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22 May
Genmab acquires biotechnology company ProfoundBio in $1.8bn deal
Credit: ArDanMe / Shutterstock
Genmab has concluded the previously announced acquisition of clinical-stage biotechnology company ProfoundBio in a $1.8bn cash transaction.
ProfoundBio specialises in the development of antibody-drug conjugates (ADCs) and technologies for cancer treatment. The latest development comes after the companies signed a definitive agreement for the acquisition in April 2024.
Genmab obtained global rights to ProfoundBio’s portfolio of next-generation ADCs, significantly bolstering its clinical pipeline. These programmes include Rina-S, an ADC being analysed in Part II of a Phase I/II clinical trial to treat ovarian cancer and other FRα-expressing solid tumours. Genmab is planning to expand the development of Rina-S within ovarian cancer and other FRα-expressing solid tumours based on these findings.
The transaction provides Genmab access to ProfoundBio’s ADC technology platforms.
These platforms are anticipated to complement Genmab’s existing suite of proprietary technology platforms, potentially leading to the creation of innovative medicines that could revolutionise cancer treatment and improve patient outcomes.
20 May
Pfizer wins cancer drug patent case against AstraZeneca
The US District Court for the District of Delaware has ordered AstraZeneca to pay $107.5m to Pfizer in damages for infringing patents related to the lung cancer drug Tagrisso. The jury found that AstraZeneca’s Tagrisso violated Pfizer’s Wyeth unit’s patent rights under US patents 10,603,314 and 10,596,162.
AstraZeneca’s spokesperson expressed the company’s disappointment with the verdict but is “confident in our IP (intellectual property) position in relation to Tagrisso” and intends to “vigorously defend” its rights.”
Tagrisso was a significant revenue generator for AstraZeneca in 2023, bringing in $5.8bn.Pfizer acquired Wyeth in 2009 and initiated the lawsuit against AstraZeneca in 2021. Pfizer claimed that Tagrisso’s use of kinase inhibitors for cancer treatment infringed on the patented methods used by Nerlynx. AstraZeneca refuted the allegations of infringement and challenged the validity of the patents.
The case is set to continue with US District Judge Matthew Kennelly presiding over a separate bench trial in June 2024 to address AstraZeneca’s remaining defences.
29 May
BMS stakes $80m on Prothena’s neurodegenerative candidate
Five months after being cleared for clinical trials, the global licence for Prothena’s neurodegenerative disease treatment candidate PRX019 has been picked up by Bristol Myers Squibb (BMS) for $80m.
The deal for the asset also includes an additional $617.5m in additional development, regulatory, and sales milestone-related payments, as well as royalties, as per a 28 May press release by Prothena.
The two companies have neither disclosed the modality of PRX019 nor the intended indication within the neurodegenerative disease space.
The US Food and Drug Administration (FDA) greenlit the drug for use in clinical trials in December 2023.
The licence deal for PRX019 is not the first time BMS and Prothena have worked together. BMS bought the US licence for Prothena’s PRX-005 for $80m in June 2021. This was followed by a worldwide licence for the same drug for $55m in October 2023.
17 May
Sanders issues warning to Novo Nordisk amid GLP-1 drug price investigation
US Senator Bernie Sanders has ramped up the pressure on Novo Nordisk after launching an investigation into GLP-1 agonist prices last month, warning in a report that the blockbuster drugs could “bankrupt our entire healthcare system”.
Last month, Sanders, who chairs the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced the launch of an investigation into the US prices of the drugs in a stark letter to Novo Nordisk CEO Lars Fruergaard Jørgensen.
The announcement has now been followed with a report that indicates that if half of US adults with obesity opt for Novo Nordisks’s Wegovy (semaglutide) or similar drugs, spending on them could reach $411bn, which would exceed the total retail prescription drug expenditure in 2022. According to the HELP Committee’s analysis, in this scenario, Medicare and Medicaid might spend $166bn a year on weight loss medications.
7 June
FDA admonishes Jiangsu Hengrui’s manufacturing site following inspection
The US Food and Drug Administration (FDA) has criticised the state of Chinese pharma company Jiangsu Hengrui’s facilities in a newly released 483 form.
In January, the agency inspected Jiangsu’s manufacturing site in the Chinese city of Lianvungang, Jiangsu province and observed a range of concerns.
The writeup by FDA investigator Arsen Karapetyan, and division director for the Center for Drug Evaluation and Research (CDER), Qiao Bobo, included concerns around cleanliness and quality controls.
It was observed that the facility’s procedures to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilisation process.