TSX Delisting Review - Haemacure Corporation (HAE)

TSX is reviewing the common shares of the Company with respect to meeting the continued listing requirements. The Company has been granted 150 days in which to regain compliance with these requirements, pursuant to the Remedial Review Process.

Surgical Adhesive Polymer Company Seeks Partners

Tissuemed has already brought to market the TissuePatch product family of multilaminate absorbable surgical sealant films. These are a range of thin, synthetic, highly adherent films that act as a barrier to air, blood and other fluids encountered in surgery.  More adherent than surgical glues, the films require no preparation and are effective within 30 seconds of contact. The technology demonstrated in these products has the ability to form the basis for new technologies or iterations of existing products. The Leeds based company is offering other companies the chance to benefit through a technology partnering initiative. The scheme, under the banner of Tissuemed Adhesive Biomaterials Technology Group, takes the form of a bespoke polymer design, synthesis and manufacturing programme that is open to third parties such as companies whose own medical devices could be enhanced by the incorporation of adhesive characteristics, surfaces or components. Examples of the types of surgical devices that may benefit from being self-adhesive to internal organs and structures include meshes, sutures and films as well as an array of implantable devices that may currently require physical means of anchoring. The programme offers companies and surgeons the chance to work with Tissuemed’s team of dedicated scientists to develop bespoke polymer designs and add new functionalities to their own products. It also offers support in a range of other areas including clinical and regulatory, physical and biochemical testing, intellectual property protection and sales and marketing expertise. Nick Woods, CEO of Tissuemed, comments, “In the same way that surgical staples revolutionised many surgical procedures in the eighties and nineties, we believe surgically effective adhesive compounds have the capability to drive advances in surgery in the foreseeable future.

Cryolife vs. Medafor - lawsuit threatens Hemostase agreement

Cryolife have recently filed legal action against Medafor Inc. Medafor is the manufacturer of Hemostase MPH which was previously distributed under the name Arista. It is also sold by Orthovita under the brand name Vitasure.

Cryolife commented on the pending action "......we may be unable to effectively leverage our existing sales force to sell HemoStase, the lawsuit we filed against Medafor regarding our distribution agreement with Medafor may adversely impact our relationship with Medafor and could hamper or prevent us from distributing HemoStase........."

FDA approves Evicel Fibrin surgical sealant

TheU.S. Food and Drug Administration (FDA) has approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgical procedures.

"Evicel provides an effective means to stop oozing from small vessels during vascular surgery when suturing, compression or other standard techniques are not effective or practical," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

This product is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances used to promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission in manufacturing, however, the potential risk for the transmission of blood-borne viruses cannot be totally eliminated.

In a pivotal study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique of applying pressure to a plastic covering (graft) placed over the open blood vessel. Eighty-three percent of those who received Evicel stopped bleeding within four minutes, compared with 39.7 percent in the control group.

Adverse events, such as anemia and graft site infection, were generally mild and occurred at about the same frequencies in the Evicel-treated group and the control group.

FDA originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery. Evicel is manufactured by OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel.

802 haemophilia patients at risk from vCJD

Figures released by the Department of Health state that 802 haemophiliacs received blood from patients who went on to develop variant Creutzfeldt-Jackob Disease (vCJD).

It comes after a haemophiliac in his 70s was found to be infected with vCJD after his death. Although the infection was not the cause of his death, he had been treated with blood from a donor who later died from vCJD.

The disease, which destroyed Britain's beef industry in the mid 1990s, is believed to have been responsible for an estimated 164 deaths since 1995.

The Haemophilia Society has now called on the Government to test the patients at risk as soon as possible to determine whether they had contracted the disease.

Health officials released the figures in response to calls from Lord Morris of Manchester, who demanded to know whether the Government had revised its assessment of the risk presented by contaminated blood following the death of the haemophiliac who was found to be infected with vCJD.

Lord Darzi, Labour's health minister in the Lords, stated in a written answer to Lord Morris: "To date, 802 haemophilia patients are registered on the UK Haemophilia Centre Doctors' Organisation database as receiving clotting factors made from UK plasma pools containing a donation from a donor who went on to develop vCJD."

The Department of Health also revealed that 66 people who are not haemophiliacs have received blood components from donors who later went onto develop vCJD. Of these, 22 are still living, three died after contracting vCJD, and the others died from unrelated causes.

Chris James, chief executive of the Haemophilia Society, said: "We now know a much larger number of people have been exposed to higher-risk blood and blood product than was previously thought. vCJD remains an illness for which there is no test and no cure.

"It is just the latest in an increasingly long line of infections that people affected by bleeding disorders have been exposed to."

Haemophilia is a blood condition in which an essential clotting factor is missing and sufferers bleed for longer than normal. Around 6,000 people are affected by the condition within the UK.

Almost 4,700 haemophilia patients were infected with hepatitis C after receiving contaminated blood products that were given during the 1970s and 1980s. Campaigners have been fighting for compensation from the Government over the scandal.

The brain-wasting disease vCJD was first detected in the mid 1990s and since then most vCJD patients are thought to have been infected after eating BSE-contaminated meat.

The number of vCJD deaths peaked in 2000, when there were 28. That number has dropped to about five a year since 2005.

The epidemic of BSE in the 1980s and 1990s was caused by cattle being fed the remains of other cattle in the form of meat and bone meal, causing an infectious agent to spread.

More than four million cattle were slaughtered after almost 200,000 were infected with the fatal neurodegenerative disease.

Scientists recently warned that Britain could see a second wave of vCJD, affecting as many as 300 people, after discovering that genetic differences can affect how long it takes a person to incubate the disease.

VNUS Medical Technologies purchased for $400 million

Covidien Ltd said on Friday it would acquire VNUS Medical Technologies for $400 million in cash to expand its vascular business.
San Jose, Calif.-based VNUS makes products that treat varicose veins and venous reflux disease, a circulatory condition that causes blood to pool in the veins of the leg. The condition can cause swollen veins and discolored skin.
Covidien, based in Dublin, Ireland, manufactures, distributes and services a diverse range of product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies.
VNUS's products include the VNUS Closure system, which employs a disposable radiofrequency catheter that controllably heats and closes diseased veins.
In a randomized clinical trial, the system was proven to be as effective as vein stripping, an open surgical procedure that has been the historical standard for treatment for venous reflux disease, but with fewer side effects and faster recovery, the company said. Commenting on the merger, Joe Almeida, president, Medical Devices for Covidien, said, "The VNUS product line will be an important addition to our innovative portfolio of vascular intervention products."

King looks to relinquish thrombin throne. Q1 results edited

Net sales of THROMBIN-JMI were $47 million in the first quarter of this year compared to $67 million last year. The decline in that sale was primarily due to a higher level of discounting and the decrease in the number of units sold.

Joseph Squicciarino

David, could you repeat your question on THROMBIN-JMI?

David Buck - Buckingham Research Group

If you looked at the IMS reported sales, they had been fairly close to what you reported in sales until this quarter, and your reported sales were considerably lower than the $52 million from IMS for the first quarter; so I was just wondering if there is any de-stocking there that you might have seen?

Joseph Squicciarino

Actually no, it was up slightly, but not much at all. It was essentially flat with year-end levels; however, the downturn was a combination of two things; price and then of course to state the obvious, a lower level of units, 5000 equivalent units that were sold, and that was split about 50-50 between the two.

Brian A. Markison

I think when you take a look at THROMBIN, we have been very consistent from day one saying that this will be an account-by-account lifecycle, those have been my exact words, and we believe we have a cost of goods advantage and we will compete very hard; so, while we’re looking at more recent data or the most recent data, it does look like share has leveled off a bit, but we’re not the sole determinant of that as you know, and if the competition wants to take it to another level on price, we’ll meet them there, that’s not a problem for us, but for now, it does look like things have leveled off a bit;............

Zymogenetics Q1 2009 - Edited

We recorded net RECOTHROM product sales of $4.5 million for the quarter compared to $1 million in the first quarter of 2008. As Stephen indicated in his comments, this number was impacted significantly by the change in wholesaler inventories over the course of the quarter. By March 31, wholesaler inventories had declined to 3 to 4 weeks of trailing sales which is what we consider to be a normal level. Therefore, we don’t expect second quarter sales to be materially impacted by wholesaler inventory changes, and our reported net sales should generally reflect the underlying demand from hospital accounts.

From the Q&A........

Brian Abrahams -Oppenheimer

I wanted to drill down a little bit more on something Stephen said earlier about pursuing strategic and tactical initiatives to try to improve RECOTHROM’s market competitiveness. I was wondering if you could maybe give us a few more details about where your efforts will be focused going forward.

Also, I know you have talked in the past about educating physicians about making a link between coagulopathies that develop and looking for antithrombin antibodies and I was just wondering what the receptivity among the physicians has been of to those efforts.

Doug Williams

We would prefer not to get into too much detail for obvious reasons about some of the tactical initiatives that Stephen currently has under way. I do think that one area that is imporant is, as you point out, this notion of helping to educate the marketplace to the ongoing nature of coagulopathies that develop and also how to be able to identify those. That is certainly one part of our strategy for really defining one of the major differentiating charactersistics of our drug versus thrombin JMI.

FDA calls Baxter Tisseel promotion materials 'misleading'

Federal regulators have warned Baxter International Inc. that materials used to promote one its surgical sealants are misleading and overstate the product's benefits. The warning letter from the Food and Drug Administration states that brochures and presentation materials from Baxter "make unsubstantiated claims of superiority" about Tisseel sealant, an injectable protein used to control bleeding during surgery on the heart and spleen. Sales representatives for the Deerfield, Ill.-based companies used the materials to market sealant to surgeons. FDA posted the letter to its Web site Tuesday morning. Regulators take issue with the company's claim that Tisseel was "97.5 percent effective," at stopping bleeding in patients taking blood thinners who were undergoing cardiopulmonary bypass surgery. The letter points out that the studies cited for this claim showed effectiveness rates of only 88.2 and 87.8 percent, well below the rate claimed by the company. Regulators lectured the company over their use of the 97.5 percent figure, explaining it is a confidence interval, a statistical measure of the reliability of an estimate, not the rate of an event itself. The warning letter also objects to the company's claim that "no competing fibrin sealant" offers the clotting benefits of Baxter's product. Regulators state they are "not aware of any such comparative clinical trials," between the company's product and competitors. The letter, dated April 14, calls on Baxter to withdrawal the materials from the market and respond to the agency's complaints within 10 business days. Company spokesman Christopher Bona said the company sent all three materials to the FDA for review at the time they were released. Only two were actually used by company sales representatives and the company pulled them from circulation in recent weeks. "There is no concern regarding Tisseel's efficacy or safety," Bona said. "Baxter is working closely with the FDA to address the details outlined in the warning letter." Tisseel was approved by FDA in 2006, replacing an earlier formulation that had been on the market since 1998. The product is marketed by Baxter's regenerative medicine division, which had sales growth of 18 percent to $408 million last year. The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing and marketing. The letters are not legally binding, but the agency can take companies to court if they are ignored. Shares of Baxter International fell 43 cents Tuesday to $49.65 in morning trading.

Haemacure Signs Term Sheet for Proposed Collaboration and Bridge Financing

Haemacure Corporation (TSX:HAE), a Montreal-based specialty bio-therapeutics company, announces that it has entered into a term sheet with Angiotech Pharmaceuticals, Inc. of Vancouver (NASDAQ:ANPI, TSX:ANP) for a senior secured bridge loan from Angiotech in the amount of US$2.5 million. Haemacure expects that the bridge loan will enable it to operate for a period of approximately ten to twelve months from the date of the closing of the loan. The bridge loan will be convertible into Haemacure securities in certain circumstances.     "This is great news for Haemacure. We look forward to closing this bridge financing and collaborating with Angiotech" said Joseph Galli, Chairman and CEO of Haemacure.     The term sheet provides that the closing of the bridge loan is expected to take place by May 31, 2009. Completion of the transaction is conditional on standard closing conditions, including negotiation and execution of loan and security documentation and related collaboration agreements between Haemacure and Angiotech. Haemacure can give no assurance that the various closing conditions will be satisfied or that the transaction will close. In connection with the bridge loan, Angiotech has advanced US$200,000 to Haemacure.