Tuesday, March 18, 2008

King Pharmaceuticals Acquires License from Gelita Medical to Hemostatic Products

King Pharmaceuticals, Inc. (NYSE:KG) and Gelita Medical BV announced today that the companies have entered into an exclusive license agreement relating to Gelita’s absorbable gelatin hemostatic products.

Pursuant to the agreement, King received an exclusive license to market, distribute and sell Gelita’s absorbable gelatin sponge in the U.S. Gelita will manufacture and supply the hemostatic product to King under the agreement. King’s THROMBIN-JMI® (thrombin, topical, bovine, USP), a topical active hemostatic agent, is often used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.

Brian A. Markison, President and Chief Executive Officer of King, stated, “The addition of Gelita’s absorbable gelatin hemostatic agents to our product line will further strengthen our expanding portfolio of hospital products. Importantly, this transaction further enhances the wide array of hemostatic options that our hospital sales team of over 110 professionals can offer physicians for the purpose of controlling bleeding during surgery.” Dr. Harrie van Baars, CEO of Gelita Medical, stated, “With King we have attracted an excellent and well focused marketing partner for our products in the U.S. market.”

King plans to begin marketing Gelita’s absorbable gelatin sponge in the U.S. after the product receives approval from the U.S. Food and Drug Administration for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita. The companies did not provide financial details relating to the transaction.

Dr. Harrie Van Baars of the Netherlands, CEO Gelita Medical, was previously CEO of Curamedical he also is also linked to company CircumventBV and the circumcision device the Smartklamp
Click Here for action Gelita is taking against Equicel
Link to FDA letter for Gelita approval Here

Novoseven

Novo Nordisk has the following interesting details plus another video.


Blood use
- Some statistics
Approximately 10,000 units of blood are required per day to meet the demands of hospitals in England and North Wales. Thirty-two thousand units of red blood cells are used per day in the USA and 26.5 million units of blood are transfused per year. Similar requirements exist throughout Europe.
To meet these demands, 2.5 million blood donations are made in the UK every year, and almost 14 million in the USA. At each donation, approximately 475 ml (1 unit) of blood are collected. 1.9 million volunteer donors in the UK and 8 million in the USA (approximately 5% of the population of each country) donate this blood. With 10% of the adult population (260,000) donating blood Denmark has the highest participation rate as well as the highest consumption of blood products per capita in Europe and is primarily due to the high acceptance of blood donation in Denmark.
Donation by apheresis is also becoming increasingly common and essential for the supply of specific components. Apheresis describes any procedure in which blood is drawn from a donor and a component (platelets, plasma or white blood cells) is separated out, with the remaining blood being returned to the body. Apheresis allows the donor's blood volume to replenish itself much more quickly than whole blood donation. One type of apheresis, plasmapheresis, is commonly used in commercial blood banks. In plasmapheresis the plasma is separated from donated blood, the red blood cells being returned to the donor.
How many components can be made from one unit of blood?
Once blood has been tested for infectious agents and blood groups have been determined, it is separated into its useful components, allowing several patients to benefit from one unit of whole blood.
Red cells are used for the treatment of certain types of anaemia, such as bone marrow failure, sickle cell disease and anaemia associated with chronic renal failure. Transfusion is also used to replace lost red cells after accidents, surgery and childbirth. Red cells have a shelf life of up to 42 days, but if fresh-frozen can be stored for up to 10 years.
Platelets are mainly used in the treatment of patients with bone marrow failure or those undergoing chemotherapy. The shelf life of platelets is up to five days.
Fresh frozen plasma (FFP) is normally used after substantial blood loss, for example following childbirth or during cardiac surgery. FFP is also used for the reversal of anticoagulant treatments, burn/shock cases and to replace clotting factors after blood transfusion. Its shelf life is one year.
Processed plasma is also fractionated for the production of factor VIII and factor IX, immunoglobulins and antibodies. Very large 'pools' of donated units of plasma are used in the production of such products.
The main uses of whole blood are: general surgery (23%), general medicine (15%), cardiothoracic surgery (13%), orthopaedics (11%), haematology (9%), accident and emergency (8%).
Expense associated with blood collection
Collecting blood is expensive. The main costs are for staff salaries, transport, storage, and for the screening tests required by individual nations in addition to blood aquisition cost. In Europe, blood is usually screened for:
Type (ABO/Rh)
Antibodies to red cell antigens
Antibodies to HIV-1/2 and HIV antigen
Antibody to HTLV I/II
Hepatitis B surface antigen and antibody to the core antigen
Antibody to hepatitis C
Syphilis
Liver function (alanine aminotransferase)
Blood transfusion
The majority of blood transfusions are heterologous (also referred to as allogenic), which means that the patient receives donated blood from another person (usually an unnamed volunteer donor via a blood bank or transfusion service such as 'The National Blood Service' in the UK or the 'American Association of Blood Banks' (AABB).
Alternatively patients can donate and later, that is during elective surgery, receive back their own blood (autologous transfusion). Autologous blood donors can give blood twice weekly for up to five weeks prior to elective surgery. After donating, the patient is immediately given IV fluids to compensate for the decrease in blood volume. The advantage of this type of donation is that disease transmission and allergic reactions are eliminated - the patient's own blood is the safest blood for their transfusion needs. Autologous transfusion is also useful for patients with rare blood types who might have difficulty in finding a compatible donor. In addition, autologously collected blood can be frozen and stored for up to 10 years. Disadvantages of autologous transfusions include the fact that the donation must be planned in advance, that it may delay surgery, and that certain medical conditions (eg cardiac conditions under which patients cannot tolerate sudden blood loss) disqualify individuals from this type of donation. Units infected with HBV or HIV from autologous donations, are not stored in the blood bank because of the potential risk of clerical error.
Blood that would otherwise be lost during surgery can also be collected and returned to the patient. This is a different kind of autologous donation called perioperative autologous transfusion or PAT and reduces the need for allogenic blood transfusion. Anticoagulant is added to this salvaged blood prior to centrifugation and washing of the resulting packed red cells. These are pumped into a transfusion bag and re-infused into the patient during or after some types of surgery, such as cardiac, gynaecologic and orthopaedic procedures.
Autologous transfusions are generally more costly than traditional heterologous transfusions and are only appropriate in certain types of treatment. Patients must be stable enough to donate their own blood and to cope with the potential anaemia that may be suffered after surgery.