Pharming waterproofs cash liferaft as delays takes wind out of US Rhucin sales
This article was originally published in Scrip
Pharming has raised €3.2 million, adding new US based specialist investors.
The Dutch firm said the new funds will strengthen its balance sheet and enable the company to extend its cash runway into the second quarter of 2012. "This guidance excludes any additional cash inflows from further partnering agreements on Rhucin and the transgenic platform and the continuing roll- out of Ruconest in Europe," Pharming said.
Ruconest (Rhucin in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with hereditary angioedema (HAE) in the EU. It is distributed in the EU by Pharming's European partner Swedish Orphan Biovitrum.
The product has fared less well in the US, where Pharming submitted an amended protocol to the US FDA in May for a Phase III trial of Rhucin after receiving "clarity" from the agency on requirements for US development of the product (scripintelligence.com, 17 May 2011).
Pharming noted that on completion of certain "clinical, regulatory and commercial milestones related to progress with Rhucin in the US", it would become entitled to up to $35 million in future milestone payments from its US partner Santarus, including a $5 million milestone payment if the FDA accepts the BLA for Rhucin for review.
Earlier this year Pharming and partner Santarus received a refusal to file letter from the FDA saying that the BLA for Rhucin was not sufficiently complete to enable a critical medical review.
Pharming is getting further behind in its race for US approval, with drugs closer to the US market showing the additional benefit of self-administration.
At a June meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee, it was decided that data from Shire supported approval of its Firazyr as a self-administered drug for HAE (scripintelligence.com, 24 June 2011).
ViroPharma's Cinryze (C1-esterase inhibitor) is approved as a prophylactic therapy for HAE, although the firm also is pursuing the acute attack indication for the drug. It won approval in the EU earlier this year for Cinryze as both a preventative therapy and a treatment for HAE acute attacks (scripintelligence.com, 16 June 2011).