All GLG News Analyses Filed Under: Infectious Disease

HLA screening for ABV hypersensitivity reaction

July 28, 2008

Analysis by: GLG Expert Contributor

Analysis of:F.D.A. Urges Genetic Test Before Giving AIDS Drug | www.nytimes.com

After the extensive studies published (Mallal et al), it becomes mandatory to perform a genetic HLA screening before starting abacavir-containing antiretroviral associations. Problems are recognizable in these points: - laboratories are not capable to front an exaggerated request of HLA typing; - ad-hoc funding have not been allocated previously - medical-legal problems are expected in the event of prescription of ABC-containing regimen without a preliminary HLA screening, should a severe reaction occurs (average occurrence: 8% of patients)

More Hot Air Than Hot Products

June 9, 2008

Analysis by: GLG Expert Contributor

Analysis of:Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com

Novartis' rhetoric seems not to be supported by the published data.  Novartis probably lags behind Merck and Sanofi-Pasteur in vaccine R&D.

Pipeline or Preening for an Aquirer?

June 9, 2008

Analysis by: GLG Expert Contributor

Analysis of:Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com

-Novartis' press conference discussed a "full pipline" of new vaccines, but the majority are still Phase I. -The meningitis vaccines being developed are not yet ready to go, and the one that is closest to being filed already has a competitor on the market.

Novartis Needs To Be Nimbler Than Larger Rivals

June 6, 2008

Analysis by: GLG Expert Contributor

Analysis of:Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com

Novartis Vaccines being smaller than its rivals has the opportunity to steal a base by being more adventurous and striking out into new areas Whilst meningococcal vaccines will be profitable, Novartis needs to build its early vaccine pipeline further with novel projects

More Progress on the Vaccine Front

June 6, 2008

Analysis by: GLG Expert Contributor

Analysis of:Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com

Novartis is developing vaccines for diseases for which there are no current products available. Group B Strep, N. meningitidis Group B and H. Pylori are all common pathogens and cause significant morbidity.

GSK gets there first (for a change)

May 21, 2008

Analysis by: GLG Expert Contributor

Analysis of:EU Approves GSK's Pre-Pandemic Bird Flu Vaccine | www.medicalnewstoday.com

Glaxo's new pandemic flu vaccine was just approved for sale and use in the EU.  It has or is trying to establish contracts with multiple countries to supply stockpiles with values in the 100's of millions

A better vaccine- so what is there to say

May 16, 2008

Analysis by: GLG Expert Contributor

Analysis of:Novartis Menveo® vaccine shows superior immune response against four types of meningitis disease in pivotal phase III trial | www.novartis.com

The vaccine has shown superiority over the existing vaccine. Unless there are major side effects it should replace what we have.

Flamel Technologies and Interferon Alpha XL

May 9, 2008

Analysis by: GLG Expert Contributor

Analysis of:Flamel Technologies Presents Results of Two Week Study of Interferon Alpha XL at the European Association for the Study of the Liver | www.pipelinereview.com

This study, although an abstract has no statistical power. Even a quick overview reveals that the ß for this study is insufficient to make the (marginallY) "significant" results achieved newsworthy. I understand the importance of disseminating information but this article fails in that regard.

Comments on Novartis Menveo vaccine

May 7, 2008

Analysis by: GLG Expert Contributor

Analysis of:Novartis Menveo® vaccine shows superior immune response against four types of meningitis disease in pivotal phase III trial | www.novartis.com

An encouraging development, however since the vaccine does not cover group B meningococcal disease, vigilance will be required among vaccinated individuals to insure that symptomatic individuals are not infected with group B meningococci.  The human bactericidal antibody response is considered the more relevant measure of antibody protection (rather than geometric mean titer).

Another player in the market

May 7, 2008

Analysis by: GLG Expert Contributor

Analysis of:Novartis Menveo® vaccine shows superior immune response against four types of meningitis disease in pivotal phase III trial | www.novartis.com

Menveo appears to have some statistical advantages over the currently available product, Menactra (sanofi aventis.) Whether the higher antibody levels translate into better or more lasting protection remains to be seen. Given recent FDA action approving meningococcal vaccine for younger pediatric age groups, if Menveo is approved for infants, I would expect that it would gain a large market share, since most physicians would rather stock a single product, and would opt for the one with the broadest utility.

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