Below is a list of the companies that made news in the healthcare sector on Friday, October 30, 2009. Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Biodel Inc. (Nasdaq:BIOD) announced Dr. Solomon Steiner, Chairman and CEO of Biodel, will present a corporate update at the Oppenheimer 20th Annual Healthcare Conference on November 3rd, 2009 at 9:40 am Atlantic Time.

AMRI (NASDAQ:AMRI) announced AMRI Director of Investor Relations Peter Jerome will present at the Oppenheimer 20th Annual Healthcare Conference in New York City on Tuesday, November 3, 2009 at 3:20 p.m. EST.

BioScrip, Inc. (Nasdaq:BIOS) announced third quarter net income of $5.7 million, or $0.14 per diluted share, on revenues of $333.5 million. These results compare to net income of $1.4 million, or $0.04 per share, on revenues of $359.4 million for the third quarter of 2008.

Celgene Corporation (NASDAQ:CELG) announced its presentation at the Oppenheimer & Co. Inc. 20th Annual Healthcare Conference on Wednesday, November 4, 2009 at 10:15 a.m. ET will be webcast live and will be available in the investor relations section of the company’s Web site at www.celgene.com. Celgene management will provide an overview of the company.

ARYx Therapeutics, Inc. (NASDAQ:ARYX) announced it will present at the Oppenheimer 20th Annual Healthcare Conference in New York on November 4, 2009 at 10:15 am Eastern.

Javelin Pharmaceuticals, Inc. (NYSE:JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, received commitments from a single institutional investor, to purchase up to 3,186,700 shares of its common stock for estimated gross proceeds of approximately $3.9 million.

China-Biotics, Inc. (Nasdaq:CHBT), a leading Chinese firm specializing in the manufacture, research, development, marketing and distribution of probiotics products, announced the appointment of Dr. Tom Gu as Vice President, effective November 2.

BMP Sunstone Corporation (Nasdaq:BJGP), announced it will participate in the following conferences: -- Oppenheimer 20th Annual Healthcare Conference, to be held November 3-4, 2009 at the Waldorf=Astoria hotel in New York.

Warner Chilcott plc (Nasdaq:WCRX) announced it has completed the acquisition of The Procter & Gamble Company's global branded prescription pharmaceutical business.

NeoStem, Inc. (NYSE:NBS), announced the Company has completed theacquisition of China Biopharmaceuticals Holdings, Inc. (OTC Bulletin Board: CHBP), a leading Chinese pharmaceutical company.

Javelin Pharmaceuticals, Inc. (NYSE:JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, received commitments from a single institutional investor, to purchase up to 3,186,700 shares of its common stock for estimated gross proceeds of approximately $3.9 million.

BSD Medical Corporation (NASDAQ:BSDM) announced published study results demonstrated improvement in overall survival, tumor response rates, and local tumor control from the addition of hyperthermia therapy, delivered using the BSD-2000 Hyperthermia System, to the standard treatment regimen for 45 patients with high-risk bladder cancer.

Safeguard Scientifics, Inc. (NYSE:SFE), a holding company builds value in growth-stage life sciences and technology companies, announced it will release its financial results for the third quarter ended September 30, 2009 prior to market open on Wednesday, November 4, 2009.

Emergent Health Corp. (OTC:EMGE) Emergent (the “Company”) is pleased to announce a forward stock split of 11 shares for each 10 shares owned.

NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced it will hold a conference call on Friday, November 6, 2009 at 9:00 a.m. ET (6:00 a.m. PT) to report results for its third quarter 2009.

Rosetta Genomics (NASDAQ:ROSG) announced Ayelet Chajut, its Executive Vice President, R&D, Head of Molecular Biology will speak at the 6th International Conference on Circulating Nucleic Acids in Plasma and Serum (CNAPS-VI).

Shire plc (NASDAQ:SHPGY) the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

Valeant Pharmaceuticals International (NYSE:VRX) announced it has agreed to acquire the rights to several prescription and cosmetic dermatology products from a privately-held, Polish specialty pharmaceutical company.

Impax Laboratories, Inc. (NASDAQ:IPXL) confirms it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICO® (fenofibrate) tablets, 48 mg and 145 mg.

PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced Michael J. Culota, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the Oppenheimer 20th Annual Healthcare Conference in New York City on Tuesday, November 3, 2009, at 10:50 a.m. Eastern Time.

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced it will report financial results for the third quarter ending September 30, 2009 on Wednesday, November 4, 2009, after the U.S. financial markets close.

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK) announced it is scheduled to make an investor presentation at the 20th Annual Oppenheimer Healthcare Conference. David Seltzer, President and Chief Executive Officer, will deliver the Company's presentation on Tuesday, November 3, 2009, at 3:55 p.m. Eastern Time.

GTx, Inc. (NASDAQ:GTXI) announced it will host a conference call and webcast on Monday, November 2, 2009 to provide an update regarding the New Drug Application for toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy.

Talecris Biotherapeutics Holdings Corp. (Nasdaq:TLCR) will release its third quarter 2009 financial results on November 9, 2009, after the stock market closes, and will host a conference call at 8:30 AM Eastern Time on November 10, 2009.

Covidien (NYSE:COV), a leading global provider of healthcare products, announced its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, announced it will report financial results for the third quarter ending September 30, 2009 on Wednesday, November 4, 2009, after the U.S. financial markets close.

Novavax, Inc. (Nasdaq:NVAX) announced it will report its 2009 third quarter financial results in a press release to be issued after 8:00 am local time on Friday, November 6, 2009.

Geron Corporation (Nasdaq:GERN) announced the company’s plan to advance clinical development of its human embryonic stem cell (hESC)-based produc , GRNOPC1, for the treatment of spinal cord injury.

On 7/15/09, Cadence Pharma (NASDAQ: CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency. The Company's 505(b)(2) NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever. <o:p> </o:p>

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The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside of the U.S. <o:p> </o:p>

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On 8/4/09, Nuvo Research (TSX: NRI.TO) (OTC: NRIFF.PK) announced that the FDA issued a new PDUFA action date for Pennsaid (diclofenac sodium) topical solution 1.5% of 11/4/09. During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application (NDA). As a result, the FDA has extended its action date by three months to provide time for a full review of the submission. <o:p> </o:p>

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On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) which granted exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10M and is also eligible to receive a US$15M milestone payment on Pennsaid's approval by the FDA, which will increase to US$20M if certain labeling criteria are agreed to by the FDA. <o:p> </o:p>

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In addition, Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid Plus and is also eligible to receive additional escalating sales milestone payments for the products totaling up to US$100M. COV assumes responsibility for all future development activities and expenses for Pennsaid Plus, including two Phase 3 clinical trials that are expected to begin in 2010. <o:p> </o:p>

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On 10/20/09, Human Genome Sciences (NASDAQ: HGSI) and GlaxoSmithKline (NYSE: GSK) announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The data demonstrate that, in BLISS-52, belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. <o:p> </o:p>

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Study results also show that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. HGSI stated that these data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points and included a greater percentage of patients receiving BENLYSTA that were able to reduce their use of steroids. Belimumab is an experimental drug and the first in a new class of drugs called BLyS-specific inhibitors being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006. <o:p> </o:p>

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Results from BLISS-76, the second Phase 3 trial of belimumab, will be announced on 11/2/09. Assuming the results from BLISS-76 are positive, HGS and GSK plan to submit marketing applications in the United States, Europe and other regions during 1H10. <o:p> </o:p>

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On 8/5/09, NeurogesX (NASDAQ: NGSX) announced that the FDA extended the PDUFA action date by three months to 11/16/09 for the Company’s pending new drug application (NDA) for Qutenza which is seeking approval to manage pain associated with post-herpetic neuralgia (PHN). The extension resulted from the Company's recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline. <o:p> </o:p>

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The information submitted in July includes a report from the Company’s recently completed C123 Study, which was performed at the request of the FDA. On 7/24/09, NGSX announced preliminary results of Study C123, which evaluated Qutenza in patients with PHN following pre-treatment with an FDA approved topical anesthetic. Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes, and no patients removed the Qutenza patch prematurely. <o:p> </o:p>

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NGSX received approval on 5/21/09 to market Qutenza in the EU. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain. <o:p> </o:p>

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On 9/29/09, Cerus Corp. (NASDAQ:CERS) announced that it will present the proposed design for a U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets at the upcoming November meeting of the FDA's Blood Products Advisory Committee (BPAC). The Committee meeting is open to the public and discussion of the INTERCEPT trial is scheduled to occur the afternoon of November 16. <o:p> </o:p>

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"The proposed Phase III clinical trial design that we'll discuss with the Advisory Committee was created through close collaboration between Cerus and the FDA Office of Blood Review," said Carol Moore, Cerus' vice president of regulatory affairs, quality and clinical affairs. "We look forward to presenting the result of this joint effort to BPAC, and hearing their views on this significant step forward toward defining a US approval pathway for INTERCEPT pathogen inactivated platelets." <o:p> </o:p>

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Cerus has previously announced that an additional Phase III platelet trial was anticipated to be necessary for US approval. The INTERCEPT platelet system was granted CE mark registration in 2002, and subsequently received additional European regulatory approvals in France (Afssaps), Switzerland (Swissmedic), Germany (Paul Ehrlich Institute marketing authorization for the German Red Cross). <o:p> </o:p>

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XenoPort (NASDAQ: XNPT) has a pending NDA for Solzira (gabapentin enacarbil) Extended Release Tablets seeking approval for the treatment of moderate to severe restless leg syndrome, which was accepted for review by the FDA on 3/16/09 and includes collaboration agreements with Glaxo and Astellas Pharma with an expected FDA decision on 11/9/09. Solzira is a new chemical entity that was developed by XNPT to improve upon the absorption characteristics of gabapentin (in a once-daily formulation) through specific transport mechanisms in the GI tract. <o:p> </o:p>

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On 10/19/09, BioElectronics (OTC: BIEL.PK) announced the initial results from the pilot section of its ongoing acetaminophen comparison study. The study, which is expected to be complete during early November, compares the effects of ActiPatch Therapy to acetaminophen in the form of Extra Strength Tylenon for the treatment of delayed onset muscle soreness (DOMS)."Thus far, results from the pilot section of this study seem to be highly statistically significant with the ActiPatch group scoring its average level of muscle soreness and discomfort at much lower levels compared to either the control group or the acetaminophen treatment group," commented principal investigator Sheena Kong, M.D. <o:p> </o:p>

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The study, which is Institutional Review Board (IRB) supervised, is currently ongoing with full study results expected during early November 2009. On 8/24/09, BioElectronics announced it would sponsor a clinical study comparing the effects of its ActiPatch Therapy to Tylenol for the treatment of muscle pain and soreness. The study is conducted in two locations utilizing three groups of subjects, including: 1) a control group, 2) a group that will utilize ActiPatch Therapy, and 3) a group that will be given acetaminophen in the form of Tylenol. <o:p> </o:p>

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Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. PRX302 is a genetically engineered version of a protein (proaerolysin) that is secreted by a specific type of bacteria (Aeromonas hydrophilia). <o:p> </o:p>

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PRX302 is the Company's lead PORxin drug, which are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 is activated by prostate-specific antigen (PSA), an enzyme that is over-produced in patients suffering from BPH and prostate cancer. PRX302 represents a potentially new treatment option for BPH and other prostate conditions with blockbuster potential based on $3 billion in annual sales for BPH drugs (e.g. Flomax, Avodart, Proscar) and the 575,000 surgical procedures that are performed each year in the top seven markets worldwide. <o:p> </o:p>

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This approach avoids side effects and other negative factors of drug therapy for BPH, including (1) the need for lifetime therapy on a daily basis; (2) the potential for sexual dysfunction; (3) fatigue / dizziness / low blood pressure; (4) the potential for drug interactions. In contrast to drug therapy and surgical procedures, PRX302 is minimally invasive and administered as a single treatment that involves a 10-minute procedure that can be conducted in a doctor's office with no catheterization required. Advantages for physicians include no capital investment, ultrasound-guided delivery, and a short procedure time. <o:p> </o:p>

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On 9/10/09, Protox announced positive 12-month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment. The International Prostate Symptom Score (IPSS) is a validated accepted clinical end-point used to assess the treatment benefit in BPH clinical studies. This index is measured on a 0-35 scale with 0 defined as having no problems and 35 defined as the high end of severe symptoms. <o:p> </o:p>

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In this Phase 2 open-label volume optimization study, 13 of the 18 patients received the optimum PRX302 dosing of (greater than)-1mL per deposit. A total of 11 of the 13 patients were evaluable at 12-months and continued to show a statistically significant and sustained improvement in IPSS of 12.1 points (which is in a similar range to surgical procedures and much better than drug therapy, which results in an improvement of about 4-7 points) representing a 55% improvement when compared to screening. <o:p> </o:p>

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No safety issues were identified in this study, as increasing volumes of PRX302 were seen to be well tolerated. No PRX302 related serious adverse events or Grade 3 or greater adverse events have been reported to date. The PRX302 related adverse events were mild to moderate, transient in nature (resolved within days) and localized to the urinary tract. In addition, no sexual dysfunction has been reported in any of the subjects dosed to date. Detailed 12-month results from this Phase 2 open-label clinical trial will be presented at the 30th World Congress of the Societe Internationale d'Urologie from November 1-5, 2009. <o:p> </o:p>

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On 9/8/09, Protox announced that it has completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. The Company recently provided guidance for reporting top-line results from the TRIUMPH study during 4Q09. <o:p> </o:p>

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Access Pharma (OTC: ACCP.OB) provided an update in mid-October on the clinical and commercial status of MuGard, which has already been launched by its partner, SpePharm, in five European countries for the prevention and treatment of oral mucositis. SpePharm is currently collecting information from approximately 1,500-2,000 patients as part of a comprehensive set of post-marketing / seeding studies being conducted in the UK, Germany, and Italy. <o:p> </o:p>

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SpePharm anticipates that data from these studies will be made on a rolling basis throughout 4Q09-1Q10 while the commercial launch of MuGard in France and other European countries will continue over the next 12-18 months. Initial patient and clinician feedback has been very positive, according to SpePharm's President / CEO, Jean-Francois Labbe, which validates interim data released from the UK study that demonstrated no cases of oral mucositis in 140 patients who received MuGard while undergoing treatment for head and neck cancer. <o:p> </o:p>

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The number of patients being evaluated in the European post-marketing studies is more than originally anticipated and Access will be able to utilize the data in North America for both marketing and licensing negotiations. A steady stream of data is expected to occur over the next 3-6 months now given the larger patient population being analyzed and compiled by SpePharm. I have confirmed with Access President / CEO, Jeffrey Davis, that data is expected in a matter of weeks with the final UK results expected first, followed by data from Germany. <o:p> </o:p>

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On 10/7/09, NeoStem (AMEX: NBS) announced that the SEC declared effective its Registration Statement on Form S-4 filed with the Commission, which is being used in connection with the proposed acquisition of China Biopharma (which owns a 51% controlling interest in Suzhou Erye). The acquisition is subject to customary closing conditions - including approval by the shareholders of each company at upcoming meetings scheduled on 10/29/09. NeoStem is an innovator and leader in the pre-disease collection, processing and long-term storage of adult stem cells for the general population to use in future medical applications that is expanding into research, medical tourism, and China for the commercialization of anti-aging / cosmetic medicine and other stem cell technologies. <o:p> </o:p>

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1.) NeoStem (U.S.) includes an exclusive worldwide license to VSELs, a strong IP sourcing network for innovative stem cell / pharmaceutical products and AMEX listing for the stock in addition to its position in the domestic market as a leading adult stem cell banking network. <o:p> </o:p>

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2.) Suzhou Erye is a high-growth generic pharmaceutical manufacturer in China with a strong core business / profitable revenue base amidst booming demand and growth in the Chinese market. <o:p> </o:p>

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3.) NeoStem (China) has strong support from the Chinese government for commercialization of cosmetic / regenerative medicine applications which will also expedite the process of U.S. development as the Company becomes a vertically integrated stem cell operation in a permissive regulatory environment that incldues strong government support. <o:p> </o:p>

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Check out NeoStem's News Room Page for a compilation of links, videos, articles, news feeds, and more for the Company and click here for my overview article outlining the three-part post-merger strategy . Other companies in my stock coverage universe with news room landing pages include Access Pharma and Protox Therapeutics . <o:p> </o:p>

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MikeHavRx.com has relocated / forwarded to my new home at http://www.proactivenewsroom.com/ with 20 stock indexes, stock research landing pages, and more. . .Subscribe by email or feed reader at the Feedburner site for my ProActive News Room blog at http://feeds.feedburner.com/ProActiveNR . Also, I will continue to manage the FDA Calendar service at BioMedReports.com and contribute articles, reports, etc. as previously. <o:p> </o:p>

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Disclosure: Long ACCP.OB, PTXRF.PK <o:p> </o:p>

NeoStem (AMEX: NBS) is an innovator and leader in the pre-disease collection, processing and long-term storage of adult stem cells for the general population to use in future medical applications that is expanding into research, medical tourism, and China for the commercialization of anti-aging / cosmetic medicine and other stem cell technologies.[More...]

NeoStem (AMEX: NBS) is an innovator and leader in the pre-disease collection, processing and long-term storage of adult stem cells for the general population to use in future medical applications that is expanding into research, medical tourism, and China for the commercialization of anti-aging / cosmetic medicine and other stem cell technologies. Click here for my mid-September article , which provides an overview and details on the pending China expansion plans as part of a merger that is expected to close by the end of October. <o:p> </o:p>

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http://www.mikehavrx.com/2009/10/three-part-china-merger-stra... <o:p> </o:p>

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NeoStem has also expanded into stem cell research as part of an exclusive licensing agreement with the University of Louisville for the identification and isolation of rare stem cells found in adult bone marrow called VSEL for short (very small embryonic-like). As the name suggests, VSELs share traits with embryonic stem cells (ESCs), including the ability to differentiate into a wide variety of cells (pluripotency) found throughout the body for many potential medical applications. <o:p> </o:p>

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1.) NeoStem (U.S.) includes an exclusive worldwide license to VSELs, a strong IP sourcing network for innovative stem cell / pharmaceutical products and AMEX listing for the stock in addition to its position in the domestic market as a leading adult stem cell banking network. <o:p> </o:p>

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2.) Suzhou Erye is a high-growth generic pharmaceutical manufacturer in China with a strong core business / profitable revenue base amidst booming demand and growth in the Chinese market. <o:p> </o:p>

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3.) NeoStem (China) has strong support from the Chinese government for commercialization of cosmetic / regenerative medicine applications which will also expedite the process of U.S. development as the Company becomes a vertically integrated stem cell operation in a permissive regulatory environment that incldues strong government support. NeoStem plans to leverage the R&D conducted in China to fast-track the U.S. FDA approval process. In addition significant funding opportunities exist in China for government supported stem cell research, including the National High Tech R&D Program (aka 863 Program) and the National Basic Research Program (aka 973 Program). <o:p> </o:p>

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NBS China plans to maximize its pre-therapeutic / R&D revenue by the supply of VSELs for clinical trials in China which will be provided exclusively through its subsidiary, Beijing RuiJieAo. NeoStem will also exploit the easier regulatory path to commercialization in China for near-term revenue potential while leveraging mature therapies / technology from NeoStem’s extensive U.S. network and collaboration agreements. <o:p> </o:p>

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NeoStem is targeting the introduction of highly mature U.S.-based therapies that lack FDA approval which is necessary for widespread use in the domestic market. NBS China intends to commercialize its first stem cell therapy for orthopedic indications in 2009 while developing a pipeline of additional therapies for CNS (central nervous system) disease, wound healing, and heart disease. The initial orthopedic market will target 80-100 million arthritis sufferers in China, while future applications will be aimed at over 25 million individuals with long-term CNS conditions and heart disease (the third largest killer in China with 1.5 million deaths per year). <o:p> </o:p>

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NeoStem will also offer medical tourism service centers to serve patients from affluent countries that have more restrictive regulatory processes such as U.S. and Europe. The Company’s medical tourism initiatives in China will offer world class SOPs (standard operating procedures), standards of care, and facilities. An estimated 7,000 patients have been treated in China’s medical tourism industry since 2001, but current offerings lack the rigorous SOPs / facilities and do not include the world class standard of care that NeoStem can offer. <o:p> </o:p>

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NBS China will coordinate the launch of anti-aging / cosmetic medicine applications with its major principal in China while simultaneously launching its legacy adult stem cell banking business. A strong pipeline of innovative stem cell based therapies has been sourced from the Company’s network of partners in the U.S. The major principal in China will focus on five provinces, Shanghai, and Taiwan on a revenue-sharing basis with no cap-ex outlay required by NeoStem. The Company’s major principal in China has successfully operated a chain of high-end clinics in eastern China for years with extensive experience serving an affluent clientele. <o:p> </o:p>

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Suzhou Erye provides a strong balance sheet, profitable operations, and a traditional pharmaceutical / vertically integrated platform that offers manufacturing, distribution, and research as part of a fully-funded business plan for the combined entity. China also offers a lower cost operating environment and a substantial domestic market opportunity for stem cell / regenerative medicine applications in a more flexible operating environment compared to the U.S. market and FDA regulations. <o:p> </o:p>

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Suzhou Erye is a vertically integrated bio-pharmaceutical company in China focused on intermediate API / antibiotics which also includes a R&D team focused on drug discovery, improving existing drugs, and traditional Chinese medicine products plus a strong distribution network covering 30 provinces in China. The Company currently has 7 SFDA approved / certified production lines that are compliant with China GMP standards and is also in the process of a three-year expansion / relocation program that is expected to be completed by 2011. <o:p> </o:p>

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NeoStem enjoys a strong IP sourcing and collaboration network that includes best in class technology in the areas outlined below. <o:p> </o:p>

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1.) Wound Care: Vincent Falanga – Composition and Methods Using Stem Cells in Cutaneous Wound Healing <o:p> </o:p>

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2.) Skin Rejuvenation: Vincent Giampapa – Method and Composition for Restoration of Age-Related Tissue Loss in the Face or Selected Areas of the Body <o:p> </o:p>

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3.) Musculoskeletal (Regenexx): Christopher Centeno – Multiple patents related to orthopedic methods / compositions <o:p> </o:p>

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4.) Cell Processing: Progenitor Cell Therapies – Collaboration to ensure cell processing meets the highest standard of cGMP requirements. <o:p> </o:p>

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5.) Very Small Embryonic-Like Stem Cells (VSELs): University of Louisville – Exclusively licensed in November 2007 for identification, isolation, and use of population of stem cells isolated from bone marrow, umbilical cord blood, and / or other sources referred to as VSELs. Also includes therapeutic applications of VSELs, including myocardial infarction (MI / heart attack), stroke, etc. <o:p> </o:p>

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Significant U.S. government funding for NeoStem includes Department of Defense grants of $800,000 for 2009 with 2010 applications underway. On 10/6/09, the Company was awarded a grant of $108,746 for the repair of bone defects by human stem cells under the American Recovery and Reinvestment Act (RRA) of 2009 from the National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS) of the National Institutes of Health (NIH). <o:p> </o:p>

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NeoStem’s strategy to greatly expand its presence and operations in China pursuant to the merger agreement will allow the Company to expedite its R&D and commercialization objectives for stem cell and regenerative medicine therapies in an environment that is more conducive to such treatments. The Company has assembled an experienced team of executives and scientific / medical advisors to implement its strategy in China to best capitalize on the opportunity, which includes both a rapidly growing middle class in China with increased spending power and a medical tourism business for those located outside of China. <o:p> </o:p>

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Upon successful closing of the China Biopharma (OTC: CHBP.OB) merger; NeoStem will emerge as a vertically integrated platform company by partnering the stem cell leadership of NeoStem with existing operations, delivery platform, and government support for R&D activities in China. Post-merger, NeoStem will offer a diversified offering of stem cell applications, including the treatment, storage, cosmetic / anti-aging, and research that will focus on VSELs along with a rapid scale-up of commercial activities in China. <o:p> </o:p>

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On 10/7/09, NeoStem announced that the SEC declared effective its Registration Statement on Form S-4 filed with the Commission, which is being used in connection with the proposed acquisition of China Biopharma (which owns a 51% controlling interest in Suzhou Erye). The acquisition is subject to customary closing conditions – including approval by the shareholders of each company at upcoming meetings scheduled on 10/29/09. Check out NeoStem’s ProActive News Room Page for a compilation of links, videos, articles, news feeds, and more for the Company. <o:p> </o:p>

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Disclosure: No positions. <o:p> </o:p>

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See my full disclaimer at MikeHavRx.com (bottom of any page). <o:p> </o:p>

NeoStem (AMEX: NBS) is an innovator and leader in the pre-disease collection, processing and long-term storage of adult stem cells for the general population to use in future medical applications. The Company's business model includes generating revenue through ongoing fees associated with a minimally invasive, proprietary stem cell collection process, in addition to fees charged to the centers for marketing and long-term storage. NeoStem targets its marketing efforts toward health conscious consumers to encourage them to donate and store their stem cells as a form of bio-insurance for possible use in later years or to address an emerging medical need. <o:p> </o:p>

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http://www.mikehavrx.com/2009/09/neostem-amex-nbs-pending-mer... <o:p> </o:p>

<o:p>   </o:p> Click here to join NeoStem on Facebook and the following are links to eight YouTube videos related to NeoStem and promising medical applications of adult stem cells, including (1) an interview with NeoStem's CEO, Robin Smith (conducted in May 2009); (2) peripheral vascular disease ; (3) multiple sclerosis (MS) ; (4) orthopedic surgery ; (5) diabetes ; (6) heart attack ; (7) heart valve development ; and (8) lupus . In addition, NeoStem also has a page at its website with more recent videos . <o:p> </o:p>

NeoStem's initial collection center network includes single physician practices in California, Pennsylvania, and Nevada. The revenues generated by these early efforts have not been significant and the Company does not expect this core business to become significant on an income statement basis. However, the importance of developing the stem cell collection centers is twofold, including (1) the ability to leverage the collection network for research (VSELs), anti-aging, cosmetic, and regenerative medicine applications and (2) potential to grow the network through multi-physician practices that target major metro areas. <o:p> </o:p>

NeoStem has also expanded into stem cell research as part of an exclusive licensing agreement with the University of Louisville for the identification and isolation of rare stem cells found in adult bone marrow called VSEL for short (very small embryonic-like). As the name suggests, VSELs share traits with embryonic stem cells (ESCs), including the ability to differentiate into a wide variety of cells found throughout the body for many potential medical applications. <o:p> </o:p>

The Company is working on a method to expand VSELs collected from individual patients while preserving their ability to differentiate in an embryonic-like manner for a wide variety of regenerative medicine applications. The use of VSELs would avoid the ethical controversies associated with ESCs, in addition to eliminating the risk of immune system reactions since VSELs originate from the patient (autologous) and would not be rejected as foreign by the body. <o:p> </o:p>

In mid-April, NeoStem announced an $11 million private placement (led by RimAsia Capital Partners and Enhance Biomedical at $5M each) aimed at expanding its operations in China. In late 2008, NeoStem signed a definitive agreement to acquire control of a China regenerative medical therapy company (Shandong New Medicine Research Institute of Integrated Traditional and Western Medicine LLC) as part of the Company's efforts to expand its medical tourism business. Through this deal, NeoStem can offer regenerative medicine therapies to people in the U.S., Europe, and other developed countries which do not currently offer such alternatives. <o:p> </o:p>

In early May, the Company filed a patent application which covers cosmetic stem cell face lift technology while simultaneously announcing an expansion to its stem cell collection network, which is located at the Giampapa Institute for Anti-Aging Medical Therapy in Montclair, NJ. NeoStem also signed a deal for the exclusive worldwide rights to an innovative technology and pending patents that involve using a patient's own stem cells derived from their bone marrow to promote healing of chronic wounds. <o:p> </o:p>

Other developments for NeoStem earlier this year include licensing the worldwide rights to Primcel, which is a stem cell product derived from a patient's own bone marrow that has demonstrated promising early-stage results for speeding up the healing of chronic wounds. The CEO of NeoStem, Dr. Robin Smith, announced in a statement that the U.S. Department of Defense appropriated $800,000 last year for NeoStem to evaluate the use of adult stem cells to treat wounds. The net amount of the grant must be distributed to the Company by October 2010 and will be $681,000. <o:p> </o:p>

NeoStem also signed an exclusive licensing agreement for Asia with Regenerative Sciences, LLC for a medical procedure known as Regenexx. This process involves extracting stem cells from a patient's own bone marrow, isolating the mesenchymal stem cells (which can develop into bone, tendon, ligament, cartilage, and muscle), culturing the cells in a proprietary solution with elements from the patient's blood, and generating millions of stem cells over a period of 2-3 weeks. The cells are re-injected into the patient's affected joints or bones to promote tissue healing and bone/cartilage restoration as an alternative to surgery. <o:p> </o:p>

In mid-May, NeoStem announced an agreement with Ceres Living to promote the sale of an innovative liquid nutritional supplement called AIO Premium Cellular Health that blends a variety of fruit extracts in an all-natural puree (including acai, pomegranate, blueberry, acerola, amla, camu camu, mango and dark cherry with 13,830 mg of whole fruit per one ounce in addition to resveratrol, green tea, and plenty of other vitamins and minerals). NeoStem and the Stem for Life Foundation will receive a portion of the proceeds from each sale in exchange for the Company providing Ceres Living with certain scientific literature and access to its scientific personnel. <o:p> </o:p>

In mid-June, the Company announced an exclusive 10-year agreement with Enhance BioMedical Holdings Limited, a Shanghai corporation, to develop a Stem Cell Collection and Treatment Network using NeoStem's proprietary adult stem cell technologies in Shanghai, Taiwan, and several Chinese provinces. Enhance BioMedical Holdings is a subsidiary of Enhance Holding Corporation, a multinational conglomerate whose CEO, Jackson Ling, invested $5M as part of the previously announced $11M private placement funding in mid-April. <o:p> </o:p>

Enhance BioMedical has healthcare provider relationships with numerous hospitals and doctors in Taiwan and Shanghai, as well as in the five provinces in China to which the Network Agreement relates. Enhance BioMedical operates the Anti-Aging and Prevention Medical Center in Taipei, Taiwan, with facilities focused on stem cell research and development and anti-aging therapies. It expects to open an additional healthcare center in Shanghai during spring 2010, which will target high net worth individuals. <o:p> </o:p>

On 7/1/09, NeoStem announced that it raised additional gross funds exceeding $4 million (M) from both institutional and private investors, adding to the previously announced capital raise in mid-April ($11M) for total proceeds of over $15M. In addition, affiliates of Suzhou Erye Pharmaceuticals Company, Ltd. increased their overall investment in NeoStem at the time to over $1M. Pending shareholder approval, NeoStem expects to close its acquisition of a 51% interest in Suzhou Erye through a merger with its current 51% owner, China Biopharma (OTC: CHBP.OB), as part of the Company’s expansion activities (e.g. medical tourism) in that country. <o:p> </o:p>

The proceeds will also be used to fund NeoStem's R&D initiatives in VSEL, expanding the Company’s U.S.-based operations, and adding seasoned individuals to the NeoStem management team who have experience in clinical drug development from the pharmaceutical and biotechnology industry, in addition to the administration of clinical trials conducted outside of the U.S. As evidence of the quality and experience of the NeoStem’s management team, below are two upcoming industry-related conferences in which the Company will participate. <o:p> </o:p>

The CEO of NeoStem, Robin Smith, M.D. MBA, has been invited to participate in the 2009 World Stem Cell Summit in Baltimore, Maryland, and will participate on the panel, "Cord Blood and Cell Banking: Answers for Patients, Researchers and Industry," which is scheduled for 9/23/09 from 4-5:15 pm (ET). In addition, the Company's Vice President of Drug Development and Regulatory Affairs, Alan Harris, M.D., Ph.D., is scheduled to speak at a conference on Clinical Applications for Age Management Medicine in Las Vegas and will present on 11/5/09 about "The Apheresis Product: A Rich Source of Pluripotent VSELs, Stem Cells and Progenitor Cells for Autologous Banking and Cellular Therapies." <o:p> </o:p>

In addition to the $4M capital raise in early July, NeoStem ended 2Q09 with about $10.5M in cash/equivalents ($10M in working capital), negligible debt, 8.5M shares of common stock outstanding, and a market cap of approximately $16M based on a closing price of $1.85/share on 15-September within a 52-week range of $0.41 – $2.72. The three-month average daily trading volume is approximately 36,000 shares with a slightly higher average 10-day average daily trading volume of 38,000 shares. <o:p> </o:p>

NeoStem posted a net loss of approximately $6.8M for the first six months of 2009 and cash used to fund operations during 1H09 was $5.2M. As of mid-2009, NeoStem has approximately 18.3M warrants outstanding (5.2M exercisable) with the majority occurring at an exercise price range of $0.50 – $3.02 per share. In addition, the Company has 2.6M options outstanding (2.1M exercisable) with the majority occurring at an exercise price range of $0.71 – $4.17 per share. <o:p> </o:p>

During 2008, NeoStem’s potential merger partner, China Biopharma, generated approximately $50M in revenue, $2.8M in net income, $41.8M in operating expenses, and posted a diluted EPS of $0.05/share. At the end of 2Q09, CHBP.OB had $2.5M in cash/equivalents, $2.4M accounts receivable, zero long-term debt, total assets of $48.8M (including $7.5M classified as intangible assets), current liabilities of $21.8M (including notes payable/short-term debt of $9.7M), and 37.1M shares of common stock outstanding. During 1H09, China Biopharma generated $9.2M in cash from operations. <o:p> </o:p>

More recently, China Biopharma has experienced positive growth trends, including revenue of $15.3M for 2Q09, representing an increase of 15% from the year-ago period. The Company attributed the growth to an increase in the production and sales of prescription drugs, which grew by about 25% from the year-ago period. China Biopharma improved its sales mix to include higher margin products in addition to an increase in volume to achieve this growth, which resulted in net income during 2Q09 of $3.9M that increased by 45% from the year-ago period. <o:p> </o:p>

NeoStem’s strategy to greatly expand its presence and operations in China pursuant to the merger agreement will allow the Company to expedite its R&D and commercialization objectives for stem cell and regenerative medicine therapies in an environment that is more conducive to such treatments. However, NeoStem has assembled an experienced team of executives and scientific/medical advisors to implement its strategy in China to best capitalize on the opportunity, which includes both a rapidly growing middle class in China with increased spending power and a medical tourism business for those located outside of China. <o:p> </o:p>

As of 7/1/09, NeoStem entered into an Amendment No. 1 to the Agreement and Plan of Merger with China Biopharmaceuticals Holdings, Inc. (“CBH”), China Biopharmaceuticals Corp., CBH’s wholly-owned subsidiary (“CBC”) and CBH Acquisition LLC, NeoStem’s wholly-owned subsidiary. Some highlights of the amended terms of the merger agreement outlined in NeoStem’s most recent SEC 10Q filing are outlined below. <o:p> </o:p>

1.) The number of shares of NeoStem common stock to be issued to the CBH Common Stockholders was reduced to an aggregate of 7.15 million shares for an exchange ratio of 0.19255 with no additional shares being escrowed – equal to approximately $0.36/share for CHBP.OB (which last traded at $0.21/share) based on NeoStem’s current price of $1.85/share as of mid-September

2.) The number of common stock shares to be issued to RimAsia will be increased to approximately 6.5 million and 8.2 million shares of NeoStem Series C Convertible Preferred Stock, each with a liquidation preference of $1.125 and convertible to shares of NeoStem Common Stock at an initial conversion price of $0.90; <o:p> </o:p>

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3.) A total of 125,000 shares of NeoStem Common Stock will be issued to Erye Economy and Trading Co. Ltd. (“EET”) (the 49% holder of Suzhou Erye); 51% of which is owned by CBH and which 51% will be acquired by; <o:p> </o:p>

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4.) The outside date for completion of the Merger is extended to 10/31/09; <o:p> </o:p>

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5.) As part of the 7/1/09 funding agreement, RimAsia shall supply additional funding to both NeoStem and CBH in an amount up to $1.6M, which includes approximately $1M advanced at the time of the 10Q filing for 2Q09. <o:p> </o:p>

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NeoStem is rapidly expanding upon its core adult stem cell collection and banking business model into related areas such as research on VSELs along with cell-based anti-aging and regenerative medicine applications in the U.S and China. While NeoStem maintains its platform business of operating a commercial autologous adult stem cell bank network, its core platform business will be enhanced and leveraged upon as the Company expands its regenerative medicine offerings and makes these available to patients through medical tourism initiatives and the local population in China. In addition, the pending merger agreement represents a near-term catalyst with a targeted completion date by the end of October which includes the core, growing business of China Biopharma and allows NeoStem to accelerate its China expansion plans beyond cell banking to include regenerative medicine, anti-aging/cosmetic medicine, and adult stem cell therapies. <o:p> </o:p>

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Disclosure: No positions. See my full disclaimer at MikeHavRx.com at the bottom of any page. <o:p> </o:p>