AVNR - Sector: Healthcare---Industry: Drug Manufacturers - Other

[setravis]

(AVNR)
AVANIR Sees Early Gains After SPA
Agreement w/FDA for Ph III Trial of Zenvia(TM)
An upside mover in early trading on Monday is AVANIR Pharmaceuticals
(AVNR). Shares have seen a high of +36%, and volume has been
108.91% above its 20-day average. The Company reached a definitive
agreement with the FDA, under the Special Protocol Assessment (SPA)
process, on the design of a single confirmatory Phase III clinical trial of
Zenvia(TM) (dextromethorphan/quinidine) for the treatment of patients
with pseudobulbar affect in patients with amyotrophic lateral sclerosis
and multiple sclerosis.The study will assess the safety, efficacy pharmacokinetics
of two doses. The primary efficacy analysis will be based
on the changes in crying/laughing episode rates recorded in the patient
diary. The trial is expected to begin by the end of 2007. Pseudobulbar
affect, also known as involuntary emotional expression disorder (IEED)
and emotional lability, is a neurologic disorder that occurs secondary to
neurologic disease or brain injury causing sudden and unpredictable
episodes of crying, laughing, or other emotional displays. Pseudobulbar
affect is estimated to impact more than 1 million people in the United
States with underlying neurologic conditions such as multiple sclerosis
(MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease,
dementias including Alzheimer's disease, stroke, and traumatic brain
injury. Episodes may occur when disease or injury damages the area
of the brain that controls normal expression of emotion. This damage
can disrupt brain signaling causing a "short circuit" and triggering involuntary
episodes. There are currently no FDA approved treatments for
pseudobulbar affect. Zenvia is a combination of two well-characterized
compounds, the active ingredient dextromethorphan, and the enzyme
inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan.
This dual action glutamate inhibitor is believed to help
regulate excitatory neurotransmission to diminish the unpredictable
emotional episodes of pseudobulbar affect. Earlier this year, AVANIR
announced positive top-line results from its Phase III clinical trial evaluating
Zenvia in diabetic peripheral neuropathic pain. Both Zenvia treatment
groups had lower pain ratings than placebo patients. The most
commonly reported adverse events were dizziness, nausea, diarrhea,
fatigue and somnolence and were generally mild to moderate in nature.
"Current treatment options are either partially effective or don't work at
all for more than one-half of people suffering from diabetic neuropathic
pain. The results of this study provide additional evidence that Zenvia,
if approved, may be a safe and effective treatment option for the millions
of Americans suffering from diabetic neuropathic pain," said Keith
A. Katkin, President and CEO of Avanir Pharmaceuticals. AVANIR'S
Abreva(R), docosanol 10% topical cream treatment for recurrent herpes
simplex labialis episodes (episodes of cold sores or fever blisters) that is
marketed by GlaxoSmithKline PLC (GSK), is the only non-prescription
cold sore medicine approved by the FDA to shorten healing time and
duration of symptoms. According to Pharmacy Times Magazine, Abreva
is the most recommended treatment by pharmacists for cold sores. The
Company recently completed the sale of currently marketed antipsychotic
drug FazaClo(R) (clozapine) to Azur Pharma in Ireland for an
upfront payment of $42 million, plus an additional $1.9 million in working
capital adjustments. AVANIR could also receive up to an additional $10
million in payments in 2009 contingent upon certain regulatory conditions,
and up to $2 million in royalties, based on 3% of annualized net
product revenues in excess of $17 million. For the third fiscal quarter
ended June 30, 2007, the Company cut its losses to $0.23 per share,
compared with a net loss of $0.56 per share, for the comparable quarter
in 2006. The Company has cumulative net losses of approximately
$248 million and cash and cash equivalents of $7.5 million.

[setravis]

UPDATE 1-Avanir shares soar on nod for involuntary-emotion drug
Mon Nov 1, 2010 11:28am EDT

* Avanir plans to engage 75 sales reps

BANGALORE, Nov 1 (Reuters) - Shares of Avanir Pharmaceuticals Inc (AVNR.O) more than doubled in value Monday after U.S. regulators approved its treatment for a genetic disorder Friday, making it attractive to larger firms looking for a strong product that has cleared the regulatory hurdle.

The U.S. Food and Drug Administration approval makes the drug Nuedexta the first approved treatment for the little known, but not that rare, condition called pseudobulbar affect (PBA) in which patients cannot control outbursts of crying or laughter. [ID:nN29270454].

On a conference call with analysts, the company said it plans to launch the drug in the United States in the first half of 2011 and engage about 75 sales representatives for its marketing.

Canaccord Genuity analyst Ritu Baral, who said Avanir might look for partners in the European markets, expects a "strong launch" in the United States.

Baral, like most analysts, expects the company to go it alone in marketing the treatment in the United States, but look for partners in Europe, where it has yet to be approved.

As of Sept. 30, the company's total cash, cash equivalents and restricted investments were $39.4 million.

Avanir said many interested companies had contacted it even before the drug was approved, and "given the great news on Friday, we would just expect to see that interest increase."

Baral, who expects the drug to reach peak sales after five years of commercialization, said large firms such as Biogen Idec (BIIB.O), Teva Pharmaceutical (TEVA.O) (TEVA.TA) and Novartis AG (NOVN.VX) that focus on central nervous system disorders could find Avanir attractive.

Large pharmaceutical companies are on the lookout for strong ready-to-market or late-stage product as many face an impending patent cliff on several blockbuster products.

Also on Monday, Avanir reiterated that it expects the treatment to cost $3,000-$5,000 annually, but said it would provide further pricing details in November or December.

CLEAN LABEL

"To add icing to the cake, there is no black box warning on Nuedexta's label, which gives Nuedexta no restrictions in its target patient population," Jefferies & Co analyst Andrew Fein said.

A black box warning on the packaging of a prescription drug highlights safety risks.
Fein said although the label specifically highlights the effectiveness of the drug in multiple sclerosis and Lou Gehrig's disease (ALS) patients, off-label usage will have a broader patient pool.

Fein expects the drug, which was denied approval about four years ago on safety concerns, to generate annual revenue of about $255 million by 2013.

The company's shares, which have lost about 12 percent since the FDA accepted the resubmission of the application in May, rose 111 percent to $5.11 Monday on Nasdaq.
---------------------------------------------------------------------------------------------------------------

Day's Range: 4.67 - 5.80
52wk Range: 1.31 - 5.80
Volume: 50,921,635
Avg Vol (3m): 2,278,910
Market Cap: 450.02M
P/E (ttm): N/A
EPS (ttm): -0.28
Div & Yield: N/A (N/A)

Technicals
Last Price Quote is:
64.89%above 13-day MA
58.83%above 50-day MA
RS Rating: 94 

[setravis]

market pulse
Nov. 1, 2010, 10:06 a.m. EDT

Avanir leads drug stocks north...

BOSTON (MarketWatch) -- Avanir Pharmaceuticals /quotes/comstock/15*!avnr/quotes/nls/avnr (AVNR 4.81, +2.39, +98.76%) led drug stocks north early Monday, with shares soaring on news that U.S. regulators have approved its neurology drug Nuedextra. Avanir shares zoomed up 120% to $5.26.

[setravis]

AVNR AVANIR Pharmaceuticals Invites Investors to Conference Call ... 

ALISO VIEJO, Calif., Nov. 1, 2010 /PRNewswire via COMTEX/ -- AVANIR Pharmaceuticals, Inc. (AVNR) today announced a management conference call to discuss the approval of NUEDEXTA(TM) (dextromethorphan hydrobromide and quinidine sulfate) by the U.S. Food and Drug Administration (FDA). The call is scheduled for today, Monday November 1, 2010 at 5:15 a.m. Pacific time / 8:15 a.m. Eastern time.

The live call can be accessed by dialing (877) 558-3407 for domestic callers and (706) 679-1941 for international callers. The conference ID number is 22130601. A webcast of the live call can be accessed by visiting AVANIR's corporate website at www.avanir.com . To view the live webcast, please go to AVANIR's website prior to the start of the call to register, download, and install the necessary software.

An archived copy of the webcast will be available on AVANIR's website for 30 days, and a telephone replay will be available through November 6, 2010, by dialing (800) 642-1687 (domestic) or (706) 645-9291 (international) and entering the conference ID number 22130601.

About NUEDEXTA

NUEDEXTA(TM) is the first and only FDA-approved treatment for pseudobulbar affect (PBA). NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide (20 mg), the ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the brain, although the mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown.

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias. The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.

NUEDEXTA Important Safety Information

NUEDEXTA can interact with other medications causing significant changes in blood levels of those medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known hypersensitivity to its components.

NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.

NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose.

The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence.

NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.

Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules in a 24-hour period, make sure that there is an approximate 12-hour interval between doses, and not take a double dose after they miss a dose.

These are not all the risks from use of NUEDEXTA. For additional important safety information about NUEDEXTA, please see the full Prescribing Information at www.NUEDEXTA.com .

About PBA

Patients suffering from existing neurological disease or brain injury may also suffer the added burden of pseudobulbar affect, or PBA. PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state. PBA outbursts result from a "short circuit" in the brain caused by another neurologic condition--such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury. PBA can have a debilitating impact on the lives of patients, caregivers and loved ones. For more information about PBA, please visit www.PBAinfo.org .

About AVANIR Pharmaceuticals, Inc.

AVANIR Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about AVANIR, please visit www.avanir.com .

About Forward-Looking Statements

Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, may be forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. These statements include, but are not limited to, AVANIR's ability to successfully market and sell NUEDEXTA in the United States, the safety and efficacy of NUEDEXTA, and the anticipated timing and success of the commercial launch of NUEDEXTA. Risks that could cause actual results to differ include the occurrence of adverse safety events with NUEDEXTA, our limited capital resources, our dependence on third parties for manufacturing and distribution of NUEDEXTA, that we may not adequately build or maintain the necessary sales, marketing, supply chain management and reimbursement capabilities on our own or enter into arrangements with third parties to perform these functions in a timely manner or on acceptable terms, and other risks that are described in further detail in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to time in other publicly available information regarding the Company. Copies of this information are available from us upon request. We disclaim any intent to update these forward-looking statements.

SOURCE AVANIR Pharmaceuticals, Inc.

[setravis]

Congress Sets Bad Precedent With AVANIR
May 26, 2011

As if AVANIR Pharmaceuticals (Nasdaq: AVNR ) investors needed another thing to cry about. The chairman of the Senate's Special Committee on Aging and three congressmen are questioning the pricing of the company's pseudobulbar affect drug, Nuedexta.

This seems kind of ridiculous to me. AVANIR got the drug approved for pseudobulbar affect, a disease for which there wasn't any other approved treatment. The company should be rewarded accordingly.

But investors shouldn't ignore the action in D.C. There's at least a small risk that AVANIR could be pressured to lower its average cost, which currently stands at about $4,365 per patient each year. Nuedexta is a mixture of two unpatented drugs. Compounding pharmacies were combining the two before the approval for 1/30th the cost.

KV Pharmaceutical (NYSE: KV-A) ran into similar problems earlier this year with preterm labor prevention drug Makena, which was also being compounded before KV gained FDA approval. The company subsequently caved and significantly lowered the cost of its drug.

Congress wants information about how much it costs to develop the drugs from AVANIR and another company, URL Pharma, which is in a similar situation. As if that should have any bearing on what price the market should pay for the drug.

It seems to me that Congress is setting a dangerous precedent that drug investors should keep a close eye on. It starts with already discovered drugs being expanded into new indications, but what's to keep it from extending to patented drugs. High-priced cancer drugs like Dendreon's (Nasdaq: DNDN ) Provenge and Bristol-Myers Squibb's (NYSE: BMY  ) Yervoy could be the next targets.

Day's Range: 4.51 - 4.73
52wk Range: 1.31 - 5.80
Volume: 6,127,015
Avg Vol (3m): 6,611,460
Market Cap: 579.52M

Technicals
Last Price Quote is:
8.42%above 13-day EMA
13.93%above 50-day EMA
RS Rating: 92