Crystal Research Releases Executive Overview of AtheroNova (AHRO)

AtheroNova (OTCBB: AHRO) is an early stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits. The Company's focus on compounds to reduce or eliminate atherosclerotic plaque deposits addresses the most lucrative segments of the multi-billion dollar prescription drug market: cardiovascular disease and stroke prevention.

Crystal Research Associates has released an executive overview of the company. The report includes investment highlights, executive overview, corporate growth strategy, intellectual property, company leadership, core story (Atherosclerosis, AtheroNova's AHRO-001, Corporate Agreements), competition, milestones, historical financial results, risks, recent events, and glossary. 

See the full report below.  

Crystal Research AtheroNova Executive Overview June 2012

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Zacks.com initiates coverage of CytoSorbents Corporation, gives Outperform rating (CTSO)

CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and absorption.

Zacks Investment Research has initiated coverage of CytoSorbents Corporation and assigned it an "Outperform" rating.

Senior Medical Device Analyst Brian Marckx writes,

"CytoSorbents' novel blood purification technology aims to revolutionize the treatment of life-threatening illnesses in the ICU.  Patients with critical care illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome and pancreatitis are some of the most seriously-ill and difficult to treat patients in the hospital.  Their CytoSorb device was CE Marked in March 2011 and subsequently commenced its initial commercialization. Near-term game-plan is to build awareness to facilitate broader roll-out in Europe.  FDA approval is a longer-term goal, the quest for which is now in the planning stage."

He continues,

"Despite certain risks, we feel the shares trade cheaper than warranted and are initiating coverage with an Outperform rating."

Read the full report at Zacks.com.  

Keryx a Buy @ The Motley Fool (KERX)

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. 

At The Motley Fool, contributor Jordo Bivona writes that "There is no shame in wanting to find cheap investments that pay off in the long run. The trouble is it can be tough to tell what is worth your money and what is cheap simply because it is worthless." In some cases, like Keryx, "the prices are low, but the stocks are worth a great deal. For these stocks, now is the time to buy and hang on until something major happens and the prices soar."

About Keryx, he writes,

"Keryx (NASDAQ: KERX) is currently selling for around $1.50 and has been floundering, primarily because its flagship drug perifosine failed its latest round of clinical trials. The drug was intended to offer a new treatment option for those suffering from colorectal cancer. When it did not live up to expectations, Keryx plummeted more than 60% and continues to fall.

...The company still has approximately $30 million in cash to fund operations, and a quarterly burn rate of around $4 million to $6 million, depending on research demands. For the company to succeed with Zerenex, it needs successful trials in its fourth quarter and a new drug application from the FDA. Recently, the stock saw a 22% gain on news of a successful clinical trial for Zerenex that was completed in Japan. Thus, this stock may be down, but it is definitely not out."

Read more at beta.fool.com. 

Hope Springs Eternal In Biotech @ Seeking Alpha (KERX)

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City. 

At Seeking Alpha, contributor Michael J. Ray writes that while it is true that hope is not the best strategy when it comes to investing, "there is one sector that does embrace hope as an investing component and that sector is speculative biotech." He argues that it is patients' hope for a cure that "highlight[s] unmet medical need, which in turn brings investors and researchers to the scene."

He points to Keryx's Perifosine as an example in which "the hope[s] of both investors and patients were dashed, and the stock price quickly declined." But he goes on to say that,

"Both KERX and BPAX are not completely out the game though. Each has other products in the pipeline, but their most touted opportunities came up empty. But this article is about hope, and hope is said to spring eternal."

He goes on to discuss 3 companies "keeping hope alive" for both patients and investors alike: Osiris Therapeutics (OSIR), Advanced Cell Technology Inc. (ACTC.OB), and Galena Biopharma, Inc. (GALE).

Read the full article at SeekingAlpha.com. 

Few Doctors Prescribing Most Opioids @ The WSJ; $IPCI

Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug. 

According to a recent article in the Wall Street Journal, "31% of the opioid prescriptions in [New York City in 2010] were written by about 530 health-care providers, or 1% of those who prescribe such drugs. Among these prescribers, oxycodone prescriptions skyrocketed 86% between 2008 and 2010. During the past 20 years there has been a ten-fold increase in the use of prescription opioids, commonly known by names such as OxyContin and Vicodin, in the five boroughs. Opioid prescriptions filled by city residents increased by 22%, to more than 2 million, in 2010 versus 2008, the data show."

While some of these prescriptions are being written by well-meaning but ill-informed practitioners, others are being issued by doctors intentionally engaging in wrongful behavior.

Deputy Mayor Linda Gibbs, co-chairwoman of the mayor's task force to combat the city's growing prescription drug epidemic, stated,

"In the face of growing opioid abuse, it is critical that we educate providers, pharmacists and patients on the potential dangers of painkiller misuse or overuse."

She continued,

"Strengthening our drug monitoring system will help us work together to both ensure that well-intentioned providers don't inadvertently overprescribe these pills—with potentially dangerous consequences—and that we have the information we need to investigate those who are actively engaging in criminal behavior." Read more at online.wsj.com. 

While it is indeed important to monitor how addictive painkillers are being prescribed, it is also important to pursue new treatments that do not pose the same risks. Intellipharmaceutics' Rexista™, now in pre-clinical development, is one such alternative. Rexista™ is an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation. This product is covered by pending patent applications. Rexista™ is a unique dosage form, designed to be resistant to well-documented abuse that is experienced with current oxycodone products. This includes abuse by injection when combined with solvents and by nasal inhalation when crushed or powdered.

Rexista™ is also designed to resist release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs, such as hydromorphone. According to Wolters Kluwer Health, OxyContin® (oxycodone hydrochloride controlled-release tablets) had estimated U.S. sales of approximately US$2.5 billion for the 12 months ending February 2012. OxyContin® currently represents 99% of the US$3 billion oxycodone sustained-release market. Read more about Rexista™ at intellipharmaceutics.com. 

Keryx Biopharmaceuticals Announces Upcoming Poster Presentation of Zerenex™ (ferric citrate) at the 49th ERA-EDTA Congress (KERX)

Keryx Biopharmaceuticals (KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City. 

The Company announced that one of its abstracts has been accepted for poster presentation at the upcoming 49th ERA-EDTA (European Renal Association European Dialysis and Transplant Association) Congress, taking place May 24-27, 2012, in Paris, France. The abstract is entitled "A Meta-Analysis of Ferric Citrate for Hyperphosphatemia: The Effects of an Oral Iron-Containing Phosphate Binder on Serum Ferritin and Saturated Transferrin in Hemodialysis Patients (Abstract # SAP534);" it highlights the dose related increases in iron storage parameters as observed in prior clinical trials of Zerenex" (ferric citrate). 

The poster will be presented on Saturday, May 26, 2012, from 9:30am to 10:45am local time.

The above referenced abstract is available for viewing on-line at http://www.m-events.com/customer/2012/era-edta/data/12575.pdf. Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

Read more at Seeking Alpha. 

Market Current on Dara Bioscience: Dara slips after reporting a Q1 net loss of $2M @ Seeking Alpha (DARA)

DARA BioSciences, Inc.(Nasdaq:DARA) is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA holds the exclusive U.S. marketing rights to Soltamox®, a novel oral liquid formulation of tamoxifen citrate, a product used widely in the treatment and prevention of breast cancer. Soltamox is the only FDA approved oral liquid version of tamoxifen citrate and fulfills a vital clinical need for patients who cannot tolerate existing tablet formulations of this drug. DARA plans to begin marketing Soltamox in the U.S. in Q3 2012.

At Seeking Alpha, a Market Current was issued about the company:

Monday, May 21, 11:24 AM Dara Biosciences (DARA -2.3%)) slips after reporting a Q1 net loss of $2M, or $0.29 cents per share, compared to a net loss of $1.3M, or $0.26 cents per share in the same period last year. The higher net loss was due primarily to business acquisition costs and the hiring of experienced staff to help execute its new oncology-focused business strategy.

Read more at Seeking Alpha. 

The Case For Keryx Biopharmaceuticals' Analyst Upgrade May Be Justified @ Seeking Alpha (KERX)

Keryx Biopharmaceuticals (NASDAQ:KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.

At Seeking Alpha, contributor VFC's Stock House argues that investors would be unwise to dismiss Keryx as a company because of the failure of Perifosine, especially given the strong potential of Zerenex. 

He writes,

"Since the Perifisone failure essentially made Keryx a 'one trick wonder' for the time being, the concerns expressed by numerous investors and media outlets regarding Zerenex have mostly been based on the solid entrenchment of Renagel in the market, and the fact that generic competition is just right around the corner. These concerns have been widespread enough to cause the mass exodus of investors and traders that led to last month's share price drop, but they ignore some unique qualities of Zerenex treatment that have not been widely discussed -- and which could offer insight into the product's true market potential."

He points out that while Renagel is "the recognized leader in its field," it also comes with some unpleasant side effects that Zerenex, so far, does not share. Another advantage is that Zerenex is a phosphate binder that is iron based; this may "enable patients to retain iron more efficiently than the competition currently on the market. This could play be key, as many patients on dialysis in end stage renal disease are anemic and are stuck on IV treatment - along with everything else - in order to maintain iron levels."

He continues,

"It's possible that Zerenex could alleviate the need for the IV and end up being considered one-stop shopping: A package deal that could provide enough of a pricing and logistical boost to make it the preferable treatment of choice. The same cannot be said, at least for the time being, for the competition, generic or not.

Given those advantages, it may be concluded that Zerenex is positioned to not only heavily compete with the competition currently on the market, but it might also have enough behind it to potentially become the market leader."

Read more at SeekingAlpha.com.