All GLG News Analyses Filed Under: Infectious Disease

It Remains to Be Seen

May 6, 2008

Analysis by: GLG Expert Contributor

Analysis of:Can biologic drugs tackle antibiotic resistance? | www.pharmaceutical-business-review.com

Microbes have a remarkable ability to mutate to allow for their survival.  Biologics can introduce new means of treating invections, but are unlikely to overcome the ability of them to become resistant.  Several biological components have been studied by companies and claim lack of resistance. These were mostly designed to have a lack of specificity thus causing greater toxicity to the patient.  As soon as specificity for the microbe is introduced, the microbe will have an ability to mutate away from suchs specificity. While it is not possible to be absolutely certain, the short term treatments will likely work as they are new agents.  The long term view is the microbes will mutate to become resistant to the new agents.

Michael GrossbardProfessor of Clinical MedicineColumbia University College of Physicians and Surgeons

Ricin Vaccine Market Relies on Threat of Terror

May 5, 2008

Analysis of:DOR BioPharma Initiates Non-Human Primate Efficacy Studies of RiVaxTM, Its Vaccine Against Ricin Toxin | www.pipelinereview.com

Ricin is an extraordinarily potent toxin that is fatal because of its ability to inhibit protein synthesis and rapidly cause multisystem failure.  Because ricin can be prepared from castro beans, it has the potential to be used in terrorist attacks.  The present vaccine has the potential to neutralize the toxicity of ricin.

TNF worked in dogs but not humans

May 5, 2008

Analysis by: GLG Expert Contributor

Analysis of:Can biologic drugs tackle antibiotic resistance? | www.pharmaceutical-business-review.com

Immunomodulation especially with antibodies is difficult.  Proteins are not as easily given and distributed through the body as low molecular weight compounds.  I believe that the first drug to be effective will pave the way for many others

Clinical Analysis of GSK's Rotarix important to success of vaccine

April 14, 2008

Analysis by: GLG Expert Contributor

Analysis of:FDA Clears Glaxo Diarrhea - Virus Vaccine | www.nytimes.com

The key to success of marketing Rotarix or similar Rotavirus vaccines is in the design of clinical trials and evaluation of criteria and results of past use of these vaccines in developing countries that have a high incidence of rotavirus diarrhea in infants.  Rotavirus vaccine use is a  prototype for preventive medicine since the key is to provide immunity to an immunologically naive population.

Cubicin not tainted but delivery device.

April 14, 2008

Analysis by: GLG Expert Contributor

Analysis of:Cubist Finds Its Antibiotic Cubicin Is Tainted | online.wsj.com

            ReadyMED® is a infusion device used primarily in outpatient settings for administering antiobiotics in the home.  ReadyMED® requires little patient or caregiver training and works by gravity.  No IV poles or pumps required and is safe and easy to use.  I think once Cardinal – Alaris medical systems isolates the issues and fixes the problem there will be little residual effects to both Cubicin and Cardinal.  Both are very patients and consumer conscious

Eric GruffPrincipalE4 Consulting

Cubist's Antibiotic Cubicin is Tainted: A Mess Not of Their Doing? Maybe, Maybe Not.

April 14, 2008

Analysis of:Cubist Finds Its Antibiotic Cubicin Is Tainted | online.wsj.com

The news that Cubist's Cubicin has been contaminated with 2-mercaptobenzothiazole (MBT) has caused great concern for patients. It appears that the MBT has leeched out of the Cardinal Health ReadyMED drug pumps that are used for delivering Cubicin. Regardless of who is at fault, everyone involved (Cubist, Cardinal, the FDA, doctors, and patients) have good reason to worry.

Let the Rotavirus battle begin!

April 7, 2008

Analysis by: GLG Expert Contributor

Analysis of:FDA Clears Glaxo Diarrhea - Virus Vaccine | www.nytimes.com

-Glaxo's Rotarix vaccine was approved last week for prevention of rotavirus infection in infants -Merck's product, Rotateq, on the market for 2 years in the US, already has an established pipeline to essentially all pediatric primary care providers -There are small differences between the 2 vaccines, but they can both be big moneymakers; Glaxo's job will be grabbing market share

Herpes Labialis Medicaments

April 4, 2008

Analysis by: GLG Expert Contributor

Analysis of:Medivir: Lipsovir Prevents Cold Sores - Phase III Clinical Trial Results First to Show Prevention by Early Treatment | pharmalive.com

This article fails to explain how Lipsovir will prevent breakouts of new lesions.  They say that early use of the ointment in an episode will shorten the duration about 1 1/2 days but where is the evidence that it prevent new episodes?  Also there is a lot of viral resistance to acyclovir, which is the anti-viral agent of Lipsovir. Redox Pharmaceutical has a drug, currently in Phase 2 testing that can be used at any time in the episode, cuts the durations of the episode by many days, and has anti-inflammatory properties without using cortisone.  Also, there is no evidence of viral resistance to its product.  Redox's product is far superior to Lipsovir, although Lipsovir is further along in its clinical tests.

Impressive Opportunity Treatment for Prevention of Pandemic Flu

March 31, 2008

Analysis by: GLG Expert Contributor

Analysis of:Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels | www.pipelinereview.com

This drug in the form of a patch will solve one problem of vaccination for the Pandemic Flu; that is the two-step process. It also may have impact on the autistic concerns associated with immunizations that are administered containing small amounts of mercury.

Prevention is better than cure - Medivir's successful phase III clinical trial for Lipsovir(R)

March 31, 2008

Analysis by: GLG Expert Contributor

Analysis of:Medivir: Lipsovir Prevents Cold Sores - Phase III Clinical Trial Results First to Show Prevention by Early Treatment | pharmalive.com

The article published in the www.pharmalive.com is presenting a very useful information for preventing common illness, such as cold sores. The successful clinical outcome from phase III trial for Lipsovir is a progressive step for Medivir to develop preventative medicine. Particularly,  the combination of an antiviral and an anti- inflammatory agent in Lipsovir can show the additional clinical significance for hydrocortisone (an anti-inflammatory agent), which is mainly used to treat atopical Eczema. Medivir has obviously showed excellent performance to satisfy FDA's rigorous requirement to achieve a certain level of significance ((p=0.001). Although the dialogue will continue with regulatory authorities before a plan for  marketing is done, nevertheless, Medivir's achievement is indicative of successful endeavour to develop a preventative medicine.  

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