first_imgMylan Technologies Inc,Mylan Inc (Nasdaq: MYL) today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day. This product is the generic version of Vivelle-Dot®, which is indicated for the treatment of symptoms associated with menopause, the treatment of hypoestrogenism and the prevention of postmenopausal osteoporosis. Mylan has a plant in St Albans which manufactures Transdermal patches and pharmaceutical labels.Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for all strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for the Southern District of New York and the U.S. District Court for the District of Vermont.Vivelle-Dot had U.S. sales of approximately $215 million for the 12 months ending Dec. 31, 2010, according to IMS Health. Currently, Mylan has 169 ANDAs pending FDA approval representing $97.9 billion in annual sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $24.8 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.This press release includes statements that constitute “forward-looking statements,” including with regard to the expected first-to-file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company’s filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com(link is external). For more information about generic drugs, please visitwww.ChoosingGenerics.com(link is external).SOURCE Mylan Inc. PITTSBURGH, March 1, 2011 /PRNewswire/last_img read more

first_imgStory Highlights Prime Minister Andrew Holness and U.S. Secretary of the Treasury Steven T. Mnuchin today signed an Energy Framework to foster cooperation on energy and infrastructure investment in Jamaica. Prime Minister Holness and Secretary Mnuchin signed the Framework to Strengthen Infrastructure Investment and Energy Cooperation at the U.S. Department of the Treasury. The Framework is part of a U.S. initiative called America Crece, or the Americas Grow.center_img Prime Minister Andrew Holness and U.S. Secretary of the Treasury Steven T. Mnuchin today signed an Energy Framework to foster cooperation on energy and infrastructure investment in Jamaica.Prime Minister Holness and Secretary Mnuchin signed the Framework to Strengthen Infrastructure Investment and Energy Cooperation at the U.S. Department of the Treasury. The Framework is part of a U.S. initiative called America Crece, or the Americas Grow.In that regard, Prime Minister Holness expressed gratitude to the US Treasury Department for its support.“Thank you to the Treasury Department for your strong support in assisting Jamaica in doing what we’ve done in terms of our fiscal turnaround and our economic reforms. We are also very thankful for the understanding and facilitation that you’ve given us in other critical regional matters. It means a lot to us and as we look to strengthen our relationship we welcome deepening partnership in energy,” said Prime Minister Holness.Under the Framework, the two countries will cooperate to:Further, diversify Jamaica’s sources of energy to power the country’s economic growth;Integrate cleaner energy sources, including natural gas and renewable energy, furthering Jamaica’s environmental goals and making Jamaica’s economy more competitive;Accelerate Jamaica’s adoption of innovative power technologies, including renewables and related micro-, mini-grid and battery storage systems;Increase Jamaica’s energy resiliency through energy source integration and catalyzing investment in rural areas and at critical infrastructure facilities; andEnhance the reliability, resilience, and efficiency of the national energy systems.“This initiative marks a major advancement for the U.S. and Jamaica that will yield additional investment and export opportunities for both countries. Additionally, the Framework provides a foundation for Jamaica to play a pivotal role in regional Caribbean energy growth, integration, and security. The agreement will help catalyze private sector capital for investments across the energy value chain, including upstream energy production, power generation, transmission, and distribution,” said Secretary Mnuchin.last_img read more

first_imgzoom European shipping majors MSC and Hapag-Lloyd have joined forces with their Asian counterparts HMM and Ocean Network Express (ONE) in a new vessel sharing agreement on Asia to West coast of South America services.The newly reorganized joint services will connect Korea, China, Japan, Taiwan with the West coast of Mexico, Peru, Chile, Columbia through three loops starting at the beginning of April.“HMM will provide reliable ‘Asia-west coast of South America’ services with competitive transit time and on-time performance,” an HMM official said.“Based on this joint services, HMM expects to consolidate its position in the Far Asia – west coast of South America market with high growth potential, and HMM will do its utmost to optimize profitability through the services.” “The new service offerings will enhance our coverage and provide fast transit times between the major ports in Asia and the West Coast ports of Mexico, Central America and South America,” Hapag-Lloyd said in a release.The first sailing dates, as well as the port terminals to be called, are yet to be determined.The port rotation, which is still subject to change, will be as follows:NW1:Keelung – Hong Kong – Shekou – Yantian – Ningbo – Shanghai – Pusan – Manzanillo – Lazaro Cardenas – Callao – Iquique – Antofagasta/Puerto Angamos – Valparaiso – Coronel – Valparaiso – KeelingNW2:Shanghai – Xiamen – Hong Kong – Ningbo – Pusan – Manzanillo – Lazaro Cardenas – Balboa – Buenaventura – Callao –– San Antonio – Coronel – Lirquen – San Antonio – Puerto Angamos – Callao – Lazaro Cardenas – Manzanillo – Yokohama/Tokyo – Pusan – ShanghaiNW3:Ningbo – Shanghai – Qingdao – Pusan – Yokohama – Ensenada – Manzanillo – Puerto Quetzal – Balboa – Buenaventura – Callao – Guayaquil – Buenaventura – Balboa – Lazaro Cardenas – Manzanillo – Ensenada – Yokohama – Pusan – Ningbolast_img read more

first_imgzoomImage Courtesy: Fincantieri Italy’s shipbuilder Fincantieri held a keel laying ceremony for MSC Cruises’ latest vessel, the MSC Seashore, on September 19.The milestone event took place at the Fincantieri shipyard in Monfalcone, Italy, where MSC Cruises revealed details of the significantly transformed overall design and new features of the ship.At 339 meters, the MSC Seashore will be the company’s longest ship when it enters service in June 2021. It is the first of two enriched “Seaside Evo” Class ships with the latest available environmental technology, extended public spaces, more cabins and the highest ratio of outdoor space per guest of any ship in the company’s fleet, the parties explained.According to Pierfrancesco Vago, MSC Cruises’ Executive Chairman, MSC Seashore represents “another proof of our long-standing commitment to preserve the environment in our ongoing journey to minimise and continuously reduce the impact of our operations.”MSC Seashore will be fitted, amongst other, with a Selective Catalytic Reduction (SCR) system and a Advanced Wastewater Treatment (AWT) system. The new build will also be fitted with shore-to-ship power which connects cruise ships while at berth to a port’s local power grid to reduce further the ship’s emissions.Other effective environmental technologies deployed on MSC Seashore include an exhaust gas cleaning system (EGCS); waste management systems; ballast water treatment systems approved by the United States Coast Guard; systems for the prevention of oil discharges from machinery spaces and various energy-efficiency improvements – from heat recovery systems to LED lighting.“It is a real challenge in terms of structural and managerial aspects, which powers the impressive workload for the shipyard and the local area. We therefore are very pleased for such a celebration which seals the fruitful partnership with MSC Cruises and we are confident that there will be other similar moments in the future,” Giuseppe Bono, Fincantieri CEO, noted.last_img read more