|RxNews Recap for Monday 02-08-10. Amgen (AMGN) jumps after hours. Neurocrine (NBIX) names ex Biogen chair to its board|
|By Mary Davila|
|Monday, 08 February 2010 20:44|
Amgen (Nasdaq: AMGN) moved higher after hours as the company announced this evening that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints. Denosumab demonstrated superiority over Zometa for both delaying the time to the first on-study skeletal related event (SRE) (fracture, radiation to bone, surgery to bone or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95), and reducing the rate of multiple SREs (hazard ratio 0.82, 95 percent CI: 0.71, 0.94). Both results were statistically significant.
Overall rates of adverse events and serious adverse events, including infections, were generally similar between the two arms. Osteonecrosis of the jaw was infrequent (22 patients receiving denosumab as compared with 12 patients receiving Zometa) and there was no statistically significant difference between treatment arms. As with previous studies in advanced cancer patients, hypocalcemia was more frequent in the denosumab arm. Both overall survival and the time to cancer progression were balanced between treatment arms. Shares of Amgen jumper nearly 3% in the after hours market.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) rose more than 8% today as shareholders applauded the announcement that the company has appointed William H. Rastetter Ph.D. to its Board of Directors effective immediately. He is the current Chairman and Chief Executive Officer of Receptos, Inc., and former Executive Chairman of Biogen Idec, Inc.
"We are very pleased to welcome Bill Rastetter to our Board of Directors," said Joseph A. Mollica, Ph.D., Chairman of the Board of Neurocrine Biosciences. "The company is very fortunate to have someone with Bill's experience and proven track record in the biotech industry. He will be a valuable resource to Neurocrine as the Company moves forward."
Dr. Rastetter is currently the Chairman and Chief Executive Officer of Receptos, a privately-held drug discovery and development company which utilizes pioneering G protein-coupled receptor (GPCR) technology, including 3-dimensional structure determination of these membrane bound proteins, to facilitate information-driven drug design for developing best- and first-in-class drugs. He is also currently the Chairman of the Board of Directors of Illumina, Inc., and is a partner in the venture capital firm Venrock.
Dr. Rastetter retired as the Executive Chairman of Biogen Idec Inc., a biopharmaceutical company, at the end of 2005 and had served in that position since the November 2003 merger of Biogen, Inc. and IDEC Pharmaceuticals Corporation. He served as Chief Executive Officer of IDEC Pharmaceuticals from December 1986 through November 2003 and as chairman of the Board of Directors from May 1996 to November 2003. Additionally, he served as President of IDEC Pharmaceuticals from 1986 to 2002 and as Chief Financial Officer from 1988 to 1993. From 1982 to 1986 Dr. Rastetter served in various positions at Genentech, Inc., a biotechnology company, and prior to Genentech he was an associate professor at the Massachusetts Institute of Technology.
Neurocrine Biosciences, Inc. engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases and disorders. The San Diego based company develops drugs for endometriosis, anxiety, depression, pain, diabetes, irritable bowel syndrome, insomnia, and other neurological and endocrine related diseases and disorders.
In other news Monday:
AdvanSource Biomaterials Corporation (Amex: ASB), a leading developer of advanced polymer materials for a broad range of medical devices, today announced that its polymer product lines are compliant with measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies as set forth in European Council Decision 1999/534/EC.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, will present at the 12th Annual BIO CEO & Invester Conference tomorrow, Tuesday, February 9, 2010 at 3:00 PM EST.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has awarded a Notice of Allowance for the “Soutschek and Manoharan” patent (Application No. 10/916,185), which covers certain chemically modified siRNAs of any length directed to any target, including siRNAs with sterol conjugates for in vivo delivery. The new patent is based on the ground-breaking research by Alnylam scientists on systemic delivery of RNAi therapeutics as documented in Soutschek et al. (Nature 432, 173-178 (11 November 2004)).
BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable, drug-free anti-inflammatory devices, today announced it has reached an agreement with SAY-GIN Ozel Egtim Yayincilik Ticaret Hizmetleri (SAY-GIN) for distribution of its ActiPatch and Allay products in Turkey.
Borealis Exploration Limited (PINKSHEETS:BOREF) has received a U.S. patent for its Avto Metals Technology covering multiple applications in several industrial and scientific fields.
Charles River Laboratories International, Inc. (NYSE: CRL) today reported its results for the fourth-quarter and full-year 2009 and provided guidance for 2010.
China Jo-Jo Drugstores, Inc. (OTCBB:CJJD) ("Jo-Jo Drugstores" or the "Company"), which operates a retail pharmacy chain in the People’s Republic of China, today announced its financial results for its fiscal third quarter ended December 31, 2009.
Corgenix Medical Corporation (OTC BB: CONX), a worldwide developer and marketer of diagnostic test kits, and Tulane University, today announced a major extension of the collaborative effort to combat viral hemorrhagic fever (VHF), an effort that will generate an additional $800,000 in contract revenue for Corgenix over the life of the contract.
The National Institutes of Health (NIH) has awarded a five-year contract totaling $15,224,927 to Tulane University for the expanded study. Collaborating with Corgenix and Tulane in this contract are The Scripps Research Institute, the University of California at San Diego, Boston University, the Broad Institute, Harvard University, Autoimmune Technologies, LLC, Vybion, Inc. and various partners in West Africa.
Cord Blood America, Inc. (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company (http://www.cordblood-america.com) focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, said today that it has finalized an agreement to process and store cord blood specimens for BioCells, Inc., headquartered in Argentina, and its affiliates in Peru, Colombia, Bolivia, Panama and Puerto Rico. Shares were up more than 15% on the day on heavy volume.
Genta Incorporated (OTCBB: GETA) announced that the Company has initiated treatment of the first subject in a new Phase 2 trial of tesetaxel in advanced melanoma. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The new trial builds on more than ten years of Genta experience in melanoma clinical research.
IMS Health (NYSE: RX), the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today announced that its stockholders approved the proposal to adopt the merger agreement providing for its acquisition by entities created by certain affiliates of TPG Capital, L.P. (“TPG”) and the CPP Investment Board (“CPPIB”).
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today additional interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial.
Heska Corporation (Nasdaq: HSKA) announces the following Webcast: What: Heska Corporation Invites You to Join Its Fourth Quarter and Year-End 2009 Earnings Conference Call on the Web When: Monday, February 22, 2010 @ 1:00 p.m. (MST) Where:www.heska.com (click on the Q4 and Year-End 2009 Earnings Call link on the front page of this website) How:Live over the Internet.
Inovio Biomedical Corporation (Amex: INO), saw its shares rise over 4% today as the leader in DNA vaccine design, development and delivery, announced today additional interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation. Similar to previously reported data from the initial lowest dose cohort of this phase I trial, the vaccine was found to be generally safe and well tolerated. While previously reported data showed significant cellular and humoral immune responses, data from this second, intermediate dose group highlighted a significantly increased and dose-related immune response specific to the antigens targeted by the vaccine.
“We are extremely pleased with the safety and tolerability profile of VGX-3100. Furthermore, analyses of the vaccinated subjects from the first two cohorts indicate that this vaccine is highly immunogenic, generating antigen-specific T-cell and antibody responses that are amongst the highest reported from any previous human studies of DNA vaccines,” stated Dr. J. Joseph Kim, President and CEO.
Lannett Company, Inc. (NYSE AMEX: LCI) today reported financial results for the fiscal 2010 second quarter and six months ended December 31, 2009.
MDRNA, Inc. (Nasdaq:MRNA), a leading RNAi-based drug discovery and development company, today announced that its lead delivery system formulation demonstrated exceptional stability over a one year period under a variety of conditions. The DiLA2 formulation maintained in vivo knockdown activity with no observed loss in potency over the course of the year-long study when stored under conditions ranging from -80 oC to 4 oC. In addition, neither change in particle characteristics such as size or charge nor loss in siRNA integrity was observed. The Company's proprietary UsiRNA constructs in the DiLA2 formulations have demonstrated superior activity for delivery to hepatocytes in rodent and non-human primates. In addition, these compounds have demonstrated inhibition of mRNA via RNAi and subsequent reduction in tumor burden in the Company's oncology programs in liver and bladder cancer. Long-term stability of the DiLA2 formulation/UsiRNA cargo is an integral part of the development of the Company's drug products and represents further progress in these programs.announced that it received a letter on February 5, 2010 from The NASDAQ Stock Market, Inc. notifying the Company that, as a result of Securities and Exchanges Commission (SEC) approved changes to NASDAQ Listing Rules, MDRNA now has a grace period of 180 days from its initial notice of non-compliance in which to regain compliance with the $50 million minimum Market Value of Listed Securities (MVLS) for continued listing on The NASDAQ Global Market as set forth in NASDAQ Marketplace Rule 5450(b)(3)(A). The Company's grace period has been extended until May 5, 2010 in order to regain compliance, which can be achieved if the Company's MVLS closes at $50 million or more for a minimum of ten consecutive business days during this time. MDRNA will continue to be listed on the NASDAQ Global Market during this period
MWI Veterinary Supply, Inc. ("MWI") (NASDAQ:MWIV) announced today that it has acquired Centaur Services Limited ("Centaur"), a supplier of animal health products and services to veterinarians in the United Kingdom.
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology , announced today that it has raised $2.3 million in a private placement of promissory notes from two accredited U.S. investors.
Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO), a development stage biotechnology company focused on personalized cancer vaccines to enhance immune system responses to tumors, has retained Market Media Connect as their communications agency of record.
Novavax, Inc. (Nasdaq: NVAX) announced today new data from a clinical study that began in May of 2009 among healthy adults 18 to 49 years of age with Novavax's trivalent seasonal influenza Virus-like Particle (VLP) vaccine. The vaccine matched the influenza strains recommended for the 2008-2009 influenza season including H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida/04/2006 strains. The study enrolled 241 subjects, including 221 who were randomized to receive either VLP vaccine at 15 mcg or 60 mcg doses or a placebo and 20 subjects who received a licensed inactivated influenza vaccine (TIV).
Earlier in the day Novavax shares were sent downward after Spanish drug company Rovi (MCE:ROVI.MC) said it was looking for a new partner to develop pandemic and seasonal influenza vaccines after the two companies were unable to come to terms on a collaboration.
The companies' inability to agree on acceptable terms for the proposed collaboration was the reason for breaking off the negotiations, Novavax said earlier on Monday. "We have decided not to continue collaborating with Novavax to develop influenza vaccines based on its virus-like-particle technology in Spain because we were unable to reach an agreement on the terms of collaboration," Rovi said in a separate statement.T he termination of the talks with Novavax means Rovi will now cancel its plans to carry out Phase III trials with the U.S. company's technology. Novavax shares dropped 13 cents to close at $2.09
Osteologix, Inc. (OTCBB:OLGX) today announced that Philip J. Young, President and CEO of Osteologix, will present a corporate overview and update at the 12th Annual BIO CEO & Investor Conference being held this week at the Waldorf Astoria Hotel in New York City. Mr. Young will highlight the company’s latest developments tomorrow, Tuesday, February 9, at 10 a.m. ET in the Duke of Windsor Room.
PPD, Inc. (Nasdaq: PPDI) today reported its financial and operating results for the fourth quarter and full year ended December 31, 2009.
Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the FDA’s Division of Reproductive and Urologic Products for the use of Androxal® in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state.
SenoRx, Inc. (Nasdaq:SENO) today announced that Chairman and Chief Executive Officer Lloyd H. Malchow is taking an indefinite medical leave of absence due to illness, and that John T. Buhler, President and Chief Operating Officer of SenoRx, will serve as acting CEO. Mr. Malchow will continue to serve on the company's Board of Directors and will remain involved in major strategic decisions during his leave of absence. Mr. Malchow has been diagnosed with cancer and will undergo medical treatment during his leave of absence.
"I am taking leave from SenoRx at a time when the organization is as strong as it's ever been and has been performing well," said Malchow. "Our management succession plan has been in place for sometime now and I am confident in John's ability to lead the company forward in implementing and refining the company's strategic plan. I feel it is in both my best interest and that of SenoRx that I focus exclusively on addressing this health challenge, and allowing the company to move forward under John's leadership." Shares of SenoRx were off less than 1% on the day.
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced that it has granted Carmot Therapeutics, Inc., a privately-held biotechnology company, an exclusive license to its proprietary Fragment-Based Lead Discovery (FBLD) technology. Carmot will use the FBLD technology, called "Chemotype Evolution," for identifying promising drug candidates in a broad range of therapeutic areas, including inflammatory, metabolic, and neurodegenerative diseases. Sunesis retains full rights to the technology for use in its future internal discovery efforts. Terms of the agreement were not disclosed.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that preclinical results presented at the “Bridging the Gap 2010” Hematologic Conference, held in Singapore City, Singapore, February 5-7, 2010, shows that STA-9090, a potent inhibitor of heat shock protein 90 (Hsp90), inhibits the Wilms’ tumor 1 (WT1) protein, a key transcription factor that drives disease progression in acute myeloid leukemia (AML) as well as certain other leukemias. STA-9090 is currently enrolling patients in two clinical trials in AML and other hematologic cancers.
“There is no established therapy that durably inhibits WT1 oncogenic functions, which means there is a tremendous urgency to develop new therapeutic options for patients whose cancer is driven by this transcription factor,” said Swaminathan Padmanabhan, M.D., Cancer Therapy and Research Center at the University of Texas Health Science Center at San Antonio. “In these studies, STA-9090 potently inhibited WT1 expression and demonstrated greater potency than the first generation Hsp90 inhibitor 17-AAG. Targeting WT1 expression by Hsp90 inhibitors such as STA-9090 may offer new strategies to limit the survival promoting effects of WT1 in myeloid leukemias including AML.”
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today that they have amended the marketing and distribution agreement for oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS). Under the new agreement, Teva extended its marketing and distribution rights to include the Nordic and Baltic regions, previously held by Active Biotech.
Tianyin Pharmaceutical Co., Inc., (NYSE TPI), a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") based in Chengdu, China, today announced fiscal results for its second quarter ended December 31, 2009. -- Q2 2010 Revenue Increased 47.9% to $14.9 Million, Net Income Increased 24.8% to $2.6 Million with adjusted EPS of $0.11 on a diluted basis.
Vyteris, Inc. (OTCBB: VYTR), developer of the first FDA-approved active transdermal drug delivery system and a leader in active transdermal drug delivery technology, announced today the private placement of $1,060,000 of Senior Subordinated Convertible Promissory Notes due 2013.
YM BioSciences Inc. (NYSEYMI, TSX: YM), today reported operational and financial results for the second quarter of fiscal 2010, ended December 31, 2009.
"This agreement reflects our strategy to leverage the value of our non-core assets while focusing our resources on advancing voreloxin into a pivotal Phase 3 trial in acute myeloid leukemia later this year," stated Eric Bjerkholt, Senior Vice President, Corporate Development & Finance of Sunesis. "The FBLD discovery technology has the potential to generate compounds which may not be identified through traditional means of drug discovery. We are pleased that we can capitalize on Carmot's use of the technology to advance its research activities while at the same time retain full rights to use the platform technology for our own internal research applications."
Synovis Life Technologies, Inc. (Nasdaq: SYNO), has received Food and Drug Administration 510(k) marketing clearance for its Flow Coupler®, an innovative extension of the company’s well-established Microvascular Anastomotic Coupler used in several surgical procedures to connect small blood vessels more quickly and with equal or greater reliability than hand suturing. The Flow Coupler incorporates Doppler technology to immediately measure blood flow after connecting the small blood vessels. Synovis will begin a limited launch of the Flow Coupler in the United States during its second fiscal quarter with a full release expected during the company’s fiscal third quarter.
“We are extremely pleased to receive FDA marketing clearance for the Flow Coupler – a milestone achievement for Synovis,” said Richard W. Kramp, Synovis Life Technologies president and chief executive officer. “The Flow Coupler’s added feature of providing real time blood flow information makes this an extraordinary product which will assist surgeons in ascertaining that critical blood supply to transplanted soft tissue has been achieved. We believe the Flow Coupler has more than twice the potential market opportunity of the Coupler, and reinforces our microsurgical group’s position as ‘the microsurgeon’s most trusted resource.’ Our specialized microsurgical sales force is eager to offer surgeons the Flow Coupler.” The Flow Coupler incorporates a 20MHz Doppler sensor to measure blood flow at the site where the vessel is joined (the anastomosis). The Doppler sensor provides surgeons reliable, real time information about blood flow through the anastomosis, enabling immediate intervention in the event of a blockage at the site. Synovis previously received a U.S. patent on this advanced technology.
Synovis’ original Coupler is widely used in microvascular surgery, including breast reconstruction in cancer patients, as well as in several applications in head, neck and hand reconstruction. The device provides a patency rate exceeding that of hand suturing while connecting vessels in approximately one-fifth of the time required by hand suturing, resulting in shorter aschemic time for the transplanted tissue, significant time savings in the operating room and cost savings. Shares of Synovis closed up $.35 on Monday.