All GLG News Analyses Filed Under: Orthopaedics

Novartis's Reclast: Be Careful How You Read the Numbers

September 21, 2007

Analysis by: GLG Expert Contributor

Analysis of:First osteoporosis study in patients with hip fracture finds once-yearly Aclasta(R)-Reclast(R) prevents additional fractures and improves survival | www.pipelinereview.com

Although Reclast is an innovative drug, the way its investigators present its data makes it look better than it really is. For instance, the study claims that Reclast achieved a 35% reduction in fractures.  Upon closer review, the placebo group had a 13.9% risk of fracture, while the Reclast group had 8.6% - that's an absolute risk reduction of only 5.3%, but a relative risk reduction of 35%, which looks much better on paper. Same for its mortality data: placebo had a 13.3% mortality rate, and the Reclast group had 9.6% mortality: that's an absolute reduction of 3.7%, which did not even achieve significance, and certainly less appealing than the 28% relative risk reduction the study reports. It also reports a 30% reduction in hip fractures, but look closer: the study group had a 2.0% rate, the placebo 3.5%, which may be a 30% relative reduction, but only a 1.5% absolute reduction. Cost efficacy data on this drug will be derived from its absolute disease reductions, not relative ones.

Reclast sounds promising (Novartis, Healthcare)

September 21, 2007

Analysis by: GLG Expert Contributor

Analysis of:First osteoporosis study in patients with hip fracture finds once-yearly Aclasta(R)-Reclast(R) prevents additional fractures and improves survival | www.pipelinereview.com

Reclast sounds like a promising new drug.  Although many osteoporosis drugs are currently on the market, this is the only one that has shown such a dramatic decrease in the recurrence of fractures, which is definitely a plus.  In terms of compliance, it is also very innovative, because instead of once weekly or once monthly, the patients only have to take it once a year.  Although, the fact that it is an infusion may not be as acceptable by some patients, in very high risk patients, it will be a very welcome addition to our current armamentarium of therapeutics. 

great but with a catch

September 20, 2007

Analysis by: GLG Expert Contributor

Analysis of:First osteoporosis study in patients with hip fracture finds once-yearly Aclasta(R)-Reclast(R) prevents additional fractures and improves survival | www.pipelinereview.com

This is a very promising study. If post-marketing does not show a major problem with new onset A-fib., this will be a great therapy. 

Reclast (Novartis) a Winner!!

September 18, 2007

Analysis by: GLG Expert Contributor

Analysis of:Novartis Drug Curbs Repeat Hip Fractures | online.wsj.com

Yearly infusions of a Zometa relative- Reclast, in elderly patients after hip fracture, prevent repeat fractures and prolong survival. Yes!! Looks like a reasonable study and this yearly IV agent is certainly more tolerable than oral bisphosphonates with the associated killer heart burn and need to take it repetitively.

Is CYT645 a Potential Treatment for Osteoporosis: Who Could Possibly Know?

September 18, 2007

Analysis by: GLG Expert Contributor

Analysis of:Cytopia Compounds show potential as treatment for bone loss | www.cytopia.com.au

The press -- at least that segment of medical media that covers biotechnology -- has seemingly picked up a press release issued by Cytopia and run with it. The press release proclaims how Cytopia's compound CYT645, an inhibitor of an enzyme that appears to be involved in bone resorption, may have potential as a treatment for osteoporosis. While this may turn out to be true, there is little to support this claim: there are no publications in the English language medical literature about CYT645; Cytopia's own website offers no plan for clinical trials, or even publication of its own CYT645 studies thus far; and the claim appears to have grown its legs out of an anecdotal report of a pre-clinical study. It seems that CYT645's potential as an osteoporosis drug would be better evaluated in about five years, at best. Until then, keep taking your calcium supplements and vitamin D.

Luc JasminAttending Neurosurgeon and a Research ScientistCEDARS-SINAI MEDICAL CENTER

Vertebroplasty vs kyphoplasty vs arcuoplasty

August 20, 2007

Analysis of:Medtronic Buys Kyphon For $3.9 Billion | www.forbes.com

Will the recent purchase of Kyphon by Medtronic signals the end of kyphoplasty? No because arcuoplasty does not restore vertebral height. Vertebroplasty, kyphoplasty and arcuoplasty essentially achieve the same goals, which brings up the question, do we need all three techniques? Arcuoplasty is the safest of a three for lower thoracic and lumbar vertebrae but until Medtronic comes up with a smaller injection needle system, vertebroplasty will be more appropriate for upper thoracic and cervical spinal levels. The arcuate system is market for osteoporotic fractures but could be improved for cancer (metastasis) related fracture.

Keith DenklerAssociate Clinical Professor of Plastic SurgeryUNIVERSITY OF CALIFORNIA, SAN FRANCISCO

Xiaflex will dramatically replace surgery

August 13, 2007

Analysis of:The Journal of Hand Surgery Publishes Initial Phase III Data on Xiaflex (formerly known as AA4500), Auxilium's Investigational Treatment for Patients with Dupuytren's Contracture | pharmalive.com

The efficacy of Xiaflex to not only open up the bent fingers of Dupuytren's, but its ability to diminish recurrence will dramatically decrease surgery rate for Dupuytren's. 

studies of low back pain therapy lead to mixed findings

August 8, 2007

Analysis by: GLG Expert Contributor

Analysis of:Statistical Significance Versus Clinical Importance: Trials on Exercise Therapy for Chronic Low Back Pain as Example | www.ncbi.nlm.nih.gov

Low back pain is a major public health problem.  While there is no single therapy that can be prescribed to every patient with this problem, the ubiquitous prescribing of physical therapy is frequently misguided.  The causes of low back pain are myriad, and the treatment algorithm needs to be tailored to the specific patient.  All patients with back pain persistent for more than one month should be referred to a spine specialist in order to make further decisions regarding diagnosis and treatment.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Novel Oral Tablet Option For the treatment of Bone Diseases

August 7, 2007

Analysis of:Genta and Emisphere Technologies File IND with FDA for Oral Drug to Treat Bone Disease | www.pipelinereview.com

As a pharmaceutical consultant, I think this IND will be novel groundbreaking treatment option for the treatment of bone diseases because it is one of first oral tablet formulation that enables oral absorption of gallium nitrate injection for treatment of cancer-related hypocalcaemia. Also this is unique collaboration of two different type drug discovery (Genta) & drug delivery companies (Emisphere). Both companies are similar size and active partner for this product. Phase 1 clinical trial that will examine initial safety and pharmacokinetics of G4544 in human subjects. I am hopeful that this oral tablet will be safe and effective since the active ingredient in G4544 has already demonstrated proof-of-concept activity in patients with multiple indications, including non-Hodgkin’s lymphoma, bone metastases, Paget’s disease, and osteoporosis.

David MandelPhysicianDAVID R MANDEL MD

dupuytrens contracture

August 7, 2007

Analysis of:The Journal of Hand Surgery Publishes Initial Phase III Data on Xiaflex (formerly known as AA4500), Auxilium's Investigational Treatment for Patients with Dupuytren's Contracture | pharmalive.com

I am a rheumatologist and treat many pts with this  condition conservativelywewill be partcipating in an upcoming clin.trial with their injectable compound that has some very unique properties to relieve the contractures and possible avoid surgery

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