SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced that the FDA’s Office of Orphan Products Development has granted Orphan Drug Designation (ODD) for SuppreMol’s lead product SM101, a recombinant human soluble Fcγ receptor IIb, for the treatment of Idiopathic Thrombocytopenic Purpura (ITP).
At present, SM101 is in a Phase Ib/IIa clinical study in ITP, with results expected in early 2011. For the same indication, the molecule has already been granted Orphan Medicinal Product Designation in Europe by the EU Commission in 2007. Further details are available on the company’s website.
European Market Expansion of 365 Energy Gains Further Momentum
365 Energy has announced the installation of the first Coulomb ChargePoint® Networked Charging Stations in Dublin, Ireland. The charging stations were provided to Ireland’s Electric Supply Board (ESB) and recently went live in the Dublin city centre. The installation of these charging stations is only the beginning of Ireland’s nationwide e-mobility infrastructure initiative. The ESB is planning to install charging stations in homes, on-street and along motor-ways throughout Ireland so that electric cars can be powered at a wide range of accessible venues.
SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced the initiation of a Phase Ib/IIa clinical trial with its lead product SM101 in Idiopathic Thrombocytopenic Purpura (ITP) in Europe. For further details on the trial and the compound, please see the complete press release.
In a Phase Ia trial in 48 healthy volunteers started in April 2009, no SM101-associated adverse reactions have been observed. Detailed results of this study will be published soon.
MediGene AG has signed a license and supply agreement with Meditrina Pharmaceuticals for the supply and commercialization of Veregen® in Greece and Cyprus. Meditrina will promote and distribute Veregen® for the treatment of genital warts in both territories. Upon the achievement of specific milestones, MediGene will be entitled to successive payments totaling up to 900 thousand euros, and will receive the first milestone payment upon the initiation of the approval procedure in Greece. In addition, MediGene will supply Meditrina with finished product and will receive double-digit royalties on net sales. MediGene believes that Greece is the sixth largest potential European market for Veregen® sales volume.
MediGene has already entered into marketing partnerships for Veregen® with Nycomed, Inc. for the USA, Solvay (acquired by Abbott on February 15, 2010) for Germany, Austria and Switzerland, Juste S.A.Q.F for Spain and Portugal and Teva Pharmaceuticals Industries Ltd. for Israel. For further information, please click here.
Also today, ProBioGen has announced that it has been granted a divisional patent on its prorietary AGE1 cell line.
The patent covers the production of Modified Vaccinia Ankara (MVA) in duck cell lines. As these cells are free from endogenous particle-associated retrovirus activity, they are superior to current production substrates derived from chicken. The discovery has wide implications for the industrial production of one of the most promising recombinant vaccine vectors against infectious disease challenges such as HIV and malaria. Read more here.
