Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, January 8-12, 2018, we had thoughts on the following: Check-Cap falls on CE mark;Genuine improvement for TG Therapeutics; Astra regains temporary Parp lead.
These snippets were previously published daily via twitter.
Astra regains temporary Parp lead
January 12, 2018
The Parp inhibition space is a fierce battle, but AstraZeneca regained the high ground when Lynparza won the first US FDA approval in breast cancer today. The new indication – metastatic breast cancer with germline BRCA mutations – will add $15m in sales this year and $204m in 2022 according to EvaluatePharma’s consensus of sellside analysts, although the more important setting for Parp inhibition remains ovarian cancer, where it was approved first and where sales will hit $1.2bn in 2022. The most immediate breast cancer competitor is likely to be Pfizer’s talazoparib, which has yielded similar-looking data in its phase III Embraca trial, although it would appear to be many months away from a commercial launch. Lynparza’s closest Parp rival, Tesaro’s Zejula, has abandoned its efforts in the BRCA population, shifting instead to a combination strategy in triple negative breast cancer with Merck & Co’s Keytruda. Nonetheless, it is reckoned to be the biggest seller in breast cancer in 2022.
Genuine improvement for TG Therapeutics
January 12, 2018
TG Therapeutics’ ublituximab might not be as far away from approval as previously feared. That’s what the group’s shareholders believe anyway, pushing the stock up 16% after TG’s management released updated clinical data on the anti-CD20 antibody at the JP Morgan conference yesterday. Last autumn the stock fell on the suggestion that objective response rates in the phase III Genuine trial might not be good enough to allow the drug to secure accelerated US approval for chronic lymphocytic leukaemia. The data has now improved, TG says, with ublituximab (TG-1101) showing an ORR of 81% when added on top of Imbruvica and 10% of the patients showing a complete response. Theoretically TG could file ublituximab for high-risk CLL in in the third quarter of this year. And data from the phase III Unity-CLL study of TG-1303, a combination of ublituximab plus another TG agent, umbralisib is due in spring, so the bull case sees TG gaining two approvals by mid-2019. But there is still some question over whether the FDA would issue an approval based on a surrogate endpoint like ORR, rather than insisting on progression-free survival or overall survival data: investors will have to hope the agency feels generous when the time comes.
Check-Cap falls on CE mark
January 11, 2018
Check-Cap has won the CE mark for its ingestible X-ray pill, intended as a method of screening for colon cancer, but investors do not seem convinced that it will trace the path walked by the similar group Given Imaging five years ago. US approval of Given’s camera capsule, PillCam, was followed swiftly by a takeover from Covidien, but Check-Cap’s shares actually sank on the Nasdaq yesterday: clearly investors do not believe a takeout is in the offing. Admittedly Check-Cap only won a CE mark rather than the more meaningful US approval, but the real reason for the muted reaction is likely to be the extraordinary success of Exact Sciences’ colon cancer screen Cologuard – a faecal test rather than an imaging pill. Moreover, PillCam does not seem to have been a major commercial hit. It now belongs to Medtronic by virtue of that company’s purchase of Covidien in 2015, and Medtronic does not consider it a major priority – analysts no longer include it in their forecasts – providing a cautionary tale for Check-Cap investors. The 5% fall yesterday means Check-Cap’s shares have lost 86% of their value since its IPO in 2015.