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Islet Sciences Announces Cell Transplant Journal's Release on Novel Methods of Isolating Piglet Isle

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By Business Wirevia The Motley Fool

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Islet Sciences Announces Cell Transplant Journal’s Release on Novel Methods of Isolating Piglet Islets

NEW YORK–(BUSINESS WIRE)– Islet Sciences, Inc., (ISLT) a clinical stage company engaged in the research, development and commercialization of therapeutics in the field of diabetes, announced today that Cell Transplant Journal released on novel methods of isolating piglet islets, a technology owned by Islet Sciences.

“This release is another validator of our approach to tackling this worldwide disease,” stated John Steel, Islet Sciences Chairman and Chief Executive Officer. “We continue to make solid important strides in executing our business strategy and this paper represents another clear milestone. Importantly, with our long term supply agreement with Spring Point Project, an FDA approved facility for porcine tissue, this novel methodology for potential production of unlimited islet cells, provides a crucial foundation for our goal to provide islet cell replacement therapy for persons with insulin dependent diabetes. Islet Sciences initial targeted group are diabetics that have had kidney transplants and may benefit from the opportunity to have islet therapy to augment outcomes.”

“This work is exciting in that we have developed a novel method of producing viable piglet islets that is reproducible and scalable in doses of islets that will be required to transplant into patients with insulin dependent diabetes,” stated Dr. Jonathan Lakey, Chief Scientific Officer and Chairman of the Scientific Advisory Board of Islet Sciences.

Below is a link and copy of the Abstract:

http://www.ncbi.nlm.nih.gov/pubmed/23394130#

In vitro maturation of viable islets from partially digested young pig pancreas

Abstract

Isolation of islets from market size pig is costly, with considerable islet losses from fragmentation occurring during isolation and tissue culture. Fetal and neonatal pigs yield insulin unresponsive islet-like cell clusters that become glucose responsive after extended periods of time. Both issues impact clinical applicability and commercial scale-up. We have focused our efforts on a cost-effective scalable method of isolating viable insulin responsive islets. Young Yorkshire pigs (mean age 20 days, range 4-30 days) underwent rapid pancreatectomy (<5 min) and partial digestion using low dose collagenase, followed by in vitro culture at 37°C and 5% CO₂ for up to 14 days. Islet viability was assessed using FDA/PI or Newport Green and function assessed using glucose stimulated insulin release (GSIR) assay. Islet

From: http://www.dailyfinance.com/2013/04/12/islet-sciences-announces-cell-transplant-journals-/

Business, Finance, Occupation & Industry

Retailers Push The Dow Higher Again

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By Jeremy Bowman, The Motley Fool

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The Dow Jones Industrial Average took one step closer to a perfect week today, gaining 63 points or 0.4%, to finish at 14,865, as a number of strong retail reports helped boost investor confidence. Ross Stores, Rite Aid, and Zumiez all jumped 6% or more, pulling up the broader sector and the market as a whole, as investors seemed to be reassured that consumers were still spending despite the payroll tax increase, and concerns about sequestration. Tomorrow’s official retail sales report could help confirm today’s news.

A lower-than-expected initial unemployment claims report also helped push stocks higher. New jobless claims dropped to 346,000, from 388,000 the week before, perhaps proving that last week’s spike was just a fluke.

Tech stocks, however, were down sharply, as a report from International Data Corp. showed that PC shipments globally dropped 14% in the first quarter, the worst quarterly drop since the research firm started tracking sales in 1994. The tech-heavy Nasdaq was the poorest performer of the three major indexes, moving up just 0.1%.

Not surprisingly, Hewlett-Packard shares took the news, particularly hard, falling 6.5%. The report also showed that rival Lenovo gained market share, while HP and Dell dropped. Lenovo finished the quarter with a 14.7% share, just slightly behind HP, with 14.8%, according to Gartner. Microsoft and Intel were also off sharply as well, falling 4.4% and 2% respectively.

Pfizer was the biggest gainer on the Dow, a strong gainer for the second day in row, moving up 2.4% after the FDA called its new breast-cancer drug a “breakthrough” innovation. The FDA designation should help speed up the approval process for palbociclib, and comes at a time when Pfizer has been dealing with a patent cliff from the recent expiration of Lipitor.

The massive wave of mobile computing has done much to unseat the major players in the PC market, including venerable technology names like Hewlett-Packard. However, HP‘s rapidly shifting its strategy under the new leadership of CEO Meg Whitman. But does this make HP one of the least-appreciated turnaround stories on the market, or is this a minor blip on its road to irrelevance? The Motley Fool’s technology analyst details exactly what investors need to know about HP in our new premium research report. Just click here now to get your copy today.

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From: http://www.dailyfinance.com/2013/04/11/retailers-push-the-dow-higher-again/

Business, Finance, Occupation & Industry

The Dow's Top Stocks on a Record-Setting Day

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By Matt Thalman, The Motley Fool

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Thanks to a few top stocks, the Dow Jones Industrial Average managed to once again set a new all-time closing high at 14,865. Today, the index rose 62 points, or 0.42%, after investors received a better-than-expected jobless claims report, despite a few technology stocks plummeting. The Labor Department reported that initial jobless claims for last week fell by 42,000, to 346,000. Economists were only expecting a decline of 23,000 from the 388,000 claims which were reported two weeks ago.  

With the jobless numbers moving in a positive direction, the markets, as a whole, ended the session on a high note. While the Dow was the top index, the S&P 500 managed to rise 0.36%, as the Nasdaq lagged behind, only gaining 0.09%.

The Nasdaq was likely pulled lower by the IDC report, which indicated that PC sales declined 14% during the first quarter of 2013. This report pulled a number of technology stocks lower, but shares of Cisco slipped away from the downward pressure, and managed to become one of the index’s top stocks. Shares of the networking giant rose 1% during today’s trading session after climbing 2.4% yesterday, and 2% on Tuesday. Today’s move came on very little news, but Cisco certainly is gaining momentum. The company also recently announced a joint project with Microsoft, in which the two will work together to provide data center customers with more functionality and lower complexity. In addition, the two will work together to improve and grow data center operations.  

Another top stock today was Chevron , which saw its shares rise 1.09%. One likely catalyst for the rise was the recent Morgan Stanley report that claimed Chevron would outperform its fellow Dow component and competitor ExxonMobil by 55% over the next few years. Morgan Stanley believes Chevron could experience higher production growth and realize better returns in the coming years. The firm also raised Chevron’s price target to $135 per share, while reducing Exxon’s to $85 per share.  

Not only does Morgan Stanley believe Chevron is cheap, but my Fool Colleague Brian Pacampara also feels that way. To read what Brian has to say about the company, click here.

Shares of Pfizer rose 2.41%, making it the true “top stock” of the Dow today. The increase came after Pfizer announced that its palbociclib, an experimental treatment for breast cancer, received the Breakthrough Therapy designation by the FDA. This is a great development for the company, as it will now have the drug expedited through the regulatory process. Currently, the drug is in the later stages of testing, and this news should help it hit the market sooner rather than later.  

More top stocks

The Motley Fool’s chief investment officer has selected his No. 1 stock for this year. Find out which stock it is in the brand-new free report, “The Motley Fool’s Top Stock for 2013.” Just click here to access

From: http://www.dailyfinance.com/2013/04/11/the-dows-top-stocks-on-a-record-setting-day/

Business, Finance, Occupation & Industry

Dow Closes at All-Time Highs

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By John Divine, The Motley Fool

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Advancing for a fourth straight day, the Dow Jones Industrial Average responded kindly to falling jobless claims. Despite the undeniable bullishness of the stock market, the labor market remains an area of serious concern — the unemployment rate stood at 7.6% in February. So Wall Street cheered the slipping jobless claims Thursday, as the Dow added 52 points, or 0.4%, to end at 14,865, an all-time record close.

Within the index, Pfizer boasts some serious momentum of its own. The drug maker started rallying yesterday on news the FDA granted “breakthrough” status to a breast cancer drug, ensuring a more timely review process. The promising treatment, palbociclib, is in phase III trials, and the FDA announcement sent Pfizer 2.3% higher to 52-week highs today.

But, strangely enough, bearishness in the tech sector really defined the day. Hewlett-Packard led the laggards with 6.9% losses. The catalyst was a serious one: Research firm IDC reported the largest year-over-year quarterly drop in PC shipments ever. HP can find solace in the fact that it’s still No. 1 in overall shipments, but being No. 1 in a market that’s imploding isn’t much to be proud of.

Microsoft also got hit big from the news, cratering 4.8%. The miserable numbers have obvious consequences for the Windows operating system, and they show Windows 8 has failed to catch on with consumers. This puts major pressure on Microsoft to succeed in the emerging tablet and mobile device markets.

Lastly, Intel shares also suffered the effects of the 14% decrease in PC sales, losing 2.5% today. Unfortunately Intel got simultaneously hit by an analyst downgrade, citing the bleak PC outlook. It doesn’t help, as the Argus Research analyst noted, that CEO Paul Otellini is leaving the company, and no one’s quite sure who’s replacing him.

When it comes to dominating markets, it doesn’t get much better than Intel’s position in the PC microprocessor arena. However, that market is maturing, and Intel finds itself in a precarious situation longer term if it doesn’t find new avenues for growth. In this premium research report on Intel, our analyst runs through all of the key topics investors should understand about the chip giant. Click here now to learn more.

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From: http://www.dailyfinance.com/2013/04/11/dow-closes-at-all-time-highs/

Business, Finance, Occupation & Industry

President Obama Unveils a Plan to Smoke Big Tobacco

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By Sean Williams, The Motley Fool

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It was a good two months late, but yesterday both political parties and the American people got to read the fine print of President Barack Obama‘s proposed 2014 federal budget.

As you might expect, quite a few Democrats supported the main points of the budget, and House Republicans in almost every respect shunned the president’s outlined measures, which included higher taxes for upper-income earners and some spending cuts as well. Ultimately, there wasn’t much new and the bipartisan bickering that ensued has become a norm on Wall Street for the past couple of years.

82 billion reasons to quit
However, what did stick out like a sore thumb was Obama‘s budget proposal that entailed raising the federal tax on cigarettes from $1.01 per pack to $1.95 – a $0.94 increase! According to calculations associated with the president’s budget proposal, the increase would raise $78 billion over the next decade, which would be enough to fund a universal preschool program for children.

Source: White House. 

In addition, it’s estimated that $1 billion in long-term health care costs would be saved from a reduction in smoking caused by the increase in prices, and $3 billion would be added to the economy thanks to a healthier labor force. Added together, Obama‘s plan to smoke the tobacco industry — the irony here is that the president was once a smoker himself — could result in an $82 billion favorable swing over the next decade.  

While the magnitude of the tax provision astounded me, I’m not actually surprised to see a cigarette tax hike included in the president’s budget proposal with the implementation of the Patient Protection and Affordable Care Act, known as Obamacare, right around the corner. The president understands the costs associated with implementing a wave of health reform, and also understands that minimizing as many long-term health problems as possible (i.e., getting young people to stop smoking) will help his health care reform bill achieve success.

No ifs, ands, or butts about it!
Big tobacco companies, on the other hand, definitely didn’t take kindly to the president’s proposal, which represents the latest threat in a series of events meant to increase the public’s awareness of the dangers of smoking.

Last year, the Centers for Disease Control and Prevention took aim at the tobacco industry with a $54 million, three-month long marketing blitz advertising the dangers of cigarette smoking, while the Food and Drug Administration exerted its force on the industry by requiring tobacco producers to disclose the quantities of 20 known harmful chemicals found in cigarettes.

Before even the CDC and FDA got involved, individual cities and locales, such as New York, got involved by banning cigarette smoking inside restaurants and in largely public places like plazas and beaches.

The weight of these measures on domestic tobacco companies is really going to start taking its toll. Even if Obama‘s budget proposal fails to pass through Congress — and every political think

From: http://www.dailyfinance.com/2013/04/11/president-obama-unveils-a-plan-to-smoke-big-tobacc/

Business, Finance, Occupation & Industry

FDA Throws ACADIA a Juicy Bone

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By Brian Orelli, The Motley Fool

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There goes the short-term bear thesis on ACADIA Pharmaceuticals .

I had recommended staying away from the company for now because it looked too risky with a long wait before the company could complete its second phase 3 trial for pimavanserin in patients with Parkinson’s disease psychosis.

But after talking to the Food and Drug Administration, ACADIA said today that the agency has agreed that the current data is “sufficient to support the filing of a New Drug Application.” That doesn’t guarantee the FDA is going to approve the drug, but it’s certainly a positive sign.

The FDA generally requires at least two successful phase 3 trials, but will accept a single trial in certain instances when there’s an unmet need. There aren’t any drugs approved to treat Parkinson’s disease psychosis, although atypical antipsychotics such as Johnson & Johnson‘s Risperdal, Eli Lilly‘s Zyprexa, Bristol-Myers Squibb‘s Abilify, and Pfizer‘s Geodon are used off label to treat Parkinson’s patients experiencing psychotic symptoms, which affects up to 60% of Parkinson’s patients.

Shares of ACADIA are up more than 50% as I write this. That’s well deserved.

Not having to do the study should speed things up a little — ACADIA hadn’t even started the second phase 3 trial — but not by the full length of the trial. There are still drug-drug interaction studies and chemistry and manufacturing tests that need to be completed; the company doesn’t expect to file the marketing application until near the end of next year.

So, why are shares up so much? Not having to run a confirmatory trial reduces the risk substantially.

Pimavanserin produced solid data in its most recent trial. Patients taking the drug saw their SAPS-PD score, a measurement of hallucinations and delusions, drop by 5.79 points while scores for placebo patients only dropped 2.73 points. The difference was statistically significant.

But this wasn’t the first trial testing pimavanserin, or even the second. ACADIA ran two previous trials, which both saw patients in the placebo group improve substantially based on the assessment scale. For the latest successful trial, the company modified the scale — that’s the PD in SAPS-PD — to include the nine items most relevant to patients with psychosis associated with Parkinson’s disease.

The modification clearly worked, but there are no guarantees that it could be repeated. Patients entering the confirmatory trial would know that the drug had succeeded, which could boost the scores of the placebo patients.

So, is ACADIA a buy now? With the risk removed, it’s more appealing, but you have to be willing to wait. We’re still a year and a half away from filing the application, and then there’s another eight to 12 months before pimavanserin will be approved.

With a market cap of $950 million, there’s some room to run once the drug hits the market in 2015. Pimavanserin shouldn’t have too much trouble taking away sales from Risperdal, Zyprexa, Abilify, Geodon, and the like since it’ll be approved

From: http://www.dailyfinance.com/2013/04/11/fda-throws-acadia-a-juicy-bone/

Business, Finance, Occupation & Industry

ACADIA Pharmaceuticals Skyrockets on Accelerated NDA Filing

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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 ACADIA Pharmaceuticals , a clinical-stage biopharmaceutical company, skyrocketed as much as 54% after it announced that it was filing an accelerated new drug application for Pimavanserin after discussions with the Food and Drug Administration.

So what: Pimavanserin, an experimental anti-psychosis drug for people with Parkinson’s disease, breezed through its late-stage clinical trial, meeting the primary endpoint of “highly significant antipsychotic activity,” and also meeting the secondary endpoint of improved motoric tolerability. ACADIA had been planning to run a confirmatory phase 3 trial, which it planned to begin enrolling patients in this quarter. However, the data thus far, and the discussion between the FDA and ACADIA, warranted an early drug submission.

Now what: I’d say this is definitely a step in the right direction toward getting Pimavanserin approved. But, let’s also keep in mind that what the FDA does initially and what its panel or final ruling may indicate can occasionally be two different things. Another factor to consider is that most Wall Street peak sales estimates for Pimavanserin are around $300 million within the U.S. Acadia’s valuation is pushing $950 million following today’s pop, meaning it’s valued at more than three times peak sales. To me, that seems a bit lofty for its first potential FDA-approved drug.

Craving more input? Start by adding ACADIA Pharmaceuticals 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 ACADIA, 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 ACADIA Pharmaceuticals Skyrockets on Accelerated NDA Filing 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.
Try any of our Foolish newsletter services free for 30 days. We Fools may not 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.

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From: http://www.dailyfinance.com/2013/04/11/acadia-pharmaceuticals-skyrockets-on-accelerated-n/

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A "Breakthrough" May Be on the Way for Breast Cancer Patients

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By Sean Williams, The Motley Fool

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The process of developing a drug from start to finish is incredibly arduous, usually involves around $1 billion in costs, and can take upwards of a decade to complete. To boot, a vast majority of drug hopefuls are destined to fail. That’s why yesterday’s news from Pfizer and the Food and Drug Administration should get breast cancer sufferers’ blood pumping.

What’s behind the “breakthrough” designation
The FDA yesterday gave Pfizer’s Palbociclib the extremely rare and relatively new “breakthrough therapy” designation based on its phenomenal mid-stage trial results and the life-threatening nature of some of the cancers it could eventually treat.

The “breakthrough therapy” designation is about three months old — it was a designation added to the Food and Drug Administration Safety and Innovation Act last year — and is targeted at expediting experimental drugs through the development and review process. According to FDASIA, a breakthrough therapy is one that, “treat a serious or life-threatening condition, and preliminary clinical evidence indicates that the drug [or combination of drugs] may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.”

Very few breakthrough therapies have been approved up to this point — then again, we’re only working with about 100 days for the Food and Drug Administration to have assigned such a designation. Vertex Pharmaceuticals‘ received the first two “breakthrough therapy” designations from the FDA for two cystic fibrosis treatments, of which both involve the use of the already FDA-approved Kalydeco. The more intriguing “breakthrough therapy” designation is Pharmacyclics‘ Ibrutinib for the treatment of two rare blood cancers, which analysts feel could have a peak sales value of $5 billion if approved.

The awe-inspiring numbers behind the designation
The potential for Vertex’s cystic fibrosis dynamic duo and Pharmacyclics’ Ibrutinib in clinical trials so far cannot be refuted, but I don’t believe they hold a candle to the ridiculously strong clinical data that Pfizer’s combination of Palbociclib and Novartis‘ Femara brought to the table in its mid-stage metastatic breast cancer trial.

The decision to assign the “breakthrough therapy” designation had to do with the end results, which showed Femara by itself providing trial patients with 7.5 months of progression-free survival, or PFS, while the combination of Palbociclib and Femara more than tripled that level to 26.1 months of PFS. I read that and my jaw hit the floor! That is the precise definition of a breakthrough drug that, if safe in trials, should be ushered through the development and review process with the utmost urgency.

Palbociclib itself targets ER+, HER2-positive breast cancer (the most common form of breast cancer) and works by inhibiting two cyclin dependent kinases, or CDKs, 4 and 6. These CDKs are essential for cell replication and their suppression has been demonstrated to interfere with tumor cell progression in advanced stages of the disease. Analysts at both Leerink Swan and JPMorgan estimate that, if approved for multiple indications, Palbociclib could have sales

From: http://www.dailyfinance.com/2013/04/11/a-breakthrough-may-be-on-the-way-for-breast-cancer/

Business, Finance, Occupation & Industry

ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting wit

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By Business Wirevia The Motley Fool

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ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting with FDA

Single Pivotal Phase III -020 Study and Other Supportive Data Sufficient for Future NDA Filing for the Treatment of Parkinson’s Disease Psychosis

Conference Call and Webcast to Be Held Today, April 11, 2013, at 8:00 am Eastern Time

SAN DIEGO–(BUSINESS WIRE)– ACADIA Pharmaceuticals Inc. (NAS: ACAD) , a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application (NDA) for the treatment of Parkinson’s disease psychosis (PDP). As a result, ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month.

ACADIA is currently focused on completing the remaining elements of its pimavanserin PDP development program that are needed for submission of an NDA. These include customary supportive studies, such as drug-drug interaction studies, and CMC development, such as stability testing of registration batches. Subject to changes that could result from future interactions with the FDA or other developments, ACADIA is currently targeting an NDA submission near the end of 2014. While the FDA has agreed to accept and review an NDA for pimavanserin on the basis of ACADIA‘s positive pivotal -020 study, along with supportive efficacy and safety data from other pimavanserin studies, the NDA will be subject to a standard FDA review to determine whether the filing package is adequate to support approval of pimavanserin for PDP.

“We are very pleased with the outcome of our meeting with the FDA, which we expect will reduce substantially both the time and cost of our PDP development program,” said Uli Hacksell, Ph.D., ACADIA‘s Chief Executive Officer. “This represents another important step toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson’s patients who suffer from the psychosis frequently associated with this disease.”

Conference Call and Webcast Information

From: http://www.dailyfinance.com/2013/04/11/acadia-pharmaceuticals-announces-expedited-path-to/

Business, Finance, Occupation & Industry

Dow Hits the Fast Lane Toward 15,000

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By Jeremy Bowman, The Motley Fool

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The Dow Jones Industrial Average jumped again today, riding a wave that carried the S&P 500 up 1.2% and lifted the Nasdaq 1.8%. The blue chips finished the day with a gain of 129 points, or 0.9%, topping 14,800 at the closing bell.

The Dow got some help from the Federal Reserve, which released the minutes from its Open Market Committee earlier than expected. After learning that 154 people had gotten the release, including employees at some major banks, the central bank was forced to release the notes at 9 a.m. instead of the usual 2 p.m. There was little new information from the Fed, but the news seemed to confirm investors’ belief that the central bankers would keep present market stimulus measures in practice until the economy improves and the unemployment rate comes down. Some at the central bank said they wanted to reduce the Fed’s bond buying, but overall the market interpreted the report favorably. Hopes for a better-than-expected earnings season also appeared to drive stocks higher.

While tech stocks pushed the Nasdaq up nearly 2%, pharmaceuticals were the biggest gainers on the Dow. Merck jumped 2.9% after announcing that the FDA had accepted a new drug application for Noxafil, a drug for the treatment prophylaxis of invasive fungal infections. Merck is seeking approval for daily use of the application, which is already used for patients over the age of 13 who are immunocompromised. The new drug application is the first step in a long approval process, but since the drug is already in use, its chances of passing are significantly higher.

Pfizer received similar good news today, climbing 2.8% after the FDA called its experimental breast cancer drug, Palbociclib, a “breakthrough therapy.” The drug is in late-stage testing and could be a life-saving treatment for many women who suffer from the often-fatal form of cancer.

There were only four losers among the 30 Dow components today, among them Wal-Mart , which fell 1%. An Indian judge said he would seek more information from the world’s largest retailer about its illegal lobbying activities in India. As Wal-Mart seeks to further penetrate the world’s second-biggest country, it has again run into legal problems, which potentially include bribery. After hours, the company received some favorable news as the Retail Industry Leaders Association, which represents Wal-Mart along with other retailers, said it would opt out of a $7.2 billion settlement with Mastercard and Visa, a decision that could give retailers greater leverage over the credit card lenders that take a significant bite out of their profits.

Can Merck beat the patent cliff?
This titan of the pharmaceutical industry stumbled into 2013 and continues to battle patent expirations and pipeline problems. Is Merck still a solid dividend play, or should investors be looking elsewhere? In a new premium research report on Merck, The Fool tackles all of the company’s moving parts, its major market opportunities,

Source: FULL ARTICLE at DailyFinance

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Should You Buy Reckitt Benckiser Today?

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By Royston Wild, The Motley Fool

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LONDON — I believe that shares in Reckitt Benckiser  are vastly overpriced and are overdue for a weighty correction. The stock has risen 19% since the turn of the year, and currently trades at a 35% premium to Canaccord Genuity‘s 3,425 pence target price.

The firm is a giant in the household cleaning product and non-prescription health-care space and whose global brands include Dettol, Clearasil, Nurofen, and Durex, among others. But in my opinion, its loss of exclusivity on its Suboxone drug — which is used to combat narcotics addiction — could harm revenues moving forward and sour investor appetite for the company.

Rivals gear up for assault
The U.S. Food and Drug Administration (FDA) halted Reckitt Benckiser‘s patent on the anti-addiction product, a move that will herald the entry of cheaper, generic rivals to the Suboxone brand and harm sales over the medium to long term. Suboxone tablet sales in the U.S. represented around 5% of the firm’s total revenues last year, while film made up closer to 10% of group turnover.

Indeed, BioDelivery Sciences International announced last month that it plans to file an NDA with the FDA for its Bunavail film by July, which is considered a massive threat to Suboxone moving forward. It reckons that the new film could grab between 25% and 35% of the branded market, and plans to launch the product next year.

Earnings pressure set to materialize
Broker Liberum Capital expects earnings per share (EPS) to nudge 1% lower in 2013 to 262 pence, before the effect of falling Suboxone revenues drive EPS 4% lower to 252 pence. The company currently trades on a price-to-earnings (P/E) ratio of 17.7 and 18.5 for this year and next, trading at a premium to a forward earnings multiple of 14.5 for the wider household goods and home construction sector.

Reckitt Benckiser has steadily built the dividend in recent years — 2012’s 134 pence shareholder payout was up 7% from the previous year — but yields are expected to remain around the 3.3% FTSE 100 average over the medium term. A figure of 3.1% and 3.3% are expected by Liberum’s analysts in 2013 and 2014, respectively.

These prospective payments provide coverage just below the safety watermark of two times for these years, although I believe that the effect of falling earnings could cast doubt on the progress of its dividend policy moving forward.

The prescription for plump returns
Although Reckitt Benckiser presents too much risk in my opinion, check out this newly updated special report that highlights a host of other FTSE winners identified by ace fund manager Neil Woodford.

Woodford — head of U.K. Equities at Invesco Perpetual — has more than 30 years’ experience in the industry, and has identified two other fantastic pharmaceutical specialists in the report set to deliver spectacular investor returns.

The report, compiled by The Motley Fool’s crack team of analysts, is totally free and comes with no further obligation. Click here now to download your copy.

link

The article Should You Buy

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Big Pharma Led the Dow to New Highs Today

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By Dan Caplinger, The Motley Fool

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Investors have been as clear as they can be about what they see as their ideal situation. In the simplest terms, they want the support that the Federal Reserve has provided to the markets without any suggestion that they desperately need that support. That’s been a fine line for the Fed to walk, but the early announcement of the Federal Open Market Committee‘s latest minutes suggests that the central bank has managed to keep its balancing act going. Investors applauded the measured approach that the Fed is apparently taking, sending the Dow Jones Industrials up 129 points to another record high, while the S&P 500 hit levels it had never seen before, even on an intraday basis.

In writing about the Dow’s pharmaceutical components this morning, I had no idea they would eventually prove to be the stars of today’s session. But Merck and Pfizer both rose almost 3% today, because of a combination of company-specific news and general bullishness on the two dividend giants. Pfizer announced that its palbociclib experimental treatment for advanced breast cancer received FDA designation as a breakthrough drug, which should help it earn an expedited development and review schedule as Pfizer plans appropriate research for the drug.

For Merck, the positive news came from the FDA‘s review of the company’s application to create a pill form of its Noxafil drug to treat fungal infections. The treatment is already available in liquid form, but Merck believes that a pill version presents a valuable additional therapy option, especially for those with compromised immune systems.

Finally, MannKind jumped about 8%. The company is expecting to finish clinical studies in the next couple of months that could help determine the fate of its Afrezza inhalable insulin product, which MannKind wants to submit for FDA approval by the fourth quarter of 2013. Speculation about MannKind’s future has driven the stock to levels it hasn’t seen since early 2011, but the stock remains well off much higher levels from 2009 and 2010, as well as before the financial crisis struck.

Merck has done a reasonably good job of getting past the expiration of its Singulair asthma drug, but it continues to battle patent expirations and pipeline problems. Is Merck still a solid dividend play, or should investors be looking elsewhere? In a new premium research report on Merck, The Fool tackles all of the company’s moving parts, its major market opportunities, and reasons to both buy and sell. To find out more click here to claim your copy today.

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Source: FULL ARTICLE at DailyFinance

News, Politics, Government

Mining Electronic Health Records Reveals Clues Of Harmful Drug Reactions

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By Zina Moukheiber, Contributor  A study published today in Nature Clinical Pharmacology and Therapeutics showcases the potential power of sophisticated data analytics when applied to electronic health records on a large scale. By predicting harmful drug side effects two years before an alert from the Food and Drug Administration, the technology can complement the FDA’s Adverse Event Reporting System, which collects information from doctors, pharmacists, and patients once a drug is on the market. Less than three years ago, bioinformaticians at Stanford University set out to capture information buried, not just in insurance claims, lab tests or medical codes, but in the rich narrative of 10 million clinical notes gleaned from 1.8 million patients on Epic Systems electronic health records. “Ninety percent of patient data comes from clinical notes,” says senior author Nigam Shah, who teaches biomedical informatics at Stanford.  Along a binary matrix, Shah and his colleagues plotted de-identified patients, diagnoses, drugs and outcomes, among other variables. Patterns emerged detecting which patients, for example, with rheumatoid arthritis took Vioxx, and subsequently suffered a heart attack, as well different variations of the same variables. Drug dosages were not taken into account. Shah and his Stanford colleagues tested their model on nine drugs that were slapped with strong warnings after deadly side effects emerged, including Vioxx and Avandia. Their algorithms were able to detect adverse effects in six of them, two years before the FDA’s alert. (Stanford had 15 years of patient data). Shah says they didn’t have enough patients to get statistically significant information on three drugs, but that will change as more patient data gets stored in electronic health records.  

Source: FULL ARTICLE at Forbes Latest

Business, Finance, Occupation & Industry

Why the Dow Jumped 128 Points Today

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By John Divine, The Motley Fool

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Still gathering momentum in anticipation of corporate earnings, the markets rallied again today. Wall Street got some help from the Federal Reserve, which released the minutes of its latest meeting earlier than expected today. Bulls cheered the release, which suggested the central bank will only slow quantitative easing efforts when the job market improves markedly. Ending at an all-time record close, the Dow Jones Industrial Average added 128 points, or 0.88%, to finish at 14,802. 

Health care was one of the strongest sectors today, and Merck shares didn’t disappoint, adding 2.9% to lead the Dow. A Jefferies analyst raised his price target on the shares to $48, citing his bullish view on pharmaceuticals, because of compelling valuation. The company also announced that the FDA will review Merck’s application to market an antifungal drug it’s trying to hawk in Europe as well.

It’s no surprise that the FDA also played a role in Pfizer‘s 2.8% climb today; drug manufacturers often live and die by the rulings of the regulator. Shares soared after the FDA labeled an experimental breast cancer treatment as a breakthrough medicine, meaning the agency will give priority review to the drug, speeding up the process it requires to get to market.

With tech stocks also flying high today, Cisco Systems advanced 2.4% Wednesday. Trading a little over 10 times forward earnings and paying a 3.3% dividend, Cisco shares offer compelling value in a Dow that’s risen 13% this year alone. The company’s new offerings with Microsoft to boost data-center productivity may also help send the stock higher if they catch on quickly.

But not everyone can be winners. Wal-Mart Stores , for instance, was one of only four decliners in the Dow, slipping 1% on PR-related negativity. The executive who called the retailer’s sales “a total disaster” in February, sparking investor fear, is leaving the company. A Facebook group of Wal-Mart critics, “Making Change,” derided the departure as “more of the same failure to address the real issues.”

Once a high-flying tech darling, Cisco is now on the radar of value-oriented dividend lovers. Get the low down on the routing juggernaut in The Motley Fool’s premium report. Click here now to get started.

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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

InVivo Therapeutics' CEO Scheduled to Appear on WCVB-TV in Boston Tonight

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By Business Wirevia The Motley Fool

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InVivo Therapeutics’ CEO Scheduled to Appear on WCVB-TV in Boston Tonight

CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that CEO Frank Reynolds is scheduled to appear on WCVB-TV in Boston tonight, April 10th during the 11:00pm EDT newscast.

InVivo Therapeutics has pioneered a treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovery and prognosis after traumatic SCI.

Last week, the U.S. Food and Drug Administration (FDA) granted two approvals to the Company, the first for Humanitarian Use Device (HUD) designation, which the Company believes will expedite the product’s path to market, and the second to approve the Company to begin a first-in-man clinical trial of the technology.

“Our technology is a true platform that can be leveraged to create products for many neurotrauma conditions, and we look forward to beginning the study for our lead product to provide the first effective treatment option for acute SCI,” said Reynolds.

WCVB-TV is the ABC affiliate for the Boston market and airs locally on channel 5.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Certain statements contained in this press release that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, and the Company intends that such statements are subject to the safe harbor created thereby. These statements include, but are not limited to, those relating to the expected approval of the FDA to conduct

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Oral Hepatitis C Cure on Its Way

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By Brian Orelli, The Motley Fool

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Gilead Sciences moved one step closer to an all-oral cure for hepatitis C on Monday when the company submitted its application to the Food and Drug Administration to market sofosbuvir for the viral infection.

The current regimen for patients with hepatitis C involves taking one of two oral drugs — either Merck‘s Victrelis or Vertex Pharmaceuticals‘ Incivek — plus an oral generic called ribavirin and a branded a pegylated interferon drug, either Merck’s PegIntron or Roche‘s Pegasys. Pegylated interferons have to be injected, which patients generally don’t like, and more importantly, they also cause uncomfortable side effects, including flu-like symptoms. Considering they have to be taken for six months or more, it’s understandable why patients don’t like them.

Short-term subdued
Sofosbuvir passed four phase 3 trials. It seems very likely that the FDA will approve the drug in eight to 12 months depending on whether the drug is given a priority review.

But for most hepatitis C patients, sofosbuvir isn’t a cure-all by itself. When the drug is combined with ribavirin, it does a pretty good job at curing patients with genotype 2 and 3, but the most common genotype in the U.S. is genotype 1. Patients with genotype 1, along with genotype 4, 5, and 6, will still have to take PegIntron or Pegasys and ribavirin if sofosbuvir is approved.

While some patients will do just that, many will wait. Hepatitis C is a slow -cting disease. Eventually the virus starts to damage the liver, including potentially causing liver cancer, but it takes a long time to get that far. Most patients can wait for a better treatment.

They’re already doing that. Sales of Incivek and Victrelis peaked shortly not long after their launches as patients wait for better treatments. Sales of sofosbuvir will likely follow the same path. At least initially.

Long-term lucrative
Gilead is testing sofosbuvir in combination with another oral medication, GS-5885, with and without ribavirin in genotype 1 patients. If the phase 3 trials turn out positive, the additional data could be added to the label after it’s approved. Doctors can prescribe it off-label before that, but they’d have to wait for GS-5885 — or a fixed-dose combination pill that contained both medications — to be approved.

How big of a blockbuster sofosbuvir becomes depends on how good the data is compared to other all-oral cocktails being developed by AbbVie , Vertex, Johnson & Johnson , and many others. The cure rates will be important, but as they exceed 90%, safety and the amount of time patients have to take the drug will become more important.

Gilead, for instance, is testing sofosbuvir and GS-5885 with and without ribavirin for eight weeks. Even if it doesn’t beat AbbVie’s all-oral cocktail, which produced a 99% cure rate in one of its phase 2 trials, a shorter time frame might help attract patients.

The other main driver for sales will be how many patients

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

QE Optimism Pushes the Dow to Triple-Digit Gains

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By Dan Carroll, The Motley Fool

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Forget yesterday’s measly market records — the Dow Jones Industrial Average is once again smashing through its former highs. As of 2:15 p.m. EDT the blue-chip index has surged 145 points, or about 1%, on good news for the future of quantitative easing. A mere three stocks on the index are in the red. Let’s find dig into just why the Dow’s rising and what the future holds for America’s easy money.

The Fed rides to the rescue
The Federal Reserve released its minutes today to the delight of Wall Street. The actual details of the most recent Fed meeting impressed few; opinions among FOMC members on the future of “QE infinity” remain mixed, with some saying the stimulus program should be slowed soon and others contending that stimulus should continue until the economy improves significantly. However, with March’s disappointing payroll data showing an economy still in recovery mode, optimism abounds that the Fed won’t touch QE any time soon. The markets have been surging with the help of the central bank’s easy money, and that trend doesn’t look to be slowing down in the near future.

That’s good news for stocks everywhere, and GE has capitalized on today’s run. Shares of the conglomerate rank near the top of the Dow picking up more than 2% so far. The company announced today that it would open up patents for crowdsourced innovation, allowing inventors to use select GE patents in order to develop new things. It’s a unique idea that should pay off for GE, which would still stand to receive royalties from new innovations while allowing opportunistic individuals to benefit from its patent base. It’s not likely to push the stock higher in the immediate future, but it’s a sign that GE is committed to an innovative future despite its size and breadth.

Health care stocks are on the move as well today, with both Pfizer and Merck pulling in gains of more than 2.5%. Both companies are still hunting for new drugs to power their future revenue as patents of older blockbusters expire, but Pfizer got a big boost today. The company’s developmental breast-cancer therapy palbociclib received a breakthrough designation from the FDA today, ensuring a speedy developmental and review cycle. It’s not the buzz of an approval, but it’s a piece of good news for breast cancer patients and Pfizer alike that palbociclib has caught the FDA‘s attention in a good way.

Not all stocks are up today, despite the surge. Travelers just can’t find its footing. The stock has lost about 0.6% today, although Travelers has been as good a bet as any on the Dow over the past year: In that time, the stock has gained more than 47%. CEO Jay Fishman pointed out how falling bond yields have pressured the company’s investments, pushing it to raise insurance coverage rates for some customers. It’s not the end of the world for the company, but

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Are Monster's Buybacks a Bad Idea?

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By Steve Symington, The Motley Fool

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Shares of Monster Beverage rose nearly 5% Monday after the company’s board of directors approved a $200 million share repurchase program. As management stated recently, the company had already used every penny of the $250 million it authorized for share repurchases less than five months ago, so it looks like they were just itching to continue increasing shareholders’ slice of the pie.

Even so, I suppose this latest authorization shouldn’t have come as much of a surprise considering the company managed to spend more than $737 million in 2012, buying back shares at an average price of $54.47 per share — or about 3% below yesterday’s closing price.

Does it make sense?
Okay, we get it; the folks at Monster are trying to send investors a not-so-subtle message that they think their stock is undervalued.

But the question remains: Is it cheap in reality?

To their credit, the stock is trading 37% below its 52-week-high set last June. Even so, that’s because the company not only made investors suffer through a few subpar earnings reports amid slowing sales, but also continues to face unrelenting heat from consumers and regulators alike after its high-caffeine energy drinks were investigated as potential culprits in five deaths.

As I wrote last month, however, the FDA did later clarify they found no conclusive links between Monster Energy and the deaths in question. Even still, that hasn’t stopped the calls for increased regulation of its products by researchers and public health experts, and this controversy is one big reason I remain hesitant to touch the stock.

What’s more, while Monster’s current price-to-earnings ratio of 28.3 is certainly an improvement over last year’s high mark of just under 48, that doesn’t necessarily mean its shares are cheap today. Rather, considering Monster’s average trailing P/E ratio over the last five years is 26, it more likely indicates the stock was simply overpriced last June.

MNST P/E Ratio TTM data by YCharts.

So let’s try something a little less scary…
In the end, I’m still not convinced there’s anything particularly compelling about shares of Monster at current levels.

Instead, I’d much prefer sticking with a company like Coca-Cola  , which boasts a ridiculously wide moat and has demonstrated long-term staying power. While Monster’s core business relies on high-octane endorsements and caters to a relatively niche group of consumers, Coke’s wide appeal has helped it thrive for more than a century. And, for patient investors, it’s a safe bet Coke will be there to quench our thirst decades from now.

However, if Coke isn’t exciting enough for you, why not take a look at industry up-and-comer SodaStream , which has made a habit of getting its ads banned — to its benefit — by aggressively panning bigger competitors like Coke and Pepsi and differentiating its own at-home carbonation solution as a superior, environmentally friendly alternative. Even better, SodaStream also gives weary Monster investors a way to play the energy drink market

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

FDA's Breakthrough Therapy Designation More Bling Than Bite

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By Brian Orelli, The Motley Fool

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If one “Breakthrough Therapy Designation” is good, three must be great.

That is, if we knew what the designation was really worth.

Johnson & Johnson announced on Monday that it had received a third Breakthrough Therapy Designation for the blood cancer drug ibrutinib that it’s developing with Pharmacyclics . The designation covers patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have a deletion of the short arm of chromosome 17.

In February, the Food and Drug Administration gave the drug the designation for patients with relapsed or refractory mantle cell lymphoma that failed prior therapy and for patients with Waldenstrom’s macroglobulinemia, a type of cancer affecting B cells.

The Breakthrough Therapy Designation was part of the last year’s FDA Safety and Innovation Act, which is supposed to speed up development review time — potentially requiring less data for approval — for drugs that treat serious diseases where there isn’t a treatment or where the product in development is a vast improvement over current options.

But Congress, in its infinite wisdom, left exactly how to implement the benefits up to the FDA. That was probably a good idea in the long run since the FDA knows what drugmakers need, but the agency isn’t particularly quick in establishing rules.

Companies are left making announcements about a designation that they don’t know exactly how they’ll benefit from. “The implications of Breakthrough Therapy Designation cannot be determined at this time,” read the press release by Johnson & Johnson’s subsidiary Janssen Research & Development.

Vertex Pharmaceuticals had the exact same wording — maybe their flack went to the same law school — in the announcement that the FDA had given Breakthrough Therapy Designation to its cystic fibrosis drug Kalydeco as both a monotherapy and in combination with VX-809.

The biotech added that it’s working with the FDA and other regulatory authorities to figure out exactly how it’ll affect the development. It sure doesn’t look like the designation will help reduce the size of the clinical trials required for approval. Vertex subsequently announced that it’s started two 500-patient phase 3 trials testing VX-809 with Kalydeco in cystic fibrosis patients with two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.

The designation might not have much benefit, but don’t ignore the drugs involved; both Vertex’s combination treatment and ibrutinib have a lot of promise. Just this week, promising data from a clinical trial testing ibrutinib in hart-to-treat chronic lymphocytic leukemia patients was presented at the American Association for Cancer Research annual meeting.

At this point, the Breakthrough Therapy Designation is like wearing a broken luxury watch; it’s a nice status symbol, but it isn’t particularly useful. Some will argue that it says that the FDA thinks the drug has promise, but that should be obvious to most investors anyway. The drugs still have to prove their worth in clinical trials to get approved.

Is bigger really better?
Involved in everything from baby powder to biotech, Johnson & …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of

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By Business Wirevia The Motley Fool

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Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL ® (posaconazole)

WHITEHOUSE STATION N.J.–(BUSINESS WIRE)– Merck (NYS: MRK) , known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company’s antifungal agent, NOXAFIL® (posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA).

Merck currently markets NOXAFIL Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as patients who have received hematopoietic stem cell transplants and have graft-versus-host disease, or patients with cancers of the blood who are experiencing prolonged low white blood cell counts (neutropenia) as a result of chemotherapy.

“Invasive fungal infections are a significant cause of illness and death among severely immunocompromised patients,” said Robin Isaacs, M.D., vice president, infectious disease clinical research, Merck Research Laboratories. “This filing for a tablet formulation of NOXAFIL is an example of Merck’s ongoing commitment to developing new therapy options for patients in the hospital setting.”

Merck is seeking FDA approval of NOXAFIL tablets for once-daily administration (following a twice-a-day loading dose on the first day of therapy). The company has filed a marketing authorization application for NOXAFIL tablets with the European Medicines Agency (EMA) and plans to seek regulatory approval for the tablet formulation in other countries around the world.

Selected safety information about NOXAFIL (posaconazole) Oral Suspension

NOXAFIL is contraindicated in persons with known hypersensitivity to posaconazole, any component of NOXAFIL, or other azole antifungal agents.

NOXAFIL is contraindicated with sirolimus. Concomitant administration of NOXAFIL with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.

NOXAFIL is contraindicated with the CYP3A4 substrates that prolong the QT interval. Concomitant administration of NOXAFIL with the CYP3A4 substrates pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to QTc prolongation and rare occurrences of torsades de pointes.

NOXAFIL is contraindicated with HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) as increased plasma concentration of these drugs can lead to rhabdomyolysis.

NOXAFIL is contraindicated with ergot alkaloids. NOXAFIL may …read more

Source: FULL ARTICLE at DailyFinance