Thermo Fisher Scientific Launches Modular Closed Cell Processing System for Cell Therapy Manufacturing

Thermo Fisher | October 15, 2020

Thermo Fisher Scientific Launches Modular Closed Cell Processing System for Cell Therapy Manufacturing
Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development and commercial manufacturing. As of mid-2020, 675 clinical trials were underway globally for cell therapy and cell-based immune-oncology, according to the Alliance for Regenerative Medicine. Yet few cell therapies in development become commercially available due to several factors: safety and efficacy requirements, difficulties in transferring research protocols to manufacturing processes, lack of scalability of these therapies, high cost of facilities, labor and equipment, and complexity of the processes involved.

Spotlight

One of the more vexing and troubling public health policy issue that has plagued the US pharma industry, yet receiving less deserving public news coverage than other industry stories, has been the existence of chronic drug shortages since the turn of the 21st century. A drug shortage is defined in which the “total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.” While the annual number has dropped since the peak year of 2011, the issue of chronic drug shortages still persists, despite attempts by the FDA and federal legislation to remedy the problem. Drug shortages continue to be severe enough to potentially cause adverse effects on patients, changes in treatment that result in suboptimal care, and higher costs to the healthcare system.

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BUSINESS INSIGHTS

Hikma strengthens US Injectables business through acquisition of Custopharm

Hikma Pharmaceuticals USA Inc. | September 27, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company and one of the largest suppliers of generic injectable medicines in the US, today announces that it has agreed to acquire Custopharm Inc. ('Custopharm') from Water Street Healthcare Partners ('Water Street'). Hikma will pay an initial cash consideration of $375 million on a debt and cash-free basis, with a further $50 million in contingent consideration payable upon the achievement of certain commercial milestones. Custopharm, a US-based generic sterile injectables company with a differentiated product portfolio and R&D pipeline, currently markets its products in the US through its commercial arm Leucadia Pharmaceuticals. Since partnering with Water Street in 2015, Custopharm has received 13 US FDA approvals, with four first-to-market Abbreviated New Drug Application (ANDA) approvals - including one with Competitive Generic Therapy (CGT) designation - and one novel 505(b)(2) NDA approval. Based in Carlsbad, California, Custopharm has 39 employees. With this acquisition, Hikma will have a differentiated US portfolio of close to 130 injectable medicines a more than fivefold increase over the last decade. Through this broad portfolio and by combining Custopharm's strong R&D capabilities with our high-quality and extensive manufacturing footprint, we will be in an excellent position to better serve the growing needs of hospitals, doctors and patients. I look forward to welcoming the team at Custopharm and Leucadia to Hikma as we continue to grow and strengthen our Injectables business. - Riad Mishlawi, President of Hikma Injectables We're excited to become part of Hikma, a global leader that shares our deep commitment to bringing generic products to market and into the hands of patients who need them. Water Street has been an outstanding partner in working with us to build an exemplary portfolio of complex generic products. We're looking forward to building on this success. - William C. Larkins, Ph.D., CEO of Custopharm and Leucadia Terms of the transaction and financial impact: The up-front consideration of $375 million is on a cash-free, debt-free basis and is being funded from Hikma's existing cash resources. The acquisition constitutes a Class 2 transaction pursuant to the UK Listing Rules.The gross assets of Custopharm at 31 December 2020 were $43 million. Losses before tax in the year to 31 December 2020 were $7.5 million. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. About Custopharm Custopharm is a leader in the generic injectables market. Its goal is to provide important new generic injectable products to the acute and specialty markets and to reach people and communities with underserved conditions. Custopharm invests significantly in developing and acquiring new products, including through strategic partnerships. It also launches newly approved products through its nationally recognized commercial organization, Leucadia Pharmaceuticals. Custopharm features a portfolio of highly differentiated generic products, including four first-to-market products: Calcitonin Salmon Injection, USP, Synthetic, Dihydroergotamine Mesylate Nasal Spray, Sodium Tetradecyl Sulfate (STS) Injection, 3%, and Valrubicin Intravesical Solution, USP. Headquartered in Carlsbad, California, Custopharm is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. About Water Street Water Street is a strategic investor focused exclusively on health care. The firm has a strong record of building market-leading companies across key growth sectors in health care. It has worked with some of the world's leading companies on its investments including Humana, Johnson & Johnson, Medtronic and Walgreen Co. Water Street's team is comprised of industry executives and investment professionals with decades of experience investing in and operating global health care businesses. The firm is headquartered in Chicago.

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Tetra Bio-Pharma Gets Orphan Drug Status For CBD Drug

Greenmarketreport | April 22, 2020

Tetra Bio-Pharma Inc. (OTCQB:TBPMF) announced its Orphan Drug development strategy and provided a management update. The company said it is focusing on generating intellectual property including use, manufacturing, and innovative molecule protection. Tetra said it received a U.S. Food and Drug Administration (FDA) Orphan Drug Designation for secondary cannabidiol (CBD) formulation of its cannabinoid topical drug PPP004 in the treatment of epidermolysis bullosa. “Each ODD application is driven by scientific data generated by Tetra’s research and development department and in line with a commercialization strategy. Tetra is positioning itself as a world leader in cannabinoid drug development and increasing its ODD portfolio provides opportunities that will allow us to generate value for shareholders. Over the coming weeks, Tetra shall expand on its commercial ophthalmic and topical drug programs,” said Dr. Chamberland CEO & CRO, Tetra Bio-Pharma Inc.

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Apricus Health Partners with Medicare Advantage Plan Devoted Health and Full-Service Retail Pharmacy Liton Rx

Apricus Health | November 04, 2020

Apricus Health, an innovative healthcare company delivering high impact, relationship-based care, today announced two new partnerships that provide its members with extraordinary services. Medicare Advantage plan provider Devoted Health and full-service retail pharmacy Liton Rx are now partnering with the Apricus Health Network which is designed by Arizona physicians. "We are committed to helping our members with a range of quality services to improve health outcomes and significantly lower costs for patients and payers," said Dr. Kishlay Anand, CEO and co-founder of Apricus Health. "Our new partnerships with Devoted Health and Liton Rx, further that mission, with both organizations sharing our core value of emphasizing extraordinary customer service."

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Spotlight

One of the more vexing and troubling public health policy issue that has plagued the US pharma industry, yet receiving less deserving public news coverage than other industry stories, has been the existence of chronic drug shortages since the turn of the 21st century. A drug shortage is defined in which the “total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.” While the annual number has dropped since the peak year of 2011, the issue of chronic drug shortages still persists, despite attempts by the FDA and federal legislation to remedy the problem. Drug shortages continue to be severe enough to potentially cause adverse effects on patients, changes in treatment that result in suboptimal care, and higher costs to the healthcare system.