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Biovitrum Strengthens Its Relationship with Wyeth - Starts to Co-Promote BeneFIX(R) in the Nordic Countries.


STOCKHOLM, Sweden -- Regulatory News:

Biovitrum (STO:BVT BVT Bouvet Island (ISO Country code)
BVT Brevet
BVT Bournville Village Trust (UK)
BVT Build Verification Test (Software testing process) 
) today announced it has entered into a new agreement, effective August 8, 2007, with Wyeth (NYSE NYSE

See: New York Stock Exchange
:WYE) to co-promote BeneFIX[R], Coagulation Factor IX coagulation factor IX Factor IX, see there  (Recombinant) for hemophilia B, in the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden). With the exception of these countries, Wyeth markets BeneFIX around the world.

Under the terms of the agreement, Biovitrum will receive a commission on BeneFIX sales, including an additional incentive if certain sales targets are exceeded, for a period of up to five years, with possible one year extensions thereafter. BeneFIX uses recombinant DNA technology recombinant DNA technology

Recombining of DNA molecules from two different species that are inserted into a host organism to produce new genetic combinations that are of value to science, medicine, agriculture, or industry.
 to replace clotting factor IX to stop or prevent bleeding in people with hemophilia B who do not have enough factor IX of their own. Hemophilia B is a rare, inherited blood clotting disorder. People with hemophilia B are deficient in factor IX which is vital in the clotting mechanism to prevent bleeding. Hemophilia B is characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with hemophilia B are dependent on protein replacement therapy with factor IX.

Biovitrum has been very successful in the Nordic market for blood diseases and will by this agreement strengthen its position with this additional product.

Comments by Martin Nicklasson, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Biovitrum:

"Blood diseases and especially hemophilia is an area of great strategic importance for us. I am delighted that Wyeth has chosen Biovitrum as a partner in the Nordic region for BeneFIX[R]. It adds to our already strong relationship with Wyeth in the hemophilia area and it confirms our ability to deliver value in the market. It also demonstrates that we are an attractive partner for co-promoting other pharmaceutical companies products in the Nordic market. Our commercial activities within this field will thereby continue to grow and generate additional revenues."

Biovitrum manufactures recombinant factor VIII used in Wyeth's ReFacto[R] for the treatment and prophylaxis of hemophilia A. Biovitrum receives royalties on Wyeth's global ReFacto[R] sales as well as co-promotion revenues from the sales of ReFacto in the Nordic countries.

About BeneFIX

BeneFIX is indicated for the control and prevention of hemorrhagic Hemorrhagic
A condition resulting in massive, difficult-to-control bleeding.

Mentioned in: Hantavirus Infections


hemorrhagic

pertaining to or characterized by hemorrhage.
 episodes in patients with hemophilia B (congenital factor IX deficiency factor IX deficiency Christmas disease, hemophilia B Hematology An X-R disorder due to a deficiency in Factor IX resulting in a bleeding diathesis Epidemiology Incidence–1/40,000 or 15-20% of hemophilias; severe disease is usually of neonatal onset Clinical,  or Christmas disease), including control and prevention of bleeding in surgical settings.

BeneFIX is not indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII and X) nor the treatment of hemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the treatment of bleeding due to low levels of liver-dependent coagulation factors.

As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting or tiredness. BeneFIX[R] may be contraindicated in patients with a known history of hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  to hamster protein. Allergic-type hypersensitivity reactions, including anaphylaxis anaphylaxis (ăn'əfəlăk`sĭs), hypersensitive state that may develop after introduction of a foreign protein or other antigen into the body tissues. , have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.

About ReFacto

ReFacto Antihemophilic Factor (Recombinant) is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
 is unknown. As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable.

con·tra·in·di·ca·tion
n.
 to the use of ReFacto. Allergic reactions such as hives hives (urticaria), rash consisting of blotches or localized swellings (wheals) of the skin, caused by an allergic reaction (see allergy). The swelling is caused by distention of the skin capillaries and escape of serum and white cells into the skin and tissues. , itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur. Please see Prescribing Information for BeneFIX and ReFacto at www.hemophiliavillage.com.

About Biovitrum

Biovitrum is one of the largest biopharma companies in Europe. With operations in Sweden and in the UK Biovitrum conducts research and develops pharmaceuticals for unmet medical needs both for common diseases and conditions that affect small patient populations. Biovitrum has a broad and balanced R&D portfolio with several projects in clinical and preclinical phases for the treatment of obesity, diabetes, inflammation and eye and blood diseases as well as a number of well defined niche indications. Biovitrum also develops and produces protein-based drugs on a contractual basis and markets a range of specialist pharmaceuticals primarily in the Nordic countries. Biovitrum has revenues of approximately SEK SEK

In currencies, this is the abbreviation for the Swedish Krona.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
 1.2 billion and 550 employees. Biovitrum's share has been listed on the OMX OMX Office Max (stock symbol)  Nordic Exchange since September 15, 2006. More information is available at www.biovitrum.com .

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Publication:Business Wire
Date:Aug 8, 2007
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