Tag Archives: Isis Pharmaceuticals

Roche, Isis Pharmaceuticals to Develop Huntington's Disease Treatments

By Dan Carroll, The Motley Fool

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Pharmaceutical firm Roche and biotech company Isis Pharmaceuticals have agreed to a partnership to develop treatments for Huntington’s disease. The two companies, which announced the agreement in a press statement on Isis’s site, will look to combine technologies and expertise in order to discover and bring drugs to market.

Roche will make a $30 million payment up front to Isis, part of a total payment schedule that could ramp up to $362 million in all if the development hits certain milestones. Roche can license any drugs Isis discovers through the first phase 1 trial’s completion. That option would leave Roche in charge of global development for a drug candidate, as well as navigating global regulatory hurdles and commercialization.

Isis’s lead drug candidate for the disease and Roche’s “brain shuttle” technology will both be explored as viable therapies for Huntington’s. Shafique Virani, Roche Partnering‘s global head of neuroscience, cardiovascular, and metabolism, explained the move in the statement: “This dual track development program ensures whichever candidate compound proves to be most promising — Isis’ lead target or Roche’s brain shuttle version — can be taken forward to pivotal clinical trials.”

Huntington’s disease currently has no effective treatment or cure, and the genetically inherited brain disorder eventually leads to patient death via complications. Current treatment options involve fighting or slowing symptoms of the disease, according to Isis’ statement.

The article Roche, Isis Pharmaceuticals to Develop Huntington’s Disease Treatments 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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Isis: Big Pharma's Little Friend

By Brandy Betz, The Motley Fool

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Roche  and Isis Pharmaceuticals  announcedMonday a new partnership for developing treatments for Huntington’s disease, an incurable neurological deterioration. The duo aims to improve drug penetration to target the proteins responsible for this fatal genetic disease.

Big pharma Roche has enough products and pipeline contenders that lessen the chance of one drug making waves. But Isis’ one approved drug has faced European rejection and will launch concurrently with a safer competitor.

Milestone payments from big pharma partners have carried Isis to Kynamro’s launch, and provided a way for the company to minimize its risk. Will the Roche deal continue this trend?

Big pharma partners
The Food and Drug Administration approved Isis’ lead drug candidate Kynamro in late January — a month after Aegerion‘s competing drug Juxtapid.  Both drugs will launch this year, vying for a small patient population. And Juxtapid’s better safety profile could crown it the winner.

Either way, Isis needs to keep moving to bring something else to market. Isis’ pipelineboasts more than 20 projects and many feature big pharma partners including GlaxoSmithKline, Sanofi , and AstraZeneca. That removes some of the risk from Isis’ shoulders.

But big pharma partnerships can become bittersweet for smaller companies that mostly exist in the development stage. Kynamro’s road to commercialization eased up with the backing of Sanofi, but it comes at the price of a profit share. Sanofi will market Kynamro in the U.S., which became the drug’s primary market thanks to the European rejection. Isis receives an initial 30% profit share that increases to 50% if the drug hits $2 billion in annual sales.

The other partnerships vary widely in how much Isis could benefit. But a large percentage of pipeline projects fail to make it through the approval process. That’s why the Roche deal could offer a further chance for Isis to spread its risk.

Huntington’s deal
Huntington’s disease causes uncontrolled movements and cognitive losses. The disease leads to death within 15 to 20 years of onset. There’s no cure for the disease or a way to slow down the progression. Available treatments, such as Valeant‘s Xenazine, simply help patients manage the symptoms.

Isis and Roche have teamed up to combine Isis’ antisense oligonucleotide, or ASO, technology with Roche’s “brain shuttle”  molecules developed to better penetrate the brain. Basically, the companies want to improve the ability of a drug to get into the brain and block the proteins causing Huntington’s.

But there’s a long road ahead before we begin to see if and how these drugs will work. What does the deal mean for Isis’ near, predictable future?

Roche paid $30 million upfront and could pay out up to $362 million in licenses and milestones. The company also has the option to license the developed drugs from Isis, but that move has to come before the end of phase 1 trials.

Foolish final thoughts
Enormous revenue potential would exist if the Isis-Roche-developed …read more

Source: FULL ARTICLE at DailyFinance

Why Regulus Therapeutics Is Poised to Keep Plunging

By Brian D. Pacampara, The Motley Fool

Filed under:

Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool’s free investing community, biopharmaceutical company Regulus Therapeutics has received the dreaded one-star ranking.

With that in mind, let’s take a closer look at Regulus and see what CAPS investors are saying about the stock right now.

Regulus facts

Headquarters (founded)

San Diego, Calif. (2007)

Market Cap

$1 billion

Industry

Biotechnology

Trailing-12-Month Revenue

$12.7 million

Management

CEO Dr. Kleanthis Xanthopoulos (since 2009)
COO Dr. Garry Menzel (since 2009)

Trailing-12-Month Return on Equity

(55%)

Cash/Debt

$98.1 million / $10.1 million

Sources: S&P Capital IQ and Motley Fool CAPS.

On CAPS, 85% of the 13 members who have rated Regulus believe the stock will underperform the S&P 500 going forward.

Just yesterday, one of those Fools, All-Star zzlangerhans, succinctly summed up the Regulus bear case for our community:

They have an enterprise value of [$150M] and all they have to justify it is their [Isis Pharmaceuticals/Alnylam Pharmaceuticals] pedigree. They won’t be submitting an IND for their first microRNA therapeutic until 2014, and their existing partnerships don’t provide much income. What concerns me the most is that their lead compound is an intravenous therapy for Hepatitis C. Where has management been for the last five years, as other companies have been demonstrating high rates of cure with all-oral regimens? The company now admits they will only be able to target a niche population that has failed other therapies. If that’s the best we can hope for from microRNA, I’ll stick with RNAi.

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The article Why Regulus Therapeutics Is Poised to Keep Plunging originally appeared on Fool.com.

Fool contributor Brian Pacampara has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. 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.

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

Should AstraZeneca and Bristol-Myers Squibb Get Married?

By Keith Speights, The Motley Fool

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It’s been quite a while since we had a big wedding in the pharma world. Sure, there have been plenty of small acquisitions, but no really big merger has happened over the past few years. One potential pharmaceutical friendship often rumored to possibly develop into something more serious involves AstraZeneca and Bristol-Myers Squibb . Would a marriage between these two companies be a match made in heaven? Let’s take a look.

Going to the chapel
If AstraZeneca and Bristol-Myers were people, we could easily spot one good reason for them to get married: They have a lot in common. Just look at the two companies’ portfolios.

Both organizations boast a strong presence in the cardiovascular market. AstraZeneca’s Crestor stands as a leading cholesterol drug with sales over $6.2 billion in 2012. Bristol-Myers’ blood thinner, Plavix, brought in $2.5 billion in sales.

Neuroscience stands out as another strong area for both companies. AstraZeneca made $2.8 billion last year from Seroquel IR and Seroquel XR schizophrenia and bipolar disorder drugs. Bristol-Myers’ Abilify treats the same indications and likewise brought in around $2.8 billion in 2012 sales.

Of course, it’s also important that married couples have differences that complement each other. That’s true for our two potential lovebirds. While sales for AstraZeneca’s Nexium and Losec/Prilosec are slowing down, they’re still contributing significantly. Bristol-Myers doesn’t count any gastrointestinal products among its leading drugs.

However, Bristol-Myers Squibb can claim success in at least one area that isn’t strong for AstraZeneca — treatment of HIV and AIDS. Combined sales for the company’s Reyataz and Sustiva HIV drugs topped $3 billion last year.

Another argument in favor of AstraZeneca and Bristol-Myers getting hitched is that they have children together. Well, sort of. Bristol-Myers Squibb bought Amylin Pharmaceuticals last year for around $7 billion. Nearly half of that amount was financed by AstraZeneca. Both companies share in the profits from Amylin’s diabetes drugs, including Bydureon and Byetta.

This wasn’t the first time AstraZeneca and Bristol-Myers collaborated in the diabetes arena. The two companies previously developed Onglyza together. However, sales for Onglyza weren’t as strong as hoped for as Merck‘s Januvia won greater market share. They also partnered on Forxiga, which has encountered its own difficulties.

Staying single
Cupid might need to shoot his arrows in another direction, though. There are at least a couple of reasons why a marriage between AstraZeneca and Bristol-Myers could be unlikely to happen.

First, both companies like to play the field quite a bit. While AstraZeneca’s relationship with Bristol-Myers has been close, the British drugmaker’s ties with Merck have been even closer in some ways. The company has also forged alliances with smaller companies, including a deal with Isis Pharmaceuticals for developing cancer drugs using Isis’ antisense technology. But the real merger prospect for AstraZeneca most frequently mentioned of late is Forest Labs. Several analysts see the company as an ideal fit for AstraZeneca.

Meanwhile, Bristol-Myers and Pfizer are joined at the hip …read more
Source: FULL ARTICLE at DailyFinance

EU Deja Vu for This Biotech's Orphan Drug

By Max Macaluso, Ph.D., The Motley Fool

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The steady stream of positive news coming from the EU’s CHMP today did not extend to Isis Pharmaceuticals and Sanofi . Unfortunately, the duo’s drug Kynamro, which is FDA-approved for the treatment of Homozygous Familial Hypercholesterolaemia in the United States, failed to win the green light from the CHMP for the second time.

What does this mean for Isis and Sanofi? And does this make Isis more vulnerable to its competitor Aegerion Pharmaceuticals ? Health-care analyst Max Macaluso dives into these issues in the following video.

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The article EU Deja Vu for This Biotech’s Orphan Drug originally appeared on Fool.com.


Max Macaluso, Ph.D. has no position in any stocks mentioned. The Motley Fool recommends GlaxoSmithKline. 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.

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

Why Cisco's Sinking the Dow This Morning

By Dan Caplinger, The Motley Fool

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The stock market is stuck in a waiting game as investors wait for a resolution to the Cypriot banking crisis. In the meantime, the U.S. economy appears to be continuing its slow but steady recovery, although pressures from China and elsewhere have started to show impacts on major U.S. companies and could pose a longer-term threat to the bull market. Weighing these countervailing factors, investors chose to be cautious, and as of 10:45 a.m. EDT, the Dow Jones Industrials had fallen 75 points, roughly in line with the broader market.

Cisco Systems led the Dow lower, falling 3.5% after getting downgraded by a Wall Street analyst. Last night’s bad news from Oracle is likely having collateral damage on Cisco, as Oracle reported a generally weak environment across its various tech segments, sending its shares down 9%. Although Oracle‘s key software segment isn’t something Cisco has a lot of exposure to, both companies are trying to broaden their product offerings to compete more directly with each other. In particular, a big decline in Oracle’s hardware systems may foretell problems ahead for Cisco’s own hardware division.

Outside the Dow, SUPERVALU has climbed almost 6% on news that it completed the sale of five of its retail grocery chains to private-equity firm Cerberus. In addition, Symphony Investors said its tender offer for SUPERVALU shares had attracted tenders for roughly 5.5% of the grocery company’s outstanding shares — far less than the 30% maximum under the offer. Moving forward, SUPERVALU will have to find a way to grow without some of its most reliable brands behind it, including Albertson’s and Jewel-Osco.

Finally, Isis Pharmaceuticals has risen 5.8% after it released data from its Phase 1 study of children with spinal muscular atrophy and the effect of its drug ISIS-SMN Rx in treating the disease. Reporting a favorable safety profile and signs of significant increases in muscle function, Isis is confident about the future development prospects for the drug, for which Isis hopes to start phase 2 and 3 programs for infants later this year and for older children in the first half of 2014.

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Source: FULL ARTICLE at DailyFinance

4 Can't-Miss Health-Care Events This Week

By Sean Williams, The Motley Fool

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With no PDUFA decisions on the plate this week, we’ll instead turn our attention to two important FDA panel meetings and two earnings reports that simply can’t be missed.

On Monday, DepoMed is expected to go before the FDA panel with its menopausal hot-flash drug, Serada. As TheStreet.com’s Aafia Chaudrey noted in early February, DepoMed’s first two Breeze trials were largely unsuccessful, with neither hitting their primary endpoints and dropout rates running very high. The Breeze-3 trial, from which this new drug application originates, demonstrates a reduction and frequency of hot flashes relative to placebo but still showed a higher number of patients dropping out of the trial because of adverse events than the placebo (16.7% to 11.5%). It’s really difficult to tell how the FDA‘s panel will perceive this data at the moment.

Later in the week, on Thursday, GlaxoSmithKline and Theravance will face the FDA panel with their long-term COPD solution, Breo Ellipta. The inhaled drug combines a long-acting beta agonist with a once daily inhaled corticosteroid to provider 24-hour relief to COPD suffers. In two mid-stage trials spanning 1,620 patients, the first trial demonstrated statistical significance at all three dosing levels, while the second demonstrated statistical significance at the lowest and mid-tiered dosing level. Both studies exhibited a reduction in COPD exacerbations, though not all figures were numerically significant. In short, Glaxo and Theravance could have a blockbuster on their hands, as long as the FDA panel feels the results show a marked improvement over existing treatments. Thursday is a key day for these two companies!

On the earnings front, I’m going to be looking forward to hearing from Aegerion Pharmaceuticals on Wednesday. Aegerion, which had its homozygous familial hypercholesterolemia, or HoFH, drug, Juxtapid, approved early by the FDA, beat Sanofi and Isis Pharmaceuticals‘ HoFH drug, Kynamro, to market. However, Kynamro’s pricing of “just” $176,000 per year significantly undercuts Aegerion’s $235,000-$295,000 annual cost. All told, I’m very interested to see how this might alter Aegerion’s pricing strategy and guidance moving forward. At a valuation nearing $800 million Aegerion is no longer cheap by any means, and it’ll need a pretty pristine forecast to impress shareholders.

Finally, on Thursday we’ll hear from Sarepta Therapeutics , which is expected to report its fourth-quarter results. Sarepta won over investors’ hearts last year with the amazing results of Eteplirsen in trials for Duchenne muscular dystrophy. Like most clinical-stage results, the actual figures won’t matter nearly as much as what CEO Christopher Garabedian has to say with regard to a potential accelerated new drug filing for Eteplirsen. Pay close attention to Garabedian’s comments on Thursday and, as a side note, keep an eye on Sarepta’s cash burn rate.

While you can certainly make huge gains in biotech and pharmaceuticals, 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 …read more
Source: FULL ARTICLE at DailyFinance

Notable ETF Outflow Detected – XBI, ISIS, PCYC, INCY

By ETFChannel.com

Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel, one standout is the SPDR S&P Biotech ETF (AMEX: XBI) where we have detected an approximate $23.9 million dollar outflow — that’s a 3.2% decrease week over week (from 7,700,000 to 7,450,000). Among the largest underlying components of XBI, in trading today Isis Pharmaceuticals, Inc. (NASD: ISIS) is off about 2.7%, Pharmacyclics, Inc. (NASD: PCYC) is up about 0.1%, and Incyte Corporation (NASD: INCY) is higher by about 1.1%. For a complete list of holdings, visit the XBI Holdings page » …read more
Source: FULL ARTICLE at Forbes Markets

For Isis CEO, A Victory After 24 Years Of Battle

By Matthew Herper Last night, the Food and Drug Administration announced the approval of Kynamro, a new drug to lower cholesterol in patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic disease that causes sky-high cholesterol levels and heart attacks at a young age. The medicine, invented by Isis Pharmaceuticals, will be marketed by Genzyme, the rare-disease specialty unit of Sanofi, the French drug giant.
Source: FULL ARTICLE at Forbes Health

FDA Approves Mipomersen For Homozygous Familial Hypercholesterolemia

By Larry Husten, Contributor The FDA said today that it had granted approval to the novel cholesterol-lowering drug mipomersen sodium for use as an adjunct to diet and drug therapy in patients with homozygous hypercholesterolemia. The drug, which was developed by Isis Pharmaceuticals, will be marketed under the brand name of Kynamro by Genzyme.
Source: FULL ARTICLE at Forbes Latest