All GLG News Analyses Filed Under: Orthopaedics

lubrication will be the ultimate answer

December 14, 2007

Analysis by: GLG Expert Contributor

Analysis of:Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair | www.pipelinereview.com

Ever since Hyaluronans (HA) have been around to lubricate the the knee, arthroplasties have declined significantly for OA. This implies that finding the precise material necessary to keep the knee capsule full will prevent further degeneration of the joint and eventually the ultimate answer to treat OA.    

Reduction of fracture is what counts!

December 3, 2007

Analysis by: GLG Expert Contributor

Analysis of:FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis | www.pipelinereview.com

Though Forteo did  increase the BMD greater than alendronate, It did not decrease the amount of no-veterbral fractures which lead to increased morbidity and mortality.

Chondrogen addresses post-surgery indication, NOT specifically OA treatment

November 30, 2007

Analysis by: GLG Expert Contributor

Analysis of:Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair | www.pipelinereview.com

Stem cells plus HA provide a physiologically relevant combination that has real potential in tissue repair and regenerative medicine. But the press release goes further than warranted, in implying that Chondrogen addresses the OA market as a whole. The trial specifically evaluated the effects of the product after meniscus surgery (likely partial menisectomy, but not specified clearly). The post-surgery market is important in itself, and the trial identifies a potentially fruitful new approach to musculoskeletal repair that has practical advantages and which could be integrated into current practice patterns without major disruption. . 

HOLD ON TO YOUR WALLETS BABY BOOMERS. Looking through a prism darkly.

November 30, 2007

Analysis by: GLG Expert Contributor

Analysis of:Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair | www.pipelinereview.com

First of all, this is not a hypothesis generating study but a fishing expedition after an orthopedic procedure intervention. Maybe that's what happens when you let orthopedists loose with statistical analysis. Patients entered the study without any baseline osteoarthritis (OA) required...just a torn meniscus. Meaning no level playing field to even judge the normally slow advance of OA by defined critical X ray changes. Absent controls for quad exercises, weight control, weight bearing activities and other analgesics we seem to have a mish-mash to judge even clinical outcomes. Since 2/3 of symptomatic OA patients do not respond predictably to intra-articular hyaluron it is a lousy control absent usual placebo group.

Oh My Aching Knees...Chondrogen and the future of non-operative treatment of knee arthritis

November 29, 2007

Analysis by: GLG Expert Contributor

Analysis of:Osiris Therapeutics Announces Positive One Year Data from Chondrogen Trial for Knee Repair | www.pipelinereview.com

Possible nonoperative treatment for arthritis of the knee which effects 10's of millions of patients, with a predictable lasting effect. Could revolutionize the treatment of arthritis which currently has no predictable, lasting  nonoperative treatments.

Betting on bone density and not osteosarcoma

November 20, 2007

Analysis by: GLG Expert Contributor

Analysis of:FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis | www.pipelinereview.com

Bone density loss a known risk with exogenous corticosteroid therapy...but also sex, age, disuse, catabolic disease should factor into outcome risk for fractures as the feared outcome. Forteo(R) is currently a second line therapy for osteoporosis issues based on  cost and osteosarcoma theoretical fears from substantial animal data. For an elderly invalid with corticosteroid dependancy this data is encouraging with known osteopenia as a back-up to oral alternatives. But final trade off will be theoretical prevention of fracture potential versus unproven malignancy fears.

Fortifying with Forteo

November 19, 2007

Analysis by: GLG Expert Contributor

Analysis of:FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis | www.pipelinereview.com

We know that PTH is a strong anabolic agent in the bone.  This study provides some quantitation in a head to head study of Forteo (Lilly) with Fosamax (Merck) in a population of steroid-induced osteoporosis patients.

A potential boon for those suffering from IBS

October 18, 2007

Analysis by: GLG Expert Contributor

Analysis of:REMICADE Reduces Incidence Of Bowel Surgeries In Ulcerative Colitis Patients, Shown By Clinical Studies | www.medicalnewstoday.com

Having IBS leads to many complications. A drug that can diminish them is clearly  beneficial and has a major place in therapy.

Approval for Aclasta

October 10, 2007

Analysis by: GLG Expert Contributor

Analysis of:Aclasta(R) receives European approval as first once-yearly treatment for postmenopausal osteoporosis | www.pipelinereview.com

In Europe - this is hardly surprising. 

An Experiment in Therapeutic Finance!

October 9, 2007

Analysis by: GLG Expert Contributor

Analysis of:Aclasta Receives European Approval As First Once Yearly Treatment For Postmenopausal Osteoporosis | www.medicalnewstoday.com

European approval of Aclasta (Reclast in the U.S.) will be in effect, an experiment in therapeutic entrepreneurial management. Only Novartis did the studies to acquire approval of the IV formulation of this bisphosphonate in the U.S., and presumably the E.U. Notwithstanding several excellent medical therapeutic questions, the delivery mode establishes a need for IV infusion centers, administration costs and recall registries. In the U.S. this will be of paramount importance since a huge segemnt of the target population, the Medicare eligible, can have the therapy approved and paid for by Medicare part B, slowing progress to the infamous donut hole. The comparative market success of the drug abroad and in the U.S. will be very interesting to watch, as will be the medical results and impact on quality and Total Cost of Therapy. Insurance and industry analysts should watch carefully as this is a marker for future endeavors.

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