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Healthcare News by GLG Council Members

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

Legality and profitability can work

February 9, 2010

GLG Expert Contributor

Superstore for medical marijuana supplies opens in Oakland | www.contracostatimes.com

Normally setting up a storefront office for the primary purpose of selling prescription to marijuana is a red flag for law enforcement officers and social movement groups.

Bruce GoldbergPresidentPharmacy Benefit Advisors 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.

Cetirizine OTC liquid. A day late and a dollar short.

February 8, 2010

Aurobindo Pharma receives final approval for Cetirizine Hydrochloride Solution (OTC) | www.pipelinereview.com

Why the delay? Teva, Taro, and Perrigo all have strong footholds in this market. Rx and OTC competition remains strong, thus what would allow a new player to grow quickly outside of eroding the price market?

Victoza may be a large step forward

February 7, 2010

GLG Expert Contributor

Novo Nordisk Receives US Approval For Victoza® (liraglutide) For The Treatment Of Type 2 Diabetes | www.medicalnewstoday.com

Victoza was approved at the end of January with head to head data already published vs. Byetta (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)60659-0/abstract) showing greater reduction of fasting blood sugar, HbA1c, and weight with less nausea. This stands to both expand the GLP-1 market and take market from Amylin/Lilly until Byetta LAR reaches the market.

Advantage for Aurobindo Pharma - Approval of Cetirizine Hydrochloride Solution

February 7, 2010

GLG Expert Contributor

Aurobindo Pharma receives final approval for Cetirizine Hydrochloride Solution (OTC) | www.pipelinereview.com

The launch of the Cetirizine Hydrochloride Solution will enhance Aurobindo Pharma's presence in the Asia. The launch of this OTC product will create significant advantage for Aurobindo Pharma.

XIAFLEX - A New Treatment for Dupuytren's Contracture

February 6, 2010

GLG Expert Contributor

XIAFLEX release approved by FDA | www.xiaflex.com

Auxilium (and BioSpecifics Technologies) have finally received approval for release of XIAFLEX, the first FDA approved nonsurgical treatment for Dupuytren's Contracture. XIAFLEX is injected directly into the Dupuytren's cord and enzymatically disrupts the collagen. When successful, the contracture is released and range of motion is improved.

B cells promote solid tumor formation - another use for Rituximab?

February 6, 2010

GLG Expert Contributor

FcRγ Activation Regulates Inflammation-Associated Squamous Carcinogenesis | www.cell.com

Using a mouse model of squamous carcinogenesis, Andreu and colleagues showed a functional role for B cells in defining a pro tumor micro environment in premalignant tissue.  In mice deplete of B cells, this process was effectively stalled.  The authors speculate that targeting B lymphocytes or their downstream effectors could therefore offer a rationale anti cancer therapeutic approach.

Lunesta helps patients achieve restful sleep

February 6, 2010

GLG Expert Contributor

Lunesta for Insomnia | sepracor.com

Lunesta helps patients to achieve restful sleep.

Lung Rx and mondobiotech seek indications for Aviptadil for rare lung diseases

February 5, 2010

GLG Expert Contributor

Lung Rx LLC, A Subsidiary Of United Therapeutics Corporation, And mondoBIOTECH holding AG Announce Today a Global Strategic Partnership Agreement for the Development Of Aviptadil Platform | www.pipelinereview.com

Aviptadil, vasoactive intestinal peptide (VIP) is a novel target for the treatment of primary pulmonary hypertension (PAH) that was shown to have beneficial effects on hemodynamics and safety in a phase II clinical trial for PAH.mondoBIOTECH and Lung Rx announced a partnership to bring Aviptadil to market, presumably to target the larger market of lung diseases with secondary pulmonary hypertension PHTN.Approved therapies for PAH have not been successful in treating seconday PHTN.

Epigenomics: PRESEPT Study – Septin 9 methylation in colon cancer

February 4, 2010

GLG Expert Contributor

Epigenomics AG Reports Conclusions from PRESEPT Study Audit | www.epigenomics.com

Epigenomics is a molecular diagnostics company with a focus on DNA methylation biomarkers aimed at diagnosing cancer before symptoms occur. Its product portfolio includes the detection of colorectal cancer in blood that is based on methylation status of the biomarker Septin9. Two of the three testing laboratories that performed Septin9 analysis achieved cancer detection rates of 62.5% and a third laboratory a somewhat lower rate of 28%. This may be due to an instrument malfunction.

Herceptin approved for stomach cancer- financial impact remains to be seen

February 4, 2010

GLG Expert Contributor

Herceptin now approved in the EU for patients with HER2-positive advanced stomach cancer | www.pipelinereview.com

It is welcome news for approximately 20% patients of stomach cancer, they will get benefited by surviving for approximately 3 months more. Helthcare institutes like NICE will be looking at this data carefully, their opinion of the survival vs cost of drug will have major impact of the marketability of Herceptin.

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