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PRTT .05 /75kVOL (1-trade), -67%
BE MG is setting up nicely now. Before we know it 1.00 will appear.imo My prediction is $2.00 March 2013
This is the lowest float OTCQB stock I have ever seen in all my shell days. According to one of their filings the float is about 25k.....Symbol .....E..S..R..N.....
The OS is held pretty much all by insiders. The last deal they were going to do they were going to give up ALL shares except for the 25k! That is insane.imo When a company gets 99.9% of the OS they usually do HUGE FORWARD SPLITS! Ive seen it before. And most of those stocks that do the FS's stay in the dollars After the fact. So this could be a 20+ for 1 FS in the making.
INNV .56 Interesting play. Ex CEO from APRI took over. I believe INNV is in the pharma acquisition business and has an extremely low float. Who knows if this can acquire something big the stock could run.
DIGP .31x.51 Has touched in the dollars before. I believe this can go back above 1.00-1.50
Prediction Alert APRI($2.33) will be one of the next bio stocks that will go from 2 range to 8 range. Quite possibly this year(2013).
Stop loses are said to reduce risks so you dont get hammered with large losses but I think they are taking candy tools. I dont know if I would ever use a stop loss. Id rather lose 50% than lose 10-20% and see that very same stock back up in 10 minutes.
PACB Man man man! This was going to be my long term 2013 hold. APRI and PSDV are my other two.
Sold way too early on PACB. I really wanted to buy back in after I sold too bc I had regretted it right after I sold. Damn. What a awesome stock. Got to love management too. Crap I might just buy back in before it goes to 5 bucks.
APRI Sleeping Giant? 5-10+ bucks 2013?
BE MG .15x.20 Crazy low prices for a OTCQB RM candidate.
BEMG .15 OTCQB Now may be the time to add this one.imo PPS is low for a 90%+ owned co ready for a Reverse Merger! Its hard to get shares this cheap under .51 for a clean co like this. Shares can be had for .15-.25 right at this moment.
This stock has moved .51-1.00 before a couple times and I believe it will do it again with higher volume soon. With a merger this will take off. It could even do a Forward Split to add liquidity.
I predict 1.50-2.00 in 2013 for BEMG.
MAQC Symbol Change complete!
SYMBOL CHANGES
13:02 1/15/2013 MAQC ZMDC Marketing Acquisition Corporation Common Stock **
APRI 2.08 I dont think it gets better than this in the biotech field. At the bottom of 52 week low and many 2013 catalysts. I am placing my bets here. This has multi-bags written all over it.imo
AFFX 3.70 Looks like the next runner. 5.50 Target? Could be in a couple months.
TROV or CLSN MMMMMMMM Who will be the biggest short term winner from 8.00?
MBDX who would of thought buying at 66 bucks would be a profit? Wow.... Didnt buy but was looking at it in the 60s....
PSDV 1.48 Is looking bullish. I think it can go 2.00+ soon.
PACB moved up to 2.80 this am. A thing to come? 3.00 coming? Continuance of buying.
AMRN 8.83 doing good
PRTT are they back to a shell now? Not sure. They never really took off. But It seems the people behind this are legit and have pull and money.
Source : Press Release
Date : 2011-09-12
Companies : Protect Pharmaceuticals, Inc.
Protect Pharma (OTCBB:PRTT) Develops Revolutionary Drug Platforms
PRINCETON, NEW JERSEY, September 12, 2011-- Protect Pharma Corp (OTCBB:PRTT) is a Pharmaceutical company with innovative drug delievery technology and promising pipeline.Unlike other drug delivery companies like Alkermes Inc. (NASDAQ: ALKS) and Apricus Bioscience Inc. (NASDAQ: APRI), the company’s technology offers increased clinical efficacy via novel delivery that enables a better therapeutic profile with lower doses.
Key Highlights
Unique Drug Delivery Platform. Protect Pharma has developed two drug delivery platforms that have very unique mechanisms of action.
Rock Solid Business Model. Protect Pharma has developed a rock solid business model designed to minimize uncertainty, reduce development costs, and reduce time to market.
An Undervalued Opportunity. Protect Pharma appears to be significantly undervalued given its potential, unique technology, and promising development pipeline.
Unique Drug Delivery Platform
Protect Pharma has developed two unique drug delivery platforms, called ProRet™ and ProProof™. ProRet™ is a unique gastro-retentive delivery platform designed to significantly prolong the absorption window for a number of key drugs. Meanwhile, ProProof™ is an abuse-deterrant formulation that limits the abuse potential of drugs that are prone to abuse.
These layered platforms enable more than one drug work at the same time, while increasing efficacy by prolonging the absorption window. Ultimately, the company hopes to apply the platform to a number of different gastro and pain-related indications.
Rock Solid Business Model
Protect Pharma’s unique business model enables it to develop innovative new products using existing pharmaceuticals to address unmet medical needs. This model minimizes discovery uncertainty, reduces the cost of development and reduces the time to market because of well defined FDA regulatory pathway (505 b(2)). Backed with a unique delivery technology, the company has already begun developing two drugs – PRTT-200 and PRTT-300. In addition, Protect has two first in class projects- PRTT-210 Once daily gastro-retentive combination drug. PRTT-310 is both abuse deterrent and once daily opioid combination product. No such combination products been approved.
PRTT-200 is a gastro-retentive once daily Pregabalin to treat diabetic neuropathic pain, fibromyalgia, epilepsy and neuralgia. With market potential estimated to be about $5 billion, the drug will directly compete against Pfizer’s Lyrica© and Eli Lilly’s Cymbalta©. Meanwhile, PRTT-300 is a once daily efficacy-enhanced, abuse deterrent that addresses a $6 billion market.
PRTT-210 is once daily gastro-retentive Pregabalin + Opioid combination while the PRTT-310 is abuse deterrent and once daily Opioid + Acetaminophen combination addressing a total $ 11 billion market opprtunities
An Undervalued Opportunity
Currently, Protect Pharma trades with a market capitalization of $43.6 million, which could represent just a fraction of its potential valuation. With target markets worth more than $11 billion, even a modest market penetration could mean significant value for shareholders. To learn more about Protect Pharma Corp (OTCBB: PRTT), check out the following resources:
Company Website
Latest 10-Q Quarterly Report
Latest 10-K Annual Report
About Protect Pharmaceuticals Corporation
Based in Princeton, New Jersey, Protect (PRTT) is a publicly held drug delivery and new product development company. Protect applies its proprietary drug delivery technologies to develop clinically effective drugs and is building a robust pipeline of product candidates based on its proprietary technologies, scientific knowledge and clinical expertise. For more information, visit www.protectpharm.com.
Safe Harbor Statement
This news release may contain certain forward-looking statements and information concerning Protect’s business, operations, financial condition and prospects. These statements are subject to various risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors. The information set forth herein should be read in light of such risks and uncertainties. The Company assumes no duty or obligation to update these statements at any future date.
Contact
Ram Sesha,CEO,
http://www.pharmaloco.com/company/Protect+Pharmaceuticals,+Inc.+/index.html
Source : Press Release
Date : 2011-02-01
Companies : Protect Pharmaceuticals, Inc. , Nectid, Inc.
PROTECT PHARMA SELLS PATENT PORTFOLIO TO GRUNENTHAL GmbH
PRINCETON, NEW JERSEY, February 1, 2011-- Protect Pharmaceutical Corporation (PRTT) announced today that it has completed the sale of two patents and patents-applications to Grunenthal GmbH, a German specialty pharmaceutical company that is a pioneer in pain drug discovery and research. The patent portfolio includes innovative pain drugs that address the large and underserved pain market.
Ram Sesha, Protect’s Chief Operating Officer, said “We are very happy to see Protect’s programs are innovative and promising enough to attract someone like Grunenthal, a leader in pain drug discovery and research.”
Protect still retains the patents related to abuse deterrent and once daily gastro-retentive drug delivery platforms and the corresponding three other ongoing projects. In the near term, Protect intends to proceed with a comprehensive program to develop and commercialize once-daily drugs for diabetic neuropathic pain, fibromyalgia, postherpetic neuralgia and epilepsy. Protect also plans to develop and commercialize once-daily opioid combinations as well as abuse-deterrent opioid combinations for moderate to severe pain.
About Protect Pharmaceuticals Corporation
Based in Princeton, New Jersey, Protect (PRTT) is a publicly held drug delivery and new product development company. Protect applies its proprietary drug delivery technologies to develop clinically effective drugs and is building a robust pipeline of product candidates based on its proprietary technologies, scientific knowledge and clinical expertise. For more information, visit www.protectpharm.com.
Safe Harbor Statement
This news release may contain certain forward-looking statements and information concerning Protect’s business, operations, financial condition and prospects. These statements are subject to various risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors. The information set forth herein should be read in light of such risks and uncertainties. The Company assumes no duty or obligation to update these statements at any future date.
Contact
Ram Sesha,COO,
http://www.pharmaloco.com/company/Protect+Pharmaceuticals,+Inc.+/index.html
Here are some press releases from last year.
Source : Press Release
Date : 2011-04-15
Companies : Protect Pharmaceuticals, Inc.
Protect Pharmaceutical Corporation Appoints Chief Executive Officer and Chief Financial Officer
PRINCETON, N.J., April 15, 2011 /PRNewswire/ -- Protect Pharmaceutical Corporation (OTCBB:PRTT.ob - News) today announced its Board of Directors has appointed current Chief Operating Officer Ramesha Sesha as its Chief Executive Officer and Chairman of the Board, effective immediately. Mr. Sesha joined Protect as the Chief Operating Officer and Board Member in March 2011, following the Patent Acquisition Agreement with Nectid Inc where he was the Founder and CEO.
Mr. Sesha has over 15 years experience in both the brand and generic pharmaceutical industry. He is an Organic chemist and was the Senior Vice President for Intellectual Property and US FDA Submissions, with Wockhardt Limited in Bedminster, New Jersey. His role included managing the IP portfolio, R & D strategy and was a part of the M & A team. He founded Nectid Inc, a privately held R & D firm and has licensed or sold 19 patents to different pharmaceutical companies in the last 24 months.
Mr. Sesha's promotion reflects Protect's strategy to ensure its scientific and corporate visions are aligned together.
The Board of Directors also approved the appointment of Keith Elison to become and serve as the Company's Chief Financial Officer, to be effective immediately. Mr. Elison has more than eleven years of experience in public company accounting and SEC compliance and reporting issues. His professional experience includes providing accounting and financial reporting assistance for small and medium-sized publicly held companies.
About Protect Pharmaceuticals Corporation.
Based in Princeton, New Jersey, Protect (PRTT) is a publicly held drug discovery and new product development company. Protect applies its proprietary drug delivery and discovery technologies to discover and develop clinically effective drugs. Protect is building a robust pipeline of product candidates based on its proprietary technologies, scientific knowledge and clinical expertise. For more information, visit www.protectpharm.com.
Safe Harbor Statement
This news release may contain certain forward-looking statements and information concerning Protect's business, operations, financial condition and prospects. These statements are subject to various risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors. The information set forth herein should be read in light of such risks and uncertainties. The Company assumes no duty or obligation to update these statements at any future date.
http://www.pharmaloco.com/company/Protect+Pharmaceuticals,+Inc.+/index.html
PRTT .50 Bio stock. Needs to file past report.
This is a website I found on PRTT
http://www.pharmaloco.com/company/Protect+Pharmaceuticals,+Inc.+/index.html
These are other stocks, private companies, or IPOs that have the same address in the filings or had it and their pps:
UREE 1.25 52week high 5.00
EASTGATE ACQUISITIONS CORPORATION IPO
http://www.nasdaq.com/markets/ipos/company/eastgate-acquisitions-corp-69594-71208
Blue Cap Development Corp
http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=139830840
Greyhound Commissary, Inc.
Horizontal Marketing, Inc.
http://ir.stockpr.com/tankebio/all-sec-filings/content/0000000000-11-002141/0000000000-11-002141.pdf
ECOLOGY VENTURES INC.
http://nvsos.gov/SOSEntitySearch/CorpDetails.aspx?lx8nvq=llxwR5NfU6ZLvLU2fmPS5Q%253d%253d
Electrohealing Technologies, Inc.
http://www.nvannualreport.com/entities-DPC-ELECTROHEALING-TECHNOLOGIES-INC.aspx
Added more MNKD today
2013 Is Off to a Strong Start
Posted by Eddy Elfenbein on January 2nd, 2013 at 10:52 am
Here are the 20 stocks for the 2013 Buy List. It’s locked and sealed and I can’t make any changes for 12 months.
For tracking purposes, I assume the Buy List is a $1 million portfolio that’s equally divided among 20 stocks. Below are all 20 positions with the amount of shares for each, and the closing price for 2012. Whenever I discuss how the Buy List is doing, the list below is what I’m referring to.
Company Ticker Price Shares Balance
AFLAC AFL $53.12 941.2651 $50,000.00
Bed Bath & Beyond BBBY $55.91 894.2944 $50,000.00
CA Technologies CA $21.98 2,274.7953 $50,000.00
Cognizant Technology Solutions CTSH $73.88 676.7731 $50,000.00
CR Bard BCR $97.74 511.5613 $50,000.00
DirecTV DTV $50.16 996.8102 $50,000.00
FactSet Research Systems FDS $88.06 567.7947 $50,000.00
Fiserv FISV $79.03 632.6711 $50,000.00
Ford Motor F $12.95 3,861.0039 $50,000.00
Harris Corporation HRS $48.96 1,021.2418 $50,000.00
JPMorgan Chase JPM $43.97 1,137.1390 $50,000.00
Medtronic MDT $41.02 1,218.9176 $50,000.00
Microsoft MSFT $26.71 1,871.9581 $50,000.00
Moog MOG-A $41.03 1,218.6205 $50,000.00
Nicholas Financial NICK $12.40 4,032.2581 $50,000.00
Oracle ORCL $33.32 1,500.6002 $50,000.00
Ross Stores ROST $54.09 924.3853 $50,000.00
Stryker SYK $54.82 912.0759 $50,000.00
Wells Fargo WFC $34.18 1,462.8438 $50,000.00
WEX Inc. WXS $75.37 663.3939 $50,000.00
http://www.crossingwallstreet.com/
SKUL Horrible. Market is killing this stock.
BBBY Looks like bounce has begun. This should be 75+ in 2013.imo
BBBY = Strong company. Lots of cash and doing a large buy back. At 52 week low too.
MAQC Wu Qing Tong Ti Suite Herbal Detox Hits Australia
Wu Qing Tong Ti Suite Offers Healing Breakthrough for Australians
A world-first breakthrough in Quantum healing technology is now available for Australian people to benefit from, thanks to the TGA approval of a new herbal detox, Wu Qing Tong Ti Suite, and the granting of distribution rights in Australia. The developers of Wu Qing Tong Ti Suite, Beijing-based ZhiMingDe International, have spent 10 years in research and development and launched this unique herbal detox product to the Chinese community in 2008. Since then millions of Chinese people have benefited. Now Australians can do the same.
Wu Qing Tong Ti Suite is a revolutionary natural herbal detox that strips toxic scales from the lungs, liver, kidneys, heart and spleen in 24 hours. It blends 5000 year old Traditional Chinese Medicine principles with a revolutionary quantum magnetisation technology which magnifies the detoxification benefits by 100 times, according to Australian distributor, Andrew Plimmer of Quantum Longevity.
In today’s society, people are constantly being bombarded by pollutants which clog up our bodies with toxic plaque which affect our energy levels, adversely affects our immune systems, and can lead to serious illness. These pollutants come from cigarette smoke, chemicals that we breathe in, preservatives and chemicals in food, and chemicals in water. The human body absorbs these pollutants but has trouble processing them through the digestive system so we store these pollutants in our organs and throughout our bodies. Some people have up to 15kg of toxic scale inside their bodies.
Once these toxins are removed, a person starts to feel healthier, they have more vitality, and their body’s disease-fighting capacities dramatically improve.
is a herbal detox that enables people to detoxify their bodies more rapidly and more powerfully than ever.
“It is the first modern herbal preparation product infused with the same miraculous Quantum Magnetisation Technology that Scientists are raving about in Quantum Medicine arena,” said Mr. Plimmer.
One of the key reasons why Wu Qing Tong Ti Suite is so effective is because the herbal detox ingredients are broken down into micro-particles, much smaller than the size of a single cell so they can penetrate and enrich individual cells in the human body more effectively than any other herbal preparation.
Each of these micro-particles inside Wu Qing Tong Ti Suite vibrates at 100 million times a second. These high frequency energy waves literally shake off toxic scales that have formed throughout the human body. It works in similar way to ultrasound technology which is used to strip off plaque from teeth. The high frequency also enables the micro-particles to resonate with the specific vibration of individual cells in the body. Doing this, raises the vibration of disordered cells and helps reset them back to a healthy vibratory state.
When the detoxification process inside Wu Qing Tong Ti Suite is finished, usually within 24 hours, people can instantly view the results. These toxins move through the blood stream, are transmitted to the liver and then move through the intestinal tract then the hepatic duct and are excreted out of the body.
When they are excreted they take the form of crystal blocks and granular scale in a rainbow of colours – different colours corresponding to the different organs that the toxic scale was removed from.
MAQC Company History:
From Year of 1991 to Year of 2008, Zhimingde International Group LLC (formerly known as YANBIAN Pharmaceuticals LLC) has been an active pioneer in China’s pharmaceutical industry, professional in R&D, manufacturing and marketing of pharmaceuticals.
the Year of 2008
In May, Beijing Zhimingde Quantum Bio-technology LLC was established.
In September, DETOX PRO received the Healthcare Product Approval Certificate issued by State Food and Drug Administration of China
In November, there are more than 30 press reportages about DETOX PRO from official media, including Reference News, Global Times, Science and Technology Daily, etc.
the Year of 2009
In February, Chinese famous TV star Mr. Du Yulu served as the Image Speaker of DETOX PRO
In March, advertising campaign of DETOX PRO Pack was initiated on CCTV.
In April, China News of CCTV International Chanel reported the DETOX PRO Pack globally
In May, Mr. Zhongquan Zou, president of Zhimingde International Group, was elected as the vice president of China Healthcare Association.
In June, Zhimingde Global Summit 2009 was held in Beijing, China, more than 5,000 global distributors attended.
In September, Mr. Zhongquan Zou, president of Zhimingde International Group, was elected as the vice president of China Quality Association for Pharmaceuticals.
the Year of 2010
In March, DETOX PRO Pack, Zhimingde’s main product, received the registration certificate issued by Therapeutic Goods Administration of Australia
In May, DETOX PRO Pack, Zhimingde’s main product, was registered as the therapeutic medicine by Health Science Authority (Singapore)
In July, DETOX PRO Pack received Free Sale Certificate issued by FDA
In October, DETOX PRO Pack received the Award for Inheritance & Innovation of TCM and Award for Outstanding Contribution to Globalization of TCM issued by 7th World TCM Convention 2010 which was held in Hague, Netherland.
In December, Zhimingde Global Convention 2010 was held in Beijing, China.
the Year of 2011
In January, Zhimingde International Group became a senior member of Council of China Medicine Daily.
In July, Zhimingde Global Summit 2011 was held in Beijing, China. More than 200 global distributors received luxury prizes for their excellent performance.
In September, Zhimingde Charitable Primary School was established in Helong City, Jilin Province. This is a milestone for Zhimingde in the process of undertaking the social responsibility.
DETOX PRO Pack received Patent Certificate issued by State Intellectual Property Office of China
the Year of 2012
In January, Maradona, a world famous soccer player, served as Image Speaker for BTN Health Management (Korea) LLC, a subsidiary company of Zhimingde International Group.
In January, Zhimingde Global Summit 2012 & Donation Ceremony of China Glorious Foundation was held in Beijing, China.
In February, Zhimingde Management Committee of Distributor was established.
In June, Zhimingde International Seminar 2012 was held in Seoul, South Korea, more than 500 global distributors attended.
In July, President Zou of Zhimingde International Group attended the China Glorious Foundation (Yanbian City) Conference, which was held by China Glorious Foundation and Jilin Provincial Government, and donated for poverty alleviation in Yanbian City.
In August, President Zou of Zhimingde International Group was invited by President of International Police Center (IPC) of United Nations to Moscow for an official visit of 5 days. Zhimingde International Group and IPC signed a commercial cooperative agreement in which IPC authorized Zhimingde to use emblem of IPC. Both partners agree to carry out common initiatives in the areas of commercial cooperation of mutual interest in Greater Russia.
MAQC Company Info:
Zhimingde International Group was founded in 2008, headquartered in Beijing, China. After five years of rapid growth, Zhimingde International Group has become one of the foremost direct-selling companies in China, and a professional manufacturer and marketer of traditional Chinese medicine (TCM) healthcare products. Zhimingde’s main product---DETOX PRO Pack, since its launch to global market in 2008, has benefited millions of people from various countries and obtained approval certifications from authoritative institutions, including FDA (USA), HAS (Singapore), TGA(Australia) and KFDA (South Korea). Zhimingde International Group is becoming a pioneer in China’s booming healthcare industry and a promoter of TCM to the whole world.
Zhimingde International Group transferred its global headquarter from Beijing to New York, located in Broadway, Manhattan, to facilitate its global expansion. Greater China market and US market used to be Zhimingde’s focuses, however, with the development of its direct-selling business, Zhimingde proceeds to launch into most countries and territories of the world.
Now Zhimingde’s markets cover Eastern Europe with Russia being the regional operation center, Western Europe with France being the regional operation center, Oceania with Australia being the regional operation center, Northeastern Asia with South Korea being the regional operation center and Southeastern Asia with Singapore being the regional operation center, and further regional developments will soon be implemented in the near future, those regions including South America (focus being Brazil market) and Middle East (focus being the United Arab Emirates market) and Africa (focus being South Africa market). Zhimingde is intensely ambitious for going global and to become one of top direct-selling companies in the world, with its unique quality products benefiting the human health.
MAQC Prediction $5.00-10.00 stock pps. Possible future uplisting to NASDAQ.
The same guy who is backing TROV also backed other runners in the past. One of them was Inhibitex. This puppy ran from 2.00 to 26.00! Now TROV started getting its action around 2.00. It is entirely reasonable that TROV can make this type of run, maybe even beyond it.imo
TROV - Will it be one of the best moving bio-techs of 2013? Time will tell. They have some big backers and some top notch Dr's on board. Plus its a low floater that can move very easily.
Right now it is $6.83. Some are saying $14.00 near term. Some say 20.00 easily.
I would like to know how much the recent deal are. My guess the up front payments and royalties aren't that big and that is why they aren't putting the figures out yet.
Nonetheless Jan will be a interesting month for TROV.imo
MNKD Could be a mover to a buck over current pps. CEO just bought 40 mil @ $2.59 a share.
ALXA APPROVED!
U.S. FDA Approves Alexza's ADASUVE (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults PR Newswire "Press Releases US - English"
MOUNTAIN VIEW, Calif. , Dec. 21, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food and Drug Administration (FDA) approved ADASUVE (loxapine) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. ADASUVE combines Alexza's proprietary Staccato delivery system with the antipsychotic drug, loxapine. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug. See below for Important Safety Information about ADASUVE, including Boxed Warnings.
"The approval of ADASUVE is an important event in the treatment of agitation. ADASUVE is the first approved non-injectable therapy for the acute treatment of agitation in adults with schizophrenia and bipolar I disorder. As noted in the consensus guidelines for Best Practices in the Evaluation and Treatment of Agitation, we believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them," said Thomas B. King , President and CEO of Alexza. "This is a landmark day for Alexza and we are proud of our accomplishments in developing this unique product. We project that ADASUVE will be available for commercial launch early in the third quarter of 2013."
"The data we have seen from the ADASUVE Phase 3 clinical trials in patients with schizophrenia and bipolar I disorder are compelling," said Michael Lesem , MD, Executive Medical Director, Claghorn-Lesem Research Clinic , Houston, TX and a principal investigator in the ADASUVE clinical trials."I believe that ADASUVE represents an important new and much needed therapeutic option in treating agitation patients who will benefit from a non-coercive therapeutic intervention that works quickly to relieve their symptoms."
The FDA approval is based on a clinical data package involving more than 1,600 patients and subjects. In two Phase 3 trials, ADASUVE was found to be effective in the acute treatment of agitation in adults with schizophrenia or bipolar I disorder. In these two studies, ADASUVE 10 mg met the primary efficacy endpoint, with statistically significant reductions in agitation as compared to placebo at the two-hour post-dose time point, as well as the principal secondary endpoint. Of note, ADASUVE exhibited rapid effects in agitated patients, with statistically significant reductions in agitation apparent starting at 10 minutes following administration of a dose versus placebo1,2.
As part of the ADASUVE development program, Alexza identified a risk of bronchospasm in certain asthma and chronic obstructive pulmonary disease (COPD) patients following dosing with ADASUVE. It is important to note that ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. ADASUVE will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS (described below).
ADASUVE Partial Prescribing Information (U.S.) Please click here for Full Prescribing Information, including Boxed WARNINGS, or visit www.adasuve.com.
INDICATIONS AND USAGE
ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder. Limitations of Use: ADASUVE must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASMand INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
Bronchospasm:
ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest
ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS
Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation)
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis
CONTRAINDICATIONS:
ADASUVE is contraindicated in patients with the following:
Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung disease associated with bronchospasm
Acute respiratory signs/ symptoms (e.g., wheezing)
Current use of medications to treat airways disease, such as asthma or COPD
History of bronchospasm following ADASUVE treatment
Known hypersensitivity to loxapine and amoxapine
WARNINGS AND PRECAUTIONS:
Neuroleptic Malignant Syndrome: May develop in patients treated with antipsychotic drugs. Discontinue treatment
Hypotension and Syncope: Use with caution in patients with known cardiovascular or cerebrovascular disease
Seizure: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold
Potential for Cognitive and Motor Impairment: Use caution when driving or operating machinery
Cerebrovascular Adverse Reactions: Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis treated with antipsychotic drugs
ADVERSE REACTIONS: The most common adverse reactions (incidence 2% and greater than placebo) in clinical studies in patients with agitation treated with ADASUVE were dysgeusia, sedation, throat irritation
ADASUVE will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS. ADASUVE should only be administered in a healthcare facility enrolled in the ADASUVE REMS program that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). In addition to product labeling, Alexza developed the ADASUVE REMS with the purpose of mitigating the risk of bronchospasm. The ADASUVE REMS includes a communication plan and an "elements to assure safe use" of the product, including provisions designed to ensure that ADASUVE will only be dispensed in healthcare settings that are enrolled in the ADASUVE REMS program.
With the ADASUVE NDA approval, Alexza also has several post-approval requirements, including a large observational clinical trial designed to gather patient safety data based on the real-world use of ADASUVE, as well as a clinical program addressing the safety and efficacy of ADASUVE in agitated adolescent patients.
About Agitation Associated with Schizophrenia and Bipolar I Disorder Agitation is a serious medical problem that can present in a number of psychiatric disorders, including schizophrenia and bipolar I disorder. Of the estimated 3.2 million patients treated for schizophrenia or bipolar I disorder in the U.S.3, about 90% suffer from agitation in their lifetime4, due to the natural course of underlying disease or non-compliance with chronic medication. Patients average 11 to 12 episodes of agitation each year5.
Agitation episodes may escalate unpredictably and, in some cases, necessitate chemical or physical restraint to relieve the individual's distress and to protect care providers and others in close proximity. Rapid, effective and safe intervention is key to returning the agitated person to a less agitated state.
About Alexza Pharmaceuticals, Inc. Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, is designed for rapid systemic drug delivery through deep lung inhalation. (Click here to see an animation of how the Staccato system works.)
ADASUVE (Staccato loxapine) is Alexza's lead therapeutic program. Grupo Ferrer Internacional , S.A is Alexza's commercial partner for ADASUVE in Europe , Latin America , Russia and the Commonwealth of Independent States countries. Alexza filed its ADASUVE Marketing Authorization Application with the European Medicines Agency (EMA) in October 2011. In December 2012 , Alexza received a positive opinion from the EMA's Committee for Medicinal Products for Human Use recommending the approval of ADASUVE in the European Union for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. The European Commission is now expected to grant marketing authorization for ADASUVE in all 27 European Union Member States, plus Iceland , Lichtenstein and Norway. A decision is expected from the European Commission in the first quarter of 2013.
For more information about Alexza, the Staccato system technology or the Company's development programs, please visit www.alexza.com. For more information about ADASUVE, please visit www.adasuve.com. ADASUVE and Staccato are registered trademarks of Alexza Pharmaceuticals, Inc.
Safe Harbor Statement This news release contains forward-looking statements that involve significant risks and uncertainties. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs, including the ability for Alexza to effectively and profitably commercialize ADASUVE in the US, the impact and risks of the ADASUVE post-marketing studies and Risk Evaluation and Mitigation Strategy (REMs) on the commercialization of ADASUVE the adequacy of the Company's capital to support the Company's operations and the Company's ability to raise additional funds and the potential terms of such potential financings. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2011 and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission . Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
References:
Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH and Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry . 2011 Jan;198(1):51-8.
Kwentus J, Riesenberg RA, Marandi M, Manning RA, Allen MH, Fishman RS, Spyker DA, Kehne JH and Cassella JV. Rapid acute treatment of agitation in patients with bipolar I disorder: a multicenter, randomized, placebo-controlled clinical trial with inhaled loxapine. Bipolar Disord. 2012 Feb;14(1):31-40.
Alexza data on file (Calculation: from NIMH prevalence; Saha 2005; Merikangas K. Lifetime and 12-month Prevalence of Bipolar Spectrum Disorder in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2007. 64(5):543-552.)
Alexza data on file (primary market research among caregivers of patients with schizophrenia (95% have agitation) and bipolar patients (87% have agitation))
Alexza data on file (primary market research among caregivers of patients with schizophrenia (have an average of 12 agitation episodes per year) and bipolar patients (have an average of 11 agitation episodes per year))
SOURCE Alexza Pharmaceuticals, Inc.
TROV anlyst have it targeted at $11-12. That may prove to be a modest target after all the licensing deals that may come.
ALXA another one with potential. It could be double from here and make it to 12.
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