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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

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.

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Source: FULL ARTICLE at DailyFinance

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Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C

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By Business Wirevia The Motley Fool

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Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C


— Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients —

FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences (NAS: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

Chronic HCV infection affects up to four million Americans, particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States. Treatment for HCV currently includes 24-48 weeks of therapy with peg-IFN, which has to be injected and is associated with significant side effects, leaving some patients unable to complete therapy. If approved, sofosbuvir would shorten HCV therapy to 12 to 16 weeks, and depending on the genotype, would either eliminate or reduce the duration of peg-IFN injections.

“Current therapies are not suitable for large numbers of patients with HCV infection, and are challenging to take and tolerate,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “Sofosbuvir’s antiviral potency, safety profile and once-daily administration have the potential to improve cure rates by simplifying and shortening therapy for patients with this disease.”

The sofosbuvir NDA is supported primarily by data from four phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV.

Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013. The European Medicines Agency (EMA) …read more

Source: FULL ARTICLE at DailyFinance

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Why Rigel Is Poised to Bounce Back

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By Brian Pacampara, The Motley Fool

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Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool’s free investing community, clinical-stage drug development company Rigel Pharmaceuticals has earned a respected four-star ranking.

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

Rigel facts

Headquarters (founded)

South San Francisco, Calif. (1996)

Market Cap

$392.1 million

Industry

Biotechnology

Trailing-12-Month Revenue

$2.3 million

Management

Chairman/CEO James Gower
President/COO Raul Rodriguez

Return on Equity (average, past 3 years)

(17.6%)

Cash/Debt

$298.2 million / $0

Competitors

Amgen

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

On CAPS, 97% of the 891 members who have rated Rigel believe the stock will outperform the S&P 500 going forward.

Just this past Friday, one of those Fools, All-Star zzlangerhans, tapped Rigel as a particularly attractive bargain opportunity:

The street responded to news of mixed results of the OSKIRA-1 phase III trial of fostamatinib … as though the trial was an unequivocal failure. In fact, the trial failed to show improvement over placebo in RA by radiographic criteria but did show stat sig improvement by clinical criteria. If this type of outcome holds through subsequent trials the company and partner AstraZeneca may submit an NDA on the basis that clinical improvement trumps radiographic improvement.

As of the end of 2012, Rigel has about [$300M] in liquid assets to support a market cap of [$392M] at [Friday’s] close. That’s a reasonable bet for a rebound, although my personal preference would have been to let the stock get beaten up further when OSKIRA-2 and OSKIRA-3 results are released later this quarter, and then hopefully mop up closer to cash.

If you want market-topping returns, you need to put together the best portfolio you can. Of course, despite its strong four-star rating, Rigel may not be your top choice.

We’ve found another growth play we are incredibly excited about — excited enough to dub it “The Only Stock You Need to Profit from the NEW Technology Revolution.” We have compiled a special free report for investors to uncover this stock today. The report is 100% free, but it won’t be here forever, so click here to access it now.

Want to see how well (or not so well) the stocks in this series are performing? Follow the TrackPoisedTo CAPS account.

The article Why Rigel Is Poised to Bounce Back 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 …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

3 Speculative Biotech Companies Primed to Pop

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By Keith Speights, The Motley Fool

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They don’t have any products on the market. They have little or no revenue. Earnings? Nada. Many people are betting that they will fail. And yet they could present some of the best investing opportunities on the market today. Here are three speculative biotech companies that appear to be primed to pop in the coming months.

All set to accelerate
With gains of 450% over the last year, one might be inclined to think that Sarepta Therapeutics has done all the popping it’s going to do. I don’t expect another run that large, but Sarepta still has plenty of upside potential.

The biotech company reported fantastic results in October from a phase 2 clinical study of eteplirsen in treating Duchenne muscular distrophy, or DMD. These results were so good that Sarepta is talking with the Food and Drug Administration about the possibility of moving ahead with accelerated approval. If the FDA gives early approval to eteplirsen, Sarepta’s stock will be off to the races again.

It’s far from a sure thing that the FDA will grant accelerated approval, though. To do so requires that the agency accept data from the phase 2 study showing eteplirsen’s increased production of dystrophin as a solid surrogate endpoint in lieu of demonstrating actual clinical efficacy. The FDA could determine that this data isn’t strong enough to warrant accelerated approval.

Even if Sarepta doesn’t win this faster path to market, I expect that eteplirsen will ultimately gain approval regardless. The drug looks to be a game-changer for DMD patients — and should be for Sarepta shareholders also. 

Zooming with Zerenex
Speaking of game-changers, Keryx Biopharmaceuticals could have one for end-stage renal disease, or ESRD, patients. Keryx announced outstanding results from a phase 3 study of Zerenex in January. The drug lowered serum phosphorus levels in ESRD patients significantly and demonstrated a good safety profile to boot.

Keryx shares are up a whopping 150% so far this year but have hovered around $7 per share for the past month. Is the stock poised for more big gains? I think so.

The biotech plans to submit a New Drug Application, or NDA, to the FDA in the second quarter. It will also follow up by mid-year with filing for European regulatory approval. Zerenex seems likely to garner positive decisions on both fronts. I suspect the submissions themselves could serve as mini-catalysts for the stock as investors are reminded about the potential for the drug.

There are some concerns, though. A couple of months ago, IPD Analytics questioned whether Zerenex would be granted New Chemical Entity, or NCE, status by the FDA. NCE status gives a drug five years of exclusivity. My view is that Keryx’s patent protection for Zerenex will be stout enough to protect the drug from generic rivals for quite a while even if NCE status doesn’t come through. 

Ready for a giant leap
MannKind stands closer than ever to taking a giant leap for its shareholders. The company expects …read more

Source: FULL ARTICLE at DailyFinance

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pSivida Reports on Resubmission to FDA of NDA for ILUVIEN® for Chronic Diabetic Macular Edema

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By Business Wirevia The Motley Fool

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pSivida Reports on Resubmission to FDA of NDA for ILUVIEN® for Chronic Diabetic Macular Edema

WATERTOWN, Mass.–(BUSINESS WIRE)– pSivida Corp. (NAS: PSDV) (ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN® for chronic diabetic macular edema (DME).

Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.

“We are pleased to see the resubmission of the NDA to the FDA,” said Dr. Paul Ashton, president and CEO of pSivida Corp. “To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”

pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula Edema (DME), licensed to Alimera Sciences, Inc., has received marketing …read more
Source: FULL ARTICLE at DailyFinance

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The Big Weight-Drug Wait

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By Keith Speights, The Motley Fool

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“Wait” seems to be the operative word for the obesity drug industry these days. Investors in VIVUS  are still waiting to see if Qsymia can attain the levels of commercial success that they anticipated. Arena Pharmaceuticals  anxiously awaits finalization of scheduling for Belviq by the slow-moving U.S. Drug Enforcement Administration. But the biggest wait of all belongs to Orexigen Therapeutics . Here’s the latest on the waiting game for the third potential weight-loss drug to hit the market — Orexigen’s Contrave.

In a hurry
After the initial New Drug Application, or NDA, for Contrave was not approved by the U.S. Food and Drug Administration, Orexigen hurried to move forward with the cardiovascular study needed to satisfy the FDA. The company launched this additional research, called the Light Study, in June. By early July, Orexigen announced that enrollment was going much faster than initially expected and could wrap up in first quarter of 2013 — taking around half the time originally anticipated.

That outlook actually proved to be pessimistic. Orexigen completed screening for the Light Study by mid-December, enrolling around 9,000 patients to participate in the study and cutting off more than a year from the initial timetable. The next major milestone for the research will be an interim analysis. That analysis can’t occur until 87 or so major adverse cardiovascular events, or MACE, occur with the patients. After the herculean efforts to get the study going so rapidly, Orexigen must now essentially wait for bad things to happen.

In January, the company announced that the resubmission process for the Contrave NDA could be hurried along somewhat. The FDA will allow a summary report from the Light Study interim analysis to be used with the NDA in lieu of a complete report. While the complete clinical study report will be required within 60 days of the resubmission, this decision cuts time out of the process.

How long will the waiting game take? Orexigen says that plans are to submit the NDA again by the end of this year. However, company executives have hedged in recent comments, stating that this time frame could be pushed back to early 2014 if the MACE rate is on the low end of the target 1% to 2% range.

Late to the game?
A key question for investors looking at Orexigen relates to how successful Contrave can be as a late entrant to the obesity drug market. With Qsymia already on the market and Belviq likely to launch in the U.S. any day now, will Contrave be too late to the game? The answer is: “It depends.”

If Arena and VIVUS manage to achieve tremendous success and develop great patient and prescriber loyalty for their drugs, Contrave could face an uphill battle to gain a foothold. VIVUS recently introduced promotions that appear to be designed to attract and hold on to customers in anticipation of near-term competition from Belviq. With the earliest possible commercial launch of Contrave still over a …read more
Source: FULL ARTICLE at DailyFinance

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NovaDel Reports Unaudited Financial Results for the Twelve Months Ended December 31, 2012

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By Business Wirevia The Motley Fool

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NovaDel Reports Unaudited Financial Results for the Twelve Months Ended December 31, 2012

BRIDGEWATER, N.J.–(BUSINESS WIRE)– NovaDel Pharma Inc. (NVDL.PK) reported unaudited financial results for the twelve months ended December 31, 2012.

As previously reported, the Company has entered into negotiations for the sale of its intellectual property and certain other assets to SUDA LTD, an Australian company listed on the ASX. An agreement has not as yet been reached. In addition, we are seeking a purchaser for our NitroMist® and ZolpiMist™ licenses together with the related NDA‘s. We are currently appealing the FDA fees levied on these products and they continue to be an impediment to the sale of the licenses.

The Company, at the end of March 2012, deregistered its common stock and exited the Securities and Exchange Commission reporting system.

The Company recorded a loss of $1,200,000 or $(0.01) per share for the twelve months ended December 31, 2012, compared to a net loss of $5,341,000 or $(0.04) per share in the twelve months ended December 31, 2011.

During the twelve months of 2012, the Company earned royalties from the license of NitroMist and ZolpiMist in the amount of $471,000. The Company also received $200,000 from the sale of NitroMist rights outside the US, Canada and Mexico. Also included in revenue is the recognition of previously received payments under various license agreements. In January, 2013, we terminated our ZolpiMist license agreement with Rechon Life Science AB. Rechon breached the initial performance clause of the license and under the terms of the agreement the license was terminated.

Expenses for the twelve months ended December 31, 2012, were $2,572,000 as compared to $4,700,000 and include amounts to maintain and expand our intellectual property base, as well as an expense accrual under a severance agreement with a former officer of the Company. The Company continues to closely manage its expenses as well as actively negotiate with its creditors to reduce its outstanding debts.

As of December 31, 2012, the Company has approximately $30,000 in cash and cash equivalents.

The current liabilities of the Company, at December 31, 2012, of $4,365,000 include fees due to the FDA approximating $2,800,000. The imposition of these fees is an impediment to our ability to raise capital to continue to develop our product opportunities or find a strategic partner. The Company has filed an appeal with the FDA for relief of the fees currently imposed and future fees relating to our licensed and marketed products. There is …read more
Source: FULL ARTICLE at DailyFinance

Health

Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension

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By Larry Husten For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. …read more
Source: FULL ARTICLE at Forbes Health

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2 Can't-Miss FDA Rulings Next Week

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By Sean Williams, The Motley Fool

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Normally, our weekly look at what’s going on within the health-care sectors involves a mixture of health-care conferences, FDA panel meetings and decisions, and a plethora of earnings reports. However, as we work our way into a holiday-shortened week thanks to Good Friday, it’s very evident that the upcoming week is going to be dominated by two FDA rulings with few earnings reports and no major conferences on the docket.

J&J for the win?
With a PDUFA date of Sunday, March 31, the FDA is expected to relay its decision on Invokana, Johnson & Johnson‘s Type 2 diabetes drug. Invokana was studied in multiple late-stage trials in patients with an elevated risk for cardiovascular disease and was shown to reduce A1C levels at a much better rate than the placebo. The more interesting tidbit is that one of the placebos in trial was Merck‘s blockbuster drug Januvia, which my Foolish colleague Brian Orelli noted was beaten in every respect by Invokana.

An approval for Invokana would be extremely intriguing, as it’s part of a new class of Type 2 diabetes drugs known as SGLT2 inhibitors. This new drug class works in the kidneys and inhibits the reabsorption of glucose so as to normalize glucose levels. At the moment, only one SGLT2 inhibitor is approved worldwide. That drug is AstraZeneca and Bristol-Myers Squibb‘s Forxiga, which is currently approved in Europe. However, it’s worth noting that Forxiga received a complete response letter in the U.S. because of concerns from the FDA about the potential for the experimental drug to cause cancer.

The skinny is that Invokana appears to support approval based on clinical data, but preceding concerns from Forxiga’s rejection hang a cloud over a guaranteed approval. J&J will definitely be a name worth keeping an eye on in the coming week.

Should United Therapeutics shareholders calm down?
Also with a PDUFA date of March 31 (honestly, what was the FDA thinking with these dates?) is United Therapeutics , with its oral treatment for pulmonary arterial hypertension, known as Treprostinil.

This is actually a new drug application resubmission for United Therapeutics, which received a complete response letter in late October. In that CRL, the FDA questioned the clinical important of the six-minute walking-distance test demonstrated in its Freedom-M study, the inability of United Therapeutics to demonstrate an improvement in time to clinical worsening in all of its late-stage trials, and an inability to demonstrate a statistically significant improvement in the 6MWD in two of its Freedom-C trials.

United Therapeutics responded by resubmitting its NDA in mid-February, much more quickly than anyone had expected.This is noteworthy, because it appears that United Therapeutics has decided not to run any additional trials. Investors probably shouldn’t expect a huge move either way, but I’d say there’s more downside risk potential at these levels than upside potential if approved.

Is bigger really better?
Involved in everything from baby powder to …read more
Source: FULL ARTICLE at DailyFinance

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3 FDA Decisions You Need to Watch in 2013

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By Keith Speights, The Motley Fool

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Sequester or no sequester, the folks at the Food and Drug Administration look to be quite busy in 2013. Their schedules are full with plenty of important decisions that could greatly impact the fates of biotech and pharma companies — and the fortunes of shareholders as well. Here are three FDA decisions that you should watch over the coming months.

1. Will Vascepa be allowed to play limbo?
Much ado has been made about when the FDA will decide on New Chemical Entity, or NCE, status for Amarin‘s cholesterol drug Vascepa and what that decision will be. However, a much more significant FDA decision this year for Amarin will be related to the supplemental New Drug Application, or sNDA, submitted by the company in late February for use of Vascepa in patients with less severe levels of triglycerides.

Vascepa, a highly refined fish oil pill, is currently approved for patients with severe hypertriglyceridemia, which involves triglyceride levels greater than or equal to 500 mg/dL. If the recently submitted sNDA is ultimately approved, patients with greater than or equal to 200 mg/dL triglyceride levels will be able to take Vascepa. This submission is extremely important for Amarin, because the number of patients in this group is around 10 times the size of those with severely high triglyceride levels. 

Amarin should hear from the FDA within the next couple of months about whether the sNDA has been accepted for review. If it is accepted, the final decision on approval for the new indication would be given in late 2013. If Vascepa is allowed to play limbo by lowering the bar for triglyceride levels, Amarin’s shares should skyrocket.

Antares Pharma anxiously awaits an FDA decision in October for Otrexup, a self-injection for the treatment of rheumatoid arthritis. The FDA announced on Feb. 27 that Antares’ NDA had been accepted for review.

Otrexup uses Antares’ Medi-Jet parenteral drug delivery system to allow patients to self-administer methotrexate, or MTX. An estimated 70% of the 1.3 million Americans with rheumatoid arthritis take MTX alone or with another therapy. MTX is available in tablet form or via injection, but better absorption of the drug is obtained through injection. Antares hopes to capture a nice chunk of the market for those patients who currently self-administer with conventional needles or pen injectors.  

Should the FDA approve Otrexup, the prospects for Antares seem to be quite good. I suspect that many patients will like the idea of taking MTX with the easier self-injection approach offered by the Medi-Jet technology. 

3. A Tivo for kidney cancer?
By the end of July, we’ll know if a “Tivo” for kidney cancer will become available. I’m referring to Tivopath, AVEO Pharmaceuticals‘ proposed brand name for its drug tivozanib. The FDA accepted the NDA for tivozanib in November and set a final decision date of July 28 of this year.

Tivozanib targets treatment of an advanced form of kidney cancer that occurs in more than 250,000 …read more
Source: FULL ARTICLE at DailyFinance

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Results of Lymphoseek® Phase 3 Clinical Trials in Breast Cancer Published in Annals of Surgical Onco

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By Business Wirevia The Motley Fool

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Results of Lymphoseek ® Phase 3 Clinical Trials in Breast Cancer Published in Annals of Surgical Oncology


– Lymphoseek Meets Primary Efficacy Endpoint in Assessment of Lymphatic Mapping Performance in Patients with Breast Cancer –

DUBLIN, Ohio–(BUSINESS WIRE)– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, today announced the peer-reviewed publication of results from two Phase 3 clinical trials of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with breast cancer. The trials assessed the performance of Lymphoseek against the standard of care, vital blue dye (VBD), in lymphatic mapping. Results demonstrated that Lymphoseek met its primary efficacy endpoint of rate of agreement, or concordance, with VBD. The study, “Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials,” was published in the current online edition of the journal Annals of Surgical Oncology [DOI 10.1245/s10434-013-2887-8].

Lymphoseek is a receptor-targeted radiopharmaceutical recently approved by the U.S. Food and Drug Administration and indicated for use in lymphatic mapping for breast cancer and melanoma. In this procedure key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer has spread to these lymph nodes.

“Lymphoseek was specifically designed to provide clinicians who perform lymphatic mapping procedures with actionable information, and we believe that the data reported in this publication demonstrate its utility and safety in identifying tumor-draining lymph nodes,” said Frederick Cope, Ph.D., Senior Vice President, Pharmaceutical Research and Clinical Development of Navidea. “These data from breast cancer patients, in conjunction with previously published data from our Phase 3 clinical trials in melanoma, comprise part of our NDA registration package for Lymphoseek with the FDA. We are confident that Lymphoseek may hold significant improvement for patients who undergo lymphatic mapping procedures.”

“Tilmanocept was originally developed at UCSD as a targeted molecular approach to help stage breast cancer and melanoma patients, and we advanced the agent through Phase 1 clinical trials with funding provided by Susan G. Komen Breast Cancer Foundation and the American Cancer Society,” said Anne Wallace, M.D., Chief, Division of Plastic Surgery; Professor of Surgery, UC San Diego School of Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer Center; and a Principal Investigator in the Lymphoseek Phase 3 clinical trials. “The results from these Phase 3 clinical trials …read more
Source: FULL ARTICLE at DailyFinance

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Diazepam Nasal Spray Demonstrates Comparable Bioavailability to Diazepam Rectal Gel in Pharmacokinet

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By Business Wirevia The Motley Fool

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Diazepam Nasal Spray Demonstrates Comparable Bioavailability to Diazepam Rectal Gel in Pharmacokinetic Study

– Data on Investigational Epilepsy Treatment Diazepam Nasal Spray Presented at the 65th American Academy of Neurology Annual Meeting

ARDSLEY, N.Y.–(BUSINESS WIRE)– Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced data from a Phase 1 study that showed a single dose of 20 mg Diazepam Nasal Spray had comparable plasma bioavailability to 20 mg of diazepam rectal gel. Diazepam Nasal Spray is being developed for the treatment of people with epilepsy who experience cluster seizures, also known as acute repetitive seizures. These pharmacokinetic data were presented at the 65th American Academy of Neurology Annual Meeting in San Diego, CA.

“Currently, the rectally-administered form of diazepam is the only FDA-approved outpatient therapy for people with epilepsy who experience cluster seizures. We believe that a nasal spray formulation offers a more accessible and socially acceptable therapeutic alternative dosage form for people with epilepsy,” said Enrique Carrazana, M.D., Acorda’s Chief Medical Officer. “This new mode of diazepam delivery can provide an important new treatment option for people with epilepsy and their caregivers.”

This was an open-label crossover study conducted in 24 healthy volunteers, who received a single dose of 20 mg diazepam nasal spray and a single dose of 20 mg diazepam rectal gel. Both the nasal spray and rectal gel were generally well tolerated and showed similar safety profiles, with mild nasal and pharyngeal irritation more frequently observed with the nasal spray.

Acorda plans to submit a 505(b)(2)-type New Drug Application (NDA) for Diazepam Nasal Spray to the U.S. Food and Drug Administration (FDA) in 2013 and rely upon FDA‘s previous findings of safety and efficacy for the reference listed drug, diazepam rectal gel. The Company has completed three pharmacokinetic studies of Diazepam Nasal Spray that will be included in the NDA submission.

About Epilepsy and Cluster Seizures (Acute Repetitive Seizures)

Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions. Seizures are symptoms of abnormal brain activity, and occur when a brief, strong surge of electrical activity affects part or all of the brain.

The Centers for Disease Control and Prevention (CDC) estimates that approximately 2.3 million adult Americans have active epilepsy. Cluster seizures, also known as acute repetitive seizures, are characterized by recognizable, recurring episodes of seizure clusters. In the U.S., there are up to 175,000 people with …read more
Source: FULL ARTICLE at DailyFinance

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Impax Pharmaceuticals Announces Presentation of RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-

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Impax Pharmaceuticals Announces Presentation of RYTARY TM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data at the American Academy of Neurology 2013 Annual Meeting

HAYWARD, Calif.–(BUSINESS WIRE)– Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NAS: IPXL) , today announced the presentation of results from its RYTARYTM (IPX066) Phase III and open-label extension trials at the 65th Annual Meeting of the American Academy of Neurology in San Diego, CA on March 18, 2013. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease. The IPX066 data was presented as part of a poster session, entitled “Movement Disorders: Parkinson’s Disease Therapy.”

The presentation of IPX066 posters was as follows:

Date and Time (all posters):
March 18, 2013 from 2:00-6:30, with authors in attendance from 5:30-6:30 PM (local time)

Presentation Title and Number:

Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Motor Fluctuations in Advanced Parkinson’s Disease
Abstract / Poster Number: 3706/ P01.065

Presentation Title and Number:

Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Early Parkinson’s Disease
Abstract / Poster Number: 3662/ P01.064

Presentation Title and Number:

Analysis of IPX066 Dosing Data in Advanced Parkinson’s Disease (PD) Patients
Abstract / Poster Number: 49/ P01.063

On January 21, 2013, Impax received a complete response letter which indicated that the FDA could not approve the NDA for IPX066 at that time. The complete response letter stated that satisfactory resolution and verification of the deficiencies identified during the inspection of the manufacturing facility in Hayward, California would be required before the NDA for IPX066 may be approved. On March 4, 2013, the Company announced the receipt of a Form 483 following an inspection by the FDA of the Hayward facility. The Form 483 contained several observations specific to IPX066 which the Company believes must be satisfactorily resolved before the NDA for IPX066 may be approved.

Open-Label Extension Study in Advanced Parkinson’s Disease (PD) Patients

Advanced PD patients with motor fluctuations …read more
Source: FULL ARTICLE at DailyFinance

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Avoid This Biotech Stock

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By Dan Dzombak, The Motley Fool

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Editor’s note: This article is a stock pitch made by a member on CAPS, The Motley Fool’s free investing community. The pitch is published unedited and is the opinion of the CAPS member whose pitch it is, in this case: zzlangerhans.

Each week, I cull a top stock idea from the pitches made on CAPS, the Motley Fool‘s 180,000-member free investing community. Want your idea considered for this series? Make a compelling pitch on CAPS with a minimum length of 400 words. Want to follow the weekly picks? Follow me on Facebook or Twitter.

Company

Chelsea Therapeutics

Star Rating (out of 5)

*

Industry

Biotechnology

Market Cap

$128 million

 

Chelsea Therapeutics Underperform Pick

Submitted By

zzlangerhans

Member Rating

99.56

Submitted On

3/12/2013

Stock Price At Underperform Recommendation

$2.00

Sources: S&P Capital IQ, Yahoo! Finance, and Motley Fool CAPS.

This Week’s Pitch:

Chelsea is definitely the soapiest soap opera of biopharma. It’s virtually impossible to keep track of the multiple trials, the changing endpoints mid-trial, the dubious and equivocal trial results, the company’s nebulous plans for regulatory submissions, and the company’s confusing descriptions of FDA communications regarding their trials and regulatory submissions. The only consistent outcome is that the binary catalysts constantly seem to find the market wrongfooted.

I think once again the market is taking Chelsea in the wrong direction, enthusiastically bidding up the share price on news that the FDA has reversed itself and stated that study 306B has the potential to serve as the basis for a Northera NDA resubmission. Of course, there’s a big difference between serving as the basis for an NDA submission and the basis for an NDA approval. And the market seems to have forgotten that the 306B topline data was actually pretty bad, with no evidence of statistically significant benefit beyond the first week of treatment.

…The FDA has shocked me before, for example by reversing themselves and approving Vanda’s Fanapt a few years ago. But in general I find it wiser to go with the FDA‘s usual approach to this type of weak NDA application rather than to bet on the black swan.

Foolish bottom line
While this CAPS All-Star thinks you should avoid Chelsea Therapeutics, one of our top health care analysts has a stock you won’t want to avoid. Our brand new free report explores the scourge of rising health care costs and identifies a company poised to profit from one of the problem’s eventual solutions. Just click here for free, immediate access.

The article Avoid This Biotech Stock originally appeared on Fool.com.

Fool contributor Dan Dzombak can be found on Twitter @DanDzombak or on his Facebook page, DanDzombak. The Motley Fool has no position in any of the …read more
Source: FULL ARTICLE at DailyFinance

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RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extens

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RYTARY TM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data to be Presented at the American Academy of Neurology Conference

HAYWARD, Calif.–(BUSINESS WIRE)– Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NAS: IPXL) , today announced that data from the RYTARYTM Phase III and open-label extension trials will be presented at the 65th Annual Meeting of the American Academy of Neurology in San Diego, California, held from March 16 to March 23. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease.

The presentation of IPX066 posters is as follows:

Date: March 18, 2013 (all posters)
Time: 2:00-6:30, with authors in attendance from 5:30-6:30 PM PT (all posters)
Location: San Diego Convention Center

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules
in Patients with Motor Fluctuations in Advanced Parkinson’s Disease
Abstract / Poster Number: 3706/ P01.065

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules
in Patients with Early Parkinson’s Disease
Abstract / Poster Number: 3662/ P01.064

Presentation Title and Number:
Analysis of IPX066 Dosing Data in Advanced Parkinson’s Disease (PD) Patients
Abstract / Poster Number: 49/ P01.063

About RYTARY TM (IPX066)

RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of RYTARY, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.

On January 21, 2013, Impax received a complete response letter which indicated that the FDA could not approve the NDA at that time. The complete response letter stated that satisfactory resolution and verification of the deficiencies identified during the inspection of the manufacturing facility in …read more
Source: FULL ARTICLE at DailyFinance

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Anacor Pharmaceuticals Reports 2012 Fourth Quarter and Year-End Financial Results

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Anacor Pharmaceuticals Reports 2012 Fourth Quarter and Year-End Financial Results

PALO ALTO, Calif.–(BUSINESS WIRE)– Anacor Pharmaceuticals (NAS: ANAC) announced today its financial results for the fourth quarter and year ended December 31, 2012.

“With the positive data from both Phase 3 trials of tavaborole for the treatment of onychomycosis, we anticipate filing an NDA around the middle of this year, and we will continue to evaluate commercialization options to maximize the value of tavaborole,” said David Perry, CEO of Anacor Pharmaceuticals. “We are looking forward to the results of the ongoing Phase 2 dose-ranging study of AN2728 in adolescents with atopic dermatitis later this month, and those results will help us determine the proper concentration and dosing of AN2728 for our anticipated Phase 3 trials.”

Fourth Quarter 2012 Highlights and Recent Developments

Clinical

  • Tavaborole – our lead topical antifungal product candidate for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
    • In the first quarter of 2013, we announced the results from two Phase 3 clinical trials in which tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints.
  • AN2728 – our lead topical anti-inflammatory product candidate for the treatment of atopic dermatitis and psoriasis. Atopic dermatitis is a chronic rash characterized by inflammation and itching and affects an estimated 40 million people in the seven major pharmaceutical markets, including approximately 10% to 20% of infants and young children.
    • In December 2012, we announced positive results from a Phase 2 safety, pharmacokinetics and efficacy trial of AN2728 in adolescents (ages 12 – 17) with mild-to-moderate atopic dermatitis. This was our second Phase 2 study of AN2728 in atopic dermatitis, and we currently have a third Phase 2 study ongoing, with results expected later this month.

Collaborations

  • Eli Lilly and Company
Business, Finance, Occupation & Industry

Spectrum Pharmaceuticals Gains Rights to Pivotal-Stage Captisol-Enabled® Melphalan

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Spectrum Pharmaceuticals Gains Rights to Pivotal-Stage Captisol-Enabled ® Melphalan

  • Product candidate is being investigated as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.
  • Melphalan has been granted Orphan designation by the FDA for this indication.
  • In a previous Phase 2 study, Captisol-enabled melphalan had acceptable safety findings, and it met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan.
  • Spectrum anticipates NDA filing in the first half of 2014 with potential commercial launch the following year, subject to FDA approval.

HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has gained global development and commercialization rights to Ligand Pharmaceuticals’ (NAS: LGND) Captisol-enabled®, propylene glycol-free (PG-free) melphalan. Captisol-enabled melphalan is currently in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.

Spectrum is assuming the responsibility for the ongoing pivotal clinical trial and will be responsible for filing an NDA, which is anticipated in the first half of 2014. Under the license agreement, Ligand will receive a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.

“We are pleased to add this late-stage program to our portfolio, which includes belinostat, for which we anticipate an NDA filing mid-year, and apaziquone, for which we expect to file an NDA in 2014,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Captisol-enabled melphalan is designed to meet the need for a formulation of melphalan that is free of propylene glycol, which has been associated with renal and cardiac side effects. The Captisol technology may allow longer duration of administration and slower infusion rates, potentially enabling a higher dose intensity of pre-transplant chemotherapy to optimize efficacy. We look …read more
Source: FULL ARTICLE at DailyFinance

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POZEN Reports Fourth Quarter & Year End 2012 Results

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POZEN Reports Fourth Quarter & Year End 2012 Results

NDA Filing for PA32540/PA8140 Expected by Q2 2013

CHAPEL HILL, N.C.–(BUSINESS WIRE)– POZEN Inc. (Nasdaq: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the fourth quarter and year ended December 31, 2012.

2012 and Recent Corporate Highlights

  • POZEN is currently preparing a New Drug Application (NDA) for its investigational products containing enteric-coated (EC) aspirin and immediate release omeprazole, including two dosage forms, PA32540 containing 325 mg of aspirin and PA8140, a low dose formulation containing 81 mg aspirin. POZEN continues to anticipate filing the NDA for both products no later than Q2 2013.
  • POZEN announced positive top-line results from two randomized, double-blind, multi-center, pivotal Phase 3 clinical trials of PA32540. Detailed results were presented in the fall at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting and the American Heart Association (AHA) Scientific Sessions 2012.
  • In August 2012, POZEN gained clarity from the Medicines Evaluation Board (MEB) in the Netherlands regarding the development program required for the approval in the European Union of PA including a lower dosage form containing 100 mg of aspirin and 40 mg of omeprazole (PA10040). The MEB agreed that no Phase 3 clinical trials for PA10040 to demonstrate the reduction of gastric ulcers vs. EC aspirin 100 mg would be necessary. MEB required 2 additional Phase 1 studies: a pharmacodynamic study demonstrating appropriate gastric pH control with PA10040 as well as a study to demonstrate bioequivalence of PA10040 to a currently marketed EC aspirin 100 mg product using aspirin as the analyte. The MEB also agreed to be the Reference Member State in a decentralized filing procedure for PA32540/PA10040.
  • Partnership discussions for PA continue to progress. While there can be no assurances, the Company expects to close a partnership deal in 2013.
  • Q4 2012 global net sales of VIMOVO® (naproxen / esomeprazole magnesium) delayed-release tablets by AstraZeneca, as defined under our agreement, were $18.4 million, up 33% from Q4 2011 and 38% vs. Q3 2012. VIMOVO sales for 2012 were $64.3 million, up 90% over the prior year, led by strong growth outside the U.S. POZEN earned a royalty of …read more
    Source: FULL ARTICLE at DailyFinance