NUVO: The following is taken from NUVELO's recent 1stQ Report and relates to their rNAPC2 compound that they obtained worldwide rights from Dendreon(DNDN). NUVO is expected to release some Phase IIa results for (ACS) within the next few weeks(2Q), however, in this recent report they indicate they are now taking the drug into trials for the potential of replacing Heparin as the front line treatment for DVT. I know that Heparin has a history of some very bad side effects, however, I'm wondering if I'm reading some bad news in the Phase IIa results for (ACS)and now they are looking for another way to salvage the drug. Management has indicated in a CC that the decision is based on observations, however, the current trial is suppose to be double blinded. Does anyone have an opinion on this issue?
"rNAPc2 is a recombinant version of a naturally occurring protein that has anticoagulant properties. We are currently investigating rNAPc2 in a Phase 2a double-blind, placebo-controlled clinical trial for potential use in treating acute coronary syndromes (ACS), including unstable angina (UA), and non-ST segment elevation myocardial infarction (NSTEMI). We plan to complete patient enrollment of this trial in the second quarter of 2005. We also plan to commence an additional Phase 2 trial with rNAPc2, a heparin-replacement study, in the second half of 2005. We have licensed worldwide rights to all indications of rNAPc2 and all other rNAPc molecules owned by Dendreon, as a result of a licensing agreement entered into with Dendreon Corporation in February 2004. Under the terms of the agreement, we paid Dendreon an upfront fee of $4.0 million ($0.5 million in cash and $3.5 million in Nuvelo common stock), and have expensed $5.6 million for this and related development costs in 2004 and $0.6 million for related development costs in the first three months of 2005. We are required to pay Dendreon milestone payments, ranging from $2.0 million to $6.0 million, for both of rNAPc2's first and second indications upon dosing of the first patient in a Phase 3 clinical trial, upon submission of a New Drug Application (NDA), and upon first commercial sale. If all development and commercialization milestones are achieved, total milestone payments to Dendreon can reach as much as $23.5 million, although we currently cannot predict if and when any of these milestone will be achieved. If rNAPc2 is commercialized, we will also be responsible for paying future royalties to Dendreon depending on certain sales volume of rNAPc2. |
