Animal Products

Following on from the Bleeding Calf Syndrome posting available HERE and other postings available Here regarding risks of animal sourced products.

I have provided further info above provided by DEFRA. To the best of my knowledge only the UK and Scotland are acting to investigate?

You can follow this link for further details also 'This intriguing disease captures the imagination. The VLA will be working with others to help discover the cause.'

I expect manufacturers will focus efforts on recombinant, plant-based technologies.

While our industry battles achieving financial success in the market with the ideal of creating an agent that is:

• of minimized risk
• efficaious
• cost effective,
• easily deliverable
• and applicable to multiple surgeries

The removal of King Pharmaceuticals crown as leader in the multi- $million Thrombin market by Zymogenetics is

a sure indicator as to market preference and acceptance of these benefits. J&J have a human sourced Thrombin following theirpurchase of Omrix.

Certainly reconstituted animal based technologies are facing severe threats currently as the link between zoonotic diseases (animal/human transfer) become more widely known. While BNP (Bleeding Calf Syndrome) transmission is far from clear it should be of concern. The lack of reporting and individual Government action highlight the inadequacies of public protection even with a cursory investigation.

While Bleeding Calf Syndrome may not pose infection risks via medical devices it exemplifies the public vulnerabilities to weak protection measures from their Governments. This is weak response and is exactly the response delivered that saw vCJD, and Prion borne infections escalate. Harvesting Bovine Materials HERE

New use for old drug could save thousands of lives

A cheap, common drug used to help women with heavy periods could save thousands of lives worldwide, by helping to prevent heavy bleeding after injuries caused in car crashes, shootings, or stabbings.

What do we know already?

Despite advances in surgery and medicine, millions of people die worldwide as a result of injuries caused by accidents and deliberate violence. These types of injuries are usually called 'trauma' by doctors. One of the main causes of death is heavy bleeding.
Heavy bleeding means there's not enough blood carrying oxygen around the body. Organs like the brain and heart stop working without a constant supply of oxygen.
The body's response to trauma injuries is to attempt to keep the blood vessels open, by breaking down blood clots in a process called fibrinolysis. Unfortunately, this can make it hard to stop the bleeding. The same thing happens after surgery, because the body reacts in the same way.
Doctors have used anti-fibrinolytic drugs after surgery for many years, to reduce blood loss. One anti-fibrinolytic drug, tranexamic acid, is cheap and known to be safe. It's also used to help reduce bleeding for women who have heavy periods.
Now researchers have tried using injections of tranexamic acid for people who have serious bleeding from trauma injuries. They carried out a very big study, in 40 countries worldwide, to see whether it would help to prevent deaths from bleeding. Half the people in the study were injected with the drug, and half with saline solution as a placebo.

What does the new study say?

People were less likely to die if they'd had tranexamic acid. In total, 16 percent of people died who'd had the placebo injection, compared with 14.5 percent of people who'd had tranexamic acid. The researchers calculated this could save 100,000 deaths each year worldwide. In the UK, about 1,800 people die each year from bleeding after injury, and the researchers calculate that routine use of tranexamic acid could save the lives of about 280 of these people.
The drug made no difference to the risk of either getting or dying from a complication such as a heart attack, stroke, or blood clot in the lung. That's important, because a drug that works to prevent bleeding might have increased the chances of getting a blood clot that caused this type of problem.
Interestingly, there was little difference in the numbers of patients who needed blood transfusions. About half of people had transfusions, whether or not they'd had tranexamic acid. This might suggest that the benefit of tranexamic acid wasn't purely down to a decrease in bleeding. However, it could also be because more people treated with tranexamic acid lived long enough to receive a transfusion, or simply that it can be hard to tell whether someone needs a transfusion or not.

How reliable are the findings?

The study was a randomised controlled trial, which is the best sort of study for finding out whether a treatment is helpful. The study looked at more than 20,000 patients, and found a clear result that those treated with tranexamic acid were more likely to survive. The results should be very reliable.

Where does the study come from?

The study was carried out by researchers from 40 countries around the world, including countries from Europe, South America, Asia, and Africa. It was published in The Lancet medical journal, owned by the publishing company Elsevier. It was paid for by the UK's Health Technology Assessment programme.

What does this mean for me?

The authors of the study recommend that doctors treating trauma patients should consider using tranexamic acid in cases of heavy bleeding, or where the patient is at risk of heavy bleeding. But writing in a separate article in the same journal, another doctor warns that very high doses of tranexamic acid have been linked to seizures after heart surgery. He says doctors should be cautious, especially if using other types of anti-fibrinolytic drugs.
The proportion of people in the study who died of their injuries may seem high. But that's because many of the injuries happened in parts of the world like rural Africa or India, where it may take longer for accident victims to get good-quality medical care. In a country like the UK, the death rate from injuries is likely to be much lower.

CryoSeal Fibrin Sealant System for Asahi

ThermoGenesis Corp. has made a deal to phase out its production of its CryoSeal wound care product line and license the product to a Japanese distributor.
Asahi Kasei Kurary Medical Co. Ltd. will pay ThermoGenesis $1 million this month so the Rancho Cordova med-tech company will continue to supply CryoSeal while Asahi ramps up production facilities and regulatory approvals in Japan. ThermoGenesis will provide the CryoSeal Fibrin Sealant System for Asahi to distribute in Japan and other Pacific Rim countries for 30 months, at which time Asahi will take over manufacturing.
ThermoGenesis will receive royalty payments on all CryoSeal products Asahi manufactures after the 30 months. Asahi has the option to acquire the CryoSeal line and patent rights any time in the next five years.
ThermoGenesis has enough CryoSeal inventory that it won’t need to engage in any “meaningful” manufacturing in the next 30 months, chief executive officer J. Melville Engle said in a news release.
“The divestiture of CryoSeal is part of our long-term strategy to focus on the development of enabling technologies for the stem cell regenerative medicine market,” Engle said. “This transaction frees up management and corporate resources to address these more strategic market opportunities.”

Spinal Sealant gets CE mark

HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for Adherus^TM Spinal Sealant. Adherus^TM Spinal Sealant is used in spinal surgeries where a water tight seal is required to prevent cerebrospinal fluid leakage from the dural repair. Prevention of cerebrospinal fluid leaks should benefit the patient in shorter hospital stays and fewer post-surgical complications such as reduced pain and fewer infections. Adherus Spinal Sealant also acts as an adhesion barrier, thereby simplifying subsequent surgeries should the need arise. The unique, single use device is terminally sterilized and can be applied in both Open and MIS procedures through either a 100mm or 150 mm tip. The CE Mark provides regulatory approval for the company to begin sales in Europe and other countries outside the U.S.

“Adherus^TM Spinal Sealant is an easy to use device that complements HyperBranch’s neurosurgical sealant product line. Adherus^TM Dural Sealant, which was first launched in 2009, is currently marketed outside the U.S. for cranial surgery. Adherus^TM Spinal Sealant has negligible swelling, degrades slowly not only provides a watertight seal but also acts as an adhesion barrier to limit scarring, a major advantage if subsequent surgery is required,” said John Conn, President and Chief Executive Officer.

The Adherus^TM products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and are bio-degradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure.HyperBranch Medical Technology, Inc. has now received CE Marks for ocular, cranial, and spinal sealants as well as a hernia mesh fixation product. The Company has completed a U.S. feasibility study and is starting the Pivotal portion of the study this month for the Adherus Dural Sealant. The Spinal product will follow the same approval path in the U.S. The company’s ophthalmic sealant is currently licensed to and marketed by BD Medical.

Scientist has succeeded in producing a replica of human collagen from tobacco plants

A scientist at the Hebrew University of Jerusalem's Robert H. Smith Faculty of Agriculture, Food and Environment has succeeded in producing a replica of human collagen from tobacco plants – an achievement with tremendous commercial implications for use in a variety of human medical procedures.

Natural human type I collagen is the most abundant protein in the human body and is the main protein found in all connective tissue. Commercially produced collagen (pro-collagen) is used in surgical implants and many wound healing devices in regenerative medicine. The current market for collagen-based medical devices in orthopedics and wound healing exceeds US $30 billion annually worldwide.

Currently, commercial collagen is produced from farm animals such as cows and pigs as well as from human cadavers. These materials are prone to harbor human pathogens such as viruses or prions (mad-cow disease). Human cadaver is scarce, and for certain indications possesses serious ethical issues.

Producing human recombinant type I pro-collagen requires the coordinated expression of five different genes. Prof. Oded Shoseyov of the Robert H. Smith Institute of Plant Sciences and Genetics in Agriculture has established the only laboratory in the world that has reported successful co-expression all the five essential genes in transgenic tobacco plants for the production of processed pro-collagen. For this work, Shoseyov was one of the recipients of a Kaye Innovation Award during the Hebrew University Board of Governors meeting in June.

Shoseyov's invention on has been patented, and the scientific findings behind it were published recently in the journal Biomacromolecules. A company, CollPlant Ltd ., has been established based on patents and technology that were developed in Shoseyov's laboratory. It has raised US$15 million to establish the first commercial molecular farming company in Israel and is already manufacturing collagen-based products that have attracted collaborative commercial interest from companies in the US, Japan Europe and Israel.

Yissum, the technology transfer company of the Hebrew University, is one of the shareholders of CollPlant.. CollPlant is a public company traded in "TASE", and the potential revenue for the Hebrew University from this invention is estimated to reach into the multi-million dollar range.

The Kaye Awards have been given annually since 1994. Isaac Kaye of England, a prominent industrialist in the pharmaceutical industry, established the awards to encourage faculty, staff, and students of the Hebrew University to develop innovative methods and inventions with good commercial potential which will benefit the university and society.

Cow Products - Why ?

Bovine Neonatal Pancytopaenia (BNP) is a newly emerging disease syndrome of calves less than one-month-old which has recently been reported in Britain and Europe.
It is often referred to as calf haemorrhagic disease, haemorrhagic diathesis, bleeding calf syndrome or blood sweating disease.
The first cases of the condition were reported in Germany in 2007.Since then, reports of confirmed cases have slowly risen in a number of European countries while the first confirmed case was recently diagnosed in Ireland and there have been four cases confirmed in Northern Ireland to date.

Typically, the clinical signs in young calves can include excessive bleeding from small abrasions of the skin, or even from injection sites, and the passing of large clots of blood in the dung.

Temperature

Calves affected with the condition normally have a high temperature and become rapidly depressed. In the majority of cases, death follows within 24 to 48 hours (mortality of about 90% is commonly reported), with aggressive veterinary treatment, including blood transfusions, normally providing only a temporary respite for the animal.

The disease syndrome tends to affect single calves in a herd although multiple calves have been affected in some herds in Britain and Germany.

Affected calves tend to be found in larger well-managed herds with a large proportion of affected farms also keeping sheep as well as cattle.

Within countries that have identified cases, a geographical pattern to the occurrence of the disease has not been identified nor has any breed or gender association been established.

On post mortem examination of affected calves, significant damage to the bone marrow has been consistently reported.

The bone marrow is responsible for producing the blood cells. Red blood cells are responsible for transporting oxygen, while white blood cells play a role protecting against infection. Platelets are responsible for blood clotting.

Of these three, the platelets are most severely affected, giving rise to the typical clinical signs of poor clotting and widespread bleeding in the calf.

While the cause of the condition is unknown, there is no evidence that the condition is infectious or that it gives rise to food safety concerns.

The fact that apparently normal calves at birth can develop clinical signs rapidly after consuming colostrum has focused the attention of researchers on colostrum. It is possible that colostrum acts as a vehicle for the introduction into the calf of the agent which damages the bone marrow.

During the 24 hours that follow the birth of an animal, the intestine allows antibodies (a form of defence against disease) which are contained in the colostrum to pass from the gut into the blood stream. This is an important step in the transfer of immunity from the mother to her offspring and plays a vital role in preventing disease in the newborn calf.

It is possible that, in a very small percentage of calves, some of these antibodies target the bone marrow cells, leading to the clinical signs of the disease. Indeed, a similar mechanism is known to cause destruction of blood cells in some newborn foals and piglets. Researchers wish to ascertain whether this is the case in affected calves and, if so, to determine what has changed in the cow or her environment which has led to the occurrence of the condition.

The Department of Agriculture, Fisheries and Food's regional veterinary laboratories are available to assist herdowners and veterinary practitioners with laboratory diagnosis and investigation of any suspicious cases.

The Department has offered to provide free post mortem examinations of any young calf with clinical signs typical of the condition.

While the condition is rare, with minimal losses to date, the Department is always vigilant to the occurrence of novel diseases or novel presentations of existing diseases. Herd owners are asked to notify their veterinary practitioner of any young calves with apparent clotting difficulties.

Dangers of bleeding control in Kidney surgery

Interrupting the blood flow for more than 20 to 25 minutes during kidney cancer surgery leads to a greater risk for patients developing chronic kidney disease, Mayo Clinic researchers have found. The team’s study was published today in the journal European Urology.
Researchers analyzed outcomes of 362 patients with only one kidney who underwent surgery between 1990 and 2008 at Mayo Clinic and Cleveland Clinic for renal cortical tumors. Using a technique called warm ischemia, surgeons kept the patient’s kidneys body temperature during the partial nephrectomy. Ischemia involves cutting off the blood supply to the kidney with clamps in order to control bleeding and to keep blood from obscuring the surgeon’s view of the kidney. Ischemia can cause tissue damage from a lack of oxygen and nutrients.
Researchers found that each additional minute of warm ischemia is associated with a five-to-six-percent increase in the odds of developing acute renal failure or reduced kidney functioning and is associated with a six percent increased risk of new onset Stage IV chronic kidney disease during long-term follow-up.
“This is the largest evaluation of warm ischemia time in patients with a single kidney who are undergoing a partial nephrectomy,” says R. Houston Thompson, M.D., a urologist at Mayo Clinic and study primary investigator. “These results suggest that every minute counts when the renal arteries and veins are clamped. When planning for the surgery, surgeons should make efforts to minimize ischemia time, especially in situations where a person only has one kidney,” says Dr. Thompson.

Medafor's board gets a vote of confidence

Shareholders of Brooklyn Center-based Medafor Inc. on Thursday decisively rejected a suitor's proposal to withhold support from the company's board after it turned down a takeover bid.
The Atlanta biomedical firm CryoLife Inc., which is Medafor's top distributor and shareholder, abandoned its $2-a-share cash and stock bid for the privately held company in March. The Medafor board dismissed it as "grossly inadequate."
But the two companies continue to duke it out in federal court, most recently over Medafor's decision to sever the distribution agreement between the two. CryoLife had also proposed withholding support for the five-member board, on the grounds that it "has overseen the destruction of Medafor's business, its technology and the value of its shares."
Shareholders who control roughly 70 percent of the company's shares voted by a 95 percent margin to re-elect the board.
At the center of the dispute is Medafor's unique blood-clotting powder, called HemoStase, which CryoLife distributes in the United States and in some markets abroad. But the legal status of that agreement is now unclear: A ruling by a federal district judge on the matter is expected soon. (While sales have temporarily lapsed in those markets as a result of the dispute, Medafor says customers will continue to be served after the ruling.)
At Thursday's meeting, held at the Northland Inn in Minneapolis, Medafor's CEO Gary Shope said the company's revenue in 2009 grew 40 percent to $13.8 million. He said trends in the business are strong through the first quarter of this year.
"The Medafor of today is a revitalized company," Shope said. "We've had a few bumps in the road, but we'll get through it."
The real problem for Medafor is the distraction and expense stemming from CryoLife's takeover bid and continuing litigation, Shope said. Had it not been for the $1.2 million the company shelled out for legal expenses last year, Medafor would have been profitable, he said.
The meeting was attended by about 175 shareholders, who listened as Shope and Chairman Michael Pasquale tag-teamed a series of questions.
Many shareholders appeared frustrated that they haven't been able to cash out their long-held stock at a profit. "I say get rid of CryoLife and let investors make some money," said Jim Karercher, a longtime investor from Ortonville, Minn.
Some asked for salary figures for the two executives, a request that was denied. CryoLife claims the company's CEO and chief financial officer earned a combined $700,000 last year.
Another shareholder asked why Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. Pasquale said the company is global, and it isn't necessary to live locally.
One noticeable absence from the meeting was Steven Anderson, CryoLife's CEO, who is a Minnesota native and a former Medtronic Inc. executive. Anderson had planned to attend the meeting, but was waylaid by a family emergency, according to CryoLife spokeswoman Nina Devlin.

CryoLife to Submit Bond After Seeking Preliminary Injunction Against Medafor

KENNESAW -- CryoLife Inc. (NYSE: CRY ) likely will be ordered to submit a bond for up to $500,000 after filing an emergency motion for preliminary injunction in a drug distribution dispute with Medafor Inc., according to an SEC filing.
CryoLife, an Atlanta-based maker of medical products that enable heart and blood vessel reconstructive surgery, said it opposed Medafor's demand for a bond in the range of $14 million to $40 million because any injunction would not harm the defendant.
The U.S. District Court in Atlanta said it requires a bond before issuing a preliminary injunction, and ordered the two litigants to submit proposed bond amounts by June 11. The filing states the court is considering a bond in the range of $100,000 to $500,000.
CryoLife accuses Minneapolis-based Medafor of violating a drug distribution agreement by allowing other companies to distribute Hemostase, an absorbable blood-clotting agent manufactured by Medafor, in territories and medical fields reserved exclusively for CryoLife.
Under the agreement, CryoLife said it is the exclusive U.S. distributor of the drug used in cardiac and vascular surgery, excluding those performed at Department of Defense hospitals; and the exclusive distributor internationally, except China and Japan , for all surgeries other than orthopedic and ear, nose and throat surgery.
Medafor, in turn, accuses CryoLife of violating their exclusive distribution deal by selling Hemostase in Spain for uses allegedly barred by the agreement.

Grifols to Acquire Talecris Biotherapeutics Creating a World Leading Provider of Life-Saving Plasma Protein Therapies

BARCELONA, Spain and RESEARCH TRIANGLE PARK, N.C., June 7, 2010 /PRNewswire via COMTEX/ -- Grifols (GRF.MC) a global healthcare company and leading producer of plasma protein therapies, and Talecris(TLCR 19.97, +4.06, +25.48%) a U.S.-based biotherapeutics products company, today announced that they have signed a definitive agreement through which Grifols will acquire Talecris for a combination of cash and newly-issued Grifols non-voting shares having an aggregate value today of approximately $3.4 billion (euro 2.8 billion), creating a global leader of life-saving and life enhancing plasma protein therapeutics.

The combination of Grifols and Talecris will create a vertically integrated and diversified international plasma protein therapies company, bringing together complementary geographic footprints and products, as well as increased manufacturing scale. Grifols' leading global footprint will benefit from Talecris' strong presence in the United States and Canada. Grifols' available manufacturing capacity will enable Talecris to increase production in the near term. As a result, the combined company will be better able to meet the needs of more patients with under-diagnosed disease states around the world.

In addition, upon completion of the transaction, the combined company will have:

• the ability to derive more protein therapies from every liter of plasma, enhancing access and availability for patients, and optimizing use of collected plasma;
• an established plasma collection operation capable of meeting the combined company's needs to address increasing patient demand and an accelerated path to improving the cost efficiency of the Talecris plasma platform;
• a broad range of key products addressing a variety of therapeutic areas such as neurology, immunology, pulmonology and hematology, among others;
• an enhanced R&D pipeline of complementary products and new recombinant projects that will drive sustainable growth;
• a well established clinical research program in the U.S.

Grifols Chairman and CEO Victor Grifols commented, "The acquisition of Talecris furthers our vision to better serve patients and health care professionals with innovative products, a strong clinical research capability and new research into recombinant therapies. We look forward to combining the strengths of both companies to improve the quality of the lives of patients around the world, while positioning the enlarged group for long term profitable growth."

Talecris Chairman and CEO Lawrence D. Stern commented, "We believe that Grifols' well-established reputation, know-how and expertise will enable the combined entity to meet the needs of more patients. Our employees will benefit from the opportunities available to them as part of a larger, global organization committed to the expansion of Talecris' existing business, the development of our pipeline products, and the maintenance of our culture of compliance and quality. Importantly, our stockholders will realize a compelling premium and benefit from the ability of the combined business to accelerate key gross margin improvement opportunities within Talecris."