ADVTX Announces New Treatment for Bleeding After Nuclear Exposure

Fibrinoplate-S a viable alternative to platelet transfusion for survivors of near-lethal doses of radiation

ANAHEIM, Calif.--(BUSINESS WIRE)--Advanced Therapeutics & Co. (ADVTX) announced today that Fibrinoplate-S™ has shown efficacy in reducing the bleeding in animals exposed to extreme doses of radiation. Survivors of a nuclear event or a dirty bomb explosion will have similar damage from the ionizing radiation of such bombs.

“Acute radiation can severely damage the bone marrow,” Richard Yen, Ph.D., M.D., CEO of ADVTX explained. “While existing medications can boost the production of red cells and white cells from the recovering bone marrow, there is no effective treatment for low concentrations of platelets except through platelet transfusion. Donor platelets, however, may not be available or adequately screened for pathogens during times of distress.”

Viable Alternative to Platelet Transfusion

ADVTX Fibrinoplate-S, a suspension formulation of human albumin spheres coated with a coagulation factor (fibrinogen), mimics the action of activated platelets. Random clots have not been observed even as bleeding improves after the administration of Fibrinoplate-S.

In preclinical trials, Fibrinoplate-S reduced bleeding within 2 hours after a bolus intravenous administration in test subjects with less than 1% of the normal platelet count. The beneficial effects last at least 24 hours. There is no need to match the recipients’ blood types. Fibrinoplate-S can be given to a large number of patients quickly.

Availability

ADVTX can scale up its production of Fibrinoplate-S quickly. Government agencies may include Fibrinoplate-S in their emergency response plans by submitting a “pre-EUA” (pre-Emergency Use Approval) to the US FDA. Licensing outside the United States is available. Visit www.ADVTX.com.

Baxter Q2 - Edited

In the second quarter, BioScience revenues totaled $1.4 billion, which represents a 2 percent increase over the prior-year period. Excluding foreign currency, BioScience sales advanced 13 percent, reflecting strong double-digit gains across several core franchises, which offset weak sales of the company's FSME vaccine, primarily in Germany. Key drivers of this performance include robust growth of antibody therapies and other specialty plasma therapeutics, strong sales of recombinant therapies, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] for the treatment of hemophilia, as well as biosurgery products.....

Advancing Innovation and Expanding Product Offering -

Initiation of a Phase III study following successful completion of a Phase II study evaluating TISSEEL fibrin sealant as a hemostatic agent in vascular surgery. These studies are being conducted for submission to the Food and Drug Administration (FDA) to support a broad hemostasis indication for this product in the United States.

Robert L. Parkinson, Jr.

Without getting into some specific rates, let me say this. In most developed markets around the world there continues to be some opportunity to convert from plasma-derived Factor VIII to recombinant forms. A great example would be Japan, which still has a fairly high—I believe it's around 30% of their usage is still in plasma-derived Factor VIII but that is converting fairly rapidly to recombinant forms, which is one of the reasons why our ADVATE is doing so well in Japan.

In other developed markets, Western Europe and the U.S., you know, we're getting in the areas of diminishing returns, I think, in terms of use of plasma-derived Factor VIII and the opportunity to upgrade to recombinant forms. Although there does seem to continue to be some residual buying. Germany is a good example in Europe, which still uses quite a bit of plasma-derived Factor VIII.

I think the real opportunity that you alluded to in your question is what we call rest of world. Okay? And first of all, in emerging developing markets around the world, for the first time hemophilia is being treated to some meaningful degree, obviously with plasma-derived Factor VIII, so the first opportunity is just patients that previously weren't treated are not being treated with plasma-derived as those economies develop and as they allocate more of their national budgets to health care spending.

All of that plasma-derived adoption, of course, represents opportunity longer term to upgrade to recombinant forms, which is why we're re registering products like RECOMBINATE and ADVATE in China and so on. Most usage in China today is plasma-derived Factor VIII and there are many patients in China that aren't being treated.

So those are examples of the long-term opportunity, frankly, that are quite exciting. First of all, adopting plasma-derived Factor VIII and then over time setting the stage for upgrade conversions to recombinant forms.

So the big opportunity is really the rest of the world. There are selective residual opportunities—I mentioned Japan, Germany, and some of the other developed markets—for continued conversion from plasma-derived to recombinant forms.

CSL, Baxter Sued Over Accusations of Blood Monopoly

July 16 (Bloomberg) -- CSL Ltd. and Baxter International Inc. were sued by a Missouri hospital over allegations they conspired to fix and raise prices for blood plasma products.

The companies used key words to encourage each other to increase supply only incrementally to keep pace with demand and not to increase supply to the extent the companies actually compete for market share, lawyers for Pemiscot Memorial Hospital, based in Hayti, Missouri, said in a complaint filed yesterday. The lawsuit was filed in Philadelphia federal court.

“As a result of the conspiracy, prices for blood plasma products were higher than they otherwise would have been,” Marc Machiz, an attorney for Pemiscot, said in the complaint. “Beginning in 2005 and continuing through the present, prices for blood plasma proteins have increased substantially.”

Baxter and Melbourne-based CSL are the world’s largest makers of blood plasma products. Last month CSL abandoned a $3.1 billion bid for Talecris Biotherapeutics Holdings Corp. after regulators blocked the plan.

The deal would have helped CSL overtake Deerfield, Illinois-based Baxter as the leader in the $15 billion global market for blood plasma-derived medical treatments such as immunoglobin, used to treat patients with weakened immune systems.

FTC Lawsuit

The U.S. Federal Trade Commission earlier sued to stop CSL’s proposed acquisition over claims the deal would leave the two largest companies with 80 percent of the U.S. market for blood plasma products.

Baxter spokesman Chris Bona said the company wasn’t aware of the lawsuit and declined further comment. Robin Gilliland, an outside spokesman for CSL, said the company hasn’t seen the complaint and has no comment.

Pemiscot’s complaint seeks to represent purchasers of blood plasma proteins in the U.S. from Oct. 1, 2004, to the present. The complaint is also seeking unspecified damages.

The FTC said last month that the plasma protein industry showed “troubling signs of coordinated behavior,” according to Pemiscot’s complaint. The FTC’s complaint describes signals between the two companies suggesting that increasing production of blood plasma products could hurt their ability to reap significant profits, according to Pemiscot’s complaint.