Merck | October 29, 2021
Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future.
"ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities.
Andrew Bulpin, head of Process Solutions, Life Science, at Merck
With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated.
The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year.
In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs.
This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver.
With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio.
Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health.
Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.
Foresee Pharmaceuticals Co., Ltd | February 24, 2022
Foresee Pharmaceuticals Co., Ltd. a Taiwan and US-based biopharmaceutical company and TRPharm, a leading Turkish healthcare company, announced today that they have entered into an exclusive license agreement for the co-development and commercialisation in Turkey and certain MENA countries of Foresee's FP-045 program, an oral allosteric Aldehyde Dehydrogenase 2 (ALDH2) activator for the treatment of Fanconi Anemia and other rare and severe diseases. Under the terms of this partnership, Foresee and TRPharm will collaborate to initially expedite the development of FP-045 in Fanconi Anemia. Turkey and the surrounding region has a high prevalence Fanconi Anemia as well as other rare diseases. Foresee will own all development data which will be used as part of its global development and registration dossier. Upon approval and commercialization in the territory, Foresee will receive significant royalties from the revenue in the territory. TRPharm will have exclusive rights to register and commercialize in the territory and will cover all related costs.
"We are very pleased to have established this collaboration with TRPharm, whose established track record of successful development, registrations and launches of rare disease products, including in hematology, makes us confident that they will make a remarkable partner for our FP-045 program. This is our second partnership with TRPharm and we look forward to continuing working together."
Dr. Ben Chien, Founder, Chairman and CEO of Foresee
İsmet Ince, General Manager of TRPharm, commented "Our purpose in TRPharm is to be the platform where health meets innovative solutions and I can think of no better example for it than this collaboration on FP-045 with Foresee. We are thrilled to have this opportunity to blaze a trail in Fanconi Anemia, which has a particularly high prevalence in our core regions, and provide relief to the patients with significant unmet need. It is an even greater pleasure to be doing this with Foresee, an esteemed international biopharmaceutical company with whom we share common views and a history of productive partnership. This collaboration also marks a step change in our R&D approach and is the culmination of a unique set of capabilities which we have developed over many years. We are confident that they will contribute materially to making this collaboration a rapid success."
About Foresee Pharmaceuticals Co. Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (6576.TWO). Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late stage and early stage programs. CAMCEVI® 42 mg is now approved in the U.S. and under regulatory review in the EU. Additionally, U.S. and EU regulatory submissions are in preparation for CAMCEVI® 21 mg. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia.
Conducting its activities with the vision of becoming a global and innovative healthcare company, TRPharm plays a leading role in Turkey & MENA and the neighboring regions thanks to its unique business model and emphasis on intellectual capital. Aiming at making its presence felt in every field with unmet healthcare needs, TRPharm focuses on enabling innovative healthcare solutions for the patients. It does so by leveraging its extensive experience at every stage, from development to commercialization, with extraordinary results. TRPharm has an extensive product portfolio in oncology/hematology, neurology, immunology and rare diseases.
Evergreen Theragnostics, Inc. | July 17, 2021
Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility.
Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227).
Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing.
The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment.
About Evergreen Theragnostics, Inc.
Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management.
About Tema Sinergie
Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.