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Two killed in blast near Bayer’s plant in Germany; FDA rejects industry plea to extend nitrosamine deadline
This week, Phispers brings you news of an explosion at a waste incineration site in Leverkusen in Germany, which is close to an industrial park that houses several chemical companies, including Bayer.
Amgen is all set to acquire Teneobio, a privately held, clinical stage biotechnology firm developing a new class of biologics called human heavy-chain antibodies for US$ 2.5 billion.
We also bring you news about companies extending their collaborations — while Japanese drugmakers Takeda Pharmaceutical and PeptiDream expanded their research collaboration and licensing agreement, AbbVie and Calico extended their deal to focus on age-related diseases.
The US Food and Drug Administration (FDA) has rejected pleas from the pharmaceutical industry to extend the deadline for conducting nitrosamine risk assessments to September 1. The agency has also requested Pfizer and Moderna to test their Covid-19 vaccines in more school-going children (between the ages of five and 11) before seeking emergency authorization, in order to assess the risk of myocarditis.
And with increasing demands for Covid-19 vaccines, CDMOs Recipharm and Catalent have announced an expansion to their existing fill and finish facilities. While Recipharm is setting up a greenfield site in Dehradun, India, Catalent is investing US$ 100 million in expanding its manufacturing facilities in Anagni, Italy.
Two killed, 31 injured due to explosion at waste incineration site near Bayer plant in Germany
On Tuesday, an explosion took place at Chempark’s waste incineration site in Leverkusen’s Buerrig district in Germany that killed two and injured 31 people. The area is close to the main industrial park that houses numerous chemical companies including Bayer, Lanxess and Evonik Industries.
Witnesses said there was a huge column of smoke over the district. Several people are still missing and the search to find them continues. “Unfortunately, the hope of finding them alive is fading,” said Chempark’s manager Lars Friedrich. The cause of the explosion, which was heard several kilometers away, is not known. Leverkusen is less than 50 km from a region that was hit by catastrophic floods last week. More than 30 companies operate at the Chempark site.
The blast occurred at 9.40 am CEST and emergency services took over three hours to extinguish the fire. The area and surrounding roads were sealed off for much of the day. Police told residents living nearby to stay indoors and shut doors and windows in case there were toxic fumes. The local residents were asked to turn off their air conditioning systems while authorities measured the air around the site for possible toxic gases.
Takeda-PeptiDream, AbbVie-Calico extend their collaborations
Japanese drugmakers Takeda Pharmaceutical and PeptiDream are expanding their research collaboration and licensing agreement first struck in December 2020 to develop peptide-drug conjugates (PDCs) for several central nervous system (CNS) targets, which play important roles in chronic neurodegenerative diseases such as Alzheimer’s disease.
The PDCs for neuromuscular diseases were first developed by PeptiDream. Takeda will pay a maximum of US$ 3.5 billion in milestone fees as well as royalties to PeptiDream.
Takeda is leveraging PeptiDream’s PDCs TfR1 receptor for neuromuscular indications. Since December, the tie-up has made “great progress”, Takeda’s neuroscience head Sarah Sheikh said in a statement.
Takeda and PeptiDream aren’t the only ones expanding their collaboration. Seven years ago, AbbVie had signed an early-stage deal with Google/Alphabet’s life sciences division Calico. The two companies are now expanding their collaboration.
The AbbVie-Calico deal focused on age-related diseases, including neurodegeneration and cancer. Back in 2018, the duo extended their collaboration, making an additional investment of US$ 1 billion. Now, the two companies are putting another US$ 1 billion in the deal (split 50:50), extending it to 2025. Under the terms, Calico is responsible for research and early development. For its part, AbbVie said it will “continue to support Calico in its early R&D efforts” and when those mid-stage tests are done, it has an option to manage late-stage development and sales.
Calico is a life sciences company founded by Alphabet together with Calico’s CEO Arthur D. Levinson, who previously led Genentech as chairman and CEO. Calico has a world-class R&D facility in the San Francisco Bay Area.
FDA rejects drug industry’s request to extend nitrosamine risk assessment deadline
The US Food and Drug Administration (FDA) has rejected pleas from the pharmaceutical industry to extend the deadline for conducting nitrosamine risk assessments to September 1. The agency stood firm on the March 31 deadline.
Industry representatives also told the FDA to align its guidance with the International Council on Harmonization’s M7 guidance on impurity testing, saying that divergent expectations have “created many challenges for the drug industry and increased the potential for disruptions to global supply chains that could ultimately lead to drug shortages.”
The FDA had issued guidance on nitrosamine testing for drugs in September 2020. It called on manufacturers to assess the nitrosamine impurity risks associated with all chemically synthesized active pharmaceutical ingredients (APIs) and all approved or marketed drug products that contain those APIs or other sources of nitrosamines by March 1, 2021. The deadline was extended to March 31 due to industry complaints over not being able to meet it.
In a virtual FDA-industry meeting held on May 4, the industry had laid out its complaints on implementing the agency’s nitrosamine guidance. The meeting was held at the request of the Association for Accessible Medicines (AAM), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Consumer Healthcare Products Association (CHPA). The minutes of that meeting were published recently.
The focus on nitrosamine impurities started when N-nitrosodimethylamine (NDMA), a potential carcinogen, was first found in valsartan, an angiotensin II receptor blocker, in mid-2018.
The industry groups complained that the FDA did not allow enough time for conducting these assessments, which they called “time-consuming” and “resource-intensive” and requested the deadline to be extended to September 1, 2021.
FDA tells Pfizer, Moderna to expand studies on 5 to 11 year olds to rule out safety issues
The US Food and Drug Administration (FDA) has requested Pfizer and Moderna to test their vaccines in more school-going children (between the ages of five and 11) before seeking emergency use authorization (EUA). The move is intended to assess whether a rare inflammation of the heart muscle (myocarditis) that has been seen in young adults shortly after vaccination is more common in younger age groups or not.
According to the FDA, adolescents who receive the vaccines are more likely to develop myocarditis than adults, even though the risk is small. And for children, they want the trials to indicate whether there is increased incidence of myocarditis.
The changes to ongoing pediatric trials (run by Moderna and Pfizer) could delay the availability of the vaccines to children between 5 and 11 years of age. As the school year approaches and the cases amongst the unvaccinated increase, pediatricians and families are impatiently waiting for Covid-19 shots.
A federal official predicted that EUA of a coronavirus vaccine for five to 11 year olds might come by late October or early November. Ray Jordan, a spokesman for Moderna, said the company was “actively discussing a proposal” with federal regulators to expand its trial, but had not settled on final numbers yet. He predicted that authorization could occur in “winter 2021-early 2022.”
EMA approves Moderna’s jab for teens: The European Medicines Agency (EMA) has recommended approving Moderna’s Covid-19 vaccine for 12- to 17-year-olds, ahead of a similar approval by the FDA. The use of the Moderna vaccine will be the same in adolescents as in people over 18, the EMA said, adding that the shot produced a comparable antibody response to that seen in 18- to 25-year-olds. The two-dose vaccine is given four weeks apart, and its human medicines committee’s recommendation was based on a study of 3,732 participants, the EMA said.
BioNTech’s malaria vaccine: After developing a two-shot Covid-19 vaccine along with Pfizer, German drugmaker BioNTech has said it plans to develop a highly effective mRNA-based vaccine to prevent malaria. BioNTech said it is aiming to begin clinical trials by the end of 2022. The World Health Organization, European Commission and other organizations have been involved in the early planning phase of this new vaccine and have offered their support to identify and set up necessary infrastructure, the company said.
Amgen in US$ 2.5 billion deal to buy out antibody drug developer Teneobio
Amgen is all set to acquire Teneobio, a privately held, clinical stage biotechnology company developing a new class of biologics called human heavy-chain antibodies. Under the terms of the agreement, Amgen will acquire all outstanding shares of Teneobio in exchange for a US$ 900 million upfront cash payment, as well as future contingent milestone payments to Teneobio equity holders, potentially worth an additional US$ 1.6 billion in cash.
Teneobio is an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”
The acquisition gives Amgen a Phase I program for a drug dubbed TNB-585, a PSMA/CD3 bispecific T cell engager in development for castration-resistant prostate cancer. Amgen plans to line that up alongside acapatamab (formerly AMG 160) and AMG 509 as a complementary therapy.
Five months back, Amgen had acquired Five Prime for US$ 1.9 billion, following up with the smaller Rodeo acquisition.
Recipharm, Catalent expand fill and finish operations in India, Italy respectively
With increasing demands for Covid-19 vaccines, contract development and manufacturing organizations (CDMOs) — Recipharm and Catalent — have announced an expansion to their existing fill and finish facilities. While Recipharm is setting up a greenfield site near Dehradun (Uttarakhand) in India, Catalent is investing US$ 100 million in expanding its manufacturing facilities in Anagni, Italy. Catalent is currently filling millions of vials of Covid-19 vaccines for AstraZeneca and Johnson & Johnson at the Anagni site.
Less than a month back, Recipharm had unveiled the construction of a new fill-finish facility in Morocco. And now, the Swedish company has announced that it is constructing another fill-finish plant in India. The Dehradun site will have the capacity to produce 1 billion units annually, delivering vials filled with liquid and powder, lyophilized vials, dental cartridges and pre-filled syringes.
The new site is designed to supply to the EU and US and will focus on securing approvals from regulators in Europe and the US. The factory is part of a partnership that Recipharm has with Nichepharm Lifesciences of India. Recipharm has an 8 percent stake in that company. The Dehradun plant will complement Recipharm’s existing sites in France, Germany and Italy.
Catalent, on the other hand, hopes that the expansion will allow it to make drug substances for complicated biologic drugs by April 2023, including Covid-19 vaccines or therapies like monoclonal antibodies. “In Europe there is a shortage of capacity of bioreactors for biologic (drugs),” Mario Gargiulo, Catalent’s region president of biologics in Europe said.
“We thought that this was the right place to create this capability, a capability that can be used for a public health emergency like Covid-19,” he added. The company plans to install two 2,000-liter single-use bioreactors at the Anagni plant, as well as the infrastructure required for another six 2,000-liter single-use bioreactors.
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