GRALISE approved yet Abbott doesn't want us to sell it?

[Anonymous]

Depomed Announces US Food and Drug Administration Approval of GRALISE(TM) (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia

MENLO PARK, Calif., Jan. 28, 2011 (GLOBE NEWSWIRE) -- Depomed, Inc. (NasdaqEPO - News) today announced that US FDA has approved GRALISE(TM) (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles. GRALISE was developed by Depomed under the code name DM-1796 and is licensed to Abbott Products, Inc. in the U.S., Canada and Mexico. The approval of GRALISE triggers a milestone payment of $48 million from Abbott to Depomed.

Michael Sweeney, MD, Vice President of Research and Development for Depomed, noted, "We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed. Further, FDA has granted GRALISE Orphan Drug status, recognizing GRALISE as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved."

"The GRALISE formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians' treatment armamentarium," said Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, Clinical Associate Professor, University of Washington Medical School in Seattle, Washington. "Patients with PHN have long struggled to manage pain following herpes zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects."

About the GRALISE Exclusive License Agreement

Depomed entered into a license agreement for GRALISE (DM-1796) with Solvay Pharmaceuticals in November 2008. Abbott Products assumed the license agreement and Solvay's obligations under it as a result of the acquisition of Solvay's pharmaceutical business by Abbott Laboratories, which was completed in February 2010. In addition to the $48 million milestone payment for approval of GRALISE, the license agreement calls for royalties of 14 to 20 percent on product sales, and sales milestone payments of up to $300 million.

Depomed announced on January 18, 2011 that the company had initiated mediation with Abbott Laboratories (NYSE:ABT - News), the parent company of Abbott Products, regarding Abbott's commercialization obligations under the license agreement.


What I don't understand is why is Abbott trying to back out of launching this drug when we have NOTHING in the pipeline? Didn't we just lay off a ton of people because we need to cut expenses and we need products to generate revenue. Abbott is under contract o launch this drug and now will have to spend a ton of money to try and get out of the legal obligation to launch this drug when we should be excited about have a new drug to sell. Didn't Abbott try to come out with a new pain drug just a couple of years ago so why is this drug not worth launching. Most companies are having their reps carry 3-5 drugs now. This is a drug that will be prescribed by primary care physicians which is exactly the doctors we wil be calling on now.

What am I missing, the logic or lack of it confuses me.

 

[Anonymous]

they backed out because they have finally realized that in this market, THERE IS NO PLACE for "extended release" versions of generic drugs anymore. Look at all of the reformulated versions of older drugs that have come out in the last 3-5 years and tell me which ones have been successful? the writing is on the wall that these types of products are just like pissing money away, new chemical entities are necessary. not new ways to charge premium dollars for decades old molecules.

 

[Anonymous]

Quintiles has kept on the 6345 contract employees until the end of March. They said they have 3 different large contracts in the works that they will need us to fill those positions. Who knows, maybe this is one of the contracts they are working on.

 

[Anonymous]

they backed out because they have finally realized that in this market, THERE IS NO PLACE for "extended release" versions of generic drugs anymore. Look at all of the reformulated versions of older drugs that have come out in the last 3-5 years and tell me which ones have been successful? the writing is on the wall that these types of products are just like pissing money away, new chemical entities are necessary. not new ways to charge premium dollars for decades old molecules.

If you would have read one of the articles you would have seen that the side effects are way way less with the extended release. We all know that patient compliance is a HUGE problem and the fewer times a patient has to take a product the better chance there is that they will actually take the medication. Throw in a little thing like better efficacy and you have a grand slam.

Did you read the following? Read this quote from an IM physician and tell me that Abbott has products with these types of advantage to sell.

"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."

Yes, it would be great to have a totally new medication but this product is one that legally Abbott is suppose to promote and looks to have great promise and would be easy to promote so why is Abbott pushing back? If Abbott had tons of new medications in the pipeline and ready to pop and thius didn't want to tie up its sales force promoting this product when it could make more money on something else I could see the reason for the pullout but that's NOT the case. In fact Abbott hs NOTHING in their pipeline.

 

[Anonymous]

such a dopey response. Did you just start in the industry this week? New product losses and success is not determined by things like compliance and side effects! Formulary coverage and patient access to drugs decides EVERYTHING! Do you really think that an insurance company will really be willing to pay premium pricing for a generic molecule because the patient only has to take it QD? MHC doesn't care about what's more convenient for the patient! If you thinks a mandatory failure of the generic won't be required you're a fool. There are literally dozens of examples of this over the last few years and NONE of them have become major successes. Also, when you point out the quotes from the I'm that were include in THE MANUFACTURER's PRESS RELEASE, you show how naive you are. EVERY drug that gets approved has quotes from some doc who is a company shill in their press release.

 

[Anonymous]

such a dopey response. Did you just start in the industry this week? New product losses and success is not determined by things like compliance and side effects! Formulary coverage and patient access to drugs decides EVERYTHING! Do you really think that an insurance company will really be willing to pay premium pricing for a generic molecule because the patient only has to take it QD? MHC doesn't care about what's more convenient for the patient! If you thinks a mandatory failure of the generic won't be required you're a fool. There are literally dozens of examples of this over the last few years and NONE of them have become major successes. Also, when you point out the quotes from the I'm that were include in THE MANUFACTURER's PRESS RELEASE, you show how naive you are. EVERY drug that gets approved has quotes from some doc who is a company shill in their press release.

I am not a newbie and have been a top 10% rep everywhere I have been so get lost. We will see who gets the last laugh by how well this products does once it gets a promotion deal. DepoMed would love to get the right back and either work out a deal with another company or possible have the right to promote the product themselves along with another company. BTW the stock is up over 30% today and if you heard the CC this morning with the pharma market experts you would hear how impressed they were about this drug and its future success and these were not company people asking the questions so it shows how little you know.
Why don't you put your money where your mouth is and short the stock if you think it will be a loser. Otherwise STFU. Abbott could have used the rights to this drug and may still do so, this delay could be a move to try and get a better deal.

 

[Anonymous]

I used to sell Famvir (Novartis product) and there is no real need I can think of for another treatment to deal with PHN/zoster pain. Docs loved Famvir in particular for PHN over most any other available treatment and side effects were practically non-existent.

There are several other anti-virals that will also "fit the bill" when treating PHN........and quite effectively as well.

There is no doubt PHN pain can be excruciating but there are multiple treatment options already available that do not have tolerance issues. I cannot imagine another PHN treatment new to the market would really make much of a splash.

 

[Anonymous]

can anyone tell whether there is possibility of use of Gralise for other indications. PHN otherwise has a very small patient base and my guess would be around $200mn peak sales...

 

[Anonymous]

Patients who were randomized to Gralise reported 5 times more dizziness, compared to those on placebo. What are the numbers for Neurontin, for the same PHN population ?

 

[Anonymous]

can anyone tell whether there is possibility of use of Gralise for other indications. PHN otherwise has a very small patient base and my guess would be around $200mn peak sales...

Yes, Depomed is very close to getting the indication for the treatment of menopausal hot flashes which will be the same drug but called Serada. Can you imagine how big that will be because there is tons of data showing the hormone replacement therapy increases all sorts of risks for women.

I don't know where you canme of with your estimate of $200 mn peak sales as I saw a published stock analyst show a chart their own firm came up with that showed estimated sales of $52.3 million in 2011, 341.1 million in 2012, 401.5 million in 2013, 466.1 million in 2014 and 517.1 million in 2015. That was an estimate of Gralise sales not the market which kind of conflicts with your own personal estimate of $200 million peak sales doesn't it.

What exactly are the sales of Simcor these days? LOL
How much Tricor and Trilipix do you think that Abbott will be selling once the patent runs out in the next year or so? If you want a job in sales at Abbott then you better hope management come up with some products to sell because the ones Abbott has in place right now are getting ready to become history very soon.

 

[Anonymous]

Patients who were randomized to Gralise reported 5 times more dizziness, compared to those on placebo. What are the numbers for Neurontin, for the same PHN population ?

I think that this quote will answer your question.
http://seekingalpha.com/article/249725-what-gralise-approval-means-for-depomed?source=yahoo

"Something important to take away from this approval is the importance of favorable labeling. The labeling Depomed received for GRALISE will be a significant factor in it’s ability to gain market share. They had listed incidence of dizziness (10.9%) and somnolence (4.5%) that were far lower than gabapentin(28.8% and 21.8%) or Lyrica (31% and 18%). This will be extremely helpful in marketing this drug, especially to managed care, where this is highly prescribed but whose patients struggle with compliance and side-effect profile. Once-daily dosing also helps differentiate from gabapentin or Lyric, where dosing is anywhere from 2-4 times a day. These advantages over current treatment options will be important in the marketing of GRALISE. We also should stress that the orphan drug designation also gives Depomed 7-years of marketing exclusivity."

Also see below:
"Approval of GRALISE was important to more than just the DM-1796 program. The approval of GRALISE was a significant step in the regulatory pathway for Serada. Remember, Serada is Depomed’s gabapentin formulation for the treatment of women with postmenopausal hot flashes; potentially a $2 billion market. Now, consider that Serada is the same drug and dosing that the FDA just approved with GRALISE. If BREEZE 3 results are positive, Depomed could certainly make a strong case for approval, backed by not only an SPA, but approval of the drug in a different indication and the support of 4 Phase 3 trials using their AcuFormTM gabapentin. Positive results in BREEZE 3 would be highly predictive of Depomed’s approval of Serada."

 

[Anonymous]

Yes, Depomed is very close to getting the indication for the treatment of menopausal hot flashes which will be the same drug but called Serada. Can you imagine how big that will be because there is tons of data showing the hormone replacement therapy increases all sorts of risks for women.

I don't know where you canme of with your estimate of $200 mn peak sales as I saw a published stock analyst show a chart their own firm came up with that showed estimated sales of $52.3 million in 2011, 341.1 million in 2012, 401.5 million in 2013, 466.1 million in 2014 and 517.1 million in 2015. That was an estimate of Gralise sales not the market which kind of conflicts with your own personal estimate of $200 million peak sales doesn't it.

What exactly are the sales of Simcor these days? LOL
How much Tricor and Trilipix do you think that Abbott will be selling once the patent runs out in the next year or so? If you want a job in sales at Abbott then you better hope management come up with some products to sell because the ones Abbott has in place right now are getting ready to become history very soon.

your numbers are wrong, 90 million for last year. Way behind projections!!!!

 

[Anonymous]

your numbers are wrong, 90 million for last year. Way behind projections!!!!

No problem with only 2 calls a week.

 

[Anonymous]

Patients who were randomized to Gralise reported 5 times more dizziness, compared to those on placebo. What are the numbers for Neurontin, for the same PHN population ?

Your selling stuff that causes dizziness? Must be very profitable.