On June 8, the Society of Investment Professionals in Germany (DVFA) and its Life Science Committee hosted its annual conference which this time focused on biosimilars. The event covered key scientific topics, regulatory pathways and commercial issues of the market.

While experts agreed that the US will soon follow the EU in establishing a regulatory pathway for filing and approval of biosimilars – with a few originator companies still taking rearguard actions – it is not yet evident whether biosimilars will conquer the markets simply because of lower prices. In many EU countries, there will be no automatic substitution as with small molecule generics so that doctors need to be convinced to prescribe a particular “branded” biosimilar.

However, while the regulatory pathway is based on comparability, this claim cannot be made for marketing as Adem Koyuncu, Partner of Mayer Brown LLP explained. He said, it will constitute a case for litigation to claim that safety and side effect profiles of a biosimilar are the same as those of the originator product as these features have not been demonstrated to the same extend during the approval procedure. So the question for marketing is to educate practitioners and patients on biosimilars as an “alternative”, not as “substitute”. In fact, as Frank Pieters of Teva Pharmaceuticals said, it may be advisable, depending on the product and the environment, to develop hybrid marketing models, mixing “generic” and “branded” approaches.  » Read more...

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.  » Read more...

- Former CSO Dr. Uwe Marx leaves for academia –

ProBioGen AG, a leading biotechnology company in cell engineering and production of biopharmaceuticals, today announced that Dr. Volker Sandig has been appointed to Chief Scientific Officer (CSO) of the company. He will take over the duties of Dr. Uwe Marx, who will take an opportunity to lead an entrepreneurial innovation team at the Technical University Berlin.

Dr. Sandig has established ProBioGen´s cell line development program in 2000 and has been responsible for the development of high producer cell lines and the customized design of new cell lines from primary sources. Prior to joining ProBioGen, he held senior management positions at Merck Research Laboratories, USA, focusing on the development of manufacturing systems for gutless adenoviruses. Using his knowledge in viral vectors, he also participated in Merck´s vaccine program. Earlier in his career, he designed experimental strategies for adenovirus-based tumor treatment and directed research projects in cell cycle regulation and artificial promoters at Max Planck Society and Hepavec, a Berlin-based biotech company. After finishing medical training, Volker Sandig received his PhD in Molecular Biology from Humboldt University, Berlin.

For more information, please click here  » Read more...