King offer little on Thrombin results for Q2 09

Net sales of Thrombin-JMI were $49 million in the second quarter of this year compared to $64 million last year. The decline in net sales was split evenly between lower price and lower volume levels.

Novo Nordisk expects to start a phase 1 trial with a recombinant long-acting factor IX compound

Within the area of haemostasis, Novo Nordisk has initiated a randomised, double-blinded, placebo-controlled, phase 2 trial with rFXIII in cardiac surgery. The aim of the trial is to investigate the safety and efficacy of rFXIII on transfusion needs in patients undergoing heart surgery. The trial is expected to enrol around 400 patients and results are expected early 2011.
The phase 1 trial with subcutaneous injection of rFVIIa has now been completed. While the study showed that subcutaneous dosing is possible, the bioavailability was lower than expected. Hence, Novo Nordisk has decided not to continue into phase 2 clinical development with this mode of administration for this compound and will instead focus on subcutaneous administration of a long-acting rFVIIa expected to enter clinical development this year.
In addition, Novo Nordisk expects to start phase 2 clinical development in the third quarter this year with the long-acting recombinant FVIIa derivative, NN7128, intended for prophylactic treatment of haemophilia patients with inhibitors. The phase 2 trial will involve around 24 patients and results are expected in 2011.
Furthermore, Novo Nordisk expects to start a phase 1 trial with a recombinant long-acting factor IX compound in the third quarter of 2009. The trial is expected to enrol around 20 patients in a dose-finding trial and the study is expected to be completed in mid-2010.

U.S. Navy Awards Entegrion Contracts for $4 Million

August 6, 2009 -- The U.S. Navy has awarded two additional contracts to the life sciences company Entegrion, Inc., for implementation of the company's proprietary technologies to improve the safety and availability of blood-derived products for treating combat injuries. Recent medical research has demonstrated that such blood component therapy is essential in responding to traumatic injury, especially on the battlefield. The base contracts total about $4 million, with an additional $2 million for expanded research.

"Our military does a heroic job in overcoming the logistical challenges of ensuring that critically needed blood supplies are available when and where they are needed," said Joseph DaCorta, Entegrion's Chief Technology Officer. "Trends in clinical practice are moving toward earlier and more aggressive use of blood components after serious injury. However, availability of such therapies is often seriously restricted by shelf-life limitations and storage requirements. Technologies like ours to produce blood-derived products that can be stored for longer periods, do not require refrigeration, and have fewer pathogens will support both military and civilian medical operations by ensuring both the safety and timely availability of blood products to treat serious injuries, particularly in remote and austere areas."

The first of the new contracts is for advanced development of Entegrion's Stasix®, a dehydrated platelet-derived hemostatic agent that can be reconstituted and transfused when needed for the control of non-compressible internal bleeding. The second contract is for advanced development of Entegrion's product, Resusix®, a dehydrated, pathogen-reduced, fresh human plasma for infusion in trauma patients to expand blood volume, correct abnormal coagulation function, and support hemostasis.

"We are honored to have been chosen by the Navy to assist them in meeting these critical requirements. For Entegrion, this represents the fourth major contract for such work over the last six years. We remain totally committed to building on our track record of providing timely and effective R&D to deliver these much needed therapeutics to both our military and the civilian markets that will follow," said Stan Eskridge, Chief Executive Officer of Entegrion.