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Drug Names(s): ESP-305, recombinant urodilatin
Description: Ularitide is a recombinant form of urodilatin, a natriuretic peptide synthesized in the distal tubular cells of the kidney. It regulates renal sodium and water excretion through binding to natriuretic peptide type A receptors, increasing intracellular cyclic guanosine monophosphate (cGMP) levels. While these effects, as well as others such as vasodilation, are also exhibited by other natriuretic peptides, urodilatin has a terminal extension that brings resistance to biological inactivation by neutral endopeptidase, whose activity is increased in decompensated heart failure. Animal studies have demonstrated enhanced diuresis and natriuresis and reduced PCWP (pulmonary capillary wedge pressure) and systemic vascular resistance relative to atrial natriuretic peptide (ANP [99-126], the active circulating isoform). The natriuretic peptides are natural antagonists to the renin-angiotensin-aldosterone system.
Deal Structure: PDL has acquired from CardioPep, through a license agreement between CardioPep and ESP Pharma, Inc., PDL's wholly-owned subsidiary, exclusive rights to conduct all subsequent development and exclusive marketing rights for Ularitide for all indications in the United States, Canada, the European Union and Switzerland. To date, the clinical development of ularitide has taken place in Europe.
In February 2008, EKR Therapeutics and PDL BioPharma announced that they have entered into an agreement under which EKR would acquire the rights to PDL's Cardene I.V. and new formulations of Cardene in development, as well as Retavase (reteplase) and ularitide. Under the terms of the agreement, PDL would receive cash payments of $85 million at closing, up to an additional $85 million in development and sales milestones for the new Cardene formulations, as well as royalties on sales of the new Cardene formulations and ularitide.
In addition to the $85 million cash payment at closing, the...See full deal structure in Biomedtracker
Partners: PDL BioPharma, Inc. Pharis Biotec GmbH
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