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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 6 NEWS #PharmaBuzz

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About

1847 Komatsuya founded (Nihei Hisamitsu) 1869 KISHINTAN launched 1871 The company name, Komatsuya, changed to Hisamitsu Joeido (Yoichi Hisamitsu) 1903 Hisamitsu & Co. (Saburo Nakatomi) established ASAHI MANKINKO® launched 1907 KAIFUKUGAN® launched 1934 SALONPAS® launched 1944 Hisamitsu＆Co. played a leading role in the incorporation of Miyaki Seiyaku Co. 1951 Hisamitsu＆Co. incorporated (Masayoshi Nakatomi) 1952 Osaka Representative Office (current Osaka Branch) established 1957 Tokyo Representative Office (current Tokyo Head Office and Branch) established 1960 Taiwan Hisamitsu Pharmaceutical Co., Ltd. (current Taipei Branch) established 1962 The company’s stocks listed in the Second Section of the Tokyo Stock Exchange; Shares listed on the Fukuoka Stock Exchange 1963 AIR® SALONPAS launched 1964 Shares listed in the Second Section of the Osaka Stock Exchange 1965 The company renamed Hisamitsu Pharmaceutical Co., Inc. 1966 Nagoya Representative Office (currently Nagoya Branch) established 1968 SALONPAS® E launched 1970 Sapporo Representative Office (current Sapporo Branch) established 1971 SALONSIP® launched Shares listed in the Second Section of the Nagoya Stock Exchange Construction of the Tosu Laboratories completed Sendai Representative Office (current Sendai Branch) established 1972 Section to the First Section of the Tokyo Shares shifted from the Second Stock Exchange, Osaka Stock Exchange and Nagoya Stock Exchange PAPSALON® launched 1975 P.T. Salonpas Indonesia established 1978 PAPSALON® G launched 1981 Masayoshi Nakatomi became a Chairman of the Board of Directors and Hirotaka Nakatomi took a charge of president & CEO 1982 SALONPAS-HI® launched 1983 Takamatsu Representative Office (current Takamatsu Branch) established Hiroshima Representative Office (current Hiroshima Branch) established 1984 VESICUM® (cream and ointment) launched 1985 SALONPAS® A launched 1986 Hisamitsu Farmaceutica do Brazil Ltda. established SALONPAS® 30 launched ANAAKI SALONPAS® A (Porous SALONPAS® A) launched SECTOR® GEL launched 1987 Hisamitsu America, Inc. established NOBINOBI® SALONSIP® launched Construction of Utsunomiya Factory completed 1988 The Nakatomi Foundation for Promotion of Health Science established MOHRUS® launched 1989 Hisamitsu’s corporate new logo used SECTOR® (cream and lotion) launched 1990 Construction of Tsukuba Laboratories completed Nakatomi Memorial Foundation established 1991 AIR® SALONPAS® EX launched 1992 VOLLEY® (cream and lotion) launched 1993 SALONSIP® HEAD PAD launched 1994 Hisamitsu’s corporate logo changed Hisamitsu KBC Augusta Golf Tournament held Hisamitsu Vietnam Pharmaceutical Co., Ltd. established 1995 Nakatomi Memorial Medicine Museum opened Operations at the Factory in Vietnam started MOHRUS® TAPE launched 1997 SALONPAS® Ae launched 1998 California Laboratories established London Representative Office (current Hisamitsu UK Ltd.) established Kumamoto Sales Office (current Kumamoto Branch) established La SALONPAS® launched Lifecella® Face Mask® launched NOBINOBI® SALONSIP® -α launched 1999 Acquires ISO 14001 Certification (Kyushu Head Office) 2000 Kyoto Sales Office (currently Kyoto Branch) established ESTRANA® launched Acquired ISO 14001 Certification (Utsunomiya Factory) 2001 Tokyo Head Office relocated to Marunouchi,Tokyo 2002 Operations at Manaus Factory in Brazil started MOHRUS® TAPE L launched Malaysia Representative Office (current Singapore Branch) established Lifecella® Essence Sheet Mask launched Hisamitsu UK Ltd. established 2003 Hisamitsu’s corporate logo changed BUTENALOCK® launched FEITAS® launched FLEX® launched Taipei Branch established 2004 The honorary consulate of Brazil opened. AIR® SALONPAS® Indomethacin 1.0% launched 2005 New Jersey Representative Office established Hisamitsu took over the ethical drugs division from SSP co.,Ltd (Hisamitsu Medical Co., Ltd. founded) MOHRUS® 60 launched KEPLAT® launched in Italy MOHRUS® PATCH launched in Hong Kong SALONPAS World Ladies Golf Tournament (currently LPGA Tour World Ladies Championship SALONPAS CUP) held SALONSIP® L launched 2006 Kagoshima Branch established Roma Representative Office (integrated with Hisamitsu UK Ltd.) established Lifecella® Gel Mask launched NOBINOBI® SALONSIP® S launched FEITAS® (lotion, cream and tick) launched TULOBUTEROL TAPE “HMT” launched NABOAL® PAP launched NABOAL® TAPE L launched 2007 Hisamitsu celebrated the 160th anniversary of the company’s founding Lifecella® Milky Lotion Sheet Mask launched FEITAS® L launched Singapore Branch established SALONPAS® LOTION launched Construction of the Utsunomiya Second Factory completed FEITAS® HOT launched CSR Promotion Office established The NAS Battery System inplemented 2008 SALONPAS® PAIN RELIEF PATCH was approved by the US-FDA BUTENALOCK® V launched AIR® SALONPAS® DX launched GAN RYO JUN® launched SALONPAS® EX launched FEITAS® L HOT launched FEITAS® (gel, tick and gel-patch) launched Lifecella® Essence Mask (3 items) launched 2009 Lifecella® Eye Mask (3 items) launched Hisamitsu® ICING SHEET launched AIR® SALONPAS® ICING SPRAY launched CHOLESTON® launched FEITAS® Z (tape, gel-patch and gel) launched Hisamitsu U.S., Inc.established Noven Pharmaceuticals, Inc. (U.S.A.) integrated FEITAS® SIP HOT launched SALONPAS® EX HOT launched 2010 BUTENALOCK® V AIR® SOKAI POWDER launched Hisamitsu® ICE TOWEL launched Fentany Transdermal System launched in the U.S FENTOS® TAPE launched

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17-20 March, 2025

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05-07 February, 2025

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07-09 February, 2025

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Kyushu Head Office (Registered head office) Saga, Tosu, Tashirodaikan-machi 40...

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https://www.hisamitsu.co.jp/english/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

“Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient

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FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding.

Impressions: 6037

NEWS #PharmaBuzz

Noven Debuts ADHD Mindful Patch Companion App at APSARD 2025

14 Jan 2025

// BUSINESSWIRE

Hisamitsu launches Salonpas Diclofenac Patch 1% for pain relief

03 Nov 2023

// BIOSPECTRUM ASIA

Hisamitsu Ordered to Suspend Biz over Salonpas OTC Data Tampering

13 Aug 2021

// JIHO

SECUADO® (asenapine) Transdermal System, the First-and-Only Transdermal Patch

13 Apr 2020

// BUSINESSWIRE

FDA Approves Noven Pharmaceuticals’ Transdermal Patch for Schizophrenia

15 Oct 2019

// BIOSPACE

Noven Pharma, Hisamitsu Pharma sue Mylan on generic Minivelle

06 May 2015

// Potters Bar PHARMA BIZ

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