Tag Archives: Biogen Idec

Biogen: It's Unlikely Patient Death Was Caused By Tecfidera

By Ed Silverman, Contributor

For a brief moment, there was significant investor anxiety that the ‘holy mother’ of all drug launches might burst like a balloon. A report that the new Tecfidera multiple sclerosis pill was possibly linked to a patient death sent shares downward amid speculation about whether the Biogen Idec drug may have a side effect problem that could thwart blockbuster sales estimates. …read more

Source: FULL ARTICLE at Forbes Latest

Biogen Idec to Report First Quarter 2013 Financial Results on April 25, 2013

By Business Wirevia The Motley Fool

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Biogen Idec to Report First Quarter 2013 Financial Results on April 25, 2013

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec Inc. (NAS: BIIB) today announced it will report first quarter 2013 financial results on Thursday, April 25, 2013, before the financial markets open.

Following the release of the financials, the Company will host a live webcast where Biogen Idec management will discuss the financial results, at 8:00 am ET. To access the live webcast, please go to the investor relations section of Biogen Idec‘s website at www.biogenidec.com. Following the live webcast, an archived version of the call will be available at the same URL, for one month.

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Biogen Idec
Karen Jewell, 781-464-2442
Investor Relations

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:

The article Biogen Idec to Report First Quarter 2013 Financial Results on April 25, 2013 originally appeared on Fool.com.

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Source: FULL ARTICLE at DailyFinance

The 1 Biotech Stock Warren Buffett Should Buy

By Sean Williams, The Motley Fool

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The biotechnology sector can be a land of immense spoils and incredible heartbreak. It’s not uncommon to see small and midsized biotech companies swing wildly in each direction because of clinical trial data or a decision by the Food and Drug Administration.

Pros and cons of owning biotech stocks
Last month I presented my case for how the typical long-term investor could use biotech stocks to their advantage. My suggestions entailed focusing on companies with established pipelines, selecting clinical-stage companies that were running a large number of trials with multiple partnerships, or buying a biotech ETF that would take a lot of the guesswork out of your purchase and spread out your risk among a number of companies.

Conversely, my Foolish cohort Brian Orelli last week presented his three reasons a long-term buy-and-hold investor like Warren Buffett would never buy a biotech company. Brian noted that Buffett’s unwillingness to follow a biotech’s upcoming pipeline, biotechs’ wild valuation fluctuations, and their often small size, would make them unlikely candidates to grace Berkshire Hathaway‘s  portfolio, which is usually looking for heavy hitters to help “move the needle,” as Brian put it.

The Buffett factor
To date, Warren Buffett and Berkshire Hathaway have been very conservative with their health-care investments, opting to own shares of some of pharma’s biggest names, including Johnson & Johnson, GlaxoSmithKline, and Sanofi.

But, with all due respect to Brian, I think Buffett is missing a crucial piece of the puzzle in his investment portfolio, and that missing piece is a biotechnology investment.

The way I see it, in its simplest form, Buffett values three things: business sustainability, growth, and income. Let’s have a look at how these three values might play into the biotech sector, and ultimately, what biotech company Buffett would be foolish to pass up.

Sustainability
By sustainability, what I’m really focusing on is an established pipeline of drugs already in existence. This would mean that many companies that have one or two drugs approved by the FDA and have the remainder of their pipeline currently in trials wouldn’t fit the bill. Warren Buffett has the “set-it-and-forget-it” type of investing style that only sustainable and established pipelines would satiate. Two names in particular that come to mind here are Amgen and Biogen Idec .

Amgen’s current portfolio should put a gleam in Buffett’s eyes, as it currently boasts 10 separate FDA-approved drugs. Headlining Amgen‘s portfolio is the combination of Neulasta and Neupogen, which both treat neutropenia, a condition in which the body lacks white blood cells because of cancer treatments or a bone marrow transplant. These two drugs delivered 3% organic growth last year and contributed to $5.2 billion of Amgen’s $15.3 billion in product sales. At the lower end of Amgen’s product portfolio, its two newest drugs contributed triple-digit growth. Xgeva, which was approved in 2010 to treat patients with bone fractures or bone pain in instances where cancer has spread to …read more

Source: FULL ARTICLE at DailyFinance

Biogen Hits Primary Endpoints in MS Study

By Dan Carroll, The Motley Fool

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Biotech company Biogen Idec‘s developmental multiple sclerosis drug daclizumab succeeded in the SELECT phase 2b trial evaluating its safety and effectiveness in treating patients with relapse-remitting MS. The trial results, originally published in The Lancet and reported by Biogen in a recent press statement, showed that two injection treatment groups had annual relapse rates at least 50% lower than a placebo group after one year.

The two treatment groups also showed that daclizumab reduced MS-related brain lesions and improved quality of life in patients, as well as reducing disability progression.

Dr. Gilmore O’Neill, Biogen’s vice president of medical research, said of the results, “Based on these initial data from SELECT, we believe DAC HYP would complement our robust portfolio of four approved MS products by potentially offering people with MS a new treatment alternative.”

Daclizumab is Biogen’s latest developmental candidate in the multiple sclerosis market it has dominated. The company’s oral MS treatment, Tecfidera, won FDA approval in late March and is poised to compete in the promising oral MS market.

The article Biogen Hits Primary Endpoints in MS Study originally appeared on Fool.com.

Fool contributor Dan Carroll and The Motley Fool have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools don’t all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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Source: FULL ARTICLE at DailyFinance

The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of Daclizumab HYP in Multiple Scler

By Business Wirevia The Motley Fool

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The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of Daclizumab HYP in Multiple Sclerosis

-Data Demonstrated That DAC HYP Significantly Reduced Annualized Relapse Rate by up to 54 Percent at One Year-

-Phase 3 Study Underway to Further Assess Once-Monthly DAC HYP for Multiple Sclerosis-

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that results from the daclizumab high-yield process (DAC HYP) SELECT clinical trial have been published as an online article in The Lancet. SELECT was a Phase 2b study designed to determine the efficacy and safety of DAC HYP in patients with relapsing-remitting multiple sclerosis (RRMS).

Published results demonstrate that both 150 mg and 300 mg subcutaneous injections of DAC HYP, administered once every four weeks, met the study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 54 percent (p<0.0001) and 50 percent (p=0.0002), respectively, compared to placebo at one year. In addition, results demonstrated that DAC HYP reduced multiple sclerosis (MS) brain lesions compared to placebo.

“DAC HYP represents the type of innovative research we are focused on cultivating as part of our MS pipeline because it potentially targets the disease in a new way,” said Gilmore O’Neill, M.D., vice president, Medical Research at Biogen Idec. “Based on these initial data from SELECT, we believe DAC HYP would complement our robust portfolio of four approved MS products by potentially offering people with MS a new treatment alternative. We look forward to continuing to work with our partners at AbbVie to progress the DAC HYP program further.”

Both doses of DAC HYP met key secondary endpoints in the study by significantly reducing the proportion of patients who relapsed at one year, as well as MS brain lesion activity, including the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 and the number of new or newly enlarging T2-hyperintense lesions at one year. Both doses of DAC HYP also demonstrated a trend in improvements in quality of life (QoL) compared to placebo as measured by the Multiple Sclerosis Impact Scale (MSIS-29) physical impact score.

“Because MS is unique to each person, we need a variety of treatment options to attack the disease in different ways,” said Ralf Gold, M.D., professor/chair of the Department of Neurology at St. Josef-Hospital/Ruhr-University in Bochum, Germany, and …read more

Source: FULL ARTICLE at DailyFinance

Elan Announces Closing of TYSABRI® Collaboration Transaction with Biogen Idec

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

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

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 MSBiogen 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

Health Care's Sweet 16 Stocks: Celgene vs. Biogen

By David Williamson and Max Macaluso, Ph.D., The Motley Fool

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Spring is in the air, and the annual NCAA March Madness college basketball tournament has once again captivated the nation. Of course, that also means Cinderella stories like Florida Gulf Coast have busted the brackets of would-be basketball prognosticators.

Here at The Motley Fool, we decided to stick with what we know, trading our basketball picks in for stock picks. We formed our own Sweet 16 filled with the top Big Pharma and Big Biotech stocks in a winner-take-all tournament determined by the collective intelligence of our CAPS community.

This matchup is a heavyweight bout between Celgene and Biogen Idec. Watch and find out which stock gets eliminated and which will advance to the next round.

Can Celgene continue to soar?
Every in-the-know biotech investor has an eye on Celgene. Shares have skyrocketed as the company outlined a plan to almost triple its profits in only a few years. But should you buy the story Celgene is selling? Make sure you understand the key opportunities and risks facing this company by picking up The Motley Fool’s brand-new premium report on Celgene. To claim your copy today simply click here now.

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Source: FULL ARTICLE at DailyFinance

1 Stock to Buy in April

By Motley Fool Staff

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As we do each month, we asked 10 of our top analysts across various sectors for one stock that looks especially compelling right now. Here are the companies they singled out.

Dan Caplinger: My stock for the month is Chinese online-search giant Baidu . I’ve been a big fan of emerging markets for a long time, and China in particular intrigues me because of the language and cultural differences that provide such a big barrier to entry in many industries. Although fast-food giants and other consumer-facing U.S. companies have done a good job of building a big presence in the nation, Baidu has managed to fend off Google and retain a commanding share of the online search market. The stock’s recent plunge in reaction to up-and-comer Qihoo 360 seems far too overblown, especially given the potential for huge growth in the search market in China and in neighboring countries that will leave room for multiple competitors in the space.

Moreover, investors are forgetting that Baidu has expansion plans beyond China, and its prospects for picking up market share in other lucrative emerging Internet markets look bright. Best of all, even if its lightning-fast growth pace slows, being able to pick up shares at a trailing multiple below 20 is a bargain that’s too tempting to resist.

John Maxfield: Apple 

If I were the world’s most interesting man (which I most certainly am not) here’s how I’d sum up my selection of Apple as the one stock to buy in April: I don’t usually buy technology stocks, but when I do they’re dirt cheap.

Apple is patently, even offensively, inexpensive. It went from over $700 per share last September — at which point even seasoned investors like David Einhorn were predicting it’d be the “first trillion-dollar company” — down to roughly $420 earlier this month. It’s the classic case of mania followed by utter despair.

On a valuation basis, the company’s stock trades for a little more than 10 times its estimated future earnings over the next 12 months. If you exclude its obscene cash hoard, that figure falls to roughly seven times earnings. And even more telling is its 2.3% dividend yield, which is bound to increase, given that Apple is in “serious discussions” about returning more capital to shareholders.

While I’ve been wrong before, and will be again, I’ve personally bought Apple at three different price points during its descent, and couldn’t be happier with the decision. 

Keith Speights: Biogen Idec  is on a roll that I don’t see stopping anytime soon. Shares are up more than 40% during the last year. The biotech currently stands as the leader in the multiple sclerosis market with blockbuster drugs such as Avonex and Tysabri. Many expect Biogen’s Tecfidera, which was recently approved by the FDA, to exceed the success of both of those drugs and become the top-selling MS drug within the next few years.

The excitement over Tecfidera stems from several important advantages …read more
Source: FULL ARTICLE at DailyFinance

The Greatest Thing Since Sliced Bread Has Arrived for MS Patients

By Sean Williams, The Motley Fool

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Last November, I examined five experimental drugs that appeared as if they had all of the tools necessary to become life-changing blockbusters from a financial and quality of life perspective. Yesterday, the first experimental drug I highlighted from Biogen Idec was approved by the Food and Drug Administration as a first-line treatment for relapsing MS.

Pardon the cliche, but I believe the greatest thing since sliced bread has just been bestowed upon MS patients whether they realize it yet or not.

Greater efficacy with fewer side effects is possible!
Tecfidera — previously known as BG-12 in trials — was studied in two different clinical trials known as Confirm and Define. In its Confirm study, Biogen noted that its pill, administered twice daily, reduced the rate of MS relapses by an impressive 49%, and was associated with a 71% to 99% drop in new or expanding lesions in both trials.

What’s truly unique about Tecfidera is its adverse events profile, which demonstrates the promise of fewer side effects with better efficacy. The most common side effects exhibited by patients on Tecfidera were flushing and gastrointestinal events, which often resulted in very low trial dropout rates. Biogen’s new medication could also lower lymphocyte counts in patients, according to its press release. 

However, compare this to Novartis‘ Gilenya or Sanofi‘s Aubagio and you’ll get a much clearer picture why Biogen’s oral medication appears superior.

Gilenya, which is approved as both a first-line and second-line MS treatment within the U.S. and comes in pill form as well, has the potential to cause serious cardiovascular problems through slowing a patients’ heart rate, can lower lymphocyte counts (similar to Tecfidera), and can potentially lead to macular edema or liver problems. Sure, it’s a once-daily pill compared to Tecfidera, which is required to be taken twice a day, but the side effects are night-and-day visible to me.

Aubagio, another pill-based drug from Sanofi, comes with even harsher warnings in the form of an FDA black box warning label. The warning specifically notes that Aubagio can cause severe liver problems that can lead to death. Additional side effects for the second-line treatment include kidney problems, high blood pressure, and breathing problems.

When given the choice of these three drugs, even with Tecfidera’s $50,000-$55,000 annual price tag, according to RBC Capital Markets analyst Michael Yee, I can almost assure you physicians and patients with any complication potential are going to opt for Biogen’s therapy.  

Biogen’s MS-sector domination
But, Biogen isn’t done there. The growing biotech behemoth recently paid $3.25 billion to acquire a full working interest in IV-based MS therapy Tysabri from Elan . The cash gives Elan the working capital to start over from a relatively empty portfolio while giving Biogen the chance to challenge Novarits, Sanofi, and Teva Pharmaceuticals in the MS arena.

Trust me, there’s little love lost in the MS sector with Teva’s $4 billion MS drug, Copaxone, …read more
Source: FULL ARTICLE at DailyFinance

Apple Falls Again As Dow Slips

By John Divine, The Motley Fool

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Nearing the end of the first quarter, the Dow Jones Industrial Average pumped the breaks, ending a bit lower today. With the markets closed for Good Friday, tomorrow is the last trading day of the month. A quick look back reveals just how bullish 2013 has been: Should the market trade evenly tomorrow, the benchmark index is on pace for 50% gains this year. Still digesting the messy Cyprus situation, the Dow ended down 33 points, or 0.2%, to finish at 14,526. 

Only a third of blue-chip stocks rose today, and UnitedHealth Group led all outperformers with gains of 1.7%. Though the sweeping changes in health care set to take place as a result of the Affordable Care Act haven’t fully taken place yet, investors hope that the larger pool of people with insurance will help providers like UnitedHealth. On top of that, the stock has some momentum behind it: It’s up more than 6% in the last month.

Still reeling from the fiscal concerns emanating from Europe, JPMorgan Chase finished 1.8% lower, to mark the third consecutive day where a financial ranks at the bottom of the Dow. But fears of being dragged down by foreign happenings aren’t the only thing holding JPMorgan back. The company’s also facing scrutiny from Washington, as investigations about everything from the Madoff scheme to rogue traders plague the bank.

Elsewhere, shares of Biogen Idec added 3.2% as Wall Street cheered news that the company’s new multiple sclerosis won FDA approval. The drug, Tecfidera, is projected to be the top oral treatment for MS, putting annual U.S. sales between $240 million and $300 million by some estimates. 

While it’s been a remarkable year for the market as a whole, the same can’t be said for Apple , which is down 15% since New Year’s Day and slipped another 2% to fall for a second straight day, as a Pacific Crest Securities analyst cut projections for second-quarter sales and EPS on tempered expectations for the iPad. While as recently as last fall we saw investors drooling about the tech giant’s prospects, today’s cautious outlook on Apple advises that it may be “attractive for investors with lower return requirements.”

There’s no doubt that Apple is at the center of technology’s largest revolution ever and that longtime shareholders have been handsomely rewarded, with more than 1,000% gains. However, there is a debate raging as to whether Apple remains a buy. The Motley Fool’s senior technology analyst and managing bureau chief, Eric Bleeker, is prepared to fill you in on both reasons to buy and reasons to sell Apple and what opportunities are left for the company (and your portfolio) going forward. To get instant access to his latest thinking on Apple, simply click here now.

…read more
Source: FULL ARTICLE at DailyFinance

Biogen Idec's TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multi

By Business Wirevia The Motley Fool

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Biogen Idec’s TECFIDERA™ (Dimethyl Fumarate) Approved in US as a First-Line Oral Treatment for Multiple Sclerosis

– Offers a Broad Spectrum of Patients with Relapsing Forms of MS an Effective and Convenient Treatment Option –

– Reduces Relapses and Disability Progression –

– Strengthens Biogen Idec’s Portfolio of Innovative Treatments for People Living with MS –

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TECFIDERA™ (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.

Image of Biogen Idec‘s TECFIDERA(TM) (dimethyl fumarate) which was approved by the U.S. FDA on March 27, 2013 for relapsing multiple sclerosis. (Photo: Business Wire)

TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.

“With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

The FDA approval of TECFIDERA is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.

In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), …read more
Source: FULL ARTICLE at DailyFinance

Is Amgen a Cash King?

By Jim Royal, The Motley Fool

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As an investor, it pays to follow the cash. If you figure out how a company moves its money, you might eventually find some of that cash flowing into your pockets.

In this series, we’ll highlight four companies in an industry, and compare their “cash king margins” over time, trying to determine which has the greatest likelihood of putting cash back in your pocket. After all, a company can pay dividends and buy back stock only after it’s actually received cash — not just when it books those accounting figments known as “profits.”

Today, let’s look at Amgen and three of its peers.

The cash king margin
Looking at a company’s cash flow statement can help you determine whether its free cash flow actually backs up its reported profit. Companies that can create 10% or more free cash flow from their revenue can be powerful compounding machines for your portfolio. A sustained high cash king margin can be a good predictor of long-term stock returns.

To find the cash king margin, divide the free cash flow from the cash flow statement by sales:

Cash king margin = Free cash flow / sales

Let’s take McDonald’s as an example. In the four quarters ending in December, the restaurateur generated $6.97 billion in operating cash flow. It invested about $3.05 billion in property, plant, and equipment. To calculate free cash flow, subtract McDonald’s investment from its operating cash flow. That leaves us with $3.92 billion in free cash flow, which the company can save for future expenditures or distribute to shareholders.

Taking McDonald’s sales of $25.5 billion over the same period, we can figure that the company has a cash king margin of about 14% — a nice high number. In other words, for every dollar of sales, McDonald’s produces $0.14 in free cash.

Ideally, we’d like to see the cash king margin top 10%. The best blue chips can notch numbers greater than 20%, making them true cash dynamos. But some businesses, including many types of retailing, just can’t sustain such margins.

We’re also looking for companies that can consistently increase their margins over time, which indicates that their competitive position is improving. Erratic swings in margins could signal a deteriorating business, or perhaps some financial skullduggery; you’ll have to dig deeper to discover the reason.

Four companies
Here are the cash king margins for four industry peers over a few periods.

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Source: FULL ARTICLE at DailyFinance

Company

Cash King Margin (TTM)

1 Year Ago

3 Years Ago

5 Years Ago

Amgen

30.1%

29.2%

39.7%

28%

Biogen Idec

29.5%

30.2%

20.8%

23.2%

Gilead Sciences

28.8%

41.8%

40.6%

37.6%

AstraZeneca

22.4%

20.8%

CHMP Issues Positive Opinion for TECFIDERA™ (Dimethyl Fumarate) as a First-Line Treatment for Multip

By Business Wirevia The Motley Fool

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CHMP Issues Positive Opinion for TECFIDERA (Dimethyl Fumarate) as a First-Line Treatment for Multiple Sclerosis in the European Union

-European Commission Decision Anticipated In Second Quarter of 2013-

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommending a marketing authorization be granted for TECFIDERA (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP, on the basis of quality, safety and efficacy data submitted by Biogen Idec, considers there to be a favorable benefit-to-risk balance for TECFIDERA.

The CHMP‘s recommendation is now referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. The U.S. Food and Drug Administration is expected to make a decision on the marketing application for TECFIDERA in the United States in the coming days.

“With the CHMP‘s positive opinion for TECFIDERA, we are one step closer to offering the European MS community a treatment with compelling efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.”

The CHMP opinion for TECFIDERA is based on data from a large clinical development program that included two global Phase 3 studies, DEFINE and CONFIRM, involving more than 2,600 RRMS patients, as well as an ongoing extension study in which some patients have been followed for more than four years. In DEFINE, TECFIDERA, administered twice-daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p<0.0001) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. In addition, both studies showed TECFIDERA significantly reduced lesions in the brain …read more
Source: FULL ARTICLE at DailyFinance

US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

By Business Wirevia The Motley Fool

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US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

– Patent Offers Protection Until 2028 and Strengthens Growing Product Patent Portfolio –

– European Patent Office Also Determines Patent Application Covering the Same Dosing Regimen Allowable –

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional protection for TECFIDERA™ (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg of TECFIDERA. This regimen is included in the proposed marketing application for TECFIDERA, which is currently under review by the U.S. Food and Drug Administration (FDA).

“The patent for this dosing regimen is recognition of the remarkable innovation TECFIDERA represents for the MS community,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “The tremendous research investment required to study and validate the patented dosing regimen is an example of innovation that leads to meaningful benefits to patients.”

The European Patent Office also recently determined that Biogen Idec‘s application for a patent covering the same dosing regimen of TECFIDERA is allowable. Once granted, this patent would also expire in 2028.

The TECFIDERA dose regimen patents add to the growing portfolio of granted patents covering TECFIDERA.

About TECFIDERA

TECFIDERA is the only currently known investigational compound for the treatment of relapsing-remitting multiple sclerosis (RRMS) that has experimentally demonstrated activation of the Nrf-2 pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.

In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg of TECFIDERA, administered either twice a day (BID) or three times a day (TID), for two years. TECFIDERA is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

About Biogen Idec

…read more
Source: FULL ARTICLE at DailyFinance

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

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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

…read more
Source: FULL ARTICLE at DailyFinance

Better Biotech Buy: Biogen vs. Celgene

By Dan Carroll, The Motley Fool

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Buying big pharma stocks isn’t the only way you can invest in today’s best-selling drugs without taking a gamble on a small, risky biotech. Some of yesterday’s fledgling biotech companies have become today’s powerhouses, boasting substantial pipelines and strong sales. Biogen Idec and Celgene have emerged as two of the top companies in the “big biotech” industry, and both stocks have rewarded shareholders handsomely recently: Celgene’s stock has rocketed up 50% over the past year, while Biogen’s has impressed by rising 46%.

There’s no doubting these stocks’ place at the top of the biotech arena, but the question is: Which one is the better buy?

Looking at the basics
Biogen hasn’t had much trouble on the financial side of things lately. The company’s driven revenue higher consistently in the last couple years, posting 9.2% growth in 2012 after 2011’s revenue rose 7% year-over-year. Those are appealing numbers for growth investors, and with Biogen following up by growing its diluted earnings per share in both 2011 and 2012, this company’s having no trouble showing shareholders the money.

Not that Celgene’s having much trouble, either. It actually outperformed  Biogen on a purely financial basis over the last couple years, raking in revenue growth of 13.7% in 2012 after a phenomenal 2011 brought in year-over-year growth of nearly 34%. Like Biogen, Celgene’s also done well in growing EPS over the past two years.

With success comes a cost, however: You’ll be paying a hefty premium for either of these hot stocks. Biogen trades at a price-to-earnings ratio of 30.7, with Celgene at an even stiffer 34.6 after its recent run-up. That’s in line with some of the other top biotech and pharmaceutical stocks, but these two companies will have to keep producing top-notch growth in order to keep up with investors’ optimism.

Can they do that? Fortunately, Celgene and Biogen both sport a number of drugs on the market and solid pipelines.

Celgene’s Revlimid advantage
Five drugs currently make up most of Celgene’s sales, but multiple myeloma drug Revlimid is the engine that makes the company go. The company’s top seller sold more than $3.7 billion last year, growing an outstanding 17.4% year-over-year. Revlimid’s patent won’t expire until 2027 in the U.S. and 2024 in Europe, offering Celgene plenty of time to take advantage of the exploding multiple myeloma market.

Research and advisory firm Decision Resources expects the market to climb to $7.2 billion by 2021 from $4.4 billion in 2011, and forecasts Revlimid to capture 64% of that market. That forecasts sales of more than $4.6 billion for Celgene’s leading drug, and while it still faces competition from Johnson & Johnson‘s Velcade — which has become one of J&J’s fastest growing blockbusters — Decision Resources predicts Velcade to remain in second place in this lucrative and growing market.

Celgene’s other drugs pale in comparison to Revlimid, unfortunately. The company’s nearly $3 billion acquisition of Abraxis BioScience in 2010 brought cancer drug Abraxane into the fold, …read more
Source: FULL ARTICLE at DailyFinance

Elan Provides Update on Tysabri Transaction and $1bn Share Repurchase

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Elan Provides Update on Tysabri Transaction and $1bn Share Repurchase

  • US and EU Regulatory Closing Conditions Satisfied
  • Dutch Auction Share Repurchase Process to Commence March 11, 2013
  • The Price Range will be $11.25 to $13.00
  • Shareholder Meeting to Approve Share Repurchase Set for April 12, 2013

DUBLIN–(BUSINESS WIRE)– Elan Corporation, plc (NYS: ELN) (the Company) today provides an update on the Tysabri Restructuring Transaction (“the Tysabri Transaction“) announced on February 6, 2013 and further information regarding the Company’s recently announced proposed $1billion share repurchase program.

Tysabri Transaction Update

The regulatory closing conditions in connection with the Tysabri Transaction are the review process under the Hart-Scott-Rodino Antitrust Improvements Act (“HSR“) in the United States and the review by the Spanish Competition Authority in Europe.

The waiting period for the US antitrust review under HSR expires today, Friday March 8, 2013. This follows the clearance earlier this week of the Tysabri Transaction by the Spanish Competition Authority. Consequently, in accordance with the terms of the Tysabri Transaction agreement with Biogen Idec, closing is expected to occur in the coming weeks.

$1billion Share Repurchase Program

Elan is also providing details of its proposed $1.0 billion share repurchase program (“Share Repurchase“) to be implemented following the close of the Tysabri Transaction.

The Share Repurchase is in addition to the unique Tysabri linked cash dividend announced on March 4, 2013, and will be effected through a tender offer, to be commenced on Monday next, March 11, 2013, by way of a “Dutch Auction”. The price range will be $11.25 to $13.00. In the event that the Share Repurchase is over-subscribed, the …read more
Source: FULL ARTICLE at DailyFinance

Biogen Idec to Present New Data on Diverse Neurological Portfolio at 65th AAN Annual Meeting

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Biogen Idec to Present New Data on Diverse Neurological Portfolio at 65th AAN Annual Meeting

– Biogen Idec’s MS Franchise Strengthened with Data for Novel Treatment Options –

– Encouraging Data on Early and Late Stage Pipeline Therapies Presented –

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) will present more than 50 company-sponsored platform and poster presentations on data supporting its multiple-marketed and pipeline therapies for neurological diseases at the 65th American Academy of Neurology (AAN) Annual Meeting in San Diego, March 16-23, 2013. The breadth of data presented demonstrates Biogen Idec‘s robust neurology research and development programs, and affirms the company’s decades-long leadership in multiple sclerosis (MS).

Biogen Idec is dedicated to addressing unmet medical needs of people living with neurological diseases through innovative science,” said Douglas E. Williams, Ph.D., executive vice president, Research and Development at Biogen Idec. “We are proud to have the deepest MS pipeline in the industry, supplied by a strong R&D neurology program. We will continue to focus on improving the lives of patients through novel scientific discovery, as well as by providing first-in-class treatments, unsurpassed patient support and educational services.”

Highlights include data on Biogen Idec‘s currently marketed products, TYSABRI® (natalizumab), AVONEX® (interferon beta-1a) and FAMPYRA® (prolonged-release fampridine tablets). The company will also present results from the investigational trials of its late-stage MS pipeline, including TECFIDERA™ (dimethyl fumarate), peginterferon beta-1a and daclizumab high-yield process (DAC HYP).

As part of the company’s overall commitment to improving the lives of people living with neurological diseases through education and support, Biogen Idec is proud to be a sponsor of the American Brain Foundation‘s 2013 Brain Health Fair, a day-long event that will take place on Saturday, March 16, 2013 in San Diego, CA. This event connects thousands of patients, families and caregivers affected by a brain disease. The Brain Health Fair will provide health screenings, educational activities for kids and teens, as well as “Brain Health Classes,” led by expert neurologists. Registration is free at BrainHealthFair.com.

Notable data from Biogen Idec at AAN 2013:

TECFIDERA

Alnylam to Webcast Presentation at Barclays Global Healthcare Conference

By Business Wirevia The Motley Fool

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Alnylam to Webcast Presentation at Barclays Global Healthcare Conference

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Alnylam Pharmaceuticals, Inc. (NAS: ALNY) , a leading RNAi therapeutics company, today announced that management will present a company overview at the Barclays Global Healthcare Conference on Tuesday, March 12, 2013 at 10:15 a.m. ET at the Loews Miami Hotel in Miami, Florida.

A live audio webcast of the presentation will be available on the News & Investors section of the company’s website, www.alnylam.com. A replay of the presentation will be available on the Alnylam website within 48 hours after the event.

About Alnylam Pharmaceuticals

Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases, including ALN-TTR for the treatment of transthyretin-mediated amyloidosis (ATTR), ALN-AT3 for the treatment of hemophilia and rare bleeding disorders (RBD), ALN-AS1 for the treatment of acute intermittent porphyria, ALN-PCS for the treatment of hypercholesterolemia, and ALN-TMP for the treatment of hemoglobinopathies. As part of its “Alnylam 5×15TM” strategy, the company expects to have five RNAi therapeutic products for genetically defined diseases in clinical development, including programs in advanced stages, on its own or with a partner by the end of 2015. Alnylam has additional partnered programs in clinical or development stages, including ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection and ALN-VSP for the treatment of liver cancers. The company’s leadership position on RNAi therapeutics and intellectual property have enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist, Ascletis, Monsanto, Genzyme, and The Medicines Company. In addition, Alnylam holds a significant equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam has also formed Alnylam Biotherapeutics, a division of the company focused on the development of RNAi technologies for applications in biologics manufacturing, including recombinant proteins and monoclonal antibodies. Alnylam’s VaxiRNA™ platform applies RNAi technology to improve the manufacturing processes for vaccines; GlaxoSmithKline is a collaborator in this effort. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 100 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, and Cell. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, please visit www.alnylam.com.

…read more
Source: FULL ARTICLE at DailyFinance