Depomed - FDA entscheid f. Blockbuster im Januar
| eröffnet am: | 29.12.10 06:57 von: | Chalifmann3 |
| neuester Beitrag: | 25.04.21 01:42 von: | Birgitdabta |
| Anzahl Beiträge: | 59 | |
| Leser gesamt: | 43468 | |
| davon Heute: | 3 | |
bewertet mit 4 Sternen |
||
|
Seite:
1
|
2
|
||
29.01.11 18:06
#26
bierro
Klasse!
Hab´s auch schon mitgekriegt, super!
Kann mir jemand von den Pharmaexperten mal in kurzen Worten erkären, was in der Branche mit "milestone-payments" gemeint ist?
Hab zwar ne englische Deutung gefunden, bin mir allerdings nicht ganz schlüssig.
Kann mir jemand von den Pharmaexperten mal in kurzen Worten erkären, was in der Branche mit "milestone-payments" gemeint ist?
Hab zwar ne englische Deutung gefunden, bin mir allerdings nicht ganz schlüssig.
31.01.11 08:09
#27
MicroV
@bierro
Es sind bestimmte vertragliche Meilensteine vereinbart wurden, wenn diese erfüllt werden, bekommt Depo von Abbott (Lizenznehmer) eine Zahlung pro Meilenstein.
im Fall von DM-1796 beispielsweise waren es:
- bei Zulassung Zahlung von 35 Mio. $
- Zulassung ohne Label bis zu plus weiteren 25 Mio. $
Außerdem gab es vorher schon Meilensteine/ Zahlungen bspw.
- für die FDA-Akzeptierung als NDA
- für Orphan-Drug-Status
etc.
Dies sind normale Vereinbarungen zwischen Bio's und deren Partnern, das spült den "kleinen" Bio's erstmal ne Menge Geld in die Tasche.
im Fall von DM-1796 beispielsweise waren es:
- bei Zulassung Zahlung von 35 Mio. $
- Zulassung ohne Label bis zu plus weiteren 25 Mio. $
Außerdem gab es vorher schon Meilensteine/ Zahlungen bspw.
- für die FDA-Akzeptierung als NDA
- für Orphan-Drug-Status
etc.
Dies sind normale Vereinbarungen zwischen Bio's und deren Partnern, das spült den "kleinen" Bio's erstmal ne Menge Geld in die Tasche.
31.01.11 11:19
#28
MicroV
aktueller Pre-Market-Kurs
bereits bei 8,01$ +28,4%
das scheint ein schöner Tag zu werden ;-)
das scheint ein schöner Tag zu werden ;-)
31.01.11 13:52
#29
bierro
Danke...
...für die Erläuterungen.
Bei Yahoo spekuliert man heute auf 10 - 12 $, was glaubt Ihr?
Ich hab zwar heute zu teuer nochmal ne Posi aufgebaut(6,50 Eur), aber die halte ich jetzt erstmal. Scheint ein gutes Invest zu sein.
@chalif Danke für den Tipp!
Bei Yahoo spekuliert man heute auf 10 - 12 $, was glaubt Ihr?
Ich hab zwar heute zu teuer nochmal ne Posi aufgebaut(6,50 Eur), aber die halte ich jetzt erstmal. Scheint ein gutes Invest zu sein.
@chalif Danke für den Tipp!
31.01.11 14:42
#30
Chalifmann3
Depomeds stock price is a gift ....
Bierro,von 2 stelligen Kursen hab ich bereits im dezember geschrieben,die werden kommen ....
Now that Depomed's (DEPO) GRALISE has been approved by the FDA, making a bull case for Depomed becomes easy. GRALISE is an extended release gabapentin formulation, formerly DM-1796, that is prescribed once-daily for the treatment of post-herpetic-neuralgia ("PHN"), which is pain associated with shingles. Approval of GRALISE triggers a milestone payment of $48 million from Abbott (ABT) to Depomed, or approximately $1 per share.
Dosing and Adverse Events make GRALISE compelling
The most compelling feature of GRALISE is the tame adverse events profile. The incidence of dizziness for patients treated with GRALISE was 10.9% versus 2.2% for placebo. The incidence of somnolence was 4.5% versus 2.7% for placebo. The incidence of headache was 4.2% versus 4.1% for placebo. The difference becomes tremendous when you juxtapose GRALISE's profile against that of LYRICA, Pfizer's (PFE) blockbuster drug with annual sales over $2 billion dollars worldwide. Besides dizziness, somnolence, and headache, LYRICA also mentions peripheral edema, weight gain and angioedema as common adverse events, unlike GRALISE. For LYRICA, the incidence of dizziness was 31% versus 9% for placebo. The incidence of somnolence was 18% versus 5% for placebo. The incidence of headache was 8% versus 4% for placebo.
Dizziness (treatment group) Dizziness (placebo group)
GRALISE 10.9% 2.2%
LYRICA 31% 9%
Somnolence (treatment group) Somnolence (placebo group)
GRALISE 4.5% 2.7%
LYRICA 18% 5%
Headache (active group) Headache (placebo group)
GRALISE 4.2% 4.1%
LYRICA 8% 4%
The dropouts rate during the clinical trials, again, demonstrates GRALISE's superior tolerability. The drop-out rate due to adverse events for GRALISE was 9.7% versus 14% for LYRICA.
Drop-out rate due to Adverse Events
GRALISE 9.7%
LYRICA 14%
Furthermore, GRALISE is dosed once-daily versus LYRICA which is dosed two-to-three times daily. Although a head-to-head study for this type of comparison would be preferred, this data is highly suggestive of GRALISE's superiority over LYRICA with regards to dosing, tolerability, and adverse events. Whether GRALISE will achieve superior sales remains to be seen.
The comparison of GRALISE to generic gabapentin (NEURONTIN) is just as impressive.
Dizziness (active group) Dizziness (placebo group)
GRALISE 10.9% 2.2%
NEURONTIN 28.8% 7.5%
Somnolence (active group) Somnolence (placebo group)
GRALISE 4.5% 2.7%
NEURONTIN 21.8% 5.3%
Headache (active group) Headache (placebo group)
GRALISE 4.2% 4.1%
NEURONTIN 3.3% 3.1%
Marketing against generics and LYRICA
One of the main issues for GRALISE's launch will be how to position the product against LYRICA and generic products. Generic LYRICA may hit the market in Q1 of 2014, while generic gabapentin is already on the market and commands a majority percentage of the total scripts for this class of drug. It is clear that detailing and labeling will play a paramount role for GRALISE. Since GRALISE appears medically superior to both LYRICA and generic gabapentin, the main issue won't be a lack of prescriptions made by physicians. More probably, the issue may involve pharmacies, generic substitution, and reimbursement from managed care.
Depomed can combat generic substitution in a number of ways. First of all, given GRALISE's significantly different dosing and pharmokinetics, the FDA was willing to work with DEPO to make sure less substitution occurs. For example, Depomed was able to ensure that the phrase "GRALISE is not interchangeable with other Gabapentin products" appears on the front of every label and bottle. Furthermore, Depomed is employing a 30-day "titration pack", similar to Pfizer's popular Z-Pak, making generic substitution somewhat more cumbersome at the pharmacy. When a physicians prescribes the "titration pack", it will be difficult for a pharmacy to switch to a generic.
Finally, GRALISE is not a controlled substance, whereas LYRICA is controlled. A controlled substance means that pharmacies have to adhere to strict rules regarding sales and distribution. For example, it is difficult for a practitioner to orally prescribe LYRICA to a pharmacy, since a written follow-up must be submitted to the pharmacy within 72 hours. Furthermore, pharmacies must keep logs and records of all controlled substance prescriptions, like those of LYRICA, for five years. These and other regulations are reasons why pharmacies tend not to stock controlled substances. But GRALISE is not a controlled substance, it will not have these issues, and will probably be preferred at the pharmacy.
GRALISE has selling points for managed care too! Slips and falls are a precursor to death in the elderly. The decrease in somnolence and dizziness seen with GRALISE could potentially save lives, but also hospital costs for managed care. In 2000, the total direct cost of all fall injuries for people 65 and older exceeded $19 billion, and is expected to reach $55 billion in 2020.
In one of Xenoport's (XNPT) clinical trials for HORIZANT (gabapentin enacarbil), one subject died after a fall, 25 days after stopping HORIZANT. The fall was deemed unrelated to HORIZANT, but the point here is that falls can be deadly for the elderly, and expensive for managed care. From this perspective, managed care may prefer GRALISE over its competitors.
Ongoing Mediation with Abbott, risk revaluation for Serada and more deals to come...
One week ago, when Depomed announced that they would enter mediation with Abbott, FDA approval was still an uncertainty. Now it's not. And everyday that Abbott delays GRALISE's launch, is another day of damages that Abbott will be forced to pay if the dispute enters arbitration. With this in mind, one can assume a speedy resolution. And with that resolution, one can expect that Abbott will pay some penalty for breaking their contract which in its current form has substantial sales milestones.
Approval not only gives Depomed more leverage when dealing with Abbott, it also revaluates the pipeline. SERADA, like GRALISE, is also a gabapentin formulation. With this recent approval, certain risks that haunted SERADA can be readjusted in Depomed's favor. Furthermore the Acuform technology is again reaffirmed. With another approval, Depomed may have more strength in any negotiations to license DM-1992 for Parkinson's, DM-3458 for GERD, ProQuin for Urinary Tract Infections, or its patents for Glumetza.
Final Thoughts
A revaluation of Depomed stock price is in order. But beyond the initial, expected bump in PPS, investors can look forward to a number of key events for continued stock price appreciation. Abbott and Depomed's resolution over GRALISE is clearly paramount. Later, Depomed will partner GRALISE both in the U.S. and the rest of world, which should bring in more cash and more favorable royalties. But also, investors can expect a revaluation of Serada, the technology as a whole, and the rest of Depomed's pipeline. Depomed's story will unfold throughout 2011, with many significant events that investors can look forward to.
For more information about Depomed's dispute with Abbott, click here
For more information about GRALISE, click here
MFG
Chali
Now that Depomed's (DEPO) GRALISE has been approved by the FDA, making a bull case for Depomed becomes easy. GRALISE is an extended release gabapentin formulation, formerly DM-1796, that is prescribed once-daily for the treatment of post-herpetic-neuralgia ("PHN"), which is pain associated with shingles. Approval of GRALISE triggers a milestone payment of $48 million from Abbott (ABT) to Depomed, or approximately $1 per share.
Dosing and Adverse Events make GRALISE compelling
The most compelling feature of GRALISE is the tame adverse events profile. The incidence of dizziness for patients treated with GRALISE was 10.9% versus 2.2% for placebo. The incidence of somnolence was 4.5% versus 2.7% for placebo. The incidence of headache was 4.2% versus 4.1% for placebo. The difference becomes tremendous when you juxtapose GRALISE's profile against that of LYRICA, Pfizer's (PFE) blockbuster drug with annual sales over $2 billion dollars worldwide. Besides dizziness, somnolence, and headache, LYRICA also mentions peripheral edema, weight gain and angioedema as common adverse events, unlike GRALISE. For LYRICA, the incidence of dizziness was 31% versus 9% for placebo. The incidence of somnolence was 18% versus 5% for placebo. The incidence of headache was 8% versus 4% for placebo.
Dizziness (treatment group) Dizziness (placebo group)
GRALISE 10.9% 2.2%
LYRICA 31% 9%
Somnolence (treatment group) Somnolence (placebo group)
GRALISE 4.5% 2.7%
LYRICA 18% 5%
Headache (active group) Headache (placebo group)
GRALISE 4.2% 4.1%
LYRICA 8% 4%
The dropouts rate during the clinical trials, again, demonstrates GRALISE's superior tolerability. The drop-out rate due to adverse events for GRALISE was 9.7% versus 14% for LYRICA.
Drop-out rate due to Adverse Events
GRALISE 9.7%
LYRICA 14%
Furthermore, GRALISE is dosed once-daily versus LYRICA which is dosed two-to-three times daily. Although a head-to-head study for this type of comparison would be preferred, this data is highly suggestive of GRALISE's superiority over LYRICA with regards to dosing, tolerability, and adverse events. Whether GRALISE will achieve superior sales remains to be seen.
The comparison of GRALISE to generic gabapentin (NEURONTIN) is just as impressive.
Dizziness (active group) Dizziness (placebo group)
GRALISE 10.9% 2.2%
NEURONTIN 28.8% 7.5%
Somnolence (active group) Somnolence (placebo group)
GRALISE 4.5% 2.7%
NEURONTIN 21.8% 5.3%
Headache (active group) Headache (placebo group)
GRALISE 4.2% 4.1%
NEURONTIN 3.3% 3.1%
Marketing against generics and LYRICA
One of the main issues for GRALISE's launch will be how to position the product against LYRICA and generic products. Generic LYRICA may hit the market in Q1 of 2014, while generic gabapentin is already on the market and commands a majority percentage of the total scripts for this class of drug. It is clear that detailing and labeling will play a paramount role for GRALISE. Since GRALISE appears medically superior to both LYRICA and generic gabapentin, the main issue won't be a lack of prescriptions made by physicians. More probably, the issue may involve pharmacies, generic substitution, and reimbursement from managed care.
Depomed can combat generic substitution in a number of ways. First of all, given GRALISE's significantly different dosing and pharmokinetics, the FDA was willing to work with DEPO to make sure less substitution occurs. For example, Depomed was able to ensure that the phrase "GRALISE is not interchangeable with other Gabapentin products" appears on the front of every label and bottle. Furthermore, Depomed is employing a 30-day "titration pack", similar to Pfizer's popular Z-Pak, making generic substitution somewhat more cumbersome at the pharmacy. When a physicians prescribes the "titration pack", it will be difficult for a pharmacy to switch to a generic.
Finally, GRALISE is not a controlled substance, whereas LYRICA is controlled. A controlled substance means that pharmacies have to adhere to strict rules regarding sales and distribution. For example, it is difficult for a practitioner to orally prescribe LYRICA to a pharmacy, since a written follow-up must be submitted to the pharmacy within 72 hours. Furthermore, pharmacies must keep logs and records of all controlled substance prescriptions, like those of LYRICA, for five years. These and other regulations are reasons why pharmacies tend not to stock controlled substances. But GRALISE is not a controlled substance, it will not have these issues, and will probably be preferred at the pharmacy.
GRALISE has selling points for managed care too! Slips and falls are a precursor to death in the elderly. The decrease in somnolence and dizziness seen with GRALISE could potentially save lives, but also hospital costs for managed care. In 2000, the total direct cost of all fall injuries for people 65 and older exceeded $19 billion, and is expected to reach $55 billion in 2020.
In one of Xenoport's (XNPT) clinical trials for HORIZANT (gabapentin enacarbil), one subject died after a fall, 25 days after stopping HORIZANT. The fall was deemed unrelated to HORIZANT, but the point here is that falls can be deadly for the elderly, and expensive for managed care. From this perspective, managed care may prefer GRALISE over its competitors.
Ongoing Mediation with Abbott, risk revaluation for Serada and more deals to come...
One week ago, when Depomed announced that they would enter mediation with Abbott, FDA approval was still an uncertainty. Now it's not. And everyday that Abbott delays GRALISE's launch, is another day of damages that Abbott will be forced to pay if the dispute enters arbitration. With this in mind, one can assume a speedy resolution. And with that resolution, one can expect that Abbott will pay some penalty for breaking their contract which in its current form has substantial sales milestones.
Approval not only gives Depomed more leverage when dealing with Abbott, it also revaluates the pipeline. SERADA, like GRALISE, is also a gabapentin formulation. With this recent approval, certain risks that haunted SERADA can be readjusted in Depomed's favor. Furthermore the Acuform technology is again reaffirmed. With another approval, Depomed may have more strength in any negotiations to license DM-1992 for Parkinson's, DM-3458 for GERD, ProQuin for Urinary Tract Infections, or its patents for Glumetza.
Final Thoughts
A revaluation of Depomed stock price is in order. But beyond the initial, expected bump in PPS, investors can look forward to a number of key events for continued stock price appreciation. Abbott and Depomed's resolution over GRALISE is clearly paramount. Later, Depomed will partner GRALISE both in the U.S. and the rest of world, which should bring in more cash and more favorable royalties. But also, investors can expect a revaluation of Serada, the technology as a whole, and the rest of Depomed's pipeline. Depomed's story will unfold throughout 2011, with many significant events that investors can look forward to.
For more information about Depomed's dispute with Abbott, click here
For more information about GRALISE, click here
MFG
Chali
31.01.11 16:28
#31
MicroV
...
bin erstmal raus, heute. habe guten profit gemacht.
bleibt bei mir auf der watchlist, ist für dieses jahr noch ne gute aktie, da noch einige news erwartet werden.
werde jetzt auf PLX gehen, die haben am 25.02.11 ein PDUFA-Date und den anderen teil in AVNR, deren produktlaunch war heute auch.
so long and good luck
bleibt bei mir auf der watchlist, ist für dieses jahr noch ne gute aktie, da noch einige news erwartet werden.
werde jetzt auf PLX gehen, die haben am 25.02.11 ein PDUFA-Date und den anderen teil in AVNR, deren produktlaunch war heute auch.
so long and good luck
31.01.11 16:57
#32
Chalifmann3
?
Warum machst du das,Avanir und Protalix sind 2 gehypte Schweine,viel teurer als DEPO !
MFG
Chali
MFG
Chali
31.01.11 16:59
#33
Chalifmann3
Wir sind noch nicht am Top !
Es geht zügig vorwärts mit DEPO,sehen wir heute noch 9 dollar ?
Schön wärs !
MFG
Chali
Schön wärs !
MFG
Chali
Angehängte Grafik:
smilie_game_004.gif
smilie_game_004.gif
01.02.11 10:05
#34
MicroV
@Chalifmann3
1. Erkläre mir mal bitte, warum PLX u. AVNR gehypte "Schweine" sein sollen, aber bitte mit fundamentalen Argumenten. Ich habe jedenfalls meine DD zu diesen Aktien gemacht.
Viel zu teuer sind diese Aktien auch nicht.
DEPO - 442 Mio.$
AVNR - 492 Mio.$ (Exklusiv-Produkt ohne Konkurrenz)
PLX - 790 Mio.$ (mit SPA und bei Zulassung Blockbusterpotential + volle Pipeline http://phx.corporate-ir.net/...wMDA5NTAxMjMtMTEtMDA1OTA3L3htbA%3d%3d)
für mich short-term-invest, ähnlich wie ich es nun bei DEPO gemacht habe.
2. Ich habe DEPO verkauft, um meinen Profit zu sichern, allerdings schliesse ich nicht aus, dass ich Ende Feb. wieder einsteige, da ich in den nächsten 4-8 Wochen mit News zu Abbott und ROW-Lizenz-Partner rechne. Vielleich komme ich dann auch etwas günstiger wieder rein ;-)
Mein Verkauf stellt auch keine Verkaufsempfehlung von DEPO dar, ich habe nur eine bestimmte Anlagestrategie, wie Du hoffentlich auch.
Viel zu teuer sind diese Aktien auch nicht.
DEPO - 442 Mio.$
AVNR - 492 Mio.$ (Exklusiv-Produkt ohne Konkurrenz)
PLX - 790 Mio.$ (mit SPA und bei Zulassung Blockbusterpotential + volle Pipeline http://phx.corporate-ir.net/...wMDA5NTAxMjMtMTEtMDA1OTA3L3htbA%3d%3d)
für mich short-term-invest, ähnlich wie ich es nun bei DEPO gemacht habe.
2. Ich habe DEPO verkauft, um meinen Profit zu sichern, allerdings schliesse ich nicht aus, dass ich Ende Feb. wieder einsteige, da ich in den nächsten 4-8 Wochen mit News zu Abbott und ROW-Lizenz-Partner rechne. Vielleich komme ich dann auch etwas günstiger wieder rein ;-)
Mein Verkauf stellt auch keine Verkaufsempfehlung von DEPO dar, ich habe nur eine bestimmte Anlagestrategie, wie Du hoffentlich auch.
03.02.11 16:52
#35
bierro
Wir haben die 10 $!
Anscheinend geht das Teil ungebremst weiter hoch. Bin froh, dass ich dringeblieben bin.
07.02.11 23:48
#37
Heiko T.
Und mal
Dank an Chalif! Bin seit 6,80(Mitte Jan.) dabei.
Depomed's Reports Results of Phase 1 Trial of Twice-Daily Formulation of DM-1992 in Parkinson's Patients
MENLO PARK, CA -- (MARKET WIRE) -- 02/07/11 -- 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.
CONTACT:
Sheilah SerradellDepomed, Inc.
650-462-5900
sserradell@depomed.com
Source: Depomed, Inc.
Depomed's Reports Results of Phase 1 Trial of Twice-Daily Formulation of DM-1992 in Parkinson's Patients
MENLO PARK, CA -- (MARKET WIRE) -- 02/07/11 -- 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.
CONTACT:
Sheilah SerradellDepomed, Inc.
650-462-5900
sserradell@depomed.com
Source: Depomed, Inc.
08.02.11 21:16
#38
Heiko T.
Nochmal Gelegenheit
zum Einstieg!
Nach Rücksetzer dreht der Kurs wieder nach oben!
http://www.nasdaq.com/aspx/...sale.aspx?symbol=DEPO&selected=DEPO
Gute News gibts auch wieder
Depomed to Present at the 13th Annual BIO CEO & Investor Conference
MENLO PARK, CA -- (MARKET WIRE) -- 02/08/11 -- Depomed, Inc. (NASDAQ: DEPO) announced today that its president and chief executive officer, Carl A. Pelzel will be presenting at the 13th Annual BIO CEO & Investor Conference in New York City on February 15, 2011 at 8:30 am EST.
The company will be webcasting its presentation and interested parties can access the live or archived presentation for up to 90 days on the company's website at www.depomed.com.
Nach Rücksetzer dreht der Kurs wieder nach oben!
http://www.nasdaq.com/aspx/...sale.aspx?symbol=DEPO&selected=DEPO
Gute News gibts auch wieder
Depomed to Present at the 13th Annual BIO CEO & Investor Conference
MENLO PARK, CA -- (MARKET WIRE) -- 02/08/11 -- Depomed, Inc. (NASDAQ: DEPO) announced today that its president and chief executive officer, Carl A. Pelzel will be presenting at the 13th Annual BIO CEO & Investor Conference in New York City on February 15, 2011 at 8:30 am EST.
The company will be webcasting its presentation and interested parties can access the live or archived presentation for up to 90 days on the company's website at www.depomed.com.
11.02.11 00:52
#39
Heiko T.
Aktie
zeigt sich sehr widerstandsfähig um die 9
After hour z.Zt. 9,54
http://www.nasdaq.com/aspxcontent/...?selected=DEPO&mkttype=after
Bin nach(trotz) Hoch von 10,40 immer noch dabei,da ich meinen mentalen Stop erst im Bereich um 8 gesetzt habe.Aus HGSI lernt man!
Denke,je nach Partner und Vorhaben des Partners könnten 16-18 Dollars drinsitzen.
Falls das mal irgendwann sein sollte würde ich aber auch dann im Fall von DepoMed nicht sofort verkaufen.
Auf jeden Fall immer mit grösserem Abstand zum Stop laufen lassen!
After hour z.Zt. 9,54
http://www.nasdaq.com/aspxcontent/...?selected=DEPO&mkttype=after
Bin nach(trotz) Hoch von 10,40 immer noch dabei,da ich meinen mentalen Stop erst im Bereich um 8 gesetzt habe.Aus HGSI lernt man!
Denke,je nach Partner und Vorhaben des Partners könnten 16-18 Dollars drinsitzen.
Falls das mal irgendwann sein sollte würde ich aber auch dann im Fall von DepoMed nicht sofort verkaufen.
Auf jeden Fall immer mit grösserem Abstand zum Stop laufen lassen!
11.02.11 05:57
#40
Chalifmann3
Heiko
Guten morgen,
Interessant,dass du bei HGSI auch dabei warst,alle genialen biotechaktien schon gehabt,hm ? Wenn du Interesse hast,dann schau doch mal in meinem Adeona Thread zu Adeona Pharmaceuticals rein,das könnte der nächste "Kracher" werden,sehr bald schon .....
MFG
Chali
Interessant,dass du bei HGSI auch dabei warst,alle genialen biotechaktien schon gehabt,hm ? Wenn du Interesse hast,dann schau doch mal in meinem Adeona Thread zu Adeona Pharmaceuticals rein,das könnte der nächste "Kracher" werden,sehr bald schon .....
MFG
Chali
11.02.11 16:13
#41
Heiko T.
Hi Chalif
dabei gewesen, aber leider zu früh raus-wie die meisten.
Deinen Thread kenne ich natürlich schon.Auf jeden Fall hochinteressant.
Ärgere mich nur,dass ich nicht schon früher dabei war.Wenn sie jetzt charttechnisch hält
zieh ich eine Posi in Erwägung.
Deinen Thread kenne ich natürlich schon.Auf jeden Fall hochinteressant.
Ärgere mich nur,dass ich nicht schon früher dabei war.Wenn sie jetzt charttechnisch hält
zieh ich eine Posi in Erwägung.
15.02.11 00:55
#42
Heiko T.
Da ist noch einiges
an Potential.Demnach sollten noch viele Fonds auf die Unterbewertung aufmerksam werden!
Sehr gelungene ausführliche Analyse von Tro Kalayjian:
Depomed: Attractive and Under-Appreciated Potential
It almost seems counterintuitive that majority shareholders of Depomed (DEPO) have been adding shares after the FDA approval of Gralise, a once-daily treatment for post-herpetic neuralgia. One might expect that large funds would look to the high volume created with an FDA decision as an opportune exit strategy. Yet that hasn't happened, several funds have filed schedule 13's indicating that they have continued to add shares or at least maintained a majority positions.
Over the past several weeks, Deltec Asset Management, and Tang Capital Partners have added to their already substantial positions. Deltec has increased ownership to 6%, Tang increased ownership to 9.9%. BlackRock (BLK) and ThirdPoint, still remain majority holders, holding 6.19% and 9.9%, respectively. Goldman Sachs (GS) has maintained its almost 2% position. Together, institutional and mutual fund owners claim about 60% of total shares.
What value do these large shareholders see? What makes Depomed different than any other biotech company? During a recent conference call, one of the participants, a senior managing director from a majority shareholder, may have disclosed the answer to the aforementioned questions. He stated that the management team at Depomed "is of the highest standards."
Management
Since early 2007, Depomed's management has been able to steer the company away from any dilutional events, despite several pipeline setbacks. Instead it has focused on legal and business development fronts to bring in cash via partnership deals, settlements and milestones. Besides management's emphasis on maintaining shareholder value, they have also excelled at shareholder communication through the use of quarterly newsletters communicating achievements and upcoming goals. They have held investor days, bringing in prominent speakers to discuss the unmet medical needs that Depomed seeks to meet. And, all of this was done after Depomed had chopped 25% of its staff, back in late 2007. Since then Depomed has been producing results with only 80 employees, which is exceptionally lean for a company that is valued at half a billion dollars.
Depomed's management team has proven that they are working on behalf of their shareholders. Of course, an excellent management alone doesn't make for an excellent investment opportunity, there has to be more.
Acuform Technology
The real star here, is Depomed's Acuform technology. In a competitive enviroment that includes failed accordion pills, defunct floating dosage forms, and ulcerating mucoadhesives, Acuform has stood out because of its biochemical versatility, as well as its intended therapeutic differentiation. The technology is as elegant as it is useful. It is a swelling polymeric gastric retentive pill that provides once or twice a day dosing. The pill swells to the about the size of a nickel, which prevents it from passing through the pylorus, keeping the pill in the stomach as it continually delivers active ingredient until it eventually dissolves. With regard to its biochemical versatility, Acuform has been successfully employed with three biochemically unique, FDA-approved products.
Trade Name Indication Chemical Property
Glumetza Diabetes highly water soluble
ProQuin UTI poorly water soluble
Gralise PHN absorbed in duodenum
Trade Name Clinical Differentiation
Glumetza Once-daily dosing, Tolerable titration, Increased bioavailability, Decreased nausea and GI upset
ProQuin Once-daily dosing, Less adverse events, Increased bioavailability, Enhanced efficacy
Gralise Once-daily dosing, Tolerable titration, increased bioavailability, decreased dizziness and somnolence
Each of these products have either demonstrated incremental value over incumbent therapies, or demonstrated the verastility of the Acuform technology. Glumetza is a vast improvement over Glucophage, which has well-known titration issues as well as it's nasty adverse events profile. ProQuin, may not be the blockbuster that Gralise will be, but it proved that Acuform can work with more difficult chemical ingredients.
GRALISE for Post Herpetic Neuralgia
Gralise is probably the most differentiated amongst all of Depomed's FDA approved products. Below is an aggregation of data from the FDA-approved prescribing information for Gralise, Pfizer's (PFE) Lyrica, and Neurontin. The data is presented as a percent over placebo, demonstrating Gralise's superiority over Lyrica and Neurontin.
§Gralise Lyrica Neurontin
Somnolence 1.8% 13% 16.5%
Headache 0.1% 4% 0.1%
Dizziness 8.7% 22% 21.3%
Drop-out rate 2.8% 7% 7%
Dosing 1x/day 2x-4x/day 3x-5x/day
The fate of Gralise is still uncertain. Although, clearly it is a well differentiated product, Abbott (ABT) signaled that it is unhappy with it's marketing obligations. Currently, mediation is ongoing.
SERADA for menopausal hot flashes
Serada, like Gralise, experienced a phase III setback. The BREEZE trials failed to meet some of their primary endpoints in October of 2009. After several negotiations with the FDA, Depomed eventually received a Special Protocol Assessment ("SPA"), so that they could switch the analysis of the data from parametric to non-parametric. This change will help minimize the impact of outliers or extreme values over the entire data set. A major confounder in the failed BREEZE trials was outliers that reported up to 99 hot flashes per day at baseline which spontaneously resolved.
In October of 2010, at the North American Menopause Society Annual Meeting, Depomed revealed how non-parametric analysis would have affected the previous clinical trial results. Below is the p-values of each of the 8 endpoints from BREEZE 1 and 2, using non-parametric analysis.
§Frequency Severity
Breeze 1 - 4 Week Endpoint p≤ 0.025 p≤ 0.025
Breeze 2 - 4 Week Endpoint p≤ 0.001 p≤ 0.025
Breeze 1 - 12 Week Endpoint p≤ 0.025 p≤ 0.05
Breeze 2 - 12 Week Endpoint p≤ 0.005 p≤ 0.025
Based on these values, we can estimate the probability of repeated results, or in other words the probability of success for Serada in BREEZE 3. Assuming that the total enrollment is equal, and using the p-values to estimate the chances of repeating results, Serada's fate in the BREEZE 3 trial looks quite favorable.
§Chances of
Repeated Success
Severity: 4 week Endpoint 95.06%
Frequency: 4 week Endpoint 97.40%
Severity: 12 Week Endpoint 92.63%
Frequency: 12 Week Endpoint 97.01%
Total: All 4 Endpoints 83.20%
Based on BREEZE 1 and BREEZE 2, BREEZE 3 has a 83.20% chance of repeating results. This doesn't factor the various other adjustments that Depomed put in place for BREEZE 3. Notable changes include, a longer run-in period, and the use of cell-phone diaries that allows clinicians to call patients to ensure correct entry, if irregular responses are reported by the patient. Depomed believes that the longer run-in period, and the cell phone diaries may make for a more accurate assessment of patient's subjective values.
It's no secret that the placebo effect can be disastrous for hot flash trials, but it seems like the BREEZE 3 is well designed to combat that. The other pressing issue is the relevance of the 6 month, secondary endpoint. The FDA asked Depomed to include the endpoint but it's not exactly certain to shareholders how important this endpoint is to the FDA. Management has stated that they believe the FDA wants to ensure a trend towards efficacy versus outright statistical significance which would be difficult to achieve in an endpoint of that duration.
Given the continued reports of the deleterious effects of hormone use, a non-hormonal, FDA-approved treatment option has serious market potential. And it appears that Serada could be the first one to market. Breeze 3 should finish enrollment soon, with data lock to follow in early Q3 and with results potentially as early as October. Pfizer's completed it's enormous 2200 patient study with Pristiq for hot flashes in May 2010, but almost 10 months after final data collection, results have not been announced. This sudden and prolonged silence could mean that trial results were poor. Noven's Mesafem is undergoing a Phase III trial for hot flashes, but the company has projected that results of the trial will be announced in Q4 of 2011. Bionovo's (BNVI) Menerba, is slated to begin it's pivotal Phase III in early Q3 2011 with data available in Q4 2012. It seems that although there is some potential competition, Depomed's Serada may be the first non-hormonal treatment to reach the market.
Serada, like Gralise, is also a gabapentin formulation. With Gralise's recent FDA approval, certain risks that haunted Serada can be readjusted in Depomed's favor. Given the overall chances of success, the market opportunity, and the approval of Gralise, I believe the market has yet to factor in Serada's value.
DM-1992 for Parkinson's Disease
On February 7th, Depomed announced that they have successfully completed a Phase I study comparing DM-1992, a novel twice-daily dosage form of LevaDopa/CarbiDopa, to Sinimet, the current gold standard treatment option for Parkinson Disease ("PD") which is dosed 4 to 6 times daily. Depomed reported that they were able to maintain mean blood levels above the therapeutic level for 24 hours using only two doses. Maintaining an adequate blood level of the drug is paramount in managing PD. The problem is so severe that some patients elect to surgically implant a pump so that they can get a continuous dose of LevoDopa/Carbidopa, like Duodopa, a patient-operated portable pump that is currently marketed by Abbott.
Obviously taking a pill to achieve the same effect is preferred, and this is how Depomed's formulation meets an unmet need, yet again.
There is definatley a market for such a product and big pharma interest. GlaxoSmithKline (GSK) partnered with Impax (IPXL) for their Phase III levadopa/carbidopa formulation. In December, GlaxoSmithKline paid $12 million upfront for rights to Impax formulation outside of the US & Taiwain. They also have committed around $180 million in milestones along with a tiered double digit royalty. In 2009, Impax was so eager to get their product onto the market that with only half of their 27 patient Phase II study enrolled, they went straight to Phase III.
Medically, it appears that Depomed's DM-1992 is superior to that formulation, in that DM-1992 is dosed twice-daily versus three-times-daily. For a twice-daily product and it's longer therapeutic window, DM-1992 could bring home a sizeable worldwide deal for Depomed. For a worldwide contract, $25 million upfront, with $200-$300 in milestones, along with a double digit royalty is conceivable. More importantly, given that DM-1992 meets an unmet need, it's possible that it could be filed as a fast-track NDA and potentially be marketed in under 3 years.
DM-3458 for Gastroesophageal reflux disease ("GERD")
Depomed has been seeking a partner for DM-3458, an investigational treatment for GERD, since it released it's proof-of-concept trial in late 2007. Why is is that almost 4 years later, no partner has surfaced? It could be that pharmaceutical companies would only become interested in DM-3458 as their patents for current proton pump inhibitors approached expiration. Now, it seems like that time has come. Last month, several generic companies recieved FDA approval to market generic versions of Pfizer's Protonix. Soon, in 2013, Johnson & Johnson's (JNJ) Aciphex will meet the same fate. And in 2014, AstraZeneca's (AZN) Nexium will go generic. So after several years, the GERD landscape has shifted in Depomed's favor and thus should be valued appropriately.
DM-3458 is unique in that it seeks to solve the problem of Nocturnal Acid Breakthrough ("NAB"). NAB affects about half of patients with GERD, patients often wake up in the middle of the night with symptoms of acid reflux. DM-3458 is a shell and core dosage form, that releases one pulse of active ingredient when taken with the evening meal, and then 4 to 6 hours later it releases another pulse. By giving two doses, DM-3458 may improve NAB symptoms and thus meet an unmet need.
There is a market for both prescription GERD treatments as well as over-the-counter ("OTC"). For example, Santarus (SNTS) received $15 million upfront from Merck (MRK) for an OTC versions of Zegerid, Santarus's flagship GERD product. The deal also included about $30 million in other pre-marketing milestones, $37.5 million in sales milestones along with a double digit royalty. In 2010, prescription Zegerid went generic.
Clearly the GERD market is an opportunity. Depomed could pull in a partner for a prescription product, an OTC product, or possibly both.
The Big Picture
In the next month, while Depomed's counsel is hard at work for the next 2 months in mediation with Abbott, it is quite possible that investors may see several business development processes progress forward. That manifestation could be in the form of continued deals for extended-release metformin, a deal for DM-1992 or DM-3458.
Depomed has the technology to re-brand, re-tool, and re-purpose an army of pharmaceutical products facing patent expiration. But besides the technology, they have a management team that knows how to preserve shareholder value, how to communicate with shareholders and wall street, and that has the drive and the foresight to succeed. Given that several products in the pipeline have recently become more desirable, it is possible Depomed will move forward on the business development front. These are some of the reasons that make Depomed a company that one would want to invest in. There is a very attractive and under-appreciated long-term potential here.
For more information on Gralise, click here
For more information on Depomed's dispute with Abbott, click here
For more information on Serada, click here
For more information on the "women's health" market potential, click here
NAMS presentations for BREEZE 1 and BREEZE 2
Recent Corporate presentation, click here
Disclosure: I am long DEPO, ABT, MRK, SNTS, NGSX, BNVI, DRRX.
Sehr gelungene ausführliche Analyse von Tro Kalayjian:
Depomed: Attractive and Under-Appreciated Potential
It almost seems counterintuitive that majority shareholders of Depomed (DEPO) have been adding shares after the FDA approval of Gralise, a once-daily treatment for post-herpetic neuralgia. One might expect that large funds would look to the high volume created with an FDA decision as an opportune exit strategy. Yet that hasn't happened, several funds have filed schedule 13's indicating that they have continued to add shares or at least maintained a majority positions.
Over the past several weeks, Deltec Asset Management, and Tang Capital Partners have added to their already substantial positions. Deltec has increased ownership to 6%, Tang increased ownership to 9.9%. BlackRock (BLK) and ThirdPoint, still remain majority holders, holding 6.19% and 9.9%, respectively. Goldman Sachs (GS) has maintained its almost 2% position. Together, institutional and mutual fund owners claim about 60% of total shares.
What value do these large shareholders see? What makes Depomed different than any other biotech company? During a recent conference call, one of the participants, a senior managing director from a majority shareholder, may have disclosed the answer to the aforementioned questions. He stated that the management team at Depomed "is of the highest standards."
Management
Since early 2007, Depomed's management has been able to steer the company away from any dilutional events, despite several pipeline setbacks. Instead it has focused on legal and business development fronts to bring in cash via partnership deals, settlements and milestones. Besides management's emphasis on maintaining shareholder value, they have also excelled at shareholder communication through the use of quarterly newsletters communicating achievements and upcoming goals. They have held investor days, bringing in prominent speakers to discuss the unmet medical needs that Depomed seeks to meet. And, all of this was done after Depomed had chopped 25% of its staff, back in late 2007. Since then Depomed has been producing results with only 80 employees, which is exceptionally lean for a company that is valued at half a billion dollars.
Depomed's management team has proven that they are working on behalf of their shareholders. Of course, an excellent management alone doesn't make for an excellent investment opportunity, there has to be more.
Acuform Technology
The real star here, is Depomed's Acuform technology. In a competitive enviroment that includes failed accordion pills, defunct floating dosage forms, and ulcerating mucoadhesives, Acuform has stood out because of its biochemical versatility, as well as its intended therapeutic differentiation. The technology is as elegant as it is useful. It is a swelling polymeric gastric retentive pill that provides once or twice a day dosing. The pill swells to the about the size of a nickel, which prevents it from passing through the pylorus, keeping the pill in the stomach as it continually delivers active ingredient until it eventually dissolves. With regard to its biochemical versatility, Acuform has been successfully employed with three biochemically unique, FDA-approved products.
Trade Name Indication Chemical Property
Glumetza Diabetes highly water soluble
ProQuin UTI poorly water soluble
Gralise PHN absorbed in duodenum
Trade Name Clinical Differentiation
Glumetza Once-daily dosing, Tolerable titration, Increased bioavailability, Decreased nausea and GI upset
ProQuin Once-daily dosing, Less adverse events, Increased bioavailability, Enhanced efficacy
Gralise Once-daily dosing, Tolerable titration, increased bioavailability, decreased dizziness and somnolence
Each of these products have either demonstrated incremental value over incumbent therapies, or demonstrated the verastility of the Acuform technology. Glumetza is a vast improvement over Glucophage, which has well-known titration issues as well as it's nasty adverse events profile. ProQuin, may not be the blockbuster that Gralise will be, but it proved that Acuform can work with more difficult chemical ingredients.
GRALISE for Post Herpetic Neuralgia
Gralise is probably the most differentiated amongst all of Depomed's FDA approved products. Below is an aggregation of data from the FDA-approved prescribing information for Gralise, Pfizer's (PFE) Lyrica, and Neurontin. The data is presented as a percent over placebo, demonstrating Gralise's superiority over Lyrica and Neurontin.
§Gralise Lyrica Neurontin
Somnolence 1.8% 13% 16.5%
Headache 0.1% 4% 0.1%
Dizziness 8.7% 22% 21.3%
Drop-out rate 2.8% 7% 7%
Dosing 1x/day 2x-4x/day 3x-5x/day
The fate of Gralise is still uncertain. Although, clearly it is a well differentiated product, Abbott (ABT) signaled that it is unhappy with it's marketing obligations. Currently, mediation is ongoing.
SERADA for menopausal hot flashes
Serada, like Gralise, experienced a phase III setback. The BREEZE trials failed to meet some of their primary endpoints in October of 2009. After several negotiations with the FDA, Depomed eventually received a Special Protocol Assessment ("SPA"), so that they could switch the analysis of the data from parametric to non-parametric. This change will help minimize the impact of outliers or extreme values over the entire data set. A major confounder in the failed BREEZE trials was outliers that reported up to 99 hot flashes per day at baseline which spontaneously resolved.
In October of 2010, at the North American Menopause Society Annual Meeting, Depomed revealed how non-parametric analysis would have affected the previous clinical trial results. Below is the p-values of each of the 8 endpoints from BREEZE 1 and 2, using non-parametric analysis.
§Frequency Severity
Breeze 1 - 4 Week Endpoint p≤ 0.025 p≤ 0.025
Breeze 2 - 4 Week Endpoint p≤ 0.001 p≤ 0.025
Breeze 1 - 12 Week Endpoint p≤ 0.025 p≤ 0.05
Breeze 2 - 12 Week Endpoint p≤ 0.005 p≤ 0.025
Based on these values, we can estimate the probability of repeated results, or in other words the probability of success for Serada in BREEZE 3. Assuming that the total enrollment is equal, and using the p-values to estimate the chances of repeating results, Serada's fate in the BREEZE 3 trial looks quite favorable.
§Chances of
Repeated Success
Severity: 4 week Endpoint 95.06%
Frequency: 4 week Endpoint 97.40%
Severity: 12 Week Endpoint 92.63%
Frequency: 12 Week Endpoint 97.01%
Total: All 4 Endpoints 83.20%
Based on BREEZE 1 and BREEZE 2, BREEZE 3 has a 83.20% chance of repeating results. This doesn't factor the various other adjustments that Depomed put in place for BREEZE 3. Notable changes include, a longer run-in period, and the use of cell-phone diaries that allows clinicians to call patients to ensure correct entry, if irregular responses are reported by the patient. Depomed believes that the longer run-in period, and the cell phone diaries may make for a more accurate assessment of patient's subjective values.
It's no secret that the placebo effect can be disastrous for hot flash trials, but it seems like the BREEZE 3 is well designed to combat that. The other pressing issue is the relevance of the 6 month, secondary endpoint. The FDA asked Depomed to include the endpoint but it's not exactly certain to shareholders how important this endpoint is to the FDA. Management has stated that they believe the FDA wants to ensure a trend towards efficacy versus outright statistical significance which would be difficult to achieve in an endpoint of that duration.
Given the continued reports of the deleterious effects of hormone use, a non-hormonal, FDA-approved treatment option has serious market potential. And it appears that Serada could be the first one to market. Breeze 3 should finish enrollment soon, with data lock to follow in early Q3 and with results potentially as early as October. Pfizer's completed it's enormous 2200 patient study with Pristiq for hot flashes in May 2010, but almost 10 months after final data collection, results have not been announced. This sudden and prolonged silence could mean that trial results were poor. Noven's Mesafem is undergoing a Phase III trial for hot flashes, but the company has projected that results of the trial will be announced in Q4 of 2011. Bionovo's (BNVI) Menerba, is slated to begin it's pivotal Phase III in early Q3 2011 with data available in Q4 2012. It seems that although there is some potential competition, Depomed's Serada may be the first non-hormonal treatment to reach the market.
Serada, like Gralise, is also a gabapentin formulation. With Gralise's recent FDA approval, certain risks that haunted Serada can be readjusted in Depomed's favor. Given the overall chances of success, the market opportunity, and the approval of Gralise, I believe the market has yet to factor in Serada's value.
DM-1992 for Parkinson's Disease
On February 7th, Depomed announced that they have successfully completed a Phase I study comparing DM-1992, a novel twice-daily dosage form of LevaDopa/CarbiDopa, to Sinimet, the current gold standard treatment option for Parkinson Disease ("PD") which is dosed 4 to 6 times daily. Depomed reported that they were able to maintain mean blood levels above the therapeutic level for 24 hours using only two doses. Maintaining an adequate blood level of the drug is paramount in managing PD. The problem is so severe that some patients elect to surgically implant a pump so that they can get a continuous dose of LevoDopa/Carbidopa, like Duodopa, a patient-operated portable pump that is currently marketed by Abbott.
Obviously taking a pill to achieve the same effect is preferred, and this is how Depomed's formulation meets an unmet need, yet again.
There is definatley a market for such a product and big pharma interest. GlaxoSmithKline (GSK) partnered with Impax (IPXL) for their Phase III levadopa/carbidopa formulation. In December, GlaxoSmithKline paid $12 million upfront for rights to Impax formulation outside of the US & Taiwain. They also have committed around $180 million in milestones along with a tiered double digit royalty. In 2009, Impax was so eager to get their product onto the market that with only half of their 27 patient Phase II study enrolled, they went straight to Phase III.
Medically, it appears that Depomed's DM-1992 is superior to that formulation, in that DM-1992 is dosed twice-daily versus three-times-daily. For a twice-daily product and it's longer therapeutic window, DM-1992 could bring home a sizeable worldwide deal for Depomed. For a worldwide contract, $25 million upfront, with $200-$300 in milestones, along with a double digit royalty is conceivable. More importantly, given that DM-1992 meets an unmet need, it's possible that it could be filed as a fast-track NDA and potentially be marketed in under 3 years.
DM-3458 for Gastroesophageal reflux disease ("GERD")
Depomed has been seeking a partner for DM-3458, an investigational treatment for GERD, since it released it's proof-of-concept trial in late 2007. Why is is that almost 4 years later, no partner has surfaced? It could be that pharmaceutical companies would only become interested in DM-3458 as their patents for current proton pump inhibitors approached expiration. Now, it seems like that time has come. Last month, several generic companies recieved FDA approval to market generic versions of Pfizer's Protonix. Soon, in 2013, Johnson & Johnson's (JNJ) Aciphex will meet the same fate. And in 2014, AstraZeneca's (AZN) Nexium will go generic. So after several years, the GERD landscape has shifted in Depomed's favor and thus should be valued appropriately.
DM-3458 is unique in that it seeks to solve the problem of Nocturnal Acid Breakthrough ("NAB"). NAB affects about half of patients with GERD, patients often wake up in the middle of the night with symptoms of acid reflux. DM-3458 is a shell and core dosage form, that releases one pulse of active ingredient when taken with the evening meal, and then 4 to 6 hours later it releases another pulse. By giving two doses, DM-3458 may improve NAB symptoms and thus meet an unmet need.
There is a market for both prescription GERD treatments as well as over-the-counter ("OTC"). For example, Santarus (SNTS) received $15 million upfront from Merck (MRK) for an OTC versions of Zegerid, Santarus's flagship GERD product. The deal also included about $30 million in other pre-marketing milestones, $37.5 million in sales milestones along with a double digit royalty. In 2010, prescription Zegerid went generic.
Clearly the GERD market is an opportunity. Depomed could pull in a partner for a prescription product, an OTC product, or possibly both.
The Big Picture
In the next month, while Depomed's counsel is hard at work for the next 2 months in mediation with Abbott, it is quite possible that investors may see several business development processes progress forward. That manifestation could be in the form of continued deals for extended-release metformin, a deal for DM-1992 or DM-3458.
Depomed has the technology to re-brand, re-tool, and re-purpose an army of pharmaceutical products facing patent expiration. But besides the technology, they have a management team that knows how to preserve shareholder value, how to communicate with shareholders and wall street, and that has the drive and the foresight to succeed. Given that several products in the pipeline have recently become more desirable, it is possible Depomed will move forward on the business development front. These are some of the reasons that make Depomed a company that one would want to invest in. There is a very attractive and under-appreciated long-term potential here.
For more information on Gralise, click here
For more information on Depomed's dispute with Abbott, click here
For more information on Serada, click here
For more information on the "women's health" market potential, click here
NAMS presentations for BREEZE 1 and BREEZE 2
Recent Corporate presentation, click here
Disclosure: I am long DEPO, ABT, MRK, SNTS, NGSX, BNVI, DRRX.
15.02.11 00:59
#43
Heiko T.
Und noch
der Link dazu
zum Nachlesen der Comments
http://seekingalpha.com/article/...-appreciated-potential?source=feed
zum Nachlesen der Comments
http://seekingalpha.com/article/...-appreciated-potential?source=feed
15.02.11 01:05
#44
Heiko T.
Besser
sowieso den oben kopierten Text über den Link verfolgen,
da im Text oben die Tabellen nicht richtig mitkopiert wurden.
da im Text oben die Tabellen nicht richtig mitkopiert wurden.
15.02.11 17:54
#45
butzerle
FDA verlangt Nachbesserungen
http://www.marketwatch.com/story/...ebounds-depomed-slides-2011-02-15
gibt offenbar ein paar Sicherheitsbedenken
gibt offenbar ein paar Sicherheitsbedenken
15.02.11 20:11
#46
Heiko T.
Es handelt
sich lediglich um eine Vergleichsstudie,die die FDA will.
http://www.finanznachrichten.de/...omed-pain-drug-shares-fall-020.htm
Sicherheitsbedenken ist zu krass formuliert.Es würden sonst neue Studien verlangt.Das ist aber nicht der Fall.
http://www.finanznachrichten.de/...omed-pain-drug-shares-fall-020.htm
Sicherheitsbedenken ist zu krass formuliert.Es würden sonst neue Studien verlangt.Das ist aber nicht der Fall.
15.02.11 22:44
#47
bierro
Ist das üblich?
Erst wird die Zulassung erteilt, und Wochen später dann ein(halber) Rückzieher?
18.02.11 19:39
#48
bierro
Zwei Szenarien aus Yahoo
Contract RESOLUTION is NEXT MAJOR CATALYST !! 13-Feb-11 08:56 am
Either RESOLUTION or SETTLEMENT of the contract dispute between ABT and DEPO is the NEXT HUGE CATALYST for DEPO.
According to DEPO's CEO, CP, the entire RESOLUTION process would take LESS than 8 weeks. He said that the process begins with MEDIATION and if necessary, it proceeds into BINDING ARBITRATION. Well, since nearly a MONTH has passed since the contract-dispute announcement, the MEDIATION process must be OVER. Therefore, ABT and DEPO have probably begun the BINDING ARBITRATION process. In this case, the arbiter is usually a retired judge who will easily figure out ABT's true motivation for the puzzling dispute.
The ARBITRATION decision is BINDING. And although DEPO may still have to go to court to obtain the AWARD given by the BINDING ARBITRATION, the chances of a court overturning the binding arbitration decision are nil. In all likelihood, ABT will abide by the arbitration decision.
Although the following are still TWO POSSIBLE OUTCOMES of the RESOLUTION process, the latter is much more likely now:
1. ABT will proceed with the launch according to the contract but with some concessions from either side. A likely change would be ABT getting the ROW (rest of world) contract to market GRALISE outside North America. This would bring about an UP-FRONT payment and additional MILESTONE payments and royalties from ABT to DEPO.
2. ABT will terminate the contract, return the North America rights to DEPO, and compensate DEPO for the lost income from royalties, future milestone payments, and the delay in marketing. The expected compensation should total about $150 million (including the $48 million milestone payment that is not being disputed by ABT).
In the case of the 2nd outcome, DEPO will proceed to sign a new GRALISE marketing contract with a different BIG-PHARMA company, which will pay DEPO an additional UPFRONT PAYMENT as well as milestone and royalty payments that will vary with the level of sales. Since GRALISE has an ORPHAN DRUG DESIGNATION in PHN, which includes a SEVEN-YEAR MARKET EXCLUSIVITY, high sales levels will likely be reached in a relatively short time.
According to DEPO's CEO, DEPO may NOW opt to sign a contract for the WORLDWIDE marketing RIGHTS for GRALISE with just one company (ROCHE?).
Thus, THE CONTRACT-DISPUTE RESOLUTION or SETTLEMENT will come BEFORE late MARCH, but it COULD COME at ANY DAY NOW (since a month has already passed).
In either case, whether ABT opts to settle the dispute by compensating DEPO or continues with the launch of GRALISE, it is still MUCH MORE BENEFICIAL for ABT to simply ACQUIRE DEPO. After all, even at $24/share (a price likely to be accepted by DEPO) , the ACQUISITION PRICE would be JUST $1.27 BILLION.
IN FACT, it is quite LIKELY that the so called MEDIATION meetings are just a COVER for ACQUISITION talks. After all, in MOST CASES where a big-pharma partnered with a small company to develop a drug, the big-pharma company ACQUIRED its small partner AFTER the APPROVAL of their partnered drug.
In that case, the NEXT BIG ANNOUNCEMENT from DEPO may be a BUY-OUT announcement.
http://messages.finance.yahoo.com/Stocks_(A_to_Z)/...&frt=1#56302
Either RESOLUTION or SETTLEMENT of the contract dispute between ABT and DEPO is the NEXT HUGE CATALYST for DEPO.
According to DEPO's CEO, CP, the entire RESOLUTION process would take LESS than 8 weeks. He said that the process begins with MEDIATION and if necessary, it proceeds into BINDING ARBITRATION. Well, since nearly a MONTH has passed since the contract-dispute announcement, the MEDIATION process must be OVER. Therefore, ABT and DEPO have probably begun the BINDING ARBITRATION process. In this case, the arbiter is usually a retired judge who will easily figure out ABT's true motivation for the puzzling dispute.
The ARBITRATION decision is BINDING. And although DEPO may still have to go to court to obtain the AWARD given by the BINDING ARBITRATION, the chances of a court overturning the binding arbitration decision are nil. In all likelihood, ABT will abide by the arbitration decision.
Although the following are still TWO POSSIBLE OUTCOMES of the RESOLUTION process, the latter is much more likely now:
1. ABT will proceed with the launch according to the contract but with some concessions from either side. A likely change would be ABT getting the ROW (rest of world) contract to market GRALISE outside North America. This would bring about an UP-FRONT payment and additional MILESTONE payments and royalties from ABT to DEPO.
2. ABT will terminate the contract, return the North America rights to DEPO, and compensate DEPO for the lost income from royalties, future milestone payments, and the delay in marketing. The expected compensation should total about $150 million (including the $48 million milestone payment that is not being disputed by ABT).
In the case of the 2nd outcome, DEPO will proceed to sign a new GRALISE marketing contract with a different BIG-PHARMA company, which will pay DEPO an additional UPFRONT PAYMENT as well as milestone and royalty payments that will vary with the level of sales. Since GRALISE has an ORPHAN DRUG DESIGNATION in PHN, which includes a SEVEN-YEAR MARKET EXCLUSIVITY, high sales levels will likely be reached in a relatively short time.
According to DEPO's CEO, DEPO may NOW opt to sign a contract for the WORLDWIDE marketing RIGHTS for GRALISE with just one company (ROCHE?).
Thus, THE CONTRACT-DISPUTE RESOLUTION or SETTLEMENT will come BEFORE late MARCH, but it COULD COME at ANY DAY NOW (since a month has already passed).
In either case, whether ABT opts to settle the dispute by compensating DEPO or continues with the launch of GRALISE, it is still MUCH MORE BENEFICIAL for ABT to simply ACQUIRE DEPO. After all, even at $24/share (a price likely to be accepted by DEPO) , the ACQUISITION PRICE would be JUST $1.27 BILLION.
IN FACT, it is quite LIKELY that the so called MEDIATION meetings are just a COVER for ACQUISITION talks. After all, in MOST CASES where a big-pharma partnered with a small company to develop a drug, the big-pharma company ACQUIRED its small partner AFTER the APPROVAL of their partnered drug.
In that case, the NEXT BIG ANNOUNCEMENT from DEPO may be a BUY-OUT announcement.
http://messages.finance.yahoo.com/Stocks_(A_to_Z)/...&frt=1#56302
17.03.11 14:59
#49
bierro
Einigung mit Abbott
NEW YORK (AP) -- Depomed will regain from Abbott Laboratories the rights to its drug Gralise, it said Thursday, and will receive a $40 million from the company.
Depomed disclosed that the companies have ended a licensing agreement on Gralise. The drug is intended to approve pain following the viral infection shingles, and the Food and Drug Administration approved its sale in January. Depomed, of Menlo Park, Calif., said it plans to start selling the drug by the end of 2011. It will look for a partner to help promote the drug to primary care physicians.
Depomed Inc. licensed Gralise to Solvay Pharmaceuticals in November 2008. Abbott, of North Chicago, Ill., acquired Solvay in 2010. Abbott paid Depomed $48 million after the FDA approved it.
Gralise is a version of gabapentin, a drug that has been on the market for more than a decade as a treatment for epilepsy and shingles-related pain. The advantage of Gralise is that it can be taken only once per day, an improvement over older versions.
http://finance.yahoo.com/news/...ns-rights-to-apf-1500513935.html?x=0
Depomed disclosed that the companies have ended a licensing agreement on Gralise. The drug is intended to approve pain following the viral infection shingles, and the Food and Drug Administration approved its sale in January. Depomed, of Menlo Park, Calif., said it plans to start selling the drug by the end of 2011. It will look for a partner to help promote the drug to primary care physicians.
Depomed Inc. licensed Gralise to Solvay Pharmaceuticals in November 2008. Abbott, of North Chicago, Ill., acquired Solvay in 2010. Abbott paid Depomed $48 million after the FDA approved it.
Gralise is a version of gabapentin, a drug that has been on the market for more than a decade as a treatment for epilepsy and shingles-related pain. The advantage of Gralise is that it can be taken only once per day, an improvement over older versions.
http://finance.yahoo.com/news/...ns-rights-to-apf-1500513935.html?x=0
14.10.11 16:06
#50
butzerle
Das war wohl nix
http://www.businessweek.com/ap/financialnews/D9QBKT5O0.htm
Seite:
1
|
1
|
2