Ithaka Life Sciences - Blog

Ithaka Life Sciences Ltd (Ithaka) is a provider of business advisory and interim management services to the life sciences sector.

Thursday, 10 March 2016

Recent events in therapeutic antibody approvals


Recombinant therapeutic antibodies are now a major element of biopharmaceutical sales. Last Spring a survey report by La Merie Publishing noted that antibody sales in 2014 were over $68Bn, up from $63Bn in 2013, and representing nearly half of the $141Bn of recombinant antibody and protein sales.

The second half of 2015 saw a surge in approvals of therapeutic antibodies with 8 antibodies of various kinds approved covering a range of applications and indications. These and other impending approvals have been reviewed in a recent article by Jan Reichert, (Reichert JM (2016) Antibodies to watch in 2016, mAbs, 8:2, 197-204), one of a series produced over the last few years which concisely summarise and update on the ever-increasing number of antibody products in market and late stage development. The article notes a further 7 therapeutic antibodies were in regulatory review in the US or Europe at the end of 2015 and suggests that of 53 antibodies in Phase III or II/III clinical trials, 8 of these may move to regulatory review during 2016. Additionally 15 other products have projected Phase III completion during 2016.

The Reichert article notes the indications and the basis for approval of these new antibody products and also comments on those in regulatory review and Phase III studies. One aspect of note is the mix of technologies used to derive the products. Of the recently approved antibodies one, Unituxin (dinutuximab, Unither), is a chimeric antibody, the first format developed for recombinant antibodies. In addition there were three humanised antibodies; one of these, Praxbind being a Fab fragment. Finally four “fully human” antibodies were approved. Protrazza (necitumumab, Eli Lilly) was generated using phage display technology whereas the others were generated using transgenic mouse platforms: Darzalex (daratumumab, Genmab/Janssen) from the Medarex/Bristol Myers-Squibb transgenic mouse technology, Repatha (evolocumab, Amgen) from Abgenix/Amgen transgenic mice and Praluent (alirocumab, Sanofi) the first approved antibody generated from the Regeneron transgenic mouse technology.

Of the recombinant technologies used to generate antibodies, humanisation methods still predominate with 24 product approvals, (not all of which are still on the market) and many in clinical trials (from our own internal surveys well over 200 are in clinical studies), whereas the later technologies have generated 5 approved antibodies from phage technology and 12 from the transgenic platforms. There are additionally 5 murine and 9 chimeric antibodies still approved for therapeutic use. We note well over 100 antibodies derived from transgenic mouse technologies in the clinic with, as noted in the Reichert review, 12 now in regulatory review, Phase III or Phase II/III clinical studies. Antibodies from phage technologies are less prevalent but we still have noted over 50 in the clinic including the 5 noted in the Reichert paper in Phase III or II/III studies. Notwithstanding the current debate about the nomenclature for innovator antibodies (see Jones TD et al. (2016) The INNs and outs of antibody nonproprietary names. mAbs, 8:1, 1-9) it seems that this area will to continue to produce a steady pipeline of products over the next few years to add to the list of innovator therapeutic antibodies (and not counting biosimilar products) that have been approved around the world.

In the next few weeks we anticipate the next update of worldwide sales figures for approved antibody products from La Merie which should further emphasise the commercial importance of this product category.

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