WoundStat Inventors Recognized for Their Outstanding Medical Research Contributions to Combat Casualty Care

BETHESDA, Md., Aug 13, 2008 (BUSINESS WIRE) -- Virginia Commonwealth University (VCU) researchers Kevin Ward, MD, Robert Diegelmann, PhD, and Gary Bowlin, PhD, this week received the Award for Excellence in recognition of their outstanding contributions to combat casualty care from the US Army Medical Research and Materiel Command, Combat Casualty Care Research Program. The three invented WoundStat(TM), a ground-breaking hemostatic agent for control of bleeding in high-pressure arterial wounds, which are a common combat injury. The award was given to the group "in recognition of their hemorrhage control research, and the resultant development of WoundStat, a product that will significantly increase survival of the combat wounded."
The award was given at the Advanced Technology Applications for Combat Casualty Care (ATACCC) 2008 Conference, and this is one of the few times the award has been given to someone who was not a member of the military.
"I'm gratified, and I'm proud of the award," said Dr. Ward. "Our team did great work in inventing WoundStat. It is rewarding knowing that your work can help save lives of warfighters and other trauma victims, and it is great to be recognized as well."

Omrix Biopharmaceuticals mulls hedge fund buyout offer

Sources inform that Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) has received a buyout offer from a US hedge fund for $25 per share, amounting to $430 million, in a deal that would take Omrix private. Omrix closed at $22.13 on Friday, giving a market cap of $378.8 million. The offer represents a 14% premium on the company's market cap.
The company had no comment on the report.
Omrix's share has risen 57% in recent months on reports that something interesting was going on there, as well as the company's quite strong financial report for the second quarter, published last week.
The sources added that, a few months ago, Omrix received an acquisition offer from Johnson & Johnson (NYSE: JNJ) unit Ethicon Inc., with which Omrix has a distribution agreement. Omrix turned the offer down because it felt that the offer was too low. Omrix president and CEO Robert Taub is now examining the offer from the US hedge fund, and he will reportedly send it to Ethicon to give it an opportunity to make a better offer of its own.
Omrix had claimed in the past that Ethicon was not making a strong enough effort in marketing the company's biosurgical sealants and other products. However, the company's appear to have settled their differences and their relationship is as good as ever.
Omrix will have to make a share buyback offer in order to sell the company to a private company and delist from Nasdaq. Omrix's holdings are quite dispersed. Taub owns 9.4% of the company and, together with four other private parties, owns 17%. The public and institutional investors own the rest, including 7% by Adage Capital Partners GP LLC, 5.6% by Oberweis Asset Management Inc., and 4.4% by Orbimed Advisors LLC.

Factor VII Curbs Bleeding in Non-Hemophiliac Trauma, Surgical Patients

Use of recombinant activated factor VII (rFVIIa) reduces the need for blood transfusion in patients without hemophilia and may also reduce mortality, according to pooled data from randomized placebo-controlled trials involving more than 3000 participants, Canadian researchers report.
"I had found it to be effective in some combat situations in Afghanistan," senior investigator Dr. Vivian C. McAlister told Reuters Health. "I was therefore dismayed when I noticed that rFVIIa was being dismissed by some influential physicians as being expensive, dangerous and ineffective."That report, by US Federal Drug Administration (FDA) physicians, he added, "was flawed because it only looked at adverse events that had been reported."To gain a more balanced picture, Dr. McAlister and colleagues at the University of Western Ontario, London conducted a meta-analysis of 22 trials involving 3184 patients without hemophilia. Trial settings included trauma, variceal bleeding, cardiac surgery, liver transplantation and other surgeries. The team's findings appear in the July issue of the Annals of Surgery."When we combined results," continued Dr. McAlister, "we found rFVIIa to be effective in controlling hemorrhage and to save lives without increasing the risk of venous thrombosis."Specifically, compared to placebo, patients receiving rFVIIa were less likely to require additional blood transfusions (odds ratio, 0.54). Mortality was not increased and may have been reduced in patients receiving rFVIIa (OR, 0.88). The mortality reduction seemed more likely when the agent was given therapeutically, rather than prophylactically.There may have been a higher incidence of arterial thromboembolic events (OR, 1.50) but not venous thromboembolic events (OR, 0.76) in patient given rFVIIa, although the differences did not reach statistical significance."There was an increased rate of heart attack in patients who received rFVIIa," Dr. McAlister pointed out, "but it is not known if this was due to the stress which they had survived or related to rFVIIa itself.""Subgroup analysis," he concluded, "suggested the most effective way to give rFVIIa is in lower doses to stop, rather than to prevent, bleeding."

Gen II Quikclot Developer gets award and eyes surgical arena

UC Santa Barbara chemistry professor Galen Stucky has been honored for his role in the development of a blood-clotting gauze that is helping save soldiers who suffer severe, life-threatening injuries in Iraq and Afghanistan. The Department of Defense’s Advanced Technology Applications for Combat Casualty Care Award was presented to Stucky Aug. 11 during the opening ceremonies of the group’s annual meeting in Florida. The ATACCC convention is the premier scientific meeting on the battlefield medical needs of the nation's soldiers and on recent advances in trauma surgery and medicine. “I am very honored,” said Stucky of the ATACCC award. “In retrospect, this project has meant more to me than any other that I’ve worked on for the past 40 years. The most important aspect of this work is the thought that it is providing life support that is needed on an immediate-response basis to both military and civilian personnel. For those who knowingly are in harm’s way, it is particularly important.”Stucky and his colleagues were asked by the Office of Naval Research to work with Connecticut-based Z-Medica to improve its zeolite-based substance, QuikClot brand hemostatic agent, which promotes instant clotting and sealing of the wound until the injured can be taken to medical facilities. Adding to the task, the Navy wanted a solution within six months.Stucky said the next step is developing ways to stop internal bleeding. Imagine a successful, blood-borne process that would stem bleeding, say, in the case of a concussion. He and his team are planning to put their efforts into a new research project to tackle the problem.

Ethicon Endo-Surgery Acquires SurgRx

Representatives of Ethicon Endo-Surgery said today that the company is acquiring SurgRx, which develops the bipolar tissue sealing system used in the EnSeal device line.
"The acquisition has the potential to expand the global availability of the EnSeal product line," Rodney Perkins MD, SurgRx chairman, said in a statement.
The acquisition gives Johnson & Johnson subsidiary Ethicon Endo-Surgery a new platform to complement its Harmonic line of ultrasonic medical devices. These devices are used to perform open and laparoscopic procedures.
Redwood City, Calif.-based SurgRx was founded in 2002 and manufactures EnSeal, which combines high compression and controlled energy delivery to quickly create strong vessel seals. The EnSeal device, cleared by the FDA in 2003, is capable of sealing vessels up to 7mm in diameter.
Ethicon develops devices for minimally invasive and open surgical procedures with a focus on interventional diagnosis in gastrointestinal health, bariatric surgery and general surgery.
Terms of the agreement were not disclosed.
Ethicon Endo-Surgery and SurgRx share a commitment to innovation, according to Karen Licitra, company group chairman and worldwide franchise chairman for Ethicon Endo-Surgery.
"Together, the combination of Harmonic and EnSeal technologies will position us to better address many different procedure needs," she said in a statement.

Omrix Ethicon - We're number 2 in Thrombin

During Omrix Q2 discussion was made on Evicel, Quixil, Evithrom, the Fibrin pad and a mystery bonus product that was just icing on the earnings cake. Revenue was up 72% year over year, led by Johnson & Johnson's Ethicon's 155% jump in sales of Omrix's biosurgical products. Most of that likely came from improved sales of Evicel -- its fibrin sealant used to stop surgical bleeding. The product was approved for use in all surgeries earlier. CEO Taub stated the obvious for the thrombin market "I'll rank the three competitors, King one, Ethicon/Omrix two and ZymoGenetics three."
On Ethicon intiatives with Evicel:
“a focus on burns and orthopedics and plastic surgery”
“an updated evicel website”

On Quixil:
“growing nicely” in Europe especially in Orthopedics.

On Evithrom:
continued “moderate growth” approx. 40% of purchasers were first time buyers.

On Fibrin Pad trials in Israel and USA:
ongoing but on target
anticipating approval first half 2010

On major costs:
Plasma costs expected to rise

On the “mystery” $ 1.9 million contributing by-product of Omrix plasma preparation:
It is an imuno-therapy product not a biosurgical
A 3 year contract is in place to continue selling these previously discarded by-products
The product is used on humans
Contractually unable to release name or country of partner

HemCon Bandages Receive Expanded Indications for Antibacterial Barrier, Including MRSA

The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million hospital patients acquire infections each year, and 103,000 die as a result. HemCon Medical Technologies Inc., a leading global medical products company focused on advanced wound care innovations, today announced new antibacterial indications by the FDA, including a barrier against MRSA, for its HemCon® Bandages, ChitoFlex® dressings and KytoStat® Bandages.
The hemostatic HemCon Bandage and ChitoFlex dressing are now approved with an antibacterial barrier indication against a wide range of harmful organisms, including the antibiotic-resistant staphylococcus aureus (MRSA), enterococcus faecalis (VRE) and acinetobacter baumannii.
Hospital-acquired infections have a significant impact on patients and health care facilities. An estimated 2.6 percent of nearly 30 million operations are complicated by surgical site infections each year according to the Institute for Healthcare Improvement. The Center for Medicare and Medicaid Services will no longer pay hospitals for additional costs associated with treating patients for certain hospital-acquired infections and medical errors. Hospital-acquired infections add an estimated $30.5 billion annually to the nation’s health care costs.
“HemCon hemostatic bandages and dressings provide an effective way to decrease the risk of infection at wound sites. Concurrently, the bandages also provide health care professionals with a viable hemostatic solution that can advance the standard of care,” said John W. Morgan, president and CEO of HemCon Medical Technologies. “This is a great step forward in improving patient care and outcomes.”
HemCon’s bandages, created from a natural substance in shrimp shells called chitosan, stop bleeding – including extensive arterial bleeding – within two to five minutes. The antibacterial barrier properties of the bandages help prevent infection transmission to other patients and health care providers and also make it easier for medical professionals to help prevent infections at incision site wounds. This potentially decreases patient complications and length of hospital stay.
HemCon dressings control bleeding by becoming extremely adherent when in contact with blood. The adhesive-like action seals the wound and attracts red blood cells to the bandage, forming a seal that stops hemorrhaging independent of the body’s natural clotting process. The bandages and dressings provide a barrier against harmful bacteria naturally because when in contact with the bacteria, the chitosan ruptures the cell walls of gram negative bacteria and prohibits reproduction.

Orthovita Q2

Product sales for the three months ended June 30, 2008 increased 30% to $19.3 million as compared to $14.9 million for the same period in 2007. Product sales for the six months ended June 30, 2008 increased 27% to $35.5 million, as compared to $28.0 million for the same period in 2007.

Sales growth for the reported periods in 2008 was primarily attributable to increased sales of our VITOSS(R) FOAM and VITAGEL(R) product portfolios in the U.S. as we further develop our U.S. field sales network. Approximately 60% of our product sales during the three and six months ended June 30, 2008 and 2007, respectively, were from products based upon our VITOSS FOAM platform co-developed with Kensey Nash Corporation. VITAGEL contributed approximately 25% of product sales for the three and six months ended June 30, 2008, as compared to approximately 19% and 20% of our product sales during the three and six months ended June 30, 2007, respectively.

King Pharmaceuticals shares dive after 2Q report

Shares of King Pharmaceuticals Inc. tumbled Thursday after the specialty drugmaker issued a disappointing second-quarter earnings report. King Pharmaceuticals has reported it saw a drop in revenue in the second quarter of the year.Total revenues for April to June were $397 million, compared with $543 million in the same period last year.King said the main reason for its decreased revenue was the arrival to the market of generic substitutes for its Altace drug.
However, Brian Markison, chairman, president and chief executive officer of King, said the firm is pleased with the continued strong performance of its Thrombin-JMI drug.
When asked for more detail on pricing and background on the thrombin market they again reiterated the perception of an "account by account fight" with a "fair amount of pressure on pricing". There was also a "a lot of pressure on the margin".

Thrombin - Recothrom Q2 sales

Bruce L.A. Carter, Ph.D., CEO of ZymoGenetics highlighted the laborious process of attaining hospital approval for the product "First, we have to enlist the support of surgeons, nurses, and pharmacists. Then we have to get RECOTHROM on the agenda for upcoming pharmacy and therapeutics committee meetings. Then we need to get the P&T committee to endorse RECOTHROM either as the addition to the formulary or a commitment to completely convert to RECOTHROM. Then we have to work with hospital pharmacists and surgical departments to process conversions and circle back to surgeons and nurses to encourage the use of RECOTHROM...........Of the 169 meetings that have taken place as of late June, decisions were made at a 103 meetings, with 66 where decision was still pending. Of the 103 meetings with decisions, 77 approved either complete conversion to RECOTHROM from bovine, or addition of RECOTHROM. 26 P&T committees declined to add RECOTHROM at this time, but many of those of course occurred before the GPO pricing agreements were in place, and before we had a full line of products.
So we need to circle back and get more surgeons at these hospitals. So through late June, the decisions were; 30% to completely convert so RECOTHROM is the only approved product, 45% of the time to add, and 25% to decline at this time.
As of mid-July, a 130 hospitals have now purchased RECOTHROM, and we are pleased to say that approximately 60% have reordered, and a third are already doing so on a routine basis.
So to reiterate; RECOTHROM is being well received by surgeons consistent with our expectations, and I think this is evidenced by a 75% positive response from decisions made to-date. The selling process in this market is long, and in some cases it is taking longer than we anticipated. We have put GPO contracts covering a large portion of the marketing place, and we now have a full line of RECOTHROM product, which will help build sales in the second half of the year, and we are confident that RECOTHROM will become the market leader in the coming years, and that our commercialization strategy is sound."
Bruce also discussed Zymo’s interpretation of the hospitals consideration in terms of facing a coagulation issues and also the threat of possible complications due bovine thrombin. Discussing price sensitivity he asserted that while not fully aware of the cost involved with Thrombin JMI, Recothrom was unlikely to be produced as cheaply as King Pharmaceuticals bovine Thrombin JMI but Omrix manufactured (Ethicon distributed) human sourced Evithrom was likely to be associated with higher costs. Bruce said "I don’t know the precise cost associated with the production of bovine thrombin -- but I would guess that it would be difficult for us to match the cost of goods of bovine thrombin. However, the other, when it comes to human thrombin in collecting plasma from humans, then I think that's a different issue. That's going to much, much more expensive." I guess Ethicon negative publicity for King's bovine product will work to Zymo's advantage...........

Interestingly many of us expected hospitals to use bovine (King), human (ethicon/Omrix) or Zymo (Recothrom)............but when queried....by Kevin DeGeeter - Oppenheimer
"Okay. And maybe two more quick questions if I may. It looks like we continue to see about 45% of these P&T committees leaving bovine on formulary base, quite putting both products on formulary, which I think is very different than what everyone was expecting previous to launch. I think we expected hospital either be bovine, human, or recombinant. First, I guess, just answer that the way which you think about the overall market, or is there something different in these early adopters that may suggest they have a different attitude towards single product on formulary versus multiple? And if it's going to be half the market, give or take, it's going to have multiple products on formulary. How does that change the sales message here?"
Bruce Carter
"I think that what we believe, as you're seeing, is that some people fully convert. Others, and I don't think it's at all surprising, say, look, you guys are new. We'd like to put you on the formulary. We're going to try you out on the formulary. We want to make sure that you can consistently supply us, so we don't want to remove the other product. So we feel comfortable that you can consistently supply us. And we believe that over a matter of time, people will convert to just one, and we believe that will be RECOTHROM.
As we've said before, we see this as a ratchet mechanism. In addition, of course, remember that a number of these people are putting us on the formulation time when we didn't have the full complement, we didn't have the 20000-unit, we didn't have the spray. So they would feel that converting completely to RECOTHROM was not appropriate at that particular point in time. So we're not surprised. We would also, as I've said once before, expect full conversion eventually."