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The hospital I practice at banned any RX of Zohydro within our entire system (two academic medical centers and 15 community health centers). I have only seen this happen with two other drugs in the last 20 years. Now, the state has taken it on and has banned it state wide in MA. More states surely to follow.
http://www.bostonglobe.com/metro/2014/03/27/with-heroin-overdoses-rise-gov-patrick-declares-public-health-emergency-mass/hOajTIJNKnSHKAnWjZ6wYL/story.html
Well Hakim said he committed three years to the Board when he was hired so they are moving at rapid speed.
Here is the link: http://www.reuters.com/article/2014/03/27/idUSnGNX5pynk+e0+GNW20140327
Actavis... Hmm...
Drugdoctor - What are you thinking Pennies to $$!!DOLLARS$$ !?!?!
Please explain which filing you are noting?
http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-sec
13/863,764 Abuse-Resistant Oral Dosage Forms And Method Of Use Thereof
Dispatch to Final Data Capture (FDC) today 3/20/14.
Issue Notification should be next week and the patent should be recorded patent should be mailed within three to four weeks.
That is great news:
http://en.wikipedia.org/wiki/Staggered_board_of_directors
I think it would be really helpful if you would add them up for us to support your "facts".
Well at least we have two things in common.
Best of luck with your investments.
Investing is speculation. If you can't read between the lines then you miss opportunities like Elite. If you need hard facts you won't get them right now. They will eventually be factual but the pps will be too high to get the type of ROI most of us here now will realize in the end.
Do a little DD of your own. There are a lot of posts. Here is a start, I know there are many more and perhaps others have links but the writing has been on the wall for at least three years.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=71089473
http://seekingalpha.com/article/1463281-actavis-abuse-deterrent-opioid-connections
Hakim would not have left Actavis and Actavis would not allowed all of this (Mikah shell etc.) to be set in motion if there were not game changing product(s). I do not see how this is excessive compensation for what is about to happen?
I am ok with Hakim getting compensated greatly for what is going to happen. It is on par with other successful pharma companies.
Look at what is happening at Actavis:
http://www.bloomberg.com/news/2013-12-19/actavis-managers-reap-115-million-after-buying-warner-chilcott.html
http://www.fiercepharma.com/story/grateful-actavis-board-adds-4m-ceos-deal-related-bonus-tally-total-49m/2014-03-12
He gave Elite, Naltrexone, the rest of Mikah and coordinated a plan with Actavis/Epic a few years ago to save Elite and turn its' ART technology into a major market player.
Does the shareholder vote have to preempt a partnership?
RE: Compensation
Top of Page: 18 in the filing:http://archive.fast-edgar.com//20140318/A8A2N22CZC22L2ZU222S2WZA9L6C2B22Z262/
No single participant may be granted an award in excess of 1,000,000 shares in a twelve-month period.
No more than 3,000,000 shares are available for grant as ISOs. The aggregate market price (determined at the date of grant) of common stock with respect to which ISO’s are exercisable for the first time by any option holder during any year under all Company plans may not exceed $100,000.
Also, keep in mind Pfizer is not the company it used to be Pfizer has hit a lot of roadblocks the last few years and has lost patent protection on many key drugs.
Meanwhile Actavis is growing by leaps and bounds:
http://www.fiercepharma.com/story/grateful-actavis-board-adds-4m-ceos-deal-related-bonus-tally-total-49m/2014-03-12
http://investorplace.com/2014/03/trade-day-actavis-act/
IMO Nasrat Hakim would be committing professional suicide if he was not to partner with Actavis. Actavis is the reason why he is at Elite and why Epic bailed Elite out in the first place.
That is absolutely correct. Their will be a definitive line in the sand between ART and ADT labeling. ADT in fact, should not even be a labeling option.
Just got a third one for the day!
Elite Pharmaceuticals, Inc.
1:36 PM (2 minutes ago)
The attached documents are the FDA’s responses to Endo & Purdue Phamra on their decisions not to pull Opana ER and to pull OxyContin from the market
It's funny you mention that. I used to think about that when Treppel was CEO too. I doubt Nasrat is pissed, he knows where this is going.
The article does not mention Elite actually however, coming from Elite's IR it's very interesting. Read between the lines folks.
A lot of new folks on this board. Here is a recent presentation that CEO Nasrat Hakim gave at the 15th
Annual Rodman & Renshaw Global Investment Conference: http://www.elitepharma.com/ELTP%20Rodman%202013.pdf
I would agree...
Sorry but you are misreading the Form 4s.
That seems like a moot point given the small percentage that Epic sold of it's total holdings. To call it "a ton of shares" is misleading. Epic sold a little under 1.8 million shares and still holds 67 million shares. Epic's CEO is Elite's CSO and Elite's CEO is a cosultant to the Epic CEO and both those roads lead back to Actavis.
Epic has made significant signals along the way that they are wholly aligned with Elite's plan such as converting out of preferred shares and continuing the original strategic alliance after it initially was due to close in 2011.
And buy during them!
Well we know one for sure... Morphine Sulfate and Naltrexone (Embeda). Elite got Naltrexone from Mikah (Hakim) via Actavis.
And of course, the Actavis/Watson merger only sealed the deal on that one: http://www.ftc.gov/sites/default/files/documents/cases/2012/10/121015watsonactavisanal.pdf
Correct Lasers and important to note that besides Hakim's business experience at Alphapharma and Actavis he holds degrees in Law and Chem. Also worth noting that Elite's legal counsel is one of the best IP firms in the country: BakerHostetler-Woodcock/Washburn
Yes, since buying in 2004 there have been major setbacks along the way. You are right, that does usually happen in the organic growth of any business. For Elite, being delisted from the NYSE and having inept leadership stalled this company for years. As a clinician though you must recognize the value in data? The potential is what made ELI trade in the dollars. Initial studies always showed some validity in the tech ph.1., ph.2, LifeTree studies but what always lacked was business acumen to figure out the next step strategically, logistically, financially etc.
Now this data is in hand:
Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study for Abuse Deterrent Product ELI-200: http://www.elitepharma.com/investor_relations.asp?goto=378
Elite Pharmaceuticals Reports Results of Pilot Bioequivalence Study for ELI-201:
http://www.elitepharma.com/investor_relations.asp?goto=377
And this data, is in the hands of entirely different leadership, during an entirely different time in the pain management pharma landscape.
There will be blips on the road, sure, but it's very hard to rationalize at this point that Elite is not imminently moving into the arena of opioids - in the short-term - as a major player in the market.
And as Nasrat Hakim said in the CC regarding lawsuits:
Unidentified Analyst
That’s what I had part. I just wanted to ask for clarification. One last quick question from you Nasrat, I ask you to speculative a bit. But given the recent court case or a federal judge rule that Teva did not infringe upon any of Purdue Pharma’s valid patents related to OxyContin, if that court cases upheld, how will this impact at least intellectual property rights if at all?
Nasrat Hakim - President and CEO
I don’t think it is practice at all. Technology is profoundly different, okay. They use a typical approach and the phase wasn’t that strong, actually it’s just thought that it’s infringing but he didn’t think it was material, but ours is totally different. It’s a pharmacological approach that does not even resemble what the case was about.
Unidentified Analyst
Okay. I was kind of just curious in terms of -- and I know that Pfizer has to pay pretty royalty fees on their technology, I was just wondering…
Nasrat Hakim - President and CEO
I will give a different speculation though. There will be very few players in this market because the anti-abuse is a huge market and in order for you to get in, you have to have patented technology. If you start right now, you are not going to get in 14 years from now, well partners with somebody that does. So we are in a great shape and need to be dancing with the (inaudible) of this world and the Purdue’s of this world and the Pfizer’s of this world and I really welcome that because at the end of today it will be a very few players and ton a billions of dollars.
From the most recent CC:
That is certainly something of interest to Elite but if the other party feels that they are the only source of financing available to us, they will view that as negotiating leverage and that’s something that's clearly not in our best interest.
Therefore important to have other sources of finance which we produce to either develop the products for ourselves or at a minimum put us in a stronger negotiating position with these potential partners. And in either instance, we expect the result to be a better deal for Elite and our shareholders.
Now the most viable of these other financing sources are the recently created Series I preferred shares which I’ll discuss in a little while and an equity line similar to the Lincoln Park equity line which was set up last year and has been a such a great help to us currently.
Now, you need to know that both of these options require an increase in the number of authorized shares, which must be approved by our shareholders. We do get a lot of inquiries on the subject and it is something that we are evaluating.
Now let’s talk about Series I. Hopefully I can provide some clarity. Series I is convertible into common stock. It’s partly pass with common which means that even though it’s call preferred stock, it still only equal and not senior to common stock.
It also includes voting rights on an as converted basis. Now that means that you can vote as a common shareholder without actually owning common stock. Series I was created to address two purposes. The first was to create a means by which Nasrat Hakim and our Chairman, Jerry Treppel, could vote the shares underlying the convertible notes payable, which had been issued to them.
Nasrat invested $10 million in Elite and Jerry invested $600,000. There weren’t enough available shares to give to them. So instead they agreed to accept the convertible note payable in stock or cash. Since we need the cash, we all have the stock, they canceled their note and received Series I share, which allows them to vote like a common shareholder and ensures that Elite doesn't have to pay them cash.
Each of them received Series I shares which converted into the same number of common shares as the note payable which they are canceling. We received comments about discounts being given and that's just not the case. This is why Jerry Treppel received only $420,000 of Series I shares and payment of the $600,000 note to them. We did different conversion prices. He had to receive less Series I shares in order to have the same number of underlying common share.
The second purpose of the Series I was to provide a viable alternate source of finance. There are 500 Series I shares authorized, and only 104 of these shares have been issued. The rest are available, having such an option is certainly a positive for our future.
One last thing of Series I and in fact, the Series I doesn’t issue of authorized common shares not being available. That is something that we will eventually have to address. But having this Series I allows us to address the issue in a timeframe that works best for Elite and our shareholders.
Finally, I wanted to talk about the stockholder rights plan. I mentioned this in our last call. So we've been receiving inquires on it. So now it’s a good time to get to comment in a little more detail.
The stockholders rights plan is often referred to as a poison pill. It’s something that management typically adopts when they feel their company is significantly undervalued and susceptible to a hostile takeover. It’s a legal mechanism, which forces an acquiring person to negotiate in good faith and it provides protection to all the other shareholders of the company.
Last summer when our stock was at $0.10 and even lower and knowing what we were working on, we all felt we weren’t a $0.10 company and thought that other parties would soon come to the same conclusion and that they would seek to buy us on the cheap and then transfer the value away from the rest of our shareholders.
I have no doubt about that but you are saying everyone else's shares get split and the CEOs do not?
The abuse could be going on at LifeTree in Salt Lake City as we speak, not sure if that would be PR'd or not. There is without doubt fast track status available, hinges solely on the FDA though. This should be fast tracked but nobody can say for sure.
I don't think you are posting all of the filing. That looks to possibly be the series E with Epic as part of the strategic alliance.
Dr. Pete Rose, between you and me he made the right decision. Not what it used to be. Best of luck
That's what I like to hear!
Not everyone can make it through med school... Like some pharmacists.
Those who consistently follow the board... take note of the daily participants who are suddenly not here. Edit: Or those, who just showed up within a minute or so before this.
I don't think it matters what degree anyone has. This does not have to do with company. The partner is Actavis. We have known that for at least 2 years.
That makes absolutely no sense...