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2.18 now! :)
Looks good to me too.
GLTY.
One of their phase 3 studies for NOH did not meet the primary endpoint. They announced during the November 3Q Earnings CC that they were going to be meeting w/ the FDA that month to see if they could change the primary endpoint of the 2nd Phase 3 trial.
From 3Q Earnings PR:
"Our operational focus during the third quarter was primarily on the completion of our two Phase III trials of Droxidopa in neurogenic orthostatic hypotension and these efforts resulted in the reporting of our first study and reaching our target enrollment in the second," commented Dr. Simon Pedder, President and CEO of Chelsea. "While we did not achieve statistical significance on our primary endpoint in Study 302, data from the study clearly demonstrate activity, support the symptomatic and functional benefits, and validate safety and tolerability of Droxidopa in neurogenic orthostatic hypotension. We are currently scheduled to meet with the FDA later this month to solicit feedback on the results of Study 302, discuss what, if any, changes could be made to strengthen then outcome of Study 301, and determine the best course of action to secure approval of Droxidopa for the treatment of symptomatic NOH in the US."
GLTA.
ChemGenex, Hospira, Announce Agreement to License, Develop and Commercialize Leukemia Drug in Europe
* Press Release
* Source: ChemGenex Pharmaceuticals Limited
* On 6:59 pm EST, Sunday December 13, 2009
MELBOURNE, Australia & LAKE FOREST, Ill.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ASX:CXS - News) and Hospira, Inc. (NYSE:HSP - News) announced today that they have entered into an exclusive agreement to license, develop and commercialize ChemGenex’s product candidate omacetaxine mepesuccinate, a novel targeted cytotoxic pharmaceutical product, in Europe, the Middle East and parts of Africa (the Territory). Applications for marketing approval of the product have been accepted for regulatory review in both the United States and Europe for treatment of patients with chronic myeloid leukemia (CML) who have failed to respond to the current standard of care treatment, imatinib mesylate, and who have the Bcr-Abl T315I mutation.
Under the terms of the agreement, Hospira will make an initial payment of €11.1 million (A$ 17.8 million), with the potential for up to an additional €74.1 million (A$ 119.4 million), in performance milestone payments based on the successful development and commercialization of omacetaxine. In addition, following successful commercialization, Hospira will pay ChemGenex a royalty on product sales in the Territory.
ChemGenex will complete registration of omacetaxine in its initial indication with the European Medicines Agency (“EMEA”), while Hospira and ChemGenex will collaborate to explore future applications in a variety of hematological malignancies. Hospira will have responsibility for commercializing omacetaxine in the Territory.
"We are very excited by the promise omacetaxine holds to improve outcomes for seriously ill patients who have stopped responding to other treatments available for their condition," said Michael Kotsanis, President Europe, Middle East and Africa, Hospira, Inc. "This agreement is a further step in Hospira's strategy to build upon our strong portfolio of oncology and hematology products."
"We are very pleased to announce this important agreement, in keeping with our corporate strategy of partnering in Europe and other parts of the world, as we prepare for the launch of omacetaxine in the U.S., if approved," said Greg Collier, CEO and Managing Director ChemGenex. "We look forward to working with the Hospira team to realize omacetaxine’s potential in the hematology-oncology space in Europe."
About Omacetaxine
Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc).
Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine is currently in global phase 2/3 clinical trials for subsequent indications within CML and has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) as well as Fast Track status by the FDA.
About ChemGenex Pharmaceuticals Limited
ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. The company is developing omacetaxine, its lead product candidate, for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been accepted by the U.S. Food and Drug Administration and a Marketing Authorisation Application has been validated by the European Medicines Agency for CML patients with the Bcr-Abl T315I mutation. ChemGenex has established a corporate alliance with Hospira to develop and commercialize omacetaxine in Europe, the Middle East and parts of Africa, and is seeking to establish commercial partnerships in the rest of the world. ChemGenex plans to commercialize omacetaxine itself in North America. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" For additional information on ChemGenex Pharmaceuticals, please visit the company’s website at http://www.chemgenex.com.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com
Safe Harbor Statement
Certain statements made herein (including for this purpose sites to which a hyperlink has been provided) that use the words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company’s technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company’s technology, the market for the company’s products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management’s current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected.
Private Securities Litigation Reform Act of 1995 --
A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including projections of certain measures of Hospira's results of operations, projections of certain charges and expenses, and other statements regarding Hospira's goals and strategy. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K filed with the Securities and Exchange Commission, which is incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
2.01 now...
GLTA.
Chelsea Therapeutics Reports Subgroup Analysis of 44 Parkinson's Patients in Study 302 Shows Highly Statistically Significant Benefits of Droxidopa Therapy
* Press Release
* Source: Chelsea Therapeutics
* On 7:30 am EST, Monday December 14, 2009
CHARLOTTE, N.C., Dec. 14, 2009 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP - News) announced that new data from a subgroup analysis of the 44 Parkinson's Disease (PD) patients enrolled in Study 302, a Phase III withdrawal study of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH), demonstrated a more robust response compared to the overall study population. Study investigators presented these data during a symposium at the XVIII WFN World Congress on Parkinson's Disease and Related Disorders in Miami.
Study 302 evaluated the efficacy and safety of Droxidopa, a pro-drug that results in increased body stores of norepinephrine, in 101 patients with symptomatic NOH. All patients in Study 302 were evaluated for functional and symptomatic improvement through multiple endpoints including the orthostatic hypotension questionnaire (OHQ). The OHQ is a global measure of disease activity consisting of a two-part questionnaire that includes the six-item orthostatic hypotension symptom assessment scale (OHSA) and the four-item orthostatic hypotension daily activities scale (OHDAS), along with corresponding OHSA, OHDAS and OHQ composite scores.
Results from this subgroup analysis demonstrate that PD patients, all of whom were on concomitant Levodopa/dopa-decarboxylase inhibitors, showed the strongest therapeutic response to Droxidopa. PD patients receiving Droxidopa showed improvement over placebo on 9 of the 10 individual items of the OHQ as well as all 3 composite measures.
On the four question OHDAS, the 44 PD patients on Droxidopa demonstrated a statistically significant improvement in their ability to perform activities of daily living that require standing for a short period of time (p<0.05), standing for a long time (p<0.01), and walking for a short time (p<0.05). This compares to the 101 total patients that only reported statistically significant improvements in activities that require standing for a short time (p<0.05) and standing for a long time (p<0.05).
The marked improvements observed across each of the individual OHDAS variables resulted in a highly significant benefit as measured by both the OHDAS composite (p<0.005) and the OHQ composite (p=0.005) scores for PD patients receiving Droxidopa in Study 302.
"To achieve such highly statistically significant results on these efficacy measures in a sub-group of only 44 patients provides substantial evidence for the magnitude of Droxidopa's therapeutic benefit in patients with Parkinson's disease," said Christopher Mathias, D Phil, DSc, FRCP, FMedSci. Professor of Neurovascular and Autonomic Medicine, Imperial College London, St. Mary's Hospital and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK and a principal investigator of the trial. "Further, the data from this study confirm that concomitant use of dopamine decarboxylase inhibitors, a mainstay of Parkinson's treatment, does not inhibit the beneficial effect of Droxidopa. This suggests that Droxidopa can be easily integrated into a patient's existing Parkinson's treatment program without affecting its therapeutic benefits or the benefits of existing therapies."
Parkinson's disease is the second most common neurodegenerative disorder in America. As a result of decreased levels of norepinephrine associated with PD, up to an estimated 20% of these patients may experience NOH symptoms associated with the disease or as a complication of medication. 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 decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, and syncope. 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, and generating significant health care costs. 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 the Study and Droxidopa Registration Program in NOH
Study 302, a Phase III trial of Droxidopa for the treatment of symptomatic NOH, was a double-blind, placebo controlled withdrawal-design study in which all patients underwent an initial open-label dose titration. Patients demonstrating both a symptomatic benefit and blood pressure improvement following titration continued on open-label Droxidopa for a 1-week run-in period prior to being randomized on a 1:1 basis to continue on active drug or be withdrawn to placebo. Results from this previously reported trial demonstrated Droxidopa's therapeutic benefit over placebo on 16 out of the study's 17 symptomatic and functional outcome variables, five of which achieved statistical significance (p<0.05).
About Droxidopa
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 systems atrophy (MSA) 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, 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 (MTX).
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 our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-1504, 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.
According to that article sometime in first half of 2010...
GLTA.
Yeah... That hasn't made any sense to me either... You would think with such big news they would be getting crazy volume... :/
JMO.
GLTA.
Insider transactions: http://www.mffais.com/heph
Huge huge huge, in my opinion.
GLTA.
Thanks! :)
I've been keeping an eye on LJPC for a while now... But in my opinion ADMP is the better buy... However, the merger won't occur until 1Q 2010 I read somewhere. Not sure if that's right though.
GLTA.
GLTA.
Very few shares outstanding.
GLTA.
Cordex looks promising, if they can pay the note that's due...
JMO.
GLTA.
Additions to December Watch List:
KOOL - ThermoGenesis Corp.
INO - Inovio Biomedical Corp.
HLCS - Helicos BioSciences Corp.
HEPH - Hollis-Eden Pharmaceuticals, Inc.
VIAP - Via Pharmaceuticals, Inc.
CXM - Cardium Therapeutics, Inc.
NLTX - Nile Therapeutics, Inc.
Do your OWN DD before investing. Do not buy or sell securities based on anyone's recommendation.
GLTA.
CHTP Article by Adam Feuerstein:
LINK: http://www.thestreet.com/_yahoo/story/10621053/1/chelsea-just-got-riskier-biobuzz.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
CHARLOTTE, N.C. (TheStreet) -- An update on my previously discussed long trade idea for Chelsea Therapeutics:
Last night, the company said it plans to meet with U.S. drug regulators seeking permission to change the primary endpoint of an ongoing phase III study of the droxidopa in patients with orthostatic hypotension.
As a result, data from this study won't be ready for release this quarter, but will be delayed into early next year, pending the outcome of the FDA meeting, the company said.
Chelsea executives explained last night that altering the ongoing phase III study to use a different primary endpoint may increase the chances for a successful outcome. [Recall, the first phase III study failed -- a negative result tossed up to bad trial design since droxidopa did show some clinical benefit to patients.]
That strategy may work, but the maneuver also significantly changes the Chelsea-droxidopa story and raises the level of risk. Instances are rare in which a company makes a radical change to a pivotal study midstream. It's not even clear if the FDA will allow the change to be made.
With Chelsea beaten up in late September on the failure of the first droxidopa trial, the risk-reward going into the second trial was much improved. To me, this made Chelsea a reasonable long trade going into the results of the second phase III study, which were due later this quarter.
The risk-reward is no longer as favorable, unfortunately, because the design of the second phase III study is now uncertain. Chelsea may get what it wants -- a new primary endpoint and a positive outcome for droxidopa. If so, the stock will definitely be higher. My worry is that the risk of the opposite happening is now a lot higher, so for me, this long trade idea no longer works.
List of stocks we're watching for December:
ANDS - Anadys Pharmaceuticals, Inc.
CHTP - Chelsea Therapeutics, Inc.
ANX - ADVENTRX Pharmaceuticals, Inc.
SNSS - Sunesis Pharmaceuticals, Inc.
NEXM - NexMed, Inc.
FCSC.OB - Fibrocell Science, Inc.
BNVI - Bionovo, Inc.
DARA - DARA BioSciences, Inc.
As always, do your OWN DD before investing. I am NOT a stock analyst, just a normal investor.
GLTA.
lol. That works too! ;)
GLTA.
Thanks!
GLTA.
If you'd like to receive email alerts, go to the bottom of the iBox and sign up.
GLTA.
Thanks!! :)
Yeah, it just keeps going up... It's up a dime after hours according to Nasdaq...
GLTA.
Will try to update iBox over the weekend...
GLTA!
Credit Suisse is the top institutional holder, correct?
GLTA.
IVD is gonna be a sleeper for a while, in my opinion.
JMO
GLTA.
Do your OWN DD before investing...
Yup... I'm surprised we're unchanged after hours instead of red...
GLTA.
ANDS 2.69 AH on 400 shares...
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx?selected=ANDS&mkttype=after
GLTA.
Great close here, imo.
GLTA.
Haven't been paying much attention to WAMU, anything new developing?
TIA.
Nice comeback today... Any of you think we'll see .06-.07 next week?
GLTA.
NLTX looks pretty promising, in my opinion.
GLTA.
Interim data to be presented Dec. 12.
http://finance.yahoo.com/news/Cytori-Completes-Enrollment-bw-4260848994.html?x=0&.v=1
GLTA.
Nice increase in price recently...
GLTA.
Looks promising, imo.
EntreMed Reports Receipt of Third Quarter Royalty Payment
* Press Release
* Source: EntreMed, Inc.
* On 4:15 pm EST, Friday December 11, 2009
ROCKVILLE, Md., Dec. 11 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), today announced the receipt of $1.7 million in royalty revenue from sales of Thalomid® during the third quarter compared to estimated royalty revenue of $3.3 million. In addition, the Company anticipates a decrease in fourth quarter and projected revenue for fiscal 2009. The difference in estimated and actual revenues for the third quarter will be reflected in the fourth quarter financial results.
EntreMed also plans to explore the sale of its rights to future royalties from sales of Thalomid® and has instituted additional expense reductions in non-clinical areas. EntreMed will continue ongoing activities in preparation for initiating a Phase II trial in ovarian cancer patients in the second quarter of 2010.
Thalomid® is a registered trademark of Celgene Corporation.
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company committed to developing primarily ENMD-2076, a selective angiogenic kinase inhibitor, for the treatment of cancer. ENMD-2076 is currently in Phase 1 studies in advanced cancers, multiple myeloma, and leukemia. The Company's other therapeutic candidates include MKC-1, an oral cell-cycle regulator with activity against the mTOR pathway currently in multiple Phase 2 clinical trials for cancer, and ENMD-1198, a novel antimitotic agent currently in Phase 1 studies in advanced cancers. The Company also has an approved IND application for Panzem® in rheumatoid arthritis. Additional information about EntreMed is available on the Company's web site at www.entremed.com and in various filings with the Securities and Exchange Commission.
Forward Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in Securities and Exchange Commission filings under "Risk Factors," including risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the failure to consummate a transaction to monetize the royalty stream for any reason, including our inability to obtain the required third-party consents; declines in actual sales of Thalomid® resulting in reduced revenues; risks associated with the Company's product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).
CONTACT:
Ginny Dunn
Associate Director, Corporate Communications & Investor Relations
EntreMed, Inc.
240.864.2643
Nice close today, hopefully a sign of much more to come!
GLTA.
Yeah. Awesome, awesome move today!
GLTY.
Nice, green close today.
GLTA.