Fibrin glue deal talks stalled / Plaintiffs claiming substance caused hepatitis infections uncompensated

Settlement talks have reached an impasse for plaintiffs involved in lawsuits against the government over claims they were infected with the hepatitis C virus after being administered fibrin glue during surgery.
The government has cited that a causal link is unclear between the glue, a compound of fibrinogen and other substances used as a surgical adhesive for stitches made in heart and other types of surgery, and the hepatitis infections.
Since the January enactment of a special measures law to provide compensation to patients, about 600 plaintiffs have reached a settlement with the government. The plaintiffs who received state compensation were infected with the virus after being administered with a fibrinogen blood product.
However, the vast majority of plaintiffs claiming they were infected by the virus after being administered fibrin glue have yet to be compensated.
So far, only four such plaintiffs have reached a settlement with the government, according to a national group of lawyers representing hepatitis C victims that were infected by the virus through tainted blood products.
This leaves about 160 plaintiffs who have been unable to claim what the government says are blanket relief measures.
A 27-year-old man from Kanagawa Prefecture was diagnosed with acute hepatitis after a heart operation when he was 5. His condition is now chronic.
For many years, he did not know what the source of his infection was, but in light of the many media reports on the issue of hepatitis caused by tainted blood products, he made an inquiry to the hospital that operated on him at the end of last year and learned that fibrin glue was used in his surgery.
He brought a case against the government in April, but no progress has been made toward reaching a settlement.
A doctor recommended that he undergo interferon treatment, which is known to be effective for hepatitis C sufferers. But treatments costs several tens of thousands of yen a month, and the man lacks the funds to pay for it.
"The glue may have saved my life, and I bear no grudge against the hospital," the man said. "But I can't think of anything else that could have caused the infection, and I want the government to compensate me soon."
Fibrin glue is believed to have been administered to about 79,000 people in the 1980s.
But the glue is applied to incisions and wounds and differs from fibrinogen, which is used as a hemostatic agent and administered by intravenous injection.
The government has said "the infection rate is unclear because [fibrin glue] is not injected directly into blood vessels."
Settlements have only been reached so far with individuals whose infection is clearly linked to the application of the glue.
"By March, we hope to collect scientific data and establish fixed criteria for settlements," a Health, Labor and Welfare Ministry spokesman said. "Should a clear causal link be found, we'll swiftly begin settlement procedures."
The lawyers group says it has confirmed cases of infection from the use of minute quantities of the glue, and on Friday submitted a written demand to five district courts at which lawsuits are in progress--those in Tokyo, Osaka, Nagoya, Fukuoka and Sendai.
"The glue's danger is clear," the demand states. "[The government] should reach settlements as quickly as possible."

CPC Adds Key Bench Strengths to Medical and Technical Advisory Team

CPC of America, Inc. (OTCBulletinBoard: CPCF.OB) , a company focused on the development of therapeutic devices that enhance the quality of patient care in endovascular procedures, announced the addition of three medical and technical advisors to its team. Dr. Olexander Hnojewyj, Dr. James L. Rogers and Richard E. Anderson will add strategically important bench strengths to the team's expertise as they work to develop MedClose(TM), an investigational*-stage vascular closure system (VCS) that is intended to seal the femoral arterial puncture site following diagnostic or interventional catheterization procedures. Information on CPC's advisory team can be found at CPC's enhanced corporate Web site, CPCMedDevices.com.

Merry Christmas and Seasons Greetings

To All Readers I would just like to pass on my thanks for your support over the past year.

So to all Merry Christmas and a Happy New Year!!!

St Jude Medical acquires Radi Medical Systems for $250 million

US-based St Jude Medical has completed the acquisition of Sweden-based Radi Medical Systems for $250 million in cash.
With this transaction, Radi Medical Systems will become part of the St Jude Medical cardiovascular division. The transaction is expected to be neutral to St Jude Medical's consolidated earnings per share in 2009 and is expected to be positive to consolidated earnings per share beginning in 2010.
St Jude Medical funded the acquisition with cash on hand outside the US as well as with the proceeds from a new three-year term loan established recently with a syndicate of banks.
In connection with the transaction, Banc of America Securities acted as financial advisor to St Jude Medical, and Sidley Austin and Mannheimer Swartling Advokatbyra are serving as legal counsel to St Jude Medical and Katsky Korins and Advokatfirmen Lindahl are serving as legal counsel to Radi Medical.
Daniel Starks, chairman, president and CEO of St Jude Medical, said: "This acquisition will accelerate the expansion of St Jude Medical's cardiovascular growth platform and benefit the customers, employees and shareholders of both companies. We look forward to capturing strategic synergies through this acquisition and further expanding our investment in our cardiovascular division technology, products and programs."
Thomas Engstrom, CEO of Radi Medical Systems, said: "We are pleased to join with the industry leader in active vascular closure and a partner who shares our vision of developing innovative cardiovascular technologies that improve patient care. This transaction brings together complementary product lines and, through St Jude Medical's sales and distribution infrastructure, extends our reach to even more physician customers for the benefit of the patients they help everyday."

Committee For Medicinal Products For Human Use Post-Authorisation Summary Of Positive Opinion For Tachosil

LONDON, Dec. 18, 2008-On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product TachoSil. The Marketing Authorisation Holder for this medicinal product is Nycomed Austria Gmbh.
The CHMP adopted new indications as follows: “to promote tissue sealing and for suture support in vascular surgery”.
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indication for TachoSil will be as follows***: TachoSil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient (see SPC section 5.1)”.

* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.

** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.

Surgical sealant developer sues Omrix

Prof. Uri Martinovich has filed a NIS 3.43 million lawsuit with the Tel Aviv District Court against Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) and its president and CEO Robert Taub for allegedly deprived him of his patent rights to the biological sealant that the company produces. Martinovich is the director of the National Hemophilia Center at Sheba Medical Center Tel Hashomer.
In November, Johnson & Johnson (NYSE: JNJ) acquired Omrix for $438 million. On Friday, Antitrust Authority director general Ronit Kan approved the acquisition, under the Restrictive Trade Practices Law (5748-1988). Taub founded Omrix in 1994.
Martinovich claims that he developed the compound for the biological sealant, but was deprived of his patent rights. He also claims that he was not paid for his invention or for the thousands of hours he spent developing it over ten years. He claims that Omrix violated agreements under which it promised to pay him $1.4 million for the rights to the invention.
Martinovich claims that Omrix paid him only $750,000, but that it refused to pay the $650,000 balance or to give him agreed-upon stock options. He is demanding payment of the amounts he claims he is owed, and to be sold 20,000 shares at $6 per share.
Omrix and Taub have not yet filed a statement of response.
Omrix closed at $24.90 yesterday, giving a market cap of $426 million.
There have been several cases in Israel in recent years in which inventors sued companies for allegedly depriving them of their rights. Cases include collagen-based matrices developer ColBar LifeSceiences Ltd. (which was acquired by Johnson & Johnson unit Ortho-McNeil Pharmaceutical, Inc. in 2006) and miniature implants developer Remon Medical Technologies Ltd.

Avigen Sells Early Stage Research Program in Hemophilia to Baxter

ALAMEDA, Calif., Dec 18, 2008 (GlobeNewswire via COMTEX) -- Avigen, Inc., a biopharmaceutical company, announced today that the company has sold the rights to its early stage blood coagulation compound, AV513, to Baxter Healthcare Corporation, a global leader in hemophilia therapy, for $7 million. Baxter acquired all rights to AV513, a compound poised for clinical research that has been shown to improve blood coagulation in preclinical models for hemophilia. Avigen has been developing AV513 as an oral therapy to treat patients with bleeding disorders, including hemophilia A.
"The sale of AV513 is an example of building value in a product that is differentiated from current therapies, and bringing it to a valuation point that generated a positive return on investment," said Kenneth Chahine, Ph.D., J.D., Avigen's president and chief executive officer. "Our team identified AV513 as a drug candidate with a novel approach for treating hemophilia and other bleeding disorders, and which offered strong IP potential in a target patient population with an unmet need. Because it was outside our neurology focus, it was our goal to follow a reasonable budget to establish AV513's value, and then move it to a better-resourced company with the expertise to develop a safe and effective therapy."
"This technology acquisition supports Baxter's efforts to research the application of novel technologies that will pioneer the next generation of hemophilia therapies," said Hartmut Ehrlich, M.D., vice president of global BioScience research and development for Baxter.

Israeli regulators approve Johnson & Johnson-Omrix deal

Healthcare company Johnson & Johnson said Thursday that it has received antitrust approval from the Israeli General Director of the Antitrust Authority for its proposed acquisition of Omrix Biopharmaceuticals Inc.
Last month, Johnson & Johnson agreed to buy Omrix, which develops and markets biosurgical and immunotherapy products, for about $438 million in a cash tender offer.
Under the deal, Johnson & Johnson commenced a tender offer to buy all outstanding shares of Omrix at $25 per share, which is expected to close by the end of December 2008.
The acquisition, which has the approval of the boards of directors of both companies, is expected to be breakeven to slightly dilutive to Johnson & Johnson's earnings per share in 2009.
Following the acquisition, New York-based Omrix will operate as a stand-alone entity reporting through Ethicon, Inc., a Johnson & Johnson company that provides suture, mesh, hemostats and other products for surgical procedures.

ZymoGenetics Presents Favorable RECOTHROM® Phase 3b Results

ZymoGenetics, Inc. (NASDAQ: ZGEN) presented positive results today from a Phase 3b clinical trial with RECOTHROM® Thrombin, topical (Recombinant). The study provided additional information about the immunologic safety of RECOTHROM and demonstrated that RECOTHROM was well tolerated when applied as an aid to hemostasis in patients, including those with pre-existing antibodies to bovine thrombin.
"In the Phase 3b study, 16% of patients entered surgery with pre-existing antibodies to bovine thrombin,” said Douglas E. Williams, Ph.D., President of ZymoGenetics. "The product label for bovine thrombin states that patients with antibodies to bovine thrombin preparations should not be re-exposed. This study indicates that RECOTHROM can be safely applied regardless of baseline anti-bovine thrombin product antibody status.”
The Phase 3b open-label, single-group, multisite study evaluated the immunogenicity and safety of RECOTHROM among 205 subjects who were at increased risk for having anti-bovine thrombin product antibodies as a result of prior surgery with a high likelihood of bovine thrombin exposure. Topical RECOTHROM was applied during a single spinal or vascular surgical procedure. Immunogenicity was evaluated by enzyme-linked immunosorbent assay at baseline and Day 29. At baseline, 173 subjects (84%) were seronegative and 32 (16%) were seropositive for anti-bovine thrombin product antibodies.
At the end of the study, no patients had developed antibodies against RECOTHROM. The immunogenicity profile of RECOTHROM did not differ among patients who entered the study with or without pre-existing antibodies to the bovine thrombin product.
RECOTHROM was well tolerated and observed adverse events (AEs) were consistent with those commonly seen in post-surgical settings. The most common AEs (reported by 10% or more of subjects) included incision site pain, procedural pain, nausea, constipation, anemia, muscle spasms, hypotension, and pyrexia. The safety results in this study were consistent with those observed in previously reported clinical trials with RECOTHROM.
RECOTHROM is being commercialized by ZymoGenetics and Bayer HealthCare. ZymoGenetics retains U.S. market rights, and Bayer provides its trained surgical sales force to support the first three years of the US market launch that began in early 2008. Bayer acquired rights to RECOTHROM in all markets outside the U.S. and is responsible for commercializing RECOTHROM in global markets.

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."

Natures Superglue

How does an aquatic bacterium that colonizes streams, rivers, and water pipes resist being swept away by a forceful current or running tap water? The answer lies in a bacterially-produced, secreted substance, consisting of polysaccharides (long chains of sugar molecules) along with other unidentified sticky molecules, on the "holdfast" at the tip of its long, slender, stalk-like appendage, with which it affixes itself to solid surfaces.

Professor Yves BrunThe common, hydrophilic bacterial strain Caulobacter crescentus (C. crescentus) is a gram-negative, rod-like bacterium that lives in all sorts of water sources, including lakes, streams, sea water, waste water, and even bottled spring water, attaching itself to solid substrates such as plants, other microorganisms, glass, stone, and metal. Evolution has enabled C. crescentus to live under nutrient-poor conditions, hence its ability to exist even in tap water. Producing no human toxins, its presence in drinking water is innocuous to humans.While studying developmental aspects of C. crescentus, Indiana University biologist Yves Brun and lab members discovered that the bacteria could not be removed with strong washing from plastic overhead transparencies. In contrast, they found that their genetically-manipulated C. crescentus mutants, which lacked these sugar molecules at the tip of the stalk, were no longer able to bind to surfaces. In collaboration, Brown University physicist Jay Tang (formerly of Indiana University) and colleagues determined that three times as much force had to be applied to remove a single C. crescentus bacterium from a glass pipette compared with a pipette containing a similar amount of commercial super glue. Furthermore, they measured the physical force required to remove C. crescentus from its affixed glass surface, determining it to be over an incredible 70 N/mm2 (newtons per square millimeter; about 5 tons/in2), equivalent to the downward force exerted by three cars balancing on a quarter.
This natural, non-toxic glue, which can be found in small quantities in drinking water, has the strongest adhesion force of any known natural material. Unlike commercial super glues, which are often toxic, it sticks well under water, even salt water, and, thus, has a wide range of potential applications, from biodegradable surgical or dental adhesives to repairing industrial surfaces that suffer rain or sea exposure.

Orthovita Q3 comments on Vitasure Intro

Michael Matson – Wachovia
Okay and then just one quick question. Can you give us the VitaSure sales for the quarter?
Anthony Koblish
The VitaSure sales were above $200,000 for the quarter. The product was launched in mid July.
Dale Provanik – Canaccord Adams
Okay and just a client of VitaSure told me that if you from the initial response you’ve seen a couple of hundred grand is pretty impressive considering what the revenue price plan is on that product. How can a contribution in this scale – do you think that you will get 50%, 60%, or 70% penetration relevant to using VitaGel and what does that 10%, what does that equate in annualized dollar rate and 20% just for above any out there?
Anthony Koblish
Well I think that you’ve got to remember that our (inaudible) for VitaGel is really around spine and orthopedics. So it is not the full Gem I [ph] hemostasis field. However, that said the combination of VitaGel and VitaSure is a very nice hemostasis to our surgery product portfolio. That is up quite well with our competitors. At the gen 1 and gen 2 products, it’s a mixed of price point approximately $200 versus upper $400 let’s say and that qualifies for VitaGel and we use them at different points in the procedure. Gen 1 products is typically used intraoperatively while the procedure is being done and the gen 2 product, VitaGel, is pretty much used at the end of procedure as you’re closing with airbrush. So it gives us a nice style of surgery portfolio. That said, I think the growth and expansion of VitaSure is going to look more like VitaGel in its early days than what the bone graft substitute platform looks like. So the nature of the biosurgery business is different.
The nature of that business is really based on getting the product into different surgery in an array of customers whereas the work of our logics in bone grafting business is more driving into a specific procedure and growing deeper and broader. So it’s a little bit of a different sales strategy and so I think with VitaGel we saw that grow a nice pace over time and really start to gain whole as it got broader and broader and broader and we expect VitaSure to do a similar type of penetration as well. But I think right now it’s too early for me to get as specific as what you ask. However, given our experience I think with VitaGel I do feel confident in the way these are rolling out and right now I’d say we’re in the learning mode and that learning is in the part where it is setback into the point where we probably got to go through a few more of the receipt back loops and cycles to see where we are and take a little bit more time. However, I agree with you. We started cold. We didn’t slip any business that was already out there, first 200K was all VITA new relationships. So I do see a great potential with that business and I do think that it will behave similarly with VitaGel over time.
Source: seekingalpha

ZymoGenetics rises following analyst upgrade

Shares of ZymoGenetics Inc. rose Friday after an Oppenheimer analyst upgraded the stock, saying Wall Street now has a more reasonable view of the stock, and more modest expectations for the company's blood clotting drug Recothrom.
With shares down 71 percent over the last year, Oppenheimer analyst Kevin DeGeeter upgraded ZymoGenetics stock to "Perform" from "Underperform." He said sales estimates for Recothrom have decreased over the last few months and noted that ZymoGenetics is reducing the price of the drug.
In afternoon trading, shares gained 21 cents, or 5.3 percent, to $4.20. Earlier they climbed as high as $4.93.
The company cut the price of Recothrom on Oct. 1, the first day of the fourth quarter. When ZymoGenetics reported its third-quarter results on Nov. 4, Chairman and Chief Executive Bruce Carter said the company was already seeing the results of the change: he expects Recothrom sales will rise to about $3 million in the fourth quarter, a 60 percent jump from the third-quarter total of $1.8 million.
In a telephone interview, ZymoGenetics Director of Corporate Communications Susan Specht said the change was made because doctors were "price sensitive" as a result of economic conditions.
Recothrom is derived from a synthetic process, while most clotting agents - products designed to reduce bleeding during surgery - are made from human or animal plasma. Specht said recombinant clotting products such as Recothrom are usually priced at a premium to plasma-derived drugs.
Some patients given cattle-derived anticoagulants develop antibodies that fight the drugs, which can cause increased bleeding.
Even with the change, she added, Recothrom still has a premium to animal-derived products.
Analyst DeGeeter said the cut is intended to make Recothrom more competitive with King Pharmaceuticals ' bovine-derived coagulant Thrombin-JMI. He said he had been concerned in the past that price pressures were going to hurt makers of all clotting drugs.

King Pharmaceuticals Inc. Q3 2008

Commenting on the Thrombin market Joseph Squicciarino - Chief Financial Officer, King Pharmaceuticals said "......with Thrombin the update on the competitive landscape is we're doing very well. Price continues to erode due to competition. We're going to be as competitive as we need to be to keep the business and the market is pretty much going as we predicted because there is no huge unmet medical need for a recombinant product that has no safety advantage."

ZymoGenetics pushes to increase lackluster sales of only drug

ZymoGenetics said Tuesday that quarterly sales for its only commercial product increased by 27 percent but still fell short of expectations, spurring a new strategy to ramp up sales.
"Sales are still low, and our focus is and must be to grow sales as quickly as possible," said Chief Executive Bruce Carter in a conference call to discuss its quarterly financial results.
The product, Recothrom, is a genetically engineered form of thrombin, a blood factor used to control surgical bleeding. Net sales of the product amounted to $1.8 million in the third quarter, versus $1.4 million in the preceding quarter.
The Seattle company reduced prices at the beginning of October and is undertaking a more aggressive campaign highlighting the risks of Recothrom's competitor, a similar product derived from bovine blood. Sales are being held down by hospital concerns about prices and limited awareness among doctors about the compound.
ZymoGenetics posted a third quarter net loss of $28.8 million, or 42 cents per share, down from $39 million, or 57 cents per share, in the same period last year.
ZymoGenetics launched Recothrom in January amid great expectations, but the market has been skeptical about the company's ability to achieve higher sales. Its stock price has suffered accordingly.
Last year ZymoGenetics was the region's largest independent biotech by market capitalization, and its share price peaked at $15. On Tuesday, shares traded at $3.85, up 3 percent; the company's market cap now ranks third among local biotechs.
In May, McAdams Wright Ragen analyst Paul Latta cut his 2008 sales outlook to $18 million from $30 million; other analysts more recently reduced that estimate to about $12 million.
On Tuesday, ZymoGenetics issued its first official guidance for Recothrom, predicting 2008 sales of $7 million. In the long term the company expects to lead the market for thrombin, said spokeswoman Susan Specht.
Some analysts have estimated that eventually Recothrom sales could reach $300 million to $400 million.

The Clotting Cascade and Blood

Highlights Cryolife Q3

BioGlue revenues were a record $36.5 million for the first nine months of 2008, compared to $32.4 million in the first nine months of 2007, an increase of 13%. This increase was primarily due to the aggregate impact of a favorable product mix, and a 4% increase in the number of BioGlue milliliters shipped, which increased revenues by 10%, and an increase in average selling prices, which increased revenues by 3%..........

Other medical device revenues in the third quarter and nine months of 2008 included $549,000 and $726,000 in sales of Hemostase MPH, which we began distributing in May of this year.........

During the quarter we were awarded another grant of $848,000, of which $212,000 has been received from the Department of Defense for our continued development of our BioFoam surgical matrix product. Our CE mark application for BioFoam is targeted to be submitted to our European notified body in December. We would expect that we would receive approval for the BioFoam CE mark in April of ’09.
Our plans are to launch this product throughout Europe beginning in the second quarter of 2009. After CE approval, we plan to conduct several post-approval studies to evaluate BioFoam in liver resections. These will be conducted at three European clinics, with approximately 15 patients per clinic.
For approval in the United States, we will need to submit an IDE application and conduct a clinical trial. We are currently targeting a December submission for the BioFoam IDE. The U.S. human study indication will be as an adjunct to control bleeding following liver resection surgery. We will initially be requesting a pilot clinical study at one or two centers, in 10 to 20 patients. We would expect our follow on pivotal U.S. study to include up to 200 patients. We estimate that it will take about two years to complete the pilot and pivotal studies in the United States.........

Other medical device revenues, which consist primarily of sales of Hemostase MPH, are expected to be between $4.5 and $5.5 million in 2009. Product and tissue processing revenues could be affected by several factors, including but not limited to, the general economic environment, and its effect on demand for the company’s products and processed tissues, and changes in foreign currency exchange rates, and their effects on revenues generated in international markets. Again, this guidance assumes foreign currency exchange rates stay near current levels...............

And from the Q & A.

Greg Brash - Sidoti & Company
Okay, and is the -- just one last question, is the Hemostase MPH, is that tracking your expectations? Are you pleased with how the product is selling and the physician feedback?
Ashley Lee
Yes, we are, we’re getting a lot of attraction with that product, and we think it’s also very complimentary to BioGlue, and we think that it’s had some impact on the BioGlue sales increases.
Greg Brash - Sidoti & Company
Okay, I mean do you think doctors are pretty brand-loyal on this market? Obviously, you’re doing pretty well, and you’re still initial launch year, but are they pretty open to trying the product?
Ashley Lee
They are open to trying the product. When you see it work, it’s a very impressive visual reaction, because it works instantaneously so I think from that stand and it’s effective, so I think that it will continue to grow.
Greg Brash - Sidoti & Company
Okay, thanks guys.

Source: seekingalpha

CPC Appoints Medical Product Service GmbH as Authorized European Representative for MedClose

SARASOTA, Fla., Oct. 29 /PRNewswire-FirstCall/ -- CPC of America, Inc.(OTC Bulletin Board: CPCF), a company focused on the development of therapeutic devices for use in endovascular procedures, today announced that it is implementing a European strategy for the development and distribution of its MedClose(TM) investigational-stage medical device. In the roll out of its strategy, CPC announced an agreement with Medical Product Service GmbH (MPS) of Germany to act as authorized European representative for the Company in seeking European regulatory approval for MedClose(TM) Vascular Closure Device(VCD). MedClose(TM) is an extravascular puncture-closure device intended to be used with a biological sealant for diagnostic and interventional cardiovascular procedures. According to published third party research, European VCD market sales for2008 are projected to total approximately $160 million. Industry experts forecast that in Europe, the penetration of VCDs into minimally invasive cardiovascular procedures will experience a 9% compound annual growth rate and drive VCD sales and revenues."The European Union offers significant opportunities to broaden theMedClose(TM) market potential," said Rod Shipman, chairman and chief executive officer of CPC of America. "By aligning ourselves with MPS, we are setting a critical path to market in Europe. Our team will work closely with MPS inbuilding key partnerships and navigating the European regulatory regime and clinical trials. We recognize the need for a safe, reliable closure system that reduces time to hemostasis and allows for faster patient ambulation and,when necessary, wound re-access. With MedClose(TM), we aim to fill that need in the U.S. and Europe."As CPC's authorized representative in Europe, MPS will provide service under the respective CE marking requirements that apply in the European Union.MPS's role will include vigilance reporting, communicating with competent authorities in individual member states, assisting in securing international product registrations, and preparing and completing dossiers for clinical trials and CE markings."MPS knows that physicians operating in catheter laboratories across theEU demand precise instruments that help improve patient safety and outcomes,"said Gehard Fromel, Principal Regulatory Consultant of MPS. "We are eager to collaborate with CPC to bring to market a product that may help the European medical community and their patients."
About Medclose
The MedClose™ VCS is a medical device that is designed to seal femoral arterial puncture sites in patients who have undergone diagnostic or interventional catheterization procedures. It utilizes a proprietary catheter delivery vascular closure system that is designed to enhance manual compression by delivering a biologic sealant which creates an elastic coagulum that is fully resorbed within 10 to 14 days.

Falling apart over Omrix

When I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment. It now turns out that while Omrix may not be of the all or nothing genre, it is a real madhouse for investors like me, who were looking for an oasis of tranquility in the biotechnology sector, a sector that has traditionally been fraught with risk.
Since the beginning of the year, Omrix has managed to issue a severe warning (in March) for the fourth quarter of 2007, plunge heavily, and replace its CFO a second time. At the beginning of this month, on the eve of Yom Kippur of all times, it issued an announcement in which it reported positive interim results in the important trial of its advanced surgical sealant, following which the share rose strongly, just as the collapse on the markets was moving into high gear. The news made the fast a bit easier to handle, but the joy was short-lived.
By the next day, Yom Kippur itself, Omrix had already updated investors with the announcement that it was halting the trial due to the occurrence of a critical fault, just a day after declaring it a success. Investors like me switched on their computers after Yom Kippur ended, only to find that the share had plummeted for the second time in six months. Later on in the month, Omrix tried to put the fiasco of the failed trial behind it with a reassuring announcement to investors about a strong third quarter. But Omrix's weary investors found little cause for cheer, and the share barely moved at all.
The denouement came last Friday when Omrix joyfully announced the resumption of the trial, as if nothing had happened at all. "We got it wrong, there was no fault," was what the announcement amounted to, and the company's share regained just a small part of the ground it lost on Yom Kippur. One can imagine how investors, who abandoned the stock on Yom Kippur after it crashed 40% following the announcement of the fault, felt last Friday when Omrix revealed it never actually happened.
The analysts covering Omrix are also finding that their patience is wearing thin. In its latest review, Citigroup describes the company's astounding u-turn as "one step forward, three steps back, one step forward." It assumes that the fault occurred for one of two reasons - either a technical failure due to human error, or bleeding in another place not treated by the sealant. Until such time as they receive further clarification, which will most likely be forthcoming on November 6, when Omrix unveils its results, Citigroup's analysts are retaining the lukewarm "Hold" recommendation they issued following the company's stiff warning in March, with a target price of just $15.
On top of all this, the Omrix roller coaster has been dogged by sporadic rumors that it could be sold for around $25 a share. The identity of the possible buyers regularly changes. Among those rumored to be in the frame are Ofer Group, Johnson & Johnson Inc. (NYSE: JNJ), Omrix's partner in the marketing and development of the aforementioned sealant and, according to "Globes", also European pharmaceutical giant Bayer AG (LSE: BYR; XETRA: BAY).

Source: Globes

Omrix Biopharmaceuticals Announces Patient Enrollment Will Resume In Fibrin Pad U.S. Phase II Clinical Trial In Mild to Moderate Bleeding

Omrix Biopharmaceuticals, Inc. ("Omrix”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that the Fibrin Pad U.S. Phase II clinical trial in mild to moderate bleeding will resume patient enrollment and continue with no modifications.
On October 9, 2008, the Company announced that the U.S. Phase II clinical trial had been suspended in order to investigate an incident of post-operative bleeding. This event met the stopping rules, as outlined in the clinical trial protocol.
Per the clinical trial protocol, upon the suspension of the study, a Data Safety Monitoring Board, or DSMB, reviewed the data related to the event. The DSMB has concluded their investigation and authorized the trial to recommence.
About the Fibrin Pad
The Fibrin Pad builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

Excerpt Vascular Solutions Inc. Q3 2008

.........Our highest sales product category in the third quarter was our hemostat products, with $5.8 million in net revenue in the third quarter, a decrease of 4% from the third quarter of 2007. The three causes for the decline were the continued reduction in sales of our Duett sealing device, which is our legacy product that we have chosen to not actively promote, the as-planned conversion from hospital pricing to distributor pricing in Germany as a result of the switch to a distributor sales model, and the decline in sales to King Pharmaceuticals.
In the third quarter of 2008, King purchased $90,000 of Thrombi-Gel and Thrombi-Pad, with an additional order planned but delayed by us until the fourth quarter due to our recently completed facility expansion. We recently -- we expect King purchases to continue at the current level until we receive FDA approval for the surgical indication for the Thrombi-Gel product, which we currently target for the end of 2009.
D-Stat Dry sales were essentially constant on a sequential quarter basis, as we have maintained our leading market share in the face of intense price competition from the non-thrombin patches.

Omrix Q3 revenue beats Wall Street view

Oct 20 (Reuters) - Biopharmaceutical company Omrix Biopharmaceuticals Inc reported a 35 percent rise in its third-quarter revenue, beating analysts' average estimate, and raised its full-year product sales outlook.
The company reported preliminary quarterly revenue of $21.3 million, compared with $15.8 million a year earlier. Analysts on average expect the company to post a revenue of $19.1 million, according to Reuters Estimates.
Omrix sees 2008 product sales of $70 million to $72 million, up from its prior forecast of $68 million to $71 million.
The company reaffirmed that it expects its biosurgery product sales in 2008 to increase about 75 percent from a year ago.
The company said its product sales guidance is partly based on the current biosurgery sales outlook provided by Ethicon Inc, a unit of Johnson & Johnson.
Ethicon has exclusive sales and marketing rights to Omrix's biosurgical products in the United States and the European Union.
Omrix shares closed at $14.48 on Friday on Nasdaq.

New Cardiology Agreement for Abbott

CHARLOTTE, N.C., Oct 09, 2008 (BUSINESS WIRE) -- Premier Purchasing Partners, LP, today announced new agreements for hemostasis and compression products for use in cardiology with Abbott Laboratories, Inc. of Abbott Park, Ill., and TZ Medical, Inc. of Portland, Ore.
The 36-month agreements, effective November 1, 2008, are available to acute and continuum of care members of the Premier healthcare alliance.
About Premier Inc., 2006 Malcolm Baldrige National Quality Award recipient
Serving more than 2,000 U.S. hospitals and 53,000-plus other healthcare sites, the Premier healthcare alliance and its members are transforming healthcare together. Owned by not-for-profit hospitals, Premier operates one of the leading healthcare purchasing networks and the nation's most comprehensive repository of hospital clinical and financial information. A subsidiary operates one of the nation's largest policy-holder owned, hospital professional liability risk-retention groups. A world leader in helping healthcare providers deliver dramatic improvements in care, Premier is working with the United Kingdom's National Health Service North West and the Centers for Medicare & Medicaid Services to improve hospital performance. Headquartered in San Diego, Premier has offices in Charlotte, N.C., Philadelphia and Washington. For more information, visit www.premierinc.com.

Cohera Medical Wins Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award

PITTSBURGH, Oct. 20 /PRNewswire/ -- Cohera Medical Inc. today announced that it has received the Pittsburgh Technology Council's 2008 Tech 50 Rising Star Award. The Tech 50 Awards recognize accomplished technology-oriented companies in southwestern Pennsylvania. The Rising Star award is given to a young (less than three years old) entrepreneurial company that offers the most unique products or services among the contending companies and shows promise of becoming a significant economic force in the area. "We are extremely pleased that Cohera Medical's tissue adhesive technology has been recognized for its innovation and economic potential,"said Patrick Daly, chief executive officer of Cohera Medical. "TissuGlu(R),our lead product candidate for use in securing planes of tissue in plastic surgery procedures, is a truly novel product candidate that shows significant potential for improving clinical outcomes and patient care. We also look forward to developing our surgical adhesive technology for otherproducts as well."

About Cohera Medical Cohera Medical Inc. is a Pittsburgh-based company that is developing are volutionary line of wound management products and surgical adhesives.Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is a sprayable bonding agent for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation and small bone fixation, which will fill similar market needs in both orthopedics and general surgery. For more information, visit http://www.coheramed.com. TissuGlu and the other Cohera products have not yet been approved for medical use by the Food and Drug Administration (FDA) in the U.S. or by any other country's regulatory authority.

Highlights from Baxter Q3 Earnings Report

..........First, within our regenerative medicine business, we continue to augment our biosurgery portfolio. During the third quarter, we announced a licensing agreement with Innocoll Pharmaceuticals for exclusive US marketing rights for their gentamicin surgical implant. This is the first biodegradable, antibiotic surgical sponge used as an adjunct therapy for prevention and treatment of surgical site infections. This product is already approved and available in 49 countries and is currently in two Phase III clinical trials in the United States.
Also within regenerative medicine, we are advancing programs and achieving milestones with our partners, Kuros Biosurgery AG. This partnership is focused on the development and commercialization of a portfolio of hard and soft tissue repair products. These products will be based on Baxter's fibrin-based biomatrix TISSEEL fibrin sealant, combined with Kuros proprietary biologics and associated binding technology.
Our development partner Kuros is currently enrolling patients in a number of Phase II clinical programs which if successful and confirmed in Phase III trials, will allow us to enter the fast-growing orthobiologic market.
...........Turning to the Plasma business. In the quarter, plasma protein sales of $338 million increased 37% with currency benefiting sales by 11 percentage points. Performance continues to be driven by the ongoing double-digit growth in global demand for plasma proteins and improved pricing. US plasma protein sales increased 7%, while international sales increased 59%. As we discussed last quarter, strong international growth was expected due to a difference year-over-year in the timing of shipments for FEIBA and PD Factor VIII tenders in the Latin American markets.
Antibody therapy sales increased 25% and totaled $307 million with currency benefiting sales by 3 percentage points. Growth was once again driven by conversion to GAMMAGARD LIQUID, pricing improvements, and strong growth in demand. Sales of our Regenerative Medicine business totaled $104 million and increased 27% with currency contributing 6 percentage points of growth. This is the result of growth of our core portfolio of products, TISSEEL, FLOSEAL and COSEAL.

Omrix shares whipsaw on Evicel nod

Omrix Biopharmaceuticals Ltd. probably wants to forget last week, when its share fell 35% after the clinical trial of its fibrin pad was suspended because of safety problems. Subsequently, however, and without any new announcement about the trial, the share recovered half the loss. Omrix closed at $15 yesterday, giving a market cap of $256 million, up from its low point of $11.60 five days after the trial suspension was announced.
Yesterday's 3.4% rise in Omrix's share can be attributed to the company obtaining European Medicines Agency (EMEA) marketing approval for Evicel liquid fibrin sealant, the company's surgical sealant and the product of its kind in the US. Johnson & Johnson (NYSE: JNJ) Ethicon Inc., which markets Evicel in the US, will also market it in Europe.

Omrix Biopharmaceuticals Receives Approval from European Medicines Agency for Evicel Liquid Fibrin Sealant (Human)

NEW YORK - (Business Wire) OMRIX Biopharmaceuticals, Inc. (“Omrix” or the “Company”) (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received approval from the European Medicines Agency (EMEA) for Evicel, the Company’s liquid fibrin sealant.
The EMEA’s approval permits EVICEL to be marketed in Europe under the following indication, “As a supportive treatment in surgery where standard surgical techniques are insufficient for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery.”
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a general hemostasis in surgery indication.
With an EMEA approval, EVICEL is licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix’ and ETHICON’s supply and distribution agreement, ETHICON has the marketing rights for the EU.

About EVICEL

EVICEL™ is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL™ is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing.

St. Jude Medical Announces U.S. and European Approval of Angio-Seal Evolution Vascular Closure Device

St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approval of the Angio-Seal(TM) Evolution(TM) Vascular Closure Device. The approval and global launch was announced at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.
The Angio-Seal Evolution device is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures. Effectively sealing the puncture helps achieve hemostasis (cessation of bleeding) quickly, enabling the patient to walk and resume activities sooner.
The Angio-Seal Evolution platform features an entirely new delivery system that significantly reduces the variability that can occur as physicians deploy and secure the Angio-Seal closure system. Consistent with its Angio-Seal predecessors, Angio-Seal Evolution achieves hemostasis through the deployment of an anchor, suture and collagen seal (each of which is bioabsorbable). With Evolution, however, single-handed deployment has been made possible for the first time, which enables physicians to more easily support the puncture site. The new device's automated collagen compaction system ensures consistent compaction of the collagen against the exterior wall of the vessel reducing procedural variables. With fewer variables in device deployment, physicians gain greater control and consistency in achieving rapid, safe and reliable hemostasis for their patients.
"The Angio-Seal Evolution takes a major step forward by automatically compacting the collagen," said Robert J. Applegate, M.D., Wake Forest University Baptist Medical Center, Winston-Salem, N.C. "The confidence it provides physicians in closing the puncture in such a short period of time with such effectiveness is outstanding."
More than 13 million catheterizations are performed worldwide each year to open narrowed or blocked arteries and perform other cardiovascular procedures. During catheterizations, physicians insert a catheter (a thin tube) through a puncture made in the femoral artery in the upper thigh and guide it through the blood vessels to the point of care. Treatments such as balloons, stents and medications are then delivered through the catheter. Once a procedure is complete and the catheter is removed, bleeding from the puncture in the femoral artery must be stopped quickly.
Unlike most vascular closure devices, the Angio-Seal Evolution closure system is fully absorbed by the body within 60 to 90 days. This reduces risks associated with foreign material left permanently in the body and allows for repeat procedures without concerns about prior placement of closure devices.
"The Angio-Seal Evolution embodies St. Jude Medical's commitment to providing physicians with more control over patient outcomes while reducing procedural variability," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. "We are confident the Evolution platform will further enhance Angio-Seal's position as the recognized leader in vascular closure and provide physicians with increased confidence in the ease of device deployment and predictability."

Ceremed Announces Collaborative Effort to Produce ApaTech's New Spinal Implant Actifuse(TM) Shape

LOS ANGELES, Oct 14, 2008 /PRNewswire via COMTEX/ -- Ceremed Inc. announced today that its collaborative effort with ApaTech Limited, a London based manufacturer of products for bone grafting, has resulted in the launch of ApaTech's latest product, Actifuse(TM) Shape, a novel, formable bone grafting solution. The new product combines Ceremed's AOC(TM) Biosoluble(TM) polymer with ApaTech's proprietary Actifuse(TM) microgranules. The resulting product's biostimulative properties are optimized by AOC's ability to be molded or cut to the contours of the grafting site.
The synthetic blend of alkylene oxide copolymers in AOC(TM) is water soluble allowing them to dissolve. The unique properties of the product include the dissolution of the product without swelling or inflammation as seen with some implant materials. The dissolved product is then eliminated from the body without further breakdown.
The launch of Actifuse Shape represents the culmination of a two year collaborative effort between the companies. The product will be manufactured in Ceremed's Los Angeles facility and shipped to ApaTech's distribution points in the UK and US. Ceremed has licensed the AOC(TM) technology to ApaTech Limited as the first of many projects in which the AOC(TM) technology is used as a passive carrier for bioactive materials and therapeutic agents. Several other derivative products related to the AOC(TM) technology are planned for release in the coming year. Ceremed currently distributes its Ostene(TM) bone hemostasis product in the United States and Europe.
"Ceremed is committed to the design and development of unique medical polymers to enhance the effectiveness of surgical procedures," says Tadeusz Wellisz, M.D., CEO of Ceremed. "We are actively seeking strategic alliances that greatly expand the impact of our products on the medical market. Ceremed's ability to rapidly bring products to market combined with the expertise in developing unique polymer blends makes us an exceptional partner for co-development."

Postoperative Bleeding Halts Fibrin Pad Trial; Omrix Falls

Only a day after reporting positive interim results from a Phase II study of its Fibrin Pad product in mild to moderate bleeding, Omrix Biopharmaceuticals Inc. said the study has been suspended to investigate an incident of postoperative bleeding.

Shares of the New York-based firm (NASDAQ:OMRI) plunged 34.5 percent, losing $6.14 Thursday to close at $11.67.

Interim analysis from the U.S. Phase II study, conducted after 90 patients were randomized 2-to-1 to receive Omrix's Fibrin Pad or Surgicel (Johnson & Johnson), showed that the Fibrin Pad was superior to Surgicel in controlling mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic and thoracic surgery.

The trial was designed to measure the proportion of subjects achieving hemostatic success at four minutes after randomization without requiring additional treatment during a subsequent six-minute observation period.

The trial was to continue enrolling patients until at least 100 subjects had been treated with Fibrin Pad, and prior to announcing the trial suspension, Omrix said it had expected to complete that enrollment by the end of this year or early next year.

The company has not disclosed any details of the suspension at this time, and representatives of Omrix could not be reached for comment.

The Fibrin Pad is designed to use the company's aprotinin-free fibrin sealant technology, the same technology that helped create Evicel, a liquid fibrin sealant that gained FDA approval as an adjunct to hemostasis in patients undergoing surgery when control of bleeding by standard surgical technique is neither effective nor practical.

As a next-generation, absorbable biosurgical product, the Fibrin Pad comprises a flexible biodegradable matrix that's coated with human fibrinogen and human thrombin and is designed to help form instant clots for rapid control of bleeding and for possible use on active bleeding sites.

It was not clear from the company's release when the incident of postoperative bleeding occurred in the U.S. Phase II trial, though analyst Jonathan Aschoff, of Brean Murray Carret & Co., wrote in a research note that it occurred after the 90th patient was enrolled and, therefore, was not included in the interim analysis.

Omrix also reported data from a separate ongoing Phase II trial in Israel that is designed to test Fibrin Pad in severe bleeding when the product is applied primarily on the bleeding site. And in that study, four patients have been treated to date with Fibrin Pad, one of whom experienced postoperative bleeding.

"While the detailed reason for this serious adverse event is still under investigation, the fact that it occurred in two patients treated with the Fibrin Pad so far" raises questions as to the product's safety profile, Aschoff wrote, adding that there likely would be some delay in the program, for which he previously had projected a mid-2010 market launch.

Omrix also has submitted an application to UK regulatory authorities to begin a pivotal study of Fibrin Pad in soft tissue severe bleeding when applied adjunctively to the standard of care. That application is under review.

In addition to Evicel, Omrix markets Evithrom (topical human thrombin), a blood-clotting protein - using the same thrombin component as Evicel - for controlling bleeding during surgery. Evithrom gained approval in 2007 and is distributed by a division of Somerville, N.J.-based Ethicon Inc.

Outside of biosurgery, the company is developing several immunotherapy products, including intravenous immunoglobulin (IVIG) for immune deficiency and autoimmune diseases, as well as other antibody-based products targeting hepatitis B, West Nile virus and smallpox vaccine-related complications.

Omrix recorded total revenue of $19.2 million for the second quarter - $18.2 million of that came from product sales - and posted a net income of $3 million, or 17 cents per share. As of June 30, the firm had a cash position of $83.1 million.