Tag: ProBioGen

Company News: ProBioGen and Merus Sign Deal on GlymaxX® ADCC Enhancement Technology

– GlymaxX® Manufacturing Technology Improves Bispecific Antibody Activity for Solid Tumor Treatment

ProBioGen AG and Merus B.V. today announced that the companies have signed a non-exclusive commercial option and license agreement on ProBioGen’s GlymaxX® fucose-engineering technology. Under the terms of the agreement, ProBioGen is granting Merus the non-exclusive right to use the GlymaxX® technology to enhance the ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity of one of its lead products, a bispecific anti-cancer antibody. The license is covering clinical development and production. Financial details have not been disclosed.

The GlymaxX® technology for the production of afucosylated antibodies and proteins is based on the stable integration of a heterologous enzyme into any antibody producer cell line, leading to the interference with the cells’ intracellular fucose biosynthesis pathway. As a unique feature differentiating it from other approaches, the GlymaxX® technology can be applied to both novel and already existing antibody producer cell lines and entire antibody expression and discovery platforms without negatively affecting their productivity. Moreover, it is simple, rapid, potent and universally applicable.

Food for Thought: The Future of Biosimilars

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.

Gertraud Unterrainer of ProBioGen explained the intricacies of developing cells lines for the production of biosimilars: the goal is to aim for the closest possible match to the originator product, not for a product that might be regarded as superior, e.g. in respect to the amount of impurities. She also stressed that activity assays are not a substitute for assessing the clinical impact of differences.

With all these details being tricky, both Falk Ehmann of the European Medicines Agency (EMEA) and Christopher Klein of Sandoz International do not expect imminent fierce competition from the many Asian and Indian companies developing biosimilars. “They can market their products in Europe,” Ehmann said, “however, they have to meet all our standards and requirements to get approval.”

Last but not least, Manfred Ruediger of LSP Life Science Partners said that as a VC, he is still refraining from investing in biosimilar companies as he still is not convinced on the investment multiples that can be reached with biosimilars within ten years time.

A link to the presentations will be available shortly here.

Company News: MediGene Signs Commercialization Agreement for Veregen / ProBioGen Is Granted New Divisional Patent on Duck Cell Line

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.

Company News: ProBioGen Announces the Appointment of Dr. Volker Sandig to Chief Scientific Officer

– 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