Ich habe zwar einen Translater aber das will
ich euch den doch nicht zumuten
So bitte die Info dazu
PR Newswire, 07/12/2001 07:03
European Commission Grants Marketing Authorization To Millennium & ILEX Partners` MabCampath(TM) (Alemtuzumab
/FROM PR NEWSWIRE BOSTON 617-482-5355/ [STK] MLNM ILXO SHR [IN] MTC BIO [SU] -- WITH PHOTO -- TO BUSINESS EDITOR:
European Commission Grants Marketing Authorization
To Millennium & ILEX Partners` MabCampath(TM) (Alemtuzumab)
New Drug for Patients with Refractory B-cell Chronic Lymphocytic Leukemia
to be Marketed by Schering AG
CAMBRIDGE, Mass. and SAN ANTONIO, Texas, July 12 /PRNewswire/ -- Millennium & ILEX Partners L.P. (M&I Partners), a joint venture of Millennium Pharmaceuticals Inc. (NASDAQ:MLNM) and ILEX(TM) Oncology Inc. (NASDAQ:ILXO), today announced that the European Commission has granted marketing authorization to the MabCampath(TM) (alemtuzumab) humanized monoclonal antibody for patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy.
(Photo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
Under this authorization, M&I Partners is granted a single license for marketing MabCampath(TM) in the 15 member states of the European Union. The drug will be marketed in Europe by Schering AG (NYSE:SHR) of Germany.
Mark Levin, Chief Executive Officer of Millennium, said, "Regulatory approval of MabCampath(TM) in Europe and the United States clearly demonstrates Millennium`s ability to execute. With the hard work and cooperation of U.S. and European regulators, we successfully accelerated a product from clinical development through the global regulatory process and onto the market. We are pleased that MabCampath(TM) represents our first commercial product and are looking forward to bringing other new drugs to market in the future."
ILEX President and Chief Executive Officer Richard L. Love said, "We are pleased that the European approval process went so well and that we achieved this milestone in a timely manner. It speaks to our expertise in oncology drug development and our commitment to bringing new therapies to market as quickly as possible. Moreover, it reaffirms our successful strategy of maintaining a European presence, with ILEX offices and regulatory personnel in London to oversee the EU approval process of our drugs. Direct contact with European regulators was a key factor in gaining MabCampath(TM)`s approval."
Chronic lymphocytic leukemia is the most prevalent form of adult leukemia, affecting approximately 120,000 patients in the U.S. and Europe. B-CLL is characterized by an accumulation of leukemic (malignant) lymphocytes that often bear the CD52+ antigen in the bone marrow, blood and other tissues. As a result of the accumulation of malignant lymphocytes, bone marrow dysfunction and enlargement of the lymph nodes, liver and spleen may occur. Patients with B-CLL may suffer from disease-related symptoms such as fatigue, bone pain, night sweats and decreased appetite and weight loss.
MabCampath(TM) appears to work by targeting the CD52+ antigen on the malignant lymphocytes. MabCampath(TM) binds to CD52+, an antigen that is present on the surface of certain leukemic lymphocytes, and induces antibody- dependent lysis (killing) following binding. This results in the removal of the malignant lymphocytes from the blood, bone marrow and other affected organs. The CD52+ antigen is also found on nonmalignant (normal) lymphocytes, monocytes, macrophages, NK cells, some granulocytes and some normal bone marrow cells.
U.S. Boxed Warning Summary: In the U.S., the drug is known as Campath(R) (alemtuzumab). Hematologic toxicity: Serious and, in rare instances fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia have occurred in patients receiving Campath(R) therapy. Infusion reactions: Campath(R) can result in serious infusion reactions. Infections, opportunistic infections: Serious, sometimes fatal, bacterial, viral, fungal, and protozoan infections have been reported in patients receiving Campath(R).
M&I Partners will conduct a post-approval clinical trial of MabCampath(TM) versus chlorambucil, the standard frontline treatment, to further examine MabCampath(TM) for the treatment of B-CLL patients. This post-approval trial is now being initiated.
The original synthesis and initial development of MabCampath(TM) was conducted by Professors Hermann Waldmann and Geoff Hale at Cambridge University between 1980 and 1995. The two scientists later moved to the University of Oxford where the antibody was developed and first manufactured at the Therapeutic Antibody Centre (TAC).
Commenting on the regulatory approval of MabCampath(TM), Professor Waldmann, Head of Oxford`s Dunn School of Pathology, said, "We are very pleased that this drug will now be available to patients who have no other approved therapeutic options available. Its evolution from the laboratory to the clinic could not have happened without the determination of a number of people. In particular, I would like to highlight the commitment of the TAC set up in Cambridge and then Oxford, and the devotion of many clinicians throughout the UK and Europe who had faith in the drug. Their energy, combined with the vision and enterprise of Millennium & ILEX Partners L.P., has now brought this project to completion."
The Marketing Authorization Application for MabCampath(TM) was submitted to the European Medicines Evaluation Agency (EMEA) in March 2000 and accepted for review in April 2000. In March 2001, MabCampath(TM) received a unanimous positive opinion for approval from the Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the EMEA.
In the U.S., Campath(R) (alemtuzumab) was approved for marketing by the Food and Drug Administration in May 2001. It is marketed by Berlex Laboratories Inc., the U.S. affiliate of Schering AG.
Prescribing information for MabCampath(TM) can be found on the Campath website at www.campath.com, or by calling 1-888-BERLEX-4.
Millennium, a leading biopharmaceutical company, applies its comprehensive and integrated science and technology platform for the discovery and development of breakthrough therapeutic and predictive medicine products, with a goal of delivering personalized medicine. Through the industrialization of this gene-to-patient platform, Millennium is also striving to accelerate the process of drug discovery and development. Headquartered in Cambridge, Mass., Millennium currently employs more than 1,400 people.
Founded in 1994 as an oncology drug development company, ILEX Oncology Inc. is strategically positioned to become a leading oncology-focused pharmaceutical company. ILEX has a marketed product in the U.S., Campath(R), and is advancing a deep pipeline of anti-cancer compounds focused on the treatment of both advanced and early disease. The pipeline comprises multiple technologies at all stages of clinical development, including apoptosis- inducing agents, cytotoxic compounds and angiogenesis inhibitors with novel mechanisms of action, and chemoprevention agents. ILEX maintains one of the biopharmaceutical industry`s most experienced in-house development organizations for oncology drugs, with locations in San Antonio, Texas; Annapolis, Md.; and Guildford, England. ILEX also conducts drug discovery research in angiogenesis inhibition, targeted medicinal chemistry and nuclear receptor biology from its laboratories in Boston and Geneva, Switzerland. Further information about ILEX can be found on the company`s website at www.ilexonc.com.
Millennium: This press release contains "forward-looking statements," including statements about our growth and future operating results, discovery and development of products, potential acquisitions, strategic alliances and intellectual property. Various risks may cause Millennium`s actual results to differ materially, including: adverse results in our drug discovery and clinical development processes; failure to obtain patent protection for our discoveries; commercial limitations imposed by patents owned or controlled by third parties; our dependence upon strategic alliance partners to develop and commercialize products and services based on our work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from our development efforts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties we face, see the reports we have filed with the Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
ILEX: Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, risks associated with clinical developments in the biopharmaceutical industry in general and MabCampath(TM) in particular; the potential failure of MabCampath(TM) to prove safe and effective for treatment of disease; market acceptance of MabCampath(TM); failure to successfully implement or complete clinical trials; the development of competing products; uncertainties related to the Company`s dependence on third parties and partners; uncertainty related to protection of the Company`s intellectual property; failure to receive market clearance from regulatory agencies; and those risks described in ILEX`s Form S-3 filed March 8, 2000 (Commission file #333-32000), and ILEX`s Annual Report on Form 10-K for the year ended December 31, 2000, and in other filings made by ILEX with the SEC. ILEX disclaims any obligation to update these forward-looking statements.
Editor`s Note: This release is available on Millennium`s website at www.millennium.com and the ILEX website at www.ilexonc.com.
|aus der Diskussion:||Schering erhält Pharma-Zulassung|
|Autor (Datum des Eintrages):||ambobobo (13.07.01 22:57:49)|
|Beitrag:||4 von 4 (ID:3964418)|
|Alle Angaben ohne Gewähr © wallstreet:online|