GTC Biotherapeutics and LEO Pharma to Develop and Market ATryn(R) in Europe, the Middle East, and Canada Tuesday November 1, 8:30 am ET
FRAMINGHAM, Mass. & BALLERUP, Denmark--(BUSINESS WIRE)--Nov. 1, 2005--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) and LEO Pharma A/S ("LEO") have entered into a collaboration agreement to develop and market ATryn® for markets in Europe, the Middle East, and Canada. ATryn® is GTC's recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The agreement includes $73 million (USD) in potential milestone payments to GTC for meeting regulatory, clinical and sales goals. These payments include a total of $5 million for achieving approval of ATryn® for the hereditary antithrombin deficiency indication in Europe, with $2 million of this total paid upon signing of the agreement. GTC will be responsible for production of ATryn® and will receive a transfer price for all product used by LEO. GTC will also receive a royalty on net sales. LEO will be responsible for sales and marketing of ATryn® in all indications for the agreed territories as well as the clinical development for acquired antithrombin deficiency indications. GTC retains all rights to ATryn® in all other territories and will continue to be responsible for obtaining approval of ATryn® for the hereditary deficiency indication in Europe.
"LEO is an excellent partner for the ATryn® program with a strong strategic interest in products for Critical Care and the management of coagulation. LEO clearly understands the opportunity for creating significant markets for ATryn®. We look forward to working with LEO in developing ATryn® in acquired deficiency indications," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer.
"LEO is firmly committed to establishing the Critical Care area as a strong and growing segment of our business. ATryn® has significant growth potential and is a natural extension of our current Critical Care portfolio. We are pleased to work with GTC to bring the first recombinant antithrombin product to our markets. Also, we are delighted that ATryn® will be the first antithrombin product that would be approved in all the countries of the European Union, providing a consistent and secure source of supply to all of our customers," says Ernst Lunding, President and Chief Executive Officer of LEO.
LEO has a long history in the treatment of thromboembolic disorders. innohep®, a low-molecular-weight heparin product is a well-known LEO product in which antithrombin binds with heparin to produce a greater anticoagulant effect. LEO has over 250 sales representatives in Europe, the Middle East, and Canada focused on Critical Care and coagulation management out of a total sales and marketing work force of 1,000 people.
GTC has developed goats with the human antithrombin gene linked to a milk-protein promoter so that they express the antithrombin protein in their milk. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, which are difficult to express in conventional production methods.
The European Medicines Agency (EMEA) is reviewing GTC's Marketing Authorization Application (MAA) for the use of ATryn® in the prophylactic treatment of patients with hereditary antithrombin deficiency (HD) during high-risk situations. The review of the MAA is expected to conclude with a determination by the EMEA in late February 2006 and will include the results of the inspections of GTC's farm and manufacturing facilities and certain clinical sites.
Potential acquired deficiency indications include severe burns, coronary artery bypass graft surgery, disseminated intravascular coagulation and sepsis. A determination of which acquired deficiency to pursue first is anticipated in the middle of 2006 following the EMEA and European Commission's determination regarding the MAA for HD.
About GTC Biotherapeutics, Inc.
GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. In addition to the ATryn® program, GTC is developing a recombinant human alpha-1 antitrypsin, a recombinant human albumin, a malaria vaccine, and a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors. In its external programs, GTC's technology is used to develop transgenic production of its partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems. One of the external programs is in clinical trials with a transgenically produced product. Additional information is available on the GTC web site, http://www.gtc-bio.com.
About LEO Pharma A/S
LEO Pharma is an independent research-based company with headquarters in Ballerup, Denmark, and affiliates and regional offices in more than 40 countries. LEO Pharma is 100% owned by the LEO Foundation and employs approximately 3,300 people. The group is one of the world's leading companies in topical dermatology and parenteral treatment of thromboembolic disorders. LEO Pharma products are marketed in more than 90 countries. Additional information is available on the LEO Pharma web site, www.leo-pharma.com.
Forward-Looking Statement for GTC Biotherapeutics
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding potential development of additional indications for ATryn®, the potential milestone payments and other renumeration from the collaboration, and the timing of EMEA's determination on the MAA for ATryn® in HD. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports as filed with the Securities and Exchange Commission, including the uncertainties associated with dependence upon the actions of partners and regulatory agencies and with the development of additional indications. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law. GTC specifically disclaims responsibility for information describing LEO and its business other than the agreement with GTC. Contact:
GTC Biotherapeutics, Inc. Thomas E. Newberry, 508-370-5374 Vice President, Corporate Communications or Feinstein Kean Healthcare for GTC Biotherapeutics, Inc. Francesca DeVellis, 617-577-8110 or LEO Pharma A/S Adam Estrup, +45 72 26 23 53 Director, Corporate Communications
Nabi Biopharmaceuticals Announces Results of StaphVAX(R) Confirmatory Phase III Clinical Trial Tuesday November 1, 8:02 am ET - Study Failed to Show that StaphVAX Prevents S. aureus Infections in Kidney Disease Patients - - Company to Increase Focus on Other Pipeline Products -
ROCKVILLE, Md., Nov. 1 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI - News) today announced that StaphVAX® [Staphylococcus aureus Polysaccharide Conjugate Vaccine] failed to meet its primary endpoint in the company's confirmatory Phase III clinical trial.
The study, a randomized, double-blinded, placebo-controlled trial of 3,600 patients on hemodialysis, found no reduction in S. aureus types 5 and 8 infections in the StaphVAX group as compared to the placebo group. The company will immediately initiate an assessment to determine the factors causing this outcome, including the vaccine target (S. aureus polysaccharide capsule) and the quality of the antibody generated by the vaccine. Results will be available within the next few months. It is important to note, however, that StaphVAX was highly immunogenic, confirming that Nabi Biopharmaceuticals' vaccine conjugation technology is effective in producing and sustaining high levels of specific antibodies.
Thomas H. McLain, chairman, president and chief executive officer, Nabi Biopharmaceuticals, stated, "We are obviously surprised and very disappointed with the results of the StaphVAX confirmatory Phase III trial. While we complete our assessment over the next few months, we will re-focus our capabilities in developing vaccine and antibody products in other areas of significant medical need. This includes advancing other bacterial vaccines in development; NicVAX(TM), a vaccine for smoking cessation; and Civacir(TM), an antibody product for the prevention of hepatitis C post-liver transplant. At the end of the third quarter, we had cash and marketable securities totaling $137 million and we will continue to generate cash margins earned on product sales. This assures our ability to accelerate the development of these programs, which are closely aligned with our business strategy and core competencies."
Next Steps
While the company completes its assessment of the Phase III trial results, it will halt further development of StaphVAX and will withdraw its Marketing Authorization Application (MAA) to market StaphVAX in the European Union.
The company will also halt the development of Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], its investigational product for the prevention and treatment of S. aureus infections, as it is based on the same capsular polysaccharide technology as StaphVAX.
The significant majority of the company's development spending in 2005 has been directed toward pre-launch and clinical activities for StaphVAX and Altastaph. Spending on these activities will stop during the fourth quarter of 2005.
In addition, the company expects to advance the development of its other vaccine programs, including: NicVAX (Nicotine Conjugate Vaccine), which is currently in Phase IIb clinical trials; its non-capsular polysaccharide-based vaccine for S. aureus (type 336) in Phase I clinical trials; its S. epidermidis vaccine in Phase I clinical trials; and, its community-acquired S. aureus program (PVL) and Enterococcal vaccine in pre-clinical development.
The company also plans to advance the clinical development of its antibody product, Civacir [Hepatitis C Immune Globulin (Human)] for the prevention of hepatitis C after liver transplant.
About NicVAX
NicVAX is Nabi Biopharmaceuticals' novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse. The company was recently awarded a $4.1 million grant by the U.S. National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, for partial funding of the company's development program for NicVAX.
By the end of 2005, Nabi Biopharmaceuticals intends to announce preliminary safety and immunogenicity results from a Phase IIb clinical study in Europe. These results will define the next clinical development steps for NicVAX. The company will manufacture NicVAX in its own vaccine facility in Boca Raton, Florida.
About Civacir
Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). Civacir is being developed for the prevention of hepatitis C after liver transplant.
The National Institutes of Health (NIH) has funded and conducted a Phase I/II clinical trial of Civacir in HCV-positive liver transplant patients at four study sites in the U.S. This randomized, controlled study evaluated the safety of dosing patients with Civacir during and after transplant surgery, the level of HCV-specific antibodies in trial subjects following dosing, liver enzyme levels (a measure of liver damage) and HCV levels in the transplanted livers.
Management will hold a conference call to discuss today's results at 8:30 AM, Eastern time. To access the conference call in the U.S., please dial: 1-877-569-0953, passcode: 2058652; for international callers, please dial: 706-634-4967, passcode: 2058652. A replay of the call will be available until November 14, 2005, midnight, eastern time. For the replay, US callers, please dial: 1-800-642-1687, passcode: 2058652; international callers, please dial: 706-645-9291, passcode: 2058652.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. We are poised to capture large commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology), and nicotine addiction. We have three products on the market today: PhosLo® (calcium acetate), Nabi-HB® [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) [Allopurinol sodium (for injection)] and a number of products in various stages of clinical and pre-clinical development. The company also filed Marketing Authorization Applications (MAA) in Europe to market
Nabi-HB® Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the trade name HEBIG(TM) for the prevention of hepatitis B disease in HBV-positive liver transplant patients; and for PhosLo, which is already marketed in the United States. The company's products in development include NicVAX, a vaccine to treat nicotine addiction, and Civacir, an antibody for preventing hepatitis C virus re-infection in liver transplant patients. For additional information on Nabi Biopharmaceuticals, please visit our Website: http://www.nabi.com.
This press release contains forward-looking statements that reflect the company's current expectations regarding future events. Any such forward-looking statements are not guarantees of future performance and involve significant risks and uncertainties. Actual results may differ significantly from those in the forward-looking statements as a result of any number of factors, including, but not limited to, risks relating to the company's ability to advance the development of products currently in the pipeline or in clinical trials; the company's ability to maintain the human and financial resources to commercialize current products and bring to market products in development; likelihood of the company to announce preliminary safety and immunogenicity results from its Phase II NicVAX study by the end of 2005; the ability of the company to manufacture NicVAX in its own vaccine facility; the possibility that the company may not realize the value of its acquisition of PhosLo; the ability of the company to prevail in patent litigation; ability to raise additional capital on acceptable terms; the company's dependence upon third parties to manufacture its products; the company's ability to utilize the full capacity of its manufacturing facility; the impact on sales of Nabi-HB from patient treatment protocols and the number of liver transplants performed in HBV-positive patients; reliance on a small number of customers; the future sales growth prospects for the company's biopharmaceutical products; and the company's ability to obtain regulatory approval for its products in the U.S. or abroad or to successfully develop, manufacture and market its products. These factors are more fully discussed in the company's Annual Report on Form 10-K for the fiscal year ended December 25, 2004 filed with the Securities and Exchange Commission.
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