Key Developments: Horizon Pharma Inc (HZNP.W)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Horizon Pharma Inc Announces Receipt Of Additional U.S. Patent Allowance For DUEXIS
Horizon Pharma Inc announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application Serial No. 13/620,150 entitled Stable Compositions of Famotidine and Ibuprofen with claims that cover DUEXIS (ibuprofen and famotidine) tablets. DUEXIS is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers. Full Article
Horizon Pharma Inc Presents Clinical Data Demonstrating RAYOS (prednisone) Delayed-Release Tablets Reduce Morning Stiffness in Patients With Active Rheumatoid Arthritis
Horizon Pharma Inc announced an additional analysis of data from the pivotal Circadian Administration of Prednisone in Rheumatoid Arthritis-2 (CAPRA- 2) trial demonstrating that patients with active rheumatoid arthritis (RA) treated with its recently approved RAYOS(R) 5 mg (prednisone) delayed-release tablets who met ACR20, DAS28 and HAQ-DI response criteria had a significantly greater reduction in morning stiffness than patients who didn't meet these criteria. Data were presented during the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Washington, D.C. The efficacy of RAYOS in the treatment of RA was assessed in the CAPRA-2 trial, a double-blind, placebo-controlled, randomized, 12-week trial in patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria. Enrolled patients were not currently being treated with corticosteroids and received non-biologic disease-modifying antirheumatic drug (DMARD) therapy for at least 6 months prior to receipt of study medication. Patients were randomized in a 2:1 ratio to treatment with RAYOS 5 mg (n=231) or placebo (n=119) administered at 10 p.m. in addition to their DMARD therapy. Patients ranged in age from 27 to 80 years (median age 57 years) old, were predominantly Caucasian and were predominately (84%) female. Full Article
Horizon Pharma Inc Announces Exercise In Full Of Overallotment Option And Completion of Public Offering Of Common Stock And Warrants To Purchase Common Stock
Horizon Pharma Inc announced the completion of an underwritten public offering of 24,638,750 units, including 3,213,750 units sold pursuant to the full exercise of an overallotment option previously granted to the underwriters (with each unit consisting of one share of its common stock and a warrant to purchase 0.5 of a share of its common stock). All of the securities were offered by Horizon at a combined price to the public of $3.50 per unit. The net proceeds to Horizon from this offering were approximately $81 million. The warrants are exercisable at $4.57 per share and expire five years from the date of issuance. The shares of common stock and warrants are immediately separable and were issued separately. Horizon expects to use the net proceeds from the offering primarily to fund ongoing commercialization activities for DUEXIS(R) and RAYOS(R), as well as for general corporate purposes. Cowen and Company, LLC, JMP Securities LLC and Stifel Nicolaus Weisel acted as joint book-running managers for the offering. Full Article
Horizon Pharma Inc Prices $75 Million Public Offering of Common Stock and Warrants to Purchase Common Stock
Horizon Pharma Inc announced the pricing of an underwritten public offering of 21,425,000 units, with each unit consisting of one share of its common stock and a warrant to purchase 0.5 of a share of its common stock. The shares of common stock and warrants are being offered at a combined price to the public of $3.50 per unit. The gross proceeds to Horizon from this offering are expected to be approximately $75 million, before deducting underwriting discounts and other offering expenses payable by Horizon. The warrants will be exercisable at $4.57 per share and will expire five years from the date of issuance. The shares of common stock and warrants are immediately separable and will be issued separately. Horizon has granted the underwriters a 30-day option to purchase up to an aggregate of 3,213,750 additional shares of common stock and warrants to purchase 1,606,875 shares of common stock to cover overallotments, if any. All of the units in the offering are being sold by Horizon. The offering is expected to close on or about September 25, 2012, subject to customary closing conditions. Horizon expects to use the net proceeds from the offering primarily to fund ongoing commercialization activities for DUEXIS and RAYOS, as well as for general corporate purposes. Cowen and Company, LLC, JMP Securities LLC and Stifel Nicolaus Weisel are acting as joint book-running managers for the offering. Full Article
Horizon Pharma Inc Announces Proposed Public Offering of Common Stock
Horizon Pharma Inc announced that it intends to offer and sell, subject to market and other conditions, units in an underwritten public offering, with each unit consisting of one share of its common stock and a warrant to purchase 0.5 of a share of its common stock. Horizon also expects to grant the underwriters a 30-day option to purchase additional shares of its common stock and warrants to purchase shares of its common stock to cover overallotments, if any. All of the units in the offering are being offered by Horizon. Cowen and Company, LLC, JMP Securities LLC and Stifel Nicolaus Weisel are acting as joint book-running managers for the offering. Full Article
Horizon Pharma Inc Announces FDA Approval of RAYOS
Horizon Pharma Inc announced that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). The FDA approval was supported by data bridging the pharmacokinetics of RAYOS to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with RAYOS experienced a statistically significant improvement in ACR20 response criteria compared to placebo. The CAPRA-1 trial supported the overall safety of RAYOS. Full Article
Covidien PLC's Mallinckrodt Enters Into Co-Promotion Agreement With Horizon Pharma, Inc.
Mallinckrodt, the Pharmaceuticals business of Covidien Plc announced that it has entered into a co-promotion agreement with Horizon Pharma, Inc. to promote DUEXIS (ibuprofen and famotidine). DUEXIS is a single-tablet combination of the non-steroidal anti-inflammatory drug ibuprofen and the histamine H2-receptor antagonist famotidine and is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers. Under the terms of the agreement, Mallinckrodt’s U.S. sales force will sell DUEXIS through December 31, 2014. Horizon and Mallinckrodt have agreed upon physician promotion targets and Mallinckrodt will be compensated for each prescription generated from these targets. The Mallinckrodt sales force is expected to begin promoting DUEXIS to physicians in August 2012. Horizon will continue to record all revenues and remain responsible for DUEXIS manufacturing, supply and regulatory activities. Full Article
Horizon Pharma Inc Files Patent Infringement Lawsuit Against Par Pharmaceutical, Inc. For Filing ANDA Against DUEXIS
Horizon Pharma Inc announced it has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Par Pharmaceutical, Inc. ("Par") and related to an Abbreviated New Drug Application ("ANDA") that Par filed with the U.S. Food and Drug Administration ("FDA") to market a generic version of DUEXIS(R) tablets. The lawsuit claims infringement of Horizon's US patent 8,067,033 that is listed in the FDA's Orange Book and expires July 18, 2026. Horizon received a Paragraph IV Patent Certification from Par on February 15, 2012, advising that Par had filed an ANDA with the FDA for a generic version of DUEXIS(R) tablets. Par alleged that its generic version of DUEXIS(R) tablets would not infringe US patent 8,067,033 or the patent is invalid or unenforceable. Par has not advised Horizon as to the timing or status of the FDA's review of its filing, or whether it has complied with FDA requirements for proving bioequivalence. The defendants in the lawsuit are Par Pharmaceutical, Inc. and its parent Par Pharmaceutical Companies, Inc. Horizon commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Par's ANDA for 30 months or until a district court decision that is adverse to the patent, whichever may occur earlier. Full Article
Horizon Pharma Inc's Subsidiary Enters Into Exclusive Agreement With Mundipharma For Commercialization Of LODOTRA
Horizon Pharma Inc announced that its Swiss subsidiary and Mundipharma International Corporation Limited and Mundipharma Medical Company have amended their exclusive distribution and supply agreements for commercialization of LODOTRA, programmed-release formulation of low-dose prednisone, in Asia to also include Mexico, Brazil, Argentina, Colombia, Venezuela, Peru, Chile, Ecuador, Dominican Republic, Guatemala, Costa Rica, Uruguay, Bolivia, Panama, Nicaragua, El Salvador and Honduras. Full Article
Horizon Pharma Inc And Sanofi Announce FDA Approval Of DUEXIS Commercial Manufacturing Facility
Horizon Pharma Inc and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved the use of the sanofi-aventis Canada Inc. manufacturing site in Laval, Quebec to manufacture DUEXIS, (ibuprofen/famotidine) a single-tablet combination of ibuprofen (800 mg) and famotidine (26.6 mg). DUEXIS was approved by the FDA in April 2011. Sanofi will serve as the primary commercial manufacturer for DUEXIS in the United States. Full Article
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