Key Developments: Theravance Inc (THRX.O)
39.58USD
17 May 2013
$0.05 (+0.11%)
$39.54
$39.46
$39.73
$39.02
810,013
1,527,187
$42.41
$17.06
Latest Key Developments (Source: Significant Developments)
Elan Corporation PLC Strikes $1 Billion GlaxoSmithKline Plc Royalty Deal With Theravance Inc-Reuters
Reuters reported that Elan Corporation PLC stepped up its bid to keep its independence by agreeing a $1 billion deal to buy 21% of the royalty that U.S. company Theravance Inc receives from GlaxoSmithKline Plc for its respiratory drugs. Full Article
FDA Approves Glaxosmithkline Plc's Breo Ellipta To Treat Lung Disease Jointly Developed With Theravance Inc-DJ
Dow Jones reported that the U.S. Food and Drug Administration approved a new drug that will be marketed by GlaxoSmithKline PLC to treat chronic obstructive pulmonary disease, or COPD. The drug, Breo Ellipta, is administered once-daily with an inhaler. The FDA's approval was expected after a federal advisory panel endorsed the product last month. Breo was developed by Theravance Inc. and GlaxoSmithKline. It has the potential to be a successor to Glaxo's Advair, which should be taken twice daily. Breo Ellipta combines the corticosteroid fluticasone with vilanterol, a new active ingredient. The FDA said the product isn't approved to treat asthma. Full Article
US FDA Advisory Panel Backs Glaxosmithkline Plc And Theravance, Inc. Lung Drug-Reuters
Reuters reported that an advisory panel to the U.S. Food and Drug Administration has recommended that the agency approve an experimental treatment for smoking-related lung damage made by GlaxoSmithKline Plc and Theravance Inc. The drug, Breo Ellipta, is a once daily inhaled treatment for chronic obstructive pulmonary disease (COPD), a condition that includes emphysema, chronic bronchitis or both. Breo consists of a corticosteroid, fluticasone furoate, which reduces inflammation and a novel long-acting beta-agonist, or LABA, called vilanterol, which is designed to open the airways. The product is inhaled through a palm-sized device called Ellipta. Full Article
Theravance Inc And Clinigen Group PLC Announces Commercialization Agreement In EU For Antibacterial VIBATIV
Theravance Inc and Clinigen Group PLC announced that they have entered into an exclusive commercialization agreement in the European Union (EU) and certain other countries located in Europe for VIBATIV (telavancin) for the treatment of nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibacterial agent with a dual mechanism of action against Gram-positive bacteria, including resistant pathogens such as MRSA. Under the terms of the agreement, Theravance has granted Clinigen exclusive commercialization rights to VIBATIV in the EU and certain other European countries (including Switzerland and Norway). In exchange, Theravance will receive a $5 million upfront payment from Clinigen and is entitled to receive tiered royalties on net sales of VIBATIV, ranging from 20% to 30%. The agreement has a term of at least 15 years, with an option to extend exercisable by Clinigen. Full Article
Glaxosmithkline Plc and Theravance Inc Announce FDA Acceptance Of New Drug Application Submission In US For ANORO ELLIPTA For COPD
Glaxosmithkline Plc and Theravance, Inc. announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as 18 December 2013. Full Article
Theravance Inc Announces Closing of Public Offering of $287.5 Million of Convertible Subordinated Notes
Theravance Inc announced that it closed the sale of its previously announced underwritten public offering of $287.5 million aggregate principal amount of its 2.125% convertible subordinated notes due 2023 (the notes), which includes the underwriters' full exercise of their option to purchase an additional $37.5 million aggregate principal amount of the notes. BofA Merrill Lynch acted as the sole book-running manager for the offering. In connection with the offering of the notes, the Company entered into privately-negotiated capped call option transactions. The aggregate cost of the capped call options was $36.8 million. In addition to paying for the cost of entering into the capped call option transactions, the Company intends to use the net proceeds of the offering for potential milestone payments to GlaxoSmithKline plc if there is any approval or launch of products under the parties' long-acting beta2 agonist (LABA) collaboration, including RELVAR or BREO (fluticasone furoate/vilanterol), ANORO (umeclidinium bromide/vilanterol), or vilanterol, for the potential repayment of debt, and for other general corporate purposes. Full Article
Theravance Inc Announces Pricing Of Convertible Subordinated Notes Offering
Theravance Inc announced the pricing of $250 million aggregate principal amount of 2.125% convertible subordinated notes due 2023 in an underwritten public offering. The Company has also granted the underwriters an option to purchase up to $37.5 million aggregate principal amount of additional notes. The offering is scheduled to close on January 24, 2013. BofA Merrill Lynch is acting as the sole book-running manager for the offering. The notes will pay interest semiannually at a rate of 2.125% per annum. The notes will be convertible at the option of the holders, at any time on or prior to the second business day preceding the maturity date, into shares of the Company's common stock at an initial conversion rate of 35.9903 shares of common stock per $1,000 principal amount of notes, which is equivalent to an initial conversion price of approximately $27.79 per share. The initial conversion price represents a conversion premium of approximately 32.5% over the last reported sale price of $20.97 per share of the Company's common stock on the NASDAQ Global Select Market on January 17, 2013. The Company intends to use the net proceeds of the offering for potential milestone payments to GlaxoSmithKline plc if there is any approval or launch of products under the parties' long-acting beta2 agonist collaboration, including RELVAR or BREO, ANORO, or vilanterol, for the potential repayment of debt, and for other general corporate purposes. Full Article
GlaxoSmithKline plc and Theravance Inc Announces Regulatory Submission for UMEC/VI (LAMA/LABA) In US
GlaxoSmithKline plc (GSK) and Theravance Inc announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD). UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA(TM) inhaler. A New Drug Application (NDA) for UMEC/VI (62.5/25mcg and 125/25mcg doses) with the proposed proprietary name ANORO ELLIPTA(TM) has been submitted to the US Food and Drug Administration (FDA), for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. Full Article
Theravance Inc Announces Initiation Of Phase 2b Study With LAMA Candidate, TD-4208, For Treatment Of COPD
Theravance Inc announced the initiation of a dose ranging Phase 2b study with TD-4208 as a nebulized aqueous solution in patients with moderate to severe COPD. TD-4208 is an investigational inhaled long-acting muscarinic antagonist (LAMA), discovered using Theravance's multivalent approach to drug design. This compound is under development by Theravance for the treatment of chronic obstructive pulmonary disease (COPD). The Phase 2b study will evaluate the bronchodilatory effect, pharmacokinetics, safety and tolerability of multiple doses of TD-4208 in patients with COPD. Approximately 60 patients will be randomized to receive four of six doses of TD-4208 (22 mcg, 44 mcg, 88 mcg, 175 mcg, 350 mcg or 700 mcg) and placebo once daily via a nebulizer during five 7-day study periods in an incomplete crossover study design. The primary endpoint of the study is trough forced expiratory volume in one second (FEV1) after the seventh dose of each treatment period. Secondary endpoints include measurements of FEV1: Peak and area under the curve from to 24 hours (AUC0-24), AUC0-12, and AUC12-24 after the seventh dose of each treatment period. Full Article
Theravance Inc Announces Initiation of Phase 2 Study With TD-9855 for the Treatment of Fibromyalgia
Theravance Inc announced today the initiation of a fibromyalgia Phase 2 study with TD-9855, the lead compound in Theravance's Monoamine Reuptake Inhibitor program. TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor (NSRI) for the treatment of central nervous system (CNS) conditions such as chronic pain and Attention-Deficit/Hyperactivity Disorder (ADHD). This Phase 2 proof-of-concept study will evaluate the safety and efficacy of two doses of TD-9855 in patients with fibromyalgia. Approximately 375 patients will be randomized to TD-9855 or placebo. Study medication will be administered once-daily for up to 9 weeks. The primary endpoint of the study is improvement in pain. Additional secondary or exploratory endpoints will assess improvement in other established fibromyalgia measures and impact on important comorbidities, such as fatigue. TD-9855 is an investigational NSRI discovered by Theravance for the treatment of CNS conditions such as chronic pain and ADHD. TD-9855 has been administered to healthy volunteers in ascending single- and multiple-dose studies evaluating safety, tolerability and pharmacokinetics. Full Article
Elan's $1 billion drug royalty deal aids bid defense
DUBLIN - Irish drugmaker Elan Corporation has agreed a $1 billion royalties deal that could soothe concerns about its potentially risky acquisition strategy and fend off a takeover bid from Royalty Pharma.
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