Shares in ImmuPharma have leapt almost 25% on the news that the UK firm's lupus treatment Lupuzor, recently returned Cephalon, has been granted approval to start Phase III studies and received fast-track designation from regulators in the USA.
ImmuPharma has just regained rights to Lupuzor (forigerimod) following the acquisition of Cephalon by Teva Pharmaceutical Industries. The Israeli firm has already got a drug, laquinimod, in two Phase II lupus studies, and a change of control clause meant that ImmuPharma could reclaim Lupuzor.
ImmuPharma linked up with Cephalon in 2008 while in the middle of a Phase IIb study, which the former designed, managed and funded. The US firm then paid $15 million before the results of the trial to bag the exclusive option to enter into a worldwide license and then exercised that option following positive data, paying a further $30 million for an exclusive worldwide license. The whole deal was valued at the time of signed at $500 million.
Now it appears ImmuPharma has quite an asset on its hands. The company revealed that the US Food and Drug Administration has granted approval to start Phase III studies with a special protocol assessment and given Lupuzor fast-track status. Furthermore, the commercial validation batches of forigerimod necessary for the trials have already been manufactured.
The London-headquartered company, which has research operations in France and Switzerland, said talks have been held with the European Medicines Agency and "the recommendations were very similar to those in the FDA’s 'end of Phase II responses". Japanese authorities have also agreed to the initiation of clinical trials there.
In discussions with big pharma
All this means that Lupuzor represents an attractive partnering opportunity and ImmuPharma says it is "now in discussions with pharmaceutical companies for a corporate deal". Chief executive Dimitri Dimitriou said “we are excited about the prospects of Lupuzor, its progress in development and the approvals of the authorities in the USA, Europe and Japan regarding its progression to the final stage of testing".
He added that "the interest we are seeing already from pharma companies as potential partners gives us great confidence". GlaxoSmithKline and Human Genome Sciences recently-launched Benlysta (belimumab), the first new drug for lupus in 50 years, is expected to be a blockbuster with sales in the region of $2-$3 billion and analysts believe the market is certainly big enough for more drugs.
ImmuPharma shares ended the day up 24.7% at 93.5 pence.