|Rexahn issues update, shares bounce back. Adeona higher on Alzheimer's study. After the bell Dynavax soars, Santarus is rocked|
|By BioMedReports.com Staff|
|Wednesday, 14 April 2010 18:13|
Below is a list of the companies that made news in the healthcare sector on Wednesday, April 14, 2010.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN),bounced back today after yesterday's sell off as the company offered additional commentary, clarifications and insights on yesterday’s announcement of its Phase IIa clinical results of Serdaxin® in the treatment of major depressive disorder (MDD).
"Based on the feedback and reaction from our shareholders, stakeholders and other market participants, it is clear that neither the purpose of the Serdaxin trial or its results were well understood," said Dr. Chang Ahn, Chief Executive Officer of Rexahn.
"The purpose of the Serdaxin Phase IIa trial was to establish as a proof of concept that Serdaxin can work as an antidepressant drug for patients suffering from Major Depressive Disorder. I am happy to say that this is exactly what the study accomplished. The trial results unambiguously reach the conclusion that patients, especially those suffering from severe depression, respond positively to Serdaxin," said Dr. Ahn.
The study showed that patients with severe MDD taking 5 mg of Serdaxin (55.6%) had statistically significant improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores after 8 weeks of treatment, compared to placebo (34.0%).
Dr. Ahn added, "Some market participants have asked us why our overall trial results were not statistically significant. The answer is simply that the Serdaxin study was never designed to achieve statistical significance as a primary objective, but rather to establish a positive signal among treated patients. This is exactly what the trial succeeded in accomplishing."
"Overall we are extremely pleased with Serdaxin’s Phase IIa results, which should be viewed as a success. As such, based on the strength of these results we are now able to move forward with a 300 patient phase IIb clinical trial in the second half of this year. We believe this study will further substantiate Serdaxin as a viable treatment for depression," Dr. Ahn concluded.
Shares shot up 39 cents or 22% closing the day at $2.15
Adeona Pharmaceuticals, Inc., (AMEX:AEN) surged today after the company announced positive results of Part 1 of its CopperProof-2 clinical study of Zinthionein ZC (zinc cysteine) in Alzheimer's disease and mild cognitive impairment.
Results from Part 1 of the study demonstrate a substantially lower incidence of adverse effects in Alzheimer's disease and Mild Cognitive Impairment subjects (33% versus 100%) in favor of Zinthionein ZC (containing 150 mg of elemental zinc acetate and 100 mg of cysteine) compared to Galzin® (containing either 50 mg or 100 mg of elemental zinc as zinc acetate). 100% of the Galzin® subjects experienced gastrointestinal distress, ranging from 100% nausea to 40% vomiting, 40% diarrhea, and 20% heartburn. The high rate of gastrointestinal adverse effects of Galzin® are consistent with prior published results of oral zinc therapy.(1) In comparison, only 33% of Zinthionein ZC subjects experienced nausea, with only one of such subjects (17% of group) having experienced vomiting. No adverse effects were noted in the placebo group.
Part 2 of the clinical study is intended to enroll 60 Alzheimer's disease and mild cognitive impairment subjects and is currently ongoing with 11 of 13 enrolled subjects from Part 1 electing to continue to Part 2 of the study. In Part 2, subjects are randomized on a 50:50 basis to either Zinthionein ZC or matching placebo. Shares jumped 25%, moving up 38 cents to close the day at $1.90.
Dynavax Technologies Corporation (NASDAQ:DVAX) soared in the after hours session as the company presented Phase 2 clinical data that demonstrate HEPLISAV™'s immunogenicity and rapid protection in patients with chronic kidney disease. In a poster session at the National Kidney Foundation Spring Clinical Meeting in Orlando, FL, Dynavax results showed that two doses of HEPLISAV protected 100% of the dialysis and pre-dialysis patients measured at week 24 in the Phase 2 study.
"Chronic Kidney Disease patients undergoing hemodialysis are at high risk of HBV infection, are hyporesponsive to current HBV vaccines, and have a worse prognosis if infected with HBV," commented Tyler Martin, M.D., Dynavax's Chief Medical Officer. "These results demonstrate that HEPLISAV can effectively protect this susceptible patient population." Dynavax presented safety and immunogenicity data for time points 4 weeks after the first immunization and 8 and 20 weeks after the second immunization.
More than 1 Million shares traded in the after hours market, pushing the stock as high as $2.66 before settling at $1.80. The stock closed the regular session at $1.45.
Santarus, Inc. (NASDAQ: SNTS) was rocked in the after hours market after it was revealed that the company received a negative judgement regarding a patent lawsuit between Santarus and Par Pharmaceuticals (NYSE:PRX) over Santarus's flagship drug, Zegerid.
Zegerid capsules and powder for oral suspension are proprietary immediate-release formulations that combine omeprazole and antacids to treat upper gastrointestinal diseases and disorders, such as heartburn, gastroesophageal reflux disease (GERD), erosive esophagitis, and gastric and duodenal ulcers; and Glumetza tablets for the treatment of type 2 diabetes. The company also offers Omeprazole tablet, which is approved for the treatment of upper gastrointestinal conditions, including GERD; and Zegerid OTC that is approved for the treatment of heartburn.
Shares initially were down more than 45% or $2.51, hovering around $2.81 before settling at $3.25. The stock closed the regular session at $5.36.
Also after the bell:
Endologix, Inc. (Nasdaq:ELGX), developer of minimally invasive treatments for aortic disorders, announced today that the first patient has been enrolled in the Company's prospective, multicenter, randomized clinical trial for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair ("EVAR"). The patient was treated at Oklahoma Heart Hospital by Jim G. Melton, DO.
Life Technologies Corporation (NASDAQ: LIFE ) today announced that its scientists have teamed with researchers from Stanford University School of Medicine, and other institutions to discover a genomic component that plays a key role in promoting breast cancer progression. A study published today in the journal Nature details how levels of a specific kind of non-coding RNA molecule in primary breast tumors regulate metastasis and tumor invasiveness and may be an important target for cancer diagnosis and therapy. A key to this finding was the ability of a new set of Applied Biosystems TaqMan® Non-Coding RNA Assays to accurately measure expression levels of this molecular marker in different breast cancer samples.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), jumped after the bell after the company, developing a novel T-cell therapy for multiple sclerosis (MS), announced the presentation of key efficacy data at the American Academy of Neurology (AAN) 62nd Annual Meeting held in Toronto, Canada.
Dawn McGuire, M.D., Chair of Opexa’s Clinical Advisory Board and the Company’s acting-Chief Medical Officer, presented data from the Phase 2b TERMS clinical trial which demonstrated promising efficacy and safety results in patients treated with Tovaxin®, the Company’s lead therapy for MS. The presentation highlighted previously communicated efficacy data as well as new immunology data that appear to link Tovaxin’s mechanism of action with observed clinical benefits.
Theravance, Inc. (NASDAQ:THRX) announced today that the first patient with opioid-induced constipation (OIC) has been dosed in a Phase 2 clinical study with TD-1211, an orally-administered peripherally selective mu opioid receptor antagonist (PUMA). TD-1211 is a potent, multivalent inhibitor of the mu opioid receptor designed to alleviate gastrointestinal side effects of opioid analgesic therapy without affecting analgesia. This "proof of concept" study is designed to assess the efficacy, tolerability and safety of TD-1211 in patients with OIC.
News from earlier in the day:
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that Joseph H. Friedman, MD, will present data from ACADIA’s previously reported Phase III trial (the -012 Study) with pimavanserin for Parkinson’s disease psychosis (PDP) at the 62nd American Academy of Neurology Annual Meeting on April 14, 2010 in Toronto, Canada. Dr. Friedman is Professor and Chief, Division of Movement Disorders, Department of Neurology, Warren Alpert Medical School Brown University, and the Director of the Neurohealth Parkinson’s Disease and Movement Disorders Center in Warwick, Rhode Island. He is an established expert in Parkinson’s disease and was one of the lead investigators in the -012 Study.
BioMed Realty Trust, Inc. (NYSE:BMR) today announced the pricing of its public offering of 11,500,000 shares of its common stock at $17.25 per share. The offering is expected to close on or about April 19, 2010. Gross proceeds from the offering will be approximately $198.4 million.
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, is pleased to announce that Professor Avi Israeli is joining the company as Chairman of the Board of Directors. Professor Israeli is a Medical Doctor specializing in Internal Medicine and in Health Care Management. He has previously served as the Director General of the Israeli Ministry of Health, as well as the Director General of The Hadassah Medical Organization. He currently heads the Department of Health Policy, Health Care Administration and Health Economics at Hebrew University and Hadassah Medical School and the School of Public Health.
BIOLASE Technology, Inc. (NASDAQ:BLTI), the world's leading dental laser company, today announced that it was awarded a new patent (U.S. Patent number 7,695,469 B2), based on a patent application that was filed in 2007, for technology that is utilized in the groundbreaking ezlase™ and iLase™ diode lasers.
CombinatoRx, Incorporated (NASDAQ: CRXX) moved higher today after the company announced the publication of new preclinical data in BLOOD, The Journal of the American Society of Hematology. In the article entitled, "Adenosine A2A receptor agonists and PDE inhibitors: a synergistic multi-target mechanism discovered through systematic combination screening in B-cell malignancies," CombinatoRx researchers, in collaboration with the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, demonstrate the powerful and unexpected synergistic interactions of A2A Agonist and PDE Inhibitors as potential adjunctive therapy to glucocorticoid (GC) containing regimens in the treatment of multiple myeloma (MM) and other B-cell malignancies.
Dialysis Corporation of America, Inc. (Nasdaq:DCAI) ("DCA"), a leading provider of outpatient kidney dialysis centers, announced today that they have entered into a definitive merger agreement for U.S. Renal Care, Inc. aka USRC, to acquire DCA.
Under the terms of the agreement, USRC, a privately-held leading provider of outpatient dialysis services, through a subsidiary, will commence a tender offer for all of the outstanding common shares of DCA for $11.25 per share in cash, followed by a merger to acquire all remaining outstanding DCA shares at the same cash price paid in the tender offer. The offer price represents a premium of approximately 72 percent over yesterday's closing stock price. The transaction is valued at approximately $112 million.
"USRC and DCA have a shared vision that is focused on providing outstanding dialysis services to patients with end stage renal disease," said Chris Brengard, Chairman and Chief Executive Officer of USRC. "USRC and DCA each have built strong regional operations and this transaction permits us to build a more efficient and stronger national operation. DCA, like USRC, has a commitment to building joint ventures with nephrologists. We are excited about the possibilities going forward with DCA, and believe that our combined operations will result in continued quality improvement for our patients and value for our stakeholders."
Upon the closing of the transaction, USRC will provide dialysis services to a base of approximately 5,500 patients through 84 outpatient dialysis facilities across nine states, more than 12 home dialysis programs, and 24 dialysis programs within acute and specialty hospital facilities.
Shares of Dialysis Corporation shot up 71.93% or $4.69, closing the day at $11.21.
Emerging Healthcare Solutions, Inc. (Pinksheets:EHSI) moved higher today as the company announced that medical technology developers in China have invited EHSI to meet next week in China to explore opportunities to deliver new cutting-edge medical technologies to the U.S. market. China has grown to be a leader in new technologies and businesses there are looking for opportunities to deliver new solutions to the U.S. market.
EHSI’s chief engineer will be meeting with technology developers in China and Korea for the next two weeks to explore their ideas for using EHSI as a platform for the delivery of new medical technology to the U.S. market. The Company expects these meetings to open doors to significant new opportunities to grow as it brings proven new products to the U.S. medical market.
Exact Sciences Corp. (Nasdaq: EXAS) announced today that it priced an underwritten public offering of 4,200,000 shares of common stock at a price of $4.50 per share to the public. The company has granted the underwriter in the offering an option to purchase up to 630,000 additional shares of common stock at the same price per share to cover any over-allotments. The number of shares in the offering represents an increase of 20%, or an additional 700,000 shares, from the previously announced offering size of 3,500,000 shares of common stock, and the number of shares in the underwriter’s over-allotment option was likewise increased by 20% from the previously announced number.
Genzyme Corporation (Nasdaq: GENZ) today reported four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial showing an estimated 71 percent of alemtuzumab treated patients remain free of clinically-active disease as much as three years after most patients received their last course of the investigational compound. The data were presented at the American Academy of Neurology annual meeting.
InterMune, Inc. (Nasdaq:ITMN) today announced top-line results from the planned Week 12 interim analysis of the Phase 2b randomized, partially-blind study evaluating the hepatitis C virus (HCV) protease inhibitor danoprevir (also known as RG7227 and ITMN-191), administered for 12 weeks in combination with PEGASYS® (pegylated interferon alfa-2a) and COPEGUS® (ribavirin), compared with placebo for the same duration plus PEGASYS and COPEGUS.
Oncolytics Biotech Inc.(TSX:ONC, NASDAQ:ONCY) announced today that abstracts covering both clinical and preclinical research with reovirus (REOLYSIN(R)) are available on the American Association for Cancer Research (AACR) website at, and on the Oncolytics website. The research is scheduled to be delivered at the 101st AACR Annual Meeting in Washington, DC, April 17-21, 2010. "Our preclinical and clinical collaborations continue to support and improve our understanding of how reovirus works, as well as its broad applicability in a growing range of potential cancer indications," said Dr. Matt Coffey, COO of Oncolytics.
PerkinElmer, Inc. (NYSE: PKI), a global leader focused on the health and safety of people and the environment, today announced that it has entered into a definitive agreement to acquire Signature Genomic Laboratories, LLC, a diagnostic genetic testing company based in Spokane, Washington.
The acquisition is expected to enable PerkinElmer to strengthen its existing genetic testing service business, expand its position in early detection of disease, specifically in the molecular diagnostics market, and provide the company with additional strengths in cancer diagnostics.
POZEN Inc. (NASDAQ: POZN), traded higher today after the company announced that it has entered into a Settlement Agreement with Teva Pharmaceuticals USA, Inc. (Teva) to resolve a U.S. patent infringement suit related to Teva’s filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration to market a generic version of Treximet marketed by POZEN’s exclusive U.S. licensee, GlaxoSmithKline. Under the terms of the Settlement Agreement, Teva will be dismissed without prejudice from the consolidated litigation currently pending in the United States District Court for the Eastern District of Texas against Teva, Par Pharmaceutical, Inc., Alphapharm Pty Ltd., and Dr. Reddy’s Laboratories, Inc., but will agree to be bound by the outcome of such litigation or any resulting settlements with third parties..
Radient Pharmaceuticals Corporation (AMEX:RPC) announced today the Journal of Immunoassay and Immunochemistry (April 2010, Volume 31) has published a peer-reviewed journal article written by Dr. Andrea Small-Howard and Mr. Holden Harris titled "Advantages of the AMDL-ELISA DR-70 (FDP) Assay Over Carcinoembryonic Antigen (CEA) for Monitoring Colorectal Cancer Patients."
The Journal of Immunoassay and Immunochemistry article introduces Onko-Sure, the AMDL-ELISA DR-70 (FDP) test developed by Radient Pharmaceuticals, as the first new in vitro diagnostic (IVD) cancer test to be cleared by the US FDA since January 14, 1982 for monitoring CRC. The article also discusses the importance of colorectal cancer screening and monitoring tools in enhancing survival in post-operative colorectal cancer patients because approximately 50% of all CRC patients treated will experience cancer recurrence. RPC's clinical trial is the first head-to-head comparison assessing the effectiveness of Onko-Sure versus CEA for monitoring CRC recurrence.
The article specifically outlines the advantages of the AMDL-ELISA DR-70 (FDP) test over CEA for monitoring CRC; the tremendous economic and healthcare benefits of routine cancer screening, including the potential to detect CRC in its earliest stages where the disease is the most preventable and/or treatable; and the merits of the AMDL-ELISA DR-70 (FDP) cancer test as a welcome, new option for CRC patients.
Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, will host a conference call on Friday, May 14, 2010 at 8:30 a.m. ET to discuss its first quarter 2010 financial results.
Exelixis, Inc. (Nasdaq:EXEL) announced today that data from clinical trials of the company's investigational compounds XL184, XL147, XL765, XL228 and XL139 will be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 4-8 in Chicago, Illinois.
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that the company will be presenting its DNA vaccine technology platform and the development of universal influenza vaccine candidates at the upcoming World Vaccine Congress to be held in Washington, DC from April 19-22.
Kendle (Nasdaq: KNDL) announced today it will release its first quarter 2010 financial results after the market closes on Wednesday, May 5, 2010.
Oculus Innovative Sciences, Inc. (NASDAQ:OCLS), a commercial medical technology company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, will be showcasing a family of new Microcyn-based healthcare products including a Medicare-reimbursable wound and skin care hydrogel at the Symposium on Advanced Wound Care (booth #934) being held in Orlando, Florida on April 17-20, 2010.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company presented key efficacy data at the American Academy of Neurology (AAN) 62nd Annual Meeting held in Toronto, Canada.
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its first quarter 2010 financial results will be released on April 22, 2010, after the markets close.
Shrink Nanotechnologies, Inc. (OTCBB:INKN), an innovative nanotechnology company developing products and licensing opportunities in the solar energy production, medical diagnostics, sensors and biotechnology research and development tools businesses, announced today that FINRA has approved of a common stock forward split of 5 for 1 which will take effect tomorrow at the opening of trading.
SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today that it will host a live webcast of its second quarter 2010 conference call on Wednesday, April 28, at 4:00 p.m. CT. The Company will issue an earnings news release after the market closes that afternoon.
Trimeris, Inc. (Nasdaq: TRMS) today announced worldwide net sales of FUZEON for the first quarter of 2010 were $24.4 million, down 12 percent from $27.8 million in the first quarter of 2009, and down 4 percent from $25.5 million in the fourth quarter of 2009.
UnitedHealth Group (NYSE:UNH) is launching the Diabetes Prevention and Control Alliance, a partnership with YMCA of the USA and Walgreens to help prevent and control diabetes, pre-diabetes and obesity.
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.