners. A company-wide task force was convened to rapidly work on response procedures.

2. Status and Future Response
Certain systems both in and outside of Japan, including logistics systems, have been taken offline as a result of the incident and our ongoing response process. Our corporate websites and email systems are operational at this time. The possibility of data leakage is currently under investigation.

Currently, Eisai Group is working closely with external experts and law enforcement in an effort to protect its systems and to make a successful recovery. We will continue to work to minimize any inconvenience to our partners and stakeholders.

Any potential impact of this incident on the consolidated earnings forecast of this fiscal year is currently under careful examination. If determined that revisions are necessary, an announcement will be made as soon as possible.

<Media Contact for this matter>
Public Relations Department: +81-(0)3-3817-5120

EISAI TO PRESENT LATEST DATA ON LEMBOREXANT AT THE 37TH ANNUAL SLEEP 2023 MEETING

by codm | Jun 2, 2023 | Newsletter

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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO^®), will be given at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3 to 7, 2023 in Indianapolis, IN, the United States.

Major poster presentations include new data about the effects of lemborexant on obstructive sleep apnea (poster numbers: #298, 299 and 300).

Eisai considers neurology, including insomnia, a therapeutic area of focus. Eisai strives to create innovative products as soon as possible in therapeutic areas with high unmet medical needs, and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with neurological diseases and their families.

SLEEP 2023 Poster Presentations

EISAI ENTERS INTO JOINT DEVELOPMENT AGREEMENT WITH BLISSBIO FOR ANTIBODY DRUG CONJUGATE BB-1701 WITH OPTION RIGHTS FOR STRATEGIC COLLABORATION

by codm | May 28, 2023 | Newsletter

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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (Headquarters: Zhejiang Province, China, “BlissBio”), for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration.

BB-1701 is an ADC that is composed of Eisai’s in-house developed anticancer agent eribulin, and anti-HER2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express HER2. The linker-payload, which uses eribulin as a payload, is a proprietary technology platform developed by Eisai’s U.S. research base Exton Site, and Eisai is investigating the possibilities of using this platform to link to various antibodies. Under a license agreement signed by the two companies in 2018, Eisai has granted BlissBio global exclusive development rights for several ADCs to use eribulin as the payload. Based on the status of the Phase I/II clinical trials of BB-1701 currently being conducted by BlissBio, the both companies have decided to co-develop this drug.

Under the terms of the joint development agreement, Eisai will make upfront and development milestone payments to BlissBio, conduct a Phase II clinical trial in breast cancer, and obtain option rights to develop and commercialize BB-1701 globally, excluding Greater China (China, Hong Kong, Macau, Taiwan). If Eisai exercises the option rights, an additional upfront payment will be made to BlissBio, as well as development and regulatory milestone payments, sales milestone payments and a certain amount of royalties on sales revenue of BB-1701 after the launch. If all development, regulatory and sales milestones are achieved, up to a total of $2 billion USD will be paid.

“BB-1701 is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma,” said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. “Our collaboration with BlissBio will accelerate the development of BB-1701 with the goal of bringing a new treatment option to patients globally.”

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to Editors]

 1.  About Bliss Biopharmaceuticals (Hangzhou) Co., Ltd.
Bliss Biopharmaceutical (Hangzhou) Co., Ltd. (“BlissBio”), is a clinical-stage biotech company dedicated on discovery, development and commercialization of anti-tumor biotherapeutics, founded by pharmaceutical veterans in 2017 in Hangzhou, Zhejiang province. BlissBio has established a unique and patented technical platform, a rich ADC-focusing pipeline, and GMP manufacture capability that could support antibody and ADC production for both clinical development and early commercialization. BlissBio has been nominated as a national high-tech biopharmaceutical enterprise in China. With “Together, We Improve Human Health” as the core value, through international and domestic collaborations, BlissBio will continue to focus on innovative drugs to address unmet medical needs.

For more information, please visit https://www.blissbiopharma.com

2.  About BB-1701 (development code)
BB-1701 is an ADC that is composed of Eisai’s in-house developed anticancer agent eribulin, and anti-HER2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express HER2 through multiplex mechanisms like direct cytotoxicity (including immunogenic cell death), a bystander effect* and immune response-induced cell death. BlissBio is currently conducting Phase I/II clinical trials in the U.S. and China for HER2-expressing solid tumors.

* Bystander effect: When the anticancer agent and antibody parts of an ADC are separated inside a targeted antigen-positive cancer cell, the released anticancer agent also affects neighboring antigen-negative cancer cells and the component cells of the cancer microenvironment.

LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

by codm | May 26, 2023 | Newsletter

After four years of follow-up, LENVIMA plus KEYTRUDA reduced the risk of death by 21% versus sunitinib in the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial
Final results will be presented at ASCO 2023 in an oral abstract session

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TOKYO and RAHWAY, N.J., May.26, 2023 – Eisai (Headquarters: Tokyo, CEO: Haruo Naito) and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) today announced data from the final pre-specified overall survival (OS) analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial investigating LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, Merck’s anti-PD-1 therapy, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). These data will be presented on Monday, June 5 at 11:54 a.m. Central Daylight Time during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502).

After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). The 24- and 36-month estimated OS rates were 80.4% and 66.4% for LENVIMA plus KEYTRUDA versus 69.6% and 60.2% for sunitinib, respectively. Results from the final pre-specified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial.

Additionally, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 53% (HR=0.47 [95% CI, 0.38-0.57]), with a median progression-free survival (PFS) of 23.9 months (95% CI, 20.8-27.7) for LENVIMA plus KEYTRUDA versus 9.2 months (95% CI, 6.0-11.0) for sunitinib; the objective response rate (ORR) was 71.3% (95% CI, 66.6-76.0) with a complete response (CR) rate of 18.3% for LENVIMA plus KEYTRUDA versus an ORR of 36.7% (95% CI, 31.7-41.7) with a CR rate of 4.8% for sunitinib.

There were no new safety signals and the safety profile at the final OS analysis was consistent with the primary analysis. Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received LENVIMA plus KEYTRUDA versus 60.3% of patients who received sunitinib. The six most common TRAEs of any grade of patients in the LENVIMA plus KEYTRUDA arm were diarrhea (56.0%), hypertension (54.3%), hypothyroidism (44.9%), decreased appetite (35.5%), fatigue (34.1%) and stomatitis (32.7%). In the sunitinib arm, the six most common TRAEs of any grade were diarrhea (45.3%), hypertension (40.3%), stomatitis (37.4%), palmar-plantar erythrodysesthesia (36.2%), fatigue (32.9%) and nausea (28.2%).

“LENVIMA plus KEYTRUDA continues to demonstrate durable clinical benefit as a first-line treatment for patients with advanced renal cell carcinoma, as shown by the clinically meaningful improvement in overall survival sustained with four years of follow up,” said Dr. Thomas Hutson, DO, Pharm.D., FACP, Director of the Urologic Oncology Program and Co-chair of the Urologic Cancer Research and Treatment Center, Texas Oncology at Baylor Sammons Cancer Center. “Furthermore, these data also showed clinically meaningful improvements in median PFS and ORR compared to sunitinib. These findings reinforce the important role of LENVIMA plus KEYTRUDA as a first-line standard of care treatment option for patients with advanced renal cell carcinoma.”

“Long-term follow up data from the CLEAR/KEYNOTE-581 trial show the responses to first-line use of KEYTRUDA plus LENVIMA were durable for many of these patients,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “Through our joint clinical development program with Eisai, we’re continuing to advance our research evaluating KEYTRUDA plus LENVIMA for other challenging cancers as we strive to help even more patients.”

“At the final pre-specified analysis, LENVIMA plus KEYTRUDA continued to demonstrate clinically meaningful efficacy across PFS, ORR and OS, providing patients and their physicians with new information about treating people living with advanced renal cell carcinoma,” said Corina Dutcus, M.D., Senior Vice President, Clinical Development, Oncology at Eisai Inc. “These results are a testament to our steadfast commitment to people living with advanced cancers, and we are grateful for the support from the patients, families and healthcare provider community for their participation in this research.”

LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma. Lenvatinib is marketed as KISPLYX^® for advanced RCC in the EU. Eisai and Merck are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types, including but not limited to endometrial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, RCC, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials.

Investor Contacts:

Study design and additional data from CLEAR/KEYNOTE-581

The CLEAR/KEYNOTE-581 trial is a multicenter, randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT02811861) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC. The major efficacy outcome measures were PFS, as assessed by independent radiologic review (IRC) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS. Additional efficacy outcome measures included confirmed ORR as assessed by IRC, health-related quality of life (HRQoL) and safety.

The trial enrolled 1,069 patients who were randomized 1:1:1 to receive LENVIMA (20 mg orally once daily) plus KEYTRUDA (200 mg intravenously every three weeks for up to 24 months), or LENVIMA (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment). KEYTRUDA was administered for up to 35 cycles (approximately two years) or until protocol-specified discontinuation criteria were met. After completing two years of combination therapy, LENVIMA may have been administered as a single agent until protocol-specified discontinuation criteria were met.

This final pre-specified OS analysis was event driven and was triggered by approximately 304 OS target events in the two treatment arms (149 events out of 355 patients for KEYTRUDA plus LENVIMA versus 159 events out of 357 patients for sunitinib).

The median duration of response was 26.7 months (95% CI, 22.8-34.6) for LENVIMA plus KEYTRUDA versus 14.7 months (95% CI, 9.4-18.2) for sunitinib.
Efficacy results were consistent across the pre-specified Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor) and International Metastatic RCC Database Consortium (IMDC) risk groups. Across the pre-specified Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor), OS and PFS were improved with LENVIMA plus KEYTRUDA versus sunitinib. Interpretation OS in favorable risk patients is limited by low number of events.
Fewer patients who were treated with LENVIMA plus KEYTRUDA received subsequent anti-cancer therapies (181 out of 355 patients, 51.0%) versus those who were treated with sunitinib (246 out of 357 patients, 68.9%), with 56 patients (15.8%) and 195 patients (54.6%) who went on to receive PD-1/PD-L1 checkpoint inhibitors, respectively. In an exploratory analysis using a 2-stage model, LENVIMA plus KEYTRUDA reduced the risk of death by 45% versus sunitinib when adjusted for subsequent anticancer medications (HR=0.55 [95% CI, 0.44-0.69]).

About renal cell carcinoma (RCC)
Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. ¹ Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCC. ² Renal cell carcinoma is about twice as common in men as in women. ³ Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases.⁴ Approximately 30% of patients with RCC will have metastatic disease at diagnosis. ⁴ Survival is highly dependent on the stage at diagnosis, and the five-year survival rate is 15% for patients diagnosed with metastatic disease. ⁵

About LENVIMA® (lenvatinib) Capsules
LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below.

Thyroid cancer
・Indication as monotherapy
(Approved in over 80 countries including Japan, the United States, China, and countries in Europe and Asia)
Japan: Unresectable thyroid cancer
The United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC)
Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI)

Hepatocellular carcinoma
・Indication as monotherapy
(Approved in over 80 countries including Japan, the United States, China, and countries in Europe and Asia)
Japan: Unresectable hepatocellular carcinoma
The United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy

Thymic carcinoma
・Indication as monotherapy (Approved in Japan)
Japan: Unresectable thymic carcinoma

Renal cell carcinoma (In Europe, the agent was launched under the brand name Kisplyx^®)
・Indication in combination with everolimus
(Approved in over 65 countries including the United States, and countries in Europe and Asia)
The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
Europe: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy
・Indication in combination with KEYTRUDA
(Approved in over 45 countries including Japan, the United States, and countries in Europe and Asia)
Japan: Radically unresectable or metastatic renal cell carcinoma
The United States: The first-line treatment of adult patients with advanced renal cell carcinoma
Europe: The first-line treatment of adult patients with advanced renal cell carcinoma

Endometrial carcinoma
・Indication in combination with KEYTRUDA
(Approved [including conditional approval] in over 45 countries including Japan, the United States, and countries in Europe and Asia)
Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy
The United States: The treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Europe: The treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery

About KEYTRUDA^® (pembrolizumab) Injection, 100mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck & Co., Inc., Rahway, NJ, USA has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

About the Eisai and Merck & Co., Inc., Rahway, NJ, USA Strategic Collaboration
In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA, known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA.

In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in multiple tumor types across more than 10 clinical trials.

Eisai’s Focus on Cancer
Eisai acknowledges “Oncology” as one of its key strategic areas, and will continue to focus on the discovery and development of anti-cancer drugs within drug discovery domains including “microenvironment”, “proteostasis disruption”, “cell lineage and cell differentiation”, and “inflammation, hypoxia, oxidative stress and cell senescence” under the Deep Human Biology Learning (DHBL) drug discovery and development organization. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

About Eisai
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.. and global) and LinkedIn (for U.S. and EMEA).

Merck & Co., Inc., Rahway, NJ, USA’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck & Co., Inc., Rahway, NJ, USA, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck & Co., Inc., Rahway, NJ, USA is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck & Co., Inc., Rahway, NJ, US
For over 130 years, Merck & Co., Inc., Rahway, NJ, USA, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck & Co., Inc., Rahway, NJ, USA continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, NJ, USA
This news release of Merck & Co., Inc., Rahway, NJ, USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

¹ International Agency for Research on Cancer, World Health Organization. “Kidney Fact Sheet.” Cancer Today, 2020.  https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf .
² American Cancer Society. “What Is Kidney Cancer?” About Kidney Cancer.
https://www.cancer.org/cancer/types/kidney-cancer/about/what-is-kidney-cancer.html .
³ American Cancer Society. “Key Statistics About Kidney Cancer” About Kidney Cancer. https://www.cancer.org/cancer/types/kidney-cancer/about/key-statistics.html .
⁴ American Family Physician. Renal Cell Carcinoma: Diagnosis and Management.
https://www.aafp.org/pubs/afp/issues/2019/0201/p179.html .
⁵ American Cancer Society. “Survival Rates for Kidney Cancer” Early detection, Diagnosis, and Staging.
https://www.cancer.org/cancer/types/kidney-cancer/detection-diagnosis-staging/survival-rates.html

EISAI’S INITIATIVES FOR DEVELOPING NEW MEDICINES FOR NEGLECTED TROPICAL DISEASES AND MALARIA AND COMMITMENT FOR FUNDING TO THE 3RD PHASE OF GLOBAL HEALTH INNOVATIVE TECHNOLOGY FUND ACTIVITIES

by codm | May 25, 2023 | Newsletter

For Print (PDF)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced that it will grant a total of 625 million yen to the Global Health Innovative Technology Fund (“GHIT Fund”) to fund the third phase of its activities, which will take place in the five-year period from FY2023 to FY2027. The GHIT Fund is a public-private partnership, co-established in April 2013 by partners such as Japanese pharmaceutical companies (including Eisai), the Japanese government, and the Bill & Melinda Gates Foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in Japan and overseas. Eisai has provided a total of 1 billion yen to the first phase (FY2013 – FY2017) and the second phase (FY2018 – FY2022) of the GHIT Fund.

In order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (NTDs) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome. It is also necessary to establish local supply systems and help patients secure access to diagnosis and treatments. The key to overcoming these challenges are industry-government-academia partnerships which transcend the usual sector boundaries.

Eisai considers making efforts to resolve the global issue of access to medicines to be its duty. Under a public-private partnership including governments, international organizations, and private non-profit organizations, Eisai has participated in 23 joint research projects to develop new medicines and vaccines for mycetoma, malaria and filariasis, with the support of the GHIT Fund.

Eisai has conducted a Phase II clinical trial of its in-house developed agent E1224 (generic name: fosravuconazole) in Sudan for the treatment of mycetoma in partnership with the non-profit organization Drugs for Neglected Diseases initiative (DNDi). Eisai is also conducting a Phase II clinical trial of antimalarial agent SJ733 in collaboration with the University of Kentucky.

Eisai considers efforts for improving access to medicines, such as the elimination of NTDs and malaria, as activities aimed at creating long-term corporate value and social impact based on its corporate concept of human health care (hhc). We will continue to strengthen cooperation with our global partners and contribute to “relieving anxiety over health” and “reducing health disparities” for people at risk of infection with NTDs and those suffering from theses diseases.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to editors]
1.  About the Global Health Innovative Technology Fund (GHIT Fund)
The GHIT Fund is a Japan-based international public-private partnership fund (PPP) that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world’s vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases.
https://www.ghitfund.org/en

2.  About Neglected Tropical Diseases (NTDs) 
Neglected Tropic Diseases (NTDs) include 20 diseases that the World Health Organization (WHO) identifies as tropical diseases which human race must overcome. More than 1.7 billion people living in the poorest and most marginalized communities worldwide are exposed to the risk of NTD infection. The spread of NTDs is mainly caused by poor hygienic conditions associated with poverty. Infections from these diseases may result in serious physical impairment and this often results in normal economic and social activities becoming highly challenging to the individual. In the worst cases, NTDs may also result in death. The prevalence of NTDs is a stumbling block to economic growth for developing and emerging countries.

The following 20 NTDs have been designated by the WHO for control or elimination: dengue fever and chikungunya, rabies, trachoma, buruli ulcer, endemic treponematoses (yaws), leprosy (Hansen’s disease), Chagas disease, African sleeping sickness (Human African trypanosomiasis), leishmaniasis, taeniasis/cysticercosis, dracunculiasis (guinea worm disease], echinococcosis, food-borne trematode infections, lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminthiasis, mycetoma, scabies and snakebite envenoming.

3.  About Mycetoma
Mycetoma was officially recognized as the 18th NTD by the WHO in 2016. It is considered to be one of the most neglected tropical diseases since there is a lack of basic information including its transmission pathway and incidence. Mycetoma is a progressive, chronic subcutaneous infectious disease. While most commonly seen in the feet, it can also occur in other parts of the body. It is caused by bacteria or fungus entering the body through a cut or wound and infecting the tissue beneath the skin.¹

Mycetoma is divided into two subtypes: Actinomycetoma (caused by bacterial infection) and Eumycetoma (caused by fungal infection). Actinomycetoma can be treated with antibiotics, with more than 90% success rate. On the other hand, while azole anti-fungal drugs can be used to treat Eumycetoma, the effectiveness is limited often resulting in recurrence and surgery or amputation of limbs.

4.  About Malaria
Malaria, one of the three major infectious diseases, is caused by malaria parasites that are transmitted to people through the bite of an infected mosquito. According to the WHO, about the half of the world’s population is exposed to the risk of malaria, and there were an estimated 247 million malaria cases in 85 countries in 2021, of which about 620,000 lost their life. In particular, infants, children under the age of five, and pregnant women are more likely to develop serious illness and are always at risk of life-threatening conditions.²

Recently, strains of malaria which are resistant to existing medicines have been reported, and the development of a new medicine with a novel mechanism of action is an urgent priority. The majority of available antimalarial medicines target the blood-stage, in which the parasites replicate within erythrocytes, but medicines for the liver and transmission stages are limited. In order to completely cure malaria, prevent relapse, and prevent malaria being spread via mosquitoes, it is necessary to develop a new antimalarial medicine which targets all stages of the parasite lifecycle.

¹ WHO Mycetoma http://www.who.int/buruli/mycetoma/en/
² WHO Malaria https://www.who.int/news-room/fact-sheets/detail/malaria