March 27 (Reuters) - U.S. Food and Drug Administration:
* FDA says approved Biogen idec's tecfidera (dimethyl fumarate)
capsules to treat adults with relapsing forms of Multiple Sclerosis
* Source text for Eikon:
* Further company coverage ((Bangalore Newsroom; +1 646 223 8780))
March 27 (Reuters) - U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.
Combined clinical trial data showed Tecfidera, formerly known as BG-12, cut the average relapse rate by 49 percent after two years compared to patients taking a placebo.
(Reporting By Toni Clarke in Washington; Editing by Tim Dobbyn)
((toni.clarke@thomsonreuters.com)(202-898-8340)(Reuters
Messaging: toni.clarke.thomsonreuters.com@reuters.net))
Keywords: BIOGEN TECFIDERA/
NEW YORK -- Spectrum Pharmaceuticals Inc. said Thursday it licensed a potential treatment for multiple myeloma from Ligand Pharmaceuticals Inc.
Ligand's drug candidate is a form of melphalan, which is already used to treat multiple myeloma. The new form of the drug is designed to be given before the patient receives a round of autologous stem cell treatment, and the companies say it could allow for longer, safer, and stronger treatment because it could have fewer side effects.
The experimental formulation of melphalan eliminates ingredients that are reported to cause kidney and heart side effects. Those side effects force physicians to use smaller doses of the drug.
Multiple myeloma is a cancer of the blood that mainly affects older adults. Spectrum, based in Henderson, Nev., said about 20,000 cases are diagnosed each year.
The Food and Drug Administration has designated the treatment an orphan drug, which means similar products will be barred from the market for up to 7 years if it is approved. Spectrum is now responsible for clinical testing of the drug and expects to file for marketing approval in the first half of 2014.
Ligand said it will get an upfront license payment of $3 million and could receive more than $50 million in milestone payments. The San Diego company will also get royalties on sales of the drug if it is approved.
Ligand raised its financial guidance, saying it now expects to report net income of 47 to 51 cents per share in 2013 on $43 million to $46 million in revenue. It had forecast income of 35 to 39 cents per share on $41 million to $44 million in revenue.
Analysts expect net income of 41 cents per share and $43.1 million in revenue, according to FactSet.
For the first quarter, the San Diego company said its net income will be between 10 and 13 cents per share in the first quarter, and revenue will be between $10 million and $11 million. Analysts are forecasting a profit of 2 cents per share with $8.5 million in revenue on average.
Shares of Ligand rose 55 cents, or 2.5 percent, to $22.41 in afternoon trading, and Spectrum shares picked up 7 cents to $7.86.
Four years before the accident at Japan’s Fukushima Daiichi plant, the U.S. Nuclear Regulatory Commission was warned about the possibility of a plant suffering simultaneous meltdowns due to a natural disaster. [NYTimes]
The accident at Japan’s Fukushima Daiichi plant in 2011 alerted the American nuclear industry and its regulators to the possibility that operators at plants with more than one reactor might have to deal with more than one meltdown at a time in a flood, earthquake or other catastrophe. Officials are now working to assure that they could master that situation.
But documents uncovered by a group that is critical of nuclear safety show that a high-level safety analyst at the Nuclear Regulatory Commission posed the possibility to his superiors in July 2007, about four years before the earthquake and tsunami that led to three simultaneous meltdowns at Fukushima Daiichi. The documents also show that in August 2008, the commission staff formally acknowledged the issue.
But until Japan’s disaster, progress in the American nuclear industry was glacial….
The warning, which now seems prophetic, predicted “common cause failures,’’ meaning single events that disable different pieces of equipment that are supposedly independent and nearly invulnerable to failing simultaneously on their own. The risk analyst, Richard Sherry, wrote that flooding or earthquakes could disrupt both normal grid power and emergency backup power.
China is trying to get a leg up on clean energy transportation by getting into the patent wars. The country has filed over 2,000 patent applications — 8 percent of the world’s total — placing China third globally. [ChinaDaily]
Greenpeace released a report yesterday warning of various fossil fuel projects around the world that could serve as “carbon bombs,” driving the planet still closer to disastrous levels of global warming. China and Australia topped the list. [The Guardian]
A global and legally-binding agreement to reduce mercury emissions was reached in Geneva over the weekend. But it still faces ratification by over 140 countries, even as studies show mercury levels around the world continue to rise. [LA Times]
The unusually cold temperatures across America’s northern Plains and New England could be due to a combination of a warming event in the upper atmosphere over the Arctic, and fluctuations in a natural cycle of tropical rainfall near the equator. [ClimateCentral]
Ikea will double its investment in renewable energy — including wind farms and solar parks — to $4 billion by 2020, as part of an effort to bring down costs for more cash-strapped consumers. [Bloomberg]
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