MBIOTEC

News:

October 20, 2009

MBiotec received a positive opinion on orphan designation for MALP-2S for the treatment of pancreatic cancer from FDA´s Office of Orphan Products Development

October 14, 2009

MBiotec presentation at BioConnect Day in Basel, Switzerland

October 6, 2009

MBiotec presentation at Bio@venture Hannover, Germany

September 4, 2009

MBiotec presentation at Seed4 Money Frankfurt, Germany

June 26, 2009

MBiotec assigned SME (small-medium enterprise) status by the EMEA

June 23, 2009

Presentation at the Venture.Med 2009 in Essen, Germany

May 8, 2009

Meet MBiotec at the Biovaria in Munich, Germany

April 14, 2009

MBiotec received a positive opinion on orphan status from COMP/EMEA

COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
April 2009 Plenary Meeting - Monthly Report

March 6, 2009

MBiotec received two questions regarding the EMEA orphan application for MALP-2S

February 26, 2009

EMEA application to register as a "Small or Medium Enterprise (SME)"

February 10, 2009

Orphan application with FDA

January 5, 2009

The 90-day review period was started. A similar application will be made to the FDA in February 2009.

November 28, 2008

MBiotec applied for Orphan Drug Designation, after successful validation of the dossier on MALP-2S by the EMEA.

November 15, 2008

MBiotec concluded a license and development agreement for MALP-2S with Ascenion GmbH, Germany. MBiotec received worldwide rights for the development of MALP-2S in cancer.



Toll-like receptor agonists and MALP-2S for cancer treatment

Toll-like receptor (TLR) agonists are a very promising new target for cancer treatment. Our proprietary drug candidate, the synthetically manufactured Macrophage Activating LipoPeptide-2, MALP-2S, is designed to specifically stimulate the TLR 2/6 dimer, which belongs to a family of receptors activating the innate immune system.

Aiming to stay focused in initial operations, MBiotec will primarily develop MALP-2S for pancreatic cancer. The COMP adopted a positive opinion recommending MALP-2S for designation as orphan medicinal product to the European Commission.

Business strategy: To maximize the potential of MALP-2S for cancer treatment by focusing on development strategy for pancreatic cancer. To gain fast market access and to develop other cancer indications subsequently.

To date, MBiotec has entered negotiations with several potential inventors/ partners to secure financing of the clinical development program for MALP-2S. Negotiations are expected to be finalized by mid 2009.