Dyax adds new Asian deal for Kalbitor to CVie
This article was originally published in Scrip
Dyax Corp has been seeking new partnerships to grow its mainstay product Kalbitor (ecallantide) since a setback for the plasma kallikrein inhibitor in Europe in late 2011, when the US firm withdrew a marketing authorization application after regulators deemed the data insufficient to demonstrate a positive risk-benefit balance.
Adding to its existing deal with OrphanPacific for Japan, Dyax has now reached a second Asian licensing agreement, with CVie Therapeutics for the exclusive development and commercialization of the hereditary angioedema (HAE) therapy in China, Hong Kong and Macau.
The subcutaneously injected product stands to become the first specific novel therapy for the immune system-related episodic swelling disorder in China, where steroids are now used mainly for management of the condition.
Nasdaq-listed Dyax will receive an upfront payment and will be eligible for development, regulatory and sales milestones plus a royalty on net product sales. CVie will cover all development, regulatory and commercialization costs in the three markets and purchase commercial supplies from Dyax on a cost-plus basis.
Neither side disclosed additional financial details, and the timing of the start of the required clinical development program in China is not yet clear. But Dyax spokesperson Jennifer Robinson told Scrip that CVie "will be speaking with regulatory officials in China to discuss the path forward to commercializing Kalbitor".
CVie is a stand-alone cardiovascular drug development operation 80%-owned by the Hong Kong-based and -listed firm Lee's Pharmaceutical Holdings (the remainder being held by a US venture capital firm), whose other existing pipeline assets include rostafuroxin.
This "personalized" oral digitoxygenin derivative antihypertensive is this year moving into a 320-patient international Phase IIb study (including in a planned 160 patients in China) that will compare it with losartan, in patients with genetic profiles indicative of adducin and EO hypertension mechanisms.
HAE affects around one in 10,000 to 50,000 people globally and is caused by deficiencies in the complement system protein, C1 esterase inhibitor, related to inherited genetic defects. This leads to repetitive acute episodes of swelling that usually affect the face, genitals, hands and feet or abdomen, and more rarely but seriously, internal organs such as the larynx.
Burlington, Massachusetts-based Dyax launched Kalbitor in the US three years ago for the on-demand treatment of acute attacks of HAE in patients aged 16 or older, and reported net sales of $28 million (+76%) for the product in the nine months ended 30 September.
It dropped ecallantide for the follow-on indication of ACE-inhibitor-induced angioedema in the middle of last year following disappointing Phase II results in this setting, but is continuing to pursue research into diagnostics to differentiate between angioedemas mediated by plasma kallikrein (bradykinin) rather than histamine, to aid in targeted therapy.
Dyax is also investigating a monoclonal antibody inhibitor of plasma kallikrein with potential for the prevention of HAE attacks mediated through this pathway.