News

Food for Thought: Finally, a Test for Alzheimer’s?

If the story by a small, Philadelphia-based company called Avid Radiopharmaceuticals communicated earlier this month holds up, there will be a reliable diagnostic test for Alzheimer’s disease available in a few years.

Such a test not only would change diagnosis but also help develop novel Alzheimer treatments as it would enable clinical researchers to check whether a drug candidate is making a difference in terms of plaque formation or reduction. At present, the only definite diagnosis of Alzheimer is by brain autopsy.

The company presented interim data  of a Phase III study of patients with a life expectancy of less than 6 months, in which the results of  a brain scan using florbetapir, a novel radiolabeled compound that specifically and sensitively binds β-amyloid, were compared to the autopsy results obtained after the patients’ death. The data were presented at the 2010 Annual Society of Nuclear Medicine (SNM) meeting in Salt Lake City. According to the abstract, the florbetapir PET brain images  are highly correlated with autopsy-confirmed β-amyloid deposition in the brain.

According to the New York Times, the company will present final data of 35 patients during next month’s ICAD, the Alzheimer’s Association International Conference on Alzheimer’s Disease 2010 in Honolulu, Hawaii.

Company News: Probiodrug Obtains Patent, Expands Boards, Wins Award

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.

Company News: Micromet Presents Updated Results From Phase 1 and Phase 2 Study of Blinatumomab

– 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.

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.

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