Shares of ZymoGenetics Inc. dipped Tuesday after the company said additional studies are likely needed to gain European regulatory approval of its only marketed product, Recothrom.
Sales of the drug, which is used to control bleeding during surgical procedures, climbed to $8.5 million from $1.8 million during the third quarter. While approved in the U.S., it is not yet approved in Europe. Seattle-based ZymoGenetics licensed all rights outside of the U.S. to Germany-based Bayer in 2007.
In a Securities and Exchange Commission filing Monday, ZymoGenetics said Bayer pulled its application with European regulators as a response to indications that the drug candidate would take an additional study to gain approval.
The Committee for Medicinal Products for Human Use said Bayer's submission did not meet the necessary standards.
The stock fell 13 cents, or just under 2 percent, to $6.61 in afternoon trading. ZymoGenetics shares have traded between $2.55 and $7.31 over the last 52 weeks.
Saturday, December 19, 2009
Synthetic Blood Platelets Are Twice As Effective
Scientists working with small particles at the nanoscale have recently revealed that they have developed a new type of synthetic blood platelets, which have twice the clotting capabilities of the standard variety. In the experiments they conducted on lab mice, the science group, which are based at the Case Western University (CWU), in Cleveland, managed to obtain an increased efficiency using their innovation than they could squeeze out of traditional clotting methods.
Technology Review reports that the nanoparticles could be the next major innovation in this field, considering that the regular drugs were so significantly exceeded in terms of performance. “We're helping to form the clot,” CWU bioengineer Erin Lavik, who has also been the leader of the new investigation, explains briefly. The scientist reveals that plans are to create blood clotting particles that are so effective that they could be used by paramedics right at an accident site, or by doctors working on injured soldiers in battlefields around the globe.
Early safety tests turned out to be very promising, but the CWU team admits that there is still a lot of work to be done until the new nanoparticles are ready to be mass-produced, and administered to patients. Speaking about the challenges associated with the development of a good blood clotting method, University of Pennsylvania Medical School physician Mortimer Poncz said, “There's a balance between the two edges of the sword--bleeding too much and clotting too much. You don't want to stop bleeding in the leg but die of a heart attack or have stroke.” He has not been involved in the new study.
The new nanoparticles are about one third the size of normal platelets. They can run through the bloodstream without experiencing obstacles, but also have the same stickiness that makes their natural counterparts so effective at stopping bleeding. While existing drugs can indeed boost the immune system's proprietary response to injury, they can also be terribly expensive, so a cheaper, more effective method was very high up on researchers' priority lists.
Technology Review reports that the nanoparticles could be the next major innovation in this field, considering that the regular drugs were so significantly exceeded in terms of performance. “We're helping to form the clot,” CWU bioengineer Erin Lavik, who has also been the leader of the new investigation, explains briefly. The scientist reveals that plans are to create blood clotting particles that are so effective that they could be used by paramedics right at an accident site, or by doctors working on injured soldiers in battlefields around the globe.
Early safety tests turned out to be very promising, but the CWU team admits that there is still a lot of work to be done until the new nanoparticles are ready to be mass-produced, and administered to patients. Speaking about the challenges associated with the development of a good blood clotting method, University of Pennsylvania Medical School physician Mortimer Poncz said, “There's a balance between the two edges of the sword--bleeding too much and clotting too much. You don't want to stop bleeding in the leg but die of a heart attack or have stroke.” He has not been involved in the new study.
The new nanoparticles are about one third the size of normal platelets. They can run through the bloodstream without experiencing obstacles, but also have the same stickiness that makes their natural counterparts so effective at stopping bleeding. While existing drugs can indeed boost the immune system's proprietary response to injury, they can also be terribly expensive, so a cheaper, more effective method was very high up on researchers' priority lists.
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