Affimed Therapeutics AG receives FDA Orphan Drug Designation for
AFM13 against Hodgkin lymphoma
(Thomson Reuters ONE) - Heidelberg, Germany, September 15, 2009 - Affimed Therapeutics AGannounced today that the US Food and Drug Administration (FDA) hasgranted orphan drug designation to the human recombinant antibodyAFM13 for the treatment of Hodgkin lymphoma. The designation entitlesAffimed to seven-year market exclusivity in the US upon approval ofthis drug candidate. AFM13 is a novel, bispecific antibody based onAffimed's proprietary TandAb technology. TandAbs are tetravalentantibodies characterized by their ability to identify and selectivelydestroy tumour cells in the human body by binding target molecules onthe surface of tumour cells and activating T-cells or natural killercells (NK cells) simultaneously. Preclinical data has shown promisingevidence for the efficacy of AFM13 in Hodgkin lymphoma. Theinitiation of the first clinical studies is expected to start in thefirst quarter of 2010.Dr. Rolf Günther, CEO of Affimed, commented: "Our promisingpreclinical data with AFM 13 convinced the FDA experts of the strongpotential of our TandAb technology for the treatment of relapsed orrefractory Hodgkin lymphoma where only limited treatment optionsexist. The positive decision on the part of the regulatory authorityconfirms the great, unmet medical need for new therapeutic approachesin this indication. Up to 10.000 people could benefit from those newtherapies in the US approximately per year. Given the plannedinitiation of the first clinical trials with AFM 13 in the beginningof 2010, the orphan drug designation is a very important signal forthe further successful global development of our lead product."For further information please contact:Affimed Therapeutics AG MC Services AGDr. Rolf Günther (CEO) Birte SteinTel.: + 49 6221 65307-0 Tel.: +49 89 210 228 12Fax: + 49 6221 65307 Fax: +49 89 210 228 8877 Birte.Stein(at)mc-services.euR.Guenther(at)affimed.comAbout Hodgkin lymphoma:Hodgkin lymphoma is a malignant type of cancer targeting thelymphatic system, with the highest incidence among those aged between20-40 years, and over 70 years. According to estimates by theAmerican Cancer Society, Hodgkin lymphoma has a yearly incidence in8,500 patients in the US alone. Despite the strong potential forrecovery at the early stage of the disease, only insufficienttherapeutic approaches have so far been developed, particularly withregard to those patients who do not respond to aggressive chemo- andradiotherapy, or those who relapse. Due to the severe side effectsand the toxicity of this combined chemo- and radiotherapy, there is agreat medical need for new treatments.About Affimed Therapeutics AG:Affimed Therapeutics AG is a therapeutic antibody company developingnovel therapies for the treatment of life threatening diseases,mainly cancer diseases like Non-Hodgkin and Hodgkin lymphoma. Thecompany has developed a highly productive technology platformenabling the generation of unique antibody formats derived from threedistinct human antibody libraries. Affimed's antibody formats includeTandAbs and Flexibodies - two tetravalent, bispecific antibodyformats that promise a superior pharmacological profile and increasedtherapeutic potential, compared to monoclonal antibodies. The companyhas built a maturing pipeline of therapeutic antibody programs. Thefirst clinical studies for the lead product AFM13 for the treatmentof Hodgkin-Lymphoma are expected in the beginning of 2010. Anotheradvanced pre-clinical candidate is developed for the treatment ofNon-Hodgkin lymphoma. Further antibody programs for the treatment ofsolid tumors and autoimmune diseases are in pre-clinical development.The private company Affimed is a spin-off of the German CancerResearch Center, with 27 employees based in Heidelberg.Orphan Drug Designation:The orphan drug designation is intended to support and advancecompanies in the development of efficient therapies for the treatmentof rare diseases. For this purpose, the U.S. Food and DrugAdministration (FDA) enacted the Orphan Drug Act in 1983 that wasfollowed by the EU in 2000 issuing the "EG-Arzneimittel-Verordnungfür seltene Leiden". The orphan drug designation is awarded to thosecompounds that have a potential therapeutic value for the treatmentof rare diseases. These diseases affect fewer than 200,000 patientsin the US and approximately 230,000 patients in Europe per year. Thedesignation provides specific benefits, including research support,eligibility for protocol assistance and possible exemptions orreductions in certain regulatory fees during development or at thetime of application for market approval. The orphan drug designationensures participating companies a seven-year market exclusivity inthe US upon approval.http://hugin.info/142251/R/1341276/320781.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 15.09.2009 - 09:00 Uhr
Sprache: Deutsch
News-ID 5813
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 396 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Affimed Therapeutics AG receives FDA Orphan Drug Designation for
AFM13 against Hodgkin lymphoma"
steht unter der journalistisch-redaktionellen Verantwortung von
Affimed Therapeutics AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
