SCOTTSDALE, Ariz., Nov 18, 2011 (GlobeNewswire via COMTEX) -- Medicis MRX -0.06% today announced that it was the successful bidder at a bankruptcy auction conducted by Graceway Pharmaceuticals, LLC (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.
Under the terms of its bid, Medicis will pay to Graceway a purchase price of $455 million. In turn, Medicis will receive Graceway's commercial pharmaceutical product portfolio, which includes prescription products in the dermatology, respiratory and women's health specialties, and certain other assets. Medicis will add to its research and development 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 will have the opportunity to launch two recently approved line extensions for the Zyclara(TM) franchise, which has several applied-for patents currently under accelerated examination in the U.S. and related patent protection in Canada already obtained.
The transaction is subject to approval by Graceway's board of directors and execution of a definitive asset purchase agreement, which will include customary closing conditions, including clearance under the Hart-Scott-Rodino Act and final approval by the bankruptcy court. While Medicis expects the transaction to be accretive in 2012, the Company anticipates updating financial guidance upon closing.
"We are pleased to announce this strategic acquisition of the Graceway product portfolio, and the ability to broaden our presence within dermatology," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "We anticipate near-term positive cash flow as we market certain newly acquired Graceway products which are currently approved for various dermatological and women's health conditions. Additionally, we are very pleased to be adding to our pipeline several mid- and late-stage products with a combined annual net sales peak potential of over $500 million in the dermatology and women's health categories."
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.1
Dermatology
Aldara(R) (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.
Atopiclair(R) 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.
Zyclara(TM) (imiquimod) Cream, 3.75% and 2.5% are indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older. Additionally, Zyclara 3.75% is indicated for the topical treatment of clinically typical visible or palpable, AK of the full face or balding scalp in immunocompetent adults.
Respiratory
Maxair(R) Autohaler(R) (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.
Women's Health
Estrasorb(R) (estradiol topical emulsion) is indicated for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
MetroGel-Vaginal(R) (metronidazole vaginal gel) 0.75% Vaginal Gel is indicated in the treatment of bacterial vaginosis.
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(R) (abobotulinumtoxinA) 300 Units for Injection, PERLANE(R) Injectable Gel, PERLANE-L(R) Injectable Gel with 0.3% Lidocaine, RESTYLANE(R) Injectable Gel, RESTYLANE-L(R) Injectable Gel with 0.3% Lidocaine, LOPROX(R) (ciclopirox) Gel 0.77% and Shampoo 1%, SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, VANOS(R) (fluocinonide) Cream, 0.1%, ZIANA(R) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL(R) (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL(R) (sodium phenylbutyrate) Tablets and Powder and the over-the-counter brand ESOTERICA(R).
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.
Under the terms of its bid, Medicis will pay to Graceway a purchase price of $455 million. In turn, Medicis will receive Graceway's commercial pharmaceutical product portfolio, which includes prescription products in the dermatology, respiratory and women's health specialties, and certain other assets. Medicis will add to its research and development 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 will have the opportunity to launch two recently approved line extensions for the Zyclara(TM) franchise, which has several applied-for patents currently under accelerated examination in the U.S. and related patent protection in Canada already obtained.
The transaction is subject to approval by Graceway's board of directors and execution of a definitive asset purchase agreement, which will include customary closing conditions, including clearance under the Hart-Scott-Rodino Act and final approval by the bankruptcy court. While Medicis expects the transaction to be accretive in 2012, the Company anticipates updating financial guidance upon closing.
"We are pleased to announce this strategic acquisition of the Graceway product portfolio, and the ability to broaden our presence within dermatology," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "We anticipate near-term positive cash flow as we market certain newly acquired Graceway products which are currently approved for various dermatological and women's health conditions. Additionally, we are very pleased to be adding to our pipeline several mid- and late-stage products with a combined annual net sales peak potential of over $500 million in the dermatology and women's health categories."
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.1
Dermatology
Aldara(R) (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.
Atopiclair(R) 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.
Zyclara(TM) (imiquimod) Cream, 3.75% and 2.5% are indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older. Additionally, Zyclara 3.75% is indicated for the topical treatment of clinically typical visible or palpable, AK of the full face or balding scalp in immunocompetent adults.
Respiratory
Maxair(R) Autohaler(R) (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.
Women's Health
Estrasorb(R) (estradiol topical emulsion) is indicated for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
MetroGel-Vaginal(R) (metronidazole vaginal gel) 0.75% Vaginal Gel is indicated in the treatment of bacterial vaginosis.
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(R) (abobotulinumtoxinA) 300 Units for Injection, PERLANE(R) Injectable Gel, PERLANE-L(R) Injectable Gel with 0.3% Lidocaine, RESTYLANE(R) Injectable Gel, RESTYLANE-L(R) Injectable Gel with 0.3% Lidocaine, LOPROX(R) (ciclopirox) Gel 0.77% and Shampoo 1%, SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, VANOS(R) (fluocinonide) Cream, 0.1%, ZIANA(R) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL(R) (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL(R) (sodium phenylbutyrate) Tablets and Powder and the over-the-counter brand ESOTERICA(R).
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.