Monday, June 2, 2008

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.
... 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.”