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4 October

Novartis split complete as Sandoz begins trading on Swiss Exchange

Credit: Shutterstock/Konektus Photo

Sandoz has completed its separation from Novartis and commenced trading under the symbol “SDZ” on the SIX Swiss Exchange.

Sandoz opened at a stock price of 24 Swiss francs on Wednesday morning. Reuters reported the company was valued at a lower-than-expected $11.2 bn (10.3bn Swiss francs).

In September, Novartis announced detailed plans on how it plans to spin-off its Sandoz subsidiary, stating its aim was to focus on being a purely innovative medicines company. 

Sandoz has recorded underwhelming financials in the past years, although the subsidiary did generate record sales of $2.4bn in biosimilars in Q2 2023. Announcing the commencment of trading, Novartis said that Sandoz “is well placed for continued profitable growth as a standalone global leader and European champion in generic and biosimilar medicines.” 

Sandoz states that cumulative worldwide savings due to biosimilars is estimated to reach $215bn between 2021 and 2026. An estimated 80% of medicines used worldwide by volume are generics and biosimilars.

9 October

UK pharma industry hits out at plans to rework statutory payment scheme

More than 20 companies working alongside the UK’s National Health Service (NHS) have condemned plans to rework the country’s statutory safety scheme for branded medicines, calling it “unworkable”.

A proposed review of the 2023 scheme to control the cost of branded health service medicines from the UK’s Department of Health and Social Care (DHSC), has drawn criticism from many pharmaceutical companies that are part of the industry body Association of the British Pharmaceutical Industry. 

Critics of the review have said that altering the laws on branded medicines could reduce patient access to medicines, harm clinical research, and undermine investment in life sciences.

Most of the criticism focuses on a proposed continuation of a cap on growth in the UK branded medicines market, a cap mechanism that members of ABPI condemn. At present, both the Statutory Scheme and the Voluntary Scheme (VPAS) require only some companies to pay back a percentage of their NHS-branded medicines sales each year to the DHSC. 

2 October

Biogen edges out competition to win first FDA approval for Actemra biosimilar

Biogen has entered the crowded arthritis market in the US following approval of its biosimilar Tofidence (tocilizumab-bavi) by the US Food and Drug Administration (FDA).

The agency approved the biosimilar for all the indications where the reference biologic – Roche’s Actemra – is approved. This includes moderate-to-severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Actemra is a humanised monoclonal antibody directed against the interleukin-6 receptor. It is a high-grossing immunology drug for Roche and generated SFr1.29bn ($1.4bn) in sales in H1 2023, as per the company’s financials. 

Biogen has a biosimilar catalogue that generated $1.95bn in sales in Q2 2023, as per the company’s financials. The portfolio includes another rheumatoid arthritis therapy, Benepali, a biosimilar for Amgen’s Enbrel (etanercept), which pulled in most of the Q2 revenue and $1.09bn in sales.

2 October

Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines

The Nobel Prize in Physiology and Medicine has been awarded to two scientists whose research allowed for the development of mRNA vaccines crucial to the fight against Covid-19. 

The Nobel Assembly at Karolinska Institute has awarded the accolade to Katalin Karikó and Drew Weissman for their work on nucleoside base modifications, which established the understanding of how the immune system identifies mRNA constructs as foreign entities.

This insight was crucial to develop mRNA vaccines that would go on to form the basis of Pfizer and Moderna’s Covid-19 mRNA vaccines.

A spokesperson for the Nobel Committee said that the pair’s work has “fundamentally changed our understanding” of how mRNA interacts with the immune system. The researchers met in the 1990s at the University of Pennsylvania where Karikó worked as an assistant professor alongside researcher and immunologist Weissman. 

The method developed by the pair meant that mRNA could be detected by the body’s immune system, allowing it to deliver its intended alterations.

9 October

Alnylam abandons plans for RNAi drug Onpattro after FDA hits the brakes

Alnylam Pharmaceuticals has had to abandon its plans to pursue a label expansion of Onpattro (patisiran) after the US Food and Drug Administration (FDA) issued a complete response letter (CRL).

The CRL was issued regarding the New Drug Application (sNDA) for Onpattro for the treatment of the cardiomyopathy of transthyretin mediated (ATTR) amyloidosis. The letter cited that there was insufficient evidence to demonstrate Onpattro’s clinical efficacy in treating cardiomyopathy caused by the wild-type or hereditary ATTR amyloidosis.

Alnylam was quick to add that the CRL did not identify any issues with the clinical trial or drug quality and manufacturing. 

The CRL is a complete turnaround from the positive recommendation Onpattro received from an FDA Advisory Committee (AdCom) panel in September regarding the label expansion.  

Onpattro is an RNA interference (RNAi) therapy that was first approved by the FDA for the treatment of hereditary ATTR amyloidosis polyneuropathy in 2018.