Nabi acquires exclusive rights to Phase III organ transplantation rejection antibody product.
Under the terms of the agreement, Fresenius Biotech has granted Nabi Biopharmaceuticals exclusive sales and distribution rights to ATG-Fresenius S in the United States and Canada for up to 15 years following the first commercial sale of the product after licensure in the United States. Nabi Biopharmaceuticals is required to make aggregate milestone payments of $1 million to Fresenius Biotech during development and a $4 million payment upon approval by the United States Food and Drug Administration (FDA). Fresenius Biotech will manufacture and supply the product from its European facility in exchange for a royalty. Nabi Biopharmaceuticals will be responsible for the clinical development, regulatory approval process, marketing and sales of ATG-Fresenius S in the United States and Canada.
In January 2005, the FDA granted Fast Track Status for ATG-Fresenius S in lung transplantation. As a result of its agreement with Fresenius Biotech, Nabi Biopharmaceuticals will assume oversight of an ongoing randomized, double-blind, placebo-controlled Phase III clinical study that is being conducted in lung transplant patients in the United States and Europe. The company may also undertake additional studies to expand the indications into other areas, such as bone marrow transplantation. Based on the outcome of its upcoming meeting with the FDA, and assuming all regulatory and clinical milestones are met, Nabi Biopharmaceuticals expects to file its Biologics License Application (BLA) for ATG-Fresenius S in early 2009.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "This agreement represents an exciting opportunity for Nabi Biopharmaceuticals to leverage our proven strengths in marketing specialized antibody products to commercialize a drug that has been used in the treatment of more than 150,000 transplant patients around the world. It is also an important step forward in our strategy to become a leading provider of products that improve both the longevity and the quality of life of transplant patients."
Dr. Thomas Gottwald, chief executive officer, Fresenius Biotech, stated, "We are very pleased to have found an experienced partner in transplantation medicine that can continue and expand the current clinical development program of ATG-Fresenius S. Nabi Biopharmaceuticals created what today is a very favorable commercial product in Nabi-HB, the current gold standard in the United States for prevention of re-infection with hepatitis B in liver transplant patients."
In 2004, over 26,000 solid organ transplants were conducted in the United States, and solid organ transplants in the United States have been increasing at an annual rate of four percent per year. More than 60 percent of these procedures involve the replacement of a kidney and 23 percent are for liver transplants. Nabi Biopharmaceuticals' transplant franchise is focused on addressing the critical, unmet medical needs of this sizeable and growing population, and ATG-Fresenius S is a highly complementary addition to the company's existing product offering.
A number of European-based studies conducted to date have shown that ATG-Fresenius S targets the cells responsible for organ rejection better than competing products. Nabi Biopharmaceuticals believes that the limited side effects, better patient tolerance and convenient dosing regimen associated with ATG-Fresenius S, will make it a highly attractive alternative to other products that are currently on the market.
Professor Emeritus Dr. Walter Land, University Hospital Munich Grosshadern in Germany, one of Europe's most highly-regarded transplant surgeons and a leading international authority in the field of transplant medicine, said, "ATG-Fresenius S is a safe and highly efficacious product that, in combination with standard immunosuppressive drugs, significantly improves the long-term survival prognosis of organ graft and transplant patients."
By drawing on its core competencies in the development, manufacture and commercialization of polyclonal antibodies, as well as its strong relationships with key opinion leaders, physicians, payers and patients across the transplant community, Nabi Biopharmaceuticals is uniquely positioned to maximize the considerable value-creation potential of ATG-Fresenius S in North America. In addition, ATG-Fresenius S complements the company's existing development infrastructure and leverages the value of existing internal development resources.
The foundation of Nabi Biopharmaceuticals' transplant franchise is Nabi- HB (Hepatitis B Immune Globulin (Human)), a polyclonal antibody product that is indicated to prevent hepatitis B infection following accidental exposure to the hepatitis B virus, but is primarily used to prevent re- infection with hepatitis B virus in HBV-positive liver transplant patients. Nabi Biopharmaceuticals' complementary product, Civacir (Hepatitis C Immune Globulin (Human)), is being developed to prevent re-infection with the hepatitis C virus in hepatitis C liver transplant patients. A Phase II proof-of-concept clinical trial for Civacir is planned for the second half of 2006.
In contrast to other immunosuppressive agents, ATG-Fresenius S works by selective suppression of activated cells, which are responsible for the rejection of transplanted organs. Transplant rejection occurs when the immune system of the patient attacks the newly transplanted organ or tissue from another donor. Rejection occurs because a normal healthy human immune system can distinguish foreign tissues and attempts to destroy them.
Nabi leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo (calcium acetate), Nabi-HB (Hepatitis B Immune Globulin (Human)), and Aloprim (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology) and nicotine addiction.
Fresenius Biotech GmbH is a company of the Fresenius Health Care Group, focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine.
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|Publication:||BIOTECH Patent News|
|Date:||Mar 1, 2006|
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