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GLG News by Kenneth Edelson

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Kenneth Edelson, MD
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December 17, 2007
Cost is key, but not enough!
Analysis of: Ipsen and Medicis announce submission of Reloxin(R) in aesthetics to the FDA | www.pipelinereview.com

Implications: Lowering cost of Botox is key, but not enough to induce patients to undergo Botox treatments.

Analysis:  I agree with Dr Auerbach's statement about cost and a lot of patients walk away from Botox treatment due to the high cost. I don't believe however that Medicis will cut the cost of Reloxin, and if they do, it will not be significant enough for doctors to lower the cost enough to appeal to more patients. I think we will be at the status quo regarding the high price of Botox/Reloxin and the high price doctors have to charge on this high hard cost product.12/14/2007 1:35:00 PM


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December 13, 2007
Reloxin Gives Allergan's Botox A Run for the Money!
Analysis of: Ipsen and Medicis announce submission of Reloxin(R) in aesthetics to the FDA | www.pipelinereview.com

Implications: For too long Allergan has monopolized the therapeutic and cosmetic market of botulinum toxin type A, and has taken full advantage of that monopoly by raising the price of Botox almost biannually. Reloxin studies are very favorable when compared to Botox, and may even surpass it in one or two aspects. There is a lesser protein load and therefore less antigenic than Botox and this may lead to a longer lasting effect. Studies already show and support this. In addition, there is a greater diffusion of the toxin from pontiff injection, and this is desirable in certain areas as the large frontalis areas of the face, and certainly in the large areas we tret for hyperhidrosis of the palms, soles and axillae, The conversion rate of units is not to be looked at as a chore of conversion, but as learning a new language. Don't look to convert units to units...just learn the required units of the new toxin. The shelf life appears to be slily longer as well. Cudos to Reloxin-watch out Botox!

Analysis:  

For too long Allergan has monopolized the therapeutic and cosmetic market of botulinum toxin type A, and has taken full advantage of that monopoly by raising the price of Botox almost biannually.
Reloxin studies are very favorable when compared to Botox, and may even surpass it in one or two aspects. There is a lesser protein load and therefore less antigenic than Botox and this may lead to a longer lasting effect. Studies already show and support this. In addition, there is a greater diffusion of the toxin from pontiff injection, and this is desirable in certain areas as the large frontalis areas of the face, and certainly in the large areas we tret for hyperhidrosis of the palms, soles and axillae, The conversion rate of units is not to be looked at as a chore of conversion, but as learning a new language. Don't look to convert units to units...just learn the required units of the new toxin.
The shelf life appears to be slily longer as well. Cudos to Reloxin-watch out Botox!


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May 29, 2007
New Organiceuticals May Help Bring Back Beauty!
Analysis of: http://www.nytimes.com/2007/04/26/fashion/26skin.html?_r=1&ref=health&oref=slogin | www.nytimes.com

Implications: All that glitters is not gold...but some might be! Anti-oxidants are the promise of saving our "hides"!

Analysis: For the most part, the cosmeceuticals sold on the first floor of major department stores in the world sell images of the lovely skin on the packaging or the model on the poster, adding little more than an expensive moisturizer etc. to the buyer's beauty aids.
There is however, a new "organiceutical" which has science behind it and shows some promise to give idebenone (Prevage) a run for the money. It is RevaleSkin by Steiffel Inc, a venerated dermatologic company producing quality dermatologic prescription drugs for over 150 years. It is made from the coffee berry and preliminary studies show it to be more effective in squelching the free radicals than other antioxidants, thereby slowing down the ravages of the environment and sunlight on our skin and immune systems. It should be released early in June 2007.


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May 28, 2007
Couldn't agree more
Analysis of: FDA May Place Ban on OTC Bleaching Creams | www.carefair.com

Implications: Keep Hydroquinones Around!

Analysis: The potential FDA ban of OTC hydroquinones is totally unnecessary! The OTC concentrations are low and have not caused any significant side effects in the scores of years they have been around. In addition, the stronger prescription strength formulas including combinations with steroids, retinoic acids, alpha hydroxy acids or sunscreens have not caused any significant issues either. The rare cases of ochronosis or rebound hyperpigmentation are just that...extremely rare.
Of course the only ones to benefit from banning the OTC hydroquinones are the drug companies who make the prescription strength formulas.


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May 17, 2007
Non-Invasive Screening of the Skin
Analysis of: New tool allows noninvasive screening of skin lesions | www.modernmedicine.com

Implications: The company hopes to apply for European regulatory approval next year, with U.S. market approval and launch to follow. The current price of the device is 15,000 EUR. This device promises to be a remarkable time and money saver for medicine. Approximately 80-95% of lesions excised by dermatologists prove non-cancerous when examined histologically. This is wasted time, money and unnecessary anxiety for patients.

Analysis: A Swedish BioTech company has developed a noninvasive device that distinguishes between melanoma, benign nevi, and basal cell carcinoma. In tests with 100 skin cancer lesions and more than 500 benign nevi, the device could distinguish malignant melanoma from benign nevi with 75% specificity at 100% sensitivity. It could also discriminate between non-melanoma skin cancer and benign nevi with 87% specificity at 100% sensitivity. The probe works by differentiating between the electrical impedance characteristics of skin cells. Values are compared to control measurements taken ipsilaterally to the lesion to generate a diagnosis. The sample size of malignant melanoma is too small but the company plans to do more clinical trial work.


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May 17, 2007
Pulsed Dye Vs Excimer Laser for Psoriasis
Analysis of: Psoriasis Challenge: pulsed dye vs. excimer lasers |

Implications: Patient satisfaction is high, but long term effects including possible carcinogenesis remain uncertain. Side effects included blistering, and hyperpigmentation in both groups, but no scarring.

Analysis: Both the excimer and Pulsed Dye Laser (PDL) can deliver long term remission for chronic plaque type psoriasis. On average, the excimer is more effective, but in a small subset, the PDL treatment worked better. Although the excimer has been specifially marketed for psoriasis, it has been confirmed that the PDL whichis muchmore widelty available, is also a very useful treatment option. Response rates varied from 69-85% in the excimer group, and 57-82% inb the PDL group.


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