Rigel slumps on rheumatoid arthritis drug results

NEW YORK -- Shares of Rigel Therapeutics Inc. lost more than a third of their value Friday on mixed results from a late-stage clinical trial of a rheumatoid arthritis drug the company helped develop.

Rigel's partner AstraZeneca PLC said Friday that fostamatinib met one of its two goals in the study: patients who took the experimental drug and methotrexate, a standard treatment for rheumatoid arthritis, had a bigger improvement in symptoms like joint swelling and tenderness than patients who took methotrexate and a placebo. However, the drug did not meet a second goal related to bone erosion and reductions in joint space.

Rigel doesn't have any approved products, and fostamatinib is its most advanced experimental drug. The company licensed fostamatinib to AstraZeneca in 2010 in a deal that could be worth more than $1 billion if the drug is approved and meets sales targets.

Citi Investment Research analyst Yaron Werber said fostamatinib doesn't compare favorably to existing rheumatoid arthritis drugs or to others in clinical development.

Rigel stock lost $2.56, or 34 percent, to $4.97. Earlier the stock fell to $4.71, its lowest price in almost four years.

The late-stage trial included 923 patients who had not been helped by previous treatment with methotrexate. The results are based on 24 weeks of treatment. AstraZeneca said it expects to report results from two other studies of fostamatinib during the second quarter.

Rigel Pharmaceuticals is based in South San Francisco, Calif. AstraZeneca, which is based in London, is one of the world's largest drug companies. The British company licensed fostamatinib from Rigel in February 2010, paying $100 million upfront.

Werber said fostamatinib doesn't seem to be as effective as biotech treatments like AbbVie Inc.'s Humira and other potential rheumatoid arthritis drugs.

"The outlook for fostamatinib is becoming more challenging given these results and the fact that the arthritis market will be getting very competitive with several oral and biologic drugs in development," he wrote.

U.S.-listed shares of AstraZeneca rose 26 cents to $50.39 in morning trading.

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The Bad Results Of Low Artistic Expectations At The Academy Awards

An incredibly easy way to test whether someone is in a defensive crouch is whether or not they’re claiming that all publicity is good publicity. And the producers of the Academy Awards are doing precisely that after a widely-maligned ceremony hosted by comedian Seth MacFarlane.

“People have complained for years and years that the Oscars were becoming irrelevant,” Neil Meron told The Hollywood Reporter. “And I think what we did this year is to really make them part of the cultural conversation, and I think that’s the important part that people will take away.”

It’s awfully depressing that the ambitions for a production with a purported billion-person audience that’s meant to celebrate an industry that creates internationally compelling images and stories is to be “part of the cultural conversation.” Hosting awards shows is a difficult thing, requiring the hosts to be funny, potentially to be musical depending on the show, to frame guest presenters artfully, to act in sketches, to switch tones effectively between humor and honor. That’s not an easy mix of skills to find in a single person, and I understand why there are so many failures to design effective ceremonies, and why people like Billy Crystal and Whoopi Goldberg end up hosting so frequently.

But in a good awards ceremony, the content itself ought to be the news, and the host’s primary job should be to showcase the content. And if you have good content, particularly that which represents conflicting viewpoints and styles, which was the case at this year’s Academy Awards, that content should propel you into the news cycle. The contrasts between Argo and Zero Dark Thirty, and between Django Unchained and Lincoln alone should have been enough to generate a compelling drive towards the end of the evening. And if Meron and company weren’t interested in making the event into a competition, then why not stick with their theme, which was music in the movies? It could have been a way of narrowing the host’s tasks, and the kind of guests that the producers needed to recruit. But then, if you’re going to screw up the sound mixing on Adele’s performance, maybe that wasn’t a good idea either. At minimum, I’d hope the ceremony could have the same technical competence as the movies it’s celebrating.

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FDA reviewers say Titan drug results not as strong as hoped

March 19 (Reuters) - Titan Pharmaceuticals Inc's experimental drug to treat opioid addiction was shown to be more effective than placebo in a clinical trial, but the results were not as strong as might be hoped, reviewers for the U.S. Food and Drug Administration said in documents published on Tuesday.

The reviewers' commentary was published on the FDA's website ahead of an advisory panel meeting to be held on Thursday. The reviewers said results of the trial prompt speculation that Titan's drug needs to be given at a higher dose and they asked the panel to advise on whether the company should explore dosing further before the product is approved.

(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: FDA TITAN/

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UPDATE 1-Novo Nordisk obesity drug results underwhelm investors

* High-dose liraglutide only slightly better than 1.8 mg

* Placebo-adjusted weight loss 4 pct at 3 mg dose

* Shares fall 4 pct on worries over obesity potential

(Adds analyst comments, latest shares)

COPENHAGEN, March 18 (Reuters) - Overweight and obese diabetes patients given high doses of Novo Nordisk's drug liraglutide achieved 6 percent weight loss in a clinical trial, only slightly above the loss seen in those on a lower dose.

The Danish group, the world's biggest insulin producer, said on Monday it was pleased with the results. But investors worried about where it left Novo's strategy for a premium-priced high-dose obesity treatment and shares in the company fell 4 percent.

Novo Nordisk said subjects with Type 2 diabetes achieved 6 percent weight loss with 3 milligrams of liraglutide in the advanced Phase III trial compared to 5 percent in those on 1.8 mg.

Patients given a placebo also lost 2 percent of their weight, so the placebo-adjusted loss for the higher dose was 4 percent, analysts noted.

"Five and 6 percent is on the low side in efficacy, but it is important to note that it is enough to be approved by the FDA (U.S. Food and Drug Administration)," said Michael Friis Jorgensen, senior analyst at Alm Brand.

He said the share price reaction was harsh but reflected broader uncertainty about Novo's prospects, following an earlier setback for new diabetes drug Tresiba in the key U.S. market.

"We are pleased about the outcome of this trial and look forward to getting the results from the two remaining trials in the SCALE programme," said Mads Krogsgaard Thomsen, chief science officer at Novo.

Soren Lontoft Hansen, an analyst at Sydbank, endorsed Thomsen's view, arguing the results were "robust" - but an analyst at a major bank, who asked not to be quoted before he published on the subject, said the results were only "so so".

The fact there was just a marginal benefit from using the highest dose was a particular concern for the company's high-price strategy, he added.

Novo wants to turn the injected drug - already on the market as a treatment for Type 2 diabetes under the brand name Victoza - into a multibillion-dollar-a-year product for the seriously obese.

While some in the industry are sceptical about using so-called GLP-1 diabetes drugs such as liraglutide to fight obesity, Thomsen believes the approach can offer cost-effective benefits.

Glucagon-like peptide-1, or GLP-1, drugs work by stimulating insulin release when glucose levels become too high. Their ability to induce weight loss is an added benefit, since type-2 diabetes is linked to obesity.

Novo Nordisk expects to complete the two remaining Phase III

trials in the so-called SCALE clinical trial programme by mid-2013.

When used in diabetes as Victoza, liraglutide is given at daily doses of either 1.2 or 1.8 mg. Novo, however, has been betting on a higher dose to produce greater weight-loss in the obese.

Novo Nordisk shares were down 4.2 percent at 1245 GMT, underperforming a 0.4 percent fall in a European drugs sector index .

(Reporting by Johan Ahlander, Stine Jacobsen and Ben Hirschler; Editing by Tom Pfeiffer)

((johan.ahlander@thomsonreuters.com)(+46 707 211027)(Reuters Messaging: johan.ahlander.reuters.com@reuters.net))

Keywords: NOVONORDISK/

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HealthSouth climbs on 4Q results and 2013 outlook

NEW YORK -- Shares of HealthSouth Corp. jumped Tuesday after the hospital operator posted strong fourth-quarter results.

THE SPARK: HealthSouth reported its quarterly results Monday, while the market was closed for President's Day. The company said its net income declined, but it saw more patients and received more revenue per patient. HealthSouth said price adjustments by health insurers and Medicare helped its results. It also saw a larger percentage of Medicare patients than it had a year ago, and patients in the most recent quarter had more acute health problems.

The company said its net income slipped 5 percent, to $41.2 million, or 44 cents per share. Revenue grew 7 percent to $552.9 million. Analysts were expecting net income of 32 cents per share and $546 million in revenue, according to FactSet.

HealthSouth said discharges of patients at hospitals open at least a year grew 3 percent. That's an important measurement of hospital performance because it excludes results from facilities that opened or closed within the last year.

THE BIG PICTURE: HealthSouth says it is the largest owner and operator of inpatient rehabilitation facilities in the U.S. The Birmingham, Ala., company runs about 100 inpatient rehabilitation hospitals and more than 20 outpatient facilities in 27 states and Puerto Rico.

HealthSouth said it expects to earn between $1.50 and $1.56 per share in 2103 and said its revenue will be between $2.27 billion and $2.3 billion. The company said the upcoming federal budget sequester would reduce its annual earnings before interest, taxes, depreciation and amortization by about $25 million.

Analysts were forecasting net income of $1.66 per share and $2.24 billion in revenue, on average.

The sequester is a series of $85 billion in automatic budget cuts that is scheduled to go into effect March 1 if federal legislators can't agree on compromise legislation.

HealthSouth said its net income fell 12 percent to $160.3 million, or $1.69 per share, in 2012, and its revenue grew 7 percent to $2.16 billion.

HealthSouth also increased stock repurchase authorization to $350 million from $125 million. Stock repurchases increase companies' profit on a per-share basis because they reduce the number of shares on the market. They can also show that a company's management believes its stock is undervalued.

THE ANALYSIS: Raymond James analyst John Ransom said the results were better than the company suggested they would be in its January guidance. Ransom said HealthSouth did a good job of keeping its costs down and said its growth in 2013 looks good if the effects of the sequester and one-time items are excluded.

"HealthSouth continues to represent an outlier within the services landscape," he wrote.

Ransom rates HealthSouth stock at "Strong Buy."

SHARE ACTION: Shares of HealthSouth rose $2.03, or 9 percent, to $24.50 in afternoon trading. The stock has traded between $18.44 and $24.99 in the last year.

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Keryx shares keep climbing on drug trial results

Shares of Keryx Biopharmaceuticals Inc. extended its gains Tuesday, a day after the drug developer said its potential kidney disease drug, Zerenex, performed much better than a placebo in a late-stage clinical trial.

THE SPARK: The New York company said Monday that Zerenex showed a "highly statistically significant" change in serum phosphorus levels compared with a placebo in patients with advanced kidney failure who were on dialysis.

The drug also improved iron levels in patients, reducing the use of intravenous iron and other agents designed to treat anemia by boosting the oxygen-carrying component of the blood. The company said that should separate Zerenex from similar treatments on the market.

THE BIG PICTURE: Keryx has no products on the market, and Zerenex is its most advanced drug. The company plans to submit an application for approval of the drug to both the U.S. Food and Drug Administration and European regulators in this year's second quarter.

THE ANALYSIS: The magnitude of how much Zerenex decreases the need for the intravenous treatments was much better than expected, Stifel Nicolaus analyst Stephen Willey said in a research note. His estimate for peak, annual sales of the drug more than doubled to a range of $550 million to $600 million.

SHARE ACTION: Up 41 percent, or $2.48, to $8.54 in afternoon trading. The stock rose as high as $8.71 earlier in the session, its highest level since May 2010. It had soared 77 percent on Monday after Keryx announced the study results. The share price has more than tripled since the start of the year.

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Individual and Small Group Insurance Premiums and the Affordable Care Act: Analytic Results

Sorry, I could not read the content fromt this page.Sorry, I could not read the content fromt this page.

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National Security Brief: Netanyahu Weakened In Surprising Election Results

Israeli Prime Minister Benjamin Netanyahu and his allies “were sharply weakened” in national elections on Tuesday, forcing him to try to form a coalition government with his opponents. The Israeli newspaper Haaretz reports: In the past decades, the general understanding on the political scene was that Israeli elections are determined, above all, by voters’ sense of personal security. Apparently, however, the 2013 elections are different. Four years of relative calm did not help Prime Minister Benjamin Netanyahu. Neither did his implied threats that the Iranian bomb is approaching, and the Arab Spring is out there raging. Many voters took advantage of the calm to vote according to what really bothered them: their economic situation, the social gaps, the fact that some Israelis bear the burden of the military and taxation while others do not, or a sense of just being plain fed up with the existing regime.

In other news:

The Pentagon said that it will not demand payment to transport French troops to Mali in American planes, however the U.S. has not agreed to a French request to provide refueling tankers for its warplanes. Meanwhile, British special forces have arrived in Mali helping to co-ordinate and advise the French military effort against the jihadi groups in the north.

The Wall Street Journal reports: Afghan rural areas will be at greater risk of falling to the Taliban if the U.S. accedes to Kabul’s demands to speed up the withdrawal of special-operations teams working with Afghan village self-defense units, an internal report prepared for the U.S. military warned.

Secretary of State Hillary Clinton will appear before both House of Congress today to answer questions about the attack that killed American diplomats and other personnel in Benghazi, Libya last September. It will be one of her last duties as America’s top diplomat.

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The (Currently) Embarrassing WI-GOV Recall Primary Results Thread.

Hey, I never said *who* it was embarrassing for.

I’m not really going to stay up and watch this one, but here’s a quick question spawned from the results thus far:

With 10% of the vote in, why does the Republican who isn’t actually REALLY in a contested primary have more votes (78,370) than all of the Democrats in the contested primary combined (69,627)?

[UPDATE: Well, now it's 16%, and Walker is continuing to do better than all the Democratic candidates on this one.  Democrats were supposed to be enthusiastic about this recall, yes?]

[ANOTHER UPDATE: Yes, I'm just being a troublemaker.  Your point?]

[POSSIBLY LAST UPDATE: Oh, OK, with 24% of the vote in the Democrats finally caught up to the guy without a real opponent.  Well, it was funny while it lasted.]

[ANOTHER UPDATE ON THE VERY HEELS OF THAT UPDATE: Spoke too soon!  Spoke too soon!  The full update has Scott Walker ahead again!  Time for a page break: this is actually starting to get interesting.]

[BLINKING UPDATE: At 44%... OK, look, I was expecting this to fizzle out by now.  I mean, as a matter of course when one side has a contested primary and the other doesn't then you tend to expect a certain amount of depressed voting totals on the uncontested side.  That is a thing that happens.  But if this was the election itself, right now Scott Walker would be winning.  This is not good news for the Democratic party, although it's certainly good news for the people of Wisconsin.]

[NOT POLL-WATCHING UPDATE UPDATE: Hey, guess who's suddenly having one of those Unity Rallies?  Why, Tom Barrett.  At his house. Because at 61% of the vote in, Scott Walker is now looming over his would-be opposition.  And Tommy there needs every one of those votes.]

[IS THIS THE UPDATE WHERE IT ALL CHANGES? At 68% it looks like the entire Democratic field, combined is close to collectively beating Scott Walker.]

[AND IT WAS A GOOD RUN WHILE IT LASTED UPDATE.  Congratulations, Wisconsin Democrats.  At 70% your five candidates, combined, finally managed to pass Scott Walker, who was 'running' against ... a guy who beat a LaFolette.  This was not a good night for your party.]

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The Maryland (and other States) Primary Results Open Thread.

Maryland’s getting pride of place because it’s a) where I live and b) has actual, non-Presidential primaries tonight.  Presidential primary results here: Maryland’s state results are going to be… here, I guess.  Looks like (as of 8:30 PM) Romney won DC & MD; Dan Bongino is ahead in the MD-SEN nomination; and the may-not-recognize-her-luck Nancy Jacobs is ahead in the absolutely vital* MD-02 race.  Polls close at 9 PM in Wisconsin.

Open election thread.

*Look, I’ve been stuck dealing with either Steny Hoyer or Elijah Cummings as a representative since I moved to Maryland.  This is the first time I’ve lived in a Maryland district that merely has a single-digit Democratic PVI: people can let me have this.

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