MannKind up on rumors, Apricus falls on offering. Cleveland BioLabs drug hits safety goal. After the bell: Santarus climbs on positive Phase III results Print E-mail
By Staff   
Wednesday, 29 September 2010 19:15

Below is a look at some of the headlines for companies that made news in the healthcare sector on September 29, 2010.

After the market closed Wednesday Santarus, Inc. (NASDAQ:SNTS) and Cosmo Pharmaceuticals S.p.A. (SIX:COPN) announced positive top-line results from the Phase III clinical study conducted in the U.S. and India to evaluate the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. Santarus and Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals, are collaborating on the budesonide MMX Phase III clinical program.

"These positive results are a major step toward the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for budesonide MMX 9 mg for the induction of remission of mild or moderate active ulcerative colitis," said Gerald T. Proehl, president and chief executive officer of Santarus. "Assuming positive results in the European clinical study we plan to submit the NDA in the second half of 2011 following the completion of an ongoing double-blind, placebo-controlled extended use study."

After the bell, on heavy volume, shares of Santarus rose 30 cents or 10.71% to $3.10.

MannKind Corporation (Nasdaq: MNKD) saw it shares leap 50 cents today after rumors circulated that Lilly could acquire the company for $12.50. Shares closed the day at $6.58, up 8.22% and continued to move higher in extended trading.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced top line results of the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS).

This second safety study included a total of 100 healthy subjects randomized among four dosing regimens of CBLB502, comparing a narrow range of doses applied as single or double injections (72 hours apart), with or without ibuprofen. Participants in the study were monitored for adverse side effects and blood samples were obtained to assess the effects of CBLB502 on various biomarkers and to further characterize the pharmacokinetics of CBLB502.

Top line results of the study demonstrated a difference in biomarker response proportional to the dose applied as single intramuscular injections of CBLB502. The demonstration of such a dose difference was the primary goal of the trial. This information will be used in the design of the definitive safety trial following further discussions with the U.S. Food and Drug Administration (FDA).

Administration of CBLB502 resulted in a rapid and potent cytokine response, similar to that seen in the prior clinical trial and in previously conducted non-human primate studies. Single and double doses of CBLB502 were well tolerated. The primary adverse event associated with CBLB502 administration was a transient flu-like syndrome consistent with what was observed in the previous trial and which generally resolved within 24 hours. There was no difference in the adverse event profile between the doses tested.

Subjects who carry a single mutation in the TLR5 gene, the target of CBLB502, which is found in about 5% of the general population, responded to CBLB502 in the same manner as normal subjects without the mutation.

Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, commented, "We are very pleased with the outcome of our second human safety study for CBLB502. The study met its objectives and has confirmed that the general side effect and biomarker profile for CBLB502 remains consistent with what was observed in our initial safety study. We will be conducting further analysis as we compile our final report for submission to the FDA, and once completed, we will prepare a manuscript describing the results of the study for submission to an appropriate scientific journal."

In July 2010, CBLB502 was granted fast track status from the FDA for reducing the risk of death following total body irradiation during or after radiation disaster. There is currently no FDA approved medical countermeasure to reduce the risk of death following a lethal dose of total body irradiation.

The Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services supported the entire cost (approximately $1.3 million) of this clinical Phase 1b human safety study as part of contract HHSO100200800059C.

Shares of Cleveland BioLabs climbed higher in after hours trading.

Apricus Biosciences (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT drug delivery technology and internal pipeline through out-licensing partnerships, today announced that it has entered into agreements with selected investors to sell up to 1,728,882 Units at a price per Unit of $5.40, for aggregate gross proceeds of approximately $9.3 million. Each Unit consists of three shares of common stock and one warrant, exercisable at a price of $2.27 per share.

Shares fell more 18% or 41 cents to $1.71.


Abbott (NYSE:ABT) has received U.S. Food and Drug Administration (FDA) market clearance for RevitaLens Ocutec, a unique next-generation multi-purpose disinfecting solution for silicone hydrogel and conventional soft contact lenses.  

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board:ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced today that it has made significant progress with its proprietary Cobalamin-targeted drug-delivery program for siRNA therapies.  

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced today the initiation of the long-term Phase 3 study of Zerenex (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The initiation of this study marks the commencement of the final component of the Company's Phase 3 registration program for Zerenex, which is being conducted in accordance with a Special Protocol Assessment (SPA) agreement with the FDA. Pursuant to the SPA agreement, the Zerenex Phase 3 registration program consists of a short-term efficacy study, which was initiated in May 2010 and is expected to be completed in the fourth quarter of 2010, and the 58-week long-term safety and efficacy study initiated today.

Medivation, Inc. (Nasdaq:MDVN) and Astellas Pharma Inc. today announced treatment of the first patient in a second Phase 3 clinical trial of the investigational drug MDV3100, which expands the Phase 3 development of the novel, triple-acting oral androgen receptor antagonist into an earlier-stage patient population. Known as PREVAIL, the trial will evaluate MDV3100 in men with advanced prostate cancer who have not yet received chemotherapy. Initiation of the PREVAIL trial triggers a milestone payment to Medivation under its collaboration agreement with Astellas.

Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its QuickVue® RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.

Almost all infants will suffer from an RSV infection before the age of two. According to the United States Centers for Disease Control and Prevention, RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States resulting in between 75,000 and 125,000 children hospitalized annually because of an RSV infection.

QuickVue RSV 10 detects RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients under the age of six.

Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today. The second milestone marks the completion of the transfer of the fostamatinib long-term open label extension study from Rigel to AstraZeneca.

YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), today reported that Pulmokine Inc. (Slingerlands, New York), a licensee of several small molecule compounds from YM, has been awarded two National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grants. The grants, totaling more than US$650,000, are Phase I awards to develop novel treatments for Pulmonary Arterial Hypertension (PAH). These compounds, originating from YM BioSciences' small molecule library, have defined mechanisms of action and, based on preliminary experiments, are believed to inhibit key processes in PAH disease development and progression. YM will continue to have a role in the ongoing development of the compounds.

Also Wednesday:

Advanced Cell Technology  (OTCBB: ACTC), a leader in the field of regenerative medicine, provided an update today on the status of its myoblast program.

Agilent Technologies Inc. (NYSE: A)
today introduced the SureSelect Kinome Target Enrichment Kit, enabling researchers to focus next-generation sequencing studies on expressed kinases (the kinome).

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company announced today that it has published results in the American Journal of Respitatory and Critical Care Medicine (Zamora et al., Am. J. Respir. Crit. Care Med., doi:10.1164/rccm.201003-0422OC, 2010) from its double-blind, placebo-controlled, randomized Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus (RSV).

Assured Pharmacy (Pink Sheets:APHY), a pharmacy service healthcare organization operating a chain of specialty pharmacies providing advanced prescription medication fulfillment solutions to sufferers of chronic pain, is pleased to announce that it has retained UHY, LLP ("UHY") to serve as the Company's independent auditors.

Bio-Clean, Inc. (OTCBB: BOCL)
is pleased to announce that its recently formed subsidiary, E-Clean Acquisitions Corporation, has entered into a Joint Venture Agreement with privately held Agrigenic Food Company, a biotechnology research firm and manufacturers of the renowned Biotec Foods®, Biomed Foods® and Biovet International® lines of dietary supplements.

BioMed Realty Trust, Inc. (NYSE:BMR) today announced that its underwriters have fully exercised their over-allotment option to purchase additional shares of common stock in connection with BioMed's previously announced follow-on offering that priced on September 23, 2010.

Bohai Pharmaceuticals Group, Inc. (OTCBB/OTCQB:BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine (TCM) in China, will host a conference call today, September 29, 2010, at 11:00 a.m. Eastern to discuss its fiscal year-end June 30, 2010 financial results.

BSD Medical Corporation (NASDAQ: BSDM) announced today that a patent has been issued to the Company for a new class of heat therapy applicators (antennas).

Cardium Therapeutics (NYSE Amex:CXM) announced that it has gained exclusive access to commercial development rights for certain novel supramacromolecular polymer complexes enabling regulatable and localized topical delivery of nitric oxide for prolonged periods of one to three weeks, to broaden and expand the Company's wound healing and tissue regeneration portfolio.

CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX) today announced that its Board of Directors is continuing its previously announced process to review strategic alternative to maximize shareholder value.

CVS Caremark Corporation (NYSE:CVS) will hold its annual Analyst Day in New York City on Friday, October 8, 2010, beginning at 8:00 a.m. (EDT). Senior members of the CVS Caremark leadership team will present an overview of the company's growth strategy, business outlook and capital allocation policies.

Edwards Lifesciences (NYSE: EW)  WHAT: Up to 1,000 new jobs will be created in Utah in the coming years as a result of heart-valve leader Edwards Lifesciences' expansion in Draper.

Eli Lilly and Company (NYSE:LLY) was given the President's Award by the National Hispanic Council on Aging (NHCOA) at its annual conference in Washington, D.C.

Generex Biotechnology Corporation (Nasdaq:GNBT), which is engaged in the research, development, and commercialization of drug delivery systems and technologies, today announced that its Board of Directors has appointed Mark Fletcher as Interim President and Chief Executive Officer effective immediately.

GlobalOptions Group, Inc. (NASDAQ: GLOI), a leading provider of domestic and international risk management services, today announced that Bode Technology, one of the world's largest forensic DNA analysis firms, has begun offering its new state-of-the-art Bode-RFID tracking system to law enforcement agencies and crime laboratories nationwide in an effort to streamline work flows and help control costs in the ever-growing field of evidence tracking and analysis.

Healthmed Services, Ltd. (OTCQB:HEME) (PINKSHEETS: HEME), an innovative software and application development company, is excited to announce Google has followed Bing and is helping launch and offer Heatlhmed's neural communicator.

HORIZON HEALTH INTERNATIONAL CORP. (PINK SHEETS:HZHI) is pleased to announce additionalFDA Label application of Enteric Lactoferrin.

Innovative Health Sciences, Inc. (PINKSHEETS: IHSN) announced today that it has selected a New York City-based manufacturer to produce its revolutionary new fitness product. In early November 2010, the Company plans to begin filming a national direct response infomercial starring its product spokesperson Forbes Riley.

Invicta Group Inc. (PINKSHEETS: IVIT) is pleased to announce the important update for ZarBee's Honey Naturals Children Cough Syrup.

Lannett Company, Inc. (NYSE AMEX:LCI) today said that the U.S. Food and Drug Administration (FDA) recently completed inspections of the company's manufacturing facilities in Philadelphia and Cody, Wyoming.

MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) today announced the pricing of its underwritten registered offering of 3,000,000 shares of its common stock at an offering price of $14.50 per share.  

MMRGlobal, Inc. (OTCBB: MMRF) announced today it has filed a patent application for an open integration tool by which patient data from any practice management system can be seamlessly uploaded into the Company's MMRPro system or other electronic records systems.

Novavax, Inc. (Nasdaq:NVAX) a clinical-stage biopharmaceutical company, announced today that Mr. Frederick Driscoll, Chief Financial Officer of Novavax, will be presenting at the BIO Investor Forum. The presentation will take place on Wednesday, October 6, 2010 at 1:00pm PT at the Palace Hotel, San Francisco, California.

Par Pharmaceutical Companies, Inc. (NYSE:PRX) announced today that it will host a conference call and live webcast on Wednesday, November 3, 2010 at 8:30AM EDT to review results for the third quarter 2010.  Par will release its financial results on November 3, 2010 before the market opens.

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA), along with the European Medicines Agency (EMA) of the European Union (E.U.) and Health Canada, the Canadian Regulatory Agency, have each approved single-use, pre-filled syringes of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for use in their respective territories.

Senesco Technologies, Inc. (NYSE Amex: SNT) reported financial results for the 12 months ended June 30, 2010.

Shengtai Pharmaceutical, Inc. (OTC Bulletin Board:SGTI) a manufacturer and distributor in China of glucose and starch as pharmaceutical raw materials and other starch and glucose products, today reported financial results for the twelve months ended June 30, 2010.

Solta Medical, Inc. (Nasdaq:SLTM), a global leader in the medical aesthetics market, continues to break new ground with its innovative marketing campaigns.  

Stellar Biotechnologies, Inc. (Stellar) (TSX-V: KLH) (PINKSHEETS: SBOTF) is pleased to announce that it has agreed to complete a CDN$ 1.05M private placement subject to acceptance by the TSX Venture Exchange, and, also, the cancellation of 1,661,241 shares of the Company's outstanding common stock.

Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS)
announced today that it received a letter, dated September 28, 2010, from The NASDAQ Stock Market notifying Sunesis that it has been granted an additional 180-day compliance period, or until March 28, 2011, to regain compliance with the $1.00 per share minimum bid price rule for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Listing Rule 5550(a)(2).

Theravance, Inc. (NASDAQ:THRX) announced today that Dr. Mathai Mammen, Theravance's Senior Vice President, Research and Early Clinical Development, is scheduled to participate in a panel discussion on the topic "What's in the Pipeline for GI Disorders" at Citi's 5th Annual Biotech Day on Tuesday, October 5, 2010, at 3:00 p.m. ET.

Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that Transcept management is scheduled to present a general business overview at the BIO Investor Forum in San Francisco on October 6, 2010 at 3:00 p.m. PDT.

Verenium Corporation (Nasdaq:VRNM), a pioneer in the development and commercialization of high-performance industrial enzyme solutions, today announced that it will now market and sell DELTAZYM® GA L-E5, a high performance enzyme for the saccharification of liquefied starch in the fuel ethanol production process.  

ViroPharma Incorporated (Nasdaq:VPHM) today announced that Vincent Milano, president and chief executive officer of ViroPharma, will present at the Jefferies 2010 Global Healthcare Conference at 10:30 A.M. ET on Wednesday, October 6, 2010.  

Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced that Justin Renz, Senior Vice President and CFO is scheduled to present at the Ninth Annual BIO Investor Forum at 10:30am PT on October 6, 2010, at the San Francisco Palace Hotel.

ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced positive survival data from a Phase 2a clinical trial in metastatic melanoma with recombinant Interleukin 21 (IL-21) as a single agent. Median overall survival was 12.4 months, and the percentage of patients surviving at 12 months was 53%.

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