Tag Archives: PML

Business, Finance, Occupation & Industry

Elan Announces Closing of TYSABRI® Collaboration Transaction with Biogen Idec

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By Business Wirevia The Motley Fool

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Elan Announces Closing of TYSABRI® Collaboration Transaction with Biogen Idec

DUBLIN–(BUSINESS WIRE)– Elan Corporation, plc (NYS: ELN) is pleased to announce the closing today of the TYSABRI® (natalizumab) Collaboration Transaction with Biogen Idec. The agreement was announced on February 6, 2013.

Under the terms of the agreement, Elan has received $3.25 billion in cash and will receive double digit tiered royalty payments, on all indications, for the life of the complete TYSABRI asset. For the first twelve months Elan will receive 12% royalties on in-market sales of TYSABRI, and thereafter, Elan will receive 18% royalties on in-market sales up to $2 billion and 25% royalties on in-market sales exceeding $2 billion. In 2012, in-market sales of TYSABRI were $1.6 billion.

About TYSABRI

TYSABRI is approved in more than 65 countries. TYSABRI is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy due to the risk of progressive multifocal leukoencephalopathy (PML). In the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS.

TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI increases the risk of PML, an opportunistic viral infection of the brain which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Biogen Idec Completes Purchase of Full Rights and Control of TYSABRI®

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By Business Wirevia The Motley Fool

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Biogen Idec Completes Purchase of Full Rights and Control of TYSABRI®

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) today announced it has completed its purchase of Elan Corporation‘s interest in TYSABRI® (natalizumab) and has gained full strategic, commercial and decision-making rights to TYSABRI. The transaction was originally announced on February 6, 2013.

“Full ownership of TYSABRI is an important step for Biogen Idec that further solidifies our leadership in MS,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “The powerful efficacy of TYSABRI makes it an important treatment for many people living with MS and we believe it has a solid growth trajectory for years to come. We are grateful to Elan for more than a decade of collaboration on TYSABRI, and for their work to provide a seamless transition as we finalized the transaction.”

Further details and updated financial guidance will be provided during Biogen Idec‘s upcoming first quarter 2013 earnings announcement.

For more than two decades Biogen Idec has been a leader in multiple sclerosis (MS), offering a wide range of therapies, unsurpassed patient support, and a robust R&D program to improve the lives of people with MS. Biogen Idec also has the deepest MS pipeline in the industry with compounds that include PLEGRIDY™ (peginterferon beta-1a); daclizumab high-yield process (DAC HYP) for monthly subcutaneous administration; and an ongoing study with TYSABRI as a treatment for secondary progressive multiple sclerosis (SPMS).

About TYSABRI

TYSABRI is approved in more than 65 countries. TYSABRI is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy due to the risk of progressive multifocal leukoencephalopathy (PML). In the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS.

TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI increases the risk of PML, an opportunistic viral infection of the …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

PMF, PCQ, PNF, PML, PCK, PNI, PMX, PZC, and PYN Declare Monthly Common Share Income Dividends

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By Business Wirevia The Motley Fool

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PMF, PCQ, PNF, PML, PCK, PNI, PMX, PZC, and PYN Declare Monthly Common Share Income Dividends

  • PIMCO MUNICIPAL INCOME FUND
  • PIMCO CALIFORNIA MUNICIPAL INCOME FUND
  • PIMCO NEW YORK MUNICIPAL INCOME FUND
  • PIMCO MUNICIPAL INCOME FUND II
  • PIMCO CALIFORNIA MUNICIPAL INCOME FUND II
  • PIMCO NEW YORK MUNICIPAL INCOME FUND II
  • PIMCO MUNICIPAL INCOME FUND III
  • PIMCO CALIFORNIA MUNICIPAL INCOME FUND III
  • PIMCO NEW YORK MUNICIPAL INCOME FUND III

NEW YORK–(BUSINESS WIRE)– The Boards of Trustees of PIMCO Municipal Income Fund (NYS: PMF) , PIMCO California Municipal Income Fund (NYS: PCQ) , PIMCO New York Municipal Income Fund (NYS: PNF) , PIMCO Municipal Income Fund II (NYS: PML) , PIMCO California Municipal Income Fund II (NYS: PCK) , PIMCO New York Municipal Income Fund II (NYS: PNI) , PIMCO Municipal Income Fund III (NYS: PMX) , PIMCO California Municipal Income Fund III (NYS: PZC) and PIMCO New York Municipal Income Fund III (NYS: PYN) (collectively, the “Funds”) announced today that they have declared the following dividends …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

A.M. Best Revises Outlook to Negative From Stable for Columbia Mutual Insurance Company and Its Insu

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By Business Wirevia The Motley Fool

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A.M. Best Revises Outlook to Negative From Stable for Columbia Mutual Insurance Company and Its Insurance Subsidiaries

OLDWICK, N.J.–(BUSINESS WIRE)– A.M. Best Co. has revised the outlook to negative from stable and affirmed the financial strength rating (FSR) of A- (Excellent) and issuer credit ratings (ICR) of “a-” of Columbia Mutual Insurance Company (Columbia) (headquartered in Columbia, MO) andits insurance subsidiaries. (See below for a detailed listing of the companies.)

The negative outlook is based on Columbia’s significant operating losses in recent years that led to a sizeable decline in its policyholders’ surplus, stemming from catastrophe weather related losses and competitive market pressures in its primary operating territory.

The affirmation of the ratings is based on Columbia’s solid risk-adjusted capitalization, conservative operating strategy and long-standing market presence. Columbia’s solid risk-adjusted capitalization is derived from its moderate underwriting leverage and adequate balance sheet liquidity, which are partially offset by its moderately adverse loss reserve development in recent years and above-average common stock leverage.

Columbia reported significant underwriting losses over the previous five-year period, driven by widespread storm losses in the Midwest that were partially mitigated by solid, albeit gradually declining, net investment income. While Columbia has expanded its marketing territory in recent years, management has undertaken numerous corrective initiatives to improve underwriting results. Specific actions include numerous commercial and personal lines rate adjustments, increased use of loss control, more accurate insurance-to-value efforts and utilization of improved underwriting tools. Additional initiatives include the run-off of the homeowners’ and dwelling fire lines of business, the cancellation of underperforming agencies, property deductible increases and improved product and geographic diversification. Columbia also has implemented an improved enterprise risk management framework, which places greater emphasis on its risk management culture, corporate governance structure and risk assessment programs.

Columbia’s business concentration in the Midwest exposes its earnings and surplus to catastrophe losses stemming from wind, hail and tornadoes, as well as the earthquakes on the New Madrid fault line. This was particularly evident in 2011 and 2012, when Columbia reported significant underwriting losses, driven by unprecedented wind, hail and tornado losses. These underwriting losses resulted in large operating losses, which led to a $57.6 million or 27% decline in policyholders’ surplus over the two-year period. However, management partially mitigates these exposures through quality reinsurance, prudent risk management strategies and geographic spread of risk. In addition, through a comprehensive reinsurance program and underwriting actions, the net probable maximum loss (PML) for a 100-year hurricane (Columbia’s largest exposure), as depicted in a PML analysis, has been reduced to …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Why Incyte Shares Plunged

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By Sean Williams, The Motley Fool

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Although we don’t believe in timing the market or panicking over market movements, we do like to keep an eye on big changes — just in case they’re material to our investing thesis.

What: Shares of biotechnology company Incyte lost as much as 13% following the disclosure in a regulatory filing that a patient had developed a case of progressive multifocal leukoencephalopathy, or PML, while taking its lead drug, Jakafi.

So what: Jakafi, which is designed to treat patients with myelofibrosis, is marketed outside of the U.S. as Jakavi by licensing partner Novartis . According to the filing, Incyte has alerted the Food and Drug Administration to this case and is in the process of informing investigators currently in clinical trials. However, the company was also clear to point out that people with myelofibrosis could be at higher risk of developing PML to begin with, and it hasn’t been determined whether Jakavi was a direct cause of this particular patient developing PML.

Now what: While I’d hardly call this finding good news, I think investors have probably overreacted to an as of now unproven case of PML as compared to the nearly 10,000 prescriptions written around the globe for Jakafi/Jakavi without any serious adverse events. Myelofibrosis patients have few treatment alternatives and Jakafi was proven to be effective in trials, so I highly doubt major corrective action is in order. Investors could be getting quite the bargain picking up Incyte shares on dips related to this news.

Craving more input? Start by adding Incyte to your free and personalized watchlist so you can keep up on the latest news with the company.

While you can certainly make huge gains in biotechs like Incyte, the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool’s free report “3 Stocks That Will Help You Retire Rich” names stocks that could help you build long-term wealth and retire well, along with some winning wealth-building strategies that every investor should be aware of. Click here now to keep reading.

The article Why Incyte Shares Plunged originally appeared on Fool.com.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

7 Active Trading Big Volume Spikes (CHTR, GLUU, INCY, JNPR, PCRX, SLCA, VCLK)

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By 24/7 Wall St.

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Active traders and more active investors looking for news lists of stocks to buy or other investing ideas often look at stocks which are very active in trading volume. Some are up big, some are down big. Either way, large spurts of trading volume often lasts for multiple days. These are the major volume spikes tracked by 24/7 Wall St. this Monday.

Charter Communications, Inc. (NASDAQ: CHTR) just had a very unusual volume spike as shares were halted on an intraday circuit breaker. Dow Jones reported that Liberty’s John Malone is close to buying a 25% stake in the company. Stay tuned as shares are up 9% at $98.20 on 1.4 million shares versus almost 1 million shares on an average day.

Glu Mobile, Inc. (NASDAQ: GLUU) was raised to Outperform at Northland Capital and that was somehow enough to send shares through the roof with a 9% gain to $3.64. What was impressive was that the rise was on over 18 million shares in mid-day trading versus about 2.5 million shares. Perhaps that new $4.50 target implying 35% upside from the $3.34 close had something to do with it.

Incyte Corporation (NASDAQ: INCY) is approaching a 300% volume spike on news that one of its patients under treatment developed the brain infection PML. Shares are down 6.6% at $23.20 on over 6 million shares versus an average daily volume of 1.63 million shares.

Juniper Networks, Inc. (NYSE: JNPR) will not look like a huge unusual volume spike with 7.2 million shares having traded against a 6 million average daily volume. The problem is that the share volume on the sell-side was so large at the market open that shares opened down about 5% at $19.08. The stock is now down only 1% at $19.97 on the day.

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is down over 7% at $27.78 after it was pointed out that insiders were selling shares. What stands out is volume at 300% of normal at about 1.4 million versus average volume of 413,000 shares per day.

U.S. Silica Holdings, Inc. (NYSE: SLCA) remains above normal in trading volume as an institutional investor was shown to be selling shares last week. The stock is actually up 3% at $22.36 so far on Monday and the 2+ million shares compares to average volume of 744,000 shares.

ValueClick, Inc. (NASDAQ: VCLK) somehow did not even make our top analyst upgrades and downgrades this morning, but Jefferies raised the rating to Buy from Hold and raised the target price by $12 to $35 and sent the stock up. This was a gain of 9.5% mid-day to $30.40, and the share count of 1.8 million compares to an average volume of only about 955,000 shares per day.

Filed under: 24/7 Wall St. Wire, Active Trader Tagged: CHTR, GLUU, INCY, JNPR, PCRX, SLCA, VCLK

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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Why Cyprus Won't Hold Back the Dow

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By Dan Caplinger, The Motley Fool

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With the stock market near record highs, investors are on edge, and the slightest hint of trouble can cause near-panic. Given the news over the weekend that not only will the European island nation of Cyprus need a bailout, but it will also come at the expense of bank depositors, visions of Great Depression-era bank runs and rhetoric about the confiscation of funds led to massive sell-offs in overseas stock markets. Yet as Fool contributor Morgan Housel noted earlier this morning, Cyprus’ bailout doesn’t deserve the huge hype that it’s getting. At least in the U.S., investors seem to have gotten that message, as the Dow Jones Industrials have recovered from initial losses of more than 100 points to trade down just 31 points as of 10:55 a.m. EDT. Broader markets are down roughly half a percent.

Within the Dow, banking stocks took the most substantial hit, with Bank of America down more than 1% and JPMorgan Chase falling 1.2%. The biggest threat from the Cypriot bailout is that bank customers in other countries will leap to the almost certainly false conclusion that their own deposits are at risk. With FDIC insurance, U.S. depositors are protected, but with ordinary Americans already predisposed against the banking industry, anything that leads more bank customers to withdraw deposits will only put an additional strain on the financial system.

Elsewhere, Incyte declined 7.2% after the company reported that a patient taking its myelofibrosis drug ruxolitinib contracted a disease called progressive multifocal leukoencephalopathy. Although this is the first case of PML associated with the drug, Incyte will get an independent assessment of the findings and could have to take additional steps in order to ensure the safety of the drug.

Finally, J. C. Penney soared more than 8% as two pieces of news helped boost the struggling retailer. One analyst said the company’s Joe Fresh concept has had a successful launch among customers, while a research group examining the value of the retailer’s real estate estimated that Penney could earn $1.2 billion in rental income by subletting store locations. Any move to unlock income will help the company, as it has been burning cash at an alarming rate during its restructuring.

J. C. Penney has been a true train wreck lately, but some value investors believe that J. C. Penney is a buy today. Make your own informed decision by claiming a copy of The Motley Fool’s must-read report on the company. Learn everything you need to know about JCP‘s turnaround odds — or lack thereof. Simply click here now for instant access.

var FoolAnalyticsData = FoolAnalyticsData || []; …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

New TYSABRI Data Reaffirm Substantial Efficacy in Treatment of People with MS and Demonstrate Stabil

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By Business Wirevia The Motley Fool

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New TYSABRI Data Reaffirm Substantial Efficacy in Treatment of People with MS and Demonstrate Stability of Anti-JCV Antibody Status

– Continued Research into Risk Stratification and PML Early Detection Provides Additional Insights for Physicians –

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) and Elan Corporation, plc (NYS: ELN) announced results from several studies of TYSABRI® (natalizumab) that demonstrate its efficacy compared to other multiple sclerosis (MS) treatments, provide additional data supporting anti-JC virus (JCV) antibody status stability, and suggest better outcomes when progressive multifocal leukoencephalopathy (PML) is detected early. These data will be presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego.

“These new data reinforce our belief in the substantial efficacy TYSABRI has demonstrated at both the early and advanced stages of relapsing forms of MS,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and chief medical officer, Biogen Idec. “We are also encouraged by the consistency in anti-JCV antibody status demonstrated over 18 months, as well as results from our pursuit of additional paths to help mitigate the impact of PML. These combined efforts may allow a more individualized approach when selecting TYSABRI treatment, while helping physicians better understand a patient’s benefit-risk profile.”

Substantial TYSABRI Efficacy Demonstrated Against First-Line Therapies

In an independent statistical analysis led by Timothy Spelman and Helmut Butzkueven, M.D. at the University of Melbourne, with contribution by Fabio Pellegrini and Annie Zhang, TYSABRI demonstrated a significantly lower rate of first relapse compared to interferon beta (IFN) and glatiramer acetate (GA). This propensity-matched analysis was conducted using data from two MS patient registries: TYSABRI Observational Program (TOP) and MSCOMET. The results indicate that relapses were not only more likely to occur in patients taking IFN and GA, but that they occurred more quickly, when compared to patients taking TYSABRI (hazard ratio 2.73, 95 percent confidence interval 2.10-3.55, p<0.001).

  • Comparison of Patients Treated with Natalizumab and Interferon-Beta/Glatiramer Using Propensity-Matched Multiple Sclerosis Registry Data (P01.211) will be available for viewing on Monday, March 18, 2013 from 2:00 to 6:30 p.m. PDT

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Source: FULL ARTICLE at DailyFinance

Science & Technology

Scientists make better SEM imaging and measurements in the nano era possible

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Since the inception of the scanning electron microscope (SEM), users have encountered the persistent problem of contamination. Cleanliness is required for imaging and to make good quality measurements, and PML has led the exploration and the development of methods to allow SEM users gather high-quality, repeatable, and quantitative measurement results. …read more
Source: FULL ARTICLE at Phys.org