|Xoma moves higher after patent award. Rexahn releases Serdaxin trial results|
|By BioMedReports.com Staff|
|Tuesday, 13 April 2010 18:34|
Below is a list of the companies that made news in the healthcare sector on Tuesday, April 13, 2010.
Rexahn Pharmaceuticals, Inc. (NYSE Amex:RNN), shares fell today after the company announced clinical results with its investigational new drug, Serdaxin for the treatment of major depressive disorder (MDD).
The randomized, double blind, placebo controlled and dose ranging clinical trial enrolled 77 patients at multiple sites in the United States. The results of the subgroup analysis are compelling and warrant further study in a larger phase 2 trial.
In the subgroup analysis, the study showed that patients with severe MDD taking 5 mg of Serdaxin had significant improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores after 8 weeks of treatment, compared to placebo. Among the 77 patients, 53 patients were classified as having severe MDD. Of the 14 patients treated with 5 mg of Serdaxin MADRS scores improved by 55.6%, compared to only 34.0% in the placebo group (n = 14), which was statistically significant (p<0.041) on an intent to treat basis.
In addition, 64.3% of patients with severe MDD treated with the 5 mg of Serdaxin were considered Responders compared to 28.6% in the placebo group (p<0.0581). A Responder is a patient with a change from baseline in MADRS score of greater than or equal to 50% after treatment. Additionally, 42.9% of patients in the treatment group were in remission with a MADRS score of less than or equal to 12 after treatment, at 8 weeks versus 14.3% in the placebo arm (p<0.209).
The trial also validates the earlier results which demonstrated Serdaxin to be safe and well tolerated without the appearance of serious side effects that are commonly linked to currently marketed antidepressant drugs, such as selective serotonin uptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), and tricyclic antidepressants (TCA). Even though the overall study did not achieve statistical significance, we believe, based on the statistically significant subgroup results, Rexahn plans to commence a Phase IIb clinical trial in the second half this year.
Shares slumped more than 51% on the news, dropping $1.89 to close the day at $1.76. Shares had run up in the past few days in anticipation of the press conference.
XOMA Ltd. (Nasdaq:XOMA), surged today as the company announced that the U.S. Patent and Trademark Office has issued two new patents that significantly expand the company's intellectual property portfolio relating to its anti-inflammatory antibody, XOMA 052, that targets interleukin-1 beta (IL-1 beta). One of the patents covers methods of treating Type 2 diabetes with high affinity antibodies and antibody fragments that bind to IL-1 beta, including XOMA 052. The high affinity antibodies, such as XOMA 052, offer potential advantages in Type 2 diabetes because they may provide greater potency, less frequent dosing, reduced dose levels, and manufacturing efficiencies. Shares shot up more than 16% on the news, moving 11 cents to close the day at 79 cents.
In other news Tuesday:
Abraxis BioScience, Inc. (NASDAQ: ABII), announced today that following a full submission, the Scottish Medicines Consortium (SMC) has accepted ABRAXANE® (paclitaxel albumin) for restricted use within the National Health Service (NHS) for Scotland in patients who would otherwise receive docetaxel or 3-weekly solvent-based paclitaxel as second-line treatment for metastatic breast cancer.
"ABRAXANE’s acceptance by the SMC is a significant milestone in our goal to provide patients in the United Kingdom and across Europe with an innovative treatment option," said Jean-François Gimonet, M.D., Vice President, European Operations of Abraxis BioScience.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that four new analyses of clinical trial data on AMPYRA™ (dalfampridine) Extended Release Tablets 10 mg are being presented at the 62nd American Academy of Neurology (AAN) Annual meeting. AMPYRA is an oral medication approved by the U.S. Food and Drug Administration (FDA) on January 22, 2010 as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed.
"AMPYRA is a new therapy, the first ever with an indication to improve walking in MS," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "The data being presented at the AAN meeting include analyses of large numbers of patients receiving therapy for up to two and a half years, providing new information on the safety and efficacy of the drug during chronic use."
Æterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), shot higher today as the late-stage drug development company specialized in oncology and endocrinology, announced that it will make an oral presentation, as well as a poster presentation on Erk/PI3K inhibitor compounds, Tuesday, April 20, at the American Association for Cancer Research (AACR) Annual Meeting, to be held April 17-21, 2010 at the Walter E. Washington Convention Center in Washington, D.C. On heavy volume, shares moved up more than 16% or 16 cents, closing the day at $1.16.
Alkermes, Inc. (NASDAQ: ALKS) today announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended–release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence. The company requested a priority review for its sNDA and if granted by the FDA, it would mean a six month review timeline. The sNDA is based on the positive results from a recent phase 3 study assessing the efficacy and safety of VIVITROL for opioid dependence. VIVITROL is an opioid antagonist administered once-monthly by intramuscular injection and is approved in the U.S. for the treatment of alcohol dependence. If approved by the FDA for the treatment of opioid dependence, VIVITROL would be the first and only non-narcotic, non-addictive drug agent available in a once-monthly formulation.
"Opioid dependence is a serious disease affecting millions of people yet there are limitations with currently available therapies," stated Richard Pops, Chief Executive Officer of Alkermes. "As the first and only non-narcotic, non-addictive, once-monthly treatment option, VIVITROL for opioid dependence could significantly change the treatment paradigm. By seeking priority review, we hope to bring this much needed treatment to patients as soon as possible."
AMRI (NASDAQ:AMRI) announced today that it has initiated a research collaboration with Navigen Pharmaceuticals, Inc. focused on the development of new drug therapies.
Under the terms of the multi-year agreement, AMRI will provide fully integrated drug discovery services including assay development, screening, in vitro ADMET, computer-aided drug discovery (CADD) and medicinal chemistry.
"AMRI has a proven track record of success working with biotech companies such as Navigen," said Michael P. Trova, Ph.D., senior vice president, chemistry.
BioMed Realty Trust, Inc. (NYSE:BMR) today announced it has commenced a public offering of 9,000,000 shares of its common stock pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission. BioMed expects to use the net proceeds of the offering to repay a portion of the outstanding indebtedness under its $720.0 million unsecured line of credit and for other general corporate and working capital purposes.
Caliper Life Sciences, Inc. (Nasdaq:CALP), a leading provider of tools and services for drug discovery and life sciences research, today announced a non-exclusive original equipment manufacturer (OEM) agreement with Access Genetics to market Caliper's LabChip GX microfluidic system for molecular diagnostic applications. Access Genetics will incorporate web-based software, materials and protocols that Access Genetics developed specifically for use with the LabChip GX and market the combined platform's benefits to a wide community of clinicians, pathologists, and physicians. The LabChip GX system provides laboratories, offering DNA-diagnostic testing, an innovative platform for automating numerous molecular tests on a common instrument system.
CAS Medical Systems, Inc. (Nasdaq:CASM) today announced that that the Japanese Patent Office has granted a new patent for the Company's LASER-SIGHT(R) technology used in the FORE-SIGHT(R) Oximeter.
Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) announced today that it has signed a definitive Clinical Trial Agreement (CTA) with the National Institute on Drug Abuse (NIDA) to jointly conduct a U.S. Phase II(b) clinical trial evaluating CPP-109, Catalyst's formulation of vigabatrin, for the treatment of cocaine addiction. As part of the CTA, NIDA, under their agreement with Veteran's Administration Cooperative Studies Program, will provide substantial resources for the estimated $10 million trial cost. Catalyst will contribute approximately $2.8 million in resources.
Corgenix Medical Corporation (OTC Bulletin Board:CONX.ob), moved higher today after the worldwide developer and marketer of diagnostic test kits, including innovative products for emerging pathogens and lethal viruses, today announced a major extension of the collaborative effort to combat important viral diseases.
The National Institutes of Health (NIH) has awarded a grant totaling $600,000 to Corgenix for the two-year study, which will focus on development of novel, recombinant-based diagnostic tests for two dangerous viruses. Collaborating with Corgenix on the study will be Tulane University, The Scripps Research Institute and Autoimmune Technologies, LLC.
"We expect this study will result in specific, cost-effective and easy to use tests for Ebola and Marburg virus detection," said Jon Geske, Ph.D., Corgenix Project Director and Principal Investigator of the program. "In addition, the resulting diagnostics will be critical for development of vaccines and other treatments for these currently incurable diseases."
This is the fourth major grant or contract given to Corgenix and its collaborative partners for virus research.
CryoLife, Inc. (NYSE:CRY), moved higher after the company announced today that the lawsuit filed by Medafor, Inc. against Steven G. Anderson, CryoLife's chairman, president and chief executive officer, in November 2009 was settled. The matter was mediated on April 6, 2010, with Myron S. Greenberg serving as mediator. The settlement does not require that Mr. Anderson make any payments to Medafor, give Medafor any of the relief that Medafor demanded of Mr. Anderson when it sued him or make any payments to any party to the lawsuit including Medafor's CEO and CFO. It does require that Medafor honor the legitimate business transaction by which Mr. Anderson purchased the shares.
"I am pleased to have settled the lawsuit and finally have the 1,000 Medafor shares registered in my name," said Steven G. Anderson, CryoLife's chairman, president and chief executive officer. "CryoLife remains Medafor's largest distributor and shareholder, and we continue to explore all of the options available to us to protect the value of our investment."
Delcath Systems, Inc. (Nasdaq:DCTH), a medical technology company testing its proprietary treatment system for primary and metastatic cancers to the liver, announced today that the American Society of Clinical Oncology (ASCO) has accepted an abstract for oral presentation of Delcath's Phase III Trial Data comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma for ASCO's 2010 Annual Meeting, to be held June 4-8, 2010 at McCormick Place in Chicago.
Dynavax Technologies Corporation (NASDAQ:DVAX) moved higher today after the company announced the pricing of an underwritten offering resulting in gross proceeds of $44 million, before deducting estimated offering expenses. 30,293,000 units are being sold at a per unit price of $1.4525. Each unit consists of one share of common stock and one warrant to purchase 0.5 of a share of common stock. Each warrant has an exercise price of $1.50 per share and is exercisable for a period of five years from the date of issuance. Shares closed at $1.44, up 3.6%.
Endo Pharmaceuticals (Nasdaq:ENDP) and Penwest Pharmaceuticals (Nasdaq:PPCO) announced today that the companies have settled litigation with Barr Laboratories, Inc. regarding the production and sale of generic formulations of Opana® ER (oxymorphone hydrochloride) Extended Release Tablets CII.
Under the terms of the settlement, Endo and Penwest have agreed to grant Barr a license to sell a generic of Opana® ER on or after Sept. 15, 2012, or earlier under certain circumstances.
EntreMed, Inc. (Nasdaq:ENMD) announced the initiation of a multi-center Phase 2 study with its lead oncology product candidate, ENMD-2076, in patients with platinum resistant ovarian cancer. The study will be conducted at up to six sites in the United States and Canada. In addition, EntreMed received a No Objection Letter (NOL) from the Therapeutic Products Directorate of Health Canada on its Clinical Trial Application to conduct the Phase 2 clinical trial in ovarian cancer patients.
Exact Sciences Corp. (Nasdaq: EXAS) announced today that it has commenced an underwritten public offering of 3,500,000 shares of common stock. The company intends to grant the underwriter in the offering an option to purchase up to 525,000 additional shares of common stock at the same price per share to cover any over-allotments.
The company expects to use the net proceeds from the offering for general corporate and working capital purposes, including the funding of strategic initiatives that the company may undertake from time to time, for product development and the furtherance of the company’s efforts to obtain FDA clearance of its sDNA colorectal cancer screening product.
Generex Biotechnology Corporation (Nasdaq:GNBT) the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that John Muir Physician Network Clinical Research Center has agreed to participate in the United States Food and Drug Administration (FDA) Expanded Access Treatment Investigational New Drug (IND) Program for the Company's flagship product, Generex Oral-lyn(TM), a proprietary buccal insulin spray product. In September 2009, the FDA approved the treatment use of Generex Oral-lyn(TM) under the FDA's Treatment IND Program.
IVAX Diagnostics, Inc. (AMEX: IVD), a fully integrated in vitro diagnostics company, and Biomerica, Inc. (OTCBB: BMRA), a global biomedical company, have signed a two-year agreement for the distribution of Biomerica’s products in the U.S. and globally, with certain country and product exclusions. Both companies moved higher on the news.
K-V Pharmaceutical Company (NYSE: KVa/KVb) today announced it has appointed Stephen A. Stamp as Chief Financial Officer and Treasurer, effective April 7, 2010. Mr. Stamp will report directly to David Van Vliet, interim CEO of the Company. Mr. Stamp has over twenty seven years of finance experience, including his tenure at Xanodyne Pharmaceuticals where he most recently served as Chief Operating Officer and Chief Financial Officer. Prior to his time at Xanodyne, Mr. Stamp spent five years at Shire Pharmaceuticals Group PLC as Group Finance Director.
Neurocrine Biosciences, Inc. (Nasdaq:NBIX) after the bell, announced that it has received approval from Health Canada to commence its second Phase I clinical trial of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) among nerve cells. NBI-98854, developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines thereby reducing the likelihood of "off target" side effects. NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of the active drug to minimize side effects associated with excessive dopamine depletion.
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that Bio-Quant, its wholly-owned subsidiary, and Ångstrom Pharmaceuticals, a privately-held pharmaceutical company, will jointly present data at the 101st Annual Meeting of the American Association for Cancer Research (AACR), in Washington, D.C. from April 17-21, 2010.
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), moved higher today as the clinical stage biopharmaceutical company developing novel monoclonal antibodies for the treatment of cancer and viral infections, announced the launch of an investigator-sponsored trial (IST) program for bavituximab and Cotara®. Bavituximab is a novel approach to treating cancer and viral infections and has demonstrated promising interim results in ongoing Phase II clinical trials in non-small cell lung cancer (NSCLC) and advanced breast cancer. Cotara is a brain cancer therapy currently in a Phase II clinical trial for recurrent glioblastoma multiforme (GBM), and has generated promising survival data in earlier studies. In a separate announcement the company announced that data from four clinical studies of bavituximab and Cotara® have been accepted for presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois. Shares were up more than 8% on the news, closing the day at $3.89.
Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq:PRXL), today announced that it has expanded its leading medical imaging capabilities with an enhanced reporting solution. Perceptive is among the first to offer a reporting solution that incorporates the industry-standard performance metrics for imaging core labs, as defined by the Metrics Champion Consortium (MCC), allowing trial sponsors to track progress against MCC criteria.
Pharmasset, Inc. (Nasdaq:VRUS) announces the oral presentation of new sustained virologic response (SVR) follow-up data in hepatitis C virus (HCV) genotype 2 and 3 non-responder patients treated for 28 days with RG7128 in combination with the standard of care (SOC), Pegasys® and Copegus®, and presentation of an in vitro combination study with PSI-7977 and PSI-938. Data from this trial suggest that the nucleoside RG7128 in combination with SOC is effective in retreatment of HCV genotype 2/3 relapsers/nonresponders and may provide an attractive option for treatment of prior non-responders and treatment-naive patients with HCV genotype 2/3. Larger studies are required to confirm these findings, determine the optimal duration of RG7128 therapy, and evaluate utility in treatment-naive genotype 2/3 patients.
Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) through its US-based subsidiary AMDL Diagnostics Inc.,announced today after the market closed the second closing of a 12% Convertible Promissory Note and Warrant financing for the sale of additional Notes in the aggregate principal amount of $5,524,425. The first financing, which closed on March 26, 2010, included one Note in the original principal amount of $925,000 and Warrants to purchase up to 1,100,000 shares of RPC common stock. Net proceeds for the first financing were approximately $540,000.
The second Convertible Promissory Note financing was offered to 25 accredited investors with similar discount terms and lender fees to that of the first financing. Net proceeds from the sale of Notes in second closing after payment of fees and discounts were approximately $3,225,000. Warrants to purchase 6,569,585 shares of RPC common stock were also issued as a part of the second closing.
In a separate announcement earlier in the day the company announced that it continues to grow its partnership with GenWay Biotech Inc. and has signed an exclusive 5-year marketing, sales and distribution agreement with the company for the commercialization of RPC's Onko-Sure™ in vitro diagnostic cancer (IVD) test in Greece. Under the terms of the agreement GenWay Biotech is responsible for the marketing and product sales in this new market. Radient Pharmaceuticals signed a similar agreement with GenWay Biotech earlier this year which gave GenWay Biotech the exclusive rights to market, sell and distribute Onko-Sure in seven other international markets. Shares of Radient closed lower in the after hours market, dropping 18% or 31 cents. Shares ended the regular trading session at $1.70, off 49 cents.
Vital Images, Inc. (Nasdaq:VTAL), a leading provider of advanced visualization and analysis software, announced today that it is collaborating with Arkansas Children's Hospital of Little Rock, Ark., to develop a Vitrea(R) pediatric cardiac application. The software is an advanced visualization tool designed specifically to meet the unique cardiac features and patient care requirements presented by pediatric patients.
Affymetrix, Inc. (NASDAQ: AFFX) today announced that it will release operating results for the first quarter after close of the stock market on Wednesday, April 21, 2010.
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced long-term efficacy data from the 12-week double-blind phase and the 12-week open-label extension phase of the confirmatory Phase III STAR trial evaluating Zenvia (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA) in patients with underlying multiple sclerosis or amyotrophic lateral sclerosis.
Baxter International Inc. (NYSE: BAX) and New York-Presbyterian Hospital/Weill Cornell Medical Center today announced results of an 18-month Phase II clinical study of GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the U.S.) for mild-to-moderate Alzheimerâ€™s disease.
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced 15 company-sponsored platform and poster presentations at the American Academy of Neurology’s (AAN) 62nd Annual Meeting in Toronto, April 10 – 17, 2010.
Charles River Laboratories International, Inc. (NYSE: CRL) will release first-quarter 2010 financial results on Tuesday, May 4th, after the market closes.
Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, will release its first quarter 2010 financial results on Tuesday, April 27, 2010 after regular trading hours end.
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that its first quarter 2010 financial results will be released on Tuesday, April 20, 2010, at 4:05 p.m. Eastern Time.
GTC Biotherapeutics, Inc. (OTCBB: GTCB) of Framingham, Massachusetts, and BIO SIDUS S.A. (“Bio Sidus”) of Buenos Aires, Argentina, announced that they have entered into a Registration License Agreement under which Bio Sidus will perform all necessary actions to obtain sales authorizations for GTC’s lead product, ATryn®, in Argentina, Uruguay and Paraguay.
Simulations Plus, Inc. (NASDAQ:SLP), a leading provider of software and consulting services for pharmaceutical R&D and environmental toxicology, announced that it expects to file its Form 10-Q quarterly report with the Securities and Exchange Commission on Wednesday, April 14, 2010, for the second quarter of its 2010 fiscal year ended February 28, 2010.
Walgreen Co. (NYSE:WAG) (NASDAQ:WAG) today announced that Ginger L. Graham, President and CEO of Two Trees Consulting and a Harvard Business School faculty member, has been elected to its board of directors effective May 1. Graham, who joins the board as an independent director, becomes the board’s 10th member.
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