In Teva, Regeneron finds its Sanofi for pain
Teva should be given credit for daring to commit to the underserved pain management space while many other big pharmas stay away. The deal with Regeneron gives the Israel-based group shared rights to an anti-nerve-growth factor (NGF) project, fasinumab, outside Asia in return for $250m up front and supporting the massive pivotal programme of up to $1bn.
The deal could help fasinumab get on better footing with Pfizer’s tanezumab, an NGF rival likely to deliver phase III data earlier than Regeneron’s candidate. Teva’s financial commitment to fasinumab far outstrips its estimated value, so it is making a bet that a combination of strong data and the pressure to reduce opioid misuse will help this class take off.
Indeed, Bernstein analyst Ronny Gal described it as a “better deal for Regeneron” because it reduces the New York-based company’s R&D outlays at a time when it needs to use cash to support launch of Praluent, an underperforming cholesterol drug. In return, Teva gets an asset that will replace TV-45070 in its pain pipeline, Mr Gal writes – that topical asset failed to reduce pain in patients with osteoarthritis of the knee.
Building NGF momentum
Fasinumab is joined by tanezumab and Amgen’s fulranumab in late-stage research, marking a remarkable turnaround for a class that had been beleaguered by US FDA concerns over occurrence of rapidly advancing osteoarthritis. Tanezumab got the go-ahead for its phase III programme last year, and fasinumab kicked off its 10,000-patient trial earlier this year (Regeneron nips at Amgen and Pfizer’s heels in pain drug race, May 3, 2016).
The safety signal was sufficient to prompt Regeneron’s long-term collaborator Sanofi – partner on Praluent and Zaltrap – to walk away from fasinumab, thus opening the door to Teva. Likewise, Amgen lost Johnson & Johnson as a partner for fulranumab.
Factors linked to safety signals have included pre-existing rapidly advancing arthritis, knee fractures or atrophic disease in the hip. Also cited has been the use of non-steroidal anti-inflammatory drugs along with NGF agents – an advisory committee convened to review the safety issues could not agree that data on this last point were persuasive, although the point has been raised by FDA staff (Therapeutic focus - Return of anti-NGF class gets FDA panel's backing, March 13, 2012).
To prevent this, Regeneron’s trial will seek to screen out patients with destructive joint disease.
The 10,000-patient study is restricted to arthritis only, whereas Pfizer's 7,000-patient programme is also seeking to show that tanezumab will work in additional settings like low-back pain and cancer-related pain, although patient numbers will likely reduce the robustness of data in these additional settings.
Low expectations
EvaluatePharma’s consensus of sellside analysts forecasts $105m in sales for fasinumab in 2022, giving it a net present value of $343m.
Thus Teva’s $250m up front suggests a bigger payoff than that – Mr Gal said the terms of the deal suggest that the partners see $500m in peak sales. This is not a huge sum compared with other Teva pain projects like the migraine shot TEV-48125, but on the other hand, assuming that Mr Gal’s estimates are correct, at $250m fasinumab might be Teva’s third-biggest clinical-stage asset.
The ability of NGF candidates to reduce pain at least as well as, if not better than, opioids is the main factor they have on their sides. It might be hard to see a situation where they are used first-line, but with risk mitigation in place they might be used for patients unable to reduce pain with NSAIDs.
The FDA is fully aware of the harms of opioid abuse, and could be favourably inclined to give NGFs the best chance possible at commercial success. If this turns out to be the case, Teva will have made a very canny bet.
To contact the writer of this story email Jonathan Gardner in London at [email protected] or follow @ByJonGardner on Twitter
