-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KTixyVbVJurxOIksp4Nxs5wPe/T7+p20bj0mzYZFFXyK8D88S9WJvHz/yXHWxMbQ Fr+AtDvJOp+6xExaOI0P6w== 0000950153-06-000792.txt : 20060324 0000950153-06-000792.hdr.sgml : 20060324 20060324140846 ACCESSION NUMBER: 0000950153-06-000792 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060317 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060324 DATE AS OF CHANGE: 20060324 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICIS PHARMACEUTICAL CORP CENTRAL INDEX KEY: 0000859368 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 521574808 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14471 FILM NUMBER: 06708485 BUSINESS ADDRESS: STREET 1: 8125 NORTH HAYDEN ROAD CITY: SCOTTSDALE STATE: AZ ZIP: 85258 BUSINESS PHONE: 2125992000 MAIL ADDRESS: STREET 1: 8125 NORTH HAYDEN ROAD CITY: SCOTTSDALE STATE: AZ ZIP: 85258 8-K 1 p72061e8vk.htm 8-K e8vk
Table of Contents

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 17, 2006
Medicis Pharmaceutical Corporation
(Exact name of registrant as specified in its charter)
         
Delaware   0-18443   52-1574808
         
(State of Incorporation)   (Commission File Number)   (IRS Employer
Identification Number)
8125 North Hayden Road
Scottsdale, Arizona 85258-2463

(Address of principal executive offices) (Zip Code)
(602) 808-8800
(Registrant’s telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 1.01 Entry into a Material Definitive Agreement.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
Exhibit Index
EX-99.1


Table of Contents

Item 1.01 Entry into a Material Definitive Agreement.
     On March 20, 2006, Medicis Pharmaceutical Corporation (“Medicis”) announced the effectiveness of a Development & Distribution Agreement (“DDA”) between Aesthetica Ltd. (“Aesthetica”), a wholly owned subsidiary of Medicis, and Ipsen Ltd. (“Ipsen”), an affiliate of Ipsen S.A. The DDA is dated as of March 17, 2006. Pursuant to the DDA, Ipsen has granted Aesthetica rights to develop, distribute and commercialize Ipsen’s botulinum toxin product (the “Product”) in the United States, Canada and Japan (the “Territory”) for aesthetic use by physicians. The Product is commonly referred to as Reloxin® in the United States aesthetic market and Dysport® for medical and aesthetic uses outside the United States. The Product is not currently approved for use in the United States.
     Pursuant to the terms of the DDA, Aesthetica paid Ipsen $90.1 million in consideration for the exclusive distribution rights in the Territory and has agreed to pay an additional $26.5 million upon successful completion of various clinical and regulatory milestones, $75.0 million upon the Product’s approval by the U.S. Food and Drug Administration (“FDA”) and $2.0 million upon regulatory approval of the Product in Japan, amounting to a total of $193.6 million. Ipsen will manufacture and provide the Product for Aesthetica for the term of the DDA. Ipsen will receive a royalty based on sales and a supply price, the total of which is equivalent to approximately 30% of net sales as defined under the DDA, provided that Ipsen will be entitled to receive specified minimum royalties which vary depending upon the applicable country within the Territory. Aesthetica will be responsible for all remaining research and development costs associated with obtaining the Product’s approval in the Territory. Pursuant to a guarantee agreement, Medicis has guaranteed all of Aesthetica’s obligations to Ipsen under the DDA. The initial term of the DDA expires on September 28, 2019. The DDA may be terminated prior to the end of the initial term under certain circumstances.
     In connection with the DDA, Aesthetica and Ipsen entered into a Trademark Assignment Agreement, pursuant to which Ipsen assigned its rights in the Reloxin® trademark throughout the world to Aesthetica. Aesthetica and Ipsen also entered into a Trademark License Agreement, pursuant to which Aesthetica exclusively licensed the Reloxin® trademark to Ipsen for use in connection with the manufacture, promotion and distribution of formulations of botulinum toxins in certain territories.
     Additionally, Aesthetica and Ipsen have agreed to negotiate and enter into an agreement relating to the exclusive distribution and development rights of the Product for the aesthetic market in Europe, and subsequently in certain other markets (the “International Agreement”). Under the International Agreement, Aesthetica would pay upfront and other milestone payments linked to the development and approval of the Product as well as royalties based on net sales. Ipsen would manufacture and supply the Product to Aesthetica. The terms of the International Agreement will be disclosed after its execution, which is expected to occur on or before April 15, 2006. If the International Agreement is not entered into by April 16, 2006, Aesthetica will be obligated to make an additional payment to Ipsen in connection with the DDA.

 


Table of Contents

Item 9.01 Financial Statements and Exhibits.
  (d)   Exhibits
  99.1   Text of press release dated March 20, 2006.

 


Table of Contents

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
     
Date: March 24, 2006  By:   /s/ Mark A. Prygocki, Sr.    
    Mark A. Prygocki, Sr.   
    Executive Vice President, Chief Financial Officer, Corporate Secretary and Treasurer   
 

 


Table of Contents

Exhibit Index
     
Exhibit Number   Description
99.1
  Text of press release dated March 20, 2006

 

EX-99.1 2 p72061exv99w1.htm EX-99.1 exv99w1
 

Exhibit 99.1
(MEDICIS LOGO)   (IPSEN LOGO)
CONTACTS:
Medicis
Medicis, Kara Stancell, Investor Relations & Corporate Communications, (602) 808-3854
Ipsen
Didier Véron, Director of Public Affairs and Corporate Communications
Tel.: +33 (0)1 44 30 42 38 — Fax: +33 (0)1 44 30 42 04
e-mail: didier.veron@ipsen.com
www.ipsen.com
RELOXIN® AGREEMENT BETWEEN IPSEN AND MEDICIS BECOMES EFFECTIVE
CONFERENCE CALL SCHEDULED WEDNESDAY, MARCH 22,
AT 11:15 A.M. ET/4:15 P.M. GMT
PARIS (France) and SCOTTSDALE, Arizona (USA)March 20, 2006—Ipsen (Eurolist by Euronext™: IPN FP) and Medicis (NYSE:MRX) today announced that the agreement whereby Ipsen Ltd, a wholly owned subsidiary of Ipsen (“Ipsen”), grants Aesthetica Ltd, a wholly owned subsidiary of Medicis (“Medicis”), rights to develop, distribute and commercialize Ipsen’s botulinum toxin product in the United States, Canada and Japan for aesthetic use by physicians is now effective. The product is commonly referred to as Reloxin® in the U.S. aesthetic market and Dysport® for medical and aesthetic markets outside the U.S. The product is not currently approved for use in the U.S. Ipsen has recovered its rights to Reloxin® at the time of this announcement.
Medicis has paid to Ipsen $90.1 million in consideration for the exclusive distribution rights in the United States, Canada and Japan and has agreed to pay an additional $26.5 million upon successful completion of various clinical and regulatory milestones, $75.0 million upon the product’s approval by the U.S. Food and Drug Administration and $2.0 million upon regulatory approval of the product in Japan, amounting to a total of $193.6 million. Ipsen will manufacture and provide the product for Medicis for the term of the agreement, which extends to September of 2019. Ipsen will receive a royalty based on sales and a supply price, the total of which is equivalent to approximately 30% of net sales as defined under the Agreement. Medicis will be responsible for all remaining research and development costs associated with obtaining the product’s approval in the territory.
Additionally, Medicis and Ipsen have agreed to negotiate and enter into an agreement relating to the exclusive distribution and development rights of the product for the aesthetic market in Europe, and subsequently in certain other markets. Under this agreement, Medicis would pay upfront and other milestone payments linked to the development and approval of Ipsen’s botulinum toxin Type A product in aesthetic indications as well as royalties based on net sales. Ipsen would manufacture and supply the product to Medicis. The terms of this agreement will be disclosed after its execution, which is expected to occur on or before April 15, 2006. If this agreement is not entered into by April 15, 2006, Medicis will be obligated to make an additional payment to Ipsen in connection with the USA, Canada and Japan agreement.

 


 

(MEDICIS LOGO)   (IPSEN LOGO)
“We are very pleased to entrust the development and distribution of Reloxin® to a leading expert of the aesthetic field such as Medicis,” said Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen. “We were looking for a partner who could optimize time to market for Reloxin®, with a quality complementary product offering and a strong presence in the USA. Medicis, with its world leading RESTYLANE® dermal filler, its leading sales force and image with both dermatologists and plastic surgeons and its previous knowledge of Reloxin®, is our preferred partner in order to maximize the penetration of Reloxin® in the US market. Our combined products will offer a very compelling alternative to practitioners in the aesthetic medicine field.”
“We are very pleased to have reached this agreement with Ipsen on terms favorable to both organizations,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “We continue to be very impressed with the sophisticated development and manufacturing programs established by Ipsen and the clinical outcomes resulting from Ipsen’s efforts to date. We are enthusiastic about having the opportunity to partner with Ipsen on this late-stage development product with a sizeable commercial potential. We stand ready to deploy the necessary resources to bring this product to the U.S. market and maximize its opportunity in one of the largest segments in the aesthetic market. We have recognized for some time the value of supplying physicians through our leading sales force Ipsen’s botulinum toxin product and the world’s leading dermal filler RESTYLANE®, and we are very pleased that it has finally become a reality.”
Conference Call
Medicis and Ipsen will host a conference call on Wednesday, March 22, at 11:15 a.m. Eastern Time (4:15 p.m. Greenwich Mean Time) to discuss today’s announcement. A live webcast will be available at http://www.medicis.com and http://www.ipsen.com. The webcast will be archived on the Medicis and Ipsen websites for two business days following the live call.
Those participating by telephone 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) 567-5763 (U.S. and Canada) or +1 (706) 679-4760 (international and local). No access code is necessary for the live call. For investors unable to participate in the live call, a replay will be available soon after the live call. The phone number to access the replay is +1 (800) 642-1687 (U.S. and Canada) or +1 (706) 645-9291 (international and local). The access code for the replay is 6792339. The replay will be available for two business days following the live call.
About Ipsen’s botulinum toxin Type A
Ipsen’s botulinum toxin Type A, developed in the field of aesthetic medicine in the USA, Canada and Japan under the trademark Reloxin® is also approved for aesthetic indications in 17 countries: Argentina, Australia, Belarus, Brazil, Columbia, Honduras, Israël, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak Republic, Ukrania, Uruguay, Vietnam, and Russia (in Russia, it is the first botulinum toxin Type A approved in this field). Ipsen is also pursuing regulatory approval for medicine indications for the product in certain additional key international markets.

 


 

(MEDICIS LOGO)   (IPSEN LOGO)
Under the trademark Dysport®, Ipsen’s botulinum toxin Type A also acts as a curariform (immobilises muscles), which was initially developed for the treatment of motor disorders and various forms of muscular spasticity, including cervical dystonia (a chronic condition in which the neck is twisted or deviated), spasticity of the lower limbs in children with cerebral palsy, blepharospasm (involuntary eye closure) and hemifacial spasm. It was later developed for the treatment of a wide variety of neuromuscular disorders. Dysport® was originally launched in the United Kingdom in 1991. Dysport® has marketing authorisations in 73 countries.
About Medicis
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and podiatric conditions and aesthetics medicine. 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 categories, including acne, eczema, fungal infections, psoriasis, rosacea, seborrheic dermatitis and skin and skin-structure infections. 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 prescription brands RESTYLANE®, DYNACIN® (minocycline HCl), LOPROX® (ciclopirox), OMNICEF® (cefdinir), PLEXION® (sodium sulfacetamide/sulfur), TRIAZ® (benzoyl peroxide), LIDEX® (fluocinonide) Cream, 0.05%, VANOS™ (fluocinonide) Cream, 0.1%, and SYNALAR® (fluocinolone acetonide), BUPHENYL® (sodium phenylbutyrate) and AMMONUL® (sodium phenylacetate/sodium benzoate), prescription products indicated in the treatment of Urea Cycle Disorder, and the over-the-counter brand ESOTERICA®.
About Ipsen
Ipsen is a European pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company’s development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders), which are growth drivers and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four R&D centres (Paris, Boston, Barcelona, London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2005, Research and Development expenditure reached 169.0 million, i.e. 20.9% of consolidated sales, which amounted to 807.1 million in the Group’s pro forma accounts set up according to the IFRS. Nearly 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen’s shares are traded on Segment A of Eurolist by EuronextTM (stock code: IPN, ISIN code: FR0010259150).
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the 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 the expected benefits of Medicis’ agreement with Ipsen, the payment of certain milestone payments to Ipsen and the entry by Medicis and Ipsen into a European distribution agreement relating to Ipsen’s

 


 

(MEDICIS LOGO)   (IPSEN LOGO)
botulinum toxin product. 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 annual report on Form 10-K and other documents we file with the Securities and Exchange Commission. At the time of this press release, the Company cannot, among other things, assess the likelihood, timing or forthcoming results of research and development projects and the risks associated with the FDA approval process, 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 core brands, in particular, the recent approval of a generic LOPROX® Cream and LOPROX® TS, or a substitutable DYNACIN® Tablet form, and any future competitive product approvals that may affect the Company’s brands. Additionally, Medicis may acquire and/or license rights, products or technologies, including rights with respect to Ipsen’s botulinum toxin product, from third parties to enter into new strategic markets. The Company periodically makes up-front, non-refundable payments to third parties for research and development work, which has been completed and periodically makes additional non-refundable payments for the achievement of various milestones. There can be no certainty in which periods 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 the potential payments associated with any such transactions. Also, there are a number of additional important factors that could cause actual results to differ materially from those projected, including the anticipated size of the markets for Medicis’ products, the availability of product supply and the receipt of required regulatory approvals; the risks and uncertainties normally incident to the pharmaceutical and medical device industries including product liability claims, the introduction of federal and/or state regulations relating to the Company’s business, dependence on sales of key products, the uncertainty of future financial results and fluctuations in operating results, dependence on Medicis’ strategy including the uncertainty of license payments and/or other payments due from third parties, the timing and success of new product development by Medicis or third parties, competitive product introductions, the risks of pending and future litigation or government investigations and other risks described from time to time in Medicis’ SEC filings including its Annual Report on Form 10-K for the year ended June 30, 2005, and other documents we file with the Securities and Exchange Commission. 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.
The forward-looking statements and targets contained herein are based on Ipsen’s management’s current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein, including risks related to regulatory approvals and competitive factors. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based unless so required by applicable law.

 


 

(MEDICIS LOGO)   (IPSEN LOGO)
Ipsen’s business is subject to the risk factors outlined in its most recent information document filed with the French Autorité des marchés financiers (dated 21 November 2005) and any other documents filed with the French Autorité des marchés financiers.
NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company. OMNICEF® is a registered trademark of Abbott Laboratories, Inc. under a license from Fujisawa Pharmaceutical Co., Ltd. RESTYLANE® is a registered trademark of HA North American Sales AB, a subsidiary of Medicis Pharmaceutical Corporation. Dysport® is a registered trademark of Ipsen. Reloxin® will, under the agreement, be the registered trademark of Medicis. All other marks (or brands) and names are the property of Medicis or its Affiliates.
# # #

 

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-----END PRIVACY-ENHANCED MESSAGE-----