AbbVie hands back rights to Biotest's RA drug after trial flop

AbbVie ($ABBV) has walked away from its claim to Biotest's (FRA:BIO) anti-CD4 monoclonal antibody, tregalizumab. The decision comes two months after Biotest posted Phase IIb data showing tregalizumab failed to outperform the placebo in terms of improvements to ACR20 scores.

Biotest CEO Bernhard Ehmer

At the time, Biotest said AbbVie had 90 days to go over the data and decide whether to continue with co-development. Almost exactly two months later, AbbVie has made its decision and left Biotest to ponder whether there is any value in continuing with development of the drug without its deep-pocketed partner. The case against developing tregalizumab as a treatment for patients with moderate to severe rheumatoid arthritis appears compelling, but Biotest will weigh up data from earlier trials and potential in other indications before making a decision.

Dreieich, Germany-based Biotest put plans to develop tregalizumab--also known as BT-061--in plaque psoriasis on hold while it worked on the Phase IIb rheumatoid arthritis study. But with results from the rheumatoid arthritis trial disappointing and Phase IIa results in plaque psoriasis already in the databank, Biotest may decide to return to its secondary indication. Whatever the decision, Biotest plans to make it reasonably swiftly, with CEO Bernhard Ehmer telling investors to expect news within the next two months.

Biotest has said the discontinuation of development would knock up to €30 million ($34 million) off this year's earnings, a consideration that contributed to its stock sliding 27% in the days following the release of the Phase IIb data. Beyond the faltering tregalizumab, Biotest's pipeline is stocked with a drug that showed the potential to help heavily pretreated multiple myeloma patients in a Phase I/IIa trial and a pair of Phase III assets to prevent hepatitis C reinfection after liver transplants and the transmission of cytomegalovirus to foetuses during pregnancy.   

- read the release

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