PHARMA TECH

Piramal Pharma Solutions Announces Sterile Fill/Finish Program Theratechnologies Inc

Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021

Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation.

The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments.

According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients."

About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide.

About Piramal Pharma Limited
Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.

About Theratechnologies
Theratechnologies  is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

Spotlight

Despite a recent global economic downturn, the world pharmaceutical market is currently estimated to be valued at around $300 billion and rising, according to the World Health Organization (WHO). In a recent post, the WHO states that more than a third of the market is controlled by 10 large drug companies located in the US and Europe, and that, combined, the Americas, Europe, and Japan will comprise 85% of the market into the foreseeable future. According to the post, pharma companies spend one-third of their revenues on marketing, estimated at about double what is spent on research and development. To say competition in the pharmaceutical industry is fierce would be an understatement.

Spotlight

Despite a recent global economic downturn, the world pharmaceutical market is currently estimated to be valued at around $300 billion and rising, according to the World Health Organization (WHO). In a recent post, the WHO states that more than a third of the market is controlled by 10 large drug companies located in the US and Europe, and that, combined, the Americas, Europe, and Japan will comprise 85% of the market into the foreseeable future. According to the post, pharma companies spend one-third of their revenues on marketing, estimated at about double what is spent on research and development. To say competition in the pharmaceutical industry is fierce would be an understatement.

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BUSINESS INSIGHTS

ITM Receives Equity Investment of EUR 25 Million from Strategic Partner Grand Pharma

ITM Isotope Technologies Munich SE | February 17, 2022

ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Grand Pharmaceutical Group Limited (GP), a diversified global pharmaceutical company listed in Hong Kong, today announced that ITM and a subsidiary of GP have entered into a definitive agreement under which GP will make a EUR 25 million (USD 28 million) equity investment in ITM. The agreement will further deepen the strategic collaboration between the two companies and support ITM to further expanding its broad pipeline of precision oncology treatments and diagnostics in Greater China. The equity investment follows the recent licensing agreement between the two companies which provides GP with exclusive rights to develop, manufacture and commercialize ITM’s precision oncology radiopharmaceutical candidates, ITM-11 (n.c.a. 177Lu-edotreotide) and ITM-41 (n.c.a. 177Lu-zoledronate) as well as ITM-11’s companion diagnostic, TOCscan® (68Ga-edotreotide) in mainland China, Hong Kong, Macau and Taiwan. “We believe GP’s investment reinforces our global leadership position as a radiopharmaceutical developer and manufacturer while providing us with additional strategic support in expanding our presence in Asia with a recognized leader by our side. While we focus on advancing the late-stage development of our lead candidate, ITM-11 in GEP-NET patients, we look forward to further enhancing our global footprint to meet the needs of a growing patient population requiring precision oncology treatments.” Steffen Schuster, Chief Executive Officer of ITM “Targeted Radionuclide Therapies and Diagnostics are a core focus area for us. We believe that ITM, as one of the largest medical radioisotope manufacturers with a broad clinical pipeline and a deep understanding of the clinical landscape, has the ability to usher in a new era of precision medicine,” said Frank Zhou, Chief Executive Officer of GP. “This second agreement is a testament to the strong relationship we have formed, sharing the common goal of providing innovative and high-quality radiopharmaceuticals to the patients we serve.” ITM is built on longstanding experience in the production and supply of high-quality medical radioisotopes for cancer treatment and diagnosis with an established global supply network. The company has forward-integrated to develop a broad pipeline of Targeted Radionuclide Diagnostics and Therapeutics designed to provide medical benefit for hard-to-treat cancer indications. The company’s lead candidate, ITM-11 (n.c.a. 177Lu-edotreotide) is being developed for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and is currently undergoing two phase III clinical trials, COMPETE for patients with grade 1 and grade 2 GEP-NETs and COMPOSE for grade 2 and grade 3 GEP-NETs. TOCscan® (68Ga-edotreotide) is the companion diagnostic to ITM-11 for the diagnosis and staging of neuroendocrine tumors (NETs). ITM-41 is in preclinical development for the treatment of osteosarcoma and bone metastases. About Targeted Radionuclide Therapy Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific entities such as receptors which are expressed on the cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization of the radioisotope potentially enables targeted treatment with minimal impact to healthy surrounding tissue. ITM Isotope Technologies Munich SE ITM, a radiopharmaceutical biotech company, is dedicated to providing the most precise cancer radiotherapeutics and diagnostics to meet the needs of patients, clinicians and our partners through excellence in development, production and global supply. With patient benefit as the driving principle for all we do, ITM is advancing a broad pipeline, including two phase III studies, combining its high-quality radioisotopes with targeting molecules to develop precision oncology treatments. ITM is leveraging its leadership and nearly two decades of radiopharma expertise combined with its worldwide network to enable nuclear medicine to reach its full potential for helping patients live longer and better. About Grand Pharmaceutical Group Limited Grand Pharmaceutical Group Limited (0512.HK) is a diversified global pharmaceutical enterprise. The company sticks to core values and principles of patients-centered, market-oriented and innovation-driven. GP has extensive capabilities in R&D, manufacture and commercialization of pharmaceutical products, advanced medical devices, active pharmaceutical ingredients, bio-technology products, and nutritional products. Its core product portfolio covers several major therapeutic areas including cerebro-cardiovascular emergency, respiratory and Ear, Nose & Throat (the “ENT”) as well as ophthalmic treatments and selective internal radiation therapy for tumor treatment. The global innovative product pipeline of GP is well-established and diversified, covering the field of precision intervention, oncology, severe anti-infection and respiratory and ENT. With the strategy of “global expansion and dual-cycle operation”, GP has formed a new pattern of domestic and international cycles that synergize with each other. GP devoted to health and dedicated to science through R&D and M&A activities. GP is accomplishing its promises to physicians and patients and trying our best to make meaningful contributions to our society.

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PHARMACY MARKET

Prescryptive Health Launches COVID-19 Treatment Solution for Pharmacists

Prescryptive Health | September 29, 2021

Healthcare technology company Prescryptive Health today announced a turn-key solution for pharmacists to treat COVID-19 through monoclonal antibody administration. This new program builds on the company's work with community pharmacists on COVID-19 testing and vaccine services and supports the National Community Pharmacists Association's effort to prepare pharmacists to provide this treatment. As in all our COVID-19 solutions, we are empowering pharmacists to help end this pandemic, through identifying, reporting, preventing, and now treating this virus, More than 90% of Americans live within five miles of a pharmacy, and pharmacists have proven again and again how essential they are in their communities. - Chris Blackley, Prescryptive Health's CEO The solution is truly turn-key, allowing pharmacists to get trained and provide COVID-19 treatment to their communities quickly. As this public health crisis continues, pharmacists can support their communities in new ways through this program. - Michele Belcher, incoming NCPA president and pharmacist at Grants Pass Pharmacy in Oregon Prescryptive Health's robust, one-hour ACPE-accredited continuing education training for COVID-19 monoclonal antibody treatment is free for pharmacists nationwide. NCPA supports the continuing education program built by Prescryptive. In combination with the NCPA resources, pharmacists have the tools necessary to prepare administering this clinical service. The innovative program also includes a clinical protocol developed by subject matter experts and leading regulators; policies and procedures to help pharmacies operationalize the service; guidance on accessing inventory as it becomes available; and billing services, through Prescryptive's partnership with AssureCare®. This program will debut in Oregon, with additional locations added across the nation in the coming weeks. Belcher and Paige Clark, VP of Programs and Policy at Prescryptive Health, will present at the NCPA conference in October on the COVID-19 treatment program, showing how pharmacists are playing a crucial role for public health in their communities. About Prescryptive Health Prescryptive Health is a healthcare technology company delivering solutions that empower consumers. Prescryptive's secure, mobile-first products connect consumers, pharmacists, and employers, ultimately providing people with the information they need to make informed decisions and take control of their health.

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PHARMACY MARKET

BC Platforms Adds Japans Mitsubishi Space Software to its Global Data Network

BC Platforms | February 21, 2022

BC Platforms (BCP), a global leader in healthcare data management and analytics, announced a new data partnership with Japan's Mitsubishi Space Software Co. Ltd. (Mitsubishi), one of the country's oldest bioinformatics companies. The collaboration, which provides secure access to Mitsubishi's cancer specific cohort of 8,000 patients, will accelerate the provision of cancer genetic data analysis services to medical institutions for cancer research. As part of the collaboration, Mitsubishi joins BCP's BCRQUEST network, which is revolutionizing drug development & personalizing care. This global, federated data partner network enables analytics and deeper insights. BCP has built this network, which reaches over 22 million patient lives in the catchment area, and data partners across Europe, North America, and Asia-Pacific to enable the realization of the full potential of real-world data. "At BCP, our mission is to accelerate the translation of research into global clinical practice through the faster generation of translatable, actionable, research insights. We encourage health systems to invest in consenting and data infrastructure as it provides strong foundations underpinning personalized medicine and ultimately improve outcomes for patients. Through our partnership with Mitsubishi, a long-standing leader in the field of bioinformatics, we expect patient lives will be directly, positively, impacted. This collaboration also adds significant data from millions of Asian patients to fuel research with connections to 30 hospitals in Japan. Such achievements are part of our continued efforts to scale our vision to build the world's leading analytics platform for healthcare and the life sciences industry." Nino da Silva, Deputy Managing Director, BCP Mitsubishi Space Software Co., Ltd., commented, "At Mitsubishi, we have long been supporting patients by utilizing and researching genomic research and providing cancer genetic data analysis services to medical institutions for cancer research. We are looking forward to working with BC Partners, and its BCRQUEST network, to enhance Japan's provision of clinical and genomic datasets to benefit research, patient care and personalized medicine." This latest data partnership builds on recent successes of delivering industry-leading interpretation services on genomics related insights, including pharmacogenomics in clinical practice in Asia and around the world. In October 2021, BCP announced its partnership with Bumrungrad International Hospital (BIH), in Bangkok, Thailand, one of the largest private hospitals in Southeast Asia and a world leader in healthcare delivery and pioneering clinical research. BCP is supporting BIH on its transition from single-gene tests to multi-gene panels for clinical pharmacogenetics, providing data interpretation support on single nucleotide variations. About BC Platforms BC Platforms is a global leader in providing a powerful data and technology platform for personalized medicine, accelerating the translation of insights into clinical practice. Our technology drives the infinite loop between personalized care and research discoveries, leveraging latest science, deep technical expertise, strategic partnerships, and harmonized, diverse data collections. Our high performing genomic data discovery and analytics platform enables flexible data integration, secure analysis, and interpretation of molecular and clinical information. Additionally, BC Platforms has developed a Global Data Partner Network BCRQUEST.com, which allows us to access real-world data equivalent to approximately 22 million patient lives, including longitudinal clinical data in addition to 500k patients' genetic data, across 14 countries in Europe, North and South America, Asia and Africa, providing rich data for pharmaceutical and medical research and development. About Mitsubishi Space Software Mitsubishi Space Software was established in 1962 as a system engineering company. Our cooperate mission is "We support future society with high-quality and highly reliable solutions based on advanced science and technology which are cultivated by space system development."

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