A Profile on Lesser-Known Player in the Biosimilar Space: NeuClone

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight an interesting company based in Sydney, Australia.

NeuClone has been operating since 2007, with its founding CEO, Noelle Sundstrom, at the helm. The company has historically focused on clinical trial development of biologics and biosimilars. It has not yet brought a product to market, but that may change soon. On its website, NeuClone describes itself as a “clinical-stage biopharmaceutical company with an exclusive focus on the development and commercialisation of high-quality biosimilar products.”

Why you may be hearing more about this company: NeuClone’s pipeline is considerable but mostly early stage; two products (trastuzumab and ustekinumab) completing phase 1 trials in healthy volunteers in December 2019 and April 2020, respectively. Both trials used US- and EU-licensed versions of the reference products, which implies the possibility for marketing them in the US and elsewhere. The company emphasizes its conduct of clinical trials using Australian participants only, which it believes gives it some inherent advantages over other biosimilar developers.

Other biosimilars in the early-stage pipeline for NeuClone include adalimumab, denosumab, palivizumab, and pertuzumab, but also two other interesting products—nivolumab (reference product, Opdivo®) and pembrolizumab (Keytruda®) are listed as in the preclinical stage of development. These two agents account for about $20 billion in sales globally each year. Bristol Myers Squibb has registered 184 patents on Opdivo, and stated in a document from 2016 that patent expiration is likely in 2027 for the US and in 2026 for the EU. Merck, the manufacturer of Keytruda, has filed a mere 154 patents, but the main patent expiration is 2028 for both the US and EU. NeuClone has signed an agreement with the Serum Institute of India as strategic manufacturing partner for each of the above-mentioned biosimilars. NeuClone will retain marketing rights in the US and other major markets, according to a press release. In addition, NeuClone says that it has another 12 (unnamed) biosimilar candidates in early stage development. This indeed represents one of the deepest portfolios in the biosimilar industry.

If the patent thickets can be managed, nivolumab and pembrolizumab could be highly enticing oncology targets for several biosimilar manufacturers.

It will be very interesting to watch the progress and evolution of this Australian upstart.

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