Depomed - FDA entscheid f. Blockbuster im Januar


Beiträge: 59
Zugriffe: 42.964 / Heute: 4
Depomed kein aktueller Kurs verfügbar
 
Chalifmann3:

Depomed - FDA entscheid f. Blockbuster im Januar

4
29.12.10 06:57
Depomed (Nasdaq:DEPO):

Das Unternehmen hat bereits zwei produkte am Markt ,Glumetza (Diabetes typ 2) und Proquin (Antibiotikum).
Glumetza wird von KG Pharma(KG) in USA und in Kanada von Biovail (BVF) vermarktet.
ProQuin wird von Esprit Pharma in USA verkauft .
In der pipeline befindet sich u.a. noch die verbesserte version von Pfizer´s blockbuster produkt Gabapentin für die bereiche (Postherpetic Neuralgia) PHASE 3 und (Diabetic Peripheral Neuropathy) PHASE 2.

Depomed hat eine Marktkap. von nur 300 mio$ davon allein schon 66 mio$ an cash und gute produkte die alle auf ein millarden dollar markt zielen.

MFG
Chali
Antworten

Werbung

Entdecke die beliebtesten ETFs von SPDR


Chalifmann3:

2-Jahres-Chart

 
29.12.10 07:16
(Verkleinert auf 70%) vergrößern
Depomed - FDA entscheid f. Blockbuster im Januar 369095
Antworten
Chalifmann3:

3 Catalysts That Could Push DepoMed Share Price Hi

 
29.12.10 20:43
3 Catalysts That Could Push DepoMed Share Price Higher
2 comments  |  by: Sheff Station December 27, 2010  | about: ABT / AZN / CLDA / DEPO /

Following FollowSend Message You are currently following Sheff Station
On December 22nd it was reported by TrackData that the DepoMed (DEPO) overall option implied volatility of 111 was above the 26-week average of 84. This volatility and high number suggests that a share move higher can possibly occur very soon as we move into 2011. This positive options activity will most likely continue as there are several catalysts that should propel DepoMed higher in January 2011.

The catalysts I will refer to first do not include the most important one which will occur on Jan 30th as that is the PDUFA date for DM-1796. DM-1796 is an extended release, once-daily tablet formulation of gabapentin for the management of postherpetic neuralgia (PHN), or pain after shingles. DepoMed has partnered with Abbott Laboratories for the rights to DM-1796 in North America. DepoMed still has the ex-North America rights but they are actively seeking a pharma partner who would be looking to expand the international growth of DM-1796.

The three catalysts that are expected to occur prior to the January 30th PDUFA date of DM-1796 are:

1) Merck (MRK) will file a Januvia & Metformin combination in the 4Q 2010 or early 2011.

2) Phase 1 results for DM-1992 should be released in Q1 2011. This is their novel formulation of Levodopa/Carbidopa, which has been the drug of choice & well recognized as the best drug for Parkinson's Disease. The drug has several has significant limitations with inconvenient dosing (4-6 times daily) and mediocre efficacy.

3) Glumetza 500mg resupply to occur in 4Q 2010.


If you look at FDA approvals for January, DepoMed is the most undervalued stock with a market cap of only $305 million with a $5.80 closing price. The company has 39 milion shares in the float, 52 million outstanding, and 66 million in cash. 60% of DepoMed shares are held by institutions. The company expects profitability in 2011. The reason is because they are able to take their technology and license it to other people for cash. They have been successful in funding the development of their clinical programs and have not needed to go to the market for cash for 3 years. If DM-1796 is approved then Abbott will owe them another $35 million and another potential $25 million, depending upon how their side effects appear in the FDA label. After approval, Abbott will also owe them a 14% to 20% royalty. This will help start the path to profitability. With all this, they are still undervalued especially when compared to other companies with PDUFA dates in January.

The other January approvals are:

AstraZeneca (AZN)- Drug/indication- Zictifa for medullary thyroid cancer. Approval decision date: Jan. 7, 2011 and a market cap of 65.5 billion.

Clinical Data (CLDA)- Drug/indication: Vilazodone for major depressive disorder. Approval decision date: Jan. 22, 2011 and a market cap of 500 million.

Orexigen Therapeutics (OREX)- Drug/indication: Contrave for obesity. Approval decision date: Jan. 31, 2011 and a market cap of 380 million.

When assessing a company with a PDUFA date it is also important that investors assess the risk vs. benefit in holding a company that has a PDUFA date. There is always risk with any biotech company but DepoMed does not take on as much risk with the development of their compounds because they are starting with known chemicals that have been used in humans for many years. This is the case with DM-1796 (gabapentin) as well. The safety profile and advantages over existing gabapentin formulations have been demonstrated from their pivotal Phase III clinical trial.

The advantage is there are not as many suprises as there would be with new drug compounds. The potential reward seems to favor the shareholder vs. the risk when looking at what DepoMed has done thus far with their safety and tolerability profile for DM-1796. The hope for shareholders is that there won't be any surprises come January and that the share price, with these pending catalysts, will continue to move higher into their January PDUFA date of January 30th

MFG
Chali
Antworten
MicroV:

wirklich interessante Company

 
06.01.11 15:11

Depomed - FDA entscheid f. Blockbuster im Januar 9448051sehr gutes charttechnisches Bild, bin seit 5,80$ auch dabei.

Hier noch eine Einschätzung zur Zulassung:

seekingalpha.com/article/244631-news-stories-miss-the-point-as-depomed-approaches-fda-target-date

Gekkowire hat da eher eine negative Einstellung, die versuchen aber bereits seit letztem Jahr den Wert mit negativen Kommentaren zu drücken. Fakt ist, dass der Wirkstoff von DM-1796 (gabapentin) bereits seit Jahren eingesetzt wird. Ich bin ehr Pro-Zulassung eingestellt. Ende Jan. wissen wir mehr.

www.gekkowire.com/

@Chalifmann3:

Nr. 3 ist ja seit gestern durchgeführt

www.businesswire.com/news/home/20110105005478/en/...y-GLUMETZA-500-mg

 

Antworten
Chalifmann3:

Hi MicroV

 
06.01.11 15:36
Da gebe ich dir Recht,wenngleich mein tipp zu Depomed früher hätte kommen können,ausserdem fährt im moment alles auf XOMA ab ! Mein zielkurs für Depomed ist 20$,es müsste schon mit dem Teufel zugehen,wenn die FDA am 30.01. ablehnt ....

MFG
Chali
Antworten
MicroV:

...

 
06.01.11 15:47
Bin da eher etwas konservativer eingestellt, mein Ziel nach Zulassung ist 10-13$, aber 20$ nehme ich natürlich auch gerne mit ,-)

Gruß
MicroV
Antworten
MicroV:

Top 15 Most Undervalued Rally Stocks...

 
08.01.11 10:13

4. DepoMed Inc. (DEPO): Drug Manufacturer. Market cap of $356.06M. The stock is currently 10.12% above its 20-day MA, 19.62% above its 50-day MA, and 62.32% above its 200-day MA. Current price at $6.74 vs. target price at $8. (implies a discount of 15.75%). Short float at 5.65%, which implies a short ratio of 5.06 days. The stock has gained 118.45% over the last year.



seekingalpha.com/instablog/666527-kapitall/...ued-rally-stocks

Gestern vom Tageslow einen schönen Rebound hingelegt, sehr, sehr stark, die nächsten 2 Wochen werden spannend, denke es geht vor der Entscheidung bis an 8$
Antworten
MicroV:

...

 
10.01.11 19:27
Depomed: Extended Release Pharmaceuticals and Extended Share Price Increases?

seekingalpha.com/article/...share-price-increases?source=yahoo
Antworten
MicroV:

DEPO Will Engage in Mediation to Resolve Disput...

 
19.01.11 09:46

Depomed Will Engage in  Mediation to Resolve Dispute With Abbott; Comments on DM-1796 Regulatory  Status and Orphan Drug Designation

www.globenewswire.com/newsroom/news.html?d=211271

merkwürdige Entscheidung von Abbott, kurz vor Zulassung.

 

Antworten
MicroV:

Transcript from Conferance Call

 
19.01.11 09:49

Depomed (DEPO) and Abbot in Serious Dispute Over Commercial Launch of DM-1796, (Live update in progress)  
January 18th, 2011 by admin Leave a reply »  
 
 
Depomed says:  
 
-Last week Abbot informed Depomed that they are not obligated to launch DM-1796 based on how Abbot interprets the contract.  
 
-Intend to aggressively pursue this  
 
-DEPO expects to see a strong return on DM-1796  
 
- Agreement compels Abbot to cause the 1st commercial sale following FDA approval..  
 
- DEPO: puzzled by Abbot’s reluctance, sounds like Abbot doesn’t think commercial potential return viable  
-Solvay did extensive due diligence on market opportunity  
 
-DEPO notes that internal abbot analysis on drug was not shared with DEPO  
 
-Next steps, clear dispute process, mediation the next step, 3 possible scenarios  
 
1st scenario, abbot reevaluates their decision  
 
-2nd Abbot wants to keep rights to DM-1796, but choose not to launch  
 
-3rd DEPO can retain  
 
 -DEPO will only consider taking the product back, if funded by Abbot  the commercial launch is successful and is cashflow positive  
 
-DEPO does not have resources to launch DM-1796  
 
-DEPO, during the resolution process ABBOtt will continue to keep their obligations  
 
-DEPO CEO, “I AM PERPLEXED BY ABBOTT’s Decision”  
 
-DEPO, FDA decision will come with FDA’s decision on Orphan drug  
 
-3-8 weeks will have a mediation with Abbot  
 
-QnA time:  
 
-Q: With PDUFA coming up with money to be owed?  
 
-Ans. Abbott should fulfill its obligations in terms of milestones  
 
-Q: Sounds like a signal that Abbott is not going to pay on time, if that happens is that a breach?  
 
-A: can’t speak to what would happen if a breach is to happen  
 
-Q_ Why wouldn’t Abbott launch this drug?  
 
-A: We are perplexed, don’t know why, although we aren’t privy to Abbott’s internal analysis  
 
-Q: Who is another partner if Abbott doesn’t want to go ahead?  
 
-A: Not gonna name names of companies.  
 
New caller  
 
-Q: Did mention that Abbott is not obligated to launch, are they obligated to pay the milestone if approved?  
 
-A: Abbott said they would fulfill the contract  
 
-Q: Anything that has changed that they are citing between now and today?  
 
 -A: ABT was excited for Orphan drug, didn’t really give us a lot of  concrete reasons, sense I have is that company may have reevaluated what  assets are best fit for the company, very mixed messages from Abbott,  
 
-Q Seems irrational that this battle wasn’t fought earlier, what is legal strategy going forward?  
 
-A: We were working with the original Solvay forecast for manufacturing  
 
-Q: How long to resolve mediation process? 1month?  
 
-A: One mouth seems plausible, want to resolve quickly  
 
-Q: Are you in labeling discussions with the FDA and is there a commercial name?  
 
-A: yes there is a commercial name, won’t comment on labeling discussions, high likelihood of meeting the PDUFA date on time.  
 
-Q: How much money will change hands here?  
 
-A; Can’t disclose the size of amount on CC  
New Caller:  
 
-Q: When is the Orphan drug status was granted?  
 
-A: In november we were notified  
 
 -Q: Actual NDA has Abbott’s name on it, does that mean that people at  Depomed do not know the substance of the conversations with the FDA?  
 
 -A; FDA will naturally go to Abbott, but Abbott is contractually  obligated to FDA discussions, often we are a party to “some” of those  discussions with the FDA  
 
-Q: How informed are you as to the FDA discussions, Highly, med, low?  
 
-A: Very highly informed  
 
-Q: If depomed gets control back, how do you get manufacturing back in line?  
 
-A: Same manufacturing site as used for technology in the past  
 
-q: So no slippage of time in the manufacturing process?  
 
-A: that is correct  
 
-Q: If funding was not an issue to reacquisition, what would be the critical path to get it launched?  
 
 -A: Critical path would be getting name on the samples and the product,  could hire a small sales focused sales force that can be done rapidly,  but won’t match Abbott’s sales power, we think we could launch on time  if we were in the position to  
 
-A: We can launch on time  
 
-Q: Partner question? Did you have discussion regarding rest of world rights?  
 
-A: in our discussions with rights in rest of world the topic of U.S. rights has come up over and over,  
 
New caller: jason from Zack’s Investment:  
 
-Q: Was there any provision that would give abbott and out?  
 
-A: No, they have no out  
 
-Q:What are Abbott specific rights  
 
 -A: PHN in North America and develop the product for other indications  in Pain (fibro the big one), we own non-pain rights like RLS  
 
-Q: Do you think abbott is trying to get a better deal?  
 
 -A: I can’t comment on that directly, we have been very open with  Abbott and have not shut the door on any discussions (”hint, hint,” my  words not depo’s )  
 
-Q: If you id budge which is more important upfront Milestone or royalty rate if you have to negotiate?  
 
–A: I can’t answer that.  
 
Call over  

Antworten
MicroV:

Termination Events of the Contract with Abbott

 
19.01.11 09:53

“Termination Event” means any  
 
(a) withdrawal of the Product in the Field from the market in the Territory,  
 
(b) material medical or scientific concerns as to toxicity, safety and/or efficacy of Product in the Field,  
 
 (c) written request of any Governmental Authority or the applicable  institutional review board or data safety monitoring board to stop  clinical trials of the Product in the Field,  
 
(d) failure of  the Product to meet all primary endpoints in clinical trials conducted  prior to Regulatory Approval of Product in the Field,  
 
(e) a  Patent Right controlled by a Third Party is identified that is not  included in the Depomed Patents and that is not otherwise licensed to  Solvay, which Patent Right (i) claims inventions reasonably necessary  for the manufacture, use, sale, offer for sale or import of the Product  in the Field in the Territory and (ii) is not available for licensing or  otherwise transferable to Solvay on terms reasonably acceptable to  Solvay, or  
 
(f) any of the following events: (i) a  determination that the Product is not approvable by FDA, as evidenced by  a written communication from FDA to Solvay, its Affiliate or  sublicensee;(ii); or (iii) managed care providers, comprising at least a  majority of the managed care environment in the United States,  blocking, materially restricting (including, without limitation,  imposition of step edits or prior authorizations) or declining coverage  and/or reimbursement for the Product.

 

Antworten
bierro:

Willkommen im Club!

 
19.01.11 19:19
Hallo Chali,

bin nach Deinem vorzüglichen Tipp heute eingestiegen. Hab mich ein wenig eingelesen und denke, hier könnte was gehen.

Wermutstropfen in FFM: Der Spread. Bin zu 4,31 rein, Ask jetzt 4,263, während das Bid mittlerweile bei 4,435 steht.

Ma kucken, ne?
Antworten
Chalifmann3:

Hi bierro,MicroV hast du heute aufgestockt ?

 
19.01.11 20:45
Depomed: Extended Release Pharmaceuticals and Extended Share Price Increases?
8 comments  |  by: Steven Breazzano January 10, 2011  | about: DEPO     Font Size:  

Depomed (DEPO) – based in Menlo Park, California, engages in the development of enhanced pharmaceuticals to improve the efficacy, convenience, and safety of existing treatments. Utilizing their proprietary AcuForm technology, the company aims to leverage this platform to provide enhanced therapeutics. Essentially, the company attaches its proprietary polymer to the drug which allows it to remain in the GI tract longer than before, thereby slowly releasing the compound into the bloodstream. As a result of the smoother delivery, side effects are reduced, efficacy is improved, and the dosage frequency is lowered. Consequently, DEPO targets well-established, orally available drugs with large patient populations that currently suffer from nasty side effects, and inconvenient dosing (multiple times per day).

Attention is currently focused on the drug candidate DM-1796 which has been submitted to the FDA for approval and currently has a PDUFA date of 1/30/11. DM-1796 is an extended release formulation of the FDA-approved immediate release pharmaceutical gabapentin for the treatment of partial epilepsy and management of postherpetic neuralgia (PHN). PHN is caused by nerve damage after affliction with shingles (herpes zoster virus) and affects approximately one in five patients diagnosed with shingles (~ 150,000 individuals) in the US. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles developing PHN. The phase III data was very promising, with pain reduction scores similar to the competition (neurontin, lyrica) but with a vastly improved tolerability profile. Therefore we view FDA approval as likely. For a lively discussion of DEPO and potential approval risks arising from some of the phase III data see this discussion. Due to the vast improvement in side effects, we believe that DM-1796 has the potential to gain significant market share and with its licensing partner, Abbot Laboratories (ABT), potential sales in the hundreds of millions are within the realm of possibility.

Potential milestone payments to DEPO from Abbott include 35 mm for US approval, and an additional payment of up to 25 mm depending on the labeling. In addition, DEPO will receive between 14% and 20% royalty payments in North America. No agreement has been reached for outside North America, but we expect that in the near term a partner will be lined up for ex-North American distribution (most likely Abbot).

To date, the company has two products currently on the market: Glumetza and ProquinXR. Glumetza, an extended release formulation of metformin used in the treatment of type II diabetes, is by far the larger of the two by revenue, accounting for approximately 9-12 mm a quarter. ProquinXR is an extended release formulation of the antibiotic Ciprofloxacin, and current quarterly revenue is a relatively insignificant < 1 mm. A lot of attention has recently been focused on the supply interruption of the 500 mg Glumetza (1000 mg remained uninterrupted), however that issue has been recently resolved and doesn’t appear to have hurt the company’s bottom line. Furthermore, due to the improved tolerability profile of Glumetza over immediate release metformin formulations, we believe Glumetza will continue to make gains in the type II diabetes market, aided by the full-court press of Santarus (marketing partner in the US).

Pipeline: While the main candidate, DM-1796, has been submitted for FDA approval, the pipeline currently consists of various stage compounds. Notably, Serada is undergoing a new, revised phase III trial (BREEZE-3), with the results expected later in 2011. While we view Serada’s potential market (menopausal hot-flashes) positively, given that hormone replacement therapy has fallen out of favor, DEPO has encountered placebo response issues in previous trials (will be discussed in subsequent articles). Further down the road, the company has several candidates in phase I trials relating to extended release formulations of Levodopa/Carbidopa for Parkinsons, and Prilosec for acid reflux

MFG
Chali
Antworten
Chalifmann3:

DepoMed vs. InterMune:

 
19.01.11 20:48
Hier mal ein interessanter Vergleich zur völlig überbewerteten "Lachnummer" Intermune,die immer noch 2 MRD wert sind,obwohl die FDA schon abgelehnt hat:

DepoMed vs. InterMune: Vastly Different Market Caps, Both Seeking FDA Approval
6 comments  |  by: Sheff Station December 28, 2010  | about: ABT / DEPO / ITMN     Font  

Undervalued or overvalued? That is the question when comparing DepoMed (DEPO) vs. InterMune (ITMN). The market cap of InterMune is 7 times that of DepoMed. A closer look shows that for investors DEPO may be the better value of the two. A firm PDUFA date of Jan 30th makes the case even stronger when you think of the royalties that Abbott Laboratories (ABT) has to pay DepoMed in the near term upon approval of DM-1796!

DepoMed is seeking approval of DM-1796 (gabapentin) which has 40 million US prescriptions worldwide. The market is large for Lyrica sales of $1.5 billion in the US and $2.8 billion worldwide in 2009.

InterMune is seeking an indication for Esbriet for idiopathic pulmonary fibrosis in the first quarter 2011 (estimated). This is a smaller market relative to the market DepoMed is entering. InterMune is seeking European approval for Esbriet after the FDA rejected the drug in 2010. InterMune does not, to my knowledge, have a firm PDUFA date with the FDA. It could occur at any time.

Below are financial statistics through the close of 12/27/10 of two companies with pending approval dates from the FDA in the first quarter of 2011.

Share Price of DEPO is $6.00 and ITMN is $38.00

Market Cap of DEPO is $316 million and ITMN is $2.13 bilion

Revenue of DEPO is $73.14 million and ITMN is 24.24 million

Revenue per share of DEPO is $1.40 and ITMN is $0.47

Gross Profit for DEPO is $52.47 million and $41.7 million for ITMN

Diluted EPS for DEPO is 0.3 and -2.16 for ITMN

Total Cash for DEPO is $66.8 mill and $128.8 mill for ITMN

Total Cash per share for DEPO is $1.27 and $2.30 for ITMN

Total Debt for DEPO is $3.15 million and $128.8 million for ITMN

Book Value per share for DEPO is .39 and -1.21 for ITMN

Float for DEPO is 39 million and is 38.4 million for ITMN

Shares Outstanding is 52 million for DEPO and 56 million for ITMN

Insiders own 7% for DEPO and 18% for ITMN

Institutions own 60% for DEPO and 75% for ITMN

Shares short as of Nov 30th 2.5 mill for DEPO and 5 mill for ITMN

Short % of float 6.5% for DEPO and 13.5% for ITMN

DEPO is the screenshot below then ITMN

Both companies are looking for an approval in 2011 for their product. Looking at the financial statistics in trying to determine which one might look like a better position to own into an FDA approval (PDUFA) date, DepoMed is the most undervalued of all the PDUFA date stocks in the first half of 2011 based on their market cap of just over $300 million dollars.

MFG
Chali
Antworten
Chalifmann3:

Aktuelles

 
19.01.11 20:53
UPDATE 2-Depomed says Abbott reluctant to market its pain drug

 Tue Jan 18, 2011 6:21pm EST

* Says will engage in mediation process with Abbott

* Drug faces FDA review date of Jan. 30

* Drug has FDA orphan drug status

* Depomed shares down 19 pct (Adds conference call details, background)

Jan 18 (Reuters) - Depomed Inc (DEPO.O) said its marketing partner Abbott Laboratories (ABT.N) has informed that it does not believe it is obligated to launch and market Depomed's pain drug.

Depomed shares were down 19 percent at $5.33 in after-hours trade. They closed at $6.58 on Tuesday on Nasdaq.

The experimental drug, DM-1796, which is awaiting regulatory decision by Jan. 30 on its use to treat neuropathic pain, was developed by Depomed and is licensed to Abbott Products, an Abbott unit, in the United States, Canada and Mexico.

On a conference call with analysts, Depomed said it learned of Abbott's reluctance last week, through a letter.

Depomed said it will engage in a mediation process with Abbott Products and believed the license agreement clearly imposes the marketing of the drug on Abbott.

The company said it expects Abbott to pay milestone payments associated with the regulatory approval of the drug, expected by the end of this month.

Depomed said the deal can earn it about $85-$135 million, depending on the ultimate product labeling.

"We are perplexed by Abbott's reluctance to adhere to their contract obligations given the in-depth market research previously undertaken regarding this product," Depomed's Chief Executive Carl Pelzel said in a statement.

If the drug's rights are offered back to Depomed during the mediation talks, it will agree to that only if Abbott provides adequate funding for the launch, Pelzel said.

"At this time, we expect to launch the drug at the same time as Abbott would have, unless some other delay occurs," the company said on the call.

Abbott assumed the rights to the drug through its acquisition of Solvay SA's (SOLB.BR) pharmaceuticals business, which was Depomed's original partner on the drug.

DM-1796 has an orphan drug designation, granted by the U.S. Food and Drug Administration to drugs that treat a condition affecting less than 200,000 Americans. It grants a marketing exclusivity of seven years in the United States upon approval

MFG
Chali
Antworten
bierro:

Zum Verständnis

 
19.01.11 21:12
Abott sieht sich nicht mehr in der Verpflichtung, DM-1796 zu vermarkten.

Depo hat´s entwickelt, Abott sollte in Lizenz produzieren und verkaufen?

Wenn Abott abspringt, und das Med. zugelassen wird, muss Abott Konventionalstrafe zahlen.

Hab ich das so richtig verstanden?
Antworten
Chalifmann3:

So in der Art sehe ich das auch

 
19.01.11 21:17
die Frage ist nur,ob abott überhaupt abspringen darf,und,sollten die Rechte rückabgewickelt werden wird die Strafzahlung mindestens so hoch sein,dass Depomed alleine vermarkten kann,hm ?!!

MFG
Chali
Antworten
Chalifmann3:

Forest Labs wartet offenbar schon ...

 
19.01.11 21:46
Abbott Laboratories’ (ABT) 11th-hour maneuver to exit a partnership with Depomed (DEPO) merely a negotiating move?

Depomed says partner Abbott is reneging on an agreement to help it launch a pain drug that may get US approval by the end of this month. Abbott, which inherited the deal with its takeover of Solvay last year, says there’s a dispute over the terms but adds little else.

Now the two companies are heading toward mediation, and, according to Depomed CEO Carl Pelzel, renegotiating the terms is not out of the question.

“We have been very open with Abbott and have not shut the door on any kind of discussions,” Pelzel told investors on a conference call. “If there were a desire to amend the contract we would have been and are very open to listen.”

According to Depomed, Abbott told the smaller company that it won’t continue a marketing relationship that was struck with drug maker Solvay, which Abbott acquired last year. The news comes as Abbott and Depomed await word from the the Food and Drug Administration, which has a January 30 deadline for deciding approval of the companies’ treatment for pain caused by shingles.

Given the timing, the move seems odd. Depomed received $25 million from Solvay in 2009 after the companies partnered to develop and market the drug, known for the time being only as DM-1796. Abbott paid Depomed $10 million when the FDA agreed to review the drug application. Abbott, which filed the application with the FDA, even sought and won so-called orphan drug status for DM-1796. That orphan status gives a drug maker a seven-year monopoly on a treatment. It’s a carrot the government offers to encourage development of treatments for rare diseases.

But there’s certainly a lot more money to come Depomed’s way now that it looks as though the drug has a shot at approval. If approved, Abbott would pay Depomed more milestone payments and royalties of up to 20%. If the drug is approved and launched, Abbott would pay Depomed up to $135 million within two years, according to Depomed.

“It’s a very good deal for Depomed,” says Jason Napodano, an analyst with Zacks Investment Research.

Napodano thinks Abbott may want to renegotiate the terms because it was a generous contract. He estimates the drug eventually may reach as much as $500 million in sales. He has an $8 a share price target on the stock.

Shares of Depomed fell 11% to $5.86 in early afternoon trading Wednesday. They fell about 8% Tuesday before the news was disclosed after markets. The stock is still up 85% over the past year.

If a deal can’t be reached with Abbott, Napodano says a number of specialty pharmaceutical companies may be interested in taking its place, including Forest Laboratories (FRX), Meda Pharmaceuticals or Purdue Pharma.

The bottom line: If you believe Depomed’s drug will be approved, it may be an opportunity to buy when the shares are down, Napodano says. The company’s partnership with Abbott may be screwed up in the short term but the drug is still expected to get US approval.

And if Abbott didn’t think the drug would get the approval, why wouldn’t it wait until the FDA rejected the application and then wriggle out of its contract

MFG
Chali
Antworten
MicroV:

@Chalifmann3

 
20.01.11 10:18

Nein, habe nicht aufgestock, da ich schon einen sehr großen %-Teil i.V.z. Gesamtportfolio habe. Bin aktuell ca. 7% im Minus, habe auch kein Stück verkauft.

Ich denke nämlich, dass Depo in einer sehr guten Ausgangslage ist, außerdem haben Sie das selbe Spielchen bereits bei ihren anderen beiden Produkten durchgemacht (mit den damaligen Partnern). Ich halte das Management für sehr fähig eine gute Lösung zu finden.

Desweiteren hat Depo 2011 noch einiges in der Pipeline, so dass selbst eine Ablehnung der FDA die Firma nicht in große Schwierigkeiten bringt.

Persönlich gehe ich aber von einer Zulassung aus. Dann wird es auch nicht sonderlich schwer einen neuen Partner zu finden - DM-1796 hat ein Potenzial von bis zu 500 Mio.$ und Orphan-Drug-Status von der FDA, außerdem steht noch die weltweite Lizensierung aus.

 

Antworten
Chalifmann3:

Depomed has an excellent litigation track record

 
20.01.11 16:02
Even if Abbott inherited a crappy contract, that doesn’t mean they can snub it and move on. Depomed has an incredible litigation track record, dealing with patent and contract issues of this kind. All of Depomed’s legal history has ended in its own favor, bringing in cash settlements from; Bristol Myers Squibb (BMY), Biovail (BVF), Esprit (now AGN), King (KG), and Teva (TEVA). In August, Depomed was one of the few pharmaceutical companies that evaded a gabapentin manufacturing lawsuit with Pfizer (PFE).

During Tuesday’s conference call, Depomed’s CEO implied that the costs to Abbott to exit the deal could be more than $100 million, not including the roughly $50 million dollar milestones due on NDA approval Furthemore, Mr. Pelzel reassured investors that Garetain launch date would not be delayed, if approved.
Depomed - FDA entscheid f. Blockbuster im Januar 374456
Antworten
bierro:

Vermarktungsstreit

 
22.01.11 19:39

Scheint ja kompliziert zu sein:

During the conference call, Mr. Pelzel noted that Abbott has North American rights for DM-1796 only for pain states, including: post herpetic neuralgia (PDUFA date 1/30/11), diabetic peripheral neuropathy (Phase 2 completed) and fibromyalgia. It was also noted in the call, that Abbott does not own the rest-of-world rights or the rights for non-pain indications, like: restless leg syndrome, chronic migraines, epilepsy, or hot flashes (currently enrolling in a Phase 3 trial). 

Also, Abott mokiert sich darüber, dass sie nur sehr eingeschränkte Vermarktungsrechte haben, und auch nur für bestimmte Diagnosen. Fragt sich nur, wie das bei dem nächsten Kandidaten(Forest Labs?) aussieht.

Aber:

Final Thoughts

It’s clear that more uncertainty has entered the picture. But there may be an opportunity here. From an after-hours low in the mid 4’s, Depomed stock price has climbed to almost 6 dollars. Clearly, someone sees an opportunity here, not only me.

Beim Verfasser herrscht Zuversicht.

seekingalpha.com/article/...abbott-depomed-dispute?source=feed

 

 

 

Antworten
MicroV:

@bierro

 
24.01.11 07:55
Sorry, das ist so nicht korrekt, wie du das schreibst.

Über die Gründe kann aktuell nur spekuliert werden.

In der Pressemeldung wurde "nur" verkündet, dass Abbott sich nicht verpflichtet sieht DM-1796 zu vermarkten/ bzw. auf den Markt zu bringen (deren Interpretation des Vertrag's zwischen Depo und Solvay).

Mr. Pelzel (von Depo) hat im CC gesagt, dass ABT nur die Lizenz-Rechte für US/ Kanada u. Mexico hat, die Lizenzen für den Rest der Welt sind noch nicht vergeben.
Antworten
bierro:

@MicroV

 
24.01.11 16:41

Richtig, aber in dem Artikel steht auch

Mr. Pelzel noted that Abbott has North American rights for DM-1796 only for pain states, including: post herpetic neuralgia (PDUFA date 1/30/11), diabetic peripheral neuropathy (Phase 2 completed) and fibromyalgia

 und nicht für

It was also noted in the call, that Abbott does not own the rest-of-world rights or the rights for non-pain indications

Vielleicht stoßen die sich ja daran.

 

Antworten
bierro:

Plus 7 %

 
24.01.11 16:54
Ist doch mal was, oder? Ich denke, hier ist noch viel positives Spekulationspotential drin.
Antworten
MicroV:

YES DEPO announced US FDA has approved GRALISE

 
29.01.11 12:02
www.thestreet.com/story/10989204/1/...-herpetic-neuralgia.html

Nachbörslich bereits +18,3% auf 7,3$

Schönes Wochenende ;-)
Antworten
bierro:

Klasse!

 
29.01.11 18:06
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.
Antworten
MicroV:

@bierro

 
31.01.11 08:09
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.
Antworten
MicroV:

aktueller Pre-Market-Kurs

 
31.01.11 11:19
bereits bei  8,01$ +28,4%

das scheint ein schöner Tag zu werden ;-)
Antworten
bierro:

Danke...

 
31.01.11 13:52
...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!
Antworten
Chalifmann3:

Depomeds stock price is a gift ....

 
31.01.11 14:42
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
Antworten
MicroV:

...

 
31.01.11 16:28
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
Antworten
Chalifmann3:

?

 
31.01.11 16:57
Warum machst du das,Avanir und Protalix sind 2 gehypte Schweine,viel teurer als DEPO !

MFG
Chali
Antworten
Chalifmann3:

Wir sind noch nicht am Top !

 
31.01.11 16:59
Es geht zügig vorwärts mit DEPO,sehen wir heute noch 9 dollar ?

Schön wärs !

MFG
Chali
Depomed - FDA entscheid f. Blockbuster im Januar 377077
Antworten
MicroV:

@Chalifmann3

 
01.02.11 10:05
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 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.
Antworten
bierro:

Wir haben die 10 $!

 
03.02.11 16:52
Anscheinend geht das Teil ungebremst weiter hoch. Bin froh, dass ich dringeblieben bin.
Antworten
Heiko T.:

Was neues!

 
07.02.11 23:36
Heiko T.:

Und mal

 
07.02.11 23:48
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.
Antworten
Heiko T.:

Nochmal Gelegenheit

 
08.02.11 21:16
zum Einstieg!
Nach Rücksetzer dreht der Kurs wieder nach oben!
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.
Antworten
Heiko T.:

Aktie

 
11.02.11 00:52
zeigt sich sehr widerstandsfähig um die 9

After hour z.Zt. 9,54

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!
Antworten
Chalifmann3:

Heiko

 
11.02.11 05:57
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
Antworten
Heiko T.:

Hi Chalif

 
11.02.11 16:13
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.
Antworten
Heiko T.:

Da ist noch einiges

 
15.02.11 00:55
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&#8804; 0.025 p&#8804; 0.025
Breeze 2 - 4 Week Endpoint p&#8804; 0.001 p&#8804; 0.025
Breeze 1 - 12 Week Endpoint p&#8804; 0.025 p&#8804; 0.05
Breeze 2 - 12 Week Endpoint p&#8804; 0.005 p&#8804; 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.
Antworten
Heiko T.:

Und noch

 
15.02.11 00:59
der Link dazu
zum Nachlesen der Comments

seekingalpha.com/article/...-appreciated-potential?source=feed
Antworten
Heiko T.:

Besser

 
15.02.11 01:05
sowieso den oben kopierten Text über den Link verfolgen,
da im Text oben die Tabellen nicht richtig mitkopiert wurden.
Antworten
butzerle:

FDA verlangt Nachbesserungen

 
15.02.11 17:54
www.marketwatch.com/story/...ebounds-depomed-slides-2011-02-15

gibt offenbar ein paar Sicherheitsbedenken
Antworten
Heiko T.:

Es handelt

 
15.02.11 20:11
sich lediglich um eine Vergleichsstudie,die die FDA will.

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.
Antworten
bierro:

Ist das üblich?

 
15.02.11 22:44
Erst wird die Zulassung erteilt, und Wochen später dann ein(halber) Rückzieher?
Antworten
bierro:

Zwei Szenarien aus Yahoo

 
18.02.11 19:39
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.

messages.finance.yahoo.com/Stocks_(A_to_Z)/...&frt=1#56302
Antworten
bierro:

Einigung mit Abbott

 
17.03.11 14:59
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.

finance.yahoo.com/news/...ns-rights-to-apf-1500513935.html?x=0
Antworten
butzerle:

Das war wohl nix

 
14.10.11 16:06
www.businessweek.com/ap/financialnews/D9QBKT5O0.htm
Antworten
Tamakoschy:

News

 
08.03.15 19:23
finance.yahoo.com/news/...s-fourth-quarter-full-210100908.html

quotes.morningstar.com/stock/depo/s?t=DEPO

finance.yahoo.com/q/pr?s=DEPO+Profile
Antworten
Chalifmann3:

von wegen das war wohl nix !

 
11.04.15 10:39
Depomed ist wohl die beste biotechaktie,die ich je empfohlen habe,mittlerweile 1,5 MRd wert mit einem Kurs von 25 dollar,Tendenz stark steigend !!!

Wie sieht es aus bei euch,wer ist noch dabei ? Bierro,was ist mit dir ?

MFG
Chali
Antworten
iwanooze:

chalif da hab ich was für dich!

 
13.04.15 14:07
www.prnewswire.com/news-releases/...sing-appeal-300064544.html
Antworten
Chalifmann3:

danke Iwanooze

 
13.04.15 15:22
sher gute Nachrichten für Depomed,aber nicht mehr für mich,denn ich habe meinen Gewinn realisiert,Depomed wird sicher weitersteigen,vor allem wenn mal irgendwann die Parkinson Geschichte weiterentwickelt und taugen sollte  ...

MFG
Chali
Antworten
iwanooze:

dann lies dir diese news!

 
07.07.15 13:29
www.marketwired.com/press-release/...n-nasdaq-hznp-2035930.htm

www.reuters.com/article/2015/07/07/...0150707?type=companyNews

hoffe du bist noch drin chalif! ;-)
Antworten
mora77:

Depomed

 
11.07.15 09:34
Bin hier seit Gestern auch dabei,wie ist eure momentane Meinung zu Depomed und zum Kursziel?  
Antworten
Cephei:

Horizon Pharma plc Increases Offer for Depomed, In

 
21.07.15 13:02
Horizon Pharma plc Increases Offer for Depomed, Inc. to $33.00 per Share

Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced today that it has increased the value of its all-stock acquisition proposal to $33.00 per share from $29.25 per share, contingent on Depomed entering into good faith discussions regarding a transaction. The increased offer represents a 60 percent premium to the closing price of Depomed on July 6, 2015, the day prior to when Horizon's initial proposal was made public.

"Based on discussions we've had with Depomed's largest shareholders as well as our own shareholders, it is clear that they and the investment community strongly support a combination of our two businesses," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "We are resolute in our commitment to acquire Depomed and we call upon Depomed's board of directors to listen to their shareholders, fulfill their fiduciary responsibilities and meet with us in order to promptly complete a negotiated transaction."
Antworten
Chalifmann3:

target

 
30.10.17 16:52
epomed, Inc. (NASDAQ:DEPO) Given a $10.00 Price Target at Royal Bank Of Canada

Posted by Stefani Robinson on Oct 30th, 2017 // No Comments

Depomed, Inc. logoRoyal Bank Of Canada set a $10.00 target price on Depomed, Inc. (NASDAQ:DEPO) in a report published on Friday, October 20th. The brokerage currently has a hold rating on the specialty pharmaceutical company’s stock.

Several other equities analysts have also recently commented on the company. Piper Jaffray Companies set a $9.00 target price on Depomed and gave the company a hold rating in a research note on Sunday, October 15th. Mizuho reaffirmed a neutral rating and issued a $6.00 target price (down from $11.00) on shares of Depomed in a research report on Friday, October 13th. ValuEngine lowered Depomed from a sell rating to a strong sell rating in a research report on Thursday, September 28th. Morgan Stanley lowered Depomed from an equal weight rating to an underweight rating and lowered their price target for the company from $12.00 to $5.00 in a report on Tuesday, August 8th. Finally, Janney Montgomery Scott lowered Depomed from a buy rating to a neutral rating and lowered their price target for the company from $18.00 to $8.00 in a report on Tuesday, August 8th. Four analysts have rated the stock with a sell rating, five have assigned a hold rating and three have assigned a buy rating to the stock. The company has an average rating of Hold and an average target price of $12.74.
Get Depomed Inc. alerts:

Shares of Depomed (DEPO) opened at 4.88 on Friday. The stock’s market capitalization is $307.38 million. The firm has a 50-day moving average of $5.74 and a 200 day moving average of $8.77. Depomed has a 52-week low of $4.77 and a 52-week high of $24.00.

Depomed (NASDAQ:DEPO) last issued its earnings results on Monday, August 7th. The specialty pharmaceutical company reported ($0.43) earnings per share (EPS) for the quarter, missing the Zacks’ consensus estimate of $0.09 by ($0.52). The firm had revenue of $100.00 million for the quarter, compared to analysts’ expectations of $100.40 million. Depomed had a negative return on equity of 45.03% and a negative net margin of 26.02%. The firm’s revenue for the quarter was down 14.3% compared to the same quarter last year. During the same quarter in the previous year, the firm posted $0.27 EPS. Equities research analysts forecast that Depomed will post $0.44 EPS for the current fiscal year.

A number of institutional investors and hedge funds have recently added to or reduced their stakes in the business. Louisiana State Employees Retirement System grew its holdings in Depomed by 0.4% in the 2nd quarter. Louisiana State Employees Retirement System now owns 25,400 shares of the specialty pharmaceutical company’s stock valued at $273,000 after buying an additional 100 shares during the last quarter. Arizona State Retirement System grew its holdings in shares of Depomed by 0.6% during the 2nd quarter. Arizona State Retirement System now owns 32,521 shares of the specialty pharmaceutical company’s stock worth $349,000 after purchasing an additional 200 shares in the last quarter. Texas Permanent School Fund grew its holdings in shares of Depomed by 1.1% during the 2nd quarter. Texas Permanent School Fund now owns 45,478 shares of the specialty pharmaceutical company’s stock worth $488,000 after purchasing an additional 517 shares in the last quarter. Nationwide Fund Advisors grew its holdings in shares of Depomed by 1.5% during the 2nd quarter. Nationwide Fund Advisors now owns 35,938 shares of the specialty pharmaceutical company’s stock worth $386,000 after purchasing an additional 533 shares in the last quarter. Finally, Municipal Employees Retirement System of Michigan grew its holdings in shares of Depomed by 4.2% during the 2nd quarter. Municipal Employees Retirement System of Michigan now owns 14,660 shares of the specialty pharmaceutical company’s stock worth $157,000 after purchasing an additional 590 shares in the last quarter. 91.29% of the stock is currently owned by hedge funds and other institutional investors.  
Antworten
Balu4u:

Kursziel 9 USD

 
24.03.18 18:03
www.analystratings.com/articles/...heir-buy-rating-on-depomed/
Antworten
Auf neue Beiträge prüfen
Es gibt keine neuen Beiträge.

Seite: Übersicht Alle 1 2 3

Hot-Stocks-Forum - Gesamtforum - Antwort einfügen - zum ersten Beitrag springen

Neueste Beiträge aus dem Depomed Forum

Wertung Antworten Thema Verfasser letzter Verfasser letzter Beitrag
4 58 Depomed - FDA entscheid f. Blockbuster im Januar Chalifmann3 Balu4u 25.04.21 01:42

--button_text--