GLG News by Centocor Remicade Prescribers: Rheumatoid Arthritis, Psoriatic Arthritis, Anklyosing Spondylitis, and Psoriasis (US)

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Starpharma gets US patent for use of VivaGel for protection against STIs

September 29, 2009

Analysis of:Starpharma gets US patent for use of VivaGel for protection against STIs | www.pharmabiz.com

Starpharma's lead product, is a vaginal microbicide gel under development for the prevention of sexually transmitted infections (STIs), including genital herpes and HIV infection. The VivaGel® product concept is designed to offer a safe, convenient and affordable means for women to protect themselves from infection with genital herpes and HIV during sex. Surveys show that there is substantial demand in North America and Europe for such a product with an estimated billion dollar market for STI prevention products in the developed world.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Stelara new Option for Psoriasis

September 26, 2009

Analysis of:Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults | www.webmd.com

The FDA approved Stelara based on three studies of 2,266 patients who either got shots of Stelara or a placebo. Patients who got Stelara were more likely to achieve the studies' benchmark for reduction in psoriasis.In a news release, the FDA notes that because Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. "Serious infections have been reported in patients receiving the product and some of them have led to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer," the FDA states.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Issues with Ustekinumab

June 23, 2008

Analysis of:Positive news on J&J's ustekinumab diminished by safety concerns - analysts | www.tradingmarkets.com

On Tuesday, the FDA's Dermatologic and Ophthalmic Drug Advisory Panel voted unanimously to approve the use of the injectable drug for the treatment of plaque psoriasis, a severe skin disease. As the FDA usually follows the recommendations of its advisory panels when reviewing new drugs for approval, it is anticipated that the regulatory body will approve the drug in the fourth quarter, analysts said. But concerns over the drug's carcinogenic potential and the panel's recommendation that the drug be administered only by a physician and not directly by the patient could diminish enthusiasm over ustekinumab and lessen the drug's potential market share.

Dipti DoshiRheumatologistHEALTHCARE PARTNERS, LLC

TRU-015 and SBI-087 both trubion's product both strong products with Different MOA , B cell depletion.

May 1, 2008

Analysis of:Trubion Announces Initiation of Phase 1 Study of SBI-087 for the Treatment of Rheumatoid Arthritis | www.pipelinereview.com

Drug therapies for RA include (NSAIDS), DMARDS, and, most recently, biologics. Biologics currently on the market for RA target immune messengers called cytokines, which promote the damaging inflammatory process, and include anti-tumor necrosis factor (TNF) drugs – infliximab , etanercept,adalimumab, Orencia, Rituximab . Biologics are typically reserved for patients with moderate to severe RA who require add-on therapy, estimated to be approximately 40 percent of the RA population. SBI-087 in phase-1 clinical trial to evaluate safety, tolerability , pharmacodynamics in RA with function class I, II or III diagnosed more than six month prior to surgery. Mechanisms Of Action: Therapeutic monoclonal antibodies (mAbs) typically act through three significant potential mechanisms of action: • Complement dependent cytotoxicity (CDC) • Antibody-dependent cellular cytotoxicity (ADCC) • Apoptosis (programmed cell death) All CD20-directed mAb therapies result in temporary B-cell depletion.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Ustekinumab

December 19, 2007

Analysis of:Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis | www.jnj.com

This drug is four times yearly This will be attractive to MDs and patients It is highly efficaciuous

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

Dipti DoshiRheumatologistHEALTHCARE PARTNERS, LLC

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

July 4, 2007

Analysis of: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).

Dipti DoshiRheumatologistHEALTHCARE PARTNERS, LLC

Roche's market share will go up .

June 18, 2007

Analysis of:New Data Confirms Significant Improvement of Disease Signs and Symptoms in Patients with Rheumatoid Arthritis | pharmalive.com

Very important new treatment emerging in field of rheumatoid arthritis along with other drugs in pipeline. IL-6 receptor blocker. New Mechanism of action. Has positive priliminary endpoint results at 24 week study for RA compared to DMARD therapy alone.

Dipti DoshiRheumatologistHEALTHCARE PARTNERS, LLC

SRV in non responders

May 28, 2007

Analysis of:"Triple Anti-HCV Drug Therapy for Nonresponders to Peginterferon/Ribavirin: Interferon Gamma (Actimmune) + Ribavirin + Pegasys or Infergen: A Pilot Study" | www.natap.org

Very nice article. Although sample size seemed very less, avaialble results look very promising. Particularly in contrast of Leevy study. Only concern is of side-effects. Would make things clear on further study with the same drug

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