Novo Nordisk is known for its diabetes drugs, but the company has been expanding its scope to neighboring areas, including cardiovascular diseases.This strategy continues to work, the latest example is a $100 million transaction obtain Prothena, a rare disease drug, is in the early stage of clinical development.
The Denmark-based pharmaceutical giant announced on Monday that it has reached an agreement to acquire a drug called PRX004. Prothena is developing this drug for the treatment of ATTR amyloidosis, which is an abnormal accumulation of amyloid deposits in the body. Characteristic diseases. Novo Nordisk’s plan initially focused on developing drugs to accumulate these protein deposits in heart tissue, called ATTR cardiomyopathy.
The $100 million is a combination of the advance payment and the recent clinical milestone payment, and no details are specified. Novo Nordisk acquires all global rights of PRX004. Depending on the progress of the drug, Prothena may earn up to $1.2 billion in revenue from achieving development and sales milestones.
Amyloidosis can originate from several different types of proteins. Specifically, in the case of ATTR, it is caused by misfolded transthyretin. ATTR mainly affects the nervous system and the heart. As this accumulation worsens, the disease becomes fatal. ATTR is a genetic disease, but in some cases it is acquired and is called wild-type ATTR.
Prothena, headquartered in Dublin, Ireland, develops drugs to treat protein disorders. PRX004 is a monoclonal antibody designed to eliminate the amyloid deposit characteristics of genetic and wild-type ATTR amyloidosis. According to the company, the drug works without affecting the natural, normal form of transthyretin. The company said that in preclinical studies, the drug promotes the elimination of amyloid by mediating phagocytes and ingesting immune cells, granules and cells of harmful bacteria. According to the company, the antibody also inhibits the formation of amyloid.
Last December, Prothena Published data From a phase 1 clinical trial testing patients with inherited forms of ATTR. In this dose-escalation study, patients received intravenous infusions every 28 days, with a maximum of 3 infusions. The results show that Prothena antibody is safe and well tolerated. In addition, in 7 patients who could be evaluated at 9 months, the drug showed a slowdown in neuropathy progression and an improvement in the pumping ability of the heart. Based on these results, Prothena is preparing to advance PRX004 to Phase 2/3 of the study.
Novo Nordisk is trying to expand beyond diabetes, but in a way based on its franchise drugs. Type 2 diabetes, obesity, cardiovascular disease, chronic kidney disease and non-alcoholic steatohepatitis are closely related, the company said in its statement. 2020 Annual ReportAccording to the company, Semaglutide is the active ingredient in Novo Nordisk’s diabetes drugs Rybelsus and Ozempic, which can be used in cardiometabolic diseases.Last year, Novo Nordisk paid US$725 million in advance Acquired Corvidia Therapeutics, A clinical-stage biotechnology whose antibodies are under development to reduce the risk of adverse cardiovascular events in patients with chronic kidney disease who have already experienced arteriosclerosis and inflammation.
The acquisition of Prothena drugs gives Novo Nordisk the opportunity to compete in ATTR amyloidosis. In 2019, the FDA approved Pfizer’s tafamidis, a capsule used to treat cardiomyopathy associated with ATTR. Pfizer drugs are designed to bind to transthyretin to prevent it from slowing down the formation of amyloid.
Alnylam Pharmaceuticals sells a drug called Onpattro, which is approved to treat ATTR that affects nerves. The drug of the Cambridge, Massachusetts-based biotechnology company uses a mechanism called RNA interference to prevent genes from producing harmful proteins.This drug is infused every three weeks, but Alnylam is still seeking FDA approval for injectable RNAi therapy Give every three months. Simultaneously, Intellia Therapeutics has early clinical data to support its experimental gene therapy, Which can provide a one-time treatment for ATTR.
Novo Nordisk’s transaction brings cash to Prothena, which it can apply to its other pipelines, including its most advanced project Birtamimab, which is still wholly owned by the biotech company. The drug is in Phase 3 testing for AL amyloidosis (a different form of amyloidosis). Another drug, prasinezumab, is in a phase 2 trial for Parkinson’s disease.
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