RxNews Recap for Tuesday 01-19-10. Immunomedics (IMMU) receives milestone payment. GenVec (GNVC) collaborates with Novartis (NVS) Print E-mail
By Mary Davila   
Tuesday, 19 January 2010 17:37

Below is a list of the companies that made news in the healthcare sector on Tuesday, January 19, 2010.

Immunomedics, Inc. (Nasdaq:IMMU), A New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases today announced the receipt of $5 million from Nycomed, GmbH, for reaching the first clinical milestone event under the license and collaboration agreement, entered into on July 11, 2008, for the worldwide rights to develop, manufacture and commercialize veltuzumab for the treatment of all non-cancer indications. Immunomedics could potentially receive up to $580 million from Nycomed upon achievement of certain clinical, regulatory, and sales-based milestones.  The terms of the agreement also provides the IMMU with escalating double-digit royalties on net sales of veltuzumab.

“We are pleased to have reached the first clinical milestone related to the development of veltuzumab in the immune thrombocytopenic purpura indication,” remarked Cynthia L. Sullivan, President and CEO of Immunomedics. “We look forward to continuing our successful collaboration with Nycomed in developing the full potential of veltuzumab in the field of autoimmune and inflammatory diseases.

Immunomedics also owns a majority stake in IBC Pharmaceuticals, Inc., and together the two companies are developing a novel Dock-and-Lock (DNL) methodology for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods.

Nycomed, based in Zurich, is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management as well as a full portfolio of OTC medications.

Shares of Immunomedics rose nearly 10% on the announcement.

Also today:

GenVec, Inc. (Nasdaq: GNVC) shares shot up over 11% as the company announced this morning that they had entered into a research collaboration and license agreement with Novartis (NYSE:NVS). GenVec and Novartis will collaborate to discover and develop novel treatments for hearing loss and balance disorders. Pre-clinical results have indicated that delivery of the atonal gene using GenVec's innovative adenovector technology could have the potential to restore hearing as well as balance function.

Under the terms of the agreement, GenVec will receive an upfront payment of $5 million. In addition, Novartis has purchased $2 million in GenVec common stock.  GenVec will also receive funding from Novartis for a research program focused on developing additional adenovectors for hearing loss. If certain clinical, regulatory and sales milestones are met, GenVec is eligible to receive up to $213.6 million, including upfront and milestone payments, in addition to royalties on future sales.

Other stocks making news Tuesday:


Alcon (NYSE:ACL), the world’s leader in eye care, announced today that it will purchase the rights in the United States for two FDA-approved topical eye care products from Sirion Therapeutics, Inc.

ALDA Pharmaceuticals Corp. (TSX VENTURE:APH)(OTCBB:APCF) Announced that it has been an eventful year and an even more eventful quarter. The company indicated that margins had affected profites. Shares plunged more than 30% on the announcement.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced the publication of new data in the journal Nature Biotechnology by Alnylam scientists and collaborators from Tekmira Pharmaceuticals Corporation, AlCana Technologies, Inc., and The University of British Columbia (UBC).  “Alnylam scientists and collaborators continue to make significant progress in advancing the translation of RNAi to create a robust drug discovery platform for innovative medicines,” said Victor Kotelianski, M.D., Ph.D., D.Sc., Senior Vice President, Senior Alnylam Fellow. “We are encouraged by the data presented at this meeting from our TTR-mediated amyloidosis and Hungtinton’s disease therapeutic programs, amongst others. We are also excited by the remarkable progress we and our collaborators are making in the delivery of RNAi therapeutics. Finally, our comprehensive study comparing in vitro and in vivo properties of canonical and dicer substrate siRNAs confirms that the naturally occurring canonical siRNA structure is indeed superior.”

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it is offering to sell 3,000,000 shares of its common stock in an underwritten public offering.

Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP) provided an update today on its Cobalamin™ oral drug delivery product development programs.

American Medical Alert Corp. (NASDAQ: AMAC), a healthcare communications solutions provider, today announced that e-pill, LLC (e-pill Medication Reminders www.epill.com) has executed an agreement to begin selling AMAC’s MedSmart Medication Reminder and Dispensing System. e-pill is the largest reseller, in terms of volume, of AMAC’s first generation medication dispensing and reminder device, MedTime®. e-pill specializes in the marketing and distribution of medication management systems and is the best known US distributor of patient compliance and medication adherence devices.

AMRI (NASDAQ: AMRI) announced today that AMRI Senior Vice President, Administration and Chief Financial Officer Mark T. Frost will present at the Jefferies 2010 Healthcare Services Conference in New York City on Tuesday, January 26, 2010 at 8:00 a.m. ET.

Arrayit Corporation (OTC Bulletin Board: ARYC), a life sciences-focused healthcare company, today announced that the Company has been selected to present at the PMWC 2010 Personalized Medicine Conference in Silicon Valley, California.

BioReference Laboratories, Inc. (NASDAQ :BRLI) announced today that Marc D. Grodman M.D., President and Chief Executive Officer, is scheduled to speak at the Jefferies 2010 Global Healthcare Conference on Monday, January 25, 2010, located in New York, NY.

BioScrip, Inc. (Nasdaq:BIOS) today announced that the Company will present at the Jefferies & Company, Inc. 2010 Global Healthcare Services Conference to be held January 25-27, 2010 at the Mandarin Oriental Hotel in New York City.

Charles River Laboratories International, Inc. (NYSE: CRL) will release fourth-quarter and full-year 2009 financial results and provide 2010 financial guidance on Monday, February 8th, after the market closes.

Cleveland BioLabs, Inc. (NASDAQ: CBLI), today announced that the first healthy volunteers have been dosed in the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS).

Following approval of the Institutional Review Board, CytoDyn, Inc. (Pink Sheets: CYDY) has discharged its duty to register a clinical trial of Cytolin®, the Company’s lead product, with the government’s website at www.clinicaltrials.gov, ID NCT01048372.

Depomed, Inc. (NASDAQ:DEPO) announced today it has received guidance from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM the company’s extended release gabapentin product candidate for the treatment of menopausal hot flashes.

Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that diluted earnings per share equaled $0.69 in the third quarter of fiscal 2010. The company also upped its 2010 guidance. Shares were up $1.11 during the day and continued to rise after the bell.

GLG Life Tech Corporation (NASDAQ:GLGL) the vertically integrated leader in the agricultural and industrial development of stevia extracts, announces the launch of Sweet SuccessSM, a breakthrough new line extension of high-grade stevia extract-based sweeteners.

Helicos BioSciences Corporation (NASDAQ: HLCS), today announced the sale of a Helicos® Genetic Analysis System to the Turku Centre for Biotechnology in Turku, Finland. The center, led by Dr. Riitta Lahesmaa, is a joint facility of the University of Turku and Åbo Akademi University. The Turku Center sale represents the 10th sale of a HeliScope™ Single Molecule Sequencer.“We are very excited by our acquisition of a Helicos System, as it will allow us to perform novel experiments using single molecule sequencing technology.” said Riitta Lahesmaa, Director of the center. “We are delighted to have the Turku Center as a customer. Their scientists appreciate the unique benefits of having single molecule analysis capability and we look forward to their efforts in generating breakthrough discoveries using Helicos technology.” stated Ron Lowy, Helicos Chief Executive Officer. Shares were up over 10% on the day and settled at $1.24

Herbalife Ltd. (NYSE:HLF) today announced that Vasilios H. Frankos, M.S., Ph.D., will retire from the FDA in March and join the company as senior vice president, product compliance and safety, effective April 2010.

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), was another biotech company that announced a milestone today. Under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany, the milestone was achieved upon initiation of a Phase 2 trial by Merck KGaA of EMD 1201081, a novel agonist of Toll-like Receptor 9 (TLR9), in combination with cetuximab (Erbitux®) in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck. According to the terms of the agreement, IDRA is entitled to receive a payment of approximately $4.3 million from Merck KGaA. The payment is expected sometime in the 1st quarter of 2010.

Alice Bexon, MBChB, Vice President of Clinical Development stated: “We are very pleased with Merck KGaA’s initiation of this randomized Phase 2 clinical trial of EMD 1201081 in combination with cetuximab in patients with head and neck cancer,” she went on to say: “Under our collaboration with Merck KGaA, the use of EMD 1201081 with cetuximab is an important step forward in the development of our novel TLR9 agonists in combination with selected targeted agents for the treatment of solid tumors.”

Idera Pharmaceuticals develops drug candidates to treat infectious diseases, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants.  Shares were up over 13% today on the news.

Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that Dr. Avtar Dhillon, Executive Chairman, will present at the 8th Annual BioPartnering North America conference on Monday, January 25th, at 10:15 a.m. at the Westin Bayshore Resort in Vancouver, BC, Canada.

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) today announced that David P. King, Chairman and Chief Executive Officer, is scheduled to speak at the Jefferies 2010 Global Healthcare Services Conference in New York, NY. LabCorp’s presentation is planned for Tuesday, January 26, 2010 at 8:30 a.m. (ET).

Maxygen, Inc. (Nasdaq:MAXY), a biotechnology company focused on the development of improved protein drugs, today announced that its majority-owned subsidiary, Perseid Therapeutics LLC, achieved a preclinical milestone under its collaboration with Astellas Pharma Inc. to co-develop and commercialize next-generation CTLA4-Ig therapeutics.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of hosted clinical development solutions, today announced that Tarek Sherif, chairman and chief executive officer, and Bruce Dalziel, chief financial officer, will present at the Jefferies Global Healthcare Services Conference at 3:00 p.m. ET. on January 26, 2010 in New York City.

Mentor Capital, Inc. (Pink Sheets:MNTR) has completed the set-up and initial funding of the Cancer Immunotherapy Index Fund. Through the CII Fund, Mentor Capital has now taken an initial equity position in each of the ten companies that make up Mentor Capital's proprietary Cancer Immunotherapy Index. The ten companies that Mentor Capital has invested in include Immunocellular Therapuetics, Ltd. (OTCBB:IMUC), Dendreon (NASDAQ:DNDN), Oncothyreon (NASDAQ:ONTY), Antigenics (NASDAQ:AGEN), Biovest International (BVTI.PK), Celldex Therapeutics (NASDAQ:CLDX), Northwest Biotherapeutics (OTCBB:NWBO), CEL – SCI Corp. (AMEX:CVM) and Generex Biotechnology (NASDAQ:GNBT) as a proxy for its wholly-owned immunotherapeutic subsidiary, Antigen Express, and Quantum Immunologics, Inc. a private company.

Neurocrine Biosciences, Inc.(Nasdaq: NBIX) saw its shares close the day on heavy volume with a spike of about 10%. No news could for found for the biopharmaceutical company focused on neurological and endocrine diseases and disorders whose product candidates address some of the largest pharmaceutical markets in the world including endometriosis, anxiety, depression, pain, diabetes, benign prostatic hyperplasia (BPH), irritable bowel syndrome (IBS) and other neurological and endocrine related diseases and disorders.

 

NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, announced today that it received a Notice of Non-Compliance (“Notice”) as part of the review process from Health Canada for its New Drug Submission (“NDS”) for the Vitaros erectile dysfunction treatment filed in February 2008. The deficiencies cited related to the product’s CMC (Chemistry, Manufacturing and Controls).

Ohr Pharmaceutical Inc. (OTCBB: OHRP) announced today that it raised $1 million through the private placement of its common stock and new warrants to holders of its Series F warrants on January 15, 2010.

Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB) announced today the completion of patient enrollment in the Phase 2B clinical study of its oral insulin capsule, ORMD-0801.

Perrigo Company (Nasdaq: PRGO; TASE) today announced that it will release financial results for its second quarter fiscal 2010 on Tuesday, February 2, 2010 at approximately 8:00 a.m. (ET).

Response Genetics Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced that Edith P. Mitchell, M.D. has been appointed to the company’s Board of Directors. Dr. Mitchell is a clinical professor of Medicine and Medical Oncology at Jefferson Medical College of Thomas Jefferson University, where she is also the program leader of Gastrointestinal Oncology.

Sinobiopharma, Inc. (OTC Bulletin Board: SNBP), "Sinobiopharma" or the "Company"), a fully integrated and highly innovative biopharmaceutical company engaged in the research and development, manufacture and marketing of pharmaceutical products in China, today announced financial results for the second quarter ended November 30, 2009.

Sunridge International (OTC Bulletin Board: SNDZ) announces plans to expand its distributor marketing network through its wholly owned subsidiary Ophthalmic International.

Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) (www.symbollon.com) announced today that it has retained Atech Solutions, LLC to facilitate the restructuring of both the corporate website for Symbollon and to develop our retail site for IoGen in preparation for the launch of the IoGen product line.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced the completion of the sale of 833,333 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters of its previously announced public offering.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it will release its fourth quarter and full year 2009 financial results on Tuesday, February 16, 2010.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that it has signed a definitive agreement to acquire Ahura Scientific, a leader in field-deployed analytical instruments for human health and public safety, for $145 million in cash plus the potential for an earn-out payment based on the achievement of certain 2010 financial targets.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it will be donating over $7 million in medicine to benefit earthquake victims in Haiti. Teva is working with several of its Non-Governmental Organization (NGO) partners to ensure these drugs are delivered to Haiti without delay.

Walgreen Co. (NYSE: WAG)(NASDAQ: WAG) announced today that it has been awarded accreditation from URAC, a Washington, D.C.-based health care accrediting organization that establishes quality standards for the health care industry.

XenaCare Holdings, Inc. (OTCBB:XCHO), a company specializing in the marketing and retail distribution of consumer healthcare products, announced today that it is expanding its multimillion dollar national advertising campaign to include direct response mailings, television commercials, national sponsorships and additional print advertising to support the rapidly growing network of retailers carrying Cobroxin, an over-the-counter (OTC) pain reliever clinically proven to treat moderate to severe (Stage 2) chronic pain.

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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