Recothrom, Evithrom, Thrombin JMI

Anyone interested in Thrombin, Zymogenetics, King and J&J should follow this blog by Joe Tartakoff.
During last week's ZymoGenetics conference call, Ed Tenthoff of Piper Jaffray asked ZymoGenetics CEO Bruce Carter if he was noticing any moves by Johnson & Johnson.
Here's the exchange:
Tenthoff: Can you just update us on where pricing is for RECOTHROM and how some of the competitors have responded, and there's, you know, we've noticed very little in terms of noise from Evithrom ...
Carter: With the bovine thrombin, we are seeing a limited discounting... And like your search for J & J (Johnson & Johnson), I guess it's fair to say they are out there, but perhaps not as much as one might have expected from the name Johnson & Johnson. In fact, I could go stronger, surprisingly little considering it's Johnson & Johnson.
Omrix Biopharmaceuticals, which sells Evithrom along with Johnson & Johnson, begs to disagree.
During Omrix's conference call to report its results, CEO Robert Taub was asked how he would characterize "your market share for thrombin versus competitors, including both King and ZymoGenetics."
His response:
"I think we -- well we'll put it this way. Obviously our market share of thrombin is lower than King and it is higher than ZymoGenetics."
Then, another analyst pressed him on why that was the case, considering that the conceptual risks associated with cow-derived thrombin (that patients would develop antibodies against the product) would probably be the same with a human-derived one.
Taub's response:
Bovine thrombin has been around for so many years, and the arguments about antibody formation, it's not very convincing and you have to be very careful. I heard that the FDA gave a warning just two or three days ago to some very aggressive promotional literature by ZymoGenetics on that. So the need, if you want, to change is not very high. So I think what's really driving it is contracts, introduction in the hospitals, bundling, and sales mention and service at this stage.
Still, Taub conceded that the thrombin market was a difficult one to break.
In a release last week announcing its first-quarter results, the company said Evithrom sales "continue moderate growth." Read the release here.
And during the call, Taub used the word "slow" twice to refer to the market for thrombin:
... As we have expected the stand-alone thrombin market is and will change slowly. It's a slow process. While stand-alone thrombin will continue to to be an important product, we also continue to believe that long-term thrombin growth will ultimately be driven by thrombin-based enhanced hemostats, where thrombin is combined with other agents such as various forms of gelatin and which will be easier to use.
Overall, it seems that Evithrom is running into many of the same hurdles as ZymoGenetics, which is having to wait for hospitals that have used the King product for years to vote to allow the use of Recothrom.
Taub:
... There seem to be very low awareness of any risks related to bovine thrombin. And the manufacture of bovine thrombin has been sitting on their market position for a long time and the ramp up is slow, because of the P&T (hospital) committees, and these contracts that have to be done... There is also less way to innovate unless you develop, which we are planning and doing with J & J.
Source: SeattlePI

Haemacure Reports on Financing Progress

MONTREAL, June 2 /CNW Telbec/ - Haemacure Corporation (TSX : HAE), a Montreal-based specialty bio-therapeutics company developing high-value humanplasma-derived protein products for commercialization, provides financing update and reports on second quarter results. Financing As a result of the commitments Haemacure has received to-date from key shareholders to exercise their Series B warrants, the Corporation is wellpositioned to meet its objective of commencing the fibrin sealant pivotalPhase II/Phase III clinical trials. The Corporation remains on schedule and onbudget with the construction of its manufacturing facility. "We are very appreciative and encouraged by the strong support we have received from our major shareholders, Firebird Management and PinetreeCapital, as demonstrated through the exercise of their Series B warrants."said Joseph Galli, Chairman and CEO of Haemacure. "This support, coupled with the recent addition of Reinaldo Diaz to our Board of Directors and the hiring of senior managers at our facility, are elements of our value creation strategy that will make Haemacure a significant player on the global scale."concluded Mr. Galli.

Reinaldo M. Diaz
Reinaldo Diaz has over 25 years of experience in the biopharmaceutical industry. Prior to joining Celtic Pharma, he was Managing Member and Co-Founder of D&A Capital Management, LLC (“D&A Capital”), a firm focused on asset management and providing advisory services to companies in the Healthcare sector, particularly biopharmaceutical companies. D&A Capital, through affiliated entities, managed the Delta Opportunity Funds (“Delta”), a group of hedge funds with over $100 million in assets under management.

Novo Nordisk and Neose Announce Completion of Initial Phase 1 Clinical Trial

COPENHAGEN, Denmark & HORSHAM, Pa.--(BUSINESS WIRE)--Novo Nordisk A/S (NYSE:NVO) and Neose Technologies, Inc. (Nasdaq GM:NTEC) today announced that Novo Nordisk has completed the initial Phase 1 clinical trial with NN7128 (GlycoPEGylated Factor VIIa), a long-acting version of NovoSeven® Coagulation Factor FVIIa (Recombinant) administered intravenously. The trial assessed the safety and pharmacokinetics of NN7128 in 30 healthy subjects.
In the trial a significant prolongation of the half-life of NN7128 was observed. Furthermore, single doses of NN7128 were well tolerated with no serious adverse events.
“We are pleased to report the successful completion of this Phase 1 study and to have demonstrated a prolonged half-life of NN7128,” said Søren Bjørn, Corporate Vice President, Biopharm Research at Novo Nordisk. “As we continue our analysis of the data collected in this study, we look forward to presenting the full results at upcoming scientific and medical meetings.”
“We are encouraged by the safety and pharmacokinetic profile that NN7128 has demonstrated in this Phase 1 study,” said George J. Vergis, Ph.D., Neose President and Chief Executive Officer. “We look forward to continued progress in the clinical development of this compound.”

Recothrom's April sales

Kevin DeGeeter, an analyst at Oppenheimer & Co., put out a report today saying that Recothrom, ZymoGenetics' treatment to stop bleeding during surgery, had $92,589 in April sales, substantially below his estimate of $750,000 for the month. He cited IMS, the market research firm.
By contrast, April sales of King Pharmaceuticals' Thrombin-JMI, which directly competes with Recothrom, jumped 11.5 percent to $23 million, according to IMS.
King has dominated the market for more than a decade and is now facing competition from both Recothrom (which was approved by the FDA in January) and Johnson & Johnson's Evithrom (which went on the market last year).
DeGeeter -- who has been bearish on Recothrom's prospects since its launch -- says:
"While we acknowledge the limitations of monthly sales data, the IMS numbers are not consistent with the upbeat comments from ZGEN management on the pace of product adoption.
ZymoGenetics has said that most of Recothrom's sales will take place during the second half of the year. Because Recothrom is bought by hospitals, committees at those institutions have to meet in order to decide whether to add the treatment to the selection of products that doctors can choose from to use. The process can take six months or more."
I e-mailed ZymoGenetics spokeswoman Susan Specht and asked whether the April sales numbers were in line with the company's expectations.
She said:
"The selling process is a long one and could take six months or more to work through with each hospital. We're making progress and expect that work to pay off in the second half of the year."
Source: The Life Sciences Blog

Cryolife Presentation

Cryolife full presentation is available for 90 days scroll down this page to find the link.
KEY Slides CLICK TO IMAGE TO ENLARGE

Celox-A delivery system

Just recieved the Video of Celox-A delivery system I would like to share with you all below and the Pdf downloadable from Adrive and verified safe HERE

Polymer Technology Group (PTG) in-licenses bioresorbable polymers from Bezwada Biomedical

Ronald Trahan Associates Inc. Ronald Trahan, 508-359-4005, x108 APR The Polymer Technology Group, Inc. (www.polymertech.com), a preeminent biomaterials company, announced today that it has in-licensed a family of bioresorbable polymers from Hillsborough, N.J.-based Bezwada Biomedical L.L.C., whose founder and president, Rao Bezwada, Ph.D., will also serve as a consultant to PTG. Terms of the agreement
were not disclosed. Polymers specifically designed to degrade under physiological conditions are often referred to as "absorbable", "biodegradable" or "bioresorbable" polymers. With this in-licensing event, PTG will now be able to offer a wider range of new and generic bioresorbable polymers to the medtech industry for use in medical devices, drug delivery and tissue engineering. "We are very happy to be working with Dr. Bezwada, who has more than 25 years of research experience in the medical device industry, including 20 years of service at Ethicon (Johnson & Johnson) prior to establishing Bezwada Biomedical in 2003," said Bob Ward, CEO of PTG. "He has been a prolific inventor (72 issued U.S. patents), has published extensively and presented frequently at both national and international meetings, including the American Chemical Society and the Society for Biomaterials," added Ward. Ward and Dr. Bezwada will make a joint presentation--"A vertically integrated approach for tailoring bioresorbable polymers: from monomers to implantable devices"--at a "Corporate Lunch Forum" on Friday, May 30th, during the upcoming 8th World Biomaterials Congress (May 28-June 1) in Amsterdam.

The polymers will find applications in:

• Minimally invasive surgery as absorbable tissue adhesive and sealant


• Drug delivery and wound care


• Medical devices
  
• Tissue engineering

HemCon Medical Technologies Leverages Sangui Technology to Expand its Wound Care Products Line

PORTLAND, Ore.--(BUSINESS WIRE)--HemCon Medical Technologies Inc. today announced it will use Witten, Germany-based SanguiBioTech GmbH’s ChitoSkin technology platform to help further innovations in hemostatic bandages and wound care dressings for the acute care market.
Under the terms of the agreement, HemCon will leverage Sangui’s technology platform to enhance and expand its product offerings for surgical and wound care. HemCon developed the chitosan-based hemostatic HemCon® Bandages and ChitoFlex® dressings that are used by military and medical first responders as well as health care professionals around the globe.
“We explored a wide variety of technology platforms to add to our new surgical and wound care offerings and feel that the Sangui chitosan platform offers great opportunities to enhance our solutions,” said John W. Morgan, president and CEO of HemCon. “We’re committed to continuing our investment to develop new choices for medical professionals and consumers. This agreement is an important step forward in realizing the full potential of chitosan-based products.”
SanguiBioTech GmbH is a wholly owned subsidiary of Sangui BioTech International, Inc. Sangui BioTech International focuses on vascular and hemostasis products. The firm specializes in developing oxygen-carrying agents to treat blocked arteries, anemia or acute blood loss through SanguiBioTech GmbH.
“We are proud to enter into an agreement with HemCon and offer our chitosan platform to help innovate new surgical and wound care products,” said Sangui Managing Director Hubertus Schmelz. “There is definitely a demand for products that can adapt to specific medical needs, especially as it relates to wound care.”
HemCon retains exclusive worldwide market and distributing rights for products developed under this structured financial agreement. HemCon will submit developed products for U.S. approvals to the FDA, while Sangui will prepare documentation for registration in the European Union.

CryoLife to Present at FBR Capital Markets Annual Spring Investor Conference

ATLANTA, May 27 /PRNewswire-FirstCall/ -- CryoLife, Inc. NYSE: CRY, a biomaterials, medical device and tissue processing company, announced today that it is scheduled to participate in the FBR Capital Markets Annual Spring Investor Conference, Thursday, May 29, 2008 at the Grand Hyatt Hotel in New York City.

Steven G. Anderson, president and chief executive officer of CryoLife, Inc., will present at 12:50 p.m. Eastern Time.

CryoLife's live presentation may be accessed through its Web site, HERE, on the Investor Relations page. An archived copy of the presentation will be available for 90 days on the same Web site.

ZymoGenetics Announces FDA Approval of RECOTHROMTM 20,000-IU Vial Size and Co-Packaging with Spray Kit

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that the United States Food and Drug Administration (FDA) has approved a Prior Approval Supplement application for a 20,000 international unit (IU) vial of RECOTHROMTM Thrombin, topical (Recombinant) and also approved co-packaging of the 20,000-IU vial with the ZymoGenetics Spray Applicator Kit.
“RECOTHROM, the first and only recombinant thrombin, is now available in both 5,000 and 20,000-IU vial sizes,” said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. “Within two weeks, we’ll be ready to ship the 20,000-IU vials, as well as spray kits co-packaged with the larger vial. This product introduction will provide our customers with flexibility to meet their needs while enhancing our ability to convert hospital thrombin usage to RECOTHROM. Additionally, we believe that our spray kit has design and convenience advantages, based on market research conducted with surgeons.”
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood.