October182011

CORRECTED - Halozyme: subcutaneous Herceptin trial met goals


* Halozyme patents valid through at least 2024By Deena BeasleyOct 18 (Reuters) - Halozyme Therapeutics , which specializes in reformulating drug products available only as infusions, said a pivotal trial of subcutaneous Herceptin, the cancer drug sold by Roche , met its goals.The under-the-skin injections offer a faster, more convenient way to administer the drug, according to Halozyme Chief Executive Officer Gregory Frost. Herceptin had 2010 global sales of $6.8 billion.In addition, Halozyme’s enzyme technology is patented globally until 2024, with formulation patents extending beyond that, he said.The Phase 3 Roche trial, involving patients with a specific type of breast cancer, showed that women receiving the subcutaneous injection responded to the drug as well as women treated with intravenous Herceptin, Halozyme said on Monday.No new safety signals were observed, with the most common side effects being infections and anemia, the company said.Frost said Roche plans to file next year for European regulatory approval of subcutaneous ready-to-use Herceptin, which takes about five minutes to administer, compared with at least 30 minutes for the intravenous infusion.Halozyme said the new formulation may also reduce pharmacy time since no preparation is needed.Roche is expected to present full details of the trial at an upcoming medical conference.Halozyme said it is “comfortable” with Wall Street estimates of a mid-single-digit royalty from Roche on sales of subcutaneous Herceptin. It also earns milestone payments from the development deal.Roche is also conducting pivotal trials of subcutaneous Halozyme-engineered Rituxan, also known as MabThera, in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.Both Herceptin and Rituxan are monoclonal antibodies that require such large-volume doses that they cannot currently be given subcutaneously.

3AM

EURO GOVT-French yield spread widens after ratings warning


The French/German 10-year government bond yield spread widened to a euro era record of 101 basis points versus around 96 bps at Monday’s settlement close. French debt also underperformed its triple-A rated peer the Netherlands.

October142011

College students echo Occupy Wall Street with protests


The “National Student Solidarity Protest” was organized by Los Angeles-based Occupy Colleges, which estimated it held events at about 140 campuses in at least 25 states.A smaller-scale action from one week ago gained momentum with the aid of social media, some old-fashioned shoe leather and dorm-room word-of-mouth, organizers said.”Our goals are in direct solidarity with Occupy Wall Street,” said Natalia Abrams, facilitator for Occupy Colleges, adding that the protest was not “anti-school.”Students across the country staged coordinated sit-ins, banner hangings, marches and walkouts.”We’re angry about the amount of debt we must attain to go to college and the drastic lack of employment opportunities,” said Sally Morgan, a graduate student at Virginia Tech in Blacksburg.Protesters were worried about what they see as a lack of social mobility in the United States.Research from Rutgers University in May showed college graduates are struggling: taking longer to get jobs, taking employment that did not typically need a college education, and earning a lot less than expected.”It’s more about waking up to this idea that this American dream — that if you work hard (and) go to college you can be propelled into the top tiers of society — just isn’t true,” Morgan said.Greg Shaw, political science professor at Illinois Wesleyan University in Bloomington, Illinois, warned that protests about tuition costs may not have staying power.”The reasons for tuition being so high is not an easy target. You can’t just blame East Coast investment bankers or Tim Geithner,” he said.”I don’t know if college campuses can sustain a level of outrage,” he added. “At the end of the semester, they have exams and go home.”Still, seeing action on campuses suggests the movement could put down deeper roots than, for example, protests this year against Scott Walker, Wisconsin’s anti-union governor. said Marshall Ganz, a lecturer in public policy at Harvard.”All through history, young people have had a special role in social change movements,” Ganz said.On Thursday, some students joined up with larger Occupy groups. Groups from Emerson College and Wellesley college came to the Occupy Boston encampment near the Boston Federal Reserve Bank.Jeffrey Juris, associate professor of anthropology at Northeastern University in Boston, said Occupy Wall Street has already inspired on-campus discussions and rallies.”Students and recent graduates who may be underemployed or unemployed, who have the impetus and the time to be involved, are among the groups at the forefront of this,” said Juris.Juris has spent time at Occupy Boston and offered extra credit to students who observe the encampment and provide an analysis related to course themes.Schools taking part ranged from Smith College in Northhampton, Massachusetts, where students handed out flyers, to Austin Community College in Austin, Texas, to Michigan State University in East Lansing and Black Hills State University in Spearfish, South Dakota.Also on the list was Kent State University in Kent, Ohio, where four unarmed college students were killed and nine wounded when National Guardsmen opened fire in May 1970 during a protest against the U.S. invasion of Cambodia.Those killings were memorialized in the iconic protest song “Ohio” by Crosby, Stills, Nash and Young.Shaw said Occupy Colleges had a long way to go before rivaling the massive Vietnam War-era protests like Kent State that shook the country.”You were protesting then about possibly being sent away to have your head shot off,” he said.

October132011

UPDATE 1-SEC tells companies to disclose cyber attacks


By Jim Finkle and Sarah N. LynchBOSTON/WASHINGTON, Oct 13 (Reuters) - U.S. securities regulators on Thursday issued guidelines for public companies to follow in disclosing cyber attacks following a rash of Internet crimes that caused lawmakers to call for clearer guidance on reporting the crimes.The guidance, posted late on Thursday by the U.S. Securities and Exchange Commission, lays out examples of things that companies may be required to disclose. The guidance comes after Senator John Rockefeller asked the SEC to issue it amid concern that companies were failing to mention data breaches in public filings.The SEC said in its guidance that if a cyber event occurs and leads to losses then companies should “provide certain disclosures of losses that are at least reasonably possible.”“Intellectual property worth billions of dollars has been stolen by cyber criminals, and investors have been kept completely in the dark. This guidance changes everything,” Rockefeller said in a statement.”It will allow the market to evaluate companies in part based on their ability to keep their networks secure. We want an informed market and informed consumers, and this is how we do it,” Rockefeller said in a statement.Tom Kellermann, chief technology officer of security firm AirPatrol Corp., said that the guidance tells companies to report cyber attacks and disclose steps to remediate problems.”They must also incorporate cyber events into their material risk reports,” said Kellermann, who has advised U.S. President Obama on cyber policy.There is a growing sense of urgency following breaches at Google Inc , Lockheed Martin Corp , the Pentagon’s No. 1 supplier, Citigroup , the International Monetary Fund and others.A report out earlier this month found that U.S. banks are losing ground in the battle to combat credit and debit card fraud because they balk at the expense of higher security. Globally, however, security is improving in the payment industry, according to data from The Nilson Report, a California trade publication.There is some hope of U.S. legislation to address the problem, although the House of Representatives appears more interested in tackling it piecemeal while the Senate is opting for a more far-reaching approach.Most of the concern has been focused on critical facilities like nuclear power, electricity, chemical and water treatment plants.

October122011

EURO GOVT-Bund futures extend losses after 30-yr debt sale


The Bund future fell as much as 78 ticks on the day to 133.77, its lowest since Aug. 25.Before the German auction, the ECB said it lent banks $1.35 billion, a fifth of the demand forecast in a Reuters poll of money markets traders early this week. Only 6 banks bid for the three-month funds, easing some concerns that Euroepan banks were facing acute problems accesssing dollars in the market.

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