First of all, on behalf of  the entire BioHorizon staff, let me welcome you to the BioHorizon Health Technology Surveillance Update.  Long time clients  and readers will remember that Surveillance Updates last graced these pages in 2005-2006 and based on your feedback we have changed the focus of this feature to better meet your needs -  we hope you  agree!

Lets start by turning our attention to  FDA approvals of note in January and February 2010.  On January 11th, Genentech Inc.’s rheumatoid arthritis therapy, Actemra (tocilizumab),  was approved for treatment of adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes  for this disease.  Serious safety concerns associated with this interleukin-6 blocker were cited as the basis for the FDA’s requirement for a post-marketing clinical trial to evaluate long term safety as well as a Risk Evaluation and Mitigation Strategy that directs Genentech to implement a communication plan for prescribing physicians detailing the appropriate approach to obtaining informed consent and side effect monitoring.

Acorda Therapeutics’ Ampyra (dalfampridine) extended release tablets were approved on January 22nd, to improve walking in multiple sclerosis patients representing the first drug approved for this use.  The FDA cautioned that Ampyra can cause seizures when given at greater than recommended doses. 

Turning to medical devices for a moment, Thoratec Corp.’s HeartMate II Left Ventricular Assist System was approved on January 20th for severe heart failure patients who are not acceptable transplant candidates.  The HeartMate II was already approved for certain patients waiting for complex medical treatments including transplants.   The FDA directed Thoratec to conduct a post-approval study to further characterize the device’s performance.

 On January 25th,  Novo Nordisk Inc got the nod for Victoza (liraglutide (rDNA) injection) the company’s once daily GLP-1 receptor agonist which is indicated for treatment of type 2 diabetes in adults and joins Eli Lilly’s twice daily Byetta in the injectable GLP-1 agonist class.

GlaxoSmithKline’s Tykerb (lapatinib) got an expanded indication from the FDA on January 29, and can now be used in combination with the Novarits product Femara (letrozole) in the treatment of hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

And finally, on February 2nd the FDA approved Auxillium Pharmaceuticals’  injectable Dupuytren’s contracture therapy, Xiaflex (collagenase clostridium histolyticum) – this is the first FDA approved non-surgical therapy inidicated for this progressive hand disease. 

We encourage our readers to visit www.fda.gov as well a company or product specific website for more details, in subsequent weekly updates we will begin to include some discussion of interesting clinical trial results from the week that was in additon to setting the table for the next week in emerging health technology.  Thanks for reading.

Tarceva is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor. By inhibiting the addition of phosphate to the EGFR associated tyrosine kinase, Tarceva may interrupt important cellular signaling pathways and thereby suppress cancer cell growth. Astra Zeneca’s Iressa® is an example of an EGFR tyrosine kinase inhibitor already approved by the FDA for use in NSCLC. According to Astra Zeneca’s third quarter financial statements for 2004, sales of Iressa for the first 9 months in the United States were $160,000,000. We have given Tarceva 10 demand/diffusion points and 65 innovation status points.

According to CDC estimates, more than 170,000 people will be diagnosed with lung cancer in the United States in 2004. Anywhere from 75-85% of these will be the non-small cell type, the most common form of lung cancer in the US. In addition, lung cancer is the most common cause of cancer death in the United States accounting for more than 25% of cancer deaths on an annual basis. Using the BioHorizon burden of illness methodology, NSCLC receives a burden of illness rating of 21.

Overall, Tarceva receives a BioHorizon Emerging Health Technology score of 46, placing it in our Moderate Impact Technology category. However, the EGFR tyrosine kinase inhibitors represent true innovation and are likely to see increasing uptake for NSCLC as well as other cancer indications. Health services clients are advised to begin or continue preliminary assessment activities for Tarceva and Iressa this quarter.

Technology Details
Target Disease / Indication: Non-Small Cell Lung Cancer
Technology Classification: Drug
Body System: Respiratory
Program Area: Medicine/Oncology
Regulatory Status: Approved
BioHorizon Impact Score: 46/100 – Moderate

The American Cancer Society estimates that 147 500 new cases of colorectal cancer will be diagnosed in the United States in 2003. This makes colorectal cancer the third most commonly diagnosed cancer and the second leading cause of cancer death in the United States.

According to Genentech, more than 2,000 patients have been treated with Avastin in clinical studies. The current BLA filing is based upon the results of a pivotal 900 patient study of Avastin plus the three other chemotherapy agents comprising the IFL regimen (5-FU/Leucovorin/CPT-11). Genentech reported that Avastin plus the IFL regimen improved median survival by approximately five months, compared to patients treated with chemotherapy alone (20.3 months versus 15.6 months).

Wall Street analysts position Avastin in the 1billion dollar/year sales range. The actual cost per patient treated is not known at this time but new cancer therapies typically cost somewhere in the $12 000 – $20 000 per patient per year range. It is critical to note that these costs will be in addition to the costs of treating metastatic colon cancer with existing chemotherapy regimens as, initially, Avastin will likely be used in addition to the IFL chemotherapy regimen.

If approved, we feel that Genentech’s Avastin has the potential to be a High Impact technology and therefore we recommend oncology programs begin some early assessment activities while watching for the FDA’s decision. Early steps would include the identification of current and predicted metastatic colon cancer patient numbers and some discussion with treating oncologists concerning future plans for Avastin in treatment regimens.

Technology Details
Target Disease / Indication: First Line Therapy in Metastatic Colorectal Cancer
Technology Classification: Drug
Body System: Gastrointestinal System
Program Area: Medicine/Oncology
Regulatory Status: Biologics License Application Submitted to FDA
BioHorizon Impact Score: 70/100 – High