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3 Can't-Miss FDA Actions This Week

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By Sean Williams, The Motley Fool

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Earnings season is getting ready to rev into high gear, but earnings are unlikely to be the talk of the sector in the days to come, with three big Food and Drug Administration actions expected in the coming week.

No headaches for Allergan shareholders
Up first is the PDUFA decision on Allergan‘s inhaled migraine medication Levadex on Monday. MAP Pharmaceuticals received a complete response letter for Levadex in March 2012 because of manufacturing deficiencies and its delivery device. Levadex wasn’t denied, though, based on safety or efficacy. This was a clean cue to investors that Levadex’s approval seemed like a sure thing barring it worked hand-in-hand with the FDA to meet its demands. With Allergan taking that cue as a reason to buy MAP earlier this year for $958 million, Monday represents decision day as to whether the company has made adequate fixes to its delivery device and manufacturing process to satisfy the FDA.

Levadex’s approval or rejection could also mean a good or bad day for Nektar Therapeutics , which looks to gain from royalty rights based on its contributions to Levadex’s development. While impossible to predict, I’m going to go out on a limb and project an approval for Allergan.

A revolutionary COPD treatment?
On Wednesday, chronic obstructive pulmonary disease, or COPD, treatment collaborators GlaxoSmithKline and Theravance are set to go before the FDA‘s panel with their combo Breo Ellipta. This revolutionary drug combines Theravance’s long-acting beta-2 agonists with Glaxo’s long-acting muscarinic antagonists into a dry powder inhaler to provide long-term COPD relief.

Studies of Breo Ellipta didn’t show statistically significant effects at all doses examined (clinical trials are a bit of trial and error on dosing), but they all showed a measurable improvement in lung function, although not all increases were dubbed significant. In addition, the adverse event profile of Breo Ellipta was similar to the current standard of treatment.  

As for Wednesday, I believe the patient pool should be enough to satisfy the FDA panel, but I’m concerned that it may focus on some of its non-statistically significant trials as a sticking point. Overall, I’m leaning toward a positive review from the FDA‘s panel, but we’ll find out more on Wednesday.

Is this the End-o for Aveed?
Finally, on Thursday we have an FDA panel meeting for Endo Health Solutions‘ Aveed, with is an extended-release male hypogonadism treatment.

The drug itself was acquired when Endo purchased Indevus Pharmaceuticals in early 2009 and is on its second go-around after receiving a complete response letter in its first attempt to gain approval. That CRL spelled out the FDA‘s concerns regarding very rare, but serious, adverse side effects, which included post-injection anaphylaxis and pulmonary oil microembolism. The FDA also noted that Endo’s risk evaluation and mitigation strategy was insufficient. 

It’s been more than three years since that initial CRL, so this should definitely be an interesting FDA panel meeting to say the

From: http://www.dailyfinance.com/2013/04/14/3-cant-miss-fda-actions-this-week/

Business, Finance, Occupation & Industry

Avoid This Pharma 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

AP Pharma

Star Rating (out of 5)

*

Industry

Health care

Market Cap

$177 million

 

AP Pharma Underperform Pick

zzlangerhans

Member Rating

99.66

Submitted On

3/26/2013

Stock Price At Underperform Recommendation

$0.63

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

This Week’s Pitch:

I’ve watched from the sidelines as AP Pharma stock ran and sagged ahead of the APF530 PDUFA, likely the result of a self-fulfilling prophecy of the “run-up” enthusiasts. As always, it is good to be an early adopter of manufactured momentum plays in low float stocks and painful to be late to the party. Getting back to fundamentals, I see AP as a prime candidate for a post-PDUFA decline regardless of outcome. In my mind, the company’s goose was cooked when results of the phase III trial indicated that APF530 was equivalent but not superior to the standard of care Aloxi. The smart money abandoned the stock and the next few years were a blur of CRL, time and resource-consuming studies, and dilution. The penny stock share price masks a startling 193M market cap, the result of a massive dilution last July that suggests the company is already looking ahead to their next act after APF530. Even if approved, APF530 is unlikely to become a significant player in the generic-dominated CINV market.

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 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 Avoid This Pharma Stock originally appeared on Fool.com.

Fool contributor Dan Dzombak can be found on Twitter @DanDzombak or on his Facebook page, DanDzombak. He 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 …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

A.P. Pharma Receives FDA Complete Response Letter for APF530

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By Business Wirevia The Motley Fool

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A.P. Pharma Receives FDA Complete Response Letter for APF530

– Company Revises Projected Launch Timing from 2H 2013 to 1H 2014 –

– Conference Call to Be Held at 8:30 a.m. Eastern Time –

REDWOOD CITY, Calif.–(BUSINESS WIRE)– A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The CRL describes the following issues that must be addressed.

  • With respect to chemistry, manufacturing and controls (CMC), the FDA has requested the refinement of one product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections be addressed.
  • The FDA has requested that a human factors validation study evaluating the usability of the APF530 syringe system together with its proposed product labeling and instructions for use be conducted with product assembled using a validated, commercial process.
  • With respect to clinical, the FDA has requested a re-analysis of the existing Phase 3 clinical data that reclassifies patients into those receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) according to the recently modified ASCO 2011 Guideline. The FDA did not request any new clinical studies.

“We appreciate the FDA‘s thorough review of the APF530 NDA,” stated John B. Whelan, A.P. Pharma’s president and chief executive officer. “While disappointed in today’s notification, we believe that the issues raised in the CRL are addressable, and we remain firmly committed to the successful development of APF530, which we believe will fulfill an important unmet need and improve the lives of patients suffering from CINV. In order to allow us time to carefully address the issues raised in the CRL, we are now projecting product launch for the first half of 2014, versus our prior guidance of the second half of 2013.”

Conference Call Details

A.P. Pharma will host a conference call on Thursday, March 28, 2013 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Interested investors may participate in …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

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

Business, Finance, Occupation & Industry

Viscount Systems Receives New U.S. Government Award

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By Business Wirevia The Motley Fool

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Viscount Systems Receives New U.S. Government Award

Will Secure First U.S. Government Sites Outside the Continental U.S.

BURNABY, British Columbia–(BUSINESS WIRE)– Viscount Systems (OTCQB:VSYS), a leading-edge, high technology supplier of security systems and software, is pleased to announce that its Freedom access control technology will secure U.S. Federal Government sites outside of the continental U.S. The systems will include the Company’s Freedom Encryption Bridge technology as well as Viscount’s enrollment and revocation list software applications. In keeping with government requests the nature of the facilities and agency involved cannot be identified.

“We are very pleased to continue to build our relationship with U.S. Federal Government agencies and to expand the territorial coverage of the Freedom platform,” noted Stephen Pineau, President and CEO of Viscount. “For this and other pending projects we have also added CRL (certificate revocation list) software to our new enrollment platform, which creates additional savings for our agency customers. The cost advantages of Freedom and the fact that it is fully compliant with U.S. Government identity management/access control standards (FIPS 201-2 and HSPD-12), provides a compelling value proposition to government customers.”

About Viscount’s Freedom Access Control Solution

Freedom Encryption Bridge is the first and only access control system that allows entry devices (ID cards, RFID readers, biometrics etc.) to be connected to, and controlled by, standard building IT networks without requiring expensive control panels. This eliminates up to 80% of the cost of traditional access control systems. Freedom also utilizes existing IT permission databases (Microsoft Active Directory or LDAP) to replace the software component of traditional systems. Freedom drastically reduces system costs while providing a much more secure software solution.

About Viscount Systems

Viscount Systems Inc., designs unified IT and physical security software platforms for building security and emergency planning. Recent awards include the 2012 Microsoft “Be What’s Next” Award, SIA Convergence Solution of the Year 2011 and Homeland Security Platinum Award for Emergency Response and Gold Award for Access Control at GOVSEC 2011.

Safe Harbor Statement

Forward looking statements: This press release and other statements by Viscount Systems Inc. may contain forward-looking statements within the meaning …read more
Source: FULL ARTICLE at DailyFinance