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M.E. Garza is one of the founders of the biotech and healthcare sector news portal BioMedReports.com. He believes in getting the news from credible sources on the street and often reaches out to CEOs and newsmakers directly for interviews and discussions about their companies. Since he began... More
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  • RxNews Recap for Thursday 02-04-10. Cyclacel (CYCC) jumps on upgrade
    Below is a list of the companies that made news in the healthcare sector on Thursday, February 04, 2010.

    Cyclacel Pharmaceuticals (Nasdaq:CYCC) rose by 32 cents, or 16.6%, to close the day at $2.30 after Roth Capital analysts initiated coverage of the stock with a buy rating and stock price target of $7.50. Cyclacel Pharmaceuticals Inc. is a development-stage biopharmaceutical company engaged in the discovery, development and commercialization of mechanism-targeted drugs to treat human cancers and other serious disorders.

    The Company markets, directly in the United States, Xclair Cream for radiation dermatitis, and Numoisyn Liquid and Numoisyn Lozenges for xerostomia through its wholly owned subsidiary, ALIGN Pharmaceuticals LLC. CYCC focuses primarily on the development of orally available anticancer agents that target the cell cycle with the aim of slowing the progression or shrinking the size of tumors.

    Cyclacel will present at the 12th Annual BIO CEO & Investor Conference, being held at the Waldorf Astoria Hotel in New York City, New York. Spiro Rombotis, President and Chief Executive Officer, will provide an overview of the Company and its progress in key programs on Monday, February 8, 2010

    In other news Thursday:

    Abiomed Inc (Nasdaq:ABMD) maker of Heart pumps posted a narrower-than-expected quarterly loss, helped by a 166 percent increase in the number of patients using its products, but it cut its fiscal 2010 revenue forecast.

    For the third quarter ended Dec. 31, the company posted a net loss of $4.6 million, or 12 cents a share, compared with a net loss of $7.7 million, or 21 cents a share, a year earlier.  Total revenue rose 32 percent to $22.8 million, as U.S. sales of the Impella left ventricle heart pump grew 116 percent to $14.5 million.  The company said it had reduced its cash burn to $600,000. Analysts on average were expecting the company to post a loss of 18 cents a share on revenue of $22.6 million, according to Thomson Reuters.

    The company also evised its full-year revenue forecast to reflect a fourth-quarter focus on existing site Impella utilization and training, rather than on new Impella site openings and the legacy business. They now see full-year revenue in the range of $84 million to $86 million, down from an earlier view of $86 million to $91 million. Abiomed said it continues to see a growth rate of 50 percent to 60 percent for Impella for the full year. Shares of Abiomed closed at $8.27, up $.26 on the day.

    Alkermes, Inc. (NASDAQ: ALKS) today announced that it has developed a novel, proprietary LinkeRx™ technology platform to enable the creation of injectable extended-release versions of antipsychotics and other central nervous system (NYSE:CNS) therapies.

    Allergan, Inc. (NYSE: AGN) today announced operating results for the quarter ended December 31, 2009. Allergan also announced that its Board of Directors has declared a fourth quarter dividend of $0.05 per share, payable on March 12, 2010 to stockholders of record on February 19, 2010.

    Aradigm Corporation (OTCBB:ARDM) (the “Company”) announced today that it received the $4 million milestone payment from Zogenix, Inc. (“Zogenix) based upon the first commercial sale in the U.S. of SUMAVEL* DosePro* (sumatriptan injection) needle-free delivery system.

    ArQule, Inc. (Nasdaq: ARQL) today announced the initiation of a Phase 2, single agent trial with ARQ 197 in germ cell tumors (GCT), including testicular and non-central nervous system (non-CNS) tumors, and a Phase 1/2 clinical trial designed to evaluate the safety of ARQ 197 administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer (NYSE:CRC) who possess the wild-type form of the KRAS gene.

    AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, today announced that the results and scientific findings of Good Laboratory Practice (NYSE:GLP)-compliant safety pharmacology and genotoxicity evaluations of AVI-4658, a drug candidate being developed by AVI for the treatment of Duchenne Muscular Dystrophy (NYSE:DMD), were published online in the International Journal of Toxicology. The publication, "Safety Pharmacology and Genotoxicity Evaluation of AVI-4658," reports that the GLP-compliant preclinical studies revealed no study related effects on health status, even when dosed at the maximum feasible dose, and there were no reports of injection site reactions. It was also reported that the genotoxicity evaluation of AVI-4658 revealed no genotoxic potential, even at very high concentrations. These results suggest AVI-4658 may have a wide therapeutic window for chronic dosing and supported the initiation of the Phase 1b/2 clinical trial of AVI-4658 that is ongoing in the United Kingdom. Shares closed the day at $1.42, down 4%.

    BioClinica, Inc., (NASDAQ: BIOC) a leading global provider of clinical trial services, has signed a three-year, multi-million dollar deal with Cephalon, Inc. for clinical trial technology and support services. As part of the Service Agreement, US-based data management staff at Cephalon will be hired by BioClinica to support clinical efforts of Cephalon.

    BioClinica will provide end-to-end clinical data management services to Cephalon global clinical trial operations. Specific tasks include data management planning, clinical study set-up for electronic data capture (NYSEARCA:EDC), medical coding, adverse event reconciliation, clinical data management, and training for the clinical sites and investigators. The deal also expands plans by Cephalon to use BioClinica’s ExpressTM electronic data capture (EDC) product as the default data capture system across clinical trial phases, from Phases I through IV. BioClinica will work with other functional service providers selected as part of Cephalon’s initiative to optimize operational efficiency. BioClinica said it will see its role with Cephalon extended from one of a technology provider to that of a “key services partner”. Shares closed the day up $.20 to finish at $4.50.

    BioCryst Pharmaceuticals (NASDAQ: BCRX) shares of the Birmingham, Alabama-based biopharmaceutical company jumped higher early toady after announcing fourth quarter earnings that beat consensus by 26 cents. The company earned $15.2 million or 35 cents a share in the three months ended December 31, and total revenue spiked by 60% to $54.9 million. BioCryst's intravenous H1N1 antiviral, peramivir, made up $22.5 million of the company's Q4 revenue boosted by the U.S. Department of Health and Human Services order of 10,000 courses. In addition the company earned a $7 million milestone payment from partner Shionogi & Co.
    BioCryst president and CEO John Stonehouse said, "We ended 2009 with a strong balance sheet and greater financial flexibility to advance our programs." Stonehouse noted that peramivir was the company's first revenue-generating discovery, as well as the first to receive marketing authorization from health officials. Shares ended the day off $.24 to close at $6.99.

    Bond Laboratories, Inc. (OTCBB:BNLB), a manufacturer of functional beverages and nutritional products, today announced the addition of two more MillerCoors® distributors in Tennessee for its Resurrection™ Anti-Hangover drink. This expands its coverage to over half the state. Mid-South Distributing, Inc. services fourteen counties and SEC Enterprises, Inc. services seventeen counties throughout southern and middle parts of Tennessee. Shares were up over 21% to close the day at $.51.

    Cross Country Healthcare, Inc. (Nasdaq:CCRN) will hold its quarterly conference call to discuss its fourth quarter and year-end 2009 financial results on Thursday, March 4, 2010, at 10:00 a.m. Eastern Time.

    Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment system for metastatic cancers to the liver, announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial. The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.
    "We remain very optimistic that the Phase III trial will achieve a successful endpoint," said Eamonn P. Hobbs, President and CEO of Delcath. "Assuming a successful trial endpoint, we remain committed to filing our NDA with the FDA in April," Mr. Hobbs added.

    Exelixis, Inc. (NASDAQ: EXEL) announced today that George A. Scangos, PhD, the company’s president and chief executive officer, will present at the 12th Annual BioCEO & Investor Conference at 8:30 a.m. EST / 5:30 a.m. PST on Tuesday, February 9, 2010 in New York.

    Illumina, Inc. (NASDAQ:ILMN) the maker tools for genetic analysis, after the bell reported better-than-expected Q4 profit, helped by strong revenue growth. The company also reiterated its 2010 earnings and revenue view.  Fourth-quarter net income was $11.7 million, or 9 cents a share, compared with $26.1 million, or 20 cents a share in the year-ago period. Excluding special items but including stock option expenses, the company earned 21 cents a share, beating consensus estimates by 1 cent, according to Thomson Reuters. Revenue for the quarter rose 12 percent to $180.6 million. Analysts were forecasting revenue of $173.0 million.  For 2010, the company still expects to earn 90 cents to $1 a share, while revenue is expected to grow about 20 percent. Shares of the company closed down 3.25% to close at $36.62 and fell further in the after hours session.

    ImmunoCellular Therapeutics (OTCBB: IMUC) announced today that Manish Singh, Ph.D., President and CEO will be presenting at the 2010 BIO CEO & Investor Conference on Tuesday, February 9th at 10 a.m. eastern time.

    Invacare Corporation (NYSE: IVC) today announced its financial results for the quarter and year ended December 31, 2009 and provided guidance for 2010.  Commenting on Invacare's 2009 results and 2010 guidance, A. Malachi Mixon, III, Chairman and Chief Executive Officer, stated, "Despite a challenging reimbursement and economic environment, 2009 was a strong year for Invacare on all critical measures. Adjusted earnings per share increased 17% for the year to $1.58 versus $1.35 in 2008. The Company generated free cash flow in 2009 of $141.6 million as compared to $59.9 million in 2008, allowing the company to reduce debt outstanding by $157.2 million and lower its ratio of debt to adjusted EBITDA to 2.3 as of the end of 2009. In 2010, based on the midpoint of its guidance at $1.75 per share, Invacare forecasts 10% growth in adjusted earnings per share. This improvement will be built upon 2009's successful cost reductions as well as a return to organic sales growth, both driven by globalization and exciting new product introductions. The Company plans to use its projected strong free cash flow in 2010 of $65 million to $75 million to continue to retire debt or pursue accretive acquisitions as available. The management team at Invacare is committed to delivering improved performance to its shareholders."

    Mixon went on to say, “The primary reimbursement risk for Invacare in 2010 which is not addressed in the guidance above is related to health care reform in the United States. However, the likelihood of a massive health care reform bill has been diminished by the outcome of the Senate election in Massachusetts. The Obama Administration's number one priority seems to have moved from health care to jobs and the economy. As a result, the Company is optimistic that the medical device excise tax will not materialize, although there is still discussion in Congress on how to achieve health care reform in the future. As discussed in an earlier filing, the Company has been evaluating its options to offset the impact of the proposed medical device excise tax on the Company’s financial results, if a bill with such a provision were to pass.”

    MedCath Corporation (Nasdaq: MDTH),  a healthcare provider focused on high acuity healthcare services and  the parent company of TexSan Heart Hospital in San Antonio, reported lower earnings for its first quarter of 2010 ended Dec. 31.

    The company reported a net loss of $2.6 million for the period, compared to a net gain of $2.2 million from the year ago period. Net revenue for the first quarter decreased 2 percent to $147.4 million, compared to $150.2 million for the first quarter of 2009.

    MedCath officials say the revenue decline was due in part to lower cases and net revenue from cardiovascular services, primarily heart surgeries.  “Although we are disappointed with our core cardiovascular net patient revenue this quarter, we are encouraged by our overall increase in admissions and outpatient cases,” says Ed French, MedCath’s president and CEO.

    Charlotte, N.C.-based MedCath owns and operates specialty hospitals that diagnose and treat cardiovascular diseases. It has interests in and operates nine hospitals around the country with a total of 676 licensed beds.

    Medizone International, Inc. (OTCBB: MZEI) announced today that every full scale test run completed thus far in its hospital room mock up facility has resulted in the total elimination of all bacteria present in the room. In this current phase of development, Medizone's scientific team will attempt to confirm, in a more realistic hospital setting, recent laboratory findings indicating extremely high antibacterial efficacy for its novel technology (6-7.2 log reductions) against the primary causative agents of hospital acquired infections (HAIs), sometimes referred to as "Super Bugs". Shares closed the day at $.28 up nearly 4% on the day.

    Mylan Inc. (Nasdaq: MYL) today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (NASDAQ:ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg. This product is the generic version of Caduet® Tablets, which combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium.

    Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the 2.5/10 mg, 2.5/20 mg, 2.5/40 mg and 10/40 mg strengths and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. Pfizer filed the lawsuit in the U.S. District Court for the District of Delaware.

    Pfizer Inc. (NYSE: PFE) and DxS (NASDAQ: QGEN) Frankfurt, Prime Standard: QIA) today announced that they have entered into an agreement to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM).

    PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today reported the results of its fourth quarter of 2009 and year ended December 31, 2009.

    Pharmacyclics, Inc. (Nasdaq: PCYC) was up more than 9% on heavy volume and no apparent news. The Sunnyvale CA based biopharmaceutical company focuses on developing and commercializing small-molecule drugs for the treatment of immune mediated disease and cancer. Shares finished the day at $4.55.

    Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the presentation of preclinical data on a series of novel compounds that simultaneously blocked two critical pathways involved in the growth and survival of cancer cells. The compounds were identified as part of the Company’s ongoing oncology drug discovery efforts. The data are being presented in both oral and poster sessions at the American Association for Cancer Research (AACR) conference on Protein Translation and Cancer in Coronado, CA.

    “Progenics’ identification of these small-molecule compounds as part of our discovery program underscores our long-standing commitment to oncology drug development,” stated Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer of Progenics. “In laboratory studies, the synthetic, small-molecule compounds blocked both phosphoinositide 3-kinase (PI3K), which is a key regulator of one molecular signaling pathway, and MNK, an oncogenic kinase in the Ras pathway. We look forward to exploring the therapeutic potential of this series of compounds which are being optimized for clinical development.” Shares closed at $4.50, up $.10 on the day and continued to rise in after hours.

    pSivida Corp. (NASDAQ:PSDV), a leading drug delivery company, today announced that its financial results for the second quarter of fiscal year 2010 will be released after market close on Thursday, February 11, 2010, followed the same day by a conference call and live webcast to discuss those results and its business scheduled for 4:30 p.m. ET.

    Senomyx, Inc. (NASDAQ:SNMX), a company focused on using proprietary taste receptor-based technologies to discover novel flavor ingredients for the food, beverage, and ingredient supply industries, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2009.

    Sequenom, Inc. (Nasdaq: SQNM) today announced the launch of the SensiGene Fetal RHD Genotyping test by Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM). This is the company's first laboratory developed test powered by its SEQureDx technology.

    "The introduction of this test is an important development in improving patient care for pregnant women in both the United States and in Europe," said Dr. Wolfgang Holzgreve, director at the University Hospital, Freiburg and Sequenom clinical advisory board member. "Fetal RHD genotyping utilizing real-time PCR has been widely used in Europe for over a decade, and has led to better patient management and is even considered for reduction of unnecessary treatment with Anti-D immune globulin. Based upon Sequenom's validation study, the SensiGene Fetal RHD Genotyping test appears to offer a higher level of sensitivity and specificity compared with the real-time PCR methodology.""Launching the first test based on our SEQureDx technology is an important milestone for Sequenom and our CLIA lab - the Sequenom Center for Molecular Medicine," stated Shawn M. Marcell, vice president, molecular diagnostics. "We believe this test represents a significant and important advancement for prenatal care. Our ability to launch this test and bring it to patients is, in no small part, directly related to the strong support of the Fetal Medicine Foundation, UK, which supplied clinical samples to us."

    Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (NYSE:TM), today announced that it will report financial results for the fourth quarter and year ended December 31, 2009 on Thursday, February 11, 2010, after the U.S. financial markets close.

    Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today provided an update on recent progress in its late-stage development programs in hepatitis C virus (HCV) infection and cystic fibrosis (NYSE:CF), reported consolidated financial results for the year ended December 31, 2009 and provided financial guidance for 2010.

    VirtualScopics, Inc. (Nasdaq:VSCP), a leading provider of quantitative imaging for clinical trials, today announced that its project balance exceeds $41 million compared to $24 million at the same time a year ago, representing a greater than 70% increase. The company defines project balance as the amount remaining to be earned from active projects and awards, and commonly referred to as backlog within the industry. The average duration of the projects included within the backlog is approximately forty-five months and the company anticipates that awarded contracts will be signed within the next several months as the projects near their start dates.

    Vice President of Business Development, Rosemary Shull stated, "These results are not only a great reflection of the strength of our business development efforts in 2009, but of the confidence our customers have in our operational performance and ability to deliver high quality results on a consistent basis." She added, "The continued growth of our backlog, which has risen from $15 million just two years ago, has been driven by both new business efforts and a greater penetration within existing customers." Ms. Shull concluded," We are looking forward to another solid year in 2010." Shares were up nearly 9% to close at $1.06
    Feb 06 8:53 AM | Link | Comment!
  • Has MedaSorb found the Holy Grail which has eluded medicine for decades?
    Anna Nicole Smith clearly didn't think she needed medical attention for systemic sepsis syndrome, a lethal blood infection, when she passed away at the Seminole Hard Rock Hotel and Casino resort in Hollywood, Florida.

    Even as I write this report, Etta James remains hospitalized in Southern California as she recovers from sepsis, an infection, her manager said was caused by a urinary tract infection.

    And as we read headlines that toxic cleaners are believed to be an underlying factor in Jett Travolta’s (son of actor John Travolta) untimely death at the age of 16, his father and mother held a fundraiser just last night in Ocala Florida for a detoxification project for local firefighters, policemen and emergency workers who have been exposed to toxins.

    Severe sepsis is a life-threatening condition, which can affect anyone, and most often develops in patients with pneumonia, trauma, surgery, burns or cancer. Over 18 million cases of severe sepsis occur each year – that’s equivalent to the entire population of Denmark, Finland, Ireland and Norway added together each year.

    The number of severe sepsis cases is growing at a rate of 1.5% per year, due mainly to the growing use of invasive procedures and increasing numbers of elderly and high-risk individuals such as cancer and HIV patients. Older people are at increased risk of sepsis as they are more prone to infections due to aging, co-morbidities, use of invasive surgical techniques and other problems.
    According to various medical publications, massive resources have been invested in developing and evaluating potential therapies, and considerable effort has been undertaken to understand the systemic inflammation and multiple-system organ failure characteristic of severe sepsis.

    Three years ago, I nearly died when my blood became infected after a severe bout with diverticulitis.  I fell very ill and ended up in the hospital for nearly three weeks as doctors fought, first to calm the severe infection that threatened to shut down my kidneys before sending me off to surgery.

    The demands made on hospital staff by patients with these types of infections, place a significant burden on healthcare resources and one publication says it accounts for 40% of total ICU expenditures. When I showed some of those same doctors who had treated me images and descriptions of MedaSorb Technologies’ (MSBT.OB) flagship CytoSorb™ therapeutic device, most of the doctors could not believe it and some felt they could really use a device like this.

    These days, the first-line of treatment doctors rely on to try to eliminate the underlying infection is antibiotics. Indeed, I remember having six or eight different antibiotic drips going into a main line and my blood was being tested every few hours in an effort to monitor how my body was responding. Depending on the patient’s clinical status, additional therapies are initiated, including drug therapy and supportive care, such as mechanical ventilation and kidney dialysis.  

    There has been considerable excitement recently among critical care clinicians who care for patients like me.  For the first time there are trials showing positive results involving new therapeutic interventions like MedaSorb’s device. I spoke to Phillip Chan, MD, PhD, the Chief Executive Officer of the company. Dr. Chan is a Board-certified internal medicine physician with a strong background in clinical medicine and research, having completed his residency at Harvard Medical School at the Beth Israel Deaconess Medical Center. Dr. Chan received his MD/PhD from Yale University School of Medicine and his BS in cell and molecular biology from Cornell.

    BioMedReports: Can you tell us about your company?

    Dr.Chan: Sure. MedaSorb Technologies Corporation is a publicly traded development stage therapeutic device company working to save lives through blood purification. At MedaSorb, we’ve developed a highly bio-compatible, porous, polymer bead purification technology that can remove things as small as drugs and toxins to things as large as antibodies from blood and physiologic fluids. Right now we are currently conducting a randomized, controlled clinical trial of up to 100 patients in Europe with our product CytoSorb to treat patients with severe sepsis, which is often called “overwhelming infection” in the lay press.  CytoSorb is a highly efficient cytokine filter designed to treat severe sepsis and septic shock by reducing potentially deadly cytokine-storm which is a well-known, major cause of organ failure and death with this disease. We’re currently driving to complete our European sepsis trial and if the outcome is positive, plan to apply for CE Mark approval for CytoSorb in the EU and, if approved, subsequently commercialize. If our European trial results are positive, we plan to present the data to the U.S. FDA and seek approval to conduct a clinical study in the United States.

    We recently announced preliminary positive proof of concept in humans, using CytoSorb to treat severe sepsis patients in the setting of lung injury in a 22 patient randomized, controlled pilot study. We reported a summary of clinical data from all 13 patients that had fully monitored, completed data sets – this is 7 treated, 6 control patients – that demonstrated improvements with CytoSorb treatment in key clinical endpoints such as 28-day and 60-day all-cause mortality, ventilator-free days, pace of ventilator weaning, organ failure scores, vasopressor use, as well as days in the intensive care unit.  To date the therapy has been safe and well tolerated by patients. There have been no serious device related adverse events in more than 500 human treatments, more than 150 of which have actually been in patients with sepsis.  

    The underlying technology is protected by a broad intellectual property portfolio of now 27 issued patents that range from composition of matter to clinical application patents, with multiple applications pending.  A key part of our know-how is related to polymer production, which we conduct at our manufacturing facility in New Jersey under strict, well-documented, reproducible processes that meet FDA clinical trial standards.

    BioMedReports: You just said something interesting that I wasn’t aware of – you said that the CytoSorb technology can also clear a person of drug substances?


    Dr. Chan: Our polymer platform technology is a highly porous polymer bead.  Although not quite the perfect analogy, imagine tiny sponges if you will.  But unlike natural materials, we can change the size and distribution of these pores in a highly reproducible way to enable the removal of different things of different sizes from blood and physiologic fluids. The CytoSorb resin is specifically designed to remove substances in the molecular weight range of 10-50 KiloDaltons in size, where most cytokines reside, a range that we call the cytokine ‘sweet spot’. But we also have the ability to change the porous nature of these beads to be able to remove other things that we want to target.  For instance, we have developed novel, highly efficient resins that can remove a variety of drugs that are common in drug overdose from blood and physiologic fluids.  

    BioMedReports: What is the market potential for this product. Can you tell us a little about that?

    Dr. Chan: Severe sepsis is one of the leading causes of death in the world. It afflicts people of all ages, particularly the very old and the very young, and it also afflicts all walks of life and all ethnicities. Unfortunately, most of your readers know someone who had developed a severe infection. It could have been something as catastrophic as a ruptured appendix, or something more common as pneumonia, maybe a bad urinary tract infection or even influenza - where the infection got out of hand and sent that person to the intensive care unit on life support, with failing critical organs like the hearts, lungs, and kidneys. This is severe sepsis and it afflicts more than a million people in the United States, roughly 1.5 million people in Europe, and an estimated 18 million people worldwide every single year. Despite the best medical care here in the United States, one in every three patients die of this disease, and in fact, more people die of severe sepsis in the United States than from either heart attacks or strokes or any single form of cancer.  It remains a major unmet medical need.

    Without better treatments for severe sepsis and its more deadly cousin septic shock, which has a mortality rate of 50% or more, the numbers are only expected to increase with trends like an aging population, an increase in antibiotic resistant bacteria, the increased use of implantable devices like artificial hips and knees, diseases like diabetes and cancer, and others that put people at high risk of infection and sepsis. All of these are driving the incidence of sepsis higher.

    BioMedReports: You know it’s interesting, we spoke to doctors about your technology to get their feel for it and the reaction we heard most was “Wow, is this real? And if it is, we could really use something like this.”  Do you get the same type of reaction out there?


    Dr. Chan: We do. We have talked to a number of thought leaders in this space. As clinicians should react, they were cautiously optimistic. They wanted, obviously, to see data, but they felt that this was a promising approach worth pursuing and an approach that could actually work. And so hopefully with some of the early data that we’ve discussed from our pilot study, and pending data from the current European sepsis trial, we’re getting to that point.

    BioMedReports: What is the potential impact that MedaSorb can have in that market we just talked about?

    Dr. Chan: In order to understand our potential impact, it is important to understand how our science and technology works and how it could affect the pathophysiology of severe sepsis. Severe sepsis is primarily caused by two problems. The first is the infection, which can often be effectively treated by antibiotics, anti-virals, or other types of agents. However, the other facet of sepsis is the body’s immune response to the infection. Normally the body produces small proteins called cytokines that help stimulate and regulate the immune system, and they’re normally helpful. But in many people with severe infection, the body’s immune system goes haywire and produces massive amounts of these cytokines, often called ‘cytokine storm’, to the point where they’re no longer helpful, but are in fact toxic to the body, causing direct cell death, damaging organs, leading to organ failure and, in many cases, death.

    For instance, certain cytokines can cause blood vessels in the lungs to become leaky, allowing inflammatory fluid, cells and other cytokines to fill up the lungs, essentially drowning the person in their own fluids. Cytokine storm can also lead to hemodynamic collapse, where the heart can no longer get blood and oxygen to critical organs, leading again, to organ injury. Cytokine storm can also shut down the kidneys, which is another major risk factor for death from severe sepsis. The role of cytokine storm in sepsis is widely accepted by clinicians and researchers, and has been very well researched.  Interestingly, if you do a Pub-med search on cytokines and sepsis you’ll literally bring up 10,000 articles.

    To drive the point home, in 2006, there was a Phase I safety study done by another company that was trying to stimulate the immune system to fight cancer with a specialized monoclonal antibody. This was reported in the New England Journal of Medicine. When they actually injected this antibody into six healthy young male volunteers, who did not have infection or cancer –they all developed cytokine storm along with the hallmarks of severe sepsis including acute lung injury, renal failure, clotting disorders, and shock.  In fact, two of the volunteers who had the worst cytokine storm actually developed severe septic shock and acute respiratory distress syndrome.

    This is just an example of how it is not the infection, but rather cytokine storm that causes multi-organ failure and sepsis. The reduction of cytokine storm has been the Holy Grail of the industry for the past 2 to 3 decades, and unfortunately most of the approaches that have been tried have only been capable of removing one cytokine or one inflammatory mediator at a time.  The problem is that different cytokines have overlapping functions and there’s so much redundancy in the immune response that if you remove one cytokine, even if it’s an important one, twenty others will take its place. So what is really necessary is a broad spectrum approach to try and remove cytokines across the board, and reduce them to a level where they are no longer toxic, but not reduce them so much that they can no longer help the body fight infection. With our product CytoSorb, we are one of the leaders in the research of reducing the effects and improving recovery from severe sepsis and cytokine storm.

    CytoSorb is a cytokine filter that can broadly remove cytokines from blood. The treatment is very simple and similar to hemodialysis, the most widely used blood purification treatment in the world. You use a standard dialysis machine found in most hospitals by leading vendors like Fresenius, Baxter, B. Braun and others, to essentially pump blood out of the body through our cartridge. The blood goes directly through our cartridge and contacts the resin. Cytokines are adsorbed and removed from blood and that “purified” blood is then put back into the body. In our clinical study we are treating for 6 hours a day for 7 days, each day with a new device. We have the ability to treat an entire person’s blood volume 20 to 30 times over the course of a 6 hour treatment. So the goal is to reduce cytokine storm, prevent and limit organ damage and allow the body time to heal and recover.

    We know that from our in vitro studies we can remove 50 to 70% of certain cytokines in the first hour of treatment, and over the course of several hours, remove 90 to 95% of certain cytokines, in our bench top circulation system that simulates human treatment.

    Our polymer resin is highly hemo-compatible. It meets what is called the ISO-10993 standard for 30-day medical device implantables. That includes things like bio-compatibility, hemo-compatibility, cyto-toxicity, geno-toxicity, acute sensitivity and other factors. Our device also has massive capacity, unlike a standard hemo-dialyzer that has very limited capacity to bind cytokines because of very limited surface area. A single one of our cartridges has 7 football fields worth of surface area on which to bind cytokines. This massive capacity is really important in trying to reduce cytokine storm and is a major differentiator between our technology and others.

    Our technology is also what we call a ‘razor blade in other people’s razor’ model, because it is compatible with standard hemo-dialysis equipment.  Hospitals would only need to purchase our CytoSorb cartridge to use it.  They have all of the other necessary equipment. It also contains no cells, no antibodies, nothing that can degrade over time, so it has excellent shelf life stability. We currently have 3 year shelf life stability at room temperature. It really has a number of significant advantages over other technologies.

    BioMedReports: Let’s talk about the trials in Europe. Has it been easier to recruit patients there then if you had done the trials in the US?

    Dr. Chan: We continue to make good progress. We’re working with a stellar group of experienced and motivated investigators, many of whom are thought leaders in critical care in Germany. That’s very important. Germany, as you know, is the largest medical device market in the EU and the 3rd largest in the world, so it makes a great first market for us. There have been a number of issues related particularly to distance, language, as well as time, differences that pose a number of challenges, but we’ve learned to adapt.

    BioMedReports: Tell us about any additional goals for the company for 2010?

    Dr. Chan: Our major goal is the successful completion of our trial, which will hopefully lead to CE Mark approval.

    BioMedReports: What are the challenges you see for the company in 2010?

    Dr. Chan: One of the major challenges for us is that we have a lot going on at the company with a lot of moving parts. There are many things we need to work toward this year including completing our clinical trial, seeking CE Mark approval, having regulatory discussions with the FDA, and other things required if we can successfully commercialize our technology.  As a development stage company we also put a lot of effort into our financing strategy so that we can continue to raise capital to fund our operations.  We have a very strong management team and we are working diligently to execute on our vision.

    BioMedReports: Have you discussed any strategic partnerships to go to market or to do the trials for example?

    Dr. Chan: If our technology works as we hope, it really has the potential to be a blockbuster product that can impact the top and bottom lines of most potential strategic partners. We have a very active business development program under way at the company that’s been going on now for more than a year. CytoSorb is an extensively patented product. It has a highly profitable business model. It’s in a market that has little competition and literally has a world of opportunity in front of it. We believe it’s a technology that is attractive to potential strategic investors and hopefully with positive data from our trial we can make something happen there, but we aren’t dependent on a strategic partnership. Whether we partner with a larger company or take the product to market directly, we’re prepared to do either.


    Safe Harbor Statement: Statements in this interview that are not historical fact are considered forward-looking statements and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Please see the Company’s SEC filings for additional details. 

    Disclosure: Long MSBT
    Feb 06 8:52 AM | Link | Comment!
  • RxNews Recap for Wednesday 02-03-10. Auxilium (AUXL) and BioSpecifics (BSTC) jump on FDA approval while LaboPharm (DDSS) drops
    Below is a list of the companies that made news in the healthcare sector on Wednesday, February 03, 2010.

     

    Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), along with thier partner, BioSpecifics Technologies Corp. (Nasdaq: BSTC),  announced early this morning that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. The Company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March. "With the safety and effectiveness of XIAFLEX demonstrated across multiple clinical trials, physicians can now use XIAFLEX to treat any symptomatic cords in patients with Dupuytren's contracture," said Larry Hurst, M.D., study investigator and Professor and Chair, Department of Orthopaedics at SUNY Stony Brook. "I believe that XIAFLEX, as a new nonsurgical treatment, could potentially become the standard of care for Dupuytren's contracture."

    BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, also announced the news the today. "We believe that patients afflicted with Dupuytren's contracture will greatly benefit from XIAFLEX, the first pharmaceutical treatment for this disabling disease. We would like to acknowledge the efforts of the scientists and clinicians who have worked with XIAFLEX over many years to usher in a new era of hope for millions of patients that suffer from this condition," stated Thomas L. Wegman, President of BioSpecifics. "We look forward to its commercial launch and to the results of clinical trials of XIAFLEX in other indications." Meanwhile, Pfizer, Inc.,(NYSE:PFE) Auxilium's marketing partner for XIAFLEX in Europe, has stated that the scientific/technical review procedure for the Marketing Authorization Approval (NYSE:MAA) for XIAFLEX in Europe began in January 2010. Pfizer is responsible for marketing XIAFLEX for Dupuytren's contracture and Peyronie's disease in 27 member countries of European Union and 19 other European and Eurasian countries.

    Shares of Auxilium rocketed more than 17% to close the day up $4.88 to $32.96. BioSpecifics saw its shares rise almost 6% closing the day at $28.54 while shares of Pfizer were off around 2%.

    Other big movers today:

    Home Diagnostics, Inc. (NASDAQ: HDIX), saw its shares soar $5.40 to close at $11.45, up more than 89% as the manufacturer and marketer of diabetes testing supplies, announced today that it signed a definitive merger agreement with Nipro Corporation (Tokyo Stock Exchange and Osaka Stock Exchange Ticker Code 8086), a global manufacturer and distributor of medical devices, pharmaceutical products and medical and glass products headquartered in Osaka, Japan, under which Nipro will acquire all outstanding shares of Home Diagnostics’ common stock, $.01 par value, for a cash purchase price of $11.50 per share (or aggregate consideration of approximately $215 million). The offer price represents an approximately 90% premium to the closing price of Home Diagnostics’ common stock on February 2, 2010, and an approximately 83% premium to Home Diagnostics’ average closing price for the preceding 90 days.

    Health Discovery Corporation (OTCBB: HDVY) shares jumped today as the company announced that it has received the final payment that was due under the agreement that settled the Company’s patent infringement lawsuit against Vermillion (Pink Sheets: VRML), formerly known as Ciphergen Biosystems, Inc. In 2006, Health Discovery Corporation sued Ciphergen Biosystems in Federal District Court for infringement of several of its patents covering the use of support vector machines (SVMs) for the discovery of biomarkers. As alleged in the complaint, Ciphergen’s researchers had used SVMs to identify the most promising biomarkers for diagnosis of ovarian cancer, the results of which had been reported in a number of medical publications. The settlement agreement, through which Ciphergen was granted a limited license to continue its use of the Company’s SVM technology only in conjunction with its protein based SELDI mass spectrometry technology, was inked in July 2007. No rights were granted under the license to use HDC's SVM technology for gene-based molecular diagnostic discovery, digital pathology interpretations, digital radiology interpretation nor any other discovery use outside of the very narrow field of SELDI-based protein discovery. Vermillion went on to further develop these biomarkers into the OVA1™ test, which was approved by the FDA in September 2009 and exclusively licensed to Quest Diagnostics. Based on these favorable developments, Vermillion recently emerged from bankruptcy and has enjoyed phenomenal growth in its share prices.

    “The results achieved by Vermillion provide further testimony to the value of Health Discovery Corporation’s proprietary SVM technology, both from a technical and a financial perspective,” said Dr. Stephen Barnhill, Chairman and CEO of Health Discovery Corporation. “In addition to our own biomarker discovery programs, we are continuing to pursue revenue-producing licensing opportunities, retroactively, as in the case of Vermillion, and going forward, to develop new applications of the technology within our intellectual property portfolio.” The applicability of SVM technology to countless uses is allowing Health Discovery Corporation to direct its licensing efforts both within and outside of the healthcare arena, including high-tech applications such as Internet search engines, electronic health records, fraud detection, security and surveillance, and fault detection and prediction in vehicles and aircraft.

    Shares of Health Discovery closed the day at $.35, up 25% on nearly 10 times the average volume.

    In news from after the market close today:

    Cardiovascular Systems, Inc. (NYSE:CSI) (Nasdaq: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, after the bell today announced financial results for its fiscal second quarter ended December 31, 2009.

    Revenue in the second quarter rose to $15.1 million, an 8-percent increase over revenue of $14.0 million in the second quarter of last fiscal year. The net loss improved at a higher rate of 22 percent to $(6.8) million, benefiting from improved gross margins and lower operating expenses. Adjusted EBITDA, calculated as loss from operations, less depreciation and amortization and stock-based compensation expense, improved by 39 percent to a loss of $(4.3) million versus $(6.9) million in the year-ago period.

    David L. Martin, CSI president and chief executive officer, commented, “Revenue grew in line with our expectation this quarter, while the net loss narrowed significantly through careful expense management. We installed optimal large vessel protocols for using the Diamondback 360° at selected target accounts. The result was an increase in device usage of over 50 percent in those accounts from the first quarter of this fiscal year. Given this success, we have broadened our program substantially for the third quarter of fiscal 2010.” The company’s Diamondback 360® PAD System treats peripheral arterial disease (PAD) in vessels throughout the leg in a few minutes of treatment time.

    Inverness Medical Innovations, Inc. (NYSE: IMA), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced after the bell today that it has entered into a binding agreement with Kroll Inc., a subsidiary of Marsh and McLennan Companies, Inc. (NYSE: MMC) to purchase its Substance Abuse Testing division (Kroll Laboratory Specialists, Inc.), its business unit providing forensic quality substance abuse testing products and services across the United States. The purchase price is $110 million cash subject to a customary working capital adjustment. The acquisition is expected to close in the first quarter of 2010 but remains subject to customary closing conditions.

    News from earlier Wednesday:

    AEterna Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ), a late-stage drug development company specialized in oncology and endocrinology, today announced that its partner, Keryx Biopharmaceuticals (KERX), has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (NYSE:SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, perifosine (KRX-0401), in patients with refractory metastatic colorectal cancer.

    Affymetrix, Inc., (NASDAQ: AFFX) today reported its operating results for the fourth quarter and fiscal year ended December 31, 2009. Total revenue for the fourth quarter was $88.8 million, as compared to total revenue of $78.6 million in the fourth quarter of 2008.

    Amarillo Biosciences, Inc. (NYSE:ABI) (OTCBB: AMAR) today announced preliminary results indicating that, in a recently completed Phase 2 clinical trial conducted in Perth, Australia at the University of Western Australia with Professors David Smith and Manfred Beilharz as principal investigators, the rate of influenza-like illness was significantly (p=0.01) reduced from 71% to 43% in interferon-treated subjects who received Fluvax (an influenza vaccine) prior to the study, compared to subjects in the placebo group who were vaccinated.

    BioClinica, Inc. (NASDAQ: BIOC) will release its financial results for the fourth quarter and full year ended December 31, 2009 on Wednesday, February 10, 2010.

    Catalyst Health Solutions, Inc. (NASDAQ:CHSI) announced today that Hai Tran, Chief Financial Officer, and Richard Bates, Executive Vice President, are scheduled to present at the UBS 20th Annual Global Healthcare Services Conference on Tuesday, February 9, 2010, at approximately 8:30 a.m. (NYSE:ET) in New York City.

    CEL-SCI Corporation (NYSE CVM) announced that Geert Kersten, Chief Executive Officer, will be presenting at the 2010 BIO CEO & Investor Conference.

    EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today announced that Nasdaq notified the Company that it has regained compliance with the minimum bid price requirement in Listing Rule 5550(a)(2) and met the requirements of the Nasdaq Listing Qualification Panel (the “Panel”) decision dated November 2, 2009.

    ERT (Nasdaq: ERES), announced today that it will release its results for the fourth quarter and full year 2009 on Thursday, February 25, 2010, after the market closes.

    Genzyme Corporation (NASDAQ: GENZ) announced today that Scott Canute, the former manufacturing head at Eli Lilly & Company and a respected leader in the field, joined the company as President of Global Manufacturing and Corporate Operations.

    GTC Biotherapeutics, Inc. (“GTC”, NASDAQ: GTCB) announced today that Geoffrey Cox, Ph.D., GTC’s Chairman and CEO, is scheduled to present on Tuesday, February 9, 2010 at 8:30 a.m. during the 12th Annual BIO CEO & Investor Conference.

    HealthSport, Inc. (OTC Bulletin Board: HSPO), the preeminent formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion, announced today that the Mexican Institute of Industrial Property has approved HealthSport's patent application relating to its bi-layer edible film strip technology.

    ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceuticals company that develops targeted anticancer therapeutics using its Targeted Antibody Payload (NYSE:TAP) technology, invites investors, journalists and the general public to listen to a live webcast of the Company's investment community meeting on February 25, 2010.

    Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

    Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(NYSE:TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (NYSEARCA:MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(NYSE:R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.

    "OLEPTRO(TM) represents Labopharm's second CONTRAMID(R) technology-based product to receive FDA approval in just over a year," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We are excited about the opportunity for OLEPTRO(TM) and are preparing the product for launch into the $11 billion-plus U.S. antidepressant market. We are working towards finalizing a commercialization path for OLEPTRO(TM) that will maximize the value of our product in this market."

    MDD is a common mental illness often characterized by a combination of social and somatic symptoms. It affects more than 14 million adults in the U.S. and is the leading cause of disability globally. OLEPTRO(TM) will offer physicians another therapeutic alternative for their MDD patients. Shares of Labopharm dropped more than 15% on the news.

    Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the dermal fillers RESTYLANE®-L and PERLANE®-L. RESTYLANE-L is approved for implantation into the mid to deep dermis, and PERLANE-L is approved for implantation into the deep dermis to superficial subcutis, both for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds

    MedLink (OTCBB: MLKNA) announced today the formation of the MedLink Community Physician Advisory Board.

    MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) announced today that it is partnering with DoctorDirectory.com, Inc. (DoctorDirectory) to promote MOXATAG through DoctorDirectory’s virtual marketing solution, IncreaseRx®. IncreaseRx® utilizes web-based educational and promotional tactics to reach thousands of prescribers with targeted sales and marketing messages.

    Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a personalized T-cell immunotherapy for multiple sclerosis (NYSE:MS), today announced that Neil K. Warma, Opexa’s president and chief executive officer, will deliver a corporate presentation at the 12th Annual BIO CEO & Investor Conference.

    PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Gregory S. Weisnar, Chief Executive Officer, will make a presentation regarding the Company at the UBS 20th Annual Global Healthcare Services Conference in New York City, on Monday, February 8, 2010, at 9:00 a.m. Eastern Time.

    Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that the results of a pre-clinical study in an animal model of ischemic stroke demonstrated that its PLacental eXpanded (NYSEMKT:PLX) cell therapy may be an effective treatment for this disorder. Results will be published in the journal Brain Research (Brain Research, Feb. 22, Vol. 1315) under the title “Transplantation of placenta-derived mesenchymal stromal cells upon experimental stroke in rats.” The study was conducted in collaboration with the Fraunhofer Institute for Immunology and Cell Therapy (IZI) in Leipzig, Germany. “The study’s positive results suggest that PLX cells may increase the time interval for successful treatment in humans suffering from ischemic stroke, but our knowledge concerning modes of action and optimal treatment paradigms must be enlarged in further experiments before considering clinical application,” said Dr. Johannes Boltze, head of the stroke research group at The Fraunhofer Institute for IZI in Leipzig, Germany and senior author of the publication.

    Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), said it would cut more than half of its workforce to focus resources on the development of its key cancer drug picoplatin. Poniard also named Ronald Martell its new chief executive officer, succeeding Jerry McMahon, who held the post for about six years.Poniard expects to incur a charge of $1 million related to the job cuts, which brings the company's total number of employees to 21, in the first quarter of 2010.The company expects to cut operating expenses by $4 million in 2010.

    The company has been trying to find a partner to market picoplatin to treat lung cancer, an indication in which the drug failed a late-stage study in November 2009.Further development of the drug to treat colorectal cancer and prostate cancer were also pegged on the partnership, which would have funded the late-stage studies of picoplatin in the two other cancer types.

    The reduction in force is a difficult but necessary step to preserve our resources as we pursue our goals of establishing a regulatory path forward for picoplatin and evaluating our strategic opportunities for this novel therapy,” said Martell in a statement.

    Poniard, however will remain fully staffed to provide clinical support activities and for its meetings with the Food and Drug Administration in the first half of 2010. The company expects $4 million in reduced annualized operating expenses due to the workforce cut. It also expects to acquire a $1 million in the first quarter of 2010 because of the reduction. Shares of Poniard fell 10% to $1.65.

    PSS World Medical, Inc. (Nasdaq: PSSI) today announced that its Board of Directors has unanimously appointed Gary A. Corless, currently the Company's Executive Vice President and Chief Operating Officer, as President and Chief Executive Officer, effective immediately. Mr. Corless succeeds David A. Smith, who has terminated his employment with the Company by mutual agreement. Mr. Corless has also been appointed a Director on the Company's Board and a member of the Executive Committee. In addition, Delores P. Kesler, a Director since 1993, has been appointed Chairman of the Board of Directors. Shares of PSSI closed down on the day.

    Repligen Corporation (Nasdaq: RGEN) announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering a recombinant form of Protein A which is identical in structure to the commercial form of Protein A from Staphylococcus aureus which is used in the production of many of the world's approved monoclonal antibodies. The patent, which will remain in force until 2028, covers a new Repligen proprietary product which is now available in commercial quantities. This product has been developed as an alternative to the legacy Staphylococcus aureus Protein A and will be the basis of Repligen's future chromatography product development. Proteins manufactured with recombinant technology have multiple advantages over a natural source such as Staphylococcus aureus including higher quality, product consistency and purity as well as improved supply chain security and a lower cost of production.

    "This action by the patent office reflects our continuing investment and commitment to our Bioprocessing business," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "This recently launched recombinant Protein A product is an important step in expanding our business through both organic growth and product acquisition."

    Sanomedics International Holdings, Inc. (Pink Sheets: SIMH) announced the appointment of Jordan Serlin as Chief Operating Officer for the company. Additionally he will sit on the company’s Board of Directors. Serlin has served as both an advisor to company CEO Keith Houlihan and operational consultant to Sanomedics since September, 2009.

    SDI (Strategic Diagnostics Inc., Nasdaq: SDIX), a provider of biotechnology-based products and services, today announced that Dr. Klaus Lindpaintner began serving as Vice President of Research & Development and Chief Scientific Officer (CSO) on February 1, 2010 as previously disclosed in its January 11, 2010 news release.

    Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients.

    ULURU Inc. (Amex: ULU), a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products, today announced it has entered into definitive agreements to sell 5,000,000 shares of its common stock at a price per share of $0.20 pursuant to a registered direct offering to institutional investors, resulting in gross proceeds of $1.0 million. The price per share represents the closing price of ULURU's common stock on February 1, 2010. There were no warrants issued to the institutional investors in this transaction.

    Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 inpatients with cystic fibrosis (NYSE:CF) who are homozygous for the F508del mutation. VX-809, an oral investigational Cystic Fibrosis Transmembrane Conductance Regulator protein (CFTR) corrector, was well-tolerated across all four dose groups studied.

    Vystar® Corporation (OTC Bulletin Board: VYST), the creator of Vytex® Natural Rubber Latex (NRL), a patented, all-natural raw material that significantly reduces antigenic proteins found in natural rubber latex, has engaged The Investor Relations Group ("IRG"), a thirteen-year-old, award-winning, corporate communications firm based in New York City, to serve as its investor relations and public relations agency.

    Feb 04 5:57 AM | Link | Comment!
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  • Hearing some interesting developments on the horizon for $NWBO. Did an article on them yesterday. Looks promising. http://bit.ly/NWBOnews
    Jul 12, 2011
  • ($RXPC.PK 3 of 3) If it were bad news, chances are they'd have something by now, since delisting decisions are usually handed down quickly.
    Apr 19, 2011
  • ($RXPC.PK 2 of 3) a listing extension would go until July [when the stock would have to be over $1 to continue being listed on Amex].
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