Depomed - FDA entscheid f. Blockbuster im Januar

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  

 

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

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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  

sehr 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

 

 

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  

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

Gruß
MicroV  

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.

http://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$  

Depomed: Extended Release Pharmaceuticals and Extended Share Price Increases?

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

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

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

merkwürdige Entscheidung von Abbott, kurz vor Zulassung.

 

 

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  

 

“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.

 

 

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?  

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  

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  

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  

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?  

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  

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  

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.

 

 

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.  

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.

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

 

 

 

 

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.  

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.

 

 

Ist doch mal was, oder? Ich denke, hier ist noch viel positives Spekulationspotential drin.  

http://www.thestreet.com/story/10989204/1/...-herpetic-neuralgia.html

Nachbörslich bereits +18,3% auf 7,3$

Schönes Wochenende ;-)