ImmuPharma chief Dimitriou is very optimistic about Lupuzor future

ImmuPharma (LON:IMM) chief executive Dimitri Dimitriou said he is very “optimistic about the future” as the company looks to seal a new licensing deal for Lupuzor, its flagship product. 

He revealed the group had “rekindled discussions” with big pharmaceuticals companies, and he is hopeful a deal can be struck.

A change of control clause meant that ImmuPharma was allowed to take back Lupuzor from partner Cephalon, which has been acquired by generic drug specialist Teva in a US$6.5 billion deal.

“A lot of money has been spent on Lupuzor, both on our side and after the deal with Cephalon,” Dimitriou said in a conference call with analysts.

“We have no payment obligations. So it is fantastic to get the product back.”

Today ImmuPharma shares shot up almost 30 per cent in early trade after the group revealed Lupuzor will move into phase III clinical trials with a fast-track designation.

This means the drug, which treats an auto-immune disease called Lupus, is being developed for an unmet medical need. 

“We have always said we hope that we would get fast-track designation,” Dimitriou told analysts.

“But it is very nice to see the letter from the FDA saying we agree to fast-track approval.”

The company also revealed today that America’s powerful Food & Drug Administration had given approval to start the next phase of development with a Special Protocol Assessment.

This SPA is an important sign-off on the company’s clinical trial protocols. 

The agency is essentially saying that, assuming no unforeseen issues, it will approve the drug if it matches or exceeds certain criteria. 

Since this all happens before the data is generated, FDA tends to be conservative when handing out SPAs.

The FDA fast-track follows the submission of phase IIb data collated in 2009. Today’s announcement also revealed that an Investigational Medicinal Product Dossier was submitted in the EU, which was approved.

ImmuPharma also said a Scientific Advice meeting with the European Medicines Agency was held and that the recommendations were very similar to those in the FDA's End of Phase II responses.  

These recommendations were incorporated into the phase III clinical programme, the company added. And finally, the authorities in Japan have agreed to the initiation of clinical trials. 

Benlysta, a rival product launched by GlaxoSmithKline and Human Genome Sciences, has underlined the market potential of the treatments in this area of medicine.

Its peak sales are estimated to be US$4 billion, but with 1.5 million sufferers in the G7 alone, there is plenty of room for a rival such as Lupuzor.

Lupuzor, meanwhile, had no shortage of interest at the time of the Cephalon deal, which was worth around US$500 million in milestone payments and royalties. 

“We have started re-kindling these discussions,” Dimitriou revealed. 

“We have seen a lot of interest from big pharma companies for this one. I can tell you as an ex-licensing professional in big pharma, this is exactly the sort product big pharma wants.

“It is ready for phase III, in a specialist area with a high margin. 

“Having an SPA is an additional bonus. One can never promise a deal, but we are very, very optimistic about the future.” 

The shares, which hit 97 pence in early trade, were changing hands at 88.75 pence at midday, for a rise of 13.75 pence, or 18 per cent.

The City was fairly bullish on today’s fast-track of Lupuzor into phase III trials.

However, Panmure Gordon analyst Savvas Neophytou cautioned: “We believe investors should be patient and expect significant share price volatility in the coming weeks.

“But, ultimately, from a purist valuation point of view, ImmuPharma shares are worth significantly more than the current share price.”

Neophytou rates the stock a ‘buy’ with a 150 pence a share price target.