www.immupharma.com
ImmuPharma plc is a drug discovery and development company. The Company, along with its subsidiaries, is principally engaged in investing in pharmaceutical research and development companies. The Company has operations in Mulhouse, France and Basle, Switzerland. The ImmuPharma plc focuses to develop drugs to treat serious medical conditions. It has five drugs in development to treat: lupus, cancer, severe pain, highly resistant infections, such as methicillin-resistant staphylococcus aureus (MRSA) and inflammatory and allergic disorders. Its wholly owned subsidiaries include ImmuPharma (UK) Limited, which is a holding company; ImmuPharma (France) SA, which is engaged in pharmaceutical research and development, and ImmuPharma AG, which is engaged in pharmaceutical research and development.
ImmuPharma says Lupuzor will move into phase III trials with Special Protocol Assessment
Any lingering doubts over Immupharma’s (LON:IMM) lead drug, Lupuzor, were dispelled this morning when the group announced it would enter phase III clinical trials.
The company also revealed this morning that America’s powerful Food & Drug Administration had given approval to start the next phase of development with a Special Protocol Assessment.
The 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.
Lupuzor is being developed to treat an auto-immune disease called Lupus, and was being taken through the clinical trial process by ImmuPharma’s partner Cephalon.
However the waters have been muddied by the takeover of Cephalon by Teva, which has its own competitor drug in the clinic.
The rights to Lupuzor were handed back to ImmuPharma last month.
However today’s announcement underlines the value of Lupuzor, and the company revealed today that it is holding discussions with pharmaceuticals companies interested in a “corporate deal”.
The FDA fast-track follows the submission of phase IIb data compiled by Cephalon from a pivotal study of the drug.
Today’s announcement also reveals 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 2 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.
ImmuPharma 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 US, Europe and Japan regarding its progression to the final stage of testing.
“The interest we are seeing already from pharma companies as potential partners gives us great confidence."
