Orexigen soars on license deal. Rexahn up on research article. BioDelivery reports positive FDA meeting Print E-mail
By BioMedReports.com Staff   
Thursday, 02 September 2010 17:47

Below is a list of the companies that made news in the healthcare sector on Thursday, September 02, 2010.


Orexigen® Therapeutics, Inc. (Nasdaq:OREX) and Takeda Pharmaceutical Company Limited (TSE:4502.to), today announced that they have entered into an exclusive partnership to develop and commercialize Contrave® (naltrexone SR/bupropion SR), Orexigen's investigational drug for the treatment of obesity, in the United States, Canada and Mexico.

Contrave is a combination therapy believed to address both biological and behavioral drivers of obesity. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

Under the terms of the agreement, Orexigen will receive an upfront cash payment of $50 million from Takeda, and Takeda will obtain an exclusive marketing right from Orexigen in the United States, Mexico and Canada while Orexigen retains the right to co-promote with Takeda in the United States. Orexigen will be eligible to receive payments of over $1 billion upon achieving certain regulatory and sales-based milestones. Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory.

Shares of Orexigen soared more than 18% on the news, closing Thursday trading at $5.43, up 84 cents.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of a research article in Bioorganic & Medicinal Chemistry Letters on the anti-tumor activity of RX-8243 and its analogues.

The article offers data demonstrating that RX-8243, an isoquinolineamine analogue, significantly inhibits the growth of human cancer cells, including paclitaxel (Taxol) resistant HCT-15 human colorectal cancer cells and the growth of tumor in in vivo model of nude mice injected with paclitaxel-resistant HCT-15 human colorectal cancer cells.

"We are encouraged by the results of this study of RX-8243, which shows the potent anti-tumor properties of this unique compound," said Chang Ahn, Chief Executive Officer of Rexahn. "The study clearly demonstrates that RX-8243 inhibited tumor formation in paclitaxel-resistant cancer model, suggesting that isoquinolineamine and its analogues have the potential to become a novel class of anti-tumor chemotherapeutics."

On heavy volume shares of Rexahn jumped nearly 5%.

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) today announced a positive meeting with the U.S. Food and Drug Administration, Meda and BDSI that occurred on Wednesday, July 21, 2010 to discuss significant modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program for ONSOLIS (fentanyl buccal soluble film).

At the meeting, FDA and Meda discussed REMS modifications that seek to reduce unintended barriers to prescribing and expand access to ONSOLIS for appropriate patients.

BDSI believes that the recently submitted proposed REMS modifications, which are under FDA review, should facilitate the ability of healthcare providers to prescribe ONSOLIS for appropriate patients as well as improve patient access through broadened distribution.

Shares of BioDelivery initially shot up to $2.73 on the news and finished the day at $2.45, up 12 cents or 5%.

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc. The milestone was triggered by Agensys’ initiation of a phase I trial for AGS-16M8F, an ADC for the treatment of cancer utilizing Seattle Genetics’ technology.

"This trial initiation increases the total number of ADC programs utilizing our technology currently in clinical trials to eight, further extending the investigation of our technology for the treatment of multiple types of cancer," said Eric L. Dobmeier, Chief Business Officer of Seattle Genetics. "Our ADC collaborations generate substantial financial resources for Seattle Genetics, including more than $130 million received to date. We also have the potential to receive approximately $2.7 billion in milestone payments if all collaborator ADCs are commercialized, as well as royalties on net sales of resulting ADC products."

NewCardio (OTC Bulletin Board:NWCI.ob) today announced that Vincent Renz, Jr., NewCardio's President and CEO, purchased 128,000 shares during his trading window in open market transactions in the two weeks following the Company's filing of its SEC Form 10-Q and earnings conference for the second quarter ended June 30, 2010.

"As discussed on our August 12, 2010 investor conference call, we are focused on the underlying fundamentals that will enable us to create long term value for our employees, customers and shareholders," commented Mr. Renz. "We continue to make steady progress with the commercialization of QTinno as our efforts to enhance market awareness and adoption through our interactions with clinical trial service providers, sponsors and regulatory authorities are starting to translate into increasing sales opportunities which we believe will drive revenue growth and expansion. In addition, we are working to identify opportunities, either through strategic partnerships or other relationships, to source additional capital that will enable us to accelerate the development and commercialization of our proven 3-D platform technology in delivering additional solutions which will advance the ECG as a diagnostic tool."

Mr. Renz continued, "Specifically, the additional capital will be focused on the commercialization of our second and third products, CardioBip™ and Cardio3KG. Based on the progress we have made in the development and validation efforts to date, as well as the size of the potential markets that these solutions will address, I do not believe the market has appropriately valued NewCardio, for either our achievements to date or the potential of our underlying 3-D technology platform. My recent purchases demonstrate my confidence in our ability to create long term value and reinforce my long-term commitment to helping the Company maximize its chances for success."

Celsion Corporation (Nasdaq:CLSN), a biotechnology drug development company, announced today that it has been awarded a competitive Phase I Small Business Innovation and Research (SBIR) grant from the National Institutes of Health (NIH), to support the proposal, "New Thermal Sensitive Carboplatin Liposomes for Cancer". This funding will support the Company's efforts to develop its proprietary heat-activated liposomal technology in combination with carboplatin, an approved and frequently used oncology drug for treatment of a wide range of cancers. The grant is valued at approximately $200,000 and will support formulation development and preclinical efficacy studies in collaboration with Duke University.

Health Discovery Corporation (OTCBB: HDVY) is pleased to announce that Herbert A. Fritsche, Ph.D., recently retired Professor of Laboratory Medicine and Chief of the Clinical Chemistry Section at The University of Texas, M.D. Anderson Cancer Center in Houston, Texas, has joined Health Discovery Corporation as Senior Vice President and Chief Science Officer, effective September 1, 2010.

Also Thursday:

AdCare Health Systems, Inc. (NYSE Amex:ADK), a recognized innovator in senior living and health care facility management, has closed the lease of three nursing homes according to the previously announced agreement to lease five additional nursing homes in Georgia.

Aspen Technology, Inc. (NASDAQ: AZPN), a leading provider of software and services to the process industries, today announced financial results for its fourth quarter and fiscal year 2010, ended June 30, 2010.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that the company's management will present at several upcoming investment conferences.

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, today announced that the Company will present at the Rodman & Renshaw Annual Global Investment Conference at The Palace Hotel in New York City on Wednesday, September 15, 2010 at 11:40 am Eastern time.

Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that the U.S. National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (NCCAM) Small Business Technology Transfer Program, has approved and funded a grant to be shared by Bionovo and Dr. Dale Leitman from the University of California at Berkeley (UCB).

Cerus Corporation (NASDAQ:CERS) announced today the successful outcome of a multi-year trial of INTERCEPT-treated platelet components conducted at the Swiss Red ross Blood Center in Basel, Switzerland.

Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced that the Board of Directors has voted to declare a dividend of $0.25 per share.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces that all five products in its novel line of XTRASORB® HCS Dressings have received Healthcare Common Procedural Coding System (HCPCS) codes.

Emerging Healthcare Solutions Inc. (PinkSheets:EHSI) announced today that Stand-By Systems (SBS) delivered a virtual demonstration of its products at a Homeland Security Procurement Fair this month.

Genome Research Group (GRG) (PINKSHEETS: KKUR) recently announced its intended merger with ChromoCure, Inc. and consolidation of the operations and technologies of both groups.Genome Research Group personnel have assumed all executive and board duties and have no current or planned operations in the USA.

Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®. Diabetes patients enrolled in these cross-over design studies will receive an insulin analog alone and the Analog-PH20 treatment for 12 weeks each.

HealthMed Services Ltd. (OTCBB: HEME), an innovative software development company, is pleased to announce that it has entered final negotiations to acquire all rights, title and interest to Neural Communicator software and hardware.

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops antibody-based targeted anticancer products, today announced that Company management will present at multiple investor conferences this month.

IntelGenx Corp. (OTCBB:IGXT) today announced the completion of a pilot study that indicates that IntelGenx has successfully developed a novel oralfilm, INT007, that is bioequivalent to a leading branded tablet containing a phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of erectile dysfunction.

K-V Pharmaceutical Company (NYSE:  KVa/KVb) announced today that it has received notification from the New York Stock Exchange ("NYSE") stating that the Company has reestablished compliance with the NYSE's minimum share price requirements for continued listing on an accelerated basis.

LifeVantage Corporation (OTC Bulletin Board:LFVN), the maker of Protandim®, a clinically proven, science-based therapy for oxidative stress, announced today that a new peer-reviewed study involving Protandim® was published in the scientific journal PLoS ONE.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Tarek Sherif, chairman and chief executive officer, and Bruce Dalziel, chief financial officer, will present at the Deutsche Bank Technology Conference at 11:05 a.m. ET (8:05 a.m. PT) on September 15, 2010 in San Francisco, CA.

MedLink (OTCBB: MLKNA), a lea ing provider of Electronic Health Records and practice management solutions, today announced a partnership with Thrasys, Inc. a provider of next-generation health information technology and solutions.MedLink and Thrasys have collaborated to provide interoperability and health record management based on SyntraNet from Thrasys, a cloud based Health Information Exchange (HIE) and Collaboration Network.

Metiscan, Inc. (PINKSHEETS: MTIZ) announced today shareholder points of interest discussed during the Company's nationwide teleconference yesterday.

Omnicare, Inc. (NYSE:OCR), a leading provider of pharmaceutical care for the elderly, announced today that it will participate in the Stifel Nicolaus 2010 Healthcare Conference on September 15 at 2:05 p.m. EDT in Boston, Massachusetts.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) announced the Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN(R) in patients with persistent or recurrent, ovarian, fallopian tube or primary peritoneal cancer (GOG186H).

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced that it will report financial results for the first quarter fiscal year 2011 on September 9, 2010 after market and will host a conference call and webcast at 4:30 p.m. EDT (1:30 p.m. PDT).

PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today announced the extension of their OneSource Laboratory Services contract with Minerva Scientific, a specialist pharmaceutical testing laboratory based in Derbyshire, UK.

Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that Professor Ashley Bush, a co-founding scientist of Prana and a member of the Company's R&D Advisory Board, has in conjunction with the University of Melbourne, Australia, and Harvard Medical School, Boston, published an article that appears online today entitled: "Iron-export ferroxidase activity of beta-amyloid precursor protein is inhibited by zinc in Alzheimer's Disease" scheduled for the September 17 edition of Cell, the prestigious peer-reviewed, international biological research journal.

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) today announced that R. Don Elsey has been appointed to the Company's board of directors, effective September 1.

Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that the Compny will release financial results for the three and six months ended June 30, 2010, after the market closes on Tuesday, September 7, 2010.

Sequenom, Inc. (Nasdaq:SQNM) today announced that Ronald M. Lindsay, PhD, executive vice president of research and development, will present an overview of the company at the following conferences in September.

Stem Cell Assurance, Inc. (Pink Sheets:SCLZ), a leader in stem cell collection and storage services for personal applications ranging from breast augmentation and facial rejuvenation procedures to Stem Cellutrition (www.stemcellutrition.com) skincare products, today announced a $1M agreement with a private funding source.

Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced today the final data set from its Phase 3 study of Ketotransdel® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada.

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.
 




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