Supernus Pharmaceuticals, Inc. (Supernus) is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, including neurological and psychiatric disorders. Supernus is developing several product candidates in neurology and psychiatry to address opportunities in epilepsy and attention deficit hyperactivity disorder (ADHD). Supernus’s two epilepsy product candidates are SPN-538 and Epliga. Epliga is in Phase III clinical trials. Supernus ADHD product candidates include SPN-810 (molindone hydrochloride), a treatment for impulsive aggression in patients with ADHD, and SPN-812, a non-stimulant treatment for ADHD. Both of these programs are in Phase II. In addition to these four products candidates, Supernus has several additional product candidates in various stages of development, including SPN-809. Its wholly owned subsidiary includes TCD Royalty Sub LLC.
Below is the Press Release
Catalyst Pharmaceutical Partners, Inc. today announced that it expects to report top-line results from its CPP-109 (vigabatrin) Phase II(b) trial around the end of September 2012 versus the previous guidance of early in the first quarter of 2013.
After discussions with our collaborators, the National Institute on Drug Abuse (NIDA) and the Department of Veterans Affairs Cooperative Studies Program (VACSP), and our statistical and regulatory consultants, we have been able to work through the complexities of modifying our statistical analysis plan. This will enable us to report top-line trial results about four months earlier than previously expected.
"We are pleased that we will be able to report the top-line results of our CPP-109 Phase II(b) clinical trial sooner than expected," said Patrick J. McEnany, Chief Executive Officer of Catalyst. "We are committed to bringing safe and effective breakthrough products for the treatment of cocaine addiction to the market as quickly as possible, and the earlier reporting of these data is consistent with that philosophy."
About the CPP-109 Phase II(b) Clinical Trial
The 24-week CPP-109 Phase II(b) clinical trial is randomized, double-blind and placebo-controlled in 207 patients recruited at 13 sites in the United States. It is designed to demonstrate that the rate of cocaine dependent subjects treated with CPP-109, who abstain from cocaine use in the last two weeks of the trial's treatment phase (weeks 8 and 9), will be higher than patients treated with placebo. Other outcomes include: i) reduction in cocaine use days; ii) increase in clean urines collected; and iii) improvements in other measures of subject well-being and cocaine craving.
About CPP-109 and Fast Track Status
CPP-109 is a GABA analog that is Catalyst's designation for vigabatrin. Catalyst licensed CPP-109 from Brookhaven National Laboratory for the treatment of cocaine and other addictions, and has been granted "Fast Track" status by the U.S. Food and Drug Administration (FDA) for cocaine addiction. Under the Federal Food, Drug, and Cosmetic Act, the FDA is directed to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Fast Track designation emphasizes communication between Catalyst and the FDA, and provides Catalyst benefits that may help to expedite the approval process. For example, Fast Track designation affords Catalyst the potential to submit a New Drug Application (NDA) for CPP-109 on a rolling or modular basis, allowing the FDA to review sections of the NDA in advance of receiving a full submission. The designation also means that Catalyst may have increased communications with the FDA regarding the design of its clinical studies, which may expedite the development and review of Catalyst's application for the approval of CPP-109 for cocaine addiction and may provide greater certainty overall in the regulatory pathway.
About Cocaine Addiction
According to the most recent Substance Abuse and Mental Health Services Administration (SAMHSA) survey, an estimated 1.5 million people, or 0.6% of the population aged 12 or over, had used cocaine in the month preceding the survey. Additionally, in 2010, approximately 637,000 people aged 12 or over had used cocaine for the first time within the preceding 12 months, an average of approximately 1,700 new users per day. In addition, approximately 699,000 patients received treatment for cocaine abuse in 2010.
Cocaine addiction is not only a U.S. health problem. In 2009, according to the United Nations Office on Drugs and Crime, there were 4.3 million -- 4.7 million users of cocaine between the ages of 15 and 64 across Europe who had used it within the past year. Catalyst believes that the direct and indirect costs of cocaine use are indicative of a global public health problem, representing a significant unmet medical need for which no adequate pharmaceutical therapies exist.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage specialty pharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases and disorders of the central nervous system, including addiction and epilepsy. Catalyst has two products in development, CPP-109 and CPP-115. It is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109, for the treatment of cocaine addiction. Both CPP-109 and CPP-115 have been granted "Fast Track" status by the FDA for the treatment of cocaine addiction. Catalyst is also planning to evaluate CPP-109 for the treatment of other addictions. Catalyst believes that it controls all current intellectual property for drugs that have a mechanism of action related to the inhibition of GABA aminotransferase. For more information about Catalyst, go to www.catalystpharma.com .
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause the Company's actual results in future periods to differ materially from forecasted results. A number of factors, including whether CPP-109 will be safe and effective for the treatment of addiction, whether the CPP-109 Phase II(b) clinical trial will be successful, whether any of the above-described benefits from having received Fast Track status from the FDA for CPP-109 will be realized by the Company, whether CPP-109 will ever be approved for commercialization, and those other factors described in the Company's filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect the Company. Copies of the Company's filings with the SEC are available from the SEC, may be found on the Company's website or may be obtained upon request from the Company. The Company does not undertake any obligation to update the information contained herein, which speaks only as of this date.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. (Peregrine) is a clinical-stage biopharmaceutical company that develops and manufactures monoclonal antibodies for the treatment of cancer and viral infections. As of April 30, 2011, the Company had three Phase II clinical programs, including two oncology programs, as well as a hepatitis C virus (HCV) program. Peregrine’s pipeline of investigational monoclonal antibodies is based on two technology platforms, including phosphatidylserine (PS)-targeting antibodies and deoxyribonucleic acid (DNA)/histone-targeting antibodies. Bavituximab is its PS-targeting antibody. Cotara is the Company’s DNA/histone-targeting antibody-based on its Tumor Necrosis Therapy (TNT) technology platform. Peregrine’s wholly owned biomanufacturing subsidiary is Avid Bioservices, Inc., which provides integrated cGMP commercial and clinical manufacturing services for Peregrine and third-party clients.
About Chelsea Therapeutics International Ltd
Company has announced an enrollment for Phase II/Phase III trials of gevokizumab to treat interleukin-1 beta-mediated inflammatory diseases
Press release read below
It has opened enrollment in two clinical trials to determine gevokizumab's potential to treat interleukin-1 beta-mediated inflammatory diseases. The first trial is XOMA's global Phase 3 study investigating the ability of gevokizumab to reduce the signs and symptoms, including vitreous haze, in patients with non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye. The second trial is a Phase 2 study to evaluate the potential for gevokizumab to improve pain symptoms, physical function and structural abnormalities in patients with erosive osteoarthritis of the hand. Patients currently are being screened in both trials.
In this study, titled A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis, the Company intends to enroll patients with active non-infectious intermediate, posterior, or pan-uveitis with a vitreous haze score equal to or greater than 2+ on the Standardization of Uveitis Nomenclature (SUN) / National Eye Institute (NEI) scale in at least one eye. They will be randomized to receive either one of two doses of gevokizumab or placebo. The study's primary endpoint is the proportion of patients demonstrating a significant reduction in vitreous haze score on Day 56. The study also will assess the effect of gevokizumab on additional endpoints, including response rates at other time points and changes from baseline in visual acuity.
Paul Rubin, M.D., XOMA's Senior Vice President of Research and Development and Chief Medical Officer, stated, "As preclinical and clinical data have shown that IL-1 beta is an important contributor to the inflammation seen in uveitis, we believe gevokizumab's ability to potently inhibit IL-1 beta signaling could be relevant in controlling this inflammation, as well as the inflammation associated with other conditions. Because of this, we established a proof-of-concept program in November 2011 to lead us to additional indications for this antibody. Included in this program is the ongoing trial in moderate to severe acne vulgaris from which we anticipate top-line data by year end. Today, we opened enrollment in the second POC indication, erosive osteoarthritis of the hand, which we believe will complete enrollment sometime around the end of 2012."
XOMA's Phase 2 proof-of-concept study of gevokizumab in active inflammatory, erosive osteoarthritis of the hand is designed to enroll approximately 90 patients who will be randomized to receive gevokizumab or placebo. The study is designed and powered to detect a significant improvement from baseline versus placebo in the mean Australian/Canadian Hand Osteoarthritis Index (AUSCAN™) pain score in the target hand at three months. The study also will capture multiple outcome measures including pain, stiffness, physical function, radiographic and MRI changes, as well as changes in C-reactive protein and concomitant acetaminophen use.
About XOMA corporation:
XOMA Corporation (XOMA), formerly XOMA Ltd., discovers and develops antibody-based therapeutics. XOMA’s drug candidate gevokizumab is an antibody that binds to the inflammatory cytokine interleukin-1 beta (IL-1 beta). Its XOMA 3AB is a biodefense anti-botulism product candidate consists of a combination of antibodies, was developed through funding from the National Institute of Allergy and Infectious Diseases (NIAID) of the United Sates National Institutes of Health (NIH). In June 2011, it discovery of two classes of human monoclonal antibodies, XOMA Metabolic Activating and Sensitizing (XMetA and XMetS), On January 17, 2012, it announced that it had acquired the United Sates rights to the perindopril franchise from Servier. The agreement includes ACEON, a marketed angiotensin converting enzyme (ACE) inhibitor, and a portfolio of three fixed-dose combination product candidates where perindopril is combined with another active ingredient(s), such as a calcium channel blocker.
News Release:
Cleveland BioLabs, Inc. today announced strong survival results for its randomized, blinded, placebo-controlled efficacy study of CBLB502 in 179 non-human primates (NHPs) conducted under Good Laboratory Practice (GLP) with elements of Good Clinical Practice (GCP), as required by the U.S. Food and Drug Administration's (FDA) Animal Rule. The study demonstrated with a high degree of statistical significance the dose-response relationship between the administration of CBLB502 and the survival of lethally irradiated animals, the study's primary endpoint.
Animals in the study received a 70% lethal dose of total body irradiation (TBI) followed by a single injection of a range of doses of CBLB502 or a placebo, in each case, 25 hours after irradiation. In addition to determination of 60-day survival, the study measured multiple pharmacodynamic parameters which the Company believes are essential for animal-to-human dose conversion.
A minimal efficacious dose of CBLB502 was determined and doses above the minimal efficacious dose formed a plateau at approximately 75% survival, compared to 27.5% survival in the placebo treated group. These results demonstrated with a high degree of statistical significance (p < 0.0001 for the trend up to the 40 ug/kg dose and p = 0.0021 for the trend up to the 10 ug/kg dose) that a single administration of CBLB502 given 25 hours after TBI led to a nearly three-fold increase in overall survival in the subject animals.
Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance, stated, "We are very pleased with the compelling survival data reported in this study. In addition to demonstrating CBLB502's effect on survival, we believe this study supports our methodology for dose conversion between animals and humans. We plan on using the findings from this trial as a basis for finalizing our remaining development steps with the FDA and, ultimately, submitting our Biologic License Application."
Yakov Kogan, Ph.D., MBA, interim Chief Executive Officer, commented: "I congratulate our team on the rigorous execution of this study. To our knowledge, this trial is the first ever GLP/GCP compliant, randomized, blinded study done with any radiation countermeasure. CBLB502 continues to exceed our expectations and we are as committed as ever to moving this program forward."
Rosetta Genomics Lts ( NASDAQ: ROSG ) touched $15.5 today, as stock jumped more than 100% since our recommendation to buy it on dips. We recommended it to buy on dips. Keep following us for such hot picks. Read our recommendation Here
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| Rosetta Genomics |
Trading Tip : Stock may have seen all upside for now and may be good for long term investment, buy on dips.
Press Release:
Rosetta Genomics Ltd., a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that Novitas, the designated Medicare Administrative Contractor for the Company's miRview(R) mets^2 assay, has informed Rosetta that it plans to cover this assay for all Medicare beneficiaries. MiRview(R) mets^2 accurately identifies the primary tumor of origin in primary and metastatic cancer including Cancer of Unknown or Uncertain Primary ("CUP").
"This is a major commercial achievement for Rosetta Genomics as Medicare coverage is a critical step toward widespread commercial adoption and payment for our lead diagnostic assay, miRview(R) mets^2, and enables access to this clinically valuable test to Medicare patients. This decision is important not only because Medicare is the largest U.S. payor, covering a large percentage of the patients for whom miRview(R) mets^2 has been ordered historically and would be expected to be ordered in the future, but also because private payors often look to Medicare's decisions when setting their own reimbursement policies," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We are particularly pleased with how rapidly we obtained Medicare coverage, as we launched our direct selling effort in the U.S. just one year ago.
"The decision by Novitas to cover the miRview(R) mets^2 assay reflects the clinical importance of determining the tumor origin in hard-to-diagnose metastatic cancers and CUP. This is particularly important as new, targeted cancer treatments are developed for site-specific cancers. We believe that the miRview(R) mets^2 assay is an important tool that can improve the ability of physicians to accurately diagnose CUP in order to optimize treatment plans," added Mr. Berlin.
The policy will cover the 45 million Medicare beneficiaries and will enable Rosetta to provide the miRview(R) mets2 assay for Medicare beneficiaries throughout the U.S. at no cost to the patient, thereby eliminating an adoption barrier for the physician ordering the test and for the patient. Novitas' decision is based on the extensive body of clinical data published in peer-reviewed journals from clinical studies conducted internally as well as at leading institutions. Once the Novitas decision is finalized with respect to reimbursement level, we will focus our efforts on obtaining appropriate coverage and reimbursement from commercial payors.
"This coverage decision will allow all appropriate Medicare patients access to the miRview(R) mets^2 assay and further recognizes the value that our assays are delivering to physicians, payors and patients. We look forward to continuing our dialogue with Novitas, and to their final decision on reimbursement level within the coming weeks," concluded Mr. Berlin.
About miRview(R) Products miRview(R) are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview(R) mets and miRview(R) mets^2 accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview(R) squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview(R) meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview(R) lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview(R) kidney accurately classifies the four most common kidney tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and Oncocytoma. miRview(R) tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview(R) mets and miRview(R) mets^2 test, 60,000 from miRview(R) squamous, 60,000 from miRview(R) meso, 54,000 from miRview(R) kidney and more than 1 million patients worldwide from miRview(R) lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the globe. For more information, please visit www.mirviewdx.com . Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, the Company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview(R) product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visit www.rosettagenomics.com .
Forward-Looking Statements Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the expectation that private-sector payors would look to Medicare's decisions when setting their own reimbursement policies and that we will be able to obtain appropriate coverage and reimbursement from commercial payors, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta's approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta's ability to obtain, maintain and protect its intellectual property; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's need and ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta's ability to successfully develop its products and services; Rosetta's ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta's technology; the ability to obtain a formal agreement for Medicare coverage and to maintain an equitable reimbursement valuation; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; and Rosetta's short operating history; as well as those risks more fully discussed in the "Risk Factors" section of Rosetta's Annual Report on Form 20-F for the year ended December 31, 2011 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.
Press Release:
Rosetta Genomics Ltd., a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that Novitas, the designated Medicare Administrative Contractor for the Company's miRview(R) mets^2 assay, has informed Rosetta that it plans to cover this assay for all Medicare beneficiaries. MiRview(R) mets^2 accurately identifies the primary tumor of origin in primary and metastatic cancer including Cancer of Unknown or Uncertain Primary ("CUP").
"This is a major commercial achievement for Rosetta Genomics as Medicare coverage is a critical step toward widespread commercial adoption and payment for our lead diagnostic assay, miRview(R) mets^2, and enables access to this clinically valuable test to Medicare patients. This decision is important not only because Medicare is the largest U.S. payor, covering a large percentage of the patients for whom miRview(R) mets^2 has been ordered historically and would be expected to be ordered in the future, but also because private payors often look to Medicare's decisions when setting their own reimbursement policies," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We are particularly pleased with how rapidly we obtained Medicare coverage, as we launched our direct selling effort in the U.S. just one year ago.
"The decision by Novitas to cover the miRview(R) mets^2 assay reflects the clinical importance of determining the tumor origin in hard-to-diagnose metastatic cancers and CUP. This is particularly important as new, targeted cancer treatments are developed for site-specific cancers. We believe that the miRview(R) mets^2 assay is an important tool that can improve the ability of physicians to accurately diagnose CUP in order to optimize treatment plans," added Mr. Berlin.
The policy will cover the 45 million Medicare beneficiaries and will enable Rosetta to provide the miRview(R) mets2 assay for Medicare beneficiaries throughout the U.S. at no cost to the patient, thereby eliminating an adoption barrier for the physician ordering the test and for the patient. Novitas' decision is based on the extensive body of clinical data published in peer-reviewed journals from clinical studies conducted internally as well as at leading institutions. Once the Novitas decision is finalized with respect to reimbursement level, we will focus our efforts on obtaining appropriate coverage and reimbursement from commercial payors.
"This coverage decision will allow all appropriate Medicare patients access to the miRview(R) mets^2 assay and further recognizes the value that our assays are delivering to physicians, payors and patients. We look forward to continuing our dialogue with Novitas, and to their final decision on reimbursement level within the coming weeks," concluded Mr. Berlin.
About miRview(R) Products miRview(R) are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview(R) mets and miRview(R) mets^2 accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview(R) squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview(R) meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview(R) lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview(R) kidney accurately classifies the four most common kidney tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and Oncocytoma. miRview(R) tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the miRview(R) mets and miRview(R) mets^2 test, 60,000 from miRview(R) squamous, 60,000 from miRview(R) meso, 54,000 from miRview(R) kidney and more than 1 million patients worldwide from miRview(R) lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the globe. For more information, please visit www.mirviewdx.com . Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, the Company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview(R) product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visit www.rosettagenomics.com .
Forward-Looking Statements Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the expectation that private-sector payors would look to Medicare's decisions when setting their own reimbursement policies and that we will be able to obtain appropriate coverage and reimbursement from commercial payors, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta's approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta's ability to obtain, maintain and protect its intellectual property; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's need and ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta's ability to successfully develop its products and services; Rosetta's ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta's technology; the ability to obtain a formal agreement for Medicare coverage and to maintain an equitable reimbursement valuation; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; and Rosetta's short operating history; as well as those risks more fully discussed in the "Risk Factors" section of Rosetta's Annual Report on Form 20-F for the year ended December 31, 2011 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.
Stock of the biotech company Arena Pharmaceutical Inc ( NASDAQ: ARNA ) soared on friday as its anti obesity drug. Stock Jumped more than 75 % to $6.39.
See below the News Release:
Arena Pharmaceuticals Inc. (ARNA) (ARNA)’s weight- loss pill gained the backing of an advisory panel, putting two obesity drugs in line for U.S. approval almost two years after regulators rejected them as too risky.
Food and Drug Administration advisers voted 18-4 yesterday that the benefits of Arena’s pill, known as lorcaserin, outweigh the risks. The FDA is scheduled to decide by June 27 on lorcaserin, and doesn’t have to follow the panel’s advice.
Arena, based in San Diego, is competing with Mountain View, California-based Vivus Inc. (VVUS) (VVUS) and Orexigen Therapeutics Inc. (OREX) (OREX), based in La Jolla, California, to introduce the first weight- loss drug since Roche Holding AG’s (ROG) Xenical in 1999. The FDA previously turned down all three drugs. Panel members raised concerns that lorcaserin provides a modest benefit while potentially raising heart risks.
“It’s time to approve this drug,” said Peter Gross, a panel member and chairman of the Hackensack Physician-Hospital Alliance in New Jersey. “We do not put our head in the sand.”
Arena more than doubled in early trading to $7.70 as of 7:28 a.m. New York time. Trading had been halted during the panel’s meeting. The company gained 7 percent May 9 to close at $3.66 in New York.
Panel members suggested that if lorcaserin gains approval, Arena should do follow-up studies on how it affects the heart. The FDA advisers made the same suggestion for a post-market study of Vivus’s pill Qnexa after backing it 20-2 in February. The agency is scheduled to decide on Qnexa by July 17.
Obesity Epidemic
More than 78 million U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta. Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the CDC.
“The advisory committee’s positive vote supports our belief in lorcaserin as a potential new treatment option,” Jack Lief, Arena’s president and chief executive officer, said in a statement. Arena has licensed lorcaserin to Tokyo-based Eisai Co. (4523) to sell in the U.S.
In failing to approve lorcaserin in October 2010, the agency said people didn’t lose enough weight on the medicine to justify the risk of developing cancer associated with the drug. The company resubmitted its application to the FDA for review in January with new data.
New analysis allayed cancer concerns, Abraham Thomas, chairman of the panel and head of the endocrinology and diabetes division at Henry Ford Hospital in Detroit, said after voting in support of the pill.
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| Arena Pharmaceuticals |
See below the News Release:
Arena Pharmaceuticals Inc. (ARNA) (ARNA)’s weight- loss pill gained the backing of an advisory panel, putting two obesity drugs in line for U.S. approval almost two years after regulators rejected them as too risky.
Food and Drug Administration advisers voted 18-4 yesterday that the benefits of Arena’s pill, known as lorcaserin, outweigh the risks. The FDA is scheduled to decide by June 27 on lorcaserin, and doesn’t have to follow the panel’s advice.
Arena, based in San Diego, is competing with Mountain View, California-based Vivus Inc. (VVUS) (VVUS) and Orexigen Therapeutics Inc. (OREX) (OREX), based in La Jolla, California, to introduce the first weight- loss drug since Roche Holding AG’s (ROG) Xenical in 1999. The FDA previously turned down all three drugs. Panel members raised concerns that lorcaserin provides a modest benefit while potentially raising heart risks.
“It’s time to approve this drug,” said Peter Gross, a panel member and chairman of the Hackensack Physician-Hospital Alliance in New Jersey. “We do not put our head in the sand.”
Arena more than doubled in early trading to $7.70 as of 7:28 a.m. New York time. Trading had been halted during the panel’s meeting. The company gained 7 percent May 9 to close at $3.66 in New York.
Panel members suggested that if lorcaserin gains approval, Arena should do follow-up studies on how it affects the heart. The FDA advisers made the same suggestion for a post-market study of Vivus’s pill Qnexa after backing it 20-2 in February. The agency is scheduled to decide on Qnexa by July 17.
Obesity Epidemic
More than 78 million U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta. Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the CDC.
“The advisory committee’s positive vote supports our belief in lorcaserin as a potential new treatment option,” Jack Lief, Arena’s president and chief executive officer, said in a statement. Arena has licensed lorcaserin to Tokyo-based Eisai Co. (4523) to sell in the U.S.
In failing to approve lorcaserin in October 2010, the agency said people didn’t lose enough weight on the medicine to justify the risk of developing cancer associated with the drug. The company resubmitted its application to the FDA for review in January with new data.
New analysis allayed cancer concerns, Abraham Thomas, chairman of the panel and head of the endocrinology and diabetes division at Henry Ford Hospital in Detroit, said after voting in support of the pill.
Cancer Risks
An FDA staff report May 8 determined the risks of cancer may be smaller than thought. An agency review of the potential for humans developing brain tumors seen in rats tested with lorcaserin found the risk is negligible, agency staff said in the report. They also determined benign breast tumors in rats were more common than malignant ones at all dose levels.
Lorcaserin affects an area of the brain that controls appetite and metabolism, according to Arena. It works in a similar way to fenfluramine, part of the fen-phen appetite- suppression drug combination pulled from pharmacies 15 years ago when it was linked to heart-valve abnormalities.
Some panel members suggested the FDA require lorcaserin to include a risk management plan that possibly screens patients for abnormalities before starting treatments and warns patients about the potential of developing a valve abnormality.
Study Results
Patients who tested Arena’s treatment in three studies lost about 3 percent more of their body weight than those who took a placebo, according to FDA staff. People who took part in trials on Vivus’s Qnexa lost 6.7 percent and 8.9 percent more of their body weight on mid and high doses compared to those who used a placebo, FDA staff said in a Feb. 20 report on the drug.
Panel members who voted against lorcaserin questioned whether the weight loss was enough.
“Weight loss is clinically discernible with lorcaserin but I’m not sure it’s clinically meaningful,” said Sanjay Kaul, a panel member and professor at the David Geffen School of Medicine at the University of California, Los Angeles.
Like Arena’s lorcaserin, the FDA declined to approve Vivus’s Qnexa in October 2010. Orexigen won a panel’s backing in December 2010 before the agency declined to approve the company’s drug, Contrave. Orexigen, developing Contrave with Osaka, Japan-based Takeda Pharmaceutical Co. (4502), agreed in September to conduct a two-year study of the medicine’s heart risks.
The Food and Drug Administration on Friday approved a new impotence drug, Vivus Inc.'s Stendra.
The pill is intended to be taken 30 minutes before sex, but Vivus said that in clinical trials, some patients were able to have sex as little as 15 minutes after taking the drug. Pfizer Inc.'s Viagra is supposed to be taken at least 30 minutes before sex. The FDA said an estimated 30 million men have importance, or erectile dysfunction.
In clinical trials, the most common side effects of Stendra, or avanafil, were headache, redness of the face and other areas, nasal congestion, back pain, and symptoms similar to the common cold. Vivus said the drug shouldn't be taken more than once per day.
Vivus licensed Stendra from Japanese drugmaker Mitsubishi Tanabe Pharma. It has worldwide rights to the drug except for some countries in the Asia-Pacific region.
Vivus has said it is talking to potential marketing partners for Stendra, and may sell the drug outright to another company. Analysts said Friday they expect Vivus to sell Stendra to another drug company to help fund future sales of its experimental obesity drug Qnexa.
"Given the large market opportunity and the potentially differentiating faster onset of action, we believe that in the hands of big pharma Stendra is probably worth around $300 million," said Cowen and Co. analyst Simos Simeonidis.
Simeonidis said Vivus will need a partner to help sell Qnexa, and will turn to a large pharmaceutical company with experience launching major drugs. He said it's also possible that another company could buy Vivus.
Rodman and Renshaw analyst Michael King said Vivus could get as much as $100 million for the rights to Stendra. He estimated that U.S. sales could peak at $483 million in 2016. After that, he said sales are likely to fall because generic versions of Viagra and other drugs will reach the market.
Vivus is based in Mountain View, Calif. The FDA was scheduled to make a decision on Qnexa this month, but announced it is extending its review by another three months. It is now expected to make a ruling by July 17.
Shares of Vivus ended the session up 72 cents, or 3 percent, at $25.15. After-hours the stock picked up 40 cents to $25.55
The pill is intended to be taken 30 minutes before sex, but Vivus said that in clinical trials, some patients were able to have sex as little as 15 minutes after taking the drug. Pfizer Inc.'s Viagra is supposed to be taken at least 30 minutes before sex. The FDA said an estimated 30 million men have importance, or erectile dysfunction.
In clinical trials, the most common side effects of Stendra, or avanafil, were headache, redness of the face and other areas, nasal congestion, back pain, and symptoms similar to the common cold. Vivus said the drug shouldn't be taken more than once per day.Vivus licensed Stendra from Japanese drugmaker Mitsubishi Tanabe Pharma. It has worldwide rights to the drug except for some countries in the Asia-Pacific region.
Vivus has said it is talking to potential marketing partners for Stendra, and may sell the drug outright to another company. Analysts said Friday they expect Vivus to sell Stendra to another drug company to help fund future sales of its experimental obesity drug Qnexa.
"Given the large market opportunity and the potentially differentiating faster onset of action, we believe that in the hands of big pharma Stendra is probably worth around $300 million," said Cowen and Co. analyst Simos Simeonidis.
Simeonidis said Vivus will need a partner to help sell Qnexa, and will turn to a large pharmaceutical company with experience launching major drugs. He said it's also possible that another company could buy Vivus.
Rodman and Renshaw analyst Michael King said Vivus could get as much as $100 million for the rights to Stendra. He estimated that U.S. sales could peak at $483 million in 2016. After that, he said sales are likely to fall because generic versions of Viagra and other drugs will reach the market.
Vivus is based in Mountain View, Calif. The FDA was scheduled to make a decision on Qnexa this month, but announced it is extending its review by another three months. It is now expected to make a ruling by July 17.
Shares of Vivus ended the session up 72 cents, or 3 percent, at $25.15. After-hours the stock picked up 40 cents to $25.55
Is Human Genome Science ( NASDAQ: HGSI ) really worth more than $2.6 billion? It is a question to be asked when time comes, but it may help to gain a stock more than 100% than yesterday's close as company has rejected $2.6 billion takeover bid from Glaxo Smithkline Plc.
Read below the news transcript:
Human Genome Sciences Inc. (HGSI) rejected an unsolicited offer from GlaxoSmithKline Plc (GSK), its partner on the lupus treatment Benlysta, to buy the U.S. company for about $2.59 billion.
The $13-a-share cash offer, which represents an 81 percent premium to yesterday’s closing stock price of $7.17, doesn’t reflect the company’s value, Rockville, Maryland-based Human Genome said today in a statement. The board is exploring alternatives including a potential sale of the company, and Glaxo has been invited to participate in that process, Human Genome said.
Glaxo is seeking to take advantage of a 76 percent slide in Human Genome shares from their 2011 peak. Sales growth for Benlysta, Human Genome’s first drug on the market, has disappointed investors, and the company may not become profitable for years. Human Genome is also collaborating with Glaxo on two other experimental drugs, darapladib to treat hardening of the arteries, and Syncria for diabetes and heart failure.
“It’s the potential of all three drugs” that’s appealing to Glaxo, said Tim Franklin, an analyst at MainFirst Bank AG in London. “I guess they’ve been watching and waiting. It’s going to be very difficult for Human Genome to argue for a higher price because obviously this is what the market thinks they’re worth.”
Human Genome more than doubled to $15 a share in trading before the Nasdaq Stock Market opened. Glaxo shares gained 1.3 percent to 1,460.50 pence at 11:43 a.m. in London. A spokeswoman for London-based Glaxo didn’t immediately return a call seeking comment.
First Drug
Benlysta, approved by by regulators in the U.S. and Europe last year, is Human Genome’s first drug to reach the market. The company lost $381 million last year on sales of $130.9 million. Analysts predict revenue will jump 79 percent this year to $234.4 million, based on the average of 19 estimates compiled by Bloomberg. The company will report its first annual profit in 2015, according to analysts surveyed by Bloomberg.
Glaxo’s offer values Human Genome at 11 times this year’s estimated sales.
SmithKline Beecham Plc, a predecessor company to Glaxo, entered into a collaboration agreement with Human Genome in May 1993, before the U.S. company’s initial public offering in December of that year.
Human Genome said it’s asked Glaxo for additional information on experimental treatments including darapladib, which is in the last of three stages of human studies usually needed for regulatory approval, and Syncria, also in late-stage testing. Syncria, also known as albiglutide, belongs to the same class of medicines as Novo Nordisk A/S (NOVOB)’s Victoza.
‘Very Promising’
The experimental diabetes therapy is a “very, very promising” new treatment, Glaxo Chief Executive Officer Andrew Witty said in February. “And we’ll see when the full data comes in before we can really articulate the full picture to you.”
“When you have so many projects together in late-stage development, it makes sense to want to integrate 100 percent of their value,” Eric Le Berrigaud, an analyst at Bryan, Garnier & Co. in Paris, said in a telephone interview. “It means Glaxo thinks these projects have a potential. Hard to say which project they are betting on the most.”
The U.S. biotechnology company has hired Goldman, Sachs & Co. and Credit Suisse Securities (USA) LLC as financial advisers and Skadden Arps Slate Meagher & Flom LLP and DLA Piper LLP as legal counsel.
No Assurance
“There can be no assurance that any transaction will occur,” Human Genome said. "HGS does not intend to discuss the status of its evaluation unless and until a specific transaction has been approved.’’
It’s unlikely any company other than Glaxo would want to bid, MainFirst’s Franklin said.
“There will be control provisions around Benlysta, darapladib and albiglutide that will protect GSK’s interests so it would not be worth anyone else bidding that price for the rest of the business,” he said.
French rival Sanofi and Switzerland’s Roche Holding AG also have made unsolicited offers for companies whose shares have fallen. Sanofi bought Genzyme Corp. for $20.1 billion last year after Genzyme’s stock declined following manufacturing woes. Roche yesterday abandoned its $6.7 billion offer for Illumina Inc. after the target company rejected the approach and refused to negotiate.
Read below the news transcript:
Human Genome Sciences Inc. (HGSI) rejected an unsolicited offer from GlaxoSmithKline Plc (GSK), its partner on the lupus treatment Benlysta, to buy the U.S. company for about $2.59 billion.
The $13-a-share cash offer, which represents an 81 percent premium to yesterday’s closing stock price of $7.17, doesn’t reflect the company’s value, Rockville, Maryland-based Human Genome said today in a statement. The board is exploring alternatives including a potential sale of the company, and Glaxo has been invited to participate in that process, Human Genome said.
Glaxo is seeking to take advantage of a 76 percent slide in Human Genome shares from their 2011 peak. Sales growth for Benlysta, Human Genome’s first drug on the market, has disappointed investors, and the company may not become profitable for years. Human Genome is also collaborating with Glaxo on two other experimental drugs, darapladib to treat hardening of the arteries, and Syncria for diabetes and heart failure.
“It’s the potential of all three drugs” that’s appealing to Glaxo, said Tim Franklin, an analyst at MainFirst Bank AG in London. “I guess they’ve been watching and waiting. It’s going to be very difficult for Human Genome to argue for a higher price because obviously this is what the market thinks they’re worth.”
Human Genome more than doubled to $15 a share in trading before the Nasdaq Stock Market opened. Glaxo shares gained 1.3 percent to 1,460.50 pence at 11:43 a.m. in London. A spokeswoman for London-based Glaxo didn’t immediately return a call seeking comment.
First Drug
Benlysta, approved by by regulators in the U.S. and Europe last year, is Human Genome’s first drug to reach the market. The company lost $381 million last year on sales of $130.9 million. Analysts predict revenue will jump 79 percent this year to $234.4 million, based on the average of 19 estimates compiled by Bloomberg. The company will report its first annual profit in 2015, according to analysts surveyed by Bloomberg.
Glaxo’s offer values Human Genome at 11 times this year’s estimated sales.
SmithKline Beecham Plc, a predecessor company to Glaxo, entered into a collaboration agreement with Human Genome in May 1993, before the U.S. company’s initial public offering in December of that year.
Human Genome said it’s asked Glaxo for additional information on experimental treatments including darapladib, which is in the last of three stages of human studies usually needed for regulatory approval, and Syncria, also in late-stage testing. Syncria, also known as albiglutide, belongs to the same class of medicines as Novo Nordisk A/S (NOVOB)’s Victoza.
‘Very Promising’
The experimental diabetes therapy is a “very, very promising” new treatment, Glaxo Chief Executive Officer Andrew Witty said in February. “And we’ll see when the full data comes in before we can really articulate the full picture to you.”
“When you have so many projects together in late-stage development, it makes sense to want to integrate 100 percent of their value,” Eric Le Berrigaud, an analyst at Bryan, Garnier & Co. in Paris, said in a telephone interview. “It means Glaxo thinks these projects have a potential. Hard to say which project they are betting on the most.”
The U.S. biotechnology company has hired Goldman, Sachs & Co. and Credit Suisse Securities (USA) LLC as financial advisers and Skadden Arps Slate Meagher & Flom LLP and DLA Piper LLP as legal counsel.
No Assurance
“There can be no assurance that any transaction will occur,” Human Genome said. "HGS does not intend to discuss the status of its evaluation unless and until a specific transaction has been approved.’’
It’s unlikely any company other than Glaxo would want to bid, MainFirst’s Franklin said.
“There will be control provisions around Benlysta, darapladib and albiglutide that will protect GSK’s interests so it would not be worth anyone else bidding that price for the rest of the business,” he said.
French rival Sanofi and Switzerland’s Roche Holding AG also have made unsolicited offers for companies whose shares have fallen. Sanofi bought Genzyme Corp. for $20.1 billion last year after Genzyme’s stock declined following manufacturing woes. Roche yesterday abandoned its $6.7 billion offer for Illumina Inc. after the target company rejected the approach and refused to negotiate.
Biodel Inc ( NASDAQ:BIOD ), stock jumped more than 20% after yesterday's sharp sell off in the stock. No announcements from the company regarding any development. Big players might preparing for upcoming news events as there might be a positive developments.
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| Biodel Inc |
Chelsea Therapeutics ( NASDAQ: CHTP ), stock jumped more than 18 % in the morning trade after company reported that its patented Northera Treatment provide durable beneficial effects. As far as hte impact of the news is concerned, stock might see big upside from here. Also One analyst Roth Capital's David Moskowitz has raised a price target from $6 to $18. He is expecting possible FDA approval as early as Q1. He believes the drug could generate $250 million of annual sales by 2015.
Our Call: Traders and Investors might take a buy positions.
Below is the News Release about Chelsea's Northera Treatment.
Northera Treatment Provides Durable Beneficial Effects on both Systolic Blood Pressure and the Symptoms of NOH in Patients with Multiple System Atrophy
Robust Symptomatic Benefit of Northera Associated with Fewer Falls in Patients with NOH and Parkinson's Disease Prone to Falling
Improvements in MDS-UPDRS and Hoehn & Yahr Scores Seen with Northera Treatment May Indicate Benefit in Non-Motor and Motor Features of Parkinson's Disease
Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) announced that new data from Phase III trials in symptomatic neurogenic orthostatic hypotension (NOH) demonstrating the activity and tolerability of NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, were presented at the Movement Disorder Society's 15th International Congress of Parkinson's Disease and Movement Disorders in Toronto, Ontario, Canada.
In addition to the two posters presentations, Chelsea sponsored a symposium detailing the clinical results of Northera for the treatment of neurogenic orthostatic hypotension and reviewing the role of norepinephrine depletion in the pathophysiology of Parkinson's disease (PD) and autonomic failure. Copies of both posters and the presentations from the symposium are available on the Chelsea website at www.chelseatherapeutics.com.
In a poster, "Safety and efficacy of Northera (droxidopa) in Multiple System Atrophy," (Abstract Number: 778), Gregor K. Wenning, MD, PhD MSc, Medical University, Innsbruck, Austria, highlighted the results of a meta-analysis of Northera Studies 301 and 302 showing the mean Orthostatic Hypotension Questionnaire (OHQ) composite score of Northera-treated patients improved significantly (2.9 units; P<0.05) from baseline to study completion when compared to placebo-treated patients (1.7 units). Greater improvement in standing systolic blood pressure, mean composite Orthostatic Hypotension Symptom Assessment (OHSA), and Orthostatic Hypotension Daily Activity Scale (OHDAS) scores of the Northera- vs. placebo-treated patients was also observed. These findings were consistent with the results of the full study population in Study 301, presented by Dr. Wenning during the symposium, in which Northera-treated patients demonstrated improvements in multiple signs and symptoms of NOH including a statistically significant (p=0.003) improvement in OHQ Composite score, statistically significant benefit in 8 out of 10 individual OHQ items and a significant improvement (p ≤ 0.001) in standing SBP compared to placebo.
Detailing the results from Northera Study 306A, in a poster "Efficacy of Northera (droxidopa) in Patients with Neurogenic Orthostatic Hypotension associated with Parkinson's disease (PD)," (Abstract Number: LB21) and during his symposium presentation, Robert A. Hauser, MD, University of South Florida, Tampa, FL, described the symptomatic benefit of Northera treatment in this population and the associated reduction in falls reported during the study. Of note, Dr. Hauser reported that data from the study suggests that a majority of patients with symptomatic NOH and PD fall, and many of these fall more than once, in a 10-week period. In Study 306A, approximately 43% of patients fell more than once during the course of the study. Among these repeat fallers, the robust benefit of Northera treatment in reducing dizziness and improving Hoehn & Yahr (HY) and the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores was associated with a 60% reduction in falls and 52% reduction in falls-related injuries.
The pronounced improvement in MDS-UPDRS and HY scores among Northera-treated patients in Study 306A further suggests that Northera may provide therapeutic benefit in the non-motor and motor symptoms of Parkinson's disease beyond the symptomatic improvement of NOH. In addition to a mean improvement of 1.37 units on Part I of the MDS-UPDRS (non-motor experiences of daily living), Northera treatment showed a mean improvement of 2.1 units on Part II of the MDS-UPDRS (motor experiences of daily living) and a 0.4 unit improvement in HY scores over the course of the treatment period.
"The results from our clinical trials in neurogenic orthostatic hypotension have consistently highlighted the broad symptomatic benefits of Northera in patients with autonomic failure and we are delighted to have had these findings showcased at the Movement Disorder Society's annual meeting," commented Dr. Art Hewitt, Chelsea's Chief Scientific Officer. "These most recent data from Study 306A, though preliminary, suggests that in addition to chronic symptoms such as dizziness, weakness and fatigue, patients with NOH associated with Parkinson's disease are at a high risk for falls and associated injuries. If our on-going trial, Study 306B, replicates these early findings, it could not only have significant implications for the future treatment of neurogenic orthostatic hypotension but could also have important implications for subsequent studies in Parkinson's disease and other movement disorders associated with norepinephrine depletion. "
About Neurogenic Orthostatic Hypotension
NOH is a neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in lightheadedness, dizziness, blurred vision and fainting episodes when a person assumes a standing position. Symptoms of chronic NOH can be incapacitating, not only putting patients at high risk for falls and associated injuries, but also severely affecting the quality of life of patients and their loved ones. The only FDA-approved treatment for orthostatic hypotension has a black box warning indicating that the drug has not been shown to be effective in alleviating the symptoms of the condition and is associated with a pronounced side-effect profile including significant supine hypertension.
About Northera
NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA [FREE Stock Trend Analysis]) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing Phase II trial and completed a Phase II trial in intradialytic hypotension (IDH) study with positive results.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, NORTHERA™ (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risk of regulatory approvals, including our planned NDA for Northera; risks and costs of drug development, including the uncertainty of cost, timing and outcome of clinical trials; our reliance on our lead drug candidates Droxidopa and CH-4051; our need to raise operating capital; our history of losses; reliance on collaborations and licenses; intellectual property risks; competition; market acceptance for our products, if any are approved for marketing; and reliance on key personnel including specifically Dr. Pedder.
Catalyst Pharmaceuticals Partners Inc ( NASDAQ: CPRX ), a small biotech company sneakily moving up since last few trading sessions. Stock has logged more than 36 % upside in last 3 trading sessions. Traders might keep an eye on the stock as you might see a huge breakout in the stock. As of now, there is no announcements from the company regarding any development.
Our Call: Keep an eye on the stock and wait for any positive development announced from the company.
Immucell Corp ( NASDAQ: ICCC ), stock jumped after company has announced that Center for Veterinary Medicine, USFDA has accepted the data of Nisin Residue in milk. Stock jumped more than 20%. Liquidity in the stock is low and there might be a hight risk game to trade the stock.
Our Call: We think the news might not significant enough to trigger a huge upside in the stock and Traders might stay away to play the stock based on news.
Below is the news from Reuters:
ImmuCell Corporation announced that the Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA) has accepted the pivotal Nisin residue data in milk and has assigned a zero milk discard time and zero meat withdrawal period. These claims are subject to obtaining the Human Food Safety (HFS) Technical Section Complete Letter and ultimately approval of the New Animal Drug Application (NADA). Zero Discard means that there would be no requirement to discard milk during treatment or for a period of time thereafter. After our first alert on penny biotech stock Genta Incorporated ( OTC: GNTA ), stock has logged an up move of more than 62 % during yesterday's trading session. We announced an alert when stock was just 28% up.
Read our alert here
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Read our alert here
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Biotech Mover: Rxi Pharmaceuticals ( NASDAQ: RXII ) announced positive Phase II efficacy results of NeuVax (E75) , Stock jumped 15 % to $1.56.
Below is the News Release:
RXi Pharmaceuticals Announces Positive NeuVaxTM (E75) Phase 2 Efficacy Results After 36 Months of Follow-Up
NeuVax (E75) demonstrates statistical significance in 3-year Disease Free Survival (DFS) in adjuvant breast cancer, with 0% recurrence in the treated group versus 22.2% in the untreated group
NeuVax continues to demonstrate an excellent safety and tolerability profile
Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study expected to initiate in 1H 2012 under FDA approved Special Protocol Assessment (SPA)
WORCESTER, Mass.--(BUSINESS WIRE)--RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced updated data from its Phase 2 clinical trial of NeuVax™ at the American Society of Clinical Oncology (ASCO) annual meeting. RXi is developing NeuVax for the adjuvant treatment of low to intermediate HER2 expressing breast cancer.
“We are committed to initiating the Phase 3 trial per the approved SPA in the first half of 2012, in order to accelerate this treatment for women who suffer from this terrible disease and who are not eligible for other HER2 directed therapies.”
The NeuVax Phase 2 trials enrolled 182 patients, including node positive and node negative, HER2 1+, 2+ and 3+ patients. All patients received standard of care (SoC) therapy and were confirmed to be disease-free prior to enrollment. Following enrollment, eligible patients were administered the NeuVax vaccine once a month for six months, followed by booster shots one every 6 months thereafter. The efficacy endpoint for the trial was disease free survival (DFS), the same endpoint in the FDA approved SPA (Special Protocol Assessment) for the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study.
“These encouraging clinical results underscore the potential for cancer immunotherapy to develop into potent and well tolerated targeted therapies,” stated Dr. Beth Mittendorf, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, who was also named the primary investigator for the Phase 3 trial. “The results of this trial suggest that NeuVax addresses an unmet medical need and clearly warrants a randomized, multicenter Phase 3 study to confirm efficacy and safety in a larger population.”
Key highlights from the Phase 2 trial include:
Statistically significant increase in disease free survival (DFS) at 36 months in the NeuVax treated group vs the control group for the planned Phase 3 patient population (p=0.035). The vaccine treated group showed no recurrences of cancer (0% recurrence rate), while the control group demonstrated a 22% recurrence rate which is consistent with historical norms. The planned Phase 3 patient population as defined in the FDA approved Special Protocol Assessment (SPA) includes breast cancer patients who are node positive, have low to intermediate HER2 expression (HER2 1+ and 2+ by IHC), are HLA A2+ & A3+ and who are disease free following standard of care therapy.
An excellent safety profile, with no serious adverse events (SAE’s) related to drug reported to date. All adverse events (AE’s) reported were minor and resolved within 24 hours.
In the ITT (intent to treat) population who received all ranges of doses and schedules, the low to intermediate HER2 expressers continued to show significant activity in improvement of DFS (p=0.045), with the vaccine group demonstrating a reduction of 66% in relative risk for recurrence. This data demonstrates strong support for targeting of low to intermediate HER2 expressers, a group for which there is currently no HER2 directed therapies.
The optimally dosed (1 milligram of E75 plus 250 micrograms of GM-CSF) group continues to demonstrate superior efficacy compared to sub-optimal doses (varying doses from 100 - 500 micrograms E75 plus 125 – 500 micrograms GM-CSF), with a recurrence rate of 3% for the optimally dosed group vs 12% for the sub-optimally dosed group and 14% for the control group.
“These promising results strongly build upon and support previously reported efficacy and safety data,” commented Dr. Mark Ahn, CEO and president of RXi. “We are committed to initiating the Phase 3 trial per the approved SPA in the first half of 2012, in order to accelerate this treatment for women who suffer from this terrible disease and who are not eligible for other HER2 directed therapies.”
About NeuVax™ (E75)
NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful Phase II trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for a Phase 3 clinical trial in adjuvant therapy of women with low-to-intermediate HER2+ status.
According to the National Cancer Institute, over 200,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for Human Epidermal growth factor Receptor 2 (IHC 1+, 2+ or 3+). Only 25% of all breast cancer patients, those with HER2 3+ disease are eligible for Herceptin® (trastuzumab; Roche-Genentech) which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2 positive patients (HER2 1+ and 2+) who achieve remission with current standard of care, but have no available HER2 targeted adjuvant treatment options to maintain their disease free status.
About RXI-109
RXi Pharmaceuticals has initiated development of clinical candidate RXI-109, a self-delivering RNAi compound (sd-rxRNA) for the reduction of dermal scarring in planned surgeries. RXI-109 is designed to reduce the expression of CTGF (connective tissue growth factor), a critical regulator of several biological pathways involved in fibrosis, including scar formation in the skin. RXi is beginning manufacturing activities with an experienced cGMP oligonucleotide manufacturer to support its IND enabling toxicology program, and is preparing a pre-IND package for submission to the FDA. Pending FDA review, the company intends to use an innovative clinical trial design to study safety and tolerability as well as initial efficacy in its first clinical trial targeted for 2012.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. For more information, visit www.rxipharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the future expectations, plans and prospects of the development of RXi Pharmaceuticals Corporation's products. These forward-looking statements about future expectations, plans and prospects of the development of the Company's products are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in the Company's most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. The Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
Genta Incorporated ( OTC: GNTA ), penny stock moving higher 28 % today and stock up more than 61 % since last 3 trading sessions. Company has announced an updated results of its Phase II clinical trials of Tesetaxel. Investors seeing a hope in the positive results of trials. Traders might keep an eye on the stock before it explode.
Below is the detailed news release from Genta Incorporated
Genta Presents Updated Results of Phase 2 Trial of Tesetaxel in Patients With Advanced Gastric Cancer
Weight-Based Dose Established for Global Clinical Studies
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| Genta Inc |
BERKELEY HEIGHTS, N.J., June 3, 2011 (GLOBE NEWSWIRE) -- Genta Incorporated (OTCBB:GNTA) today announced updated interim results from a trial of tesetaxel used as 2nd-line treatment in patients with advanced gastric cancer. The ongoing trial is lead by the M.D. Anderson Cancer Center in Houston, TX. The data are presented in conjunction with the 2011 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL. Tesetaxel is the leading oral taxane in clinical development.
The trial is evaluating 3 cohorts of patients, all of whom had failed one prior chemotherapy regimen that must have included a platinum-containing compound (cisplatin, oxaliplatin, or carboplatin) and a fluoropyrimidine compound (5-fluorouracil [5-FU] or capecitabine [Xeloda®; Hofmann LaRoche, Inc.]). Two patient cohorts were treated over a range of "fixed" (as opposed to "weight-based") doses starting at 40-45 mg (Cohort 1) and 50-60 mg (Cohort 2), whereas Cohort 3 is using conventional weight-based dosing at the previously identified maximally tolerable dose (MTD).
In Cohorts 1 and 2, wide variations in body weight were observed. By example, body surface area (BSA, a composite measure of weight and height), of an average U.S. adult male approximates 1.7 m2, whereas the median BSA for patients in the first 2 study cohorts was 1.9 and 2.0 m2, respectively. One major response was observed in each of 11 and 13 patients in the first 2 cohorts, respectively; however, no episodes of > Grade 3 neutropenia were observed in either fixed-dose cohort, suggesting that patients had been substantially under-dosed. Accordingly, Cohort 3 – which is currently open to accrual – employs a starting dose of 27 mg/m2 with escalation to 35 mg/m2 as tolerated in subsequent cycles. Data from this cohort are too early to evaluate.
Since overall survival (OS) is the primary endpoint in planned Phase 3 studies, an analysis of OS was conducted across all 3 cohorts in which any patient's actual starting dose converted to a weight-based dose of > 26 mg/m2. With early followup, median OS in this group of 12 patients has not been reached, but currently exceeds a median of 7.5+ months. For context, docetaxel (Taxotere®; Sanofi, Inc.), a standard taxane, is approved for 1st-line treatment of gastric cancer. Four publications have reported the use of docetaxel as 2nd-line therapy in gastric cancer that show response rates ranging from 5% to 19% and median OS ranging from 3.5 to 8.4 months.
"While fixed dosing is convenient, the extremes of body weight observed in Western subjects has lead to substantial under-dosing, which in a global study would greatly increase the risk of under-treatment in seriously ill patients," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "We now have a broadening experience in 1st and 2nd-line gastric cancer in both Western and Asian patients, both alone and in combination with other agents. Consequently, we have high confidence that safe and potentially effective dosing schedules of tesetaxel have been identified for these disparate populations."
Tesetaxel in Advanced Gastric Cancer
In a completed Phase 2a study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m2 once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine. All but 2 patients had also received a 3rd chemotherapy drug. Results showed 7 major objective responses (5 confirmed and 2 unconfirmed) in 35 evaluable patients, with 14 patients having achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients.
About Tesetaxel
Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
Unlike standard taxanes that must be administered intravenously, tesetaxel is a capsule that is taken by mouth. Compared with the standard agents, clinical and preclinical data show that tesetaxel:
Is active in diseases that are resistant to standard taxanes
Is not associated with serious (occasionally fatal) hypersensitivity reactions
Eliminates requirements for premedication (e.g., steroids, antihistamines, etc.)
Reduces damage to peripheral nerves
Offers flexible and convenient dosing for patients
Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
About Gastric Cancer
Cancer of the stomach (gastric cancer) is the second most common cause of death worldwide due to cancer. The disease is the fourth most common type of cancer, and approximately one million new cases of gastric cancer are diagnosed each year. The illness shows a marked geographic distribution, with most cases arising in East Asia. The disease is especially prevalent in Korea, Japan, and China. The American Cancer Society estimates that approximately 21,000 new cases of gastric cancer will be diagnosed in the U.S. during 2010, resulting in approximately 11,000 deaths.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company is developing tesetaxel, a novel, orally absorbed taxane that is in the same class of drugs as paclitaxel and docetaxel. As the leading oral taxane in clinical development, tesetaxel has been evaluated in a broad program of completed or ongoing Phase 2a/Phase 2b clinical trials. The Company has announced that gastric (stomach) cancer will be the lead indication for Phase 3 registration studies. A second portfolio compound, Genasense® (oblimersen sodium) Injection, is a modified DNA-based antisense drug that may enhance the effectiveness of anticancer therapy. The Company has recently announced that a randomized trial of Genasense did not increase overall survival in patients with advanced melanoma. Genta is exclusively marketing Ganite® (gallium nitrate injection) in the U.S, which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite® and Genasense® are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words "potentially," "anticipate," "could," "calls for," and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
the Company's ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
the safety and efficacy of the Company's products or product candidates;
the timing of commencement and completion of any clinical trials;
the Company's assessment of its clinical trials;
the Company's ability to develop, manufacture, license, or sell its products or product candidates;
the Company's ability to enter into and successfully execute any license and collaborative agreements;
the adequacy of the Company's capital resources and cash flow projections, the Company's ability to obtain sufficient financing to maintain the Company's planned operations, or the risk of bankruptcy;
the adequacy of the Company's patents and proprietary rights;
the impact of litigation that has been brought against the Company; and
the other risks described under Certain Risks and Uncertainties Related to the Company's Business, as contained in the Company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2011 and its most recent quarterly report on Form 10-Q.
