GLG News by Dr. Sunil Dhawan MD, Clinical Assistant Professor of Dermatology
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Obagi Medical Products recent Q1 2011 results have some important implications
May 7, 2011
Obagi Medical Products Reports First Quarter 2011 Results | finance.yahoo.com
The recent first quarter call from Obagi Medical Products indicates that the legal battles with the founder appear to be over. Also a ban on hydroquinone products in Texas may have a temporary minor effect on the company, but can and should be resolved in a favorable manner.
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Leo pharma's phase 3 actinic keratosis trial shows promise
December 25, 2009
Positive results for LEO Pharma’s phase III actinic (solar) keratosis trials on the face and scalp | www.pipelinereview.com
This trial of Leo pharma's new Ak topical shows great promise. The results were positive, and further trials on non facial areas are ongoing. The advantage of this product is that treatment only requires 3 days, though the product can be irritating. Other products for actinic keratosis can also irritate. This will be the second product from Leo, to be released in 2012,as they will be marketing Taclonex as well, as of 2010. This is the beginning of a strong dermatology company in the US.
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November 19, 2009
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.
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Presta Trial shows good results for Enbrel
October 14, 2009
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.
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Will the withdrawl of Efalizumab effect the biologic market?
April 15, 2009
Efalizumab withdrawn from US Market | www.medscape.com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
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Aurobindo terbinafine approval- what effect will this have?
January 21, 2009
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.
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Filler Warnings- Are They Necessary?
November 24, 2008
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.
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Will access to dermatology care suffer with increased cosmetic procedures ?
August 1, 2008
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.
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Will prescription drug spending decreases affect dermatology?
July 18, 2008
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.
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Protopic use can prevent relapse
July 7, 2008
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.
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New uses for old meds- benefit or drawback?
July 7, 2008
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.
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Evolence Approval- what effect will it have on the filler market
July 2, 2008
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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June 27, 2008
What Skin Care Routines and Treatments Are Effective for Adolescent Acne? | www.medscape.com
This article is important in that, for the most part , it describes a basic therapeutic regimen for adolescent acne patients. The only error is describing the inflamed lesions as "infections." Acne is predominantly an inflammatory condition, not an infectious one, though a bacteria is involved in creating inflammation. I prescribe a retinoid such as tretinoin- Retin A, Differin, Ziana, or Tazorac to "unclog the blocked oil gland. For inflammation I use a topical clindamycin, or combination products such as Duac,etc. Oral antibiotics like tetracycline, doxycycline ( Doryx), minocycline ( Solodyn), are added. Finally Isotretinoin ( Accutane) is used fpor more severe or resistant cases. Oral contraceptives such as Yaz can be used in females. The new Allergan aquisition ,Aczone, offers promise as the first non antibiotic topical anti inflammatory agent. Lasers/IPL and home based devices have not been found to offer enough or sustained relief.
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Allergan's acquisition of Aczone- is this significant?
June 25, 2008
Allergan Aquisition of Aczone | agn360.client.shareholder.com
This article is important in that this acquisition is the first new product for Allergan's dermatology division in several years. This is also the first novel molecule in 5-7 years that has been released. The issues of having to get blood tests with this topical agent have been solved. The obvious paring of this antiinflammtory with Allergan's Tazorac retinoid product will drive sales of both products.
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This article may change atopic dermatitis treatment by pediatricians
May 19, 2008
Guidelines Issued for Treating Atopic Eczema in Children | www.medscape.com
This article is important in that it is a good summary of the current knowledge and treatment methods for atopic dermatitis for pediatricians. It is needed in that this condition is inadequately treated, and a periodic refresher is needed for all physicians. Both pharmacologic and non pharmacologic methods are discussed.
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Unlicensed person injecting silicone unlikely to impact filler market
May 19, 2008
Renal Failure Linked to Cosmetic Soft-Tissue Filler Injections | www.medscape.com
This article is important in that it makes the public aware that they should avoid all unlicensed persons who re injecting any substance into their bodies. These especially include those injecting silicone mixtures. The public will become more aware and should have more confidence in licensed practitioners who are injecting FDA approved materials such as Restylane, Perlane, Juvederm Ultra, Radiesse, etc. It is unlikely that this event will adversely impact the field. This is especially true in light of the previous illegal injection of Botox by an unlicensed person, and that this had minimal effect on the volume of Botox injected.
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Long term use of Allergan's Botox does not decrease efficacy
April 1, 2008
Efficay of Bolinum toxin does not sag over time | www.medscape.com
This article is important in that it lays to rest a misconception that long term repeated use of Botox ( Allergan) leads to decreased efficacy. Efficacy was maintained, and no neutralizing antibodies were found to Botox. This will reassure most users of Botox, and patients as well.
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Serious Skin Reactions with TNF antagonists
April 1, 2008
Serious Skin Reactions with TNF antagonists | www.medscape.com
This article is important in that it defined the incidence of serious skin reactions to the three common TNF antagonists- Enbrel, Humira, and Remicade. The incidence is relatively low in comparison to the numbers of patients treated. Any foreign protein has the potential for eliciting these reactions, and these reports are to be expected. The reactions range from the milder Erythema Multiforme to the more serious Toxic Epidermal Necrolysis. The reactions are more common in female patients receiving these products for rheumatoid arthritis.
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AN2728 phase 2a results encouraging.
March 31, 2008
Anacor Pharmaceuticals Announces Positive Results from Phase 2A Clinical Trial of AN2728 in Psoriasis Patients | www.pipelinereview.com
Anacor's recent release of the data from their phase 2a study of AN 2728 for psoriasis were encouraging. Over 69% actively treated plaques of psoriasis improved versus only 6% of placebo treated plaques. The study was limited by the short duration- only 28 days versus up to 16 weeks for other trials, the limited number of patients- usually even phase 2 trials have a larger number of patients, and the use of the same patient for both active and placebo ointments. Also the strict definition of "improvement" was not given. A larger and longer study, with separate actively treated and placebo treated patients is needed. Also the use of standard criteria for psoriasis grading such as Pasi score reduction , reduction in psoriasis disease activity, or investigator global assesment will be important.
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Psoriasis associated with comorbidities- Is this to be expected?
March 31, 2008
Research Shows Patients With Psoriasis at Increased Risk for Developing Other Serious Medical Conditions | www.pharmalive.com
This article is important in that it is one of the first to confirm what is a widely held belief among many dematologists who treat many patients with psoriasis. Specifically that these patients suffer a higher rate of cardiovascular diseases, depression, malignancy, etc. This makes perfect sense as the immune system in these patients is activated and in essence there is a chronic state of inflammation throughout the body. This could lead to blood vessel damage in various organs such as the heart, etc., and to cardiac events. Chronic inflammation can also increase the risk of malignancy, and any chronic potentially debilitating disease like psoriasis has a significantly higher incidence of depression.
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