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Neurogen Announces Adipiplon Preclinical and Clinical Data to Be Presented at Neuroscience 2007
Tuesday November 6, 7:00 am ET
BRANFORD, Conn.--(BUSINESS WIRE)--Neurogen Corporation (Nasdaq: NRGN - News), a drug discovery and development company, today announced that data from several preclinical and clinical studies with adipiplon (formerly NG2-73), the Company’s lead compound for the treatment of insomnia, will be presented on November 6 in five posters at Neuroscience 2007, the Society for Neuroscience annual meeting in San Diego, California.
To date adipiplon has been tested in over 600 subjects in eight clinical studies. Results from two Phase 2b studies with adipiplon in chronic primary insomnia patients were announced earlier this year. These data demonstrated doses that met primary endpoints for sleep induction and for sleep maintenance, with statistical and clinical significance, and with no next-day residual effects. In these Phase 2b studies, adipiplon also achieved statistical significance over placebo for improvement in patient-assessed sleep quality. In addition, this critical measure of patient satisfaction was achieved in a Phase 2a study of adipiplon in transient insomnia—a model of insomnia conducted with healthy volunteers.
Adipiplon has a novel profile, different from currently marketed GABA insomnia drugs and from GABA drugs in development for the treatment of insomnia. Adipiplon is a partial GABA agonist with preference for the alpha-3 subtype receptor, which is associated with the reduction of anxiety, as well as hypnotic, or sleep effects. In clinical studies to date, adipiplon has been shown to be safe and well tolerated.
Posters will be displayed at the Neuroscience 2007 meeting at the San Diego Convention Center in Exhibit Halls B-H in the “Sleep: Systems and Behavior” session on Tuesday, November 6, from 8:00 a.m. – noon PT.
Tuesday, November 6, 2007
"I. Preclinical characterization in vitro of NG2-73 as a potent and selective partial allosteric activator at the benzodiazepine site of GABA(A) receptors with predominant efficacy at the (alpha)3 subunit"
(Abstract control number: 112013)
Poster Board Number: AAA26, 10:00-11:00 a.m. PT
"II. Preclinical characterization in vivo of NG2-73, an (alpha)3-subunit preferring GABA(A) receptor partial allosteric activator, as a sedative-hypnotic agent with an improved side effect profile relative to zolpidem"
(Abstract control number: 111951)
Poster Board Number: AAA23, 11:00 a.m.-12:00 p.m. PT
"III. Clinical trial data demonstrating sedative-hypnotic efficacy of the (alpha)3-subunit preferring GABA(A) receptor partial allosteric activator, NG2-73: Translational validity of pharmacokinetic/pharmacodynamic (PK/PD) relationships derived from preclinical studies"
(Abstract control number: 111673)
Poster Board Number: AAA17, 9:00-10:00 a.m. PT
"IV. Further pharmacological exploration of (alpha)3-subunit preferring GABA(A) receptor partial allosteric activators: Evidence for anxiolysis and reduced sedative tolerance of NDT 9530021"
(Abstract control number: 112734)
Poster Board Number: AAA21, 9:00-10:00 a.m. PT
"V. Further pharmacological exploration of (alpha)3-subunit preferring benzodiazepine site partial allosteric activator sedative-hypnotics: Anticonvulsant activity of NDT 9530021 in rats"
(Abstract control number: 107530)
Poster Board Number: AAA24, 8:00-9:00 a.m. PT
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, obesity, pain, Parkinson’s disease, restless legs syndrome (RLS), and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Bought some NRGN today, what an ugly day in the neighborhood today!
Neurogen Corporation Announces Appointment of Kenneth J. Sprenger to Vice President, Clinical Development and Operations
Neurogen Corporation (Nasdaq: NRGN), a small molecule drug discovery and development company, announced today that Kenneth J. Sprenger, M.D., M.B.B.Ch,, B.Sc.. has been appointed to the position of Vice President, Clinical Development and Operations.
William H. Koster, CEO, said, “Ken has been responsible for all clinical development activities for our most advanced compound, adipiplon, for the treatment of insomnia--eight clinical studies in over 600 subjects, including two successful Phase 2b studies announced earlier this year. He has also been a key contributor to building the Company’s clinical development infrastructure, which has been critical to our transition from an early-stage discovery company to a mid-stage drug development firm. It gives me great pleasure to recognize his contributions to Neurogen and to announce his appointment to vice president.”
Dr. Sprenger joined Neurogen in January 2005 as Senior Director, Clinical Development and Operations and was promoted to Executive Director the following year. Before joining Neurogen, he had served as Global Clinical Leader for new chemical entities at Bayer Pharmaceuticals in West Haven, Connecticut, where he headed clinical development for vardenafil (Levitra®) and was also closely involved with registration, launch, and marketing planning. Vardenafil was approved by the FDA in 2003. Previously Dr. Sprenger was Medical Director for Bayer in South Africa, where he was responsible for the Company’s Pharmaceutical Medical Department and Bayer’s medical affairs in African countries. Prior to his experience at Bayer, he practiced as a pediatrician and pediatric cardiologist at hospitals in Durban and Cape Town.
Dr. Sprenger holds a B.Sc. in medicine and his M.B.B.Ch. from the University of the Witwatersrand in Johannesburg. He also holds a doctorate in immunology from the University of Cape Town.
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, obesity, pain, Parkinson’s disease, and restless legs syndrome (RLS). Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Neurogen Corporation Announces Appointment of Stephen R. Davis as President
Neurogen Corporation (Nasdaq: NRGN), a small molecule drug discovery and development company, announced today that Stephen R. Davis, previously Executive Vice President and Chief Operating Officer, has been appointed President, effective immediately. As part of on-going succession planning by Neurogen’s Board of Directors, he has also been selected as the eventual successor to William H. Koster, CEO of Neurogen.
The Company also announced that Dr. Stephen Uden has resigned his position as Executive Vice President, Head of R&D, to pursue other interests.
Dr. Koster said, “I’m extremely pleased to announce that Steve Davis is assuming the role of President of Neurogen. He has played key roles in the operations of Neurogen for thirteen years, and his contributions have been central to building the Company. He established, with large pharmaceutical companies, drug discovery and development partnerships valued at over $400 million and has also guided the Company in raising over $200 million in equity financings, as well as providing critical business and marketing perspectives to our scientific decisions. Steve and I continue to work closely together and I am delighted to have him take on his expanded role. Appointing Steve as my eventual successor provides the Company with continuity and strength in its management structure.
“I also want to take this opportunity to thank Steve Uden for his contributions to the Company. Steve has built a strong drug development infrastructure to complement Neurogen’s considerable drug discovery capabilities. We wish him the very best with his future ventures.”
Mr. Davis has been responsible for the business operations of Neurogen, including the business development, finance, and legal functions of the Company. Prior to joining Neurogen as Chief Financial Officer in 1994, he practiced as a corporate and securities attorney with Milbank, Tweed, Hadley and McCloy. At Milbank, Mr. Davis focused on transactions which raised capital in public and private markets for established companies, as well as the formation of numerous joint ventures and alliances. He began his career with Arthur Andersen & Co., where he focused on auditing and advising clients in regulated industries.
Mr. Davis holds a B.S. in accounting from Southern Nazarene University and a J.D. from Vanderbilt University.
Neurogen Announces Adipiplon as Nonproprietary Name for NG2-73
Neurogen Corporation (Nasdaq: NRGN), a drug discovery and development company, today announced that the United States Adopted Names (USAN) Council, in consultation with the World Health Organization (WHO), has approved the nonproprietary name “adipiplon” for Neurogen’s wholly-owned drug candidate for treatment of insomnia, NG2-73.
About adipiplon (formerly NG2-73)
To date adipiplon has been tested in over 600 subjects in eight clinical studies. Recent Phase 2b studies with primary chronic insomnia patients demonstrated doses that met primary endpoints for sleep induction and for sleep maintenance, with statistical and clinical significance. These doses evidenced no next-day residual effects. Also in these Phase 2b studies, adipiplon achieved statistical significance over placebo for improvement in patient-assessed sleep quality. This critical measure of patient satisfaction was also achieved in a Phase 2a study of adipiplon in transient insomnia—a model of insomnia conducted with healthy sleepers.
Adipiplon has a novel selectivity profile, different from currently marketed GABA insomnia drugs and from GABA drugs in development for treatment of insomnia. Adipiplon is a partial GABA agonist preferential for the alpha-3 subtype receptor, which is associated with the reduction of anxiety, as well as hypnotic, or sleep effects. In clinical studies to date, adipiplon has been shown to be safe and well tolerated.
Oversold with an Improving RSI (NRGN) from nightly stockcharts.com scan
Neurogen Corporation Announces Second Quarter 2007 Financial Results
Neurogen Corporation (Nasdaq: NRGN), a drug discovery and development company, today announced financial results for the three and six month periods ended June 30, 2007.
Neurogen recognized a net loss for the second quarter of 2007 of $13.6 million, or $0.33 per share on 41.8 million weighted average shares outstanding. This compares to a net loss during the second quarter of 2006 of $12.5 million, or $0.36 per share on 34.5 million weighted average shares outstanding. The Company recognized a net loss for the six months ended June 30, 2007 of $33.0 million, or $0.79 per share on 41.8 million weighted average shares outstanding, as compared to a net loss of $27.0 million, or $0.78 per share on 34.5 million weighted average shares outstanding for fiscal 2006.
Neurogen’s total cash and marketable securities as of June 30, 2007 totaled $70.9 million.
William H. Koster, Ph.D, President and CEO said, "I’m extremely pleased with our progress and clinical results as we head into the second half of 2007. We hit the primary endpoints in our two Phase 2b studies in chronic insomnia with NG2-73 in June, achieving rapid onset of sleep and sleep maintenance in chronic insomnia patients. The data have confirmed the very rapid sleep onset seen in our previously reported Phase 2a transient insomnia study. Since reporting the top-line data, analyses of other endpoints in the trials revealed that NG2-73 achieved statistical significance over placebo on the subjective measure of sleep quality. This measure of patient satisfaction has now been consistently seen across three Phase 2 studies. NG2-73 has now been tested in over 600 subjects in eight clinical studies to date."
He continued, “Our MCH1 antagonist for obesity, NGD-4715, continues to advance in Phase 1 studies. Our VR-1 antagonist, NGD-8243, partnered with Merck, is moving forward in the clinic, and Aplindore, our D2 partial agonist, remains on track to commence Phase 2 studies in both Parkinson’s disease and Restless Legs Syndrome later this year.”
Operating revenue for the second quarter of 2007 increased to $5.5 million from $1.8 million for the second quarter of 2006 and for the six month period of 2007, increased to $7.9 million from $5.6 million for the comparable period of 2006. The increase in operating revenue for the quarter and the six month period is due to the acceleration of revenue recognition from the conclusion of the research portion of the Company’s collaboration with Merck to discover and develop VR1-based drugs for pain and other indications. The research portion of the collaboration is due to conclude on August 28, 2007. Merck continues pursuing development on several VR-1 compounds from the research collaboration program.
Research and development expenses for the second quarter of 2007 increased to $16.4 million from $11.8 million in the second quarter of 2006 and for the six month period of 2007, increased to $35.3 million from $27.6 million in the comparable period of 2006. The increase in R&D expenses for the quarter and six month periods is due mainly to increased spending in Neurogen’s insomnia and obesity clinical programs, as well as in preclinical drug development programs.
General and administrative expenses for the second quarter of 2007 increased to $3.5 million, compared to $3.2 million for the same period in 2006 and for the six month period of 2007, increased to $7.2 million from $6.2 million for the comparable period of 2006. The increase for the quarter and six month periods is due mainly to increases in patent, legal, and administrative services.
Webcast
The Company will host a conference call and webcast to discuss second quarter results at 8:30 a.m. EDT today, August 2, 2007. The webcast will be available in the Investor Relations section of www.neurogen.com and will also be archived there. A replay of the call will be available after 1:00 pm ET today and accessible through the close of business, August 16, 2007. To replay the conference call, dial 888-286-8010, or for international callers, 617-801-6888, and use the pass code: 86783659.
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, Parkinson’s disease and restless legs syndrome (RLS), pain, obesity, and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Safe Harbor Statement
The information in this press release contains certain forward-looking statements, made pursuant to applicable securities laws that involve risks and uncertainties as detailed from time to time in Neurogen's SEC filings, including its most recent 10-K. Such forward-looking statements relate to events or developments that we expect or anticipate will occur in the future and include, but are not limited to, statements that are not historical facts relating to the timing and occurrence of anticipated clinical trials, and potential collaborations or extensions of existing collaborations. Actual results may differ materially from such forward-looking statements as a result of various factors, including, but not limited to, risks associated with the inherent uncertainty of drug research and development, difficulties or delays in development, testing, regulatory approval, production and marketing of any of the Company's drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of the Company's drug candidates or other properties of drug candidates which could make them unattractive for commercialization, advancement of competitive products, dependence on corporate partners, the Company’s ability to retain key employees, sufficiency of cash to fund the Company's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. For such statements, Neurogen claims the protection of applicable laws. Future results may also differ from previously reported results. For example, positive results or safety and tolerability in one clinical study provides no assurance that this will be true in future studies. Neurogen disclaims any intent and does not assume any obligation to update these forward-looking statements, other than as may be required under applicable law.
NEUROGEN CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except per share data)
(unaudited)
Three Months
Ended
June 30, 2007
Three Months
Ended
June 30, 2006
Six Months
Ended
June 30, 2007
Six Months
Ended
June 30, 2006
Operating revenues:
License fees $3,867 $1,115 $5,232 $2,230
Research revenues 1,666 700 2,706 3,400
Total operating revenues 5,533 1,815 7,938 5,630
Operating expenses:
Research and development 16,373 11,803 35,296 27,632
General and administrative 3,473 3,167 7,230 6,185
Total operating expenses 19,846 14,970 42,526 33,817
Operating loss (14,313 ) (13,155 ) (34,588 ) (28,187 )
Other income, net 562 626 1,446 1,315
Income tax benefit 112 -- 223 --
Net loss $(13,639 ) $(12,529 ) $(32,919 ) $(26,872 )
Basic and diluted loss per share $(0.33 ) $(0.36 ) $(0.79 ) $(0.78 )
Shares used in calculation of loss per share:
Basic and diluted 41,840 34,534 41,793 34,492
NEUROGEN CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
(unaudited)
June 30, 2007 December 31,
2006
Assets
Cash and cash equivalents $37,132 $56,170
Marketable securities 33,785 51,401
Total cash and marketable securities 70,917 107,571
Receivables from corporate partners 145 209
Other current assets, net 2,766 2,813
Total current assets 73,828 110,593
Net property, plant and equipment 26,246 27,085
Other assets, net 54 61
Total assets $100,128 $137,739
Liabilities and Stockholders’ Equity
Current liabilities
Unearned revenue from corporate partners, current portion 7,499 7,520
Other current liabilities 9,265 9,935
Total current liabilities 16,764 17,455
Long term liabilities
Unearned revenue from corporate partners, net of current portion -- 6,768
Loans payable, net of current portion 8,241 8,976
Total liabilities 25,005 33,199
Total stockholders’ equity 75,123 104,540
Total liabilities and stockholders’ equity $100,128 $137,739
Neurogen Corp.
Elaine Grimsell Dodge, 203-315-4615
edodge@nrgn.com
Source: Business Wire (August 2, 2007 - 5:02 AM EST)
News by QuoteMedia
www.quotemedia.com
Bullish Engulfing Patterns (NRGN) from nightly stockcharts.com scan
Bought back my NRGN, not sure why this has been slapped so badly(the fund companies are still buying)
June 25, 2007 - 7:06 AM EDT
Neurogen Announces Positive Results for Proprietary Insomnia Drug in Two Chronic Insomnia Clinical Trials
NG2-73 Achieves Statistical Significance for Primary Endpoints in Each Study at All Doses Tested
Conference Call Scheduled for 8:30 a.m. Today
Neurogen Corporation (Nasdaq: NRGN) today announced positive top-line results from two dose-ranging, Phase 2b clinical trials in chronic insomnia patients with the Company’s proprietary insomnia agent, NG2-73, an alpha-3 preferring GABA(A) partial agonist. Multiple formulations were studied in each trial to determine the best profile for rapidity of sleep onset and maintenance of sleep through the night without residual sedation the next day.
The objective of the first trial--Study 202--was to measure efficacy in sleep maintenance, or the ability to maintain sleep throughout the night after falling asleep. In this study, NG2-73 achieved statistically significant results versus placebo (overall p<0.001) at all doses tested in the primary endpoint of sleep maintenance (measured by Wake After Sleep Onset - or WASO). Study 202 was the first study in which NG2-73 has been studied for sleep maintenance in chronic insomnia patients and confirms efficacy in this group. It included eight different controlled release doses of the compound.
The objective of the second trial – Study 203 – was to demonstrate efficacy in sleep onset, or the amount of time it takes to fall asleep, in chronic insomnia patients. In this study, NG2-73 achieved statistically significant results versus placebo (overall p<0.0001) at all doses tested in the primary endpoint of sleep onset (measured by Latency to Persistent Sleep – or LPS on the first two nights of treatment). Study 203 included two immediate release forms and three controlled release doses of NG2-73.
William H. Koster, PhD, President and CEO of Neurogen, said, “We are very pleased with the results of these studies. We wanted to answer two questions in these trials. First, can we achieve our target profile in chronic insomnia patients of rapid onset of sleep which is maintained throughout the night without next-day residual effects and, second, do we have a controlled release formulation of the drug that we believe we can take forward? The results of these studies indicate the answer to both questions is yes.
“From the sleep onset study it appears we have continued to demonstrate the rapid onset of action in insomnia patients which was observed in our previously reported transient insomnia study. We believe this has the potential to be an important differentiating feature of NG2-73. From the sleep maintenance study we have now established efficacy in chronic insomnia patients and, importantly, we observed five doses that achieved sleep maintenance but did not appear to cause next-day residual effects. Each of these doses used the same formulation technology which is the form we plan to take forward in future studies.”
Study 202: primary endpoint sleep maintenance
Study 202 was a randomized, double-blind, placebo-controlled, cross-over study conducted at five sites in the U.S. It was designed to determine the safety and efficacy of eight different dose and formulation profiles of NG2-73 compared to placebo. Total doses ranged from 3 mg to 12 mg. The primary endpoint was wake after sleep onset (WASO). In addition, sleep onset, as measured by latency to persistent sleep (LPS) and additional measures of sleep maintenance were explored in several secondary endpoints. The study was completed by 36 patients with chronic insomnia, aged up to 64 years. Each patient was randomly assigned to five treatment periods of study drug or placebo. The three nights of each treatment period were conducted in a sleep lab. The first two nights employed polysomnography to objectively measure various sleep parameters and PK testing occurred on the third night. Each WASO assessment was an average of two nights of sleep lab PSG measurements. PSG and PK data will be used to create exposure/response relationships in PK/PD models to determine optimum dose/formulations.
In top-line results of Study 202, NG2-73 demonstrated statistically significant improvement over placebo for reducing WASO at all dose and formulation profiles tested. Eight distinct dose and formulation profiles were tested in addition to placebo.
The following table shows mean WASO totals in minutes for each arm of the study:
Placebo
5mg
“A”
10mg
“A”
1mg IR+
2mg “A”
2mg IR+
4mg “C”
2mg IR+
5mg “A”
2mg IR+
5mg “B”
2mg IR+
10mg “B”
3mg IR+
2mg “A”
WASO (mean -minutes) 73.4 62.7 44.6 53.5 41.7 48.2 50.8 48.0 61.2
p value
(compared to placebo)
0.033 <0.001 <0.001 <0.001 0.001 0.017 <0.001 0.020
IR--basic, or immediate release formulation of NG2-73
Different sustained formulations are designated as “A,” “B,” or “C”
Study 203: primary endpoint sleep onset
Study 203 was a randomized, double-blind, placebo-controlled, parallel group study conducted at 21 sites in the U.S. It was designed to determine the safety and efficacy of five different dose and formulation profiles of NG2-73 compared to placebo. Total doses ranged from 3 mg to 7 mg. The primary endpoint was the time it takes to fall asleep as defined by Latency to Persistent Sleep (LPS) on the first two nights of treatment. Sleep maintenance was also explored in several secondary endpoints. The study included 258 chronic insomnia patients, aged up to 64 years, who received study drug or placebo for approximately 14 days. The first two and last four nights of the study were performed in sleep labs and polysomnography was used to measure various sleep parameters. Each LPS assessment was an average of two nights of sleep lab PSG measurements. For the interim period of the study, patients self-medicated in their homes and kept sleep diaries. Approximately one-third of patients returned to the sleep lab for an additional night for PK testing. PSG and PK data will be used to create exposure/response relationships in PK/PD models to determine optimum dose/formulations.
In top-line results of Study 203, NG2-73 demonstrated statistically significant improvement over placebo for reducing LPS on the first two nights of treatment at all dose and formulation profiles tested. Five treatment arms were tested in addition to placebo.
The following table shows mean LPS difference from baseline in minutes:
Placebo 3mg IR 7mg IR 1mg IR+
2mg “A”
3mg IR+
2mg “A”
2mg IR+
5mg “B”
LPS (mean -minutes difference from baseline) -23.2 -48.3 -56.4 -52.2 -47.2 -47.1
p value
(compared to placebo)
0.0002 <0.0001 0.0008 0.0016 0.0005
IR--basic, or immediate release formulation of NG2-73
Different sustained formulations are designated as “A” or “B”
Safety Profile
In both studies, NG2-73 was safe and well tolerated at all doses tested. One drug-related SAE was observed. The favorable safety and tolerability profile of NG2-73 observed in studies 202 and 203 was consistent with that observed in previous studies. NG2-73 has now been tested in more than 600 subjects.
Secondary Endpoints
Both studies included several secondary (exploratory) endpoints to obtain additional data on sleep onset, sleep maintenance and potential side-effects. These measures included LPS, WASO, Total Sleep Time (TST), Sleep Efficiency (SE), Wake Time During Sleep (WTDS), Digit Symbol Substitution Test (DSST) and Visual Analog Scales (VAS) on sedation. With regard to secondary endpoints, data from Study 202 – the sleep maintenance study -- were internally consistent and statistically significant with respect to sleep onset and maintenance. In this study, the controlled release formulation using matrix “A” described above generally performed best on all parameters with no next-day residual sedation effects. In study 203--the sleep onset study – sleep maintenance, as measured by the secondary endpoints described above, was not observed. In both studies, as expected, residual effects as measured by DSST, were observed in higher doses and with formulations with more prolonged release profiles.
Webcast
Neurogen will host a conference call and webcast to discuss this announcement at 8:30 ET today. The webcast will be available in the Investor Relations section of www.neurogen.com and will also be archived there. A replay of the call will be available after 1:00 pm ET today and accessible through the close of business, July 9, 2007. To replay the conference call, dial 888-286-8010, or for international callers, 617-801-6888, and use the pass code: 95330673.
About Neurogen’s Insomnia Program
Neurogen had announced results from Phase 2 testing in transient insomnia for NG2-73 in May 2006. The primary endpoint of that study measured the efficacy of NG2-73 in reducing time to onset of persistent sleep in a well established clinical model of transient insomnia in healthy adults. In the multi-center, 369 subject study, NG2-73 was shown to significantly reduce time to onset of persistent sleep versus placebo at all doses tested. NG2-73 was well-tolerated at all doses, with no drug-related serious adverse events or drug-related subject withdrawals.
To date, NG2-73 has been tested in Phase 1 and Phase 2 studies involving over 600 individuals and has been well tolerated at all doses tested.
Many prescription drugs approved for treatment of both onset and maintenance symptoms of insomnia work by modulating the gamma-aminobutyric acid (GABA) system of neurotransmitters. GABA is a chemical naturally released in certain parts of the brain in order to inhibit brain activity. Preclinical studies suggest that NG2-73 is pharmacologically distinct from currently marketed insomnia agents, as well as those in development, preferentially modulating alpha-3 receptor subtypes of the GABA-A neurotransmitter system. This preference for alpha-3 may result in sleep induction and maintenance without the side effect profile of currently marketed agents.
Helpful websites for information on insomnia:
National Sleep Foundation http://www.sleepfoundation.org
National Institutes of Health http://www.nih.gov
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, obesity, pain, Parkinson’s disease, restless legs syndrome (RLS), and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Neurogen Safe Harbor Statement
The information in this press release contains certain forward-looking statements, made pursuant to applicable securities laws, which involve risks and uncertainties as detailed from time to time in Neurogen's SEC filings, including its most recent 10-K. Such forward-looking statements relate to activities, events or developments that Neurogen believes, expects or anticipates will occur in the future and include, but are not limited to, earnings estimates, statements that are not historical facts relating to Neurogen’s future financial performance, its growth and business expansion, its financing plans, the timing and occurrence of anticipated clinical trials, and potential collaborations or extensions of existing collaborations. These statements are based on certain assumptions made by Neurogen based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various factors, including, but not limited to, risks associated with the inherent uncertainty of drug research and development, difficulties or delays in development, testing, regulatory approval, production and marketing of any of Neurogen's drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of Neurogen's drug candidates or other properties of drug candidates which could make them unattractive for commercialization, advancement of competitive products, dependence on corporate partners, Neurogen’s ability to retain key employees, sufficiency of cash to fund Neurogen's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. Although Neurogen believes that its expectations are based on reasonable assumptions, it can give no assurance that the anticipated results will occur. For such statements, Neurogen claims the protection of applicable laws. Future results may also differ from previously reported results. For example, positive results or safety and tolerability in one clinical study provides no assurance that this will be true in future studies. Forward-looking statements represent the judgment of Neurogen’s management as of the date of this release and Neurogen disclaims any intent and does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required under applicable law.
Neurogen Corp.
Elaine Grimsell Dodge, 203-315-4615
edodge@nrgn.com
Source: Business Wire (June 25, 2007 - 7:06 AM EDT)
News by QuoteMedia
www.quotemedia.com
Must be about to offer new stock(secondary coming) Has to be reason for sell-off in NRGN.
Neurogen Proprietary Insomnia Compound Data to Be Presented at Associated Professional Sleep Societies Annual Meeting
Neurogen Corporation (Nasdaq: NRGN) today announced that data from previous Phase 1 and Phase 2a clinical studies for NG2-73, the Company’s lead compound for the treatment of insomnia, will be presented in three sessions at the SLEEP 2007 Annual Meeting of the Associated Professional Sleep Societies (APSS) in Minneapolis, Minnesota on June 11 and 13. Two Phase 2b clinical studies with NG2-73 in chronic insomnia patients are currently being conducted by the Company.
Data to be presented at the APSS meeting at the Minneapolis Convention Center include the following:
Monday, June 11, 2007
"Safety and Tolerability in Early Phase I Studies of NG2-73, a Novel
GABA(A) Sleep Agent"
(Abstract number 0116)
Poster presentation, 10:15 - 11:15 a.m. CDT
Exhibit Hall B
Wednesday, June 13, 2007
"Effects of NG2-73 on Sleep Onset, Quality and Next Day Function in a
Transient Insomnia Study"
(Abstract number 0705)
Poster presentation, 10:15 - 11:15 a.m. CDT
Exhibit Hall B
"Pharmacokinetic-Pharmacodynamic Effects of NG2-73, a Novel GABA(A)
Agonist, and Zolpidem"
(Abstract number 0118)
Oral presentation, 2:15 -2:30 p.m. CDT
This presentation will be included in the session entitled "030:
Hypnotic Alcohol Pharmacology."
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, obesity, pain, Parkinson’s disease, restless legs syndrome (RLS), and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Neurogen Safe Harbor Statement
The information in this press release contains certain forward-looking statements, made pursuant to applicable securities laws, which involve risks and uncertainties as detailed from time to time in Neurogen's SEC filings, including its most recent 10-K. Such forward-looking statements relate to activities, events or developments that Neurogen believes, expects or anticipates will occur in the future and include, but are not limited to, earnings estimates, statements that are not historical facts relating to Neurogen’s future financial performance, its growth and business expansion, its financing plans, the timing and occurrence of anticipated clinical trials, and potential collaborations or extensions of existing collaborations. These statements are based on certain assumptions made by Neurogen based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various factors, including, but not limited to, risks associated with the inherent uncertainty of drug research and development, difficulties or delays in development, testing, regulatory approval, production and marketing of any of Neurogen's drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of Neurogen's drug candidates or other properties of drug candidates which could make them unattractive for commercialization, advancement of competitive products, dependence on corporate partners, Neurogen’s ability to retain key employees, sufficiency of cash to fund Neurogen's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. Although Neurogen believes that its expectations are based on reasonable assumptions, it can give no assurance that the anticipated results will occur. For such statements, Neurogen claims the protection of applicable laws. Future results may also differ from previously reported results. For example, positive results or safety and tolerability in one clinical study provides no assurance that this will be true in future studies. Forward-looking statements represent the judgment of Neurogen’s management as of the date of this release and Neurogen disclaims any intent and does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required under applicable law.
Neurogen Corp.
Elaine Grimsell Dodge, 203-315-4615
edodge@nrgn.com
Source: Business Wire (June 4, 2007 - 7:30 AM EDT)
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AP
Neurogen Files $100M Shelf Registration
Tuesday May 29, 5:25 pm ET
Neurogen Files $100M Shelf Registration With SEC
BRANFORD, Conn. (AP) -- Drug developer Neurogen Corp. on Tuesday said it filed a $100 million universal shelf registration statement with the Securities and Exchange Commission.
The filing will permit Neurogen to offer and sell debt securities, shares of its common or preferred stock, or warrants to purchase its securities or stock.
The company will receive all net proceeds from the sale of securities. The company intends to use the proceeds for general corporate purposes, including funding research and development programs, capital expenditures, working capital and repayment or refinancing of its debts.
Shares of Neurogen slipped 12 cents to $7.61 Tuesday.
One of my fav biotechs, new 52 wk high & more good news:
Neurogen Proprietary Insomnia Compound Data Presented at American Psychiatric Association Annual Meeting
Tuesday May 22, 8:00 pm ET
# BRANFORD, Conn.--(BUSINESS WIRE)--Neurogen Corporation (Nasdaq: NRGN - News) today announced that data from previous Phase 1 and Phase 2a clinical studies for NG2-73, the Company's lead compound for the treatment of insomnia, were presented today at the American Psychiatric Association (APA) annual meeting in San Diego. Two Phase 2b clinical studies with NG2-73 in chronic insomnia patients are currently being conducted by the Company. Data presented at the APA meeting include the following abstracts:NG2-73, a Novel GABA(A) Partial Agonist, Rapidly Induced Sleep in a Transient Insomnia Study (Phase 2a)
NG2-73 is a partial GABA(A) agonist with preference for receptors containing the (alpha)3 subunit. Preclinical studies suggest that this compound has sedative hypnotic effects, supporting development as a potential treatment for insomnia.
This double-blind, placebo-controlled, randomized, multi-center study was designed to determine the effects of 1,3,10 and 20mg of NG2-73 compared to placebo on sleep onset as measured by Latency to Persistent Sleep (LPS) in healthy adults. The study design incorporated a single-night, polysomnography (PSG) model of transient insomnia using both first night sleep laboratory adaptation and "phase-advance" effects. Subjects were dosed in the sleep laboratory 2.5 hours prior to median habitual bedtime. "Lights off" and PSG recording started 30 minutes later. Safety was monitored by adverse event recording, physical exams, vital signs, electrocardiogram (ECG) and clinical laboratory tests. 369 healthy subjects aged 24-63 with no self-reported sleep disorders were enrolled.
LPS was statistically significantly reduced, compared to placebo, at all doses of NG2-73, and demonstrated a dose-response relationship. The mean times for LPS were 30.8 minutes for the Placebo group, and 17.8, 10.6, 7.8, and 6.6 minutes for the 1, 3, 10, and 20 mg NG2-73 groups, respectively. NG2-73 also had a statistically significant effect on Total Sleep Time and Sleep Efficiency at doses of 3mg and above. All doses had a statistically significant effect on "refreshing sleep," which was subjectively rated by study participants. NG2-73 was generally well tolerated, with adverse events (AEs) primarily reflecting an extension of the drug's sedative effects, including sedation, somnolence and dizziness. There were no drug-related, serious AEs or discontinuations, and no clinically important changes in safety labs, vital signs, or ECGs.
In this study, NG2-73 was shown to be a potent, well-tolerated, sedative hypnotic that significantly reduced time to onset of persistent sleep versus placebo at all doses tested.
# Exposure-Response Modeling of the GABA(A) receptor partial agonist NG2-73: An Approach for Determining Target Onset and Duration of Sleep Efficacy while Minimizing Next Morning Effects (Phase 1)
NG2-73, a GABA(A) partial agonist with preference for activation of (alpha)3 subunit receptors, represents a potential insomnia treatment with comparable efficacy and potentially fewer safety concerns relative to existing therapeutics. As with all therapeutics, determination of appropriate dose(s) and dosage formulation(s) is imperative to an efficient development program. To assist informed decision making, NG2-73 clinical development is being supported through intensive Exposure-Response (ER) modeling, in order to identify an optimal pharmacokinetic (PK) profile for sleep onset and maintenance while minimizing next morning effects.
Study 1, a Phase 1 crossover study where 19 subjects received single oral doses (1, 3, 5, 10 mg NG2-73, zolpidem 10 mg (Z10), and placebo), compared ER between NG2-73 doses and zolpidem. Plasma concentrations associated with half-maximal visual analog scale effects were approximately 13-fold greater for zolpidem vs. NG2-73. Maximal concentration (Cmax) for NG2-73 10 mg was approximately 6-fold less than Z10. Altogether, ER indicated an approximate 4-5 mg oral NG2-73 dose would provide similar maximal response relative to Z10, which supported Study 2 dose selection. From digit symbol substitution test (DSST) modeling, next morning NG2-73 concentrations of less than 2 ng/mL were targeted to minimize residual effects.
Study 2, a Phase 2a parallel group study (placebo, 1, 3, 10 and 20 mg NG2-73) in healthy adults (N=369, PK in 133 subjects), evaluated NG2-73 sleep onset (latency to persistent sleep, LPS) relative to placebo. NG2-73 Cmax related to half-maximal LPS decrease was less than Cmax observed from NG2-73 1 mg. DSST ER modeling consistently supported the less than 2 ng/mL target to minimize next morning effects.
ER models guided doses and formulations for ongoing Phase 2b patient studies, which aim to confirm these relationships in patients, and establish the concentrations necessary for sleep maintenance. Model-based development using ER will continue supporting informed NG2-73 clinical development decisions.
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, obesity, pain, Parkinson's disease, restless legs syndrome (RLS), and depression. Neurogen conducts its research and development independently and, when advantageous, collaborates with world-class pharmaceutical companies to access additional resources and expertise.
Neurogen Safe Harbor Statement
The information in this press release contains certain forward-looking statements, made pursuant to applicable securities laws, which involve risks and uncertainties as detailed from time to time in Neurogen's SEC filings, including its most recent 10-K. Such forward-looking statements relate to activities, events or developments that Neurogen believes, expects or anticipates will occur in the future and include, but are not limited to, earnings estimates, statements that are not historical facts relating to Neurogen's future financial performance, its growth and business expansion, its financing plans, the timing and occurrence of anticipated clinical trials, and potential collaborations or extensions of existing collaborations. These statements are based on certain assumptions made by Neurogen based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from those expressed or implied by such forward-looking statements as a result of various factors, including, but not limited to, risks associated with the inherent uncertainty of drug research and development, difficulties or delays in development, testing, regulatory approval, production and marketing of any of Neurogen's drug candidates, adverse side effects or inadequate therapeutic efficacy or pharmacokinetic properties of Neurogen's drug candidates or other properties of drug candidates which could make them unattractive for commercialization, advancement of competitive products, dependence on corporate partners, Neurogen's ability to retain key employees, sufficiency of cash to fund Neurogen's planned operations and patent, product liability and third party reimbursement risks associated with the pharmaceutical industry. Although Neurogen believes that its expectations are based on reasonable assumptions, it can give no assurance that the anticipated results will occur. For such statements, Neurogen claims the protection of applicable laws. Future results may also differ from previously reported results. For example, positive results or safety and tolerability in one clinical study provides no assurance that this will be true in future studies. Forward-looking statements represent the judgment of Neurogen's management as of the date of this release and Neurogen disclaims any intent and does not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required under applicable law.
Contact:
Neurogen Corp.
Elaine Grimsell Dodge, 203-315-4615
edodge@nrgn.com
Source: Neurogen Corporation
I know it is off topic, but you are a big reason why I sold my DNDN shares today when I did at 6.43,thank you surf!!! I hope that someday day I will be able to repay the favor back to you.
Thank you surf!!! I consider you to be the only true helper/non-pumper I have come across on these boards!! I can't believe more people have not marked you! I guess it is because too many are looking to make a quick profit. I am kind of new to investing, only starting out with about $1100 dollars. Looking for a job right now so I can add to the amount I am able to invest. I figure once I have around 50 grand or so I will be able to do this fulltime. I wish you all the best surf, because unlike many, you are HONEST!Also, here are the stocks I am invested in right now if you think I should be warned about any of them. PDGT, SPNI. RBID, ONGO, ALT, VRA. i KNOW THERE ARE A LOT OF RISKY ONES, BUT i AM ON DESPERATE TIMES RIGHT NOW AND CAN'T REALLY PROFIT FROM AWESOME LONG TERM INVESTMENTS LIKE APPLE RIGHT NOW. Take care surf, I WILL be keeping in touch with you good man. If I had the money, you and I would be making almost IDENTICAL INVESTMENTS. I hope someday that can happen!! Also, have you looked into COR, they have been having some success with CX-717.
You get a chance take a look at the fund companies buying into NRGN, even BLACKROCK has taken a stake in NRGN. I believe over 85% of the float is in fund companies hands. NRGN is going to see higher highs all year (buy on any weakness)
Heck, it is my Birthday!! RGEN, MEDX, ALNY, POTP, MYL. Have fun everyone!
Wanna run a chart on RGEN for me and tell me what you think? You might want to., Do it now though. Timing may be of the essence here.
NRGN has been coming on all 2007 & is still cheap(most of float is held by the big boys)
NRGN trying to breakout of it trading range(should be a nice EOY for the stock.
surf
NRGN into it's year end rally mode....I will guess it will get near 7 in the coming weeks.
surf
NRGN was just added back into one of my IRA accounts. This little Biotech company has always had a large following in the funds club(37% owned by fund company's). NRGN could be very big in the future & needed a starting place on IHUB.
surf
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http://www.neurogen.com/
http://finance.yahoo.com/q/ks?s=NRGN
http://www.form4oracle.com/company?cik=0000849043&ticker=nrgn
http://www.mffais.com/nrgn.html
Neurogen Corporation engages in the drug discovery and development with a focus on small molecule drugs for various disorders, including neurological diseases, pain, metabolic diseases, and inflammation. The company, through its Accelerated Intelligent Drug Discovery system, focuses on the development of drugs primarily relating to insomnia, pain, depression/anxiety, and obesity/diabetics. Its primary product candidate, insomnia compound, NG2-73, a phase II clinical trial product, is being developed to treat sleep disorders. The company is also developing vanilloid receptor-1, NGD-8243, a phase I clinical trial product, for the treatment of pain in collaboration with Merck Sharp & Dohme Limited. Neurogen’s preclinical trial products include receptors for corticotrophin releasing factor-1 to treat depression, anxiety, and/or stress related disorders; and melanin concentrating hormone receptor-1, a mediator of food intake. The company was incorporated in 1987 and is based in Branford, Connecticut.
http://www.neurogen.com/pipeline.htm
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