Welcome!

News Feed Item

Closer Look: BioLineRx's Multi Billion Dollar Schizophrenia Drug

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:

Drugs in Clinical trials:

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)

Drugs in Pre-clinical:

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:

http://www.biomedreports.com/20130115119111/biolinerxs-potential-multi-billion-dollar-schizophrenia-drug.html

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

Follow Us

News developments and live healthcare sector updates are available constantly via twitter at: http://twitter.com/BioMedReports

About BioMedReports.Com

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

Add to Digg Bookmark with del.icio.us Add to Newsvine

Media Contacts Only:
M. Davila
Assistant Editor
BioMedReports.Com
e-mail: Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
As you move to the cloud, your network should be efficient, secure, and easy to manage. An enterprise adopting a hybrid or public cloud needs systems and tools that provide: Agility: ability to deliver applications and services faster, even in complex hybrid environments Easier manageability: enable reliable connectivity with complete oversight as the data center network evolves Greater efficiency: eliminate wasted effort while reducing errors and optimize asset utilization Security: imple...
High-velocity engineering teams are applying not only continuous delivery processes, but also lessons in experimentation from established leaders like Amazon, Netflix, and Facebook. These companies have made experimentation a foundation for their release processes, allowing them to try out major feature releases and redesigns within smaller groups before making them broadly available. In his session at 21st Cloud Expo, Brian Lucas, Senior Staff Engineer at Optimizely, will discuss how by using...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lead...
The session is centered around the tracing of systems on cloud using technologies like ebpf. The goal is to talk about what this technology is all about and what purpose it serves. In his session at 21st Cloud Expo, Shashank Jain, Development Architect at SAP, will touch upon concepts of observability in the cloud and also some of the challenges we have. Generally most cloud-based monitoring tools capture details at a very granular level. To troubleshoot problems this might not be good enough.
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
SYS-CON Events announced today that CAST Software will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CAST was founded more than 25 years ago to make the invisible visible. Built around the idea that even the best analytics on the market still leave blind spots for technical teams looking to deliver better software and prevent outages, CAST provides the software intelligence that matter ...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
SYS-CON Events announced today that Daiya Industry will exhibit at the Japanese Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Ruby Development Inc. builds new services in short period of time and provides a continuous support of those services based on Ruby on Rails. For more information, please visit https://github.com/RubyDevInc.
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busine...
As businesses evolve, they need technology that is simple to help them succeed today and flexible enough to help them build for tomorrow. Chrome is fit for the workplace of the future — providing a secure, consistent user experience across a range of devices that can be used anywhere. In her session at 21st Cloud Expo, Vidya Nagarajan, a Senior Product Manager at Google, will take a look at various options as to how ChromeOS can be leveraged to interact with people on the devices, and formats th...
First generation hyperconverged solutions have taken the data center by storm, rapidly proliferating in pockets everywhere to provide further consolidation of floor space and workloads. These first generation solutions are not without challenges, however. In his session at 21st Cloud Expo, Wes Talbert, a Principal Architect and results-driven enterprise sales leader at NetApp, will discuss how the HCI solution of tomorrow will integrate with the public cloud to deliver a quality hybrid cloud e...
SYS-CON Events announced today that Yuasa System will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Yuasa System is introducing a multi-purpose endurance testing system for flexible displays, OLED devices, flexible substrates, flat cables, and films in smartphones, wearables, automobiles, and healthcare.
Is advanced scheduling in Kubernetes achievable? Yes, however, how do you properly accommodate every real-life scenario that a Kubernetes user might encounter? How do you leverage advanced scheduling techniques to shape and describe each scenario in easy-to-use rules and configurations? In his session at @DevOpsSummit at 21st Cloud Expo, Oleg Chunikhin, CTO at Kublr, will answer these questions and demonstrate techniques for implementing advanced scheduling. For example, using spot instances ...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
SYS-CON Events announced today that Taica will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Taica manufacturers Alpha-GEL brand silicone components and materials, which maintain outstanding performance over a wide temperature range -40C to +200C. For more information, visit http://www.taica.co.jp/english/.