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Daily Dose Newsletter

Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Tuesday
May222012

Doctors credit stem cell therapy for saving girl's life (Video) (PSTI)

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an off-the-shelf product that requires no tissue matching or immune-suppression treatment prior to administration. PLX-PAD comprehensive clinical development plan has been recognized by both the EMA and FDA, targeting a sub-population of 20-million patients of Peripheral Artery Disease (PAD) market.

The Company recently announced that the compassionate use of its PLX Cells had saved the life of a young Romanian girl suffering from aplastic bone marrow, a condition in which patients have no blood-forming hematopoietic stem cells in their bone marrow. Her doctor, Professor Reuven Or, explained that "With her body rejecting all possible treatment -- and with no other options -- we finally turned to Pluristem's PLX cells, which literally saved her life." Read more

Below is a video from Reuters about the girl, her condition, and the remarkable reversal of her disease. 

Tuesday
May222012

CytoSorbents Publishes Responses to Frequently Asked Questions - May 2012 (CTSO)

CytoSorbents Corporation (OTC.BB: CTSO) is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in life-threatening illnesses. 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 adsorption.

The Company has prepared a list of Frequently Asked Questions ("FAQs") and responses in answer to a number of questions from shareholders on May 16, 2012. Other common inquiries are also included. 

The company provides detailed answers to the following questions:

  • If there is so much interest in CytoSorb®, why are Q1 2012 sales low and why the decline from Q4 2011? 
  • Why has it taken longer to hear news on things that were discussed in presentations or press releases months ago? 
  • What are your thoughts about focus on Germany, versus expansion through distributors elsewhere? 
  • What are the plans to publish the data from the European Sepsis Trial and can you give an update on the dosing study and other studies? Are the results of the dosing study needed to sell CytoSorb? 
  • Are you contemplating manufacturing in Europe or utilizing a contract manufacturer? 
  • There seems to be a lot of bashers on the stock message boards that post negative comments constantly, always trying to instill fear and doubt into shareholders who believe in the company. What can be done? 
  • If there is so much potential in the company, why is your stock so low and what do you plan to do about it? 

Read the answers at CytoSorbents.com

 

Monday
May212012

Achillion Announces Additional Proof-of-Concept Data With ACH-2684 for the Treatment of Hepatitis C (ACHN)

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) is an innovative biopharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. The Company's highly skilled and experienced discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease - HCV and resistant bacterial infections. 

The Company has "reported proof-of-concept data from a Phase 1b clinical trial demonstrating that patients with chronic hepatitis C (HCV) genotype 1 (GT 1) treated with ACH-2684, a second-generation protease inhibitor, achieved a mean maximum 3.73 log10 reduction in HCV RNA after three-day 400 mg monotherapy with once-daily (QD) dosing. The compound also demonstrated good safety and tolerability both in healthy volunteers and in patients with HCV."

Michael D. Kishbauch, President and Chief Executive Officer of Achillion, commented, 

"We believe ACH-2684, with its potent antiviral activity achieved without boosting and once-daily dosing, is one of the most intriguing protease inhibitors in clinical development for the treatment of HCV. As we continue to focus our efforts on advancing our internally developed all-oral, interferon-free HCV regimen consisting of ACH-1625, our next generation protease inhibitor, in combination with ACH-3102, a second generation pan-genotypic NS5A inhibitor, we believe that the profile of ACH-2684 provides a significant strategic and therapeutic option for potential combinations with either ACH-3102 or other direct-acting antiviral agents." 
Monday
May212012

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.
Monday
May212012

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."
Monday
May212012

Rodman & Renshaw on Amylin: Why does AMLN Takeover Chatter Always Come Before Slow Bydureon Rx Figures? (AMLN)

Amylin Pharmaceuticals (NASDAQ:AMLN) is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. The company is particularly focused on the therapeutic potential of new peptide hormone drug candidates and the creation of novel and groundbreaking therapies for the treatment of diabetes, obesity, and other metabolic diseases.

Rodman & Renshaw has issued a report on Amylin, assigning it a Market Underperform / Speculative Risk rating and a $22 Target Price.

Analyst Michael G. King, Kr writes,

"Overall, this week’s report appears to be as disappointing as last week’s was encouraging. Last week’s report showed gains across the board for AMLN and the GLP-1 class. This week those gains were given back, and AMLN products were hit harder than Victoza. Additionally, we pulled the weekly Rx statistics from Victoza two years ago (Figure 3 and Table 5). Despite the GLP-1 market growing some 20% in the two years since the launch of Victoza, the absolute NRx generated by Bydureon is almost half that achieved by Victoza at the same point in the respective launches."

Read the full report below.

Rodman Renshaw on Amylin Pharma 5 21-12

 

Friday
May182012

MIT Enterprise Forum of NYC & LES NYC Presents: The Age of "Big Data" in Bioscience is Here, But are we prepared for it? June 7, 2012

MIT Enterprise Forum of New York City and LES NYC are presenting a panel discussion entitled "The Age of Big Data in Bioscience is Here, But are we prepared for it?" The discussion will be held June 7, 2012 at K&L Gates, LLP, located at 599 Lexington Ave. - 32d Floor - Seminar Room, New York, NY. 

DESCRIPTION: 

The bioscience research community is producing more and larger sets of data in its quest to understand biology and manage disease. Much of these data are being generated by teams of scientists spanning many institutions and geographies. As we come to appreciate these data as a new asset class, we need to understand how to properly manage, protect and share this asset so its value can be realized. 

A distinguished panel of experts will discuss managing and protecting "Big data" as i) intellectual property, ii) trade secrets and iii) open source. We will explore opportunities and challenges including storage and access issues, data protection, ownership (who owns the "$1,000 genome" data – the producer or the purchaser?) and future advances in analysis and utility. 

AGENDA:

5:30pm - 6:00pm: Reception
6:00pm - 7:30pm: Panel Discussion
7:30pm - 8:30pm: Networking

REGISTRATION:

Free to members of MIT Enterprise Forum
$50 non-members, $10 extra at door
All members and guests are welcome.

PANEL:

Moderator: Eric Vieira, PhD, Assistant Director/Business Development, Mount Sinai School of Medicine. 

Speakers: Louis C. Cullman, Esq., Partner, K&L Gates, LLP, Primary Outside IP Counsel to the Bill and Melinda Gates Foundation's Global Health Program; Brett Davis, Senior Director/Oracle Health Sciences, Oracle; and David Greenwald, PhD, Co-Founder and Managing Director, Relay Technology Management. 
Friday
May182012

Crowdsourcing AAN: Recap of R&R and Pharm3r Twitter Survey

Rodman & Renshaw has released a report in conjuction with Pharm3r about a data-mining project to crowd source opinions and in interest in new drugs on Twitter. Pharm3r is unique data-mining company that tags plain text in order to mine such disparate sources as chat boards, blogs, and Twitter feeds.

Analyst Michael King, Jr. writes,

"Our first foray into this novel approach to crowd-sourcing opinions and views on various topics begins with the recent 2012 American Academy of Neurology (AAN), which took place April 21-28 in New Orleans. While AAN deals with dozens of topics, Pharm3r gathered views on the 24 most common discussions. Relevant tweets were scanned for a predetermined list of topics between April 20th and 30th. Each topic is also accompanied by a sentiment score...

We view the combination of Twitter volume (number of tweets) and sentiment of those tweets as highly relevant data points in assessing interest in a drug within a period of time. The ability to view that interest compared to other relevant drugs at a time of high interest and tweeting provide an opportunity for potential insight into clinician, patient, and investor interest."

The results from the project include the following:

"Starting with multiple sclerosis (MS), the updated safety regulation in the US and EU spurred a significant volume of relatively negatively tweets for Gilenya (fingolimod), while Lemtrada (alemtuzumab) and BG-12 tweets generated relatively high sentiment...Turning to therapies for Amyotrophic Lateral Sclerosis (ALS), CK2017357 (‘357) from Cytokinetics (CYTK, Market Outperform) bested Biogen’s dexpramipexole in both volume and sentiment."

Read more below. 

 

 

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