|RxNews Recap for Monday: MDRNA soars on siRNA delivery patent. Oxygen Biotherapeutics up on product launch. GenVec discontinues Phase III trial.|
|By BioMedReports.com Staff|
|Monday, 29 March 2010 19:47|
MDRNA, Inc. (NASDAQ:MRNA), soared today after the RNAi-based drug discovery and development company announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application covering methods for the delivery of siRNAs as well as a broad array of compounds with pharmacological activity. The patent identifies and protects peptides that were discovered using MDRNA's proprietary Trp Cage Phage Display Library and describes targeting peptides that demonstrate high binding affinity to, and internalization by, hepatocellular carcinoma cells.
Shares reached an intra-day high of $1.49 but pulled back late in the day to settle at $1.18, up 17 cents or 16.95%. Volume of 25 Million shares was more than ten times the daily average.
Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) surged today after announcing that the company has begun distribution for its newly formulated Dermacyte(TM) Oxygen Concentrate for the beauty and skin care market. The over-the-counter product is a scientifically designed perfluorocarbon concentrate to enhance oxygen delivery to skin. Dermacyte(TM) Oxygen Concentrate is the first product in a broad and diverse cosmetic line currently under development. It uses the company's patented Oxycyte technology, an oxygen carrier scientifically designed to enhance oxygen delivery to tissues such as skin. Some potential benefits of increased oxygenation to the skin include a decrease in the appearance of fine lines, wrinkles and dryness.
After reaching an intra-day high of $7.50, shares settled at $5.71, up $1.07 or 23% on the day.
In news after the market closed:
GenVec, Inc. (Nasdaq:GNVC) shares were rocked after the company announced after the market closed that it is discontinuing its Phase 3 clinical trial of TNFerade™ in patients with locally advanced pancreatic cancer based on results of an interim analysis. This interim analysis of overall survival, conducted after the 184th death (two-thirds of total expected events), was designed to determine whether the study should continue.
GenVec has determined, after conferring with its independent Data Safety Monitoring Board, that the PACT trial would not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval in the population chosen for study. This randomized, controlled trial compared treatment with TNFerade (in combination with standard of care (SOC)) to SOC alone in patients with locally advanced pancreatic cancer.
In the after hours market shares of GenVec fell 75%, dropping $2.11 to close at 70 cents.
Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) today announced that two presentations related to ANA598, the Company's non-nucleoside polymerase inhibitor in Phase II development for the treatment of hepatitis C, are scheduled for the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 14-18, 2010.
Cephalon, Inc. (Nasdaq:CEPH) shares dropped after the bell as the company announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. "Although we reached statistical significance on both primary endpoints, the Complete Response letter raised questions regarding the robustness of the PGI-S data," said Dr. Lesley Russell, Cephalon's Chief Medical Officer. "We have already reviewed this issue with the FDA and will be scheduling a meeting with the Agency in the near future to discuss it further." Shares fell more than 5% or $3.87 in the after hours session.
EntreMed, Inc. (Nasdaq:ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, today reported results for the three months and twelve months ended December 31, 2009.
Medivation, Inc. (Nasdaq:MDVN) today announced that the Company is implementing a plan to reduce its workforce and operating costs in order to focus its resources on prioritized dimebon trials and the continued development of MDV3100. The Company will reduce the number of staff by 23, or approximately 20 percent. The reduction is effective March 29, 2010. "We need to take this difficult, yet necessary, step to manage our portfolio, operations and cash flow, to carry us through as many data readouts as possible to maximize the probability of success for our company. Our top priority is further analysis of the CONNECTION data to better understand the impact on the development of dimebon for Alzheimer's and Huntington diseases," said David Hung, M.D., president and chief executive officer of Medivation.
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced that it had entered into an agreement with Astellas Pharma Inc., under which Astellas will be able to review certain confidential information related to OSI. "We are pleased that Astellas has now responded to our previous offer to review non-public information and has entered into a non-disclosure agreement with us which contains an appropriate standstill provision," stated Dr. Colin Goddard, CEO of OSI Pharmaceuticals, Inc. "This agreement will allow Astellas to participate in our ongoing process and is consistent with the basic provisions we have offered other parties. We are taking this step – which reflects our board’s prior commitment to explore the availability of a transaction that reflects the full intrinsic value of our company – in order to ensure that our stockholders have the full benefit of a complete, open and fair process."
In other news Monday:
AGA Medical Holdings, Inc. (AGA Medical) (Nasdaq:AGAM) today announced the settlement of a patent infringement lawsuit between the company and Medtronic, Inc. This dispute relates to the January 2007 patent infringement action against the company, filed by Medtronic, Inc., alleging that substantially all of AGA Medical’s AMPLATZER® occluder and vascular plug devices infringe three of Medtronic’s method and apparatus patents on shape memory alloy stents .
Adeona Pharmaceuticals, Inc. (AMEX:AEN) shares rose today on rumors that Pfizer (NYSE: PFE) might be interested in the company. Adeona is a development-stage, specialty pharmaceutical company that is developing orally active, proprietary, late-stage drug candidates for the treatment of autoimmune and central nervous system diseases, primarily treatments for rheumatoid arthritis (RA), multiple sclerosis (MS), dry age-related macular degeneration (AMD) and fibromyalgia. Shares were up more than 21% to close the day at $1.90. Volume of 5 Million shares was four times the daily average.
ARYx Therapeutics, Inc. (NASDAQ: ARYX) today reported results of operations and provided an update on its products for the fourth quarter and year ended December 31, 2009. Said Dr. Paul Goddard, chairman and chief executive officer of ARYx: "2009 was a year of mixed results for ARYx. We continued to progress with the development of our three lead product candidates towards achievement of the target profiles we had set for them. However, the consequence of not completing a licensing agreement for budiodarone, our novel antiarrhythmic agent, to a large pharmaceutical company left ARYx in a difficult situation. We committed in February 2010 to optimize the value in the near-term that we believe exists for each of our product candidates by retaining Cowen and Company, an investment bank, to explore strategic alternatives. At the same time, we substantially reorganized the company to support this process and to reduce our spend,"
Cellceutix Corporation (OTC.BB:CTIX), a bio-pharmaceutical company that develops small molecules to treat cancer and inflammatory disease, today announced positive results in an animal study of its recently acquired autism compound, KM-391. In this carefully conducted study, KM-391 was given orally over 90 days to groups of rats at two dosage levels. At each dosage level, KM-391 demonstrated significant improvements in the test animals when compared to both the "no treatment" group and the "active control" (fluoxetine) group on the parameters of brain plasticity, serotonin levels and behavioral function. These parameters were selected as important indicators of the effect needed to successfully treat autism.
Dragon Pharmaceutical Inc. (TSX:DDD)(OTC.BB:DRUG) jumped more than 13% today after the company announced that it has entered into a definitive merger agreement to be acquired by Chief Respect Limited, a Hong Kong corporation, which is a newly created entity controlled by Dragon Pharma's Chairman and Chief Executive Officer, Yanlin Han, for $0.82 per share in cash. Mr. Han is the largest shareholder of the Company owning 37.95% of the total outstanding shares. Headquartered in Vancouver, Canada, Dragon Pharmaceutical is a leading manufacturer and distributor of a broad line of high-quality antibiotic products including Clavulanic Acid, an API to combine with Amoxicillin to fight resistance, and 7-ACA, a key intermediate to produce cephalosporin antibiotics, and formulated cephalosporin antibiotic drugs.
Enzo Biochem Inc. (NYSE:ENZ) said today that a decision released Friday by the Court of Appeals for the Federal Circuit reversing a district court’s summary judgment will enable the Company to pursue a claim for substantial damages against Applera Corporation, now Life Technologies Corporation. (NASDAQ: LIFE).
Genta Incorporated (OTCBB: GETA.OB) today reported results for the quarter and year ended December 31, 2009. The Company also provided an overview of recent corporate highlights and anticipated milestones..
GlaxoSmithKline (NYSE:GSK) announced today that it has re-submitted the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration. The re-submission provides an update to the initial application in 2009. The withdrawal of the initial application was not the result of new findings related to safety or efficacy. The update to the submission has not changed the interpretation of the data submitted.
Generex Biotechnology Corporation (Nasdaq:GNBT) the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has expanded its plans for its United States Food and Drug Administration (FDA) Expanded Access Treatment IND Program for its flagship product, Generex Oral-lyn(TM), to include licensed and qualified Nurse Practitioners in the United States..
Hologic, Inc. (Hologic or the Company) (Nasdaq:HOLX), today announced that interim data from the first large-scale independent evaluation of clinical performance of Cervista® HPV HR compared to Hybrid Capture 2 (hc2), were presented at the 4th Biennial Meeting of AOGIN (Asia-Oceanic Research Organization in Genital Infection and Neoplasia) in New Delhi, India on March 26-28, 2010. Cervista HPV HR is a diagnostic test for the detection of 14 high-risk human papillomavirus (HPV) types. A preliminary analysis of data from 5,043 patients showed the Cervista HPV HR test performed as follows: Overall HPV positivity for this cohort was 12.2 percent for the Cervista HPV HR test and 14.6 percent with the hc2 test.
Inovio Biomedical Corporation (NYSE AMEX: INO) today reported financial results for the quarter and year ended December 31, 2009. Total revenue was $2.6 million and $9.1 million for the quarter and year ended December 31, 2009, respectively, compared to $327,000 and $2.1 million for the quarter and year ended December 31, 2008, respectively.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a Phase I study with its selective androgen receptor modulator (SARM) LGD-4033 was featured today in a poster presentation at the 14th International Congress of Endocrinology in Kyoto, Japan. This Phase I clinical trial was the first study in humans of LGD-4033, and evaluated the safety, tolerability and pharmacokinetic profiles of the molecule in a single escalating dose, double blind, placebo-controlled study in 48 healthy volunteers. LGD-4033 is a non-steroidal selective androgen receptor modulator (SARM), expected to produce the therapeutic benefits of testosterone with improved safety, tolerability and patient acceptance.
Medicis Pharmaceutical Corp. (NYSE:MRX) saw its share volume and price pop today after a rumor circulated that Johnson and Johnson (NYSE:JNJ) might be interested in the Company. Medicis is a specialty pharmaceutical company focusing primarily on the treatment of dermatological and aesthetic conditions. Shares rose more than 3% on the day but pulled back in the after hours session..
MannKind Corporation (Nasdaq:MNKD) today announced that it has successfully achieved all milestones of a research agreement with The Multiple Myeloma Research Foundation (MMRF) to develop a novel, first-in-class inhibitor for the treatment of multiple myeloma. The MMRF awarded MannKind a $1 million grant through its 2007 Biotech Investment Award program, a multi-year, results-driven commitment to fund the development of innovative and effective treatments for multiple myeloma, based on clearly defined milestones. The final milestone of the research agreement was achieved based on selection of an IRE-1 (inositol-requiring enzyme-1) inhibitor for evaluation in the preclinical studies that are required to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration.
Neogen Corporation (Nasdaq:NEOG) announced today that its net income for the third quarter of FY 2010, which ended Feb. 28, increased 38% from the previous year to $3,881,000. Adjusted for a 3-for-2 stock split effective Dec. 15, net income in the quarter rose to $0.17 per share, compared to the prior year's $0.12.
NexMed, Inc. (NASDAQ: NEXM), rose more than 6% today after the specialty CRO with a pipeline of products based on the NexACT® technology, announced that the Company has filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) for a Phase II trial of its recently acquired cancer drug candidate PrevOnco™, in combination with doxorubicin in patients with advanced, unresectable hepatocellular carcinoma (HCC). The FDA has 30 days to comment on the IND before NexMed can proceed with human testing.
Novavax, Inc. (Nasdaq:NVAX) released the final results from a Phase II clinical trial evaluating Novavax's trivalent seasonal influenza Virus-like particle (VLP) vaccine candidate in healthy adults. The study enrolled healthy volunteers 18 to 49 years in age who were immunized with a single injection of Novavax's trivalent seasonal influenza VLP vaccine matched to the influenza strains recommended for the 2008-2009 influenza vaccine. Preliminary data from this trial were reported in 2009. The data shows that NVAX's trivalent seasonal influenza VLP vaccine induced a robust hemagglutination inhibition antibody response against all three strains in the vaccine."The data released today show that our VLP influenza vaccine not only induces a robust HAI response but also enhances the NAI response far above that induced by TIV," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. Shares rose more than 5% on heavy volume to close the day at $2.48.
Regulus Therapeutics Inc., co-founded by Alnylam Pharmaceuticals (Nasdaq:ALNY) and Isis Pharmaceuticals (Nasdaq:ISIS), today announced the publication of new results in the journal Nature Biotechnology by Regulus scientists and collaborators. The new study demonstrated that systemic treatment of a microRNA therapeutic targeting microRNA-10b in tumor-bearing mice inhibits breast cancer metastasis. Cancer-related metastasis is a major cause of mortality and current cancer treatments have limited utility suppressing the metastatic spread of cancer cells. microRNA therapeutics targeting miR-10b represent a promising approach for the discovery and development of a novel anti-metastatic agent..
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today that Thomas Stankovich has resigned from his position as chief financial officer of the Company to pursue other interests, effective April 2, 2010. .
Rosetta Genomics, Ltd. (NASDAQ:ROSG), shot up today after the developer and provider of microRNA-based molecular diagnostics, announced the publication of an article describing the development and validation process of miRview™ mets, the company’s microRNA-based test for identification of primary origin of metastases. In the study described in Modern Pathology, the overall sensitivity was approximately 85%, and the sensitivity of a single answer prediction was approximately 90%. Overall specificity was 97%-99%. "This publication is yet another validation of the significant advantage of microRNAs as biomarkers," said Kenneth A. Berlin, President and CEO of Rosetta Genomics. "Their high tissue specificity, stability in a wide range of sample types and the large amount of biological information they carry makes microRNAs ideal biomarkers for a range of disease states and indications, including metastatic cancer. As we have previously announced, we expect to launch a second generation of our miRview™ mets in the second half of 2010. This new version is expected to be able to identify approximately twice the number of origins compared with the first generation test." Shares closed up more than 16% on the news.
Senesco Technologies, Inc. (NYSE Amex: SNT) reported today that on March 26, 2010, the company entered into definitive agreements with institutional and accredited investors for a private placement of up to 11,497 shares of Convertible Preferred Stock of the Company and Warrants to purchase up to 35,928,125 shares of Common Stock for a gross purchase price of approximately $11,497,000. Investors in this financing included certain members of Senesco's Board of Directors, including Harlan Waksal, M.D., and Christopher Forbes. Senesco primarily intends to utilize the proceeds of this private placement to help advance its multiple myeloma research & development program; with the goal of initiating a Phase 1b/2a clinical trial for multiple myeloma.
Sigma® Life Science, the innovative biological products and services brand of Sigma-Aldrich® (Nasdaq:SIAL), today announced that it has added 2,200 new Prestige Antibodies® powered by Atlas Antibodies to its industry-leading portfolio. The development brings Sigma Life Science's total Prestige Antibody portfolio to 8,300, covering 6,900 human protein targets, and further expands the Company's overall monoclonal and polyclonal antibody offering to over 30,000 in total.
Sinovac Biotech Ltd. (Nasdaq:SVA), a leading China-based vaccine manufacturer, announced today it has entered into exclusive license, supply and distribution agreements with Parenteral Biotech Ltd., a subsidiary of Parenteral Drugs (India), Ltd., an India-based pharmaceutical company. Pursuant to the agreements, Parenteral is authorized to register, supply and distribute Sinovac's Anflu (seasonal influenza vaccine) and PANFLU.1 (H1N1 vaccine) to the government of India and private market in India.
Tianyin Pharmaceutical Co., Inc., (NYSE Alternext: TPI), rose higher today after the manufacturer and supplier of modernized traditional Chinese medicine based in Chengdu, China, announced that it has appointed James Jiayuan Tong, M.D. Ph.D., as its Chief Financial Officer and Chief Business & Development Officer, effective April 1st, 2010. In addition, Dr. Tong will join the Company's Board of Directors on April 1.
inVentiv Health, Inc. (Nasdaq:VTIV) moved higher today after the company announced after the close of business on Friday that is has been approached by financial investors regarding a possible acquisition of the company. To consider possible courses of action, inVentiv has formed a special committee of the Board of Directors, which has retained Goldman, Sachs & Co. as a financial advisor. inVentiv does not expect to make further comments about this matter unless it enters into a definitive agreement. There can be no assurance that inVentiv will enter into any transactionAlso Monday:Biostar Pharmaceuticals, Inc. (OTC Bulletin Board: BSPM) ("Biostar" or "the Company"), the Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsule ("Xin Aoxing"), and a variety of pharmaceutical products and medical nutrients, today announced that its 2009 fourth quarter and year end financial results will be released after the market close on Wednesday, March 31, 2010.
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