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BioHorizon Health Technology Surveillance Update: February 8, 2010

tim — Mon, 08 Feb 2010 19:41:52 +0000

The BioHorizon Health Technology Surveillance Update gives readers a concise, high level overview of the most important emerging health technology developments on a ongoing basis including key FDA approvals, substantive clinical trial results and upcoming events of importance.

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.

Surveillance Summary Apr 3 – Apr 9, 2004

admin — Fri, 09 Apr 2004 15:50:11 +0000

Our emerging health technology surveillance system experienced light activity throughout Week 15 of 2004 with a total of 12 technologies updated. Of these, 5 were new detects and 7 were already present in the Biohorizon database. The average impact score was 36, down 6 from last week. A fairly narrow spectrum of target diseases was represented, with a tendency towards oncology indications (7 updates). Humira was the only updated technology that fell in the Biohorizon High Impact Technology category, while 4 Moderate Impact Technologies and 7 Low Impact Technologies experienced updates.

This week we feature Pfizer’s torcetrapib, a Phase I therapy for the treatment of low HDL cholesterol, and Abbott Laboratories’ FDA approved Humira® for rheumatoid arthritis.

Biohorizon currently designates torcetrapib as a Moderate Impact Technology and Humira as a High Impact Technology.

Week at a Glance
Technologies updated this week in the BioHorizon database

Technology Company Target Disease Score
Humira® Abbott LAbs Rheumatoid Arthritis 67/100
Torcetrapib Pfizer Dyslipidemia 64/100
BAY 43-9006 Onyx/Bayer Renal Cell Carcinoma 39/100
Teduglutide NPS Short Bowel Syndrome 36/100
NeuroVax™ Immune Response Corp Mutiple Sclerosis 34/100
INGN 241 Introgen Therapeutics Malignant Melanoma 33/100
Elsamitrucin Spectrum Non-Hodgkin’s Lmphoma 33/100
Puricase® Savient Gout 30/100
Extina Connetics Inc. Seborrheic Dermatitis 30/100
Factor 5A1 Senesco Lung Cancer 24/100

Surveillance Summary Mar 27 – Apr 2, 2004

admin — Fri, 02 Apr 2004 15:43:12 +0000

The Biohorizon emerging health technology surveillance system experienced moderate to heavy activity throughout Week 14 of 2004 with a total of 23 updated technologies. Of these, 2 were new detects while 21 were already present in the Biohorizon database. The average impact score was 42, up two from last week. A broad spectrum of target diseases was represented, with a tendency towards oncology indications (11 updates) due to a prominent oncology conference held during the week (AACR 95th Annual Meeting). No updated technologies were assigned to the Biohorizon High Impact Technology category, while 18 Moderate Impact Technologies and 5 Low Impact Technologies were updated.

Week at a Glance
Technologies updated this week in the BioHorizon database

Technology Company Target Disease Score
FM-VP4 Forbes Medi-Tech Hyperlipidemia 62/100
Preos NPS Osteoporosis 56/100
SnET2-PDT Miravant AMD 54/100
Altropane™ Boston Life Science Parkinson’s Disease 54/100
AC162352 Amylin Obesity 53/100
CMV Vaccine Vical Incorporated CMV 52/100
RSD 1235 Cardiome Pharma Atrial Fibrillation 49/100
Exenatide LAR Amylin Type 2 Diabetes 48/100
Canvaxin™ CancerVax Malignant Melanoma 47/100
Neurodex™ Avanir Pseudobulbar Affect 46/100

Surveillance Summary March 20 – 26, 2004

admin — Fri, 26 Mar 2004 15:36:42 +0000

Our emerging health technology database experienced light activity throughout Week 13 of 2004 with 14 technology updates. 1 High Impact Technology, 8 Moderate Impact Technologies, and 5 Low Impact Technologies were updated. The mean impact score for the week was 40, up three from last week. Of note, 6 of the updated technologies were newly detected during Week 13. The diseases targeted by this week’s technologies were varied with no dominant pathology evident. Please see the table below for this week’s top ten technologies to watch.

Week at a Glance
Technologies updated this week in the BioHorizon database

Technology Company Target Disease Score
Enoximone Myogen CHF 67/100
Velac® Connetics Corporation Acne 62/100
OraQuick® OraSure Technologies HIV 56/100
Periostat CollaGenex Rosacea 50/100
INKP-102 InKine Pharmaceuticals Colon Disease 49/100
Fontolizumab Protein Design Labs Crohn’s Disease 39/100
Nuvion® Protein Design Labs Ulcerative Colitis 35/100
Fosrenol® Shire Pharmaceuticals Hyperphosphatemia 35/100
Anidulafungin Vicuron Pharmaceuticals Aspergillosis 35/100
Pirfenidone Intermune IPF 31/100

Surveillance Summary March 13 – 19, 2004

admin — Fri, 19 Mar 2004 21:12:10 +0000

Our emerging health technology database experienced light activity throughout Week 12 of 2004 with 10 technology updates. 8 Moderate Impact Technologies and 2 Low Impact Technologies were updated. None of the 10 updates were for newly detected technologies and, for the first time in 2004, no technology updates occurred in the High Impact category. Mean Impact Score for the week was 37, the lowest mean experienced in 2004. Please see the table below for this week’s top ten technologies to watch.

Week at a Glance
Technologies updated this week in the BioHorizon database

Technology Company Target Disease Score
Zenapax Protein Design Labs Asthma 50/100
Dexanabinol Pharmos Traumatic Brain Injury 51/100
tgAAC94 Targeted Genetics Rheumatoid Arthritis 45/100
PA-457 Panacos HIV 43/100
R112 Rigel Pharma Allergic Rhinitis 40/100
MVA-HPV-IL2 Transgene HPV/cervical cancer 40/100
XL 119 Exelixis Hepatobiliary Cancer 36/100
MLN2704 Millenium Prostate Cancer 34/100
Tarceva™ OSI Phamaceuticals Non Small Cell Lung Cancer 33/100
Tezacitabine Chiron Gastroesophageal Cancer 1/100

Surveillance Summary March 6 – 12, 2004

admin — Fri, 12 Mar 2004 21:05:14 +0000

23 technologies were updated or added to the Biohorizon Emerging Health Technology Database in Week 11. This represents moderate activity and places Week 11 as the most active week so far in 2004. 2 of the updated technologies, Daxas and Acomplia, were designated as High Impact Health Technologies, 18 received a Moderate Impact score, while the remaining 3 were placed in the Low Impact category. The mean Biohorizon Impact Score for the week was 42, very much in line with the 2004 average. Please see the table below for this week’s Top Ten Technologies to watch.

Week at a Glance
Technologies updated this week in the BioHorizon database

Technology Company Target Disease Score
Daxas Altana COPD 78/100
Acomplia™ Sanofi Smoking cessation/Obesity 75/100
Xibrom Ista Pharmaceuticals Cataracts 59/100
DSC-104 Discovery Laboratories Asthma 53/100
Pexelizumab Alexion Myocardial Infarction 49/100
Aromasin Pfizer Breast Cancer 49/100
Fasudil Schering AG Angina 43/100
Faslodex Astra Zeneca Breast Cancer 43/100
RSR13 Allos Brain Cancer 42/100
Riquent LaJolla Lupus 42/100

Surveillance Summary Feb 25 – March 5, 2004

admin — Fri, 05 Mar 2004 20:56:14 +0000

Our surveillance program experienced light activity throughout Week 10 of 2004. A total of 18 technology updates were recorded; 4 of these were new additions to the Biohorizon Emerging Health Technology Database (new detects), while the remaining 14 were updates made to existing technology records. This week’s average Health Technology Impact Score is 45, up three from last week’s average of 42, and up seven from the 2003 average of 38. High Impact Technologies updated this week include: Boston Scientific’s Taxus coronary artery stent, Pfizer’s Exubera for diabetes, and Eli Lilly/Ligands LY519818, also for diabetes.

Week at a Glance
Technologies updated this week in the BioHorizon database

Technology Company Target Disease Score
Taxus Boston Scientific Coronary Artery Disease 84/100
Exubera Pfizer Diabetes 71/100
LY519818 Eli Lilly/Ligand Diabetes 70/100
Estorra Sepracor Insomnia 55/100
Antegren Biogen IDEC Multiple Sclerosis 53/100
IPL 512 602 Inflazyme Asthma 51/100
Pegasys Roche Hepatitis C 50/100
Amevive Biogen IDEC Moderate to Severe Psoriasis 50/100
Serostim Serono HARS 49/100
I2S Transkaryotic Therapies Hunter Syndrome 48/100

Surveillance Summary Feb 14 – Feb 20, 2004

admin — Sun, 29 Feb 2004 20:38:36 +0000

Our surveillance program experienced light activity throughout Week 8 of 2004. A total of 20 technology updates were recorded; 2 of these were newly detected technologies added to our database (New Detects), while 18 updates were made to already existing technology records. This week’s average Health Technology Impact Score was 41.85, slightly above the 2004 average of 38. Cordis Corporation’s coronary artery stent CYPHER and Genentech’s Avastin are this week’s updated technologies in the High Impact Technology category.

Week at a Glance
Technologies updated this week in the BioHorizon database

Technology	Company			Target Disease	 		Score
CYPHER™		Cordis			Coronary Artery Disease		86/100
Avastin™	Genentech		Metastatic Lung Cancer		72/100
Indiplon	Neurocrine		Insomnia			54/100
Zidaxin		Sciclone		Hepatitis C			54/100
Periostat	Collagenex		Rosacea				50/100
MS-325		Epix			Multiple Sclerosis		50/100
MyVax		Genotope		Non-Hodgkins Lmphoma		47/100
PT-141		Palatin			Erectile Dysfunction		47/100
Gvax®		Cell Genesys		Non-Small Cell Lung Cancer	30/100
Ramoplanin	Genome Therapeutics	CDAD				30/100

Surveillance Summary Feb 7 – Feb 13, 2004

admin — Fri, 13 Feb 2004 20:21:09 +0000

Our surveillance program experienced moderate activity throughout week 7 of 2004. A total of 19 technology updates were recorded; 12 of these were new technologies added to our database, while the remaining 7 updates occurred for already existing technology records. Etanercept, Remicade and Visudyne were the only High Impact technologies updated during week 7. Please note that Erbitux, previously designated as Moderate Impact, was elevated to our High Impact designation.

Surveillance Summary Jan 31 – Feb 6, 2004

admin — Fri, 06 Feb 2004 14:09:07 +0000

Our surveillance program experienced heavy activity throughout week 6 of 2004. A total of 27 technology updates were recorded; 9 of these were new technologies added to our Emerging Health Technology Database (‘new detects’), while the remaining 18 updates occurred for already existing technology records. 8 of the 18 or 44% are currently in our High Impact category: Avastin, Namenda, Rebif, Spiriva, Iressa, Pegasys, Rituxan and Caduet. Note that Avastin, previously designated as Moderate Impact, was elevated to our High Impact designation.

This week, we feature Genentech’s Avastin™ (bevacizumbab) for metastatic colorectal cancer and Forest Laboratories’ recently FDA approved Alzheimer’s treatment Namenda™ (memantine).

Both have earned our High Impact designation, and in our view merit preliminary assessment activities.