Vanda Pharmaceuticals, Inc. (VNDA)

[surf1944]

Vanda Pharmaceuticals Named the 2013 Life Science Firm of the Year by the Tech Council of Maryland
Press Release: Vanda Pharmaceuticals Inc. – 14 hours ago

WASHINGTON, May 23, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (VNDA) today announced that the company has been named the 2013 Life Science Firm of the Year by the Tech Council of Maryland (TCM). Vanda was honored at the TCM's 25th Annual Tech Awards Celebration held in Bethesda, Maryland. The Tech Awards Celebration recognizes the leaders and innovators in the technology and life science communities in Maryland and the surrounding regions.
"We are deeply honored to receive this recognition from the Tech Council of Maryland," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "We are privileged to work in a region that is supportive of our efforts to develop new treatments designed to improve the lives of others."
In selecting Vanda for this award, the TCM recognized Vanda's commitment to address patient needs and the company's work to develop tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder (Non-24). Vanda recently announced positive results in the SET and RESET Phase III efficacy studies for Non-24. Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently no treatment for Non-24 has been approved by the U.S. Food and Drug Administration (FDA). Vanda is targeting a New Drug Application submission with the FDA for tasimelteon in mid-2013.
About The Tech Council of Maryland
The Tech Council of Maryland (TCM) is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. TCM's mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed. For more information, visit www.techcouncilmd.com.

[mlkrborn]

Target raised:
May 17, 2013
07:37 EDT VNDA Vanda Pharmaceuticals price target raised to $17 from $11 at Lazard Capital
Lazard Capital raised its price target for Vanda Pharmaceuticals shares citing positive feedback on the company's sleep disorder drug tasimelteon. The firm keeps a Buy rating on the stock.

[surf1944]

7:01AM Vanda Pharma beats by $0.10, misses on revs (VNDA) 4.90 : Reports Q1 (Mar) loss of $0.15 per share, $0.10 better than the Capital IQ Consensus Estimate of ($0.25); revenues were unchanged from the year-ago period at $8.1 mln.

Cash:
Cash decreased by $9.5 mln in the first quarter of 2013, compared to decreases of $10.6 mln in the first quarter of 2012 and $14.0 mln in the fourth quarter of 2012. Vanda's Cash as of March 31, 2013 totaled $110.9 mln.

2013 FINANCIAL GUIDANCE
2013 financial guidance assumes a mid-year NDA submission for tasimelteon for Non-24 is accepted by the FDA for Standard Review. 2013 expenses are expected to reflect lower research and development spending as compared to 2012 and an increase in commercial spending that is commensurate to progress with the tasimelteon NDA filing.

Full year 2013 decrease in Cash is expected to be between $45.0 and $50.0 mln, compared to $47.5 mln for 2012.
Total 2013 operating expenses are expected to be between $57.0 and $62.0 mln.
This includes Fanapt intangible asset amortization of $1.5 mln and $4.0-6.0 mln of non-cash stock based compensation. Total 2012 operating expenses were $61.0 mln.
2013 operating expense guidance assumes $4.3 mln in milestone payments due upon the acceptance by the FDA of a tasimelteon NDA submission and $3.0-4.0 mln in NDA filing-related expenses.

[surf1944]

6:56AM Vanda Pharma reports successful completion of pre-NDA meeting with FDA on tasimelteon for the treatment of non-24-hour disorder in the totally blind (VNDA) 3.95 : Co announced that it held a pre-NDA meeting with the Division of Neurology Products of the FDAto discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing. Based on this successful completion of the pre-NDA meeting, Vanda is targeting an NDA submission for tasimelteon in mid-2013.

[surf1944]

4:09PM Vanda Pharma confirms withdrawal of marketing authorization application for Fanaptum in the European Union (VNDA) 3.80 +0.08 : This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for co to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia. The results of this study will not be available in the timeframe allowed in the Centralised Procedure. Co intends to reassess its European regulatory strategy for Fanaptum once the results from the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) become available.

[surf1944]

6:56AM Vanda Pharma announces Phase IIb/III clinical study in major depressive disorder did not meet the primary endpoint (VNDA) 4.34 : Co announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD. The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as compared to placebo. Both tasimelteon and placebo treated patients had an approximately 40% reduction of their MDD symptoms from baseline. Tasimelteon was shown to be safe and well-tolerated, consistent with observations in prior studies. Given these current proof of concept clinical study results, Vanda has decided to discontinue all activities in this indication. Vanda has recently reported positive results in two phase III clinical studies of tasimelteon in Non-24-Hour Disorder (Non-24) and plans to submit a New Drug Application to the FDA in mid-2013.

[surf1944]

6:31AM Vanda Pharma announces 'positive' results in the second Phase III study (RESET) of tasimelteon for the treatment of non-24-Hour disorder; tasimelteon significantly maintains entrainment of circadian rhythms (VNDA) 4.12 : Co announced positive results for the second Phase III study of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24). The RESET study (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder), demonstrated the maintenance effect of 20mg of tasimelteon to entrain melatonin and cortisol circadian rhythms in individuals with Non-24. Tasimelteon treated patients maintained their clinical benefits while placebo treated patients showed significant deterioration in measures of nighttime sleep, daytime naps, and timing of sleep. The RESET study demonstrates the efficacy of chronic treatment with tasimelteon in Non-24 and further supports the results of the SET study, which established the ability of tasimelteon to entrain the master body clock and significantly improve the clinical symptoms of Non-24. Co plans to submit a New Drug Application (NDA) to the FDA in mid-2013. Co will meet with the FDA in Q1 of 2013 for a pre-NDA meeting on tasimelteon in the treatment of patients with Non-24.

[Sry8]

Can anyone give a fair PPS value (guess) where we will end up before EOY? Thx

[hm36tm]

Nice call last week...

[surf1944]

6:55AM Vanda Pharma announces positive Phase III results for Tasimelteon in the treatment of non-24-hour disorder (VNDA) 3.22 : Co announced positive results from the SET (Safety and Efficacy of Tasimelteon) Phase III study, evaluating tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder. Tasimelteon succeeded in the primary endpoint of Entrainment of the melatonin (aMT6s) rhythm as compared to placebo. Additionally, tasimelteon demonstrated significant improvements across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep. Tasimelteon also showed significant improvements over placebo in the Non-24 Clinical Response Scale (N24CRS) as well as in the Clinical Global Impression of Change (CGI-C), an overall global functioning scale. These results provide evidence of a direct and clinically meaningful benefit to patients with Non-24. In the SET study, tasimelteon was demonstrated to be safe and well tolerated. Vanda expects to report top-line results from the second Phase III study (RESET) for tasimelteon in Non-24 in the first quarter of 2013. Vanda plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in mid-2013.

[juxtaposezen]

Vanda Announces Positive Phase III Results For Tasimelteon In The Treatment Of Non-24-Hour Disorder

http://ih.advfn.com/p.php?pid=nmona&article=55506759&symbol=VNDA

[surf1944]

1:30AM Vanda Pharma receives negative opinion from CHMP on Fanaptum for the treatment of schizophrenia (VNDA) 3.22 : Co announces that the European Medicines Agency's Committee for Medicinal Product for Human Use has issued a negative opinion recommending against approval of Fanaptum for the treatment of schizophrenia in adult patients in the European Union. The CHMP was of the opinion that the benefits of Fanaptum did not outweigh its risks and recommended against marketing authorization at this point in time. Vanda intends to appeal this opinion and request a re-examination of the decision by the CHMP.

[juxtaposezen]

As did I today. Phase III data coming on Tasimelteon, cash rich no debt. I had an alert set to remind me to pick some up if it dropped which triggered today:

The following Stock Alert has been triggered:

VANDA PHARMACEUTICALS INC - Sale price dropped to 3.0200
Last Sale: 3.02 at 10:40:29
Price when alert was set: 3.21 on 12/07/12 09:04:51 EST

Current Quote for VNDA
Last: 3.02
Change: -0.12 (-3.82 %)
High: 3.14
Low: 3.02
Annual High: 5.47
Annual Low: 2.92
Previous Close: 3.14
Volume: 897293
100-Day Avg. Volume: 131661
200-Day Moving Avg: 4.16

DJIA: 13257.04 (+8.6)
NASDAQ: 3022.57 (+0.27)
S&P500: 1429.73 (+1.89)

[surf1944]

Took postilion in VNDA, setting up for EOY move into Jan 2013...

Total Cash (mrq): 134.40M
Total Cash Per Share (mrq): 4.76
Total Debt (mrq): 0.00
Total Debt/Equity (mrq): N/A
Current Ratio (mrq): 4.04
Book Value Per Share (mrq): 0.54

[surf1944]

7:03AM Vanda Pharma: Tasimelteon has been shown for the first time to restore daily cortisol rhythms in totally blind patients suffering from Non-24-Hour Disorder (VNDA) 4.00 : Co's tasimelteon has been shown for the first time to restore daily cortisol rhythms in totally blind patients suffering from Non-24-Hour Disorder (Non-24). Tasimelteon was previously reported to entrain the 24-hour rhythm of melatonin secretion in patients with Non-24. Cortisol is a key regulatory hormone which exhibits a circadian rhythm, rising in the early morning and falling in the evening. The circadian regulation of the cortisol rhythm is necessary for the human body to be prepared for a wide range of daily activities and physiologic functions, including blood pressure variation, utilization of fatty acids, circulating lymphocytes and immunity. A growing body of data suggests that tasimelteon's entraining effects are accomplished through a direct resetting of the master body clock, located in the suprachiasmatic nucleus (SCN) of the hypothalamus. Tasimelteon is a circadian regulator in development for the treatment of Non-24 in totally blind individuals.

[surf1944]

7:04AM Vanda Pharma announces Fanapt was granted market approval in Israel for the treatment of schizophrenia (VNDA) 4.00 : Vanda will commercialize Fanapt in Israel through its partner Megapharm Ltd.

[surf1944]

7:57AM Vanda Pharma presents new data at SLEEP 2012 Annual Meeting: 70% of totally blind individuals with sleep complaints suffer from chronic circadian rhythm sleep disorder (VNDA) 4.23 : Co announced that data presented at SLEEP, the 26th annual meeting of the Associated Professional Sleep Societies, show that 70% of totally blind people with sleep complaints suffer from Non-24-Hour Disorder (Non-24). Non-24 is a circadian rhythm disorder characterized by a chronically misaligned body clock. There are currently no FDA approved medications for the treatment of Non-24. Of the 143 totally blind subjects with sleep complaints in the study, 70% were found to not be entrained to a 24-hour day and, as a result, diagnosed with Non-24. Circadian period in Non-24 patients ranged from 24.08 to 25.34, with a median tau of 24.45, meaning study subject's internal clocks delay a median of 27 minutes every day. The effect is cumulative, putting subjects to sleep later and later each day until they cycle around the clock and begin again.Vanda is currently studying the efficacy of tasimelteon in Non-24 in two multi-national Phase III studies, SET and RESET, which are ongoing and expected to be completed by the end of 2012.

[mlkrborn]

Vanda Pharma presents new data at SLEEP 2012 Annual Meeting: 70% of totally blind individuals with sleep complaints suffer from chronic circadian rhythm sleep disorder (VNDA) 4.23 : Co announced that data presented at SLEEP, the 26th annual meeting of the Associated Professional Sleep Societies, show that 70% of totally blind people with sleep complaints suffer from Non-24-Hour Disorder (Non-24). Non-24 is a circadian rhythm disorder characterized by a chronically misaligned body clock. There are currently no FDA approved medications for the treatment of Non-24. Of the 143 totally blind subjects with sleep complaints in the study, 70% were found to not be entrained to a 24-hour day and, as a result, diagnosed with Non-24. Circadian period in Non-24 patients ranged from 24.08 to 25.34, with a median tau of 24.45, meaning study subject's internal clocks delay a median of 27 minutes every day. The effect is cumulative, putting subjects to sleep later and later each day until they cycle around the clock and begin again.Vanda is currently studying the efficacy of tasimelteon in Non-24 in two multi-national Phase III studies, SET and RESET, which are ongoing and expected to be completed by the end of 2012.

[surf1944]

7:17AM Vanda Pharma misses by $0.12 (VNDA) 4.39 : Reports Q1 (Mar) loss of $0.28 per share, $0.12 worse than the Capital IQ Consensus Estimate of ($0.16); revenues rose 8.0% year/year to $8.1 mln (no rev est) Research and development expenses are expected to be between $42.0 and $47.0 million. This compares to $29.0 million in 2011. The increase of $13 to $18 million over 2011 reflects our ongoing investment in the development of tasimelteon for Non-24 and MDD. R&D expenses include approximately $2.5 million of SBC. Excluding SBC, R&D expenses are expected to be between $39.5 and $44.5 million.

[surf1944]

7:22AM On The Wires (WIRES) : Vanda Pharmaceuticals (VNDA) has acquired an exclusive world-wide license from Eli Lilly (LLY) to develop and commercialize a small molecule neurokinin 1 receptor antagonist for all human indications.

[surf1944]

Vanda Pharma shares fall on analyst downgrade
Vanda Pharmaceuticals falls as analyst lowers expectations for schizophrenia drug Fanapt
Associated PressAssociated Press – Tue, Mar 13, 2012 3:44 PM EDT

NEW YORK (AP) -- Shares of Vanda Pharmaceuticals Inc. declined Tuesday after an analyst downgraded the stock, saying he expects weaker sales of the company's schizophrenia drug Fanapt.

THE SPARK: Jefferies & Co. analyst Corey Davis downgraded Vanda shares to "Hold" from "Buy" and cut his price target to $4.50 per share to $8.50. Davis said he is reducing his estimates for sales of Fanapt because of stiff competition and a delay in the drug's approval in Europe. Davis said Dainippon Sumitomo's drug Latuda is selling well, and low-cost generic versions of Eli Lilly and Co.'s drug Zyprexa and Pfizer Inc.'s Geodon are competing with Fanapt.

Davis said prescriptions for Fanapt were unchanged in the fourth quarter of 2011 compared to the third quarter, although Vanda got more money from Novartis AG, which markets the drug. He said European Union regulators might want more data from a trial of Fanapt, and may not approve the drug until late 2013.

THE BIG PICTURE: The Rockville, Md., company reported $31.3 million in revenue in 2011. Of that total, $4.5 million came from Fanapt royalties, and the rest was recognized from Novartis' initial payment for Fanapt. Vanda said 120,000 prescriptions for Fanapt were written in 2011, more than double the total of 55,000 from 2010.

The company said it has received a three-month extension to prepare a response to EU regulators about Fanapt, and will submit more information by mid-May.

Vanda is also developing tasimelteon, a potential treatment for sleep and mood disorders. Tasimelteon is receiving orphan drug incentives in the U.S.

SHARE ACTION: Vanda Pharmaceuticals shares lost 26 cents, or 5.5 percent, to $4.51 in afternoon trading. The stock is down 33.3 percent since Aug. 4, when the company reported its second-quarter results.

[Penny Roger$]

~ Tuesday! $VNDA ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $VNDA ~ Earnings expected on Tuesday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=VNDA&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=VNDA&p=W&b=3&g=0&id=p54550695994



~ Google Finance: http://www.google.com/finance?q=VNDA
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=VNDA#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=VNDA+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=VNDA
Finviz: http://finviz.com/quote.ashx?t=VNDA
~ BusyStock: http://busystock.com/i.php?s=VNDA&v=2


<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=VNDA >>>>>>



http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

[surf1944]

Cash levels and short position in VNDA should help raise the share price in the coming weeks:
Total Cash (mrq): 161.45M
Total Cash Per Share (mrq): 5.74
Total Debt (mrq): 0.00
Total Debt/Equity (mrq): N/A
Current Ratio (mrq): 4.90
Book Value Per Share (mrq): 1.34

Avg Vol (3 month)3: 196,106
Avg Vol (10 day)3: 120,400
Shares Outstanding5: 28.12M
Float: 26.27M
% Held by Insiders1: 1.50%
% Held by Institutions1: 71.90%
Shares Short (as of Dec 15, 2011)3: 1.44M
Short Ratio (as of Dec 15, 2011)3: 4.90
Short % of Float (as of Dec 15, 2011)3: 6.80%
Shares Short (prior month)3: 1.64M

[surf1944]

Vanda Pharmaceuticals, Inc. (VNDA) – The value in this company is purely in its growth prospects. Trading near its 52-week low, and having missed earnings in a release in early August, this may be an excellent buying opportunity if the company is able to turn itself around. Furthermore, given the attractiveness of its lead drug in the effective treatment of schizophrenia, the company may become an acquisition target. With a microcap market capitalization and average daily trading volume around 150,000 shares per day, investors should take care in this name.

http://seekingalpha.com/article/293435-6-deeply-undervalued-biotech-companies?source=yahoo

[surf1944]

8. Vanda Pharmaceuticals, Inc. (VNDA): Biotechnology Industry. Market cap of $164.95M. Net institutional shares sold over the current quarter at 926.5K, which is 3.53% of the company's 26.26M share float. The stock is a short squeeze candidate, with a short float at 5.84% (equivalent to 10.28 days of average volume).

http://seekingalpha.com/article/290509-10-biotech-stocks-being-dumped-by-big-money-managers?source=yahoo

[surf1944]

7:07AM Vanda Pharma enters into an exclusive license agreement with Biotoscana Farma S.A. for Commercialization of Fanapt in Argentina (VNDA) 7.18 : Under the terms of the agreement, Biotoscana will seek regulatory approval for Fanapt in Argentina. Vanda will supply Biotoscana with Fanapt drug product for packaging and sale and Biotoscana's CNS specialty sales force will promote Fanapt to psychiatrists in Argentina.

[surf1944]

European Medicines Agency Accepts Vanda Pharmaceuticals Inc.'s Marketing Authorization Application For Oral Iloperidone Tablets

Press Release Source: Vanda Pharmaceuticals Inc. On Tuesday July 26, 2011, 7:00 am

ROCKVILLE, Md., July 26, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ:VNDA - News) announced today that the European Medicines Agency (EMA) accepted for evaluation Vanda's Marketing Authorization Application (MAA) for oral iloperidone tablets. Iloperidone is an atypical antipsychotic for the treatment of schizophrenia in adults.

"The submission in the European Union is an important milestone towards advancing the iloperidone franchise," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "This continues our efforts to expand the availability of Fanapt® to markets outside the U.S. and Canada."

Iloperidone is currently marketed in the U.S. by Novartis Pharmaceuticals Corporation, an affiliate of Vanda's sublicensor Novartis Pharma AG, under the name Fanapt®. Under a 2009 agreement, Novartis has exclusive rights relating to the development and commercialization of iloperidone in the U.S. and Canada. Under the terms of such agreement, Vanda retained rights to commercialize iloperidone oral and long-acting injectable formulations outside the U.S. and Canada.

[scstocks]

Vanda Pharmaceuticals to Announce Second Quarter 2011 Financial Results on August 4, 2011

Date :

07/20/2011 @ 3:00PM

Source :

PR Newswire

Stock :

Vanda Pharmaceuticals Inc. (MM) (VNDA)

Quote :

7.1 -0.06 (-0.84%) @ 7:57PM

Vanda Pharmaceuticals to Announce Second Quarter 2011 Financial Results on August 4, 2011

Vanda Pharmaceuticals Inc. (MM) (NASDAQ:VNDA)
Intraday Stock Chart

Today : Wednesday 20 July 2011

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced it will release results for the second quarter of 2011, on Thursday, August 4, 2011, before the market opens. A full text copy of the release will be disseminated at that time.

Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer, will host a conference call to discuss the results at 10:00 AM ET on Thursday, August 4, 2011. Also participating on the call will be James Kelly, Senior Vice President and Chief Financial Officer. To participate in the conference call, dial the appropriate number below shortly before the 10:00 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos.

The teleconference dial-in numbers are as follows:

Domestic callers 1-866-314-5232

International callers 1-617-213-8052

Participant Passcode 16117516

The conference call will be broadcast simultaneously and archived on the Company's website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

A replay of the call will be available on Thursday, August 4, 2011, beginning at 1:00 PM ET and will be accessible until Thursday, August 11, 2011, at 5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers. The access number is 57140859.

ABOUT VANDA PHARMACEUTICALS INC.:

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.

Company Contact:Cristina MurphyCommunications ManagerVanda Pharmaceuticals Inc.(240) [e-mail]

SOURCE Vanda Pharmaceuticals Inc.

http://ih.advfn.com/p.php?pid=nmona&article=48513770&symbol=VNDA

[surf1944]

Vanda Pharmaceuticals Enters into an Exclusive License Agreement with Probiomed S.A. de C.V. for Commercialization of Fanapt in Mexico

Press Release Source: Vanda Pharmaceuticals Inc. On Monday July 11, 2011, 7:00 am EDT

ROCKVILLE, Md., July 11, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA - News), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced its exclusive license agreement with Probiomed S.A. de C.V., a wholly owned pharmaceutical operating unit of Proquifin S.A. de C.V., for the commercialization of Fanapt™ in Mexico.

"We are very excited to achieve this step on the path towards making Fanapt™ available in Mexico and are very pleased to have Probiomed as our commercial partner," said Mihael H. Polymeropoulos, M.D., Vanda's Chief Executive Officer. "This marks an important milestone for the Fanapt™ brand," added Dr. Polymeropoulos. Probiomed's founder and CEO, Jaime Uribe de la Mora, stated, "Fanapt™ represents a strategic franchise opportunity for our company's neurosciences business unit. We are very pleased to be Vanda's partner for Fanapt™ in Mexico. We expect to submit the regulatory dossier for market authorization review by the end of 2011."

Under the terms of the agreement, Probiomed will seek regulatory approval for Fanapt™ in Mexico. Vanda will supply Probiomed with Fanapt™ drug product for sale and Probiomed's specialty sales force will promote Fanapt™ to psychiatrists and commercialize the drug in Mexico.

With a market of $9.3 billion in annual sales, Mexico is the second largest pharmaceutical market in Latin America and the 14th largest pharmaceutical market in the world.(1)

(1) Source, IMS

About Probiomed

Probiomed is a privately owned Mexican company with more than 40 years of experience in research, development, manufacturing and commercialization of pharmaceutical, biotechnology and vaccines for human health. Probiomed's neuroscience expertise includes development, manufacturing, sales and marketing of antipsychotics and medicines to treat depression, anxiety and bi-polar diseases, in addition to other central nervous system disorders.

[halpern6]

chart setting up real nice as well....IMO

[surf1944]

As the Market Dips, It's Time to Look for Biotech Sector Deals

http://seekingalpha.com/article/274471-as-the-market-dips-it-s-time-to-look-for-biotech-sector-deals?source=yahoo

[surf1944]

7:10AM Vanda Pharma reports EPS in-line, misses on revs (VNDA) 7.86 : Reports Q1 (Mar) net of breakeven, in-line with the Thomson Reuters consensus of ($0.00); revenues fell 39.5% year/year to $7.5 mln vs the $8.1 mln consensus.

[surf1944]

Vanda Pharmaceuticals, Inc. (VNDA) is trading around $7.30. Vanda is a biotechnology company, based in Maryland. These shares have traded in a range between $6.04 to $11.55 in the last 52 weeks. The 50 day moving average is $7.36 and the 200 day moving average is $7.53. VNDA is estimated to lose about 2 cents per share in 2011 and make a profit of 13 cents per share for 2012. See Yahoo Finance data here.
In the product development pipeline, Vanda has "Tasimelteon" which is an oral compound for sleep and mood disorders. It also has Fanapt, which belongs to a class of medications for schizophrenia. You can learn more about its pipeline here.
Why Vanda shares could surge higher: Vanda recently announced trials have started for its schizophrenia drug. For more analysis on Vanda read this article, which also notes Vanda as a potential takeover target:

http://seekingalpha.com/article/265705-7-dirt-cheap-biotech-stocks-with-huge-upside?source=yahoo

[surf1944]

7:01AM Vanda Pharma receives Orphan Drug designation in Europe for tasimelteon (VNDA) 7.25 : Co announced that the European Commission has granted Orphan Drug designation for tasimelteon, an oral dual melatonin receptor agonist in Phase III clinical trails for Non-24-Hour Sleep/Wake Disorder in blind individuals with no light perception.

[mlkrborn]

Good solid pharma with profit!

[surf1944]

Vanda Pharma posts 4Q profit as costs decline
Vanda Pharmaceuticals reports 4th-quarter profit on lower sales and compensation expenses

On Thursday February 10, 2011, 10:55 am

ROCKVILLE, Md. (AP) -- Vanda Pharmaceuticals Inc. said Thursday it turned a profit in the fourth quarter on reduced expenses, including lower costs related to its schizophrenia drug Fanapt.

The company reported net income of $2.2 million, or 8 cents per share. A year earlier Vanda lost $9.2 million, or 34 cents per share. Its revenue grew to $7.3 million from $4.5 million on greater revenue from licensing agreements.

Analysts expected a loss of 14 cents per share and $7.6 million in revenue, according to estimates compiled by FactSet.

The Food and Drug Administration approved Fanapt in May 2010. Vanda said its cost of goods sold decreased in the most recent quarter, with total operating expenses halved to $7 million.

Novartis AG markets Fanapt in the U.S. and Canada, and most of Vanda's revenue derives from a $200 million payment from the Swiss drugmaker that Vanda is recording gradually. It recorded $6.8 million in revenue from that payment during the fourth quarter of 2010, along with $511,000 in royalty revenue from Fanapt sales.

In 2010 the company earned $7.2 million, or 25 cents per share, reversing its 2009 loss of $35.9 million, or $1.33 per share. Revenue jumped to $35.2 million from $4.5 million.

Shares of Vanda Pharmaceuticals rose 62 cents, or 8.9 percent, to $7.61 in morning trading.

[surf1944]

4:01PM Vanda Pharma Initiates Phase III clinical study aimed at resetting the body clock (VNDA) 6.36 +0.01 : Co announced it has initiated a Phase III clinical trial to evaluate tasimelteon in patients with non-24-hour sleep wake disorder, a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness.

[surf1944]

Vanda Pharmaceuticals (VNDA)
EV/Rev = -1.31

Current share price: $6.15

Vanda is one of the few biotechs I follow that is actually trading below it's cash value. Vanda's primary product is fanapt - an atypical treatment for schizophrenia. Vanda has a licencing agreement with Novartis (NVS) for the sales of Fanapt. Vanda is fresh of a 52-week low of $6.20 and Fanapt sales have been, well, abysmal. The company reported only 4,000 total prescriptions of the schizophrenia drug in June - but it was only launched in January and they are hoping for further increases in sales. Vanda's revenue has largely come in the form of milestone payments from Novartis with Fanapt's royalties reaching only $1.5 million for the quarter.

Along with a potential increase in Fanapt sales, whether or not Vanda is a good buy relies largely on revenues realized from it's pipeline. Vanda is currently developing an injectable formulation of Fanapt that may add to their bottom line. Vanda is also developing Tasimelteon for the treatment of Non-24-Hour Sleep/Wake Disorder in blind individuals. Tasimelteon has reported positive phase III trials for improvement of sleep onset in this patient population. The company expects to file a new drug application (NDA) for Tasimelteon with the FDA in 2011.

Vanda is covered by three research analysts with an average 'buy' rating and an average one year price target of $13.50/share.

http://seekingalpha.com/article/222299-five-potential-small-cap-biotech-bargains?source=yahoo

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Vanda Pharmaceuticals Reports Second Quarter 2010 Results

http://finance.yahoo.com/news/Vanda-Pharmaceuticals-Reports-prnews-839670169.html?x=0&.v=1

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VNDA may be worth a trade here at its current cash level & the large short position:

Total Cash (mrq): 202.42M
Total Cash Per Share (mrq): 7.26
Total Debt (mrq): 0.00
Total Debt/Equity (mrq): N/A
Current Ratio (mrq): 6.15
Book Value Per Share (mrq): 0.96

Avg Vol (3 month)3: 580,981
Avg Vol (10 day)3: 319,962
Shares Outstanding5: 27.88M
Float: 27.22M
% Held by Insiders1: 14.13%
% Held by Institutions1: 83.40%
Shares Short (as of Jun 15, 2010)3: 4.15M
Short Ratio (as of Jun 15, 2010)3: 10.30
Short % of Float (as of Jun 15, 2010)3: 15.00%
Shares Short (prior month)3: 4.38M

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Vanda Pharmaceuticals Downgrade: Why I Don't Buy It

Vanda Pharmaceuticals (VNDA) received a downgrade from Madison Williams last week to "reduce" from "buy."

Analyst David Moskowitz cited a physicians survey conducted by Madison Williams as the reason behind the downgrade, according to publicly released information. The survey of psychiatrists concluded that Novartis (NVS) was doing an "abysmal" job at handling Fanapt's commercial launch, which took place earlier this year.

With the downgrade, Madison also lowered their price target for VNDA to $7 from $19.

While not discounting this "survey" entirely, it sounds a bit bogus to me since the $21 million in sales posted by Novartis in the quarterly report is hardly an "abysmal" number, especially considering that Fanapt was not on the market for the full first quarter. As for the psychiatrists questioned in the survey, I'd have to wonder if it was a random scientific poll of opinions, or just a smattering of phone calls and emails to contacts in the rolodex sitting on David Moskowitz's desk.

I've never been a fan of surveys or polls, especially this type where the public has no idea who or what was asked and in what pretense.

The price target to seven dollars is also a questionable target, in my opinion, based on the fact that Vanda is sitting on over $200 million in the bank and has just turned its first-ever quarterly profit.

It's also hard to judge the potential of Fanapt based on just one quarter (that wasn't a full quarter) of sales numbers, especially when Novartis is involved - it's not like these guys are new to the game. I'd put more faith in the seven dollar number if the sales numbers don't grow to much more than the $21 million number over the next quarter or two, but even then it'll be too premature to call it a dead-beat drug.

The timing of this downgrade is curious as well, as it seemed to coincide with a rise in the number of shares sold short, as if those "in the know" knew it was coming.

The one piece of information that became apparent from Vanda's quarterly report that could have scared off some investors is the royalty number of ten percent that Novartis pays to Vanda - roughly in line with what Titan Pharmaceuticals (TTNP.pk) will receive.

Other than that, to see shares of VNDA trading for just over eight dollars when things are picking up for the company just doesn't add up - unless you're of the mind that a 'tree shake' is taking place and someone wants your shares.

This is one of those opportunities where the shorts will play their games and the small investor has a chance to take advantage of those games by buying-in for an attractive price.

What's even more attractive right now, however, is TTNP.PK falling to $1.20 - and in a similar fashion to VNDA-- there's real no reason for that drop either, other than it looks like someone else wants to pick up as many shares as they can while dropping the price.

Of course, this is all just my opinion - each investor should do his or her own DD.

Disclosure: Long TTNP, no position VNDA.

http://seekingalpha.com/article/203322-vanda-pharmaceuticals-downgrade-why-i-don-t-buy-it

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Biotech Busts And Breakthroughs

The markets keep getting tougher. Vanda Pharmaceuticals ( VNDA - news - people ), (its 20% decline during the month puts it second-to-worst on our losers list) is facing an unsuccessful launch of its schizophrenia drug Fanapt, according to Madison Willliams analyst David Moskowitz. Merck's ( MRK - news - people ) new entrant, Saphris, is soaking up all the demand, while Novartis ( NVS - news - people ), which markets Fanapt, seems to be putting little weight behind the product.


http://www.forbes.com/2010/05/01/biotech-busts-breakthroughs-business-healthcare-april-2010.html?partner=yahootix

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Biotech Calendar: Key Dates for May

Vanda Pharmaceuticals(VNDA) first-quarter earnings, including update on commercial launch of the schizophrenia drug Fanapt.

http://www.thestreet.com/_yahoo/story/10742806/1/biotech-calendar-key-dates-for-may.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

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Fanapt First Quarter Sales Bode Well for Vanda, Novartis

Vanda Pharmaceuticals (VNDA) and marketing partner Novartis (NVS) announced the commercial launch of Vanda's schizophrenia drug Fanapt in early January, and this week Novartis released first quarter sales results for the product that at one point was issued a non-approvable letter from the FDA.

According to a Novartis media release dated April 20th, Fanapt raked in a total of $21 million for the quarter, a solid start for a new drug entering a $14-$20 billion market.

While the VNDA share price went largely unchanged on the news, the $21 million in Fanapt revenue generated by Novartis should come as an encouraging sign for things to come, because it puts a projected first year of $100 million well within reach. That wouldn't be too bad a take for first year sales at all and would beat a lot of skeptical market sentiment about the potential of the product.

It's also conceivable that the powerhouse influence of the Novartis name, combined with the fact that many schizophrenia patients switch medications often, could even have Fanapt surpass the $100 million mark in first year sales.

Due to an existing marketing agreement, Vanda will receive a cut of the Fanapt revenue from Novartis, while Titan Pharmaceuticals (TTNP.PK) will also receive an 8% take on all sales up to $200 million and a 10% take on sales above that mark.

As the milestone payments and royalty revenues start rolling in for Vanda, the company looks to submit its sleep-aid drug Tasimelteon for FDA marketing approval at some point in 2011.

With Fanapt sales underway at a respectable pace and with the company holding a notice of allowance from the US Patent Office regarding an injectible form of Fanapt, the future looks brighter every day for Vanda Pharmaceuticals. A share price of close to twenty dollars is highly likely at some point during this year, in my opinion, especially if Novartis can build on the existing momentum of first quarter Fanapt sales.

An outright buyout of Vanda by a larger pharma is also possible-- in my opinion-- most likely by Novartis, who has already invested a significant amount in Vanda Pharmaceuticals and Fanapt.

Disclosure: No positions.
http://seekingalpha.com/article/199981-fanapt-first-quarter-sales-bode-well-for-vanda-novartis

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Vanda Pharma VNDA Hapoalim Outperform $23

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4:01PM Vanda Pharma announces U.S. patent allowance for a long-acting injectable formulation of fanapt in the U.S. (VNDA) 10.29 -0.08 : Co announced that the U.S. Patent and Trademark Office has issued a notice of allowance for its patent application of a microsphere, long-acting injectable formulation of its antipsychotic product, Fanapt (iloperidone). When issued, this U.S. patent will expire on October 30, 2022, and in addition, the U.S. Patent and Trademark Office has granted a patent term adjustment of 300 days, leading to an effective expiration date of August 26, 2023.

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Vanda Pharma VNDA Jefferies & Co Buy $22 to $20

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7:35AM Vanda Pharma reports Q4 results (VNDA) 10.63 : Vanda Pharma reports Q4 earnings of ($0.34) vs ($0.16) First Call consensus; revs of $4.55 mln vs $3.34 mln First Call consensus. Co reports that their primary objective over the next quarter is to conserve cash while supporting the Fanapt launch. In addition, the Company intends to engage in discussions with several foreign regulatory agencies to review their filing requirements with respect to Fanapt(TM). Vanda also plans to continue the clinical, regulatory and commercial evaluation of tasimelteon. Although Vanda incurred transaction-related costs of approximately $6.0 million in the fourth quarter of 2009, which included financial advisor fees, consulting fees, legal expenses and employee bonuses, and $2.0 million in Fanapt inventory costs, Vanda's fixed overhead costs are expected to be ~$10.0 mln to $12.0 mln annually. Vanda will recognize revenue of $26.8 million in 2010 for the amortization of the deferred upfront payment received from Novartis.

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Competitive Schizophrenia Market

Companies:Eli Lilly Co.Novartis AgVanda Pharmaceuticals, Inc. By Zacks Equity Research , On Tuesday January 12, 2010, 1:42 pm EST

Recently, Novartis (NYSE: NVS - News) launched Fanapt (iloperidone) in the U.S. Its twice daily tablets are for the treatment of schizophrenia in adults. Fanapt received approval from the US Food and Drug Administration (FDA) in May 2009.

Clinical trials have shown that Fanapt improved symptoms in schizophrenic patients compared to a placebo therapy. The most common adverse drug reactions were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia and weight gain.

Under an agreement with Vanda Pharmaceuticals (NasdaqGM: VNDA - News), Novartis acquired exclusive commercialization rights to Fanapt in the U.S. and Canada in October 2009. In addition, Novartis has the rights to develop and commercialize an injectable form of the drug for these markets. Vanda will receive an upfront payment of $200 million as well as the potential to receive milestone payments of up to $265 million. Vanda also will receive royalties on the US and Canadian net sales of Fanapt.

In December 2009, Eli Lilly (NYSE: LLY - News) received FDA approval for Zyprexa Relprevv (olanzapine), the new extended-release injectable version of its blockbuster drug Zyprexa for the treatment of schizophrenia in adults. With respect to treatment option, the approval is significant as the Zyprexa Relprevv injection maintains therapeutic drug levels for up to four weeks, when the disease relapses following irregular intake of prescribed medications. Long-acting treatments play a beneficial role since non-adherence to medication is a big problem for the patients.

Schizophrenia is a chronic, severe and disabling mental disorder affecting 2.4 million Americans or about 1.1% of the adult population in the U.S. While there is no cure for the disease, proper medication can keep it in check. As per estimates, the global schizophrenia market was valued at $15.9 billion in 2008 which is expected to reach $17.2 billion by 2015.

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Vanda Pharma VNDA Jefferies & Co began with a Buy $22