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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

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INTERVIEW #SpeakPharma
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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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15-19 December, 2024

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CONTACT DETAILS

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Country

Japan

Address

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

Telephone

+81-(0)3-5293-1720

enquiries@pharmacompass.com

Website

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

Impressions: 4587

VLOG #PharmaReel

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DATA COMPILATION #PharmaFlow

[Sponsored by another company]

CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025.

Impressions: 400

NEWS #PharmaBuzz

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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