Celsus, Volution To Merge To Form Rare Disease Company

The biopharmaceutical companies, Celsus Therapeutics and Volution Immuno Pharmaceuticals SA, have agreed to merge in an all-stock transaction under which the companies will combine to form a new company, Akari Therapeutics PLC, focused on rare and orphan autoimmune and inflammatory diseases.

Under the deal, Volution will become a wholly owned subsidiary of Celsus, and Celsus will rename itself to Akari Therapeutics. On a pro forma basis and based upon the number of shares of Celsus common stock to be issued in the transaction, current Celsus security holders will own approximately 8.32% of the combined company and current Volution security holders will own approximately 91.68% of the combined company on a fully diluted basis. The transaction has been approved by the board of directors of both companies and by RPC Pharma, the sole shareholder of Volution. The transaction is expected to close in the third quarter of 2015, subject to the approval of the shareholders of Celsus as well as other customary conditions.

The key therapeutic focus of the new company will be on rare and orphan autoimmune and inflammatory diseases caused by dysregulation of complement C5, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS). Volution's lead drug candidate is Coversin, a C5 complement inhibitor. Coversin is a recombinant small protein derived from a native protein discovered in the saliva of the Ornithodoros moubata tick, where it modulates the host immune system to allow the parasite to feed without alerting the host to its presence or provoking an immune response. The drug is scheduled to enter Phase II clinical trials within the next 18 months, with data readouts expected from two of these Phase II trials by the end of 2016.

C5 inhibition is a new form of treatment that was commercially advanced by Alexion Pharmaceuticals in 2007 with US Food and Drug Administration approval of Soliris (eculizumab) to treat PNH. Soliris is also indicated to treat aHUS. The drug had 2014 sales of $2.2 billion. Although the precise binding site is different, Coversin acts on C5 in the same way as eculizumab, inhibiting C5 activation and release of C5a and the formation of the membrane attack complex (MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including PNH, aHUS, and Guillain Barré syndrome, according to information from Volution.

Source: Celsus Therapeutics and Volution Immuno Pharmaceuticals

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