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Old 04-20-2010, 07:58 AM   Nav to Top  #91
Finco05
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Thanks for discussion

Link to new article on ACUR by The Street

Acura Pharma FDA Panel Preview | Drugs | Financial Articles & Investing News | TheStreet.com


Want to add this:

You mentioned ACUR doesnt have the best license agreement with King. They havent disclosed the revenue specific details other than the %s increase based on combined product revenue. The license agreement is LIMITED to certain products (opioid analgesic) and territories (Canada, US, and Mexico). King paid ACUR $30mm for agreement, pays $28mm for each new drug, $50mm combined product revenue milestone, plus royalties from 5% - 25% based on revenues targets for all products combined. In addition, King pays all R&D, manufacturing and selling expenses.

Meanwhile, ACUR will be able to take an FDA approved drug(s) / platform and shop it to all territories outside US, Canada, and Mexico. In addition, ACUR can license products not covered under the King license within the US, Canada, and Mexico.

Last edited by Finco05; 04-20-2010 at 10:04 AM..
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Old 04-20-2010, 01:19 PM   Nav to Top  #92
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I do not believe at approval of acurox the market will price in future drugs on the Acurox platform... these future drugs are several years away... and the drug approval process is sometimes very unpredictable, though I agree that approval of Acurox helps to validate the platform.

I also don't believe that the market will price in outside US markets since regulatory approval for the major outside markets EU and Japan are several years away. I think most countries outside these markets don't really care about abuse deterance... they would just go with the generic cheap pain killer.

I get your drift and your right... I shouldn't claim to know the royalty rates since I don't know at what tier the 6 different rates kick in nor at what revenue... I was aware of the 5-25% as they are detailed in the SEC filings as well as the milestone payments.

I still think that 14 dollars is what we will get at approval, this gives acura a market cap of approx 650 million. I would definitely welcome much higher price....

What is your price estimate?

remember the short opiod market is about 1.5 billion short opiod market and that there is no abuse deterrance labeling they are fighting to include the clinical trials in the labeling and there are many generic versions of the drug (without abuse deterance).

Thanks for taking the time to challenge my posts... its been a while since anyone actually responded to them... I was beginning to wonder if anyone was even reading them.

FDA needs to hurry up and post those briefing documents...

Originally Posted by Finco05 View Post
Thanks for discussion

Link to new article on ACUR by The Street

Acura Pharma FDA Panel Preview | Drugs | Financial Articles & Investing News | TheStreet.com


Want to add this:

You mentioned ACUR doesnt have the best license agreement with King. They havent disclosed the revenue specific details other than the %s increase based on combined product revenue. The license agreement is LIMITED to certain products (opioid analgesic) and territories (Canada, US, and Mexico). King paid ACUR $30mm for agreement, pays $28mm for each new drug, $50mm combined product revenue milestone, plus royalties from 5% - 25% based on revenues targets for all products combined. In addition, King pays all R&D, manufacturing and selling expenses.

Meanwhile, ACUR will be able to take an FDA approved drug(s) / platform and shop it to all territories outside US, Canada, and Mexico. In addition, ACUR can license products not covered under the King license within the US, Canada, and Mexico.
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Old 04-20-2010, 01:45 PM   Nav to Top  #93
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Briefing documents are out
2010 Meeting Materials, Anesthetic and Life Support Drugs Advisory Committee
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Old 04-20-2010, 04:28 PM   Nav to Top  #94
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I've had various price models/estimates from years back. Couple thoughts - this is very rough and more for discussion than anything final.....

$14 x 45mm shares = around $650 mkt

of that $14, roughly $1 is cash or roughly $50mm of $650mm

if we assume $600mm value / 15 multiple thats $43mm revenue

So, the obvious questions / drivers:

1) acurox alone revenue potential
2) p/e multiple
3) any additional valuation given for:
- platform / additional drugs potential
- 5 pipeline drugs
- markets outside the "Territory" covered in King license (I've always heard/read that FDA is more stringent vs. other countries -- approval by FDA means rubber stamp elsewhere).
4) anyone want to buy the company -- if I remember, the options granted to the officers can't be sold until a change of control. In addition, the vc's will want to cash-in. With so many shares held by insiders, their best value is to sell to a company vs try to unload in the open market.

My thought -- $14 could be right, but I expect this to go north of $25 (believe it hit $20 in 2007 - which means nothing other than its so tightly held it can move quickly).
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Old 04-20-2010, 04:46 PM   Nav to Top  #95
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Originally Posted by dorkytom View Post
Briefing documents are out
2010 Meeting Materials, Anesthetic and Life Support Drugs Advisory Committee
What do you think of the AC questions?

My thoughts:
FDA wants/needs to encourage drugs that help prevent abuse.
They are being asked to approve a label of abuse-deterrence or similar.
What is the definition of abuse-deterrent?
Is anything really 100% deterrent to give FDA enough CYA to approve such a label?
Thus, the punt to the Advisory Committee and what seems to be lay-up questions.


1. Discuss what constitutes an adequate degree of abuse-deterrence to warrant
description in the product’s label and the potential implications regarding
overstating these effects.

(adequate degree -- vague enough -- you might not get 100% of addicts from abusing, but can prevent the house mom and their children from getting addicted.)

2. Based on the results of the studies assessing the effects of niacin on drug liking:
(a) Were the studies conducted appropriately to assess the effects of niacin on
the abuse liability of oxycodone?
(b) If not, what changes should be made to the studies?
(c) Is the presence of niacin in the formulation a potentially effective
deterrent?
(d) Are the effects of ingesting the product with food or aspirin/NSAIDS
sufficient to reduce the deterrent effect of niacin to a level that is no longer
clinically relevant?

(All the studies were conclusive and designed with FDA input. Again, food and aspirin may reduce niacin effect for the already addicted -- but non-addicts following prescription instructions will not be taking with food/aspirin.)

3. Was the degree of flushing seen in patients treated in the clinical trials acceptable
for this product with properties targeted at deterring misuse and abuse?

(Yes -- met endpoints set by FDA)

4. Please vote on whether Acurox should be approved for the indication of the
treatment of moderate to severe pain taking into consideration your conclusion
regarding the deterrent effect of the niacin, as well as the potential deterrent
effects of the other features specific to the Acurox formulation of oxycodone.

(Focus is on Niacin but also reminds of other important deterrents - snorting, injection - which obviously are not questioned)


Seems like a lay-up to me. Their other option is to have a product out there with no deterrent qualities while they hope for something that is 100% deterrent to be developed years down the road - if ever. Meanwhile, millions of non-abusers /non-addicts get exposed.

Last edited by Finco05; 04-20-2010 at 05:52 PM..
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Old 04-20-2010, 06:31 PM   Nav to Top  #96
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There are two items brought up in the FDA briefing document that concern me.

1) whether the effects of Niacin are largely mitigated if the user has a full stomach?

2) Why did Acura not disclose or perfom a clinical trial inconjunction with Aspirin when the FDA requested it?

I mean I would hope FDA would of disclosed those concerns to them during their meeting after the complete response letter, but yet Acura decided to do another clinical trial on patients that were fasting and did not include aspirin? It doesn't make sense.

Study AP-ADF-114 | Acura Pharmaceuticals



***Update

I think I'm the only person to catch onto this but in the FDA Erata Corrections they changed it to say

"the Division suggested, but did not require, the applicant assess the effects of co-administration of aspirin."

http://www.fda.gov/downloads/Advisor.../UCM209142.pdf
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Last edited by dorkytom; 04-20-2010 at 06:43 PM..
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Old 04-20-2010, 06:44 PM   Nav to Top  #97
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I assume the aspirin / niacin affect is already understood. "The Applicant did not include pretreatment with aspirin in abuse liability studies. In the absence of data to the contrary, the logical assumption is that pretreatment with a cyclo-oxygenase inhibitor would likely blunt any vasodilatory reaction."

Reading comments from the recent FDA approval for Purdue's reformulation, I am more confident of ACUR approval.....Bob Rappaport is overseeing ACUR meeting Thurs.

Purdue's recent approval is and ER and ACUR is an IR. Purdue's has no oral deterrent while ACUR at least attempts with Niacin.

These quotes show they are not expecting or needing 100% deterrence for approval. Something better than what we have now can be approved....


Link http://www.medscape.com/viewarticle/719875

"The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication," FDA officials noted in a news release. "The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended."

.........

In an FDA news release, Bob Rappaport, MD, said, "Although this new formulation of [oxycodone] may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction."

Dr. Rappaport is the director of the Division of Anesthesia and Analgesia Products in the FDA's Center for Drug Evaluation and Research.

"As with all opioids, safety is an important consideration," Dr. Rappaport added. "Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."

Last edited by Finco05; 04-20-2010 at 07:20 PM..
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Old 04-20-2010, 06:53 PM   Nav to Top  #98
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Below is a copy of the article (think the link requires membership)


FDA Approves New Formulation of Controlled-Release Oxycodone

Yael Waknine

April 7, 2010 — The US Food and Drug Administration (FDA) has approved a new formulation of controlled-release oxycodone HCl (Oxyontin, Purdue Pharmaceuticals) designed to discourage misuse and abuse of the medication, which is indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is required for an extended period of time.

Controlled-release oxycodone tablets contain a large quantity of the drug, allowing extension of the dosing interval. Individuals seeking to abuse oxycodone have been able to release high levels of the opioid medication from the previously approved formulation, potentially resulting in overdose. According to the US Substance Abuse and Mental Health Services Administration's National Survey on Drug Use and Health, approximately 500,000 people abused oxycodone for the first time in 2008.

"The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication," FDA officials noted in a news release. "The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended."

Libby Holman, a representative from Purdue Pharmaceuticals, told Medscape Pharmacists: "It is Purdue's position that we will not speculate on the impact that the formulation will have on misuse and abuse. This formulation is not tamper resistant and can still be abused."

According to a company news release, "Purdue elected to reformulate OxyContin to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction."

"There is actually no discrepancy at all [between the FDA's and Purdue's statements]. We completely agree with Purdue's statement," Karen Riley, MPH, medical products team leader in the FDA Office of Public Affairs, told Medscape Pharmacists, while noting that data indicate a potential for reducing the risk of overdose caused by tampering and the risk for abuse from snorting or injection.

In an FDA news release, Bob Rappaport, MD, said, "Although this new formulation of [oxycodone] may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction."

Dr. Rappaport is the director of the Division of Anesthesia and Analgesia Products in the FDA's Center for Drug Evaluation and Research.

"As with all opioids, safety is an important consideration," Dr. Rappaport added. "Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."

As a condition of approval, the manufacturer is required to conduct a postmarketing study to evaluate the potential benefits of the new formulation with respect to abuse and misuse of oxycodone. In addition, a risk evaluation and mitigation strategy is being implemented that will include the issuance of a medication guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics for pain.

In 2007, Purdue pled guilty to a felony count of misbranding oxycodone extended-release tablets with the intent to defraud and mislead, with respect to the formulation being less likely to cause abuse, addiction, tolerance, and withdrawal.
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Old 04-20-2010, 07:38 PM   Nav to Top  #99
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Thanks for the links to Purdue's drug...

I have no doubt that Acurox will be approved.... its matter of whether they will get a labeling that indicates some deterant effect (via their clinical trials on the label).

To tell the truth I need to reread the briefing documents... I was up all night and to I'm letting myself get caught over pointless arguments that the FDA reviewer makes... for example I got really concerned wondering why the hell the incidences of naseua and vomitting were so high in the Acurox group compared to placebo. Then after looking at that for an hour I realized this is a stupid point to be highlighted by the FDA reviewer since we're comparing to placebo not a pure oxycontin group.

I looked up a phase III study for Tapentadol which had a pure oxycontin group at 10mg and they saw 59% incidence of naseua and vomittiing... so the cases are actually about the same or lower in Acurox.
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Old 04-22-2010, 03:53 PM   Nav to Top  #100
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F*ck .... Acur failed at the committee meeting... niacin not seen as effective abuse deterrent... 19 to 1 against approval.
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