|By Marketwired .||
|January 15, 2013 07:01 AM EST||
LOS ANGELES, CA -- (Marketwire) -- 01/15/13 -- BioLineRx engages in identifying, in-licensing, and developing therapeutic candidates. Its lead clinical therapeutic candidate under development is BL-1020, which is in Phase II/III clinical trials to improve cognitive function in schizophrenia patients. BL-1020 is an orally available, first in class GABA enhanced antipsychotic that combines dopamine antagonism with GABAergic activity.
BL-1020 is being tested against Johnson and Johnson's schizophrenia drug Risperdal, which generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007.
According to Wikipedia: "Risperdal is the trade name for risperidone, an antipsychotic drug which is mainly used to treat schizophrenia but also used for other conditions. Due to its strong serotonin, dopaminergic, and adrenergic antagonism, risperidone was approved by the FDA in 1993 for the treatment of schizophrenia. In 2007, risperidone was approved as the only drug agent available for the treatment of this disease in youths, ages 13-17. It was also approved that same day in the treatment of bipolar disorder for people ages 10-17. In 2006, the FDA approved risperidone for the treatment of irritability in children and adolescents with autism. This decision was based in part on a study of autistic people with severe problems containing violent meltdowns, aggression, and self-injury."
With all of the above indications, it is evident risperidone is an important and versatile drug.
Recently, a pair of companies announced they were on track in the early development with another candidate using risperidone. Earlier this month, Durect Corporation announced its licensee, Zogenix reported positive single-dose pharmacokinetic results from the Phase I clinical trial of Relday, a once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia.
Zogenix needed this bit of good news as its pain killer drug Zohydro was shot down by an FDA Advisory Committee by a vote of 11-2 against recommending the drug to the FDA for approval, causing its stock price to plummet 42% on December 10th, 2012.
BioLine uses risperidone as the positive control for antipsychotic efficacy in its phase II/III CLARITY trial. The study is designed as a randomized, double-blind clinical trial to examine acute (6 weeks) and long-term (6 months) antipsychotic and cognitive efficacy, safety, and tolerability of BL-1020. The cognition primary endpoint measure will utilize the MATRICS Cognitive Consensus Battery (MCCB), and cognitive benefit will be assessed by comparing the change from baseline in total MCCB score. These scores will compare BL-1020 to risperidone at the landmarks of six, 12 and 24 weeks.
Significant upcoming Catalyst:
BioLineRx has stated that they will present the Phase II/III CLARITY trial results during the week of March 18, 2013.
So what is the big deal with another schizophrenia drug? As mentioned above, JNJ's Risperdal has raked in billions of dollars in revenue before going off of patent protection in 2010. BL-1020 has patent protection through 2033. The preliminary results for BL-1020 indicate it's as effective, if not more effective and safer than Risperdal. If the data that is expected to be released in March confirms the previous results, we can expect a massive move in the stock price.
Acadia, recently reported positive Phase III data for its drug Pimavanserin, which is in development as a potential treatment for Parkinson's disease psychosis (PDP). Pimavanserin is specific to PDP and has the potential to be a multi-billion dollar drug if approved as evident by Acadia's stock price surging over 200% intraday on 11/27/12, hitting a high of $6.50 (over $7 in the pre-market trading session).
Pimavanserin's first Phase III study failed to meet its primary endpoint, but after re-tailoring the trial, Acadia has now seen success with the drug. While PDP is different from schizophrenia, both are defined as a form of psychosis. The market potential for both combined is massive, demonstrated in part by Risperdal's 7 year revenue of over $24B.
It's also worth noting that Acadia ended development of its own schizophrenia drug AM-831 in July of 2012. Acadia and its partner Meiji Seika Pharma Co. stated that the drug did not meet certain criteria for advanced testing -- Drug companies know treatment for schizophrenia is a very lucrative market.
Below, let's take a look at a balance sheet summary for BioLine.
Balance Sheet Total Cash (mrq): $ 26.38M Total Cash Per Share (mrq): $ 1.75 Total Debt (mrq): $ 44.85K Total Debt/Equity (mrq): 0.24 Current Ratio (mrq): 3.91 Book Value Per Share (mrq): 1.25 Shares Outstanding5: 15.06M Float: 12.33M
Market Cap (intraday): $43.08M
"I have highlighted the numbers that stick out to me above in bold. Bioline having a $43M market cap has to be the result of the company flying under the radar of speculative investors and traders. If positive results are announced in March, I have to think the stock will at least gap up over 100% because BL-120 could be worth billions if ultimately approved for sale," said Scott Matusow.
Bioline having $1.75 cash per share is good, along with $26.3M in cash and a current burn rate of about $4.5M a quarter. This gives the company over a year of breathing room to operate before they might have to engage in a possible cash raise.
BL-120 is not the only drug the company has in its pipeline:
BL-1020 Schizophrenia (Currently in Phase II/III trial) BL-1040 AMI (Currently in CE Mark Registration Trial) BL-5010 Skin lesions (Phase I/II complete) BL-7040 Inflammatory Bowel Disease ( Phase II) BL-8040 Acute myeloid leukemia & other hematological cancers (Phase II ready) BL-1021 Neuropathic Pain (Currently in Phase I trial)
BL-8020 HCV BL-6030/1 Bacterial Infection (BIJ) BL-7010 Celiac Disease BL-5040 Cachexia (BIJ) BL-7020 Psoriasis (BIJ) BL-7060/EDP29 AMI BL-8010/EDP30 Retinopathy BL-8030 HCV
"I find the potential of Bioline to be very enticing since the company has only a $43M market cap and over $26M in the bank. As mentioned above, I feel Bioline has been flying under the radar and offers a good opportunity at its current price. Also of note, 2 analyst firms have slapped a buy rating on the stock with one assigning a target price of $11.
"Sarepta was flying under the radar until it recently grabbed investor attention with positive data releases for Eteplirsen, which is in Phase II clinical stage for the treatment of Duchenne muscular dystrophy (DMD). In July 2012, following a 1:6 reverse split, Sarepta was trading around $3.30 a share. Currently the stock trades for over $27 as investors and traders have taken notice of the huge developing story at Sarepta. While it's not likely that Bioline will see a stock price anywhere near the $27 range anytime soon, I do feel it's a good bet its stock price can see a very large percentage gain if the CLARITY trial results are positive in March, and nice price appreciation beforehand in anticipation of the results.
"The stock has formed a longer term rounding bottom and is showing signs of reversal after breaking out of its down channel. The MACD and RSI are very bullish. First target appears to be the 38.2% retrace at $4.00.
"Overall, I like Bioline for at least a nice catalyst trade, and expect the stock to be trading much higher over the next month. If the Phase II data release is positive, which it should be, I would expect a stock price over $5," said Scott Matusow.
Disclosure: Author Scott Matusow @scottmatusow is long BLRX.
The full report including the stock chart is available at:
Healthcare investors and Biotech traders interested in accessing BioMedReports' new complete database of clinical trials and upcoming FDA and world-wide regulatory decisions which can be used to make more profitable trades and see upcoming catalysts can go to: http://biomedreports.com/fdacal.html
News developments and live healthcare sector updates are available constantly via twitter at: http://twitter.com/BioMedReports
BioMedReports is a news and research portal covering financial biotech news for the entire Healthcare Sector of the market. BioMedReports is not paid or compensated to report the news and developments of publicly traded companies. BioMedReports sells a premium product for subscribers and full disclosures and information about the stocks and news mentioned in this news release are available at BioMedReports.Com
Media Contacts Only:
e-mail: Email Contact
ProfitBricks has launched its new DevOps Central and REST API, along with support for three multi-cloud libraries and a Python SDK. This, combined with its already existing SOAP API and its new RESTful API, moves ProfitBricks into a position to better serve the DevOps community and provide the ability to automate cloud infrastructure in a multi-cloud world. Following this momentum, ProfitBricks has also introduced several libraries that enable developers to use their favorite language to code ...
Apr. 18, 2015 09:30 AM EDT Reads: 1,253
SYS-CON Media announced today that John Treadway’s blog has exceeded 475,000 page views. John Treadway, Vice President at Cloud Technology Partners, has surpassed 475,000 page views on the SYS-CON family of online magazines, which includes Cloud Computing Journal, Internet of Things Journal, Big Data Journal, Microservices Journal, and several others. His blog home page at SYS-CON can be found at JohnTreadway.SYS-CON.com.
Apr. 18, 2015 09:15 AM EDT Reads: 1,303
SYS-CON Media announced today that Blue Box as launched a popular blog feed on Cloud Computing Journal. Cloud Computing Journal aims to help open the eyes of Enterprise IT professionals to the economics and strategies that utility/cloud computing provides. Blue Box Cloud gives you unequaled agility, without the burden of designing, deploying and managing your own infrastructure. It’s the right choice when public cloud just won’t do. Blue Box Cloud is a managed Private Cloud as a Service (...
Apr. 18, 2015 08:00 AM EDT Reads: 1,228
SOASTA, the leader in performance analytics, today reported record growth of the CloudTest community, exceeding 30,000 registered users of the CloudTest platform in Q1 2015. SOASTA also announced widespread adoption of its Web and mobile testing solutions, with more than 1,600 customers completing more than 285,000 tests using CloudTest during the quarter. This rapid growth shows that DevOps-driven digital businesses are embracing a more continuous approach to testing, and CloudTest is meeting t...
Apr. 18, 2015 08:00 AM EDT Reads: 972
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will mee...
Apr. 18, 2015 07:00 AM EDT Reads: 1,533
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applicatio...
Apr. 18, 2015 06:00 AM EDT Reads: 2,215
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Compa...
Apr. 18, 2015 05:30 AM EDT Reads: 2,144
VoxImplant has announced full WebRTC support in the newest versions of its Android SDK and iOS SDK. The updated SDKs, which enable audio and video calls on mobile devices, are now compatible with the WebRTC standard to allow any mobile app to communicate with WebRTC-enabled browsers, including Google Chrome, Mozilla Firefox, Opera, and, when available, Microsoft Spartan. The WebRTC-updated SDKs represent VoxImplant's continued leadership in simplifying the development of real-time communication...
Apr. 18, 2015 02:45 AM EDT Reads: 1,783
Chef and Canonical announced a partnership to integrate and distribute Chef with Ubuntu. Canonical is integrating the Chef automation platform with Canonical's Machine-As-A-Service (MAAS), enabling users to automate the provisioning, configuration and deployment of bare metal compute resources in the data center. Canonical is packaging Chef 12 server in upcoming distributions of its Ubuntu open source operating system and will provide commercial support for Chef within its user base.
Apr. 18, 2015 01:45 AM EDT Reads: 1,703
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquir...
Apr. 18, 2015 01:00 AM EDT Reads: 892
PubNub on Wednesday released an open source template to allow developers to add Skype-like video chat into their apps. The free template provides a fully functional video chat platform using WebRTC, PubNub and Google Authentication for a global, reliable collaboration solution. “While the WebRTC protocol has created huge excitement as a way to deliver video chat ubiquitously, there’s still a gap between the protocol itself and the ability to deploy a working, globally scaled, collaboration appl...
Apr. 18, 2015 01:00 AM EDT Reads: 7,385
Today, IT is not just a cost center. IT is an enabler and driver of business. With the emergence of the hybrid cloud paradigm, IT now has increasingly more capabilities to create new strategic opportunities for a business. Hybrid cloud allows an organization to utilize multi-tenant public clouds, dedicated private clouds, bare metal hosting, and the associated support and services for the right use cases through an on-demand, XaaS model. This model of IT creates tremendous opportunities for busi...
Apr. 18, 2015 12:00 AM EDT Reads: 3,813
SYS-CON Events announced today that Optimal Design, an Internet of Things solution provider, will exhibit at SYS-CON's Internet of @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Optimal Design is an award winning product development firm offering industrial design and engineering services to the consumer, medical, and defense markets.
Apr. 17, 2015 05:30 PM EDT Reads: 1,565
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists will discuss how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations m...
Apr. 17, 2015 05:00 PM EDT Reads: 1,620
SYS-CON Events announced today that kintone has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. kintone promotes cloud-based workgroup productivity, transparency and profitability with a seamless collaboration space, build your own business applic...
Apr. 17, 2015 04:45 PM EDT Reads: 1,451