Key Developments: Mylan Inc (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Mylan Inc Reaffirms FY 2013 EPS Guidance
7:30am EDT 

Mylan Inc announced that it is its reaffirming fiscal 2013 adjusted diluted EPS guidance range of $2.75-$2.95 per share. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report EPS of $2.87 for fiscal 2013.  Full Article

Mylan Inc's Subsidiary Announces TARCEVA Settlement Agreement
Wednesday, 24 Jul 2013 07:30am EDT 

Mylan Inc announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a settlement agreement with OSI, Pfizer and Genentech that will resolve patent litigation related to Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg. This product is the generic version of TARCEVA, and is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission.  Full Article

Mylan Inc Announces Judgment To Infringe Mylan Patent For Perforomist Inhalation Solution
Thursday, 18 Jul 2013 07:30am EDT 

Mylan Inc. announced that the United States District Court for the Northern District of West Virginia has granted Mylan's motion for partial summary judgment finding that the production and marketing of Teva's generic version of Mylan's Perforomist Inhalation Solution infringes one of Mylan's Orange Book listed patents (U.S. Patent No. 6,667,344) on Perforomist. Teva's abbreviated new drug application (ANDA) for a generic Perforomist has not yet been granted tentative or final approval by the U.S. Food and Drug Administration.  Full Article

Mylan Inc Confirms First-To-File Patent Challenge Relating To Vimpat
Monday, 15 Jul 2013 07:30am EDT 

Mylan Inc announced that the Company has been sued by UCB, Inc., UCB Pharma GMBH, Research Corporation Technologies, Inc. and Harris FRC Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. This product is the generic version of Vimpat, which is approved as an adjunctive therapy to treat partial-onset seizures of people diagnosed with epilepsy aged 17 years and older. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs have filed a lawsuit against Mylan and several other ANDA filers in the United States District Court for the District of Delaware.  Full Article

U.S. District Court Issues Final Judgment in Favor of Mylan Inc in Patent Infringement Litigation Against Sunovion's Brovana Product
Monday, 8 Jul 2013 09:49am EDT 

Mylan Inc announced that the U.S. District Court for the Southern District of New York has issued a Final Judgment and Order following a ruling by the Court of Appeals for the Federal Circuit in favor of Mylan Specialty L.P., f/k/a Dey Pharma, L.P. The Order states that five of Mylan's patents related to its Perforomist Inhalation Solution are valid and enforceable. Further, the Order states that Sunovion's Brovana product infringes each of those patents. Mylan previously announced a settlement agreement with Sunovion resolving the litigation relating to Sunovion's Brovana product. In May 2012, the U.S. District Court for the Southern District of New York issued a Final Judgment and Order stating that Sunovion has acknowledged that two Mylan patents related to its Perforomist Inhalation Solution are valid, enforceable and infringed by Sunovion's Brovana product. As a result of the two Court Orders, all seven Mylan patents relating to Perforomist have been upheld as valid and enforceable and infringed by Sunovion's Brovana product.  Full Article

Mylan Inc Issues Senior Notes-Form 8-K
Thursday, 27 Jun 2013 05:19pm EDT 

Mylan Inc reported in its Form 8-K that Mylan Inc. (Company) entered into an indenture, dated as of June 25, 2013, among the Company, the guarantors named therein and The Bank of New York Mellon, as trustee, which governs the terms of the Company’s $500 million aggregate principal amount of 1.800% Senior Notes due 2016 and the $650 million aggregate principal amount of 2.600% senior notes due 2018. The 2016 Notes bear interest at a rate of 1.800% per annum, accruing from June 25, 2013. Interest on the 2016 Notes is payable semi-annually in arrears on June 24 and December 24 of each year, beginning on December 24, 2013. The 2016 Notes will mature on June 24, 2016. The 2018 Notes bear interest at a rate of 2.600% per annum, accruing from June 25, 2013. Interest on the 2018 Notes is payable semi-annually in arrears on June 24 and December 24 of each year, beginning on December 24, 2013. The 2018 Notes will mature on June 24, 2018, subject to earlier repurchase or redemption in accordance with the terms of the Indenture. The Company used the net proceeds of the offering of the Notes to repay all of its outstanding $1.13 billion in U.S. Term Loans pursuant to the terms of the credit agreement, dated November 14, 2011 and amended December 7, 2012, among the Company, certain lenders and Bank of America, N.A., as administrative agent. The Company expects to use any incremental proceeds from the offering of the Notes for general corporate purposes.  Full Article

Mylan Inc Reaffirms FY 2013 EPS Guidance
Thursday, 2 May 2013 04:06pm EDT 

Mylan Inc announced that it remains very confident in outlook for business in fiscal 2013 and are reaffirmed fiscal 2013 guidance, including adjusted diluted EPS guidance range of $2.75 to $2.95. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report EPS of $2.87 for fiscal 2013.  Full Article

Mylan Inc's Mylan Pharmaceuticals Launches Generic Version of Zovirax Ointment
Wednesday, 3 Apr 2013 03:01pm EDT 

announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acyclovir Ointment USP, 5%. This product is the first generic version of Valeant International's Zovirax Ointment, which is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. Acyclovir Ointment USP, 5% had U.S. sales of approximately $230 million for the 12 months ending Dec. 31, 2012, according to IMS Health. Mylan is shipping this product immediately.  Full Article

Mylan Inc's Mylan Specialty L.P Launches Generic Version of Xopenex Inhalation Solution
Monday, 18 Mar 2013 11:04am EDT 

Mylan Inc announced that its subsidiary Mylan Specialty L.P. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL (0.0103%), 0.63 mg/3 mL (0.021%), and 1.25 mg/3 mL (0.042%), (Concentrate). This product is the generic version of Sunovion's Xopenex Inhalation Solution, which is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children six years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL, 0.63 mg/3 mL, and 1.25 mg/3 mL, had U.S. sales of approximately $438.8 million for the 12 months ending Dec. 31, 2012, according to IMS Health. Mylan has begun shipping this product.  Full Article

Mylan Inc Issues Q1 2013 EPS Guidance Below Analysts' Estimates; Reaffirms FY 2013 Revenue And EPS Guidance-Conference Call
Wednesday, 13 Mar 2013 12:00pm EDT 

Mylan Inc announced that for first quarter of 2013, it expects earnings per share (EPS) in the range of $0.60-$0.62. For fiscal 2013, it expects revenue to be in the range of $7 billion to $7.4 billion and earnings per share (EPS) in the range of $2.75 to $2.95. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report EPS of $0.63 for first quarter of 2013; revenue of $7.2 billion and EPS of $2.86 for fiscal 2013.  Full Article

Mylan earnings rise, but dollar drags on revenue

- Generic drugmaker Mylan Inc reported a quarterly profit that edged past Wall Street expectations but said weakness of the Indian and Japanese currencies against the dollar would put 2013 revenue at the low end of its forecast range of $7 billion to $7.4 billion.

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