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    Meiji Seika Pharma Co Ltd., the Meiji group's pharmaceutical division , is made up of more than 5700 workers dedicated to health and empowerment of people. Manufacturing and sale of ethical pharmaceuticals, agricultural chemicals and veterinary drugs.

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    “Due to its 20-year mastery in micronization, Inke has emerged a cornerstone in treating global respiratory diseases”

    This week, SpeakPharma interviews Miquel Bachs, CEO of Inke, a company with over two decades of expertise in micronization and particle engineering, and a leader in providing high-quality, effective solutions in the global fight against chronic respiratory diseases such as COPD and asthma. In this insightful conversation, Bachs shares Inke’s strategic vision, technological innovations, and commitment to sustainability, offering a comprehensive look at how the company is shaping the future of respiratory health. HIGHLIGHTS// Inke’s strategic vision/ technological innovations/ commitment to sustainability Studies suggest that 13 percent of people over 40 years of age, the world over, have chronic obstructive pulmonary disease (COPD). Given the increasing prevalence of respiratory diseases, how does Inke position itself as a leader in the development and manufacturing of respiratory APIs? Inke has established itself as a global leader in generic respiratory API development through our unique blend  of technological innovation, expertise in micronization, and a comprehensive portfolio of inhalation therapies. With over 20 years of experience in micronization and particle engineering, our ability to customize APIs to meet specific client requirements has resulted in highly effective, high-quality products tailored for respiratory therapies. The increasing prevalence of chronic respiratory diseases, such as COPD and asthma, has only underscored Inke’s pivotal role in supporting the pharmaceutical industry’s need for advanced treatments. We specialize in bronchodilators and other critical respiratory APIs that improve patient outcomes and meet the stringent regulatory requirements of global health authorities. Our end-to-end approach, from early-stage API development to commercial-scale production, ensures that we maintain the highest standards of quality, safety, and efficacy. As the market for respiratory APIs continues to evolve, Inke remains committed to expanding its portfolio to address unmet therapeutic needs. Beyond respiratory APIs, we are also prioritizing growth in CNS treatments and building on our expertise in complex molecule synthesis. This strategic focus allows us to provide an integrated solution that not only meets current market demands but also anticipates future pharmaceutical trends. HIGHLIGHTS// comprehensive portfolio of inhalation therapies/ over 20 years of experience in micronization and particle engineering/ specialize in bronchodilators and other critical respiratory APIs/ prioritizing growth in CNS treatments In the field of micronization, what differentiates Inke’s approach from that of other manufacturers of respiratory APIs? What sets Inke apart in micronization is our advanced particle size reduction technology and our dedication to precision. Our facility is equipped with various milling techniques such as Cone, Jet, and Pin mills, allowing us to reduce particle size while stabilizing the amorphous content to ensure consistent quality. Our in-depth understanding of respiratory APIs, combined with our ability to tailor solutions for each customer, results in APIs with improved solubility, stability, and bioavailability, which are critical for the efficacy of inhalation products. This, along with our exceptional quality standards and a flawless audit track record, has positioned us as a key partner for major players in the inhalation market. HIGHLIGHTS// advanced particle size reduction technology/ technological innovations/ tailor solutions/ improved solubility, stability, and bioavailability Developing complex APIs can be challenging. How does Inke ensure a smooth and successful partnership throughout the development and manufacturing process, including customization, ensuring regulatory compliance and timely delivery? At Inke, we are dedicated to fostering strong partnerships with our clients through a collaborative approach that prioritizes open communication and mutual understanding. Our commitment to quality and personalized service sets us apart in the pharmaceutical landscape. Our team takes the time to engage in comprehensive discussions to customize our solutions, ensuring alignment with client specifications across all batches and grades. This commitment to flexibility allows us to respond effectively to evolving requirements, solidifying Inke’s reputation as a reliable partner. We understand that navigating regulatory landscapes can be challenging. That's why our team is equipped to manage all aspects of the regulatory process with meticulous attention to detail. From the submission of Drug Master Files (DMFs) and Certificates of Suitability to crafting precise responses to potential Deficiency Letters, we ensure compliance at every step. Moreover, we offer extensive support in patent and intellectual property matters, providing technical assistance and guidance tailored to the specific requirements of each region. Our unwavering dedication to quality, coupled with our agile response capabilities, enables us to deliver exceptional results while maintaining transparency and trust. At Inke, we are committed to building lasting relationships that drive success for both our clients and our organization. HIGHLIGHTS// ensuring alignment with client specifications/ manage all aspects of the regulatory process/ support in patent and intellectual property matters Given Inke’s global presence, what are the key markets for growth and how does Inke plan to expand its market reach and strengthen its position in these regions? Inke is strategically focused on expanding its footprint in the European and US markets, where we continue to prioritize our efforts. The US market remains pivotal for us, especially considering our successful FDA inspections and ongoing regulatory compliance efforts that solidify our reputation. Japan is another significant market where we have established a robust presence, reflecting our commitment to high-quality manufacturing and innovation. Looking ahead, China represents a key growth opportunity for Inke. With 12 active DMFs registered, we are well-positioned to tap into this burgeoning market. Our strategy involves leveraging our existing capabilities to navigate regulatory landscapes and fostering strong partnerships within the region, thereby enhancing our market reach and influence in the pharmaceutical sector. HIGHLIGHTS// expanding footprint in the European and US markets/ China represents a key growth opportunity for Inke With Inke expanding into contract manufacturing organization (CMO) services, how does this new offering align with Inke’s broader strategic goals, and what advantages does it provide to pharmaceutical partners? At Inke, the introduction of CMO services is a natural extension of our core expertise in the development and manufacturing of high-quality generic APIs. Our expansion into CMO is part of a strategic move to diversify our service portfolio, allowing us to offer end-to-end solutions for our clients. The CMO service integrates seamlessly with our expertise in API manufacturing, particularly in micronization, which has been a key differentiator for Inke for over two decades. With our advanced particle engineering capabilities, we can offer tailored solutions that meet specific technical and regulatory requirements. Whether it is small-batch production or scaling up to commercial quantities, we offer the flexibility to accommodate a wide range of customer needs. This adaptability, paired with our deep expertise in micronization, allows us to support evolving project needs, maintaining the highest standards of consistency, quality, and performance that define Inke’s footprint. HIGHLIGHTS// CMO is part of a strategic move to diversify our service portfolio/ deep expertise in micronization What is Inke’s commitment to sustainability and corporate social responsibility and how is it integrating sustainable practices into its operations and product development? At Inke, we recognize that integrating environmental, social, and governance (ESG) principles into our operations is not just a responsibility but a pathway to long-term success. Our ESG vision is centered around aligning business growth with sustainable practices that positively impact our communities and the environment. We are dedicated to environmental responsibility, actively implementing initiatives such as efficient wastewater treatment and water reuse systems to minimize our ecological footprint. Our recent investments in energy efficiency include the installation of a 135 kWp solar panel system, which underscores our commitment to reducing emissions and resource consumption across our manufacturing and research facilities. Inke is also committed to fostering a diverse and inclusive workforce. With a notable increase in our team members, particularly in operations and quality assurance, we prioritize career development and the well-being of our employees. By adhering to high regulatory standards, we ensure our products meet stringent global requirements, enhancing our transparency and compliance. Through these initiatives, Inke aims to cultivate sustainable practices that not only support our business objectives but also contribute positively to the pharmaceutical industry and society at large. HIGHLIGHTS// integrating ESG principles/ efficient wastewater treatment and water reuse systems/ installation of a 135 kWp solar panel system/ diverse and inclusive workforce

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    28 Oct 2024
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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

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    24 Oct 2024
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    NEWS #PharmaBuzz

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    Japan Approves CSL And Arcturus' Updated COVID-19 Vaccine For JN.1 Strain
    Japan Approves CSL And Arcturus' Updated COVID-19 Vaccine For JN.1 Strain

    13 Sep 2024

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    https://www.businesswire.com/news/home/20240913667150/en

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    Meiji Seika Pharma Opens Boston Office For Investment Opportunities
    Meiji Seika Pharma Opens Boston Office For Investment Opportunities

    08 Aug 2024

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    https://www.businesswire.com/news/home/20240808269845/en

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    Meiji Seika to supply Japan with self-amplifying mRNA Covid-19 vaccine
    Meiji Seika to supply Japan with self-amplifying mRNA Covid-19 vaccine

    22 Mar 2024

    // ENDPTS

    https://endpts.com/meiji-seika-pharma-to-supply-japan-with-self-amplifying-mrna-covid-19-vaccine-in-fall-winter-of-2024/

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    22 Mar 2024
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    Meiji Seika Pharma Presents Positive Findings from Phase II Study of ME3183
    Meiji Seika Pharma Presents Positive Findings from Phase II Study of ME3183

    13 Oct 2023

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    https://www.businesswire.com/news/home/20231012881091/en

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    Adcock Ingram Completes Construction of a New Manufacturing Facility in India
    Adcock Ingram Completes Construction of a New Manufacturing Facility in India

    31 May 2023

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    https://www.businesswire.com/news/home/20230530005041/en

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    31 May 2023
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    Meiji Seika Pharma, Adcock Complete Construction of New Manufacturing Facility
    Meiji Seika Pharma, Adcock Complete Construction of New Manufacturing Facility

    31 May 2023

    // CONTRACT PHARMA

    https://www.contractpharma.com/contents/view_breaking-news/2023-05-31/meiji-seika-pharma-adcock-ingram-pharma-complete-construction-of-new-manufacturing-facility/?widget=listSection

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    31 May 2023
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    Drugs in Development

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    Meiji Seika Launches REZUROCK® Tablets in Japan for Chronic Graft-Versus-Host Disease

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    Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).


    Lead Product(s): Belumosudil

    Therapeutic Area: Immunology Brand Name: Rezurock

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Sanofi

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 22, 2024

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    Lead Product(s) : Belumosudil

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Sanofi

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Meiji Seika Launches REZUROCK® Tablets in Japan for Chronic Graft-Versus-Host Disease

    Details : Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).

    Brand Name : Rezurock

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 22, 2024

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    Meiji Seika Receives Approval for REZUROCK® in Japan for Chronic Graft-Versus-Host Disease

    Details:

    Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).


    Lead Product(s): Belumosudil

    Therapeutic Area: Immunology Brand Name: Rezurock

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Sanofi

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 26, 2024

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    Lead Product(s) : Belumosudil

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Sanofi

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Meiji Seika Receives Approval for REZUROCK® in Japan for Chronic Graft-Versus-Host Disease

    Details : Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).

    Brand Name : Rezurock

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 26, 2024

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    New Drug Application for ME3208 Submitted in Japan for Chronic Graft-Versus-Host Disease

    Details:

    Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).


    Lead Product(s): Belumosudil

    Therapeutic Area: Immunology Brand Name: Rezurock

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Sanofi

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 27, 2023

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    Lead Product(s) : Belumosudil

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Sanofi

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    New Drug Application for ME3208 Submitted in Japan for Chronic Graft-Versus-Host Disease

    Details : Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).

    Brand Name : Rezurock

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 27, 2023

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    ME3208 Receives Orphan Drug Designation in Japan for Chronic Graft-Versus-Host Disease

    Details:

    Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).


    Lead Product(s): Belumosudil

    Therapeutic Area: Immunology Brand Name: Rezurock

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Sanofi

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 24, 2023

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    Lead Product(s) : Belumosudil

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Sanofi

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ME3208 Receives Orphan Drug Designation in Japan for Chronic Graft-Versus-Host Disease

    Details : Rezurock (belumosudil mesylate), a selective ROCK2 inhibitor, is indicated for the treatment of patients with Chronic Graft-Versus-Host Disease (chronic GVHD).

    Brand Name : Rezurock

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 24, 2023

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    A Novel Anti-PD-1 Agonist Antibody with Immunosuppressive Effect Discovered Through Joint Research Between Meiji Seika Pharma and The Foundation for Bio...

    Details:

    A novel anti-PD-1 agonist monoclonal antibody, which inhibits the function of PD-1 (anti-PD-1 blocking antibodies) leading in enhanced anti-tumor immunity.


    Lead Product(s): Monoclonal Antibody

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Large molecule

    Sponsor: Foundation for Biomedical Research and Innovation at Kobe

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 16, 2023

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    Lead Product(s) : Monoclonal Antibody

    Therapeutic Area : Immunology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Foundation for Biomedical Research and Innovation at Kobe

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    A Novel Anti-PD-1 Agonist Antibody with Immunosuppressive Effect Discovered Through Joint Research...

    Details : A novel anti-PD-1 agonist monoclonal antibody, which inhibits the function of PD-1 (anti-PD-1 blocking antibodies) leading in enhanced anti-tumor immunity.

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    January 16, 2023

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    First Patient Dosed in Phase II Study of ME3183, a Selective PDE4 Inhibitor, in Patients with Plaque Psoriasis in the United States and Canada

    Details:

    In non-clinical studies, ME3183, a selective phosphodiesterase-4 (PDE4) inhibitor, showed greater anti-inflammatory effect and its inhibitory effect on TNF-α production was approximately 30-fold greater than the existing orally-available PDE4 inhibitor for psoriasis.


    Lead Product(s): ME3183

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: ME3183

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 07, 2022

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    Meiji Seika Pharma

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    Lead Product(s) : ME3183

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    First Patient Dosed in Phase II Study of ME3183, a Selective PDE4 Inhibitor, in Patients with Plaq...

    Details : In non-clinical studies, ME3183, a selective phosphodiesterase-4 (PDE4) inhibitor, showed greater anti-inflammatory effect and its inhibitory effect on TNF-α production was approximately 30-fold greater than the existing orally-available PDE4 inhibitor ...

    Brand Name : ME3183

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 07, 2022

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    Meiji Completed Phase I Studies and Moves Onto Phase II Study of ME3183, a Selective PDE4 Inhibitor for the Treatment of Psoriasis

    Details:

    ME3183 is an orally-available and selective inhibitor for phosphodiesterase 4 (PDE4) discovered by Meiji. In the study, ME3183 has been shown to be safe and well-tolerated across the doses tested.


    Lead Product(s): ME3183

    Therapeutic Area: Dermatology Brand Name: ME3183

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 24, 2021

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    07

    Meiji Seika Pharma

    Japan
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    Meiji Seika Pharma

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    Lead Product(s) : ME3183

    Therapeutic Area : Dermatology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Meiji Completed Phase I Studies and Moves Onto Phase II Study of ME3183, a Selective PDE4 Inhibito...

    Details : ME3183 is an orally-available and selective inhibitor for phosphodiesterase 4 (PDE4) discovered by Meiji. In the study, ME3183 has been shown to be safe and well-tolerated across the doses tested.

    Brand Name : ME3183

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 24, 2021

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    Intas Enters License Agreement with Meiji and Dong Commercialize DMB-3115

    Details:

    Under the terms of the agreement, Intas was granted the exclusive license rights to market DMB-3115 worldwide, excluding Japan, Korea and certain countries in Asia.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: DMB-3115

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Intas Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement July 21, 2021

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    08

    Meiji Seika Pharma

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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Intas Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Intas Enters License Agreement with Meiji and Dong Commercialize DMB-3115

    Details : Under the terms of the agreement, Intas was granted the exclusive license rights to market DMB-3115 worldwide, excluding Japan, Korea and certain countries in Asia.

    Brand Name : DMB-3115

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    July 21, 2021

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    Meiji Seika Pharma: Promising Results of Phase I Clinical Trial of DMB-3115

    Details:

    A single subcutaneous injection of DMB3115 in healthy volunteers was well tolerated. The reported adverse events corresponded with the known safety profile of ustekinumab.


    Lead Product(s): Ustekinumab

    Therapeutic Area: Dermatology Brand Name: DMB-3115

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Dong-A Socio Holdings

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 21, 2021

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    09

    Meiji Seika Pharma

    Japan
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    Meiji Seika Pharma

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    Lead Product(s) : Ustekinumab

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Dong-A Socio Holdings

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Meiji Seika Pharma: Promising Results of Phase I Clinical Trial of DMB-3115

    Details : A single subcutaneous injection of DMB3115 in healthy volunteers was well tolerated. The reported adverse events corresponded with the known safety profile of ustekinumab.

    Brand Name : DMB-3115

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    May 21, 2021

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    Eisai to Take Over Manufacturing and Marketing Approval for Equfina® 50 Mg Tablets (safinamide Mesilate)INn Japan from Meiji Seika Pharma

    Details:

    Eisai will take over by transfer the manufacturing and marketing approval of Equfina from Meiji. Eisai, as the manufacturer and distributor of Equfina in Japan, will continue to provide information on the proper usage of Equfina.


    Lead Product(s): Safinamide Mesylate

    Therapeutic Area: Neurology Brand Name: Equfina

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Eisai

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement September 07, 2020

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    10

    Meiji Seika Pharma

    Japan
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    Not Confirmed

    Meiji Seika Pharma

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    Lead Product(s) : Safinamide Mesylate

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Eisai

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Eisai to Take Over Manufacturing and Marketing Approval for Equfina® 50 Mg Tablets (safinamide Me...

    Details : Eisai will take over by transfer the manufacturing and marketing approval of Equfina from Meiji. Eisai, as the manufacturer and distributor of Equfina in Japan, will continue to provide information on the proper usage of Equfina.

    Brand Name : Equfina

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    September 07, 2020

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