Surfactants in the News Again, FDA grants orphan status to Chiesi Pharma in the wake of Discovery Lab's Approval - $DSCO

According to the FDA's Orphan Drug product website, Chiesi Pharmaceuticals (an Italian-private pharma company) has been granted Orphan drug designation for 'Synthetic Surfactant Comprised Of Dppc, Popg Na, Synthetic Sp-C Analogue And Synthetic Sp-B Analogue' for the treatment of preterm neonatal respiratory distress syndrome (RDS). Recall that the FDA recently approved Discover Labs ($DSCO) synthetic surfactant too (aka: Surfaxin).

Chiesi currently has an approved animal-sourced product for neonatal RDS, Curosurf; this new orphan designation is specifically for a synthetic drug candidate.  The companies previously approved products include Curosurf  (all are animal-sourced products).  In the US, Cornerstone Therapeutics ($CRTX) has  marketing rights.

NeoStem Provides Updates and Reports Year End Results; $NBS

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.  The acquisition of PCT gives NeoStem not only access to a world class contract manufacturing cell therapy company but provides a platform and expertise around the evaluation, development and regulatory requirements to develop autologous, allogeneic, immunomodulatory and vaccine-based therapeutics. NeoStem also holds the worldwide exclusive license to VSEL(TM) Technology, which uses very small embryonic-like stem cells, shown to have several physical characteristics that are generally found in embryonic stem cells, and is pursuing the licensing of other technologies for therapeutic use. 

 

NeoStem has reported its audited results for 2011: 

 

"Consolidated revenues for the year ended December 31, 2011 were $73.7 million compared to $69.8 million for 2010. The Company's consolidated net loss for 2011 was $56.6 million, which included $10.3 million of non-cash equity-based compensation expense, $19.4 million of goodwill impairment charges and $9.0 million of depreciation and amortization. Overall, the Company's consolidated cash loss for 2011 was $15.5 million (see reconciliation below). Net loss attributable to NeoStem common shareholder interests for 2011 was $47.8 million, or $0.54 per share. 

 

As of December 31, 2011, the Company had consolidated cash and cash equivalents of $12.7 million, and an additional $2.5 million in cash held in escrow (classified in Other Assets)." 

 

Despite a persistently difficult financial environment, Neostem believes that "the opportunities that exist today in cell therapy are robust and growing" and that current conditions make this "an opportunistic time to pursue the monetization of the Company's 51% ownership of Suzhou Erye Pharmaceutical Co., Ltd. and bolster its cell therapy business." 

 

Read the full release at Nasdaq.com.  

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Pluristem's ($PSTI) PLX Cells Effective in Treatment of Acute Myocardial Infarction (AMI) in Animal Trial

Daily Dose Conclusion: The stock has moved up well here in midday trading as investors are excited that PSTI is exploring other indications beyond just CLI. Pluristem data helps raise the questions (and the makes the boundaries a bit more foggy) between autologous and allogeneic pro's and con's. This is clearly an allo product (pills in a bottle if you will) but the cells are from the placenta and PSTI claims they are immuno-privledged. Other companies have shown definitively that only autologous cells remain resident and provide functional ongoing neo-angiogenesis. Pluristem has said their cells are cleared, so as such we are concerned that PSTI's allo-cells are cellular short term approach (maybe very beneficial near term) but unlikely to show long term benefits in man. We just don't know.  Certainly the animal data presented look's good.

Of greater focus for investors should be PSTI's start of the CLI trial ? Is this on hold until manufacturing is cleared in the new facility, or will it start prior  ?  Keep an eye (or a heart out) for data from ASTM on DCM - dialtaed cardio-myopathy, NeoStem NBS in AMI-STEMI, Baxter-CMI, Cytori (AMI) and MesoBlast and Athersys, both AMI too.

View the full PSTI chart at Wikinvest

Significantly Improved Cardiac Function, Smaller Infarct Size With Greater Regional Left Ventricle Wall Thickness and the Pronounced Stimulation of New Vessels Formation Were Observed in Animals Treated With PLX Cells

Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR) today announced that its PLacental eXpanded (PLX) cells, tested in a preclinical animal model of acute myocardial infarction (AMI), proved to effectively improve several cardiac hemodynamic parameters in animals that received those cells. The study was conducted in collaboration with Professor Christof Stamm, MD and Professor Carsten Tschope MD and their respective staffs at the Center for Regenerative Therapies (BCRT), Berlin, Germany.

Twenty mice suffered an AMI by ligating the left anterior descending (LAD) coronary artery via thoracotomy. Immediately following the AMI, animals were given either PLX cells (n=10) or cell-free medium as a control (n=10) into the border zone of the infarct. Additionally, five animals underwent a sham (placebo) operation by incurring the thoracotomy but without ligation of the LAD.

After 4 weeks, transthoracic echocardiography was performed, the mice were sacrificed and their hearts examined histologically. Hemodynamic studies demonstrated improved cardiac contractile function in the mice which received the PLX cells as compared to control-treated mice. The improved cardiac contractile function included a statistically significant increase in stroke volume (p=0.01) (fig. 1) and ejection fraction (p=0.06) (fig. 2). Additionally, PLX cell-treated hearts had significantly smaller infarct sizes (p=0.04) and greater regional Left Ventricular (LV) wall thickness (fig. 3). Histological analysis indicated that those animals treated with PLX cells displayed a statistically significant higher number of mature arterial vessels in the infarct border zone than in control animals (p=0.004) and suggests that PLX cells induce the formation of new blood vessels into ischemic myocardium (fig. 4). Charts and images accompanying this release are available at http://media.globenewswire.com/cache/11974/file/12981.pdf

See the full press release @ NASDAQ.com

Cytomedix $CMXI - 2011 Financial Results Call on Friday, March 30, 2012

Cytomedix, Inc. (OTCBB: CMXI), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that the Company will release financial results for the three and twelve months ended December 31, 2011, following the close of the market on Thursday, March 29, 2012.

Martin Rosendale, Chief Executive Officer, and Andrew Maslan, Chief Financial Officer, will host a conference call beginning at 10:00 a.m. Eastern Time on Friday, March 30, 2012, to discuss the fourth quarter and year end 2011 financial results and to answer questions. Shareholders and other interested parties may participate in the call by dialing 888-679-8034 (domestic) or 617-213-4847 (international) and entering passcode 23291244. The call will also be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.

A replay of the conference call will be available beginning two hours after its completion through April 6, 2012 by dialing 888-286-8010 (domestic) or 617-801-6888 (international) and entering passcode 78509324. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com and www.cytomedix.com.

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ATHX Athersys initiated overweight at Piper Jaffray ($1.67)

Athersys (NASDAQ: ATHX) initiated overweight at Piper Jaffray ($1.67).

• Target is $4

• Analyst is Edward Tenthoff

Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem^(R) cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.

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Leerink Swann Analyst Rick Wise initiated coverage of Unilife Corporation with an “outperform” rating $UNIS

Leerink Swann analyst Rick Wise initiated coverage of Unilife Corporation (NASDAQ: UNIS) with an “outperform” rating and a $5-$6 valuation range, citing shares represent a compelling opportunity to participate in the potentially dramatic growth of a still young company that already has created a solid business platform.

Highlights from the Leerink report include:

• We are initiating coverage of UNIS with an Outperform rating.
• We see UNIS as well positioned in the current environment to sell its drug delivery systems to biopharmaceutical customers for life cycle extensions of injectable drugs and provide competitive differentiation for development stage biologics – all which we expect to be relayed at the upcoming analyst meeting (3/28).
• Despite what we view as a differentiated technology platform with numerous near-term catalysts, we also see a stock down ~40% since its last capital raise (Nov. 2011; versus S&P500) that reflects investor disappointment regarding timing of supply contracts; however, management has consistently pointed to the 2H‟12 as the likely timing for deal announcements.
• We recommend that long-term investors build a position as we believe UNIS offers (1) numerous near-term catalysts with potential for significant upside if a high volume deal is announced; (2) valuation is attractive even using management's most conservative forecast assumptions; and (3) a likely decision in 2Q to invest in a second manufacturing line because it will signal management‟s conviction for product demand. This is tempered by the inherent uncertainty of the licensing process and the need to generate near-term operating cash flow – current cash will last through 1Q'13 (F'3Q'13).
• Our $5-6/shr valuation for UNIS is supported by a discounted cash flow analysis and forward 2-year sales we expect UNIS to trade at 3.6x our 3Q'13 to 2Q'14 sales estimate of $110M.

Rodman & Renshaw Raise Target Price of Omeros Corp (NASDAQ:OMER) to $16/sh

Omeros Corporation (NASDAQ: OMER) is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, coagulopathies and disorders of the central nervous system. Their most clinically advanced product candidates are derived from their proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological and other surgical and medical procedures. Leveraging clinical development experience and expertise in inflammation and the central nervous system, Omeros has built multiple development programs targeting large markets. By combining late-stage PharmacoSurgery  product candidates with this deep and diverse pipeline of preclinical development programs, Omeros creates multiple opportunities for commercial success.

Omeros has released the results from its Phase 3 clinical trials of combination drug OMS302. This large 405-patient study demonstrated that OMS302 successfully maintained pupil dilation compared to placebo in intraocular lens replacement surgeries. It furthermore met its secondary endpoint, reducing post-operative pain in study participants. The success of OMS302 is particularly relevant because,

"A well-dilated pupil is imperative for a safe and successful surgery, as most of lens replacement procedures – in particular cataract surgeries – are performed behind the pupil. If the pupil fails to dilate properly (decreasing the surgeon’s operative field), there is an increased risk of complications. OMS302 not only successfully maintained pupil dilation during surgery, but also decreased pain in the postoperative period compared to placebo. Both outcomes are clinically relevant for surgeons and patients. OMS302 was well tolerated, and the adverse event profile for the drug was similar to placebo."

Due to the results of this study, the Rodman & Renshaw analysts are maintaining their Market Outperform rating and raising their Target Price from $13 to $16/sh.

See the full report below.

Rodman & Renshaw Report on Omeros Corp

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SciClone ($SCLN) Reports Financial Results for the Fourth Quarter and Year 2011 and Outlook for 2012

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) is a revenue-generating, profitable, China-centric specialty pharmaceutical company with a substantial commercial business and a product portfolio of therapies for oncology, infectious diseases and cardiovascular, urological, respiratory, and central nervous system disorders.

SciClone Pharmaceuticals has reported its financial results for the fourth quarter and year ended December 31, 2011. Reported revenues increased by 75% in the fourth quarter compared to revenues in the prior year. Overall, revenues increased 57% for the calendar year when compared to the previous calendar year. This growth in revenue is largely due to the expansion of the ZADAXIN® business in China and SciClone’s acquisition of NovaMed Pharmaceuticals, Inc. in April, 2011. 

Friedhelm Blobel, PhD., SciClone President and Chief Executive Officer, commented, 

"SciClone delivered solid financial performances in the fourth quarter and full year of 2011, driven by the continued strong revenue growth of ZADAXIN, Depakine® and our other marketed products in China, and managed by the well coordinated efforts of our integrated SciClone and NovaMed sales and marketing teams. We believe that 2011 was a year of significant strategic advancement for our Company marked by important accomplishments that strengthen our business, market position and reputation. Prime among these was the transition from a typical biotech to a China-focused specialty pharmaceutical company."

He continued, 

"With the successful integration of NovaMed, we have largely completed this transition. And we have significantly expanded our portfolio of marketed and pipeline products and expanded our commercial capability. Our 23% annual ZADAXIN revenue growth, which exceeds the growth rate of the China pharmaceuticals market, and the overall strengthening of our China platform, position SciClone in the top-performing echelon of multi-national companies in this important and growing market. We are confident that we have put the right strategies, management talent and infrastructure in place to continue to capitalize on the significant growth opportunities inherent in the China market. We look forward to continuing this impressive growth in 2012."

Read the full press release at investor.sciclone.com.