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Depomed Announces US Food and Drug Administration Approval of GRALISE(TM) (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia
globenewswire
MENLO PARK, Calif., Jan. 28, 2011 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq
EPO - News) today announced that US FDA has approved GRALISE(TM) (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles. GRALISE was developed by Depomed under the code name DM-1796 and is licensed to Abbott Products, Inc. in the U.S., Canada and Mexico. The approval of GRALISE triggers a milestone payment of $48 million from Abbott to Depomed.
"The approval of GRALISE is a major step toward achieving our key strategic objective of sustainable profitability in 2011 and beyond," said Carl Pelzel, President and CEO of Depomed. "I'd like to thank everyone on the Depomed and Abbott teams involved in the development and approval of this important therapy for their hard work and dedication," added Mr. Pelzel.
Michael Sweeney, MD, Vice President of Research and Development for Depomed, noted, "We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed. Further, FDA has granted GRALISE Orphan Drug status, recognizing GRALISE as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved."
"The GRALISE formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians' treatment armamentarium," said Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, Clinical Associate Professor, University of Washington Medical School in Seattle, Washington. "Patients with PHN have long struggled to manage pain following herpes zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects."
About GRALISETM
GRALISE was approved on the basis of two phase 3 trials involving 359 patients treated with GRALISE and 364 treated with placebo. Safety was evaluated in all 723 patients and the efficacy assessment was based on the second phase 3 trial, a randomized, double-blind, placebo-controlled study of 452 PHN patients. In this trial, GRALISE achieved a statistically significant reduction in average daily pain score compared to placebo. Patients in the study were randomized into two treatment arms: placebo or 1800 mg of GRALISE dosed once-daily. Secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.
A total of 359 patients with PHN have received GRALISE at doses up to 1800 mg QD during placebo-controlled clinical studies. In these trials, 9.7% of patients treated with GRALISE and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the GRALISE treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of GRALISE-treated patients who experienced adverse reactions, the majority of those adverse reactions were either "mild" or "moderate". The most common treatment-emergent adverse events associated with GRALISE treatment were dizziness (10.9% with GRALISE vs. 2.2% placebo), somnolence (4.5% vs. 2.7%) and headache (4.2% vs. 4.1%).
GRALISE is to be titrated over a two-week period to an 1800 mg once-daily dose, given with the evening meal. GRALISE tablets swell in gastric fluid and gradually release gabapentin. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
The GRALISE NDA was submitted under Section 505(b)(2) of the Food, Drug and Cosmetic Act because it also references certain toxicity, safety and other data of Neurontin(R), the formulation of gabapentin initially approved by the FDA.
As previously announced, GRALISE has received Orphan Drug designation.
About the GRALISE Exclusive License Agreement
Depomed entered into a license agreement for GRALISE (DM-1796) with Solvay Pharmaceuticals in November 2008. Abbott Products assumed the license agreement and Solvay's obligations under it as a result of the acquisition of Solvay's pharmaceutical business by Abbott Laboratories, which was completed in February 2010. In addition to the $48 million milestone payment for approval of GRALISE, the license agreement calls for royalties of 14 to 20 percent on product sales, and sales milestone payments of up to $300 million.
Depomed announced on January 18, 2011 that the company had initiated mediation with Abbott Laboratories (NYSE:ABT - News), the parent company of Abbott Products, regarding Abbott's commercialization obligations under the license agreement.
About Post-Herpetic Neuralgia
PHN is a persistent neuropathic pain condition caused by nerve damage after a shingles or herpes zoster viral infection and afflicts approximately one in five patients diagnosed with shingles in the United States. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles, developing PHN. The pain associated with PHN reportedly can be so severe that patients are unable to resume normal activities for months. Approximately 70,000 to 100,000 Americans are affected by PHN each year. The pain associated with PHN can interfere with daily activities such as sleep and recreational activities and can be associated with clinical depression.
Important Safety Information
GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
The safety and effectiveness of GRALISE in patients with epilepsy has not been studied.
Antiepileptic drugs (AEDs), including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Gabapentin should be withdrawn gradually. If gabapentin is discontinued, this should be done gradually over a minimum of one week.
GRALISE Availability
Depomed currently expects GRALISE will be available in 300 mg and 600 mg tablets later this year.
Conference Call
Depomed will be hosting a conference call on Monday, January 31, 2011 at 8:00 AM EST to further discuss the matters disclosed above.
The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. GLUMETZA(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. GRALISETM (gabapentin) is a once-daily treatment approved for management of post-herpetic neuralgia (PHN) and has been licensed to Abbott Products Inc. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its early stage pipeline. Product candidate Serada(R) is in Phase 3 clinical development for menopausal hot flashes. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
globenewswire
MENLO PARK, Calif., Jan. 28, 2011 (GLOBE NEWSWIRE) -- Depomed, Inc. (Nasdaq
EPO - News) today announced that US FDA has approved GRALISE(TM) (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles. GRALISE was developed by Depomed under the code name DM-1796 and is licensed to Abbott Products, Inc. in the U.S., Canada and Mexico. The approval of GRALISE triggers a milestone payment of $48 million from Abbott to Depomed."The approval of GRALISE is a major step toward achieving our key strategic objective of sustainable profitability in 2011 and beyond," said Carl Pelzel, President and CEO of Depomed. "I'd like to thank everyone on the Depomed and Abbott teams involved in the development and approval of this important therapy for their hard work and dedication," added Mr. Pelzel.
Michael Sweeney, MD, Vice President of Research and Development for Depomed, noted, "We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed. Further, FDA has granted GRALISE Orphan Drug status, recognizing GRALISE as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved."
"The GRALISE formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians' treatment armamentarium," said Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, Clinical Associate Professor, University of Washington Medical School in Seattle, Washington. "Patients with PHN have long struggled to manage pain following herpes zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects."
About GRALISETM
GRALISE was approved on the basis of two phase 3 trials involving 359 patients treated with GRALISE and 364 treated with placebo. Safety was evaluated in all 723 patients and the efficacy assessment was based on the second phase 3 trial, a randomized, double-blind, placebo-controlled study of 452 PHN patients. In this trial, GRALISE achieved a statistically significant reduction in average daily pain score compared to placebo. Patients in the study were randomized into two treatment arms: placebo or 1800 mg of GRALISE dosed once-daily. Secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.
A total of 359 patients with PHN have received GRALISE at doses up to 1800 mg QD during placebo-controlled clinical studies. In these trials, 9.7% of patients treated with GRALISE and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the GRALISE treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of GRALISE-treated patients who experienced adverse reactions, the majority of those adverse reactions were either "mild" or "moderate". The most common treatment-emergent adverse events associated with GRALISE treatment were dizziness (10.9% with GRALISE vs. 2.2% placebo), somnolence (4.5% vs. 2.7%) and headache (4.2% vs. 4.1%).
GRALISE is to be titrated over a two-week period to an 1800 mg once-daily dose, given with the evening meal. GRALISE tablets swell in gastric fluid and gradually release gabapentin. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
The GRALISE NDA was submitted under Section 505(b)(2) of the Food, Drug and Cosmetic Act because it also references certain toxicity, safety and other data of Neurontin(R), the formulation of gabapentin initially approved by the FDA.
As previously announced, GRALISE has received Orphan Drug designation.
About the GRALISE Exclusive License Agreement
Depomed entered into a license agreement for GRALISE (DM-1796) with Solvay Pharmaceuticals in November 2008. Abbott Products assumed the license agreement and Solvay's obligations under it as a result of the acquisition of Solvay's pharmaceutical business by Abbott Laboratories, which was completed in February 2010. In addition to the $48 million milestone payment for approval of GRALISE, the license agreement calls for royalties of 14 to 20 percent on product sales, and sales milestone payments of up to $300 million.
Depomed announced on January 18, 2011 that the company had initiated mediation with Abbott Laboratories (NYSE:ABT - News), the parent company of Abbott Products, regarding Abbott's commercialization obligations under the license agreement.
About Post-Herpetic Neuralgia
PHN is a persistent neuropathic pain condition caused by nerve damage after a shingles or herpes zoster viral infection and afflicts approximately one in five patients diagnosed with shingles in the United States. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles, developing PHN. The pain associated with PHN reportedly can be so severe that patients are unable to resume normal activities for months. Approximately 70,000 to 100,000 Americans are affected by PHN each year. The pain associated with PHN can interfere with daily activities such as sleep and recreational activities and can be associated with clinical depression.
Important Safety Information
GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.
The safety and effectiveness of GRALISE in patients with epilepsy has not been studied.
Antiepileptic drugs (AEDs), including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Gabapentin should be withdrawn gradually. If gabapentin is discontinued, this should be done gradually over a minimum of one week.
GRALISE Availability
Depomed currently expects GRALISE will be available in 300 mg and 600 mg tablets later this year.
Conference Call
Depomed will be hosting a conference call on Monday, January 31, 2011 at 8:00 AM EST to further discuss the matters disclosed above.
The conference call will be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. GLUMETZA(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. GRALISETM (gabapentin) is a once-daily treatment approved for management of post-herpetic neuralgia (PHN) and has been licensed to Abbott Products Inc. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its early stage pipeline. Product candidate Serada(R) is in Phase 3 clinical development for menopausal hot flashes. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
der alte Thread war zu alt deswegen neu
http://seekingalpha.com/article/249511-depomed-s-stock-price…
http://seekingalpha.com/article/249511-depomed-s-stock-price…
http://www.marketwatch.com/story/depomed-falls-on-abbott-dis…
If the drug is approved, Depomed said Abbott was obligated to spend $85 million to $135 million on launch costs for the first two years, under the terms of their agreement.
klingt alles sehr aufregend
If the drug is approved, Depomed said Abbott was obligated to spend $85 million to $135 million on launch costs for the first two years, under the terms of their agreement.
klingt alles sehr aufregend
Wie siehst du den heutigen Anstieg, übertrieben?
Nein sehe ich nicht übertrieben, mal sehen was die Amis machen .
Yahoo board ist guter Stimmung mit wilden Kurszielen, aber naja.
http://messages.finance.yahoo.com/mb/DEPO
GL
Yahoo board ist guter Stimmung mit wilden Kurszielen, aber naja.
http://messages.finance.yahoo.com/mb/DEPO
GL
Trading Spotlight
Besten Dank, les mich mal durch. Suche noch eine Top Biotec Wert!
CPBM.ob ist bei mir unter Beobachtung, ist aber otcbb also achtung
aber in USA kaufen wenn überhaupt, absoluter Low Floater.
Ersten kurse vorbörslich bei 9 Dollar von Depo
aber in USA kaufen wenn überhaupt, absoluter Low Floater.
Ersten kurse vorbörslich bei 9 Dollar von Depo
webcast jetzt
Im Board schreiben sie es kämen neue News over the weekend? Ahnung?
Antwort auf Beitrag Nr.: 40.985.796 von Shareholder33 am 04.02.11 18:30:15
Bisher nichts gekommen!
aber hier mal letzte Us Twitter React. about DEPO:
http://www.nasdaq.com/aspx/sentiment.aspx?symbol=MLKNA&symbo…
Bisher nichts gekommen!
aber hier mal letzte Us Twitter React. about DEPO:
http://www.nasdaq.com/aspx/sentiment.aspx?symbol=MLKNA&symbo…
Antwort auf Beitrag Nr.: 40.991.975 von Spekulist am 07.02.11 02:13:53
Sorry,falscher Link!
Der ist richtig:
http://www.nasdaq.com/aspx/sentiment.aspx?symbol=DEPO&select…
Sorry,falscher Link!
Der ist richtig:
http://www.nasdaq.com/aspx/sentiment.aspx?symbol=DEPO&select…
Depomed's Reports Results of Phase 1 Trial of Twice-Daily Formulation of DM-1992 in Parkinson's Patients
MENLO PARK, CA--(Marketwire - February 7, 2011) - Depomed, Inc. (NASDAQ: DEPO) today announced that in its second Phase 1 pharmacokinetic-pharmacodynamic study in Parkinson's patients, DM-1992, Depomed's investigative novel gastric-retentive, extended-release formulation of levodopa/carbidopa, maintained therapeutic blood levels of levodopa over 24 hours in a twice-daily formulation.
Two distinct twice-daily formulations of DM-1992 were tested in the study. Both formulations are projected at steady state to consistently maintain levodopa blood levels above the efficacious threshold of 300ng/mL for 24 hours, as mean levodopa blood levels after 24 hours exceeded 300ng/mL. DM-1992 was well tolerated in the study.
"We believe DM-1992 may meet a significant unmet need of Parkinson's patients for a twice-daily formulation of levodopa/carbidopa that maintains therapeutic blood levels throughout the night, when the symptoms of Parkinson's disease can be particularly severe," said Carl Pelzel, Depomed's President and CEO. "We look forward to discussing further development of DM-1992 with potential collaborative partners," added Mr. Pelzel.
"We are pleased our reformulations of DM-1992 performed as we expected in Parkinson's patients. We believe we have product candidate ready to advance to Phase 2 clinical testing," said Dr. Mike Sweeney, vice president research and development of Depomed. "We would like to thank The Michael J. Fox Foundation for its support in funding a portion of the trial," added Dr. Sweeney.
The company expects to present the trial results at a scientific conference later this year.
Phase 1 Trial Design
DM-1992 is an investigative novel gastric-retentive, extended-release dosage form of Levodopa/Carbidopa, a marketed therapy used in the treatment of Parkinson's disease. The Phase I trial in DM-1992 was a randomized, open-label crossover study that enrolled 16 patients with stable Parkinson's disease at two leading neurology centers in Russia. The objective of the study was to compare the pharmacokinetics-pharmacodynamics of two distinct twice-daily formulations of DM-1992 and a generic version of Sinemet CR sustained-release Levodopa/Carbidopa dosed three times daily, as well as the safety and tolerability of the formulations. Patients in the trial received a full day's dose of each of the three treatments being studied (two doses of each DM-1992 (460mg levodopa and 150mg carbidopa per dose) twelve hours apart, and three doses of generic levodopa/carbidopa over a 12 hour period (200mg of levodopa and 50mg of carbidopa per dose). Blood samples were drawn and finger tapping was determined during the 24 hour period following administration of each treatment.
About Parkinson's disease
Parkinson's disease is a chronic, degenerative neurological disorder that affects nearly one million Americans, with significant prevalence growth expected over the next 25 years due to aging population demographics. Six million worldwide are estimated to have Parkinson's. While the average age at onset is 60, disease onset starts by age 40 in an estimated five to 10 percent of patients, and people as young as 30 can also be affected. Current therapies are effective in addressing only the mild/moderate motor symptoms of the disease and have significant long-term side effects. There are no drugs available that target the numerous non-motor aspects of the disease as well as the underlying degenerative process.
About The Michael J. Fox Foundation for Parkinson's Research (MJFF)
MJFF is dedicated to finding a cure for Parkinson's disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson's today.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. GRALISE™ (gabapentin) is a once-daily treatment approved for management of post-herpetic neuralgia (PHN) and has been licensed to Abbott Products, Inc. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its early stage pipeline. Product candidate Serada® is in Phase 3 clinical development for menopausal hot flashes. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995.
The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the potential benefits of DM-1992; potential business development transactions; our research and development efforts; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
MENLO PARK, CA--(Marketwire - February 7, 2011) - Depomed, Inc. (NASDAQ: DEPO) today announced that in its second Phase 1 pharmacokinetic-pharmacodynamic study in Parkinson's patients, DM-1992, Depomed's investigative novel gastric-retentive, extended-release formulation of levodopa/carbidopa, maintained therapeutic blood levels of levodopa over 24 hours in a twice-daily formulation.
Two distinct twice-daily formulations of DM-1992 were tested in the study. Both formulations are projected at steady state to consistently maintain levodopa blood levels above the efficacious threshold of 300ng/mL for 24 hours, as mean levodopa blood levels after 24 hours exceeded 300ng/mL. DM-1992 was well tolerated in the study.
"We believe DM-1992 may meet a significant unmet need of Parkinson's patients for a twice-daily formulation of levodopa/carbidopa that maintains therapeutic blood levels throughout the night, when the symptoms of Parkinson's disease can be particularly severe," said Carl Pelzel, Depomed's President and CEO. "We look forward to discussing further development of DM-1992 with potential collaborative partners," added Mr. Pelzel.
"We are pleased our reformulations of DM-1992 performed as we expected in Parkinson's patients. We believe we have product candidate ready to advance to Phase 2 clinical testing," said Dr. Mike Sweeney, vice president research and development of Depomed. "We would like to thank The Michael J. Fox Foundation for its support in funding a portion of the trial," added Dr. Sweeney.
The company expects to present the trial results at a scientific conference later this year.
Phase 1 Trial Design
DM-1992 is an investigative novel gastric-retentive, extended-release dosage form of Levodopa/Carbidopa, a marketed therapy used in the treatment of Parkinson's disease. The Phase I trial in DM-1992 was a randomized, open-label crossover study that enrolled 16 patients with stable Parkinson's disease at two leading neurology centers in Russia. The objective of the study was to compare the pharmacokinetics-pharmacodynamics of two distinct twice-daily formulations of DM-1992 and a generic version of Sinemet CR sustained-release Levodopa/Carbidopa dosed three times daily, as well as the safety and tolerability of the formulations. Patients in the trial received a full day's dose of each of the three treatments being studied (two doses of each DM-1992 (460mg levodopa and 150mg carbidopa per dose) twelve hours apart, and three doses of generic levodopa/carbidopa over a 12 hour period (200mg of levodopa and 50mg of carbidopa per dose). Blood samples were drawn and finger tapping was determined during the 24 hour period following administration of each treatment.
About Parkinson's disease
Parkinson's disease is a chronic, degenerative neurological disorder that affects nearly one million Americans, with significant prevalence growth expected over the next 25 years due to aging population demographics. Six million worldwide are estimated to have Parkinson's. While the average age at onset is 60, disease onset starts by age 40 in an estimated five to 10 percent of patients, and people as young as 30 can also be affected. Current therapies are effective in addressing only the mild/moderate motor symptoms of the disease and have significant long-term side effects. There are no drugs available that target the numerous non-motor aspects of the disease as well as the underlying degenerative process.
About The Michael J. Fox Foundation for Parkinson's Research (MJFF)
MJFF is dedicated to finding a cure for Parkinson's disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson's today.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. GRALISE™ (gabapentin) is a once-daily treatment approved for management of post-herpetic neuralgia (PHN) and has been licensed to Abbott Products, Inc. The company also has a robust pipeline including one in Phase 3 clinical development, and other product candidates in its early stage pipeline. Product candidate Serada® is in Phase 3 clinical development for menopausal hot flashes. Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995.
The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the potential benefits of DM-1992; potential business development transactions; our research and development efforts; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Danke, also abwarten und Tee trinken
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