Savings will be used to commercialize Rhucin for hereditary angioedema.

Pharming is saving €10 million (about $12.35 million) worth of cash through the partial spin-out of its DNage subsidiary back to the latter’s former shareholders. The deal essentially settles €10 million worth of future earn-out payments to former DNage shareholders in the form of five million Pharming shares and a 49% stake in the age-related diseases therapeutics business. Pharming says it aims to sell off even more of DNage once new investors have been found and will retain only a minority holding in the firm. In the meantime DNage will be provided with limited bridge funding.

Reducing the financial commitments to the DNage operation means Pharming can focus its resources on the commercialization of its lead recombinant protein product, Rhucin®, explains Sijmen de Vries, M.D., CEO. “Our priority is the commercialization of Rhucin for acute HAE [hereditary angioedema] attacks and the clinical development of C1 inhibitors for the follow-on indications in the field of kidney transplantation,” says Dr. de Vries. “The [restructuring] will provide for optimal allocation of our resources to the Rhucin/C1 franchise, with the objective of making Pharming financially sustainable on the basis of future revenues from these priority projects.”

Rhucin is a recombinant human C1 esterase inhibitor, which is currently undergoing regulatory review by the European regulatory authorities as a replacement therapy for patients with HAE. In December 2009, the firm started its pre-BLA process for Rhucin with the FDA. Pharming already has marketing/distribution agreements in place for the product throughout the EU and in additional European countries. The most recent of these agreements, signed in 2010, granted Swedish Orphan Biovitrum a license to distribute Rhucin in 24 EU countries as well as in Norway, Iceland, and Switzerland.

Pharming says it expects to initiate the clinical phase of development for its C1 inhibitor product in the field of transplant rejection during the first half of 2010.

DNage is focused on the development of novel therapeutics that target the nucleotide excision repair DNA repair system. The firm was acquired by Pharming in 2006. DNage’s lead product is Prodarsan®, a mixture of small molecules in development initially for treatment of premature ageing diseases in patients suffering from Cockayne Syndrome. A Phase I trial with Prodarsan has been successfully completed, and additional clinical trials are in the planning, according to the firm. The company projects starting a Phase III trial by late 2010.

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