Recombinant clotting factor VIII with the name Vihuma® approved

  • Market launch in Germany end of April 2017
  • Vihuma® is a 4th generation recombinant human factor VIII preparation from a human cell line
  • Vihuma® is an optimal portfolio supplement for Biotest

DREIEICH, Germany I March 1, 2017 I Today, the European Commission (EC) has approved the first, 4th generation human factor VIII preparation manufactured by Octapharma AG under the name Vihuma®. Biotest AG will distribute Vihuma® in Germany from the end of April 2017. The approval in Switzerland has already been applied for and Biotest expects to start marketing Vihuma® in Switzerland in the fourth quarter.

Vihuma® is produced from a human cell line and thereby recreates a natural preparation similar to Biotest’s Haemoctin®, which is derived from human plasma. In contrast to conventional recombinant factor VIII preparations made with the aid of hamster cells, Vihuma® contains natural human structures. The similarity of Vihuma® to human Factor VIII is reflected in the name: "human".

Vihuma® is indicated for the treatment and prevention of bleeding episodes in children and adults with haemophilia A (congenital factor VIII deficiency). It is a high-quality alternative for patients in favor of a recombinant product to the recombinant factor VIII preparations available to date. In studies in previously treated patients, the 4th generation recombinant clotting factor has proved to be safe, effective and well tolerated.

“With a recombinant factor VIII preparation from a human cell line, which has many of the advantages of a natural plasma clotting factor, we are continuing our strategy of using particularly well tolerated preparations," states Dr Thomas Becker, Senior Director Haematology of Biotest AG. "We can now offer an alternative to patients who, together with their doctor, deliberately opt for a recombinant factor VIII preparation.”

About recombinant factor VIII

A recombinant clotting factor VIII is produced using biotechnology and is not obtained from human plasma. The blueprint (i.e., the gene) for human factor VIII is introduced into a mammalian cell and inserted into the DNA, so it “combines” with the existing genetic material. Hamster cells, which read the human gene and then produce factor VIII, are generally used as in place of mammalian cells. Despite the incorporated human gene, however, a hamster cell is not capable of producing a factor VIII that corresponds exactly to the human model. There are small structural differences that can affect tolerability. The recombinant factor VIII that Biotest will launch on the market is produced in a human cell line and thus comes closest to the natural human model.

About Biotest

Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of transplant medicine, clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

SOURCE: Biotest

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