GLG News by Cosmetic Dermatologists (US)

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Peplin merger with Leo pharma

November 19, 2009

Analysis of:Leo Pharma completes merger pact with Peplin | www.pharmabiz.com

The recent merger of Peplin with Leo pharma is of some significance and will benefit both companies. It would have been difficult for Peplin to fully develop and market their flagship product alone.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Presta Trial shows good results for Enbrel

October 14, 2009

Analysis of:New data from PRESTA trial demonstrate the benefit of Enbrel in patients with psoriasis & psoriatic arthritis | www.pharmabiz.com

This trial showed predicatably good results for Enbrel in patients with psoriasis and psoriatic arthritis. This included improvement in signs and symptoms and quality of life. This will increase sales of Enbrel in the short term. However the two newer agents, Humira and Stelara have better efficacy, and more convenient dosing regimens. Both will be doing similar studies.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Will the withdrawl of Efalizumab effect the biologic market?

April 15, 2009

Analysis of:Efalizumab withdrawn from US Market | www.medscape.com

This article is important in that the withdrawal of efalizumab by Genentech was appropriate in view of its serious side effect of progressive multifocal leukoencephalopathy (PML). This biologic agent was already declining in usage because of its other side effects, and the presence of other strong competitors with equal or higher efficacy and less side effects. This was to be compounded by the impending release of ustekinumab

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Aurobindo terbinafine approval- what effect will this have?

January 21, 2009

Analysis of:Aurobindo Pharma gets approval for Terbinafine Tablets | myiris.com

This article is important in that it confirms another terbinafine competitor to the Novartis Lamisil brand is being released. The majority of terbinafine prescriptions in North America are generic. The market for this product will be good at least until more effective oral or topical agents are released. The majority of the prescriptions are for onychomycosis (toenail fungus). The newer products will be released in 3-4 years, at which time the market for terbinafine will shrink significantly.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Filler Warnings- Are They Necessary?

November 24, 2008

Analysis of:FDA Faults Wrinkle Fillers Over Warnings | online.wsj.com

This article is important in that it discusses a rare but known side effect of filler injections- reactions to these agents. These reactions include allergies, infections, etc. The incidence is low- approximately 1000 cases out of 1.5 million injections. The majority of these reactions were not serious. The various fillers were not differentiated, but it is likely that the hyaluronic acid fillers like Restylane/Perlane/Juvaderm will have the lowest incidence as they are the closest to human hyaluronic acid that is present in the skin. This article and the FDA warning is unlikely to effect the use or sales of these fillers.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Will access to dermatology care suffer with increased cosmetic procedures ?

August 1, 2008

Analysis of:As Doctors Cater to Looks, Skin Patients Wait | www.nytimes.com

 This article is important in that it describes a growing trend among dermatologists to offer a higher level of "customer service" for their cash paying cosmetic patients. This has contributed in a small way to the long waits for non cosmetic dermatology patients to be able to see a dermatologist. A larger cause of the long waits is the small number of dermatologists being trained, and many of them working less than a full schedule. As the waits become longer and access more difficult, many dermatologists will opt out of managed care plans and move toward a cash/fee for service practice. This trend is already beginning. Also many primary care physicians are also offering ancillary procedures, and access for their patients may also become limited, which has more serious implications.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Will prescription drug spending decreases affect dermatology?

July 18, 2008

Analysis of:Patients Curb Prescription Spending | online.wsj.com

This article is important in that it describes a worrying trend for branded  pharmaceutical companies. As copays for branded products go up and the patients economic status worsens, the use of these drugs will fall. This may be especially true for medications in dermatology, where the perceived need may be less than that for a cardiac drug. The pipelines in dermatology are smaller due to high drug development costs, and limited means to recover them, because the market is smaller than that for other conditions. Many of our patients are complaining about difficulty in getting insurers to cover their branded products, and copays and requests for prior authorizations have increased exponentially. A positive factor is that many of the products in dermatology still enjoy several years of patent protection.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Protopic use can prevent relapse

July 7, 2008

Analysis of:Intermittent tacrolimus Ointment therapy Helps Prevent Relapse Of Stabilized Atpoic Dermatitis | www.medscape.com

This article is important in that it confirms a commonly used method in clinical dermatology practice. Namely that of using Protopic for longer term maintenance to prevent flares, and to act as a topical steroid sparing agent. This has been done since the introduction of Protopic, and among dermatologists there are no significant safety concerns over its long term use. Elidel, from Novartis, should also be studied, though it is commonly acknowledged to be a weaker topical immunomodulator, albeit better tolerated.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

New uses for old meds- benefit or drawback?

July 7, 2008

Analysis of:One drug, many uses. Good idea? | www.indystar.com

This article is important because it describes a growing concern that is not well known to the investment community or the public. Due to increased pressure from the generic companies, the FDA, and the public many companies are finding new uses for older medications. This is very true in dermatology and other smaller specialties where the cost of new drug development is higher than many smaller companies can support. Unfortunately this strategy, while good for keeping the bottom line high initially, will eventually hurt these same companies because the alternative uses will run out, and newer medications will be needed. Both strategies are needed in order to ensure a good pipeline of medications both old and new.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Evolence Approval- what effect will it have on the filler market

July 2, 2008

Analysis of:FDA Approves EVOLENCE®, a New Generation Collagen-Based Facial Filler | www.investor.jnj.com

This article is important because it outlines the rationale and benefits of the new collagen based filler from Ortho-Neutrogena/ Johnson and Johnson. This filler appears to last at least 6 months, and does not require pre testing as other collagen based fillers have needed in the past. The fact that this filler has been used overseas is reassuring. The remaining products will have some increased competition, though both Restylane/ Perlane ( Medicis),  Juvederm (Allergan), and Radiesse( Bioform) do last longer than 6 months, and have few if any significant side effects as well. Pricing as well as positive patient and physician experience will dictate if this product will be successful in this increasingly crowded market. This product will do better if it had been brought to market earlier.

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