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. 

ZymoGenetics Announces Workforce Reduction and Restructuring

ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today a reduction in its workforce of approximately 32 percent, or 161 employees, as part of a corporate restructuring. ZymoGenetics is reorganizing its operations to focus resources on assets with the potential to generate the greatest value for shareholders. The company expects to realize an annual reduction in operating expenses of approximately $30 million beginning in the third quarter as a result of these actions.

"We're taking steps to reduce our costs, align our spending with our highest corporate priorities and conserve our financial resources," said Douglas E. Williams, chief executive officer of ZymoGenetics. "While it is very difficult taking these actions, they are necessary given challenging market conditions and the changing focus of our business plan. Going forward, we believe that ZymoGenetics will be a stronger, more sustainable company with substantially reduced dependence on the capital markets for funding. We appreciate the significant contributions made by all of our employees, including those departing, toward the company's progress to date and in support of our plan to build a valuable and sustainable business."

ZymoGenetics will continue to build the market for its approved product, RECOTHROM(R) Thrombin, topical (Recombinant), while pursuing the research, development and commercialization of novel biologic therapeutics. The company will discontinue ongoing research activities in oncology and focus future research efforts in immunology, its core strength. Collaborative transactions will receive greater emphasis to facilitate the development and commercialization of the company's product candidates, while retaining significant rights to participate in downstream value generation. The recently announced transaction with Bristol-Myers Squibb for PEG-Interferon lambda serves as a model for this strategy. The company is reducing its internal product development infrastructure related to this shift in strategy, and will pursue increased outsourcing in the future. Headcount has been reduced in most areas of the company, with the greatest impact coming in research, manufacturing and other development-related functions, as well as administrative departments. Resource commitments to RECOTHROM commercial activities and PEG-Interferon lambda development have been maintained, consistent with the company's value generation strategy.

Kensey Nash Corporation F3Q09 (Qtr End 3/31/09)

Total revenues for the quarter were $20.6 million, or comparable to the prior year and as I mentioned earlier inline with our guidance for the quarter. When we look at our net sales for the quarter, sales of biomaterial products were $12.9 million. This represents an increase of 3% year-over-year. Within this biomaterial segment, we have cardiovascular products, which are primarily Angio-Seal component sales. These sales increased 6% year-over-year and our spine medicine products increased 11% year-over-year...........

Angio-Seal royalties were $5.3 million or flat year-over-year. Again, this is due to the negative impact of foreign exchange. If you exclude the negative impact, the actual estimate of royalties would have increased by approximately 7% year-over-year. Again unit sales were up year-over-year and I think that's important to keep in mind in looking at the performance of the Angio-Seal and the performance of St. Jude with these products in the marketplace and the ongoing strength and of the product as it continues to dominate in this sector...........

From the Q & A

Spencer Nam – Summer Street Research

Thanks for taking my questions. Excuse me, just couple of quick questions. First of all, on the Angio-Seal, I was wondering if you could give us any color on the competitive dynamics right now with the Angio-Seal evolution out there? And how definitions are comparing Angio-Seal versus some of the passive closure devices? Are you seeing any change in the – how physicians are preferring one part of another recognizing that Angio-Seal does have the super majority of the market at this point?

Joseph Kaufmann

I can only give you my view of this world. I certainly can’t speak for St. Jude. And I really don’t have a lot of information on Evolution. As far as the – how that product is doing specifically in the marketplace. But I can tell you in terms of what we see or hear in the marketplace is that, with a product like Angio-Seal and the reason why it continues to do so well and continue to dominate the market is, because quite frankly it’s a very good product. It has great, great clinical data, great labeling, it’s easy to use. The passive devices and always has been our position at Kensey Nash is they don’t work. They are – they become relatively expensive band-aids as opposed to doing the job that closure devices are intended to do. So, that’s why we think we have been able to or St. Jude has been able to command such great market share in a continuing large market share. So, I’m sure there is always going to be other competition that comes into the market and we will, - we could do well for either a short period of time or may somewhere down the road come up with a better idea, but I haven’t seen it yet.

Source: Seeking Alpha

St Jude Q1 '09 - edited

Total sales of cardiovascular products for the first quarter of 2009 were $240 million, up 15% over the first quarter of 2008 including $12 million of unfavorable foreign currency translations. On a constant currency basis, first quarter cardiovascular product sales increased 21% versus last year. This product category includes sales of products that St. Jude Medical acquired from Radi Medical Systems in December 2008. Within this category of products sales of vascular closure products in the first quarter of 2009 were $98 million, up 9% over the first quarter of 2008. Sales of heart valve products in the first quarter of 2009 were $81 million, a 4% increase over the first quarter of 2008.

For the second quarter of 2009, we expect cardiovascular product sales to be in the range of $235 million to $250 million. We now expect full year 2009 cardiovascular product sales to be in the range of $955 million to $985 million. This 2009 outlook range is slightly less than the full year 2009 guidance range we provided last quarter which primarily reflects the stronger US dollar versus the yen.