Sanofi SA stepped up its acquisition activities in late December 2021 with plans to buy a US company with an advanced biologics platform. Sanofi is to pay $1 billion upfront for San-Francisco-based Amunix Pharmaceuticals Inc whose lead product, AMX-818, is poised to enter clinical development in early 2022 for patients with HER2 breast cancer. Amunix is developing biologics that crosslink tumours and T cells in order to induce the destruction of cancer cells.
A monoclonal antibody developed by Novartis to treat chronic spontaneous urticaria, also known as chronic hives, did not show superiority to the marketed drug omalizumab in two Phase 3 trials. Announcing the trial results on 20 December, Novartis said that ligelizumab demonstrated superiority against placebo but not against omalizumab, known commercially as Xolair. Xolair, developed by Roche, has been approved for six indications in the US, including chronic idiopathic urticaria.
People at risk of infection from the HIV-1 virus have a new option for preventing the disease following US Food and Drug Administration approval of Apretude (cabotegravir extended release injectable suspension), developed by ViiV Healthcare. Apretude is a long-acting anti-viral medication which inhibits HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells.
Belgium-based argenx SE has won US Food and Drug Administration approval for its first product, Vyvgart (efgartigimod), for the treatment of generalised myasthenia gravis, a neuromuscular disease that causes weakness in the skeletal muscles. Vyvgart is an antibody fragment that binds to the neonatal Fc receptor, preventing the receptor from recycling immunoglobulin G (IgG) back into blood. This leads to a reduction in IgG levels, including reductions in abnormal anti-acetylcholine receptor (AChR) antibodies which are present in myasthenia gravis.
A new treatment for sickle cell disease, Oxbryta (voxelotor), received a positive opinion from the European Medicines Agency on 17 December for patients 12 years of age and older. This is the same drug and patient group that received an accelerated approval from the US Food and Drug Administration in 2019. Concurrent with the EMA opinion, the FDA expanded the label of Oxbryta to include children from the age of four up to 11 years.
The European Medicines Agency has issued a negative opinion for the Alzheimer’s disease treatment Aduhelm (aducanumab) saying that studies supporting the drug’s application were conflicting and did not show overall effectiveness in treating adults with early stage disease. Under the EU’s regulatory procedures, the sponsor, Biogen, Inc, has 15 days to appeal against the opinion. Aduhelm is an immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against amyloid-beta levels in the brain.
Venture capitalists, led by Ysios Capital and Forbion Growth, have assembled $80 million for NorthSea Therapeutics BV, enabling the Netherlands-based company to progress its lead product for non-alcoholic steatohepatitus (NASH) into Phase 3. The Series C financing was also supported by Novo Seeds and Sofinnova, among others.
Genenta Science SpA, an Italian gene therapy company, began trading on the US Nasdaq market on 15 December following an initial public offering that yielded gross proceeds to the company of about $36 million. On the second day of trading, the company had a market capitalisation of $196 million. Genenta is one of many European company to list on Nasdaq in order to broaden its investor base and establish a commercial presencez in the US.
Vaccitech Plc, co-inventor of the Oxford-AstraZeneca Covid-19 vaccine, is to acquire a US company with a complementary technology platform, positioning it for a further geographical expansion. The target company, Avidea Technologies Inc, has a similar research history to Vaccitech, but a different discovery platform. Vaccitech is paying $40 million upfront for Avidea of which $12.5 million is cash and $27.5 million is in shares. There is also a possibility of milestone payments. Vaccitech is listed on the US Nasdaq market.
The US Food and Drug Administration has approved the first drug for the prevention of acute graft versus host disease (GvHD), a condition that occurs when donor bone marrow or stem cells attack healthy tissues in a patient undergoing a treatment for certain cancers, or an organ transplant. The drug, Orencia (abatacept), is already on the market having been approved for rheumatoid arthritis in 2005. The manufacturer is Bristol Myers Squibb Co.