50th Annual Meeting of the American Society of Hematology

SAN FRANCISCO, Dec 03, 2008 /PRNewswire-USNewswire via COMTEX/ -- The American Society of Hematology (ASH), the world's largest professional association of blood specialists, expects more than 20,000 attendees at the 50th ASH Annual Meeting from December 6-9, 2008, at the Moscone Center in San Francisco, CA. The meeting will showcase the latest research and treatments for blood disorders. In honor of the Society's golden anniversary, there will also be several special programs including a unique video project featuring influential figures in hematology.
"It is my distinct honor to serve as President during this celebratory year in the Society's history. The ASH annual meeting continues to be the premier forum for physicians and researchers from around the world to hear the most up-to-date developments in hematology, and this year will be no exception," said Kenneth Kaushansky, MD, 2008 ASH President, and Helen M. Ranney Professor and Chair of the Department of Medicine at the University of California, San Diego School of Medicine. "In addition to presenting research that affects hematologists in every area of the discipline, this year's meeting underscores 50 years of unprecedented growth and advancement in the field."
Highlights of the meeting include special symposia, education programs, special interest seminars, and scientific sessions. As part of the 50th anniversary celebration, the meeting will also feature historical displays showcasing major scientific discoveries and clinical advances in the specialty. Several world-renowned scientists will share their life stories and speak about groundbreaking medical discoveries during the Pioneers in Hematology sessions.
The Special Symposium on the Basic Science of Hemostasis and Thrombosis will provide an opportunity for communication among scientists in the field and focus on the most important basic science contributions from 2008 to each of the three major areas of the field: thrombosis, blood coagulation and fibrinolysis, and platelet biology. In September, the Surgeon General's Call to Action to Prevent and Reduce Deep-Vein Thrombosis and Pulmonary Embolism encouraged public awareness of this blood condition that affects nearly 1 million Americans each year. The symposium will take place on Tuesday, December 9, from 7:30 - 9:00 a.m. PST.
This year's Practice Forum, "The Patient, the Hematologist, and the Unexpected," will focus on two areas of unexpected results encountered commonly enough to raise the interest of the hematology community. Additionally, this session will look at the public policy environment that will shape the practice of hematology and the Society as it enters its 51st year. This event will take place Saturday, December 6, from 6:00 - 7:30 p.m.
Another highlight of the meeting is the Presidential Symposium, which will focus on hematopoietic stem cells (HSCs). These cells are known for their role in the cure of a variety of diseases as well as for providing an understanding of stem cell development in all mammalian biology. During the symposium on Tuesday, December 9, from 9:45 - 11:45 a.m., three eminent investigators who have made significant contributions to our understanding of HSC biology will discuss the properties of these cells and their role in the human body.
Neal S. Young, MD, of the National Heart, Lung, and Blood Institute, National Institutes of Health, will discuss the pathophysiology of bone marrow failure and how clinical observations of patients with this disease have provided insights into the biology of autoimmunity, viral pathogenesis, and cancer at this year's E. Donnall Thomas Lecture on Monday, December 8, from 9:30 - 10:30 a.m. Bob Lowenberg, MD, Ph.D., of the Erasmus University Medical Center in the Netherlands, will give the Ham-Wasserman Lecture on Saturday, December 6, from 12:30 - 1:30 p.m. Dr. Lowenberg's lecture will focus on the numerous genetic abnormalities found in acute myeloid leukemia patients and ways to use this information to develop individualized therapies. Both the E. Donnall Thomas Lecture and the Ham-Wasserman Lecture represent areas of medicine that have evolved immensely over the last 50 years.
This year's plenary policy forum, "50 Years of Progress in Hematology," which is co-sponsored by ASH and the European Hematology Association, will feature Nobel Prize winner Peter Agre, MD, who will discuss how his research on water channels in red blood cells, as well as the research of others that originated in hematology, grew to have profound and catalytic influences on numerous areas of science.
For the complete annual meeting program and abstracts, visit www.hematology.org.

Study: Terumo TR Band™ Hemostasis Device Reduces Radial Artery Occlusion by 56%

A new study, conducted by Dr. Samir B. Pancholy of Mercy Hospital in Scranton, Pennsylvania, shows that the concept of "guided compression" in transradial procedures can reduce radial artery occlusion by 56%, especially when facilitated by the use of the TR Band™ Hemostasis Device.
While infrequent (in the single digits), radial artery occlusion is a discouraging complication of radial artery access.
Although it is usually benign for the patient, it precludes future radial access. For example, if the radial artery occludes after a diagnostic catheterization, any subsequent PCI procedures must be done via the femoral artery.

But there are a number of methods for achieving hemostasis in a radial procedure. Pancholy looked at data from his own lab and saw that patients on whom he had used the TR Band, as opposed to the commonly-used HemoBand, had significantly lower rates of radial artery occlusion. So Dr. Pancholy devised a randomized clinical study to test the efficacy of the TR Band in preventing radial artery occlusion.
500 consecutive patients undergoing transradial catheterization were prospectively enrolled in the study. 250 consecutive patients received hemostasis by application of HemoBand (Group I) and the next 250 patients received hemostasis using the inflatable TR band (Group II). Radial artery patency was studied the time of application of the hemostasis device, at 30 minutes, 60 minutes and at 24 hour and 30 days using Barbeau’s test.
The results were that 28 patients in Group I (11.2%), developed evidence of early occlusion (at 24 h), compared to 11 patients (4.4%) in Group II (P<0.005).>

Starch Medical Launches New, Bioinert Surgical Hemostats

SAN JOSE, Calif., Dec. 2 /PRNewswire/ -- Starch Medical Inc, a San Jose, CA-based medical device manufacturer, announces the CE approval of its PerClot(TM) Polysaccharide Hemostatic System (PHS) and the StarFoam(TM) Absorbable Polysaccharide Hemostat. Introduction of PerClot(TM) PHS will commence this month in the European Union and other select international markets. The StarFoam(TM) Absorbable Polysaccharide Hemostat will launch during the 2nd quarter, 2009.
PerClot(TM) PHS is an absorbable, surgical hemostat composed of Absorbable Modified Polymers (AMP(TM)). AMP(TM) technology incorporates sophisticated, plant-based polymer modification processes that yield biocompatible, polysaccharide particles. There is no thrombin, collagen, or other human or animal components in AMP(TM) particles. A family of customized, single-use application instruments will enhance the delivery of AMP(TM) to the wound site for the control of capillary, venous and arterial bleeding in both open and minimally invasive surgical procedures.
The StarFoam(TM) Absorbable Polysaccharide Hemostat, also developed with AMP(TM) technology, is produced in a hemostatic foam (wafer) configuration. Application of StarFoam(TM) will feature a simple "press and release" technique.
David Lang, President of SMI, commented, "The clinical introduction of PerClot(TM) PHS and its proprietary, integrated AMP(TM) technology represents the next generation of polysaccharide hemostatic agents. The StarFoam(TM) product line will offer surgeons a choice of hemostatic formats for a range of surgical wounds. Compared to current polysaccharide based hemostats, PerClot(TM) PHS and StarFoam(TM) demonstrate superior hydrophilic action and enhanced adhesive strength. These performance features, coupled with custom delivery systems, have been favorably received in a diverse range of surgical applications in Europe, Asia and Latin America."
SMI is a privately-held medical device company engaged in the design, manufacture, marketing and licensing of breakthrough, hemostatic solutions. Starch Medical's proprietary, patent-pending technology platform (AMP(TM)), including powders, foams and films, will focus on the worldwide, multi-billion dollar biomaterial, hemostasis, and wound care marketplace. For additional information, distribution inquiries, and licensing options, visit http://www.starchmedical.com/.

ZymoGenetics' longtime CEO is stepping down

ZymoGenetics Chief Executive Bruce Carter will step down Jan. 2, to be succeeded by current President Douglas Williams.
Carter, 65, a prominent figure in local biotech circles, became president and chief executive of ZymoGenetics in 1998, when the Seattle company was a subsidiary of Novo Nordisk.
He led the spinoff that turned the Seattle-based biotech into an independent company in 2000. Eight years later, he presided over the launch of the company's first commercial product, Recothrom, a genetically engineered form of a blood protein used to control surgical bleeding.
He leaves as ZymoGenetics, which once ranked highest in market capitalization among Seattle-area biotech firms, has seen its shares plummet 77 percent in the past year because investors are disappointed at sluggish Recothrom sales.
"It has been an honor to lead ZymoGenetics and a privilege to work with so many bright and talented people. It is also satisfying to think that discoveries at ZymoGenetics have led to lives saved," said Carter in a statement.
"In many ways it is sad to leave, but all organizations are invigorated by new blood, and I am confident that in Doug we have the right person to drive this company forward and capitalize on the opportunities we have created for patients and shareholders."

It's official: J&J to pay $438m for Omrix

Biological sealant maker Omrix Biopharmaceuticals today officially announced that Johnson & Johnson (NYSE: JNJ) will acquire the company for $438 million - $25 per share. Omrix rose 16.3% in early trading today to $24.60, giving a market cap of $421 million, after rising 30% on Friday, when reports of the acquisition first emerged.
Johnson & Johnson (JNJ) and Omrix Biopharmaceuticals (OMRI), a biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced a definitive agreement whereby Omrix will be acquired for approximately $438 million in a cash tender offer. Omrix is expected to operate as a stand-alone entity reporting through ETHICON, a J&J company and leading provider of suture, mesh, hemostats and other products for a wide range of surgical procedures.
The acquisition of Omrix would strengthen its presence in active, biologic-based hemostats and convergent products for various surgical applications. ETHICON currently has exclusive distribution rights in the U.S. and the European Union for EVITHROM(TM) Thrombin Topical (Human) and EVICEL(TM) Fibrin Sealant (Human), two active, biologic-based hemostats manufactured by Omrix. ETHICON and Omrix are also partnering on a Fibrin Pad product candidate, currently in Phase II clinical trials, as an adjunct to control mild to moderate soft tissue bleeding.
Terms
-J&J to purchase all outstanding shares through a tender for $25/share
- 18% premium over last close and ~51% over last months average trading price
- $358M total net of estimated cash on hand
Assuming this transaction closes in 2008, Johnson & Johnson is expected to incur an estimated one-time, after-tax charge of approximately $120 million reflecting the write-off of in-process research and development charges (IPR&D). The acquisition is expected to be breakeven to slightly dilutive to Johnson & Johnson’s earnings per share in 2009.
Omrix has taken a big hit this year dropping from their 52 week high of 38.18 to a low of just 8.99 after a disappointing update regarding their phase 2 fibrin coagulant patch. I think JnJ got a pretty good bargain here.

Omrix Q3

Robert Taub
Thank you, Asaf. As Asaf mentioned, this quarter was another record quarter for biosurgery product sales – $9.5 million. Evicel is continuing to be a strong performer. The number of total accounts continues to increase steadily, and in quarter three, end user sales by our partner, Ethicon, once again included a very significant amount of repeat business. By year-end, we believe that total sales of Evicel will be approximately the same as our competitor.
Additionally, as mentioned in a recent press release, we announced that the EMEA approved Evicel in Europe. Evicel is now licensed for marketing in 27 plus three countries – the 27 countries of the European Union plus another three in Europe, and Ethicon will begin to sell Evicel on a country-by-country basis as Quixil is gradually phased out.
Next, Evithrom, our human-based thrombin standalone product continues to experience moderate dollar sales growth in this market. In quarter three, the total number of accounts purchasing Evithrom, however, increased by 50%, with new customers comprising 52%. As you're probably aware, however, there is currently fierce price competition in the thrombin standalone market, and as we have predicted, the market is moving toward thrombin enhanced hemostats, and we are currently developing two such products.
I would now like to update you on our Fibrin Pad. As you may recall, we have two trials, one in the U.S. in mild-to-moderate bleeding and a second one in Israel in severe bleeding.
With respect to the U.S. trial, we completed enrollment of the 90 patients needed to conduct interim analysis. We were pleased to report that the analysis showed superiority of the Fibrin Pad over Surgicel. Having demonstrated superiority, we are now able to continue with open-label enrollment. The trial will continue to enroll patients only to the Fibrin Pad arm, and according to the study design, we are required to treat at least 100 total patients for safety, which means another additional 40 patients with the Fibrin Pad.
Shortly after we announced that we had achieved superiority we were informed that the U.S. Phase II study had been suspended after a patient had experienced postoperative bleeding. This patient was not among the first 90 enrolled, but part of the subsequent 40 already. Many of you have asked why the trial was suspended if rebleeding is an expected event in surgery and in this protocol. The reason is simple. The protocol is written so that if there is a case of postoperative bleeding the trial must be suspended and an investigation must be conducted. Therefore, the decision to suspend the trial was an administrative one.
A Data Safety Monitoring Board, or DSMB, conducts the investigation and then provides a recommendation on how the trial is to proceed or if it is to be modified or even discontinued. We have now reported that the DSMB concluded their investigation and recommended that the clinical trial resume without any modifications, which it did.
I want to clarify that the DSMB's role is not to determine the relationship between the adverse event and the product. We, however, conducted a thorough product investigation and concluded that there is no issue with the clinical material.
I would still like to emphasize that a trial continuation with no modification is the absolute best case outcome. Therefore, we remain on target to complete enrollment of the 130 patients by the end of '08 or early '09. Although we still expect to be within the window of prior timeline guidance, due to the two-week investigation we are now more comfortable with an early '09 time frame. Once we complete the two-month follow-up and finish analyzing the data, we expect to file the BLA with the FDA in the first half of '09 and then assuming a standard 10-month review, we expect the approval in the first half of 2010.
Now, regarding the severe bleeding indication, I am pleased to inform you that we now have the approval from the British MHRA on behalf of the European Union to conduct a study in soft tissue severe bleeding.
I draw your attention to the fact that the indication and protocol are quite similar to the mild-to-moderate study which is ongoing in the United States. This EU severe bleeding study will be a pivotal study leading to an indication for the use of the Fibrin Pad in severe bleeding in soft tissue surgery. This kind of bleeding is different from the target bleeding in the exploratory Phase II study which we started some time ago in Israel.
Indeed, the Israeli study was purposefully designed to be the most challenging as it addresses the control of severe bleeding when the product is applied directly onto the resected solid organ, such as a kidney, a prostate, a liver or highly vascularized organs, and these organs are not soft tissues.
As you know, we reported a postoperative bleeding event in the Israeli trial. We are conducting an investigation, and pending the conclusion of the investigation of the rebleeding case we have decided to discontinue enrollment of additional patients in that Israeli trial and are focusing on initiating the European trial. But you should understand that the clinical development plan of the Fibrin Pad is proceeding well with a mild-to-moderate study in the United States and a severe bleeding study which will be initiated in Europe in the first half of '09.
Let me give you some details on the European study design. As I mentioned, it is a pivotal clinical study evaluating the safety and efficacy of our Fibrin Pad in soft tissue severe bleeding in abdominal, pelvic, retroperitoneal and noncardiac thoracic surgery. The study is a randomized multicenter clinical study evaluating the superiority of Fibrin Pad versus the standard treatment in controlling challenging severe bleeding in soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.
Alright. Now, moving on to our passive immunotherapy business. Immunotherapy product and byproduct sales amounted to $10.1 million in the third quarter of 2008. And regarding our Phase III clinical trial in the United States for IVIG, the trial is proceeding according to expectations, and we are on track to file the BLA in the third quarter of 2009.
Erik Schneider – UBS
Okay. Great. Evithrom in the U.S., you previously said that it was – had higher sales than Zymo's Recothrom. Both are now in IMS. What is it – what's different about that channel that the IMS data show Evithrom with smaller dollars, but you're confident that they're actually larger?
Robert Taub
No, we don't know what ZymoGenetics sales are other than what we read in a press release from analysts or from their own public statement, so all I can say is that we definitely are way ahead of ZymoGenetics in terms of sales.
Erik Schneider – UBS
Okay. And what we've heard from them is that they're having trouble selling the product and in fact they're seeing pricing pressure in that market, particularly, with hospitals focused on saving money where they can. Have you seen anything like that with either Evithrom or that could be affecting Evicel going forward?
Robert Taub
No, I think that I mentioned in my script that there is a fierce price competition in the thrombin area, and I think ZymoGenetics itself is triggering that. So yes, there's tremendous competition in pricing currently ongoing, but we haven't seen anything in Evicel or in the (inaudible) area. So I don't think it's an overall statement here that has to be made about the Zymo stats in the United States, but rather a very specific thrombin related situation with Kings, ZymoGenetics, Ethicon and Omrix.
Source - seekingalpha

Zymogenetics Q3 highlights

Bruce Carter CEO (ZGEN)
Thank you, Doug. I’ll update you now on RECOTHROM sales. Net sales for the third quarter were $1.8 million versus $1.4 million in the second quarter, a 27% increase. If we discount the wholesale pipeline filling in quarter two, the quarter-on-quarter increase in sales is nearly fourfold. Nevertheless, sales are still low and our focus is and must be to grow sales as quickly as possible.
Year-to-date through September, 177 P&T committees have made a decision about RECOTHROM. Fifty-nine have made RECOTHROM the sole thrombin on the formulary. Fifty-two have added RECOTHROM to the formulary and thus have more than one thrombin product. So 63% of committees have had a positive outcome. Sixty-six committees had declined to add RECOTHROM up to the end of September, which is approximately 37%.
We have now been on the market for most of this year. What have we learned that will help us convince customers to buy our product? We have learned that there is a limited awareness of and ability to properly diagnose bovine-immune mediated coagulopathies from surgeons, nurses, and pharmacists. So we must focus on making customers aware of the occurrence and consequences of bovine-immune mediated coagulopathies.
Second, we have to highlight the advantages of our Recombinant product, RECOTHROM. Third, we’ve been listening to the pharmacists concerns about their budgets and we’ve responded to their concerns with a new pricing strategy.
What are we doing to educate the market with respect to bovine-immune coagulopathies? Well, we recently sponsored a webinar in which surgeons discussed recent cases that they had experienced this year where they had to deal with this issue. The webinar’s educational objective was to create an awareness of the clinical presentation of coagulopathies and to demonstrate the overall impact and consequences to patients and to the hospital’s use of resources. It highlighted three cases from this year showing that this is a current problem.
We’re also convening a consensus panel of expert hematologists, surgeons and pharmacists and this consensus panel will evaluate the scientific evidence and other information available in the area of post-operative bleeding, identifying gaps in the scientific literature and education of health care professionals and we’ll recommend actions to close these gaps.
What are we doing to demonstrate some of the advantages of our product? We will present data from our Phase IIIb trial at the American Society of Hematology in December. This was a 200 patient study using RECOTHROM in patients undergoing repeat spinal or vascular surgery and thus patients having a high likelihood of prior exposure to bovine thrombin and as such, an increased risk of having pre-existing antibodies to bovine thrombin.
The primary objective of this study was to demonstrate that RECOTHROM can be given safely to patients with pre-existing antibodies to bovine thrombin and I would remind you again that the back box falling on bovine thrombin says “patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.”
The third way to influence purchases is of course price and most of the declines that we had through the end of the fourth quarter are related to pricing. We’ve listened to our customers concerns and responded at the beginning of October, with an enhanced discounting program that allows conversion to RECOTHROM while at the same time being budget neutral to these hospitals.
Our new pricing has only been in place since the beginning of October, but we are beginning to see its effect. We have seen hospitals where we had been approved for an addition to the formulary switching to full conversion, but we are very pleased to see hospitals which had previously declined RECOTHROM converting fully to RECOTHROM on the formulary.
We believe that fourth quarter net sales will be in the region of $3 million, a 60% increase on the third quarter and thus 2008 sales will be in the region of $7 million.
We are facing challenges with a long hospital sales cycle and pricing concerns; however, we believe that the Recombinant protein is better than a protein from human or cow blood.
We believe RECOTHROM is best in class with a strong label and product profile and we believe that with our new pricing strategy, we are seeing increased traction in the marketplace. The process has taken longer than we had projected, but we believe RECOTHROM will be the market leader in the coming years.........
Source: seekingalpha

BioSyntech

Established in 1995 and traded on the TSX Venture since 2004, BioSyntech has created and developed innovative biotherapeutic thermogels for regenerative medicine (tissue repair) and therapeutic delivery, which appeal to large unsatisfied markets.
BST-DermOn™ is a topical therapy, which conforms well to the wound and may help stimulate the natural healing process. It may maintain the wound’s moist environment while allowing gas exchange. The wound healing, as well as inherent hemostatic and bacterio-static properties of the chitosan component of BST-DermOn™ has well-documented in the scientific literature. Our animal studies have shown that it stimulates and supports the intrinsic healing process of slow or non-healing wounds.
Claude LeDuc President and CEO BioSyntech Inc. said "As part of the implementation of the streamlined business plan we will concentrate and focus our efforts and resources on advancing BST-CarGel® through the clinic. While we continue to believe strongly in the market opportunity of our other programs, given the current limited financial resources at BioSyntech, enrollment for the BST-DermOnTM clinical trial and development work on BST-InPodTM has been suspended at this time."

Researchers Use New Method to Control Bleeding in Hemophilia

MILWAUKEE, Nov 13, 2008 /PRNewswire via COMTEX/ -- Investigators at Children's Research Institute, BloodCenter of Wisconsin's Blood Research Institute and the Medical College of Wisconsin have discovered a new way to help the blood clot by having the missing clotting factor packaged in the patient's own platelets. In the October 2008 edition of Blood, investigators describe how a gene-modified bone marrow transplant can be used to initiate clotting in hemophilia. This type of approach may work in the 30 to 35 percent of hemophilia patients that have developed inhibitory antibodies against the missing clotting protein.
The bone marrow is removed from the patient and stem cells are treated with Factor VIII, a clotting factor, which is placed in the platelets. The marrow is given back to the patient, who then retains the essential clotting mechanisms to stop bleeding that otherwise would lead to complications.
For people suffering from hemophilia, this research means the potential relief of a constant, burdening disease. People who have hemophilia previously had to be treated every time they bled. Currently, they can receive treatments three times a week, but these are very costly and time consuming. The results from this study provide hope that people with hemophilia could potentially lead a disease-free life.
The scientific community once believed that hemophilia would be treated successfully by gene therapy. Research then showed that gene therapy typically resulted in the patient not retaining a substantial amount of clotting factor, which is integral in preventing serious bleeding.
This research was a collaborative effort that included investigators Qizen Shi, PhD, MD; David A. Wilcox, PhD; and Robert Montgomery, MD.

Vascular Solutions Ranked as One of the 500 Fastest Growing Technology Companies in North America

Vascular Solutions, Inc. today announced that it has once again been included on the 2008 Deloitte Technology Fast 500, a ranking of the 500 fastest growing technology companies in North America. Rankings are based on percentage revenue growth over five years, from 2003-2007.
Vascular Solutions' CEO, Howard Root, commented: "This is the fifth year that we have been ranked as one of the 500 fastest growing technology companies in North America, which is a testament to the continued dedication and hard work of our employees. It is especially pleasing to be able to achieve our 346% revenue growth over the past five years through advancing our mission of delivering excellence in vascular devices. We are honored to be one of just three Minnesota companies on the Deloitte's Technology Fast 500 list for 2008."