FDA and DEA send joint warning letters to illegal opioid sites

European Pharmaceutical Review | October 03, 2019

The FDA and DEA have, for the first time, sent joint warning letters to four networks which were illegally selling opioid products. The US Food and Drug Administration (FDA) has issued warning letters to four online networks which were illegally marketing unapproved and misbranded versions of opioid medicines. The cautions were sent as joint with the Drug Enforcement Administration (DEA). A total of 10 websites were found to be within the networks, which also violated the Controlled Substances Act (CSA) by failing to register their online pharmacies. The sites have been told they must cease selling the opioids, including unapproved tramadol, immediately.

Spotlight

With breakthroughs in molecular engineering and antibody humanization, monoclonal antibodies (Mab) are one of the fastest-growing classes of biopharmaceuticals for multiple clinical indications including cancer, cardiovascular disease, autoimmune disorders, and infectious disease. Most therapeutic antibody candidates are initially generated using hybridoma technology or primary B cell screening after antigen immunization. In the antibody discovery workflow, primary screens identify clones with specific attributes (i.e. binding specificity, cross-species reactivity, selectivity, and affinity).

Spotlight

With breakthroughs in molecular engineering and antibody humanization, monoclonal antibodies (Mab) are one of the fastest-growing classes of biopharmaceuticals for multiple clinical indications including cancer, cardiovascular disease, autoimmune disorders, and infectious disease. Most therapeutic antibody candidates are initially generated using hybridoma technology or primary B cell screening after antigen immunization. In the antibody discovery workflow, primary screens identify clones with specific attributes (i.e. binding specificity, cross-species reactivity, selectivity, and affinity).

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PHARMA TECH

Pfizer, BioNTech COVID-19 vaccine works in more contagious coronavirus variants

Pfizer | January 11, 2021

Newly emerged variants of the novel coronavirus have sparked a key question: Will existing COVID-19 vaccines be less effective against them? But scientists have preliminary data showing that may not be the case, at least for Pfizer and BioNTech’s shot. Researchers from the University of Texas and Pfizer found that, in lab dishes, the vaccine was able to neutralize an engineered version of a variant, which bears an N501Y mutation in its spike protein. The finding was published in bioRxiv and hasn’t been peer-reviewed. Variants of coronavirus with this mutation were first discovered in the U.K. and South Africa and immediately grabbed global attention because they are more contagious. Currently available COVID vaccines—including Pfizer and BioNTech’s Comirnaty, or BNT162b2—target the spike protein of SARS-CoV-2, the coronavirus behind COVID-19. The N501Y mutation improves the ability of the virus’ spike protein to bind to its receptor on human cells, making it easier to gain entry for infection. To test whether Comirnaty worked against the mutation, the scientists collected antibodies from 20 vaccinated trial participants and compared their ability to kill off the engineered virus with the N501Y mutation to their ability to neutralize the strain on which Pfizer and BioNTech based Comirnaty.

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PHARMACY MARKET

Evergreen Theragnostics Increases Alpha Radiopharmaceutical Production Capabilities

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.

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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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