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All GLG News Analyses Filed Under: Orthopaedics

Analyses are solely the work of the authors and have not been edited or endorsed by GLG.

Not without potential side effects

July 24, 2007

GLG Expert Contributor

Aclasta Recommended For European Approval As The First Once-yearly Treatment For Women With Postmenopausal Osteoporosis | www.medicalnewstoday.com

Though once a year therapy for osteoporosis will be great, the downside of the medication needs to be considered. The incidence of cardiac arrthymias and the need for long term therapy for that must be put into the equation. It is unclear at this point how significant this may be.

Medtronic's Bryan disc has all the elements of success

July 23, 2007

GLG Expert Contributor

Medtronic Neck Disc as Good as Fusion: FDA Staff | www.medscape.com

-Medtronic is likely to see excellent sales of its cervical disc replacement products -The data on the Bryan disc is strong, and FDA will likely grant approval shortly -Medtronic has come to market with the first FDA approved cervical disc replacement, and the surgical community is eager to incorporate these devices in their practices

Potential risks of autologous chondrocyte implantation and alternative techniques

July 20, 2007

GLG Expert Contributor

Genzyme Announces Positive Results from Carticel® Study at Major Sports Medicine Meeting | www.genzyme.com

Articular cartilage injury is a relevant problem in orthopaedic surgery as especially younger people have sports injuries. Articular cartilage injury is followed by a long history of joint problems most probably ending in arthritis of the envolved joint, most often the knee joint. The repair of articular cartilage defects remains one of the most challenging problems in orthopaedic surgery. Several techniques have been elaborated, and a very nicely performed prospective clinical study could show that microfracturing has an outcome comparable to that of autologous chondrocyte implantation (Journal of Bone and Joint Surgery, Volume 86-A, pages 455-64). The above article reports on a good method, but does not sufficiently outline potential risks, or alternative operation techniques in the opinion of this author who has been dealing with injured and degenerated joint for 10 years.

Benefits of autologous chondrocyte implantation versus potential risks

July 19, 2007

GLG Expert Contributor

Findings from Four Year, Multi-Center Clinical Study on Autologous Chondrocyte Implantation Presented, Coincide with New Product Labeling | www.pipelinereview.com

Articular cartilage injury is common, and it is common especially in younger, sports active people. Articular cartilage injury is followed by a long history of joint problems most probably ending in arthritis of the envolved joint, most often the knee joint. The repair of articular cartilage defects remains one of the most challenging problems in orthopaedic surgery. Several techniques have been elaborated, and also evaluated in experimental, and prospective clinical studies. Still, all techniques hitherto developed have risks or only a little potential of leading to renewal of real, mechanically bearable joint cartilage. The above article reports on a good method, but does not sufficiently outline potential risks in the opinion of this author who has been dealing with injured and degenerated joint for 10 years.

Roche/BioCryst psoriasis trial design

July 19, 2007

GLG Expert Contributor

Roche And BioCryst Advance BCX-4208/R3421 Into Phase II Psoriasis Trial | www.medicalnewstoday.com

I just wrote on the drug.  This analysis is solely on the trial design.

An antiinflammatory with few side effect

July 10, 2007

GLG Expert Contributor

Third Pivotal Naproxcinod Phase 3 Study To Start For Patients With Osteoarthritis Of The Hip | www.medicalnewstoday.com

Osteoarthriitis is a chronic condition. We try to use Tylenol like products to avoid side effect of NSAIDS. Tylenol itself is not without issue. In many cases it may not work. We then need to use a NSAID . Long term use leads to BP issues and renal issues. There are also the potential bleeding problems. If this drug can show minimal problems it has a clear place in this market,.

New Drug for Osteoarthritis of Knee Could Have Great Promise

July 5, 2007

GLG Expert Contributor

Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the Knee | www.pipelinereview.com

- this drug is a real breakthough - mechanism of action is totally   different from all other forms of therapy for osteoarthitis of knee - the possibility exists that it could be used for osteoarthritis of ALL   injectable joints, greatly enlarging it's potential market

Anesiva versus Genzyme in knee OA

July 5, 2007

GLG Expert Contributor

Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the Knee | www.pipelinereview.com

Anesiva's Adlea showed pain relief for 12 weeks with a single 1 mg (?ml) injection.  The question is, how does it compare with the competition.

Dipti DoshiRheumatologistHEALTHCARE PARTNERS MEDICAL GROUP What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Phase 2 study showing that a 1mg treatment with Adlea(TM) effective for 12 week persistant pain in OA patients

July 4, 2007

Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the Knee | www.pipelinereview.com

Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. Its short duration of systemic exposure (hours) relative to the long duration of analgesia (12 weeks) resulting from a single treatment course of Adlea is particularly important in this typically elderly and vulnerable patient population and may potentially offer a safer treatment option in the management of chronic osteoarthritis pain. Importantly, the prolonged analgesic effect resulting from a single or stepped dose, localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opioids (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction).

Long term data needed

June 20, 2007

GLG Expert Contributor

Prexige® Study Shows Significantly Less Impact On Blood Pressure Than Ibuprofen In Osteoarthritis Patients With Controlled Hypertension | www.medicalnewstoday.com

This is only a 4 week study and indeed shows an improvement in blood pressure. As osteoarthritis is a long term, chronic problem, long term results are needed. What happens to renal function and bleeding issues long term need to be addressed as well.

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