Rhucin is under review at the EMEA, and the company recently had a pre-BLA meeting with the FDA.

Pharming secured a convertible debt financing of €7.5 million (about $10.82 million). “This financing provides a good basis for Pharming to work with the EMEA and FDA to bring Rhucin forward through the regulatory review process and also allows the company to complete commercialization partnerships for Rhucin,” says Sijmen de Vries, M.D., CEO.

Rhucin® is Pharming’s lead candidate and is under review at the EMEA as a treatment for acute attacks of hereditary angioedema (HAE). Additionally, the company reported on December 9, 2009, that it had completed a pre-BLA meeting with the FDA.

Rhucin is a recombinant human C1 esterase inhibitor and belongs to the class of so-called serine-protease inhibitors, or serpins. It regulates several inflammatory pathways in the body by inhibiting certain proteins that are part of the human defense system, Pharming explains.

Patients who suffer from HAE have a deficiency of functional C1INH resulting from a mutation in the C1 inhibitor gene. Deficiency of functional C1 inhibitor leads to excessive activation of the complement system and other immunological and hemostatic pathways, giving rise to angioedema attacks. The firm believes that administration of C1 inhibitor protein can normalize the immune response and stop the angioedemic attacks.

Pharming uses a quality-controlled proprietary production and purification technology from the milk of rabbits and reportedly allows for commercial-scale production. Rhucin does not carry the risk of transmission of human infectious agents as it is not isolated from human blood sources, according to Pharming.

The €7.5 million financing has been structured in the form of a one-year (nonlisted) convertible debt instrument that is convertible into Pharming shares at €0.50 (approximately $0.72). The debt has a 9% per annum coupon and is subordinated to the existing €10.9 million (roughly $15.71 million) convertible bond.

In addition, 15 million warrants are being issued to investors with an exercise price of €0.50 and an expiration date of December 31, 2012. Pharming has access to an additional €2.5 million (about $3.6 million) under this convertible debt agreement on mutually acceptable terms to investors and the company.

The convertible debt can be repaid in cash in whole or in part at the option of the investor if a commercialization deal for Rhucin materializes. Under specific conditions, the conversion price and exercise price of the warrants could be reduced according to the lowest five-day, volume-weighted average share price along with a 5% discount following a notice of conversion.

Pharming is working on treatments for genetic disorders and aging diseases, specialty products for surgical indications, and nutritional products. Besides Rhucin, it has two biopharmaceuticals in clinical development. Prodarsan is being evaluated for premature aging and rhC1INH in organ transplant; both are in Phase I.

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