Medicis Announces Close of Graceway Acquisition

SCOTTSDALE, Ariz., Dec. 2, 2011 (GLOBE NEWSWIRE) -- Medicis (NYSE:MRX) today announced that it has completed its acquisition of substantially all of the assets of Graceway Pharmaceuticals, LLC (Graceway), following approval by Graceway's board of directors, clearance under the Hart-Scott-Rodino Act and final approval by the U.S. bankruptcy court overseeing Graceway's Chapter 11 case and the Canadian court overseeing the receivership of Graceway's Canadian subsidiary. Medicis announced on November 18, 2011, that the Company was the successful bidder at a bankruptcy auction conducted by Graceway for substantially all of the outstanding U.S. and Canadian pharmaceutical assets of Graceway. Graceway filed for Chapter 11 bankruptcy protection on September 29, 2011.

"We are pleased to announce the close of this important transaction as Medicis broadens its presence within dermatology," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "We are confident that key Graceway products currently in the marketplace represent a sound investment in the future of Medicis.  The Graceway research and development (R&D) pipeline includes several patented and patent-pending, mid- and late-stage assets which may represent annual net sales peak potential of over $500 million.  We remain committed to the growth of our current brands and are excited at this opportunity to diversify our product portfolio."

Terms of the Transaction

Under the terms of the transaction, Medicis paid to Graceway a purchase price of $455 million for Graceway's commercial pharmaceutical product portfolio, which includes prescription products in the dermatology, respiratory and women's health specialties, and certain other assets. Included in the purchase is a strong R&D pipeline: 

• a formulation-stage dermatology project with an applied-for patent and projected annual peak sales in excess of $200 million;
    
• a Phase 2 dermatology new chemical entity product currently patent-protected through 2016 with a potential patent term extension of up to five years and projected peak sales in excess of $200 million; and
     
• a nearer-term women's health product which has completed Phase 2 and will soon enter Phase 3 with an applied-for patent and projected annual peak sales in excess of $100 million. 

Additionally, Medicis has the opportunity to launch two recently approved line extensions for the Zyclara™ franchise, which has several applied-for patents currently under accelerated examination in the United States and related patent protection in Canada already obtained.

Medicis funded the transaction from its existing cash balances. 

Current 2011 Guidance

The Company will allocate the $455 million lump-sum payment to the acquired Graceway assets and liabilities, including, but not limited to, intangible assets and in-process R&D. Medicis is in the process of completing a valuation to determine the amounts to be assigned to the acquired assets, including intangible assets and their related amortization periods, and the amount of in-process R&D.  As a result of this transaction, the Company will be providing non-generally accepted accounting principles (non-GAAP, defined below) diluted earnings per share (EPS, defined below) and non-GAAP diluted cash EPS (defined below) guidance.

Based upon information available currently to the Company's management, the Company's financial guidance for the remainder of 2011 is anticipated as follows:

Calendar 2011
(in millions, except per share amounts)
	First	Second	Third	Fourth	Calendar
	Quarter	Quarter	Quarter	Quarter	Year-End
	(3/31/11)	(6/30/11)	(9/30/11)	(12/31/11)	2011
	Actual	Actual	Actual	Estimated	Estimated
Revenue	$165	$191	$185	$187-$200	$728-$741
Non-GAAP diluted EPS objectives	$0.50	$0.64	$0.56	$0.63-$0.69	$2.33-$2.39
Non-GAAP diluted cash EPS objectives	$0.55	$0.68	$0.61	$0.68-$0.74	$2.52-$2.58

Additional 2011 Guidance Considerations

Revenue, non-GAAP diluted EPS and non-GAAP diluted cash EPS objectives include certain assumptions associated with:

• the Company's decision, effective July 1, 2011, to stop shipment of the Legacy Strengths¹ of SOLODYN^® to wholesalers. The Company's guidance issued today in the table above reflects the decrease in sales and profitability associated with the Legacy Strengths. The average selling price (ASP) for the Legacy Strengths is approximately $200 higher than that of the current strengths.
     
• continued acceptance of newer strengths of SOLODYN by physicians;
    
• levels of managed care rebates for SOLODYN and the Company's other therapeutic brands;
    
• the Company's early 2011 discontinuation of TRIAZ^® and decision to no longer promote PLEXION^®;
    
• the exclusion of all revenue and expenses associated with LipoSonix, as the Company began classifying the LipoSonix business as a discontinued operation in the first quarter of 2011;
     
• competition in the dermal filler and botulinum toxin markets;
    
• gross profit margins of approximately 90-91% of revenues;
    
• selling, general and administrative (SG&A) expenses of approximately 47-49% of revenues;
    
• R&D expenses of approximately 5-6% of revenues;
   
• depreciation and amortization of approximately $29-$30 million for the year;
   
• effective tax rate of approximately 39-40%; and
    
• fully diluted weighted average shares outstanding of approximately 66-67 million shares.

The above guidance does not take into account the following:

• revenue and operating expenses associated with the Graceway transaction. If the Company is able to re-label and subsequently ship product within the fourth quarter 2011, the impact on the quarter's cash EPS is expected to be minimal, as any incremental revenue would be offset by associated operating expenses.
   
• Any expenses that may result from the Graceway transaction, including, but not limited to, acquired in-process R&D and amortization related to acquired intangibles associated with the Graceway transaction;
   
• changes in levels of managed care rebates, and the associated impact on sales, reserves, profitability and the ASP, for SOLODYN and the Company's other therapeutic brands. The Company is actively engaged in a strategy, which management believes will significantly reduce the Company's exposure to managed care restrictions for SOLODYN and the Company's other therapeutic products. This strategy includes, among other things, negotiating new, multi-year contracts to begin in 2012 with targeted managed care organizations and pharmacy benefit managers, which, in aggregate, account for approximately 40% of the insurable lives for the Company's therapeutic products. SOLODYN was the 7^th largest infectious disease prescription product in the U.S. for 2010,² and we believe that our anticipated growth of SOLODYN will increase the risk of managed care restrictions. If we are successful in our negotiations, we would anticipate having to accrue additional sales reserves, not contemplated in our above revenue guidance, totaling approximately $12-$17 million, and a corresponding impact on EPS guidance for the fourth quarter 2011.
    
• proceeds from the disposition of the LipoSonix business;  
    
• special charges associated with R&D milestones or contract payments;  
    
• the financial impact of fluctuations in the Company's stock price and the resulting effect on its Stock Appreciation Rights (SARs);  
    
• the financial impact of potential share repurchases made under the Company's previously announced Stock Repurchase Plan;
    
• the financial impact of legal settlements; 
    
• additional recognized losses on our auction rate securities investments; 
    
• recognized losses resulting from impairments on our intangible assets;
    
• the impact of accounting for new collaborative arrangements with Medicis partners;
    
• the financial impact of changes in accounting or governmental pronouncements;
    
• charges related to the accounting for our investment in Revance or Hyperion;
   
• material changes to the demand for ZIANA^® associated with the launch of a competitive product;
    
• material changes to our assumptions regarding sales of SOLODYN to wholesalers and the demand for SOLODYN associated with the anticipated November 2011 launch of generic forms of the Legacy Strengths of SOLODYN;
    
• material changes to our assumptions regarding returns, including associated returns reserves, of SOLODYN and the Company's other therapeutic brands;
     
• the timing of additional SOLODYN patent allowances, if any;
    
• uncertainty relating to the reduction of the ASP, including reserves, for covered products as a result of the rise in costs associated with consumer rebate programs, including MediSAVE and other point-of-sale offers;  
    
• changes in reimbursement policies of health plans and other health insurers;
    
• the impact of the U.S. economy on the Company's aesthetic and therapeutic franchises; and
    
• significant changes in assumptions and estimates used for calculating various sales reserves.

At the time of this disclosure, Medicis believes these objectives are attainable based upon information currently available to the Company's management.

Conference Call / Webcast

Medicis will host a conference call and webcast for the investment community on Monday, December 5, 2011, at 11 a.m. Eastern Time (8 a.m. Pacific Time), to discuss corporate strategy, the Graceway acquisition, financial guidance and other company updates. A live webcast will be available at http://www.Medicis.com/company/index.asp. The webcast will be archived on the Company's website for 10 business days following the live call.

Callers should dial in approximately 10 minutes prior to the start of the call. No reservation is necessary to participate on the call. The phone number to join the conference call is +1 (877) 233-0981 (U.S. and Canada) or +1 (706) 679-5708 (international and local). The access code for the live call is 31818427. For investors unable to participate on the live call, a replay will be available soon after the live call. The phone number to access the replay is +1 (855) 859-2056 (U.S. and Canada) or +1 (404) 537-3406 (international and local). The access code for the replay is 31818427. The replay will be available for 10 business days following the live call.  

Key Graceway Pharmaceutical Products (See Important Safety Information Below)

The following key Graceway pharmaceutical products to be acquired represent in excess of $125 million in annual revenues.³

Dermatology

Aldara^® (imiquimod) Cream, 5% is indicated for: the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults; the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), when surgical methods are medically less appropriate and patient follow-up can be reasonably assured; and the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old or older. The histological diagnosis of sBCC should be established prior to treatment since safety and efficacy of Aldara Cream have not been established for other types of basal cell carcinomas (BCC), including nodular and morpheaform (fibrosing or sclerosing) types. Efficacy was not demonstrated for molluscum contagiosum in children aged 2–12.

Atopiclair^® Nonsteroidal Cream is a nonsteroidal cream indicated to manage and relieve the itching, burning and pain experienced with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis. Atopiclair Nonsteroidal Cream helps to relieve dry, waxy skin by maintaining a moist skin environment which is beneficial to the healing process.

Zyclara™ (imiquimod) Cream, 3.75%and 2.5% are indicated for the topical treatment of clinically typical visible or palpable AK of the full face or balding scalp in immunocompetent adults. Additionally, Zyclara 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older. Efficacy was not demonstrated in molluscum contagiosum in children aged 2-12.  

Respiratory

Maxair^® Autohaler^® (pirbuterol acetate inhalation aerosol) is indicated for the prevention of and reversal of bronchospasm in patients aged 12 years and older with reversible bronchospasm, including asthma. It may be used with or without concurrent theophylline and/or corticosteroid therapy.

Women's Health

Estrasorb^® (estradiol topical emulsion)is indicated for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause.

MetroGel-Vaginal^® (metronidazole vaginal gel) 0.75% Vaginal Gel is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginitis).

Diluted Earnings Per Share

Diluted earnings per share amounts are calculated using the "if-converted" method of accounting regardless of whether the Company's outstanding convertible bonds meet the criteria for conversion and regardless of whether the bondholders actually convert their bonds into shares.

Non-GAAP Diluted Earnings Per Share

Historically, the Company's non-GAAP diluted EPS amounts have been calculated excluding certain items, such as R&D charges which result from payments made to Medicis partners, transaction costs, the impairment of long-lived assets, gains resulting from the sale of subsidiaries, charges related to the accounting for our investment in Revance or Hyperion and litigation reserves.

In this press release, management is providing another financial measure, diluted cash EPS, which excludes amortization, in addition to all of the items identified in the paragraph above.

Use of Non-GAAP Financial Information

The Company provides non-GAAP financial information in this press release. Management measures the Company's performance using non-GAAP financial measures, such as those that are disclosed in this press release, to provide meaningful supplemental information regarding its operational performance and to enhance its investors' overall understanding of its core financial performance. This information facilitates management's internal comparisons to the Company's historical core operating results and competitors' core operating results, and is a basis for financial decision making. Management believes that Medicis' investors benefit from seeing the Company's results on the same basis as management, in addition to the GAAP presentation, where applicable. In our view, non-GAAP financial measures, such as non-GAAP diluted EPS and non-GAAP diluted cash EPS, which are based on non-GAAP net income as defined below, are informative to investors, allowing them to focus on the ongoing operations and core results of Medicis' business. Historically, Medicis has provided similar non-GAAP information to its investors and believes that the use of such numbers provides consistency in the Company's financial disclosures. This information is not in accordance with, or an alternative for, information prepared using GAAP. Non-GAAP net income excludes certain items, such as R&D charges which result from payments made to Medicis partners, transaction costs, amortization (for calculation of diluted cash EPS only), the impairment of long-lived assets, gains resulting from the sale of subsidiaries, charges related to the accounting for our investment in Revance or Hyperion and litigation reserves. These items may have a material effect on the Company's net income and diluted earnings per common share calculated in accordance with GAAP. The Company excludes such charges and the related tax benefits when analyzing its financial results, as the items are distinguishable events or large non-cash expenses related to intangibles. Management believes that, by viewing the Company's results of operations excluding these charges, investors are given an indication of the ongoing results of the Company's operations.

About Medicis

Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. The Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. The Company's products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.

The Company's products include the brands DYSPORT^® (abobotulinumtoxinA) 300 Units for Injection, PERLANE^® Injectable Gel, PERLANE-L^® Injectable Gel with 0.3% Lidocaine, RESTYLANE^® Injectable Gel, RESTYLANE-L^® Injectable Gel with 0.3% Lidocaine, LOPROX^® (ciclopirox) Gel 0.77% and Shampoo 1%, SOLODYN^® (minocycline HCl, USP) Extended Release Tablets, VANOS^® (fluocinonide) Cream, 0.1%, ZIANA^® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL^® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL^® (sodium phenylbutyrate) Tablets and Powder and the over-the-counter brand ESOTERICA^®.

For more information about Medicis, please visit the Company's website at www.Medicis.com. Printed copies of the Company's complete audited financial statements are available free of charge upon request.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act.  All statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements, including, but not limited to:

• the Company's future prospects; 
     
• revenues, gross profit margin, expense, tax rate, cash flows and earnings guidance; 
    
• the contribution of Graceway on-market products and R&D pipeline assets; 
     
• current estimates with respect to projected peak sales, or net sales peak potential, for certain Graceway products; 
     
• the Company's ability to harness synergies in areas such as women's health; 
    
• intellectual property protection for certain Graceway products; 
    
• the Company's opportunities relating to extensions of certain Graceway products; 
    
• the Company's ability to successfully negotiate contracts with managed care organizations and pharmacy benefit managers; 
    
• information regarding business development activities and future regulatory approval of the Company's products; 
    
• the Company's ability to consummate repurchases under its Stock Repurchase Plan due to changes in the Company's stock price, economic or other market conditions or corporate or regulatory requirements; 
    
• the commercial success of the Company's products; 
    
• the patentability of certain intellectual property; 
   
• the potential for generic competition to SOLODYN and other Medicis products; 
    
• the future expansion of the aesthetics market; 
    
• the ability of Solta Medical, Inc. to make payments under the sale agreement for LipoSonix; and 
    
• expectations relating to the Company's product development pipeline. 

These statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. The Company's business is subject to all risk factors outlined in the Company's most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, Annual Report on Form 10-K for the year ended December 31, 2010, and other documents we file with the Securities and Exchange Commission (SEC). At the time of this press release, the Company cannot, among other things, assess the likelihood, timing or forthcoming results of R&D projects, the risks associated with the U.S Food and Drug Administration (FDA) approval process and risks associated with significant competition within the Company's industry, nor can the Company validate its assumptions of the full impact on its business of the approval of competitive generic versions of the Company's primary brands, and any future competitive product approvals that may affect the Company's brands.

Additionally, Medicis may acquire and/or license products or technologies from third parties to enter into new strategic markets. The Company periodically makes up-front, non-refundable payments to third parties for R&D work that has been completed and periodically makes additional non-refundable payments for the achievement of various milestones. There can be no certainty about the periods in which these potential payments could be made, nor if any payments such as these will be made at all. Any estimated future guidance does not include, among other things, the potential payments associated with any such transactions.

There are a number of additional important factors that could cause actual results to differ materially from those projected, including, but not limited to:

• the anticipated size of the markets and demand for the Company's products;
     
• the availability of product supply or changes in the costs of raw materials;
     
• the receipt of required regulatory approvals;
    
• competitive developments affecting our products;
    
• product liability claims;
     
• the introduction of federal and/or state regulations relating to the Company's business;
    
• dependence on sales of key products;
     
• changes in the treatment practices of physicians that currently prescribe the Company's products, including prescription levels;
     
• the uncertainty of future financial results and fluctuations in operating results, and the factors that may attribute to such fluctuations as set forth in our SEC filings;
    
• dependence on the Company's strategy (including the uncertainty of license payments and/or other payments due from third parties);
     
• changes in reimbursement policies of health plans and other health insurers;
    
• changes in levels of managed care rebates, and the associated impact on sales, reserves, profitability and the ASP, for SOLODYN and the Company's other therapeutic brands. The Company engages in negotiations from time to time, as management believes necessary, to enhance the longer-term sustainability of these brands. Such negotiations may result in increased managed care rebates, which may have a negative impact on sales, reserves, profitability and the ASP for affected products.
     
• decreases in revenues associated with the FDA's requirement, effective March 2011, that prescription benzoyl peroxide products that are not approved through a New Drug Application, such as TRIAZ, not be sold as prescription products;
    
• the timing and success of new product development by the Company or third parties;
     
• the inability to secure patent protection from filed patent applications, inadequate protection of the Company's intellectual property or challenges to the validity or enforceability of the Medicis proprietary rights;
     
• the risks of pending and future litigation or government investigations; and
    
• other risks described from time to time in the Company's filings with the SEC.

Forward-looking statements represent the judgment of Medicis management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.

Important Safety Information about DYSPORT (abobotulinumtoxinA) 300 Units for Injection

What is the most important information you should know about DYSPORT?

Spread of Toxin Effects: In some cases, the effects of DYSPORT and all botulinum toxin products may affect areas of the body away from the injection site.  These effects can cause symptoms of a serious condition called botulism.  Symptoms of botulism can happen hours to weeks after injection and may include swallowing and breathing problems, loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, or loss of bladder control.  Swallowing and breathing problems can be life threatening and there have been reports of death.

The risk of symptoms is probably greatest in children and adults treated for muscle spasms, particularly in those patients who have underlying medical conditions that could make these symptoms more likely.

The toxic effects have been reported at doses similar to those used to treat muscle spasms in the neck.  Lower doses, in both approved and unapproved uses, have also caused toxic effects.  This includes treatment of children and adults for muscle spasms.

These effects could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.

Do not have DYSPORT treatment if you: are allergic to DYSPORT or any of its ingredients (see the end of the Medication Guide for a list of ingredients), are allergic to cow's milk protein, had an allergic reaction to any other botulinum toxin product, such as Myobloc^® (rimabotulinumtoxinB) or Botox^® (onabotulinumtoxinA), or have a skin infection at the planned injection site.

The dose of DYSPORT is not the same as the dose of any other botulinum toxin product.  The dose of DYSPORT cannot be compared to the dose of any other botulinum toxin product you may have used.

DYSPORT may not be right for you if: you have surgical changes to your face, very weak muscles in the treatment area, your face looks very different from side to side, the injection site is inflamed, you have droopy eyelids or sagging eyelid folds, deep facial scars, thick oily skin, or if your wrinkles can't be smoothed by spreading them apart.

Tell your doctor about all your medical conditions, including if you have: a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis, or Lambert-Eaton syndrome), allergies to any botulinum toxin product or had any side effect from any botulinum toxin product in the past, a breathing problem (such as asthma or emphysema), swallowing problems, bleeding problems, diabetes, or a slow heart beat or other problem with your heart rate or rhythm, plans to have surgery, had surgery on your face, weakness of your forehead muscles (such as trouble raising your eyebrows), drooping eyelids, or any other change in the way your face normally looks.  Patients with a disease that affects muscles and nerves who are treated with typical doses of DYSPORT may have a higher risk of serious side effects, including severe swallowing and breathing problems.

Human Albumin

This product contains albumin taken from human plasma. Steps taken during donor screening and product manufacturing processes make the risk of spreading viral diseases extremely rare. In theory, there is also an extremely rare risk of contracting Creutzfeldt-Jakob disease (CJD). No cases of spread of viral diseases or CJD have ever been reported for albumin.

Allergic Reaction to Injecting in the Skin

It is not known if an allergic reaction can be caused by injecting DYSPORT into the skin.  The safety of treating excessive sweating with DYSPORT is not known.

Common Side Effects

The most common side effects are nose and throat irritation, headache, injection site pain, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products.  Using DYSPORT with certain other medicines may cause serious side effects.  Do not start any new medicines while taking DYSPORT without talking to your doctor first.

Especially tell your doctor if you: have received any other botulinum toxin product in the last four months, have received injections of botulinum toxin, such as Myobloc or Botox in the past (be sure your doctor knows exactly which product you received), have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine.

Use in Specific Populations

DYSPORT should not be used in children or in women who are pregnant or breastfeeding.

Ask your doctor if DYSPORT is right for you.

Full prescribing information and Medication Guide for DYSPORT is available by contacting the Company or visiting www.Medicis.com.

Important Safety Information about Graceway Products Mentioned in this Release

Aldara:

Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of Aldara Cream and may require an interruption of dosing.

Flu-like signs and symptoms may accompany, or even precede, local inflammatory reactions and may include malaise, fever, nausea, myalgias and rigors.  An interruption of dosing should be considered.

When treating external genital and perianal warts/condyloma, severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling which can lead to urinary retention.  Dosing should be interrupted or discontinued for severe vulvar swelling.

Exposure to sunlight (including sunlamps) should be avoided or minimized because of concern of heightened sunburn susceptibility.  Patients should be advised to use sunscreen and wear protective clothing (e.g., hat) when using Aldara Cream.

Safety and efficacy have not been established for Aldara Cream in the treatment of actinic keratoses with repeated uses, i.e., more than one treatment course in the same area, or in areas of skin greater than 25 cm².

The safety and efficacy of Aldara Cream have not been established for other types of basal cell carcinomas, and is not recommended for treatment of BCC subtypes other than the superficial variant.  The safety and efficacy of treating sBCC lesions on the face, head and anogenital areas has not been established. 

The effect of Aldara Cream on the transmission of external genital warts is unknown.  Aldara Cream may weaken condoms and diaphragms.  Sexual contact should be avoided while the cream is on the skin. New external genital warts may develop during treatment.  Aldara Cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, recta, or intra-anal human papilloma viral disease.

Safety and efficacy in immunocompromised patients has not been established. In clinical studies, the most commonly reported adverse events (incidence >28%) were application site reactions: itching, burning, erythema, flaking/scaling/dryness, scabbing/crusting, edema, induration, excoriation, erosion, ulceration. Other reported reactions (>1%) include fatigue, fever, and headache.

Atopiclair:

The use of Atopiclair Nonsteroidal Cream is contraindicated in any patient with a known history of hypersensitivity to any of the ingredients.  Atopiclair Nonsteroidal Cream does not contain milk, wheat, peanuts, or animal derivatives.  Atopiclair Nonsteroidal Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil).  Patients with a known allergy to nuts or nut oils should consult their physician before using this topical preparation.  For external, topical use only; avoid contact with eyes.

Zyclara:

Intense local skin reactions including skin weeping or erosion can occur after a few applications of Zyclara Cream and may require an interruption of dosing.  Administration of Zyclara Cream is not recommended until the skin is healed from any previous drug or surgical treatment.

Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling.  Severe vulvar swelling can lead to urinary retention; dosing should be interrupted or discontinued.

Flu-like signs and symptoms may accompany, or even precede, local skin reactions and may include fatigue, nausea, fever, myalgias, arthralgias, malaise and chills.

Zyclara Cream is not recommended for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral (HPV) disease, as it has not been studied.  Treatment with Zyclara has not been evaluated for the prevention or transmission of HPV.

The effect of Zyclara Cream on the transmission of genital warts is unknown.  Zyclara Cream may weaken condoms and diaphragms.  Sexual contact should be avoided while the cream is on the skin.

Zyclara Cream should be used with caution in patients with pre-existing autoimmune conditions because imiquimod activates immune cells.  Avoid concomitant use of Zyclara Cream and any other imiquimod cream because of increased risk for adverse events.

Exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) should be avoided or minimized during use of Zyclara Cream. Patients should be advised to wear protective clothing (e.g., hat) when using Zyclara Cream.

In clinical studies for actinic keratosis, the most common adverse events involved skin reactions in the application area including erythema, scabbing/crusting, flaking/scaling/dryness, edema, erosion/ulceration, and exudate.  Most local skin reactions were rated as mild to moderate.

In clinical studies for external genital warts, the most frequently reported adverse reactions were local skin and application site reactions.  These included erythema, edema, erosion/ulceration, and exudate at the genital warts site.  Most local skin reactions were rated as mild to moderate.

Maxair Autohaler:

Maxair Autohaler can produce paradoxical bronchospasm, which can be life threatening.  If paradoxical bronchospasm occurs, Maxair Autohaler should be discontinued immediately and alternative therapy instituted.  It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Maxair Autohaler, like other inhaled beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or other symptoms.  Although such effects are uncommon after administration of Maxair Autohaler at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.  The clinical significance of these findings is unknown. Therefore, Maxair Autohaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients.  Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.

Maxair Autohaler may interact with beta blockers, diuretics, monamine oxidase inhibitors, and tricyclic antidepressants. 

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

Maxair Autohaler is contraindicated in patients with a history of hypersensitivity to pirbuterol or any of its ingredients.

The following adverse reactions were reported more frequently than 1 in 100 patients: nervousness (6.9%), tremor (6.0%), headache (2.0%), dizziness (1.2%), palpitations (1.7%), tachycardia (1.2%), cough (1.2%), and nausea (1.7%).

Estrasorb:

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

Close clinical surveillance of all women taking estrogen is important.  Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.  There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogenic doses.

CARDIOVASCULAR AND OTHER RISKS

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a sub-study of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo.  It is unknown whether this finding applies to younger postmenopausal women.

Other doses of conjugated estrogens with medroxyprogesterone acetate, and other combinations of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar.  Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrasorb should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active deep-vein thrombosis, pulmonary embolism or history of these conditions; active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease.

Estrasorb should not be used in patients with known hypersensitivity to its ingredients; known or suspected pregnancy. There is no indication for Estrasorb in pregnancy.  There appears to be little or no increased risk of birth defects in women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer.  The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12-fold greater than in nonusers, and appears dependent on duration of treatment and on estrogen dose.

The CE/MPA sub-study of WHI reported that estrogen plus progestin increased the risk of ovarian cancer.

A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.

Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases.  If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

Retinal vascular thrombosis has been reported in patients receiving estrogens.  Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine.  If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued.

In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications.

Estrogen administration leads to increased thyroid-binding globulin levels.  Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy.

Estrogens should be used with caution in individuals with severe hypocalcemia.

Estrogens may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in patients with these conditions.

Estrasorb should not be used in close proximity to sunscreen application because estradiol absorption may be increased.

In clinical studies, the most commonly reported adverse events (≥ 4%) were endometrial disorder, infection, breast pain, headache, sinusitis, and pruritus.

MetroGel-Vaginal:

Convulsive seizures and peripheral neuropathy have been reported in patients treated with oral or intravenous metronidazole.  MetroGel-Vaginal therapy should be discontinued if abnormal neurologic signs are present.  MetroGel-Vaginal should be administered with caution to patients with central nervous system diseases.

Psychotic reactions have been reported in alcoholic patients who used oral metronidazole and disulfiram concurrently.  Metronidazole vaginal gel should not be administered to patients who have taken disulfiram within the last two weeks.

Patients with severe hepatic disease metabolize metronidazole slowly resulting in the accumulation of metronidazole and its metabolites in the plasma.  MetroGel-Vaginal should be administered cautiously in these patients.

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time.  The possible drug interaction should be considered when metronidazole vaginal gel is prescribed for patients on this type of anticoagulant therapy.

MetroGel-Vaginal contains ingredients that may cause burning and irritation of the eye.  In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water.

MetroGel-Vaginal is contraindicated in patients with a prior history of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.

In clinical studies, the most common reported adverse events (≥4%) were vaginal discharge (12%), symptomatic Candida cervicitis/vaginitis (10%), vulva/vaginal irritative symptoms (9%), gastrointestinal discomfort (7%), headache (5%), nausea and/or vomiting (4%).

NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. All trademarks are the property of their respective owners.

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¹ The Legacy Strengths of SOLODYN include the 45 mg, 90 mg and 135 mg forms.
² Noah Pines. "Infectious Diseases." Medical Marketing and Media August 2011: 40-41.
³ IMS Health NPA MAT 9/11

            Kara Stancell (media)
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