Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Florebetapir’

My theme for blog posts this week has been the diagnosis and detection of Alzheimer’s Disease, a therapeutic area I was first introduced to while working as a Global Project Director at the Canadian CRO, CroMedica before it was acquired by PRA. The then CEO of CroMedica, Erich Mohr Ph.D is now Chairman and CEO of MedGenesis Therapeutix Inc. in Victoria, BC.

This privately held biopharmaceutical company is working on developing new products for neurological diseases and the treatment of Parkinson’s Disease, Glioblastoma Multiforme (GBM) and Intractable Epilepsy. I have added MedGenesis to my list of emerging biotechnology companies to watch, and look forward to writing further as their pipeline develops.

Which brings me back to Alzheimer’s disease (AD), an area which I think will touch many of us as we and our parents become older. Last week, I was visiting my elderly mother in England who struggles to remember when I am visiting, and has little or no short term memory. It’s sad to see her in a restaurant have a completely blank face when she goes up to a buffet, then cannot remember where she was sitting.

While we all have age-related decline in our memory as we get older, how do you know if it may be something more such as AD? The Alzheimer’s Association have published a useful list of 10 warning signs, that may suggest seeing a doctor:

  1. Memory loss that disrupts daily life
  2. Challenges in planning or solving problems
  3. Difficulty completing familiar task at home, at work or at leisure
  4. Confusion with time or space
  5. Trouble understanding visual images and spatial relationships
  6. New problems with words in speaking or writing
  7. Misplacing things and losing the ability to retrace steps
  8. Decreased or poor judgment
  9. Withdrawal from work or social activities
  10. Changes in mood or personality

While there is no cure for AD, early diagnosis using biomarkers (see my blog post on Lilly’s florbetapir and blog post on Novartis’ Aß40 oligomers), could lead to slowing disease progression as new therapeutic agents come through development to market.

Dementia, AD and other cognitive disorders are challenging for caregivers and family’s to deal with. In many ways a tangible, physical illness is easier.  Not knowing the rate of progression and the future, it is difficult to plan ahead. Helping my elderly mother maintain her independence in the face of the mental challenges she faces is something that we as a family have to face up to, as I am sure many others will too.

A company I have been watching for a while is Philadelphia based Avid Radiopharmaceuticals, now a wholly owned subsidiary of Lilly. They have a novel imaging biomarker, florebetapir (18F-AV-45) in development for the detection of Alzheimer’s disease.

In a press release last week, Lilly announced that the FDA had assigned a priority review to the marketing application of florebetapir. The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA meet on January 20, 2011.

Bayer have a competitor product in development, forebetapen (BAY 94-9172). Both florebetapir and florebetapen are 18F radiolabelled imaging biomarkers that bind to amyloid plaque in the brain.  When used in conjunction with a Positron Emission Tomography (PET) scan, they enable the accumulation of amyloid that occurs in Alzhemeir’s disease to be visualized.

Phase 3 trial results for florebetapir published earlier this year showed that the brain amyloid burden seen in the PET scans positively correlated with the plaques seen in autoposies of the same patients.  Proof that what the imaging biomarker shows is an accurate representation of the underlying pathology.

What makes the use of florebetapen and florebetapir interesting is that it is already common practice to use imaging tracers with PET scans. Fluorodeoxyyglucose (FDG) is widely used in the diagnosis, staging and treatment of oncology patients as a result of its ability to show the intense glucose uptake that occurs with most cancers.

Both Avid and Bayer products are most likely to be approved based on the clinical data presented to date.  It will be interesting to see the prices that they intend to charge.

As for the market opportunity, they are likely to have a role to play in the early diagnosis of patients with mild cognitive impairment, since at present it is difficult to diagnose these patients and differentiate Alzheimer’s disease from other forms of dementia.  Most likely, models will be developed that look for a correlation between accumulation of amyloid plaque and decline in cognitive function, from which a probability of developing Alzheimer’s disease can be calculated.

Imaging biomarkers are likely to place an increasingly important role in the development of new products by biotechnology companies and in the design of clinical trial endpoints.

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