June 10, 2011- FORT LEE, NEW JERSEY - Kedrion S.p.A., a global leader in biotherapeutics, announced today it has acquired Koate®-DVI (antihemophilic factor, human) franchise effective June 2, 2011. Kedrion acquired Koate-DVI following Grifols’ acquisition of Talecris. Under the agreement Grifols will contract-manufacture Koate-DVI for seven years and thereafter Kedrion shall have an option to transfer manufacturing to one of Kedrion’s state of the art facilities.
Kedrion has established Kedrion Biopharma Inc. as its wholly owned US subsidiary responsible for product marketing and distribution in the United States. The new subsidiary will have the exclusive right to sell Koate-DVI in the US market and future products. Kedrion has a nationwide sales force in place to discuss Koate-DVI and handle any other inquiries.
Please call 1-855-353-7466 to be contacted by your Kedrion representative within 24 hours.
Patients, bleeding disorder treatment centers and channel members can access all potencies through their current sources. There will be no interruption in supply.
Customer service, medical inquiries and reimbursement services requests can also be addressed by contacting 1-855-353-7466.
Koate-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is demonstrated deficiency of activity of the plasma factor, factor VIII. Koate-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent the bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia. Koate-DVI contains naturally occurring von Willebrand’s factor, which is co-purified as part of the manufacturing process. However, it has not been investigated for efficacy in the treatment of von Willebrand’s disease, and hence is not approved for such usage. The product is processed using a Double Viral Inactivation (DVI) treatment consisting of solvent detergent and dry heat at 80° C for 72 hours. Koate-DVI is supplied in single dose bottles with the total units of factor VIII activity stated on the label of each bottle. Sterile water for injection, a sterile double-ended transfer needle, a sterile filter needle, and a sterile administration set are provided. Koate-DVI is available 250, 500 and 1,000 IU vials for dosing titration.
Important Safety Information
Koate-DVI is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. Reactions include tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.
For additional information on Koate-DVI, see the full prescribing information at www.koate-dvi.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Kedrion develops, manufactures and distributes human plasma derived medicinal products, which improve people’s quality of life. Though new to United States the company plays a major role worldwide providing critical therapies in 40 other countries. International headquarters are based in Italy with a focus on high quality products, relentless commitment to research and development, and substantial industrial capacity to ensure continuous supply.
“We are very excited to enter the dynamic United States market,” notes Paolo Marcucci, CEO of Kedrion. “We invest in people, innovation and research to support the medical and scientific communities worldwide, for ongoing product and process improvement and to contribute to making treatments widely available. We look forward to introducing two other products into the market in the second half of the year.”
Additional information about Kedrion can be found at www.kedrionusa.com. The Koate-DVI package insert is attached to this press release and can be accessed through the Koate-DVI website (www.koate-dviusa.com). For other inquiries please contact Joe Gibbons at 1-484-459-4952.