Alzheimer-specialist Probiodrug AG last week not only obtained a new US patent covering the inhibition of the enzyme glutaminyl cyclase (QC) for the treatment of CNS diseases. The company also announced the appointment of Dr Claus Braestrup, former President & CEO of Lundbeck A/S to Chairman of the Supervisory Board and Prof Dr Lennart Mucke, Director of the Gladstone Institute of Neurological Disease in San Francisco, Calif. to its Scientific Advisory Board. Moreover, the company was awarded the “IQ Innovationspreis Mitteldeutschland” by the Industrial Initiative for Central Germany for its innovative therapeutic strategy to combat Alzheimer’s disease. In May, Probiodrug hosted the PSP 2010 conference with more than 150 scientists to discuss its approach.
– Update Presented at the 15th Annual Congress of the European Hematology Association (EHA) –
Micromet, Inc. (NASDAQ: MITI) today announced updated clinical data from a Phase 1 and a Phase 2 trial, respectively, of its lead product blinatumomab (MT103). The data were presented at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.
Results of the analysis from a Phase 2 trial in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL) demonstrate that a prolonged hematologic relapse-free survival was observed in patients treated with blinatumomab. A pivotal trial in adult MRD-positive ALL patients is scheduled to begin in Q3, 2010.
Updated results from a Phase 1 trial of blinatumomab in patients with relapsed non-Hodgkin’s lymphoma (NHL) demonstrated durable responses ranging up to 30 months. Blinatumomab is the first in a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.
A conference call will be hosted tomorrow, June 15, 2010, at 08:30am ET / 02:30pm CET / 01:30pm UK time. Dial-in details and the complete announcements are available here.
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.
In a recent article (“Simply Obscene”) the influential German news magazine “Der Spiegel” (20/2010, May 17, 2010) stated the pharma industry was using “with the unscrupulousness of a stock jobber” a loophole in Germany’s highly regulated health care system to charge extremely high prices for basically useless cancer medications. In particular, the article featured Yondelis by Pharma Mar, Nexavar by Bayer, Hycamtin and Tyverb by GlaxoSmithKline, Erbitux by Merck KGaA, Sutent by Pfizer, Iressa by AstraZeneca, Avastin, Xeloda, Mab-Thera and Herceptin by Roche and Alimta by Lilly as examples for cancer drugs providing only marginal survival benefits at enormous costs and stated this was “lawful looting of the health care system”. The only exception according to the authors of the article was Novartis’ Gleevec.
This week, the Competence Network Malignant Lymphomas published an open “letter to the editor” (only available in German) stating that in the case of lymphoma therapy the authors of the article had done “obviously sloppy work”: “Therapy costs of lymphocyte-specific antibody Rituximab [MabThera] amount to €24,000, not €134,000 per year. Several independent studies have demonstrated that overall survival in both follicular and diffuse large B cell lymphoma is prolonged on average by several years (!), in fact without substantial side effects.” Der Spiegel had stated extension of survival in these two indications was “not proven”.
The letter also said that administrative costs for studies to optimize therapies had increased by a a factor of 10 in the last couple of years due to legal requirements.
The article of Spiegel magazine is available online in German, however without the tables featuring treatment costs and extension of survival for the drugs mentioned.