FDA Approves Sculptra Aesthetic

Sanofi-aventis U.S. recently announce that the FDA approved Sculptra Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, which are treated with the appropriate injection technique in healthy patients.

Sculptra Aesthetic works gradually to offer natural-looking results that can last up to 2 years, according to the company.

“We are excited by the FDA approval of Sculptra Aesthetic because it changes the landscape of what physicians can offer patients seeking natural and gradual-looking results from an aesthetic injectable that is long-lasting,” said Doris Day, MD, clinical assistant professor of dermatology at New York University and in private practice in New York City, in a company-issued press release. “Sculptra Aesthetic allows for a natural correction.”

The FDA approval of Sculptra Aesthetic is based on results from a randomized, comparative, evaluator-blinded, parallel group, multi-center study of 233 patients. Patients received Sculptra Aesthetic or an approved human-derived collagen for the treatment of their nasolabial fold wrinkles. Sculptra Aesthetic was administered in a single treatment regimen, at 3-week intervals, for up to four treatment sessions for the correction of shallow to deep nasolabial fold contour deficiencies using a deep dermal grid pattern (cross-hatch) injection technique. The Sculptra Aesthetic patients were followed for an additional 12 months. Sculptra Aesthetic treatment effects were maintained up to 25 months after the last treatment session, while the human-derived collagen was effective up to 3 months.

No serious adverse events were reported in this study for either treatment, according to Sanofi-aventis. Commonly occurring short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling and were reported in both treatment groups. Other adverse events reported during the 25-month trial included small bumps and lumps, some with a delayed onset and were mild or moderate in intensity. Most side effects resolved on their own; one small lump required treatment by the healthcare provider.

Full prescribing information can be found at www.sculptraaesthetic.com.

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Medicis Announced Approval of New Acne Drug Doses

Medicis recently announced that the FDA has approved additional strengths of Solodyn (minocycline HCl, USP) Extended Release Tablets in 65 mg and 115 mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

“We are very pleased to announce the approval of these new strengths of Solodyn,” said Jonah Shacknai, chairman and chief executive officer of Medicis. “These additional strengths will complement the current Solodyn lineup to offer physicians more precise weight-based dosing options, and make Solodyn the first and only extended release minocycline with five FDA-approved dosing strengths. We believe physicians and patients will appreciate the value of this greater dosing precision.”

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Head Lice Treatment Approved

Sciele Pharma, Inc., a Shionogi Company, announced the availability of Ulesfia (Benzyl Alcohol Lotion 5%), the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects. The FDA approved Ulesfia for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia is available now by prescription nationwide in time for peak head lice season.

“We are pleased to introduce Ulesfia during the summer camp months and ahead of the back-to-school period, two settings and seasons when head lice infestations are prevalent and cause anxiety for parents and children,” said Ed Schutter, president and chief operating officer of Sciele Pharma, in a press release. “This novel product delivers on our goal to provide an effective FDA-approved head lice treatment that does not contain a neurotoxic chemical and addresses possible resistance issues.”

According to the company, Ulesfia’s unique mechanism of action is facilitated through the use of benzyl alcohol, which prevents lice from closing their spiracles, thereby asphyxiating them within 10 minutes and causing death.

Sciele is collaborating with the National Association of School Nurses to help educate health professionals and the public about head lice.

Full prescribing information for Ulesfia (Benzyl Alcohol Lotion 5%) is available at www.sciele.com.

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FDA Requires Cancer Warnings for TNF Blockers

The FDA announced that it is requiring stronger warnings in the prescribing information for the class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, Crohn’s disease and other inflammatory diseases.

The FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α). The drugs in this class include infliximab (Remicade), etancercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).

According to the FDA, this action was taken based on the completion of an investigation it first announced in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.

Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.

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MelaFind Pre-Market Approval Application Accepted for Review

Electro-Optical Sciences, Inc., (EOS) recently announced that the FDA formally accepted for filing the company’s pre-market approval (PMA) application for MelaFind, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. The FDA’s action means that the PMA application was sufficiently complete and ready for substantive review, according to the company. The filing date for regulatory purposes is June 9, 2009, the date the FDA received the PMA submission. The FDA also confirmed that the PMA application will receive expedited review and processing.

“We’re extremely pleased that the FDA has formally accepted the MelaFind PMA for review. This brings us one step closer to realizing our goal of offering clinicians a reliable tool to help them to detect melanoma while it is still in its earliest, most curable stages,” said Joseph V. Gulfo, MD, president and CEO, in a press release. “We look forward to advancing our discussions with the FDA and obtaining the agency’s feedback on the MelaFind PMA and next steps in the review process.”

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FDA Accepts NDA for New Imiquimod Product

Graceway Pharmaceuticals announced that results from a Phase III program evaluating short-course regimens of two concentrations of imiquimod cream (3.75% and 2.5%) demonstrated imiquimod 3.75%, administered daily on two 2-week treatment cycles, separated by a 2-week non-treatment period, produced clearance rates superior to placebo for actinic keratosis (AK). Imiquimod 3.75% was also more effective than 2.5% with comparable safety. The new data, presented at the American Academy of Dermatology Summer Academy Meeting, are in a new drug application (NDA) accepted for review by the FDA for imiquimod 3.75% utilizing a 2-week cycle regimen in the treatment of AK.

With respect to the treatment of AK, the existing approved 5% imiquimod formulation is indicated only for the treatment of nonhyperkeratotic, nonhypertrophic AK on a very limited area of the skin (ie, less than 25 cm2) for a full 16 weeks of treatment. The intent of the clinical studies conducted with the new 3.75% imiquimod formulation was to evaluate a new treatment paradigm for clinically typical AK lesions on patients with extensive disease (ie, patients with 5 to 20 AK lesions over the full face or balding scalp), according to the company.

“We believe that the new 3.75% imiquimod formulation and its 2-week treatment cycle regimen could offer physicians a new predictable treatment option for their patients who present with typical AK lesions on affected fields of skin,” said Jefferson J. Gregory, chairman and CEO of Graceway Pharmaceuticals.

“Topical imiquimod 5% can be difficult for some AK patients because of the required full 16-week dosing,” said Dr. Neil Swanson, professor and chairman, Department of Dermatology, Oregon Health and Science University, in a company press release. “These data demonstrate the 2-week cycle regimen at a lower concentration may be an effective and convenient treatment option.”

Study Details

In four double-blind, placebo controlled studies, 969 adults with 5 to 29 AK lesions in a treatment area >25 cm2 (full face or balding scalp) were randomized to either placebo, imiquimod 3.75% or 2.5% (1:1:1). Patients applied up to 500 mg of cream daily for two cycles, 2-week or 3-week, separated by a no-treatment interval of 2 or 3 weeks. Primary efficacy was assessed 8 weeks after the last dose.

Data from the Phase III program revealed that both the 3.75% and 2.5% imiquimod formulations administered once-daily over a large surface area (>25 cm2) of the full face or balding scalp in 2- or 3-week cycles were statistically superior to placebo. The data revealed that 3.75% imiquimod patients had 36% complete clearance of AK versus 6% for placebo. The 2.5% imiquimod patients showed 31% complete clearance of AK versus 6% for placebo. The differences between the 3.75% and 2.5% concentrations were statistically significant for partial clearance and percentage reduction in lesion counts from baseline. Comparable efficacy was demonstrated for both regimens (2 weeks and 3 weeks) at each concentration.

The majority of patients in all imiquimod groups had increases in the number of lesions from baseline during treatment, consistent with the unmasking of subclinical AK lesions. Clearance rates reflect treatment of both visible/palpable and new lesions.

Local skin reactions, such as erythema are consistent with treatment response. The most commonly reported severe local skin reactions with the 3.75% concentration during the 2-week treatment cycle regimen were erythema (25%), scabbing/crusting (14%), ulceration (11%), and flaking/scaling/dryness (8%). The longer 3-week cycle regimen was associated with a higher frequency of adverse events, rest periods and severe local skin reactions than was observed with 2 two-week cycle regimen.

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Other Drug News

Peplin Initiates its Final Phase III Clinical Trial for PEP005 Gel in AK

Peplin, Inc., recently announced the initiation of its second non-head Phase III clinical trial to confirm the efficacy and safety of PEP005 (ingenol mebutate) gel for the treatment of actinic keratoses (AKs) when applied to non-head locations, which include the trunk and extremities.

This second pivotal Phase III trial for non-head locations, known as REGION-Ib, is designed to replicate the recently completed REGION-I trial and confirm the results of PEP005 gel, which showed a total clearance rate across all anatomical non-head locations of 27.4% (P<0.0001), a median lesion reduction of 66.7% (P<0.0001) and statistical significance when compared to vehicle for clearance of AK’s on the chest and the especially difficult-to-treat locations, the arm and back of hand.

“Achieving this additional milestone immediately following the rapid enrollment in our Phase III head trials, demonstrates our commitment to progressing PEP005 gel through the final phase of our clinical development process. Based on the data we generated in the REGION-I trial, we believe PEP005 gel with its short course of therapy represents a significant advance in the treatment of a common skin condition, which if left untreated can progress to squamous cell carcinoma,” said Chief Executive Officer Tom Wiggans, in a press release.

REGION-Ib is a randomized, double-blind, vehicle-controlled clinical trial that will be conducted at multiple sites in the United States. Peplin expects to enroll about 200 patients who will self-apply the study medication (0.05%) or vehicle gel for two consecutive days to a 25 cm2 treatment area containing four to eight AK lesions. As with prior trials, the primary efficacy endpoint for the REGION-Ib trial will be the complete clearance rate of AK lesions and the secondary efficacy endpoint will be the partial clearance rate of AK lesions within the treatment area. Peplin will also measure the overall median reduction of AK lesions.

In addition to the REGION-Ib trial on non-head locations, Peplin recently completed enrolment in its REGION-IIa and REGION-IIb trials for head locations, which include the face and scalp, and announced the results from its REGION-I trial, the first Phase III for non-head locations, earlier this year. Peplin will complete their Phase III clinical trials for AK by the end of this year and plans to file a New Drug Application in mid-2010.

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Taro Receives Patent for Lice Treatment

Taro Pharmaceutical Industries Ltd., announced that the U.S. Patent and Trademark Office has issued a patent covering its malathion lotion 0.5% (Ovide) (patent no. US 7,560,445).

The patent is for a highly pure form of malathion for topical pharmaceutical use and a method of making pure pharmaceutical-grade malathion, as well as for a formulation containing the pharmaceutical-grade malathion and a method for treating head lice.

According to the company, in the past year, more than 250,000 prescriptions for Ovide were filled in the United States, making it the number one prescription treatment for head lice in the country.

More information can be found at www.taro.com.

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Michelson Diagnostics Releases Clinical Handheld OCT Probe for European Market — U.S. to Follow

Michelson Diagnostics has put on the European market its first CE-certified clinical Optical Coherence Tomography (OCT) probe and processing system, which has been given the name Vivosight. The new Vivosight probe is specified with X-Y scanning, to enable high resolution 3D mapping of flat tissue such as skin to a depth of 1 mm. According to the company, the multibeam design provides double the image resolution (ie, better than 10 µm) available from conventional single-beam designs, resulting in crisper, clearer OCT images, showing more clinical detail.  

"We have achieved clinical CE-mark certification for the product, enabling sales for clinical use in Europe." said Jon Holmes, chief executive officer, "This will be followed by a 510(k) for the equivalent in the U.S. market, hopefully by the end of 2009." The VivoSight OCT scanner is being designed specifically for clinical applications, and will be available with stub lens for topical uses. It is currently not cleared for clinical use or sale in United States. 

For more information, visit www.michelsondiagnostics.com.

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Medicis and Revance Announce Agreement for Development of Next-Generation Neurotoxin

Medicis Pharmaceutical Corporation and Revance Therapeutics, Inc., recently announced that the companies have entered into a license agreement granting Medicis worldwide aesthetic and dermatological rights to Revance’s novel, investigational, injectable botulinum toxin type A product (RT002) currently in pre-clinical studies. The objective of the RT002 program is the development of a next-generation neurotoxin with favorable duration of effect and safety profiles.

Under the terms of the agreement, Medicis will pay Revance $10 million at signing, additional milestone payments totaling approximately $94 million upon successful completion of certain clinical, regulatory and commercial milestones, and a royalty based on sales and supply price, the total of which is equivalent to a double-digit percentage of net sales. Other than the $10 million payment at signing, Medicis currently does not anticipate incurring research and development expenses related to this transaction in 2009, nor does the Company anticipate making milestone payments sooner than 2010. Revance will retain certain therapeutic rights to the product. Additional terms were not disclosed.

RT002 is an investigational, next-generation, injectable neurotoxin that integrates Revance’s proprietary, purified botulinum toxin type A molecule with the patented TransMTS peptide technology. Pre-clinical data suggest that the TransMTS technology may enhance delivery of the drug to the target, which may positively affect duration of effect and safety profiles.

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US Senate Panel Approved 12-year Exclusivity for Biologic Drugs

The U.S. Senate Health, Education, Labor and Pensions Committee voted 16 to 7 in favor of a proposal to protect biologic drugs from generic competition for 12 years. The measure is part of a larger healthcare bill.

The measure passed despite the Obama administration’s decree that a 7-year exclusivity limit was adequate.

The decision by the Senate committee will require agreement from the full Senate and also from the House of Representatives.

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S&A News

AAD Issues Revised Position Statement on Vitamin D

In July, the American Academy of Dermatology (AAD) issued a revised position statement on vitamin D after an updated review of the increasing body of scientific literature on this vitamin and its importance for optimal health. According to the AAD, these revisions address this growing issue and strive to facilitate greater awareness of the state of the science and the role of the dermatologist in this area. The AAD also explained in a press release that, as evidence about the role of vitamin D continues to grow and change, it will update its position if necessary to continue to provide timely guidance on the issue.

The AAD’s revised position statement continues to emphasize the importance of obtaining vitamin D from nutritional sources and dietary supplements rather than from unprotected exposure to ultraviolet radiation. It now also recommends that physicians provide information on options to obtain vitamin D safely to their patients who are at high-risk for vitamin D insufficiency. According to the AAD, members should use the National Academy of Sciences Institute of Medicine reference standard as a minimum guideline for intake levels, but consider recommending a daily total dose of 1000 IUs of vitamin D for adult high-risk groups, such as those with dark skin, elderly persons or people who properly protect themselves from the sun’s harmful rays on a regular basis.

The Board of Directors also indicated its support for the National Council on Skin Cancer Prevention’s recently drafted statement on vitamin D.

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AAD Commends Reclassification of Tanning Beds as Carcinogenic

The American Academy of Dermatology (AAD) recently announced that it commends the International Agency for Research on Cancer (IARC) for its re-categorization of indoor tanning devices as carcinogenic to humans, according to a July 30 press release. This classification places indoor tanning in the highest cancer risk category afforded by this international agency, which is a division of the World Health Organization (WHO).

“The American Academy of Dermatology applauds the IARC and the World Health Organization for confirming what the Academy has known for many years — that ultraviolet light is the primary cause of skin cancer and avoiding excessive exposure to the sun and other forms of ultraviolet radiation, such as indoor tanning, is the solution,” said dermatologist David M. Pariser, MD, FAAD, president of the American Academy of Dermatology in the press release.

The review concluded that the risk of melanoma increases by 75% when use of tanning beds and sunlamps begins before 30 years of age. This high-risk tanning behavior, seen primarily in females, could explain the increasing melanoma rates for females 15 to 29 years old, according to the AAD. Since 1992, melanoma has increased 3.1% annually in male and female Caucasians, but in recent years it is increasing more rapidly in young Caucasian women (3.8% since 1995).

Previously, the AAD supported the WHO’s 2005 recommendation that no person under the age of 18 should use a tanning bed. Nearly 30 million people tan indoors in the United States annually and of these, 2.3 million are teens.

The AAD recently lauded the state of Texas for being the first state to prohibit the use of indoor tanning devices for anyone under the age of 16.5 — the most restrictive law in the country.

The American Academy of Dermatology Association (AADA) position statement on indoor tanning opposes indoor tanning and supports a ban on the production and sale of indoor tanning equipment for non-medical purposes. Additionally, the AADA has urged the FDA to take action that will ban the sale and use of tanning equipment for non-medical purposes. Unless and until the FDA bans the sale and use of tanning equipment for non-medical purposes, the AADA supports the following requirements for indoor tanning facilities: no minor should be permitted to use tanning devices, a Surgeon General’s warning should be placed on all tanning devices, and no person or facility should advertise the use of any UVA or UVB tanning device using wording such as safe, safe tanning, no harmful rays, no adverse effect, or similar wording or concepts.

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In Brief…

PhotoMedex Appoints… a new CEO. With the recent resignation of Jeffrey O’Donnell, President and CEO, the Board of Directors appointed Dennis McGrath, who has served as its Chief Financial Officer since 2000.

Avidas Pharmaceuticals and LaRon Pharma Inc… have entered into an agreement for LaRon to co-promote Avidas’ key prescription-only convenience kits, Avidoxy DK defence kit and Scalacort DK defence kit. Under the terms of the agreement, LaRon will provide sales support focused on primary care and internal medicine physicians in the United States, while Avidas will continue its sales force specialty focus in dermatology. Avidas will also maintain full marketing rights for each of the products. Specific financial terms of the deal were not disclosed.