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Picked up a chunk this morning at 1.38.
Patent Infringement Complaint:IntelGenx Corp. Receives Buprenorphine/Naloxone Sublingual Film Product Patent Infringement Complaint
SAINT LAURENT, Quebec, Aug. 26, 2013 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx") previously announced the submission to the U.S. Food and Drug Administration ("FDA") of an Abbreviated New Drug Application ("ANDA") filing for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, which had been submitted by Par Pharmaceutical Companies, Inc., our commercialization partner for this product. The reference listed drug is Suboxone(R) (buprenorphine and naloxone) Sublingual Film. On August 20, 2013, IntelGenx learned that, in response to filing of the ANDA, it was named as a codefendant in a lawsuit pursuant to Paragraph IV litigation filed by Reckitt Benckiser Pharmaceuticals and Monosol RX in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 8,475,832 and 8,017,150, each of which relate to Suboxone(R). IntelGenx believes the ANDA product does not infringe those or any other patents, and will vigorously defend itself in this matter. Since Paragraph IV litigation is a regular part of the ANDA process, IntelGenx does not expect any unanticipated impact on our already planned development schedule.
Spent the last week slowly unwinding ALL of my IGXT position. It feels great! All of the complaining on this board was killing me. I could not believe that people would rather complain than just sell and move on. Many of you people finally convinced me to put my money where my mouth is. Its been real. Good luck to all!
You say this ad nauseam. I hope you are very wrong. Real companies move based on REPORTED earnings not a press release saying earnings will come with a disclaimer at the bottom saying we may be wrong about that. Most people here don't want a pump and dump pop on a PR. Forfivo may end up being a complete bust with no earnings at all. Have you considered that? If it is not bringing in revenue then Horst already knows it and a PR promising earnings would brand him a liar. Just saying.
IGXT Seeking Alpha Article: IntelGenx CEO Provides Insight Into The Company's Catalysts
http://seekingalpha.com/article/1157681-intelgenx-ceo-provides-insight-into-the-company-s-catalysts?source=email_rt_article_title
Last week I had the pleasure to talk with IntelGenx Technologies' (IGXT.OB) President and Chief Executive Officer, Dr. Horst G. Zerbe. Dr. Zerbe shared with us his insights on IntelGenx's catalysts, pipeline, and commercialization strategies. Prior to founding IntelGenx, Dr. Zerbe served as President of Smartrix Technologies, and as Vice President of R&D at LTS Lohmann Therapy Systems. Dr. Zerbe holds over 40 patents in drug delivery related fields and has published numerous scientific papers in recognized journals.
Ben Yoffe: Mr. Zerbe, I would like to begin with the company's oral thin-film formulation of Rizatriptan. What can you tell us about the product, and how high is it on your priority list?
Zerbe: Rizatriptan is a 5-HT1 agonist used for the treatment of migraine headaches. It was developed by Merck & Co. (MRK) and is available in 5 and 10 mg tablets (Maxalt) and orally disintegrating tablets (Maxalt-MLT®).
IntelGenx has formulated Rizatriptan as an immediate release oral film using its Versafilm technology. IntelGenx's immediate release oral film consists of a rectangular piece of a thin and flexible polymeric film. For a single administration, the film is placed on the tongue and disintegrates in the mouth, following contact with saliva, within one to two minutes. Conveniently, the administration of the oral film does not require water.
In 2012, we successfully completed a bioequivalency study demonstrating that our film is bioequivalent to the reference product Maxalt MLT®. In October, 2012, we conducted a pre-NDA meeting with the FDA. The agency confirmed that it agrees with our proposed filing strategy for a 505(b)(2)NDA submission. We are currently in the final stages of preparing the application and plan to file by the end of Q1/2013.
Based on our current information, IntelGenx's Rizatriptan film is the first oral film product for the treatment of migraine for which a 505(b)(2)NDA will be submitted to FDA. We believe that the product has significant market potential and it is therefore very high on our priority list.
Yoffe: Does the company's Rizatriptan film have any safety, efficacy or cost benefits compared to the Merck's tablets?
Zerbe: As far as safety and efficacy of the product are concerned, by successfully completing a bioequivalency study confirming that the product is bioequivalent to Merck's Maxalt MLT® orally disintegrating tablet, it is assumed that the product is also therapeutically equivalent and that there are no therapeutically relevant differences between the products with regard to safety and efficacy. Regarding product costs, while we have no information regarding the manufacturing costs of Maxalt MLT tablets, we believe that the film product is significantly less expensive due to the fact that generally manufacturing costs of orally disintegrating tablets (ODT's) are generally higher than those of orally disintegrating films. The main reasons are that the manufacturing procedure of ODTs often requires lyophilization of the drug in order to render it rapidly dissolving. In addition, they require a complicated and therefore very expensive packaging system. This typically results in a noticeable price advantage of the film over the ODT.
Yoffe: What can you tell us about the distribution agreement for this product?
Zerbe: In 2010, IntelGenx and Redhill Biopharma (RDHL) entered into a co-development and licensing agreement. Under the terms of the agreement, IntelGenx is responsible for the development of the product, including formulation and clinical development, regulatory affairs, as well as manufacturing scale-up and commercial manufacturing, while Redhill is responsible for funding the project. Redhill is also responsible for identifying a commercialization partner for the product. In return, the parties will share any revenues from royalties and milestone payments at varying rates based upon defined parameters.
Yoffe: Could you be more specific about the defined parameters?
Zerbe: Under the terms of the agreement, we are not at liberty to disclose any financial details of the deal.
Yoffe: I did a little research and found that Redhill disclosed in a recent FORM 20-F, details about your agreement as follow: 1. In case that Rizatriptan film will be marketed by Redhill, royalty payments to IntelGenx will be 20% of net sales. 2. If the product will be marketed by third party sublicensees, Redhill required to make royalty payments to IntelGenx of 60% of the first $2 million of net sublicense fees, and 40% of net sublicensing fees thereafter. 3. If Redhill will bear the regulatory costs in a sublicense arrangement, royalties to IntelGenx will be 20% of net sublicense fees until Redhill will recover these costs, plus 10% interest. If IntelGenx bears such costs, it will get 70% of net sublicense fees.
So, according to your statements, if Redhill will fund the regulatory costs and commercialization partner will be involved, the royalty payments to IntelGenx will be 20% of net sublicense fees until Redhill will recover the regulatory costs, plus 10% interest, and 40% of net sublicensing fees thereafter. Am I correct?
Zerbe: That is correct.
Yoffe: What are your expectations regarding the company's ongoing commercial launch of Forfivo in the U.S.?
Zerbe: Forfivo was recently launched by our commercialization partner Edgemont Pharmaceuticals. It is still too early to clearly describe how the product is performing. However, there are early indications that the co-pay program that Edgemont has introduced is achieving success. We remain confident that Edgemont will reach the projected sales targets for this year.
Yoffe: Do you have plans to market Forfivo in the rest of the world?
Zerbe: Yes, we do. At this time, we focus on those geographic areas and jurisdictions that endorse products that have been approved by the FDA. We are in active negotiations with companies in the MENA (Middle East/North Africa) region. Additionally, we plan to pursue similar partnerships in Central and South America.
Yoffe: Are there any other developments that IntelGenx is currently working on?
Zerbe: We are very aggressively progressing the development of our key pipeline products and recently completed a pilot bioequivalency study for our antihypertensive INT0001 which will allow us to file an ANDA for that product in the second half of 2013. We are also expecting the results from a pilot biostudy for our ED film to be available in February of 2013.
Yoffe: In closing, what is the financial picture for IntelGenx? Does the company have enough cash to get through all of the upcoming steps or will you be looking for additional funding?
Zerbe: Our financial situation is very solid. We expect to be both cash flow positive and profitable at the operational level in 2013 and we therefore do not anticipate raising capital for operational purposes.
IntelGenx Risks: Regulatory agencies may decline to approve the company's regulatory submissions in a timely manner, or may not approve a drug candidate at all. The firm may require substantial funding to advance the clinical progress of its candidates, which could be dilutive to current shareholders. There is competition for the company's drugs from several public and private companies developing pharmaceuticals. Sales of the firm's drugs could depend upon reimbursement from private, as well as public, reimbursement agencies.
Moreover, small cap stocks, especially those with market caps under $100 million are consider to be risky investments.
Looks like my suspicions were correct. I was expecting a CLSN fail (sold a load of calls there) and it looks like this morning money is flowing toward DCTH as a result.
IGXT tweeted news coming in near future (aka viral network):
@IntelGenx: @hoss_stocks Good to hear you're excited for what's coming down the pipeline. Watch for news to be released in the near future IGXT.
I have had similar thoughts. The Adversa pain product will not even launch until the second half of 2016. The revenue chart shows rather significant revenue from the PAR project before then in 2015. If they are the same how could revenue be charted so far in advance of the launch? Up front payments? So indeed it is a puzzle with many interesting possibilities. If it were something like a thin film THC product I could imagine that generating a lot of excitement.
From HOSS at Stock Traders Talk Radio on $IGXT : http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83560856
$IGXT -Could not agree more HOSS. Multiple catalysts coming soon. PAR deal, Migraine Film, ED Film. 2013 will be very interesting to watch unfold for people with medium to long term gratification needs or load and hold as you call it.
In at $1.46. I find myself wondering if a negative decision on CLSN could have a positive impact on DCTH. Either way there are many good catalysts coming.
You need to grab 200 more shares to round it out before it takes off. :)
On that I would say we agree. What matters is potential Par revenues and how they develop into actual revenues. Investors can do a risk-adjusted Net Present Value analysis just as well as Raghuram Selvaraju Ph.D. or any other analyst out there. If fair value is $8 everyone will know it as soon as the Par details are released far before Aegis can crank out a target raise.
Very often in speculative biotechs investors want to see actual revenues not hear about what revenues are EXPECTED to be. This will take a lot of time. It is completely possible in theory that not a single product in this very deep pipeline will take off and the price could eventually go down from here. There is no certainty in life. Horst has already said we are now cash flow positive, its just that noone yet knows the exact figures.
Care to explain to everyone the logic behind your decision to continue holding this stock? I am really curious what your rationale is.
Re: "We are no where near the target they have now" Thats because it is an 18 month target. Its been no where near 18 months. That will be in 2014. When Par is disclosed and factored in it could be $5-$8. We cant know until we see the details.
From October 5, 2012
Price Target
Our 18-month price target for IGXT is $3.00 per share.
Valuation Methodology
We utilize a risk-adjusted Net Present Value (rNPV) analysis to determine our price target objective. Using a discounted cash flow
analysis, we derive an rNPV-based total firm value of $180 million, which translates into a price per share of $3.00, assuming 65 million
fully-diluted shares outstanding and $17 million in cash as of the end of 2013.
The news I am waiting on won't come until 2015 when the Par deal causes revenues to hit 40 million. Shares at .65 might just seem like a pretty good deal.
Now I will be curious to see if with this type of strong downward move on higher than normal volume, will it trigger a bounce off of the 50MA at .64? Or will it continue down to flirt with the 200? Both could happen. MACD is crossing over so it has some down room.
Funny thing though is the trade shows up in red as a sell rather than a buy on time sales? go figure.
They filled it no problem and dropped it to .645 x .65.
My understanding is the old AUTO, which is Automated Trading Desk, LLC. It is now owned by Citigroup Inc. They must have changed it to ATDF for Automated Trading Desk. My order was routed by Think or Swim/TD Ameritrade. But TD Ameritrade also use others like CSTI, NITE or ETRF. ATDF handles orders from all sorts of other firms.
I have an odd lot of 1155 sitting at .65. Lets see if they nibble.
Yea I have done that several times, put in an order.02 or so below the bid and have it filled pretty quickly. It only seems to happen on down days/weeks. On an up day/week they will not touch it.
They did not fill the entire order though. I think that means it will go lower no problem over the next few days. I do sleep a little better when I am locked and loaded though.
Not only did I see it I have the confirmation, lol. I put 2500 at .65 just to see if anyone would bite and sure enough they did. They did not move the bid lower. They just reached down and filled my order.
Well I plan to pick up about a 4k lot to throw on the pile so I AM feeling the love. I just can't decide where to put the order in at. Last time I waited too long and had to chase it up a bit. This time the concern is not waiting long enough for it to settle. Every penny drop is $40 saved on the order. I am torn between setting it at .64 and .61. If it bounces off the 50MA I will wish I had done it at .65. Seems I am patient when I should be in a hurry and in a hurry when I should be patient. Which one is this? Hurry up and wait? Lol. The support line looks like its around .59 and rising over time. That should make .61 possible with the spread but maybe not till next week. Who knows.
I got a fill today at .66 which surprised me. The bid was .66 and the ask was .67 when they filled it and the low today was .66 so far. Surprised they filled it at the bid but I will not complain.
I wonder why sumatriptan ($1,349M) has higher sales than rizatriptan ($371M)? Perhaps because everyone has heard of Imitrex compared to Maxalt? Could be adverse events?
Looking at some studies it appears rizatriptan may be superior:
http://www.ncbi.nlm.nih.gov/pubmed/8912486
Does this new combination INT0028 increase appetite?
Slide 15 of the Oct 2012 presentation says that combining Buprenorphine with Dronabinol decreases the metabolite 11-OH-THC. It seems that this may be the metabolite that contributes to delayed onset hunger.
11-Hydroxy-Delta 9-tetrahydrocannabinol, abbreviated as 11-OH-THC, is the main active metabolite of THC which is formed in the body after cannabis consumption. 11-Hydroxy-THC has been shown to be active in its own right but the effects produced are not necessarily identical to those of THC. This might partially explain the biphasic effects of cannabis, whereby some effects such as increased appetite tend to be delayed rather than occurring immediately when the drug is consumed.
If I read correctly Dronabinol leads to 11-OH-THC metabolite which causes hunger. Buprenorphine added to the Dronabinol blocks 11-OH-THC thereby blocking some of the “high” and the hunger. I could be misapprehending some of this information though.
I was not sure if the company said that it increases appetite or you just assumed that because Buprenorphine alone does?
Wow congrats Gary!!!
I am hoping you are right but if it breaks the 52 week I am afraid there is no looking back. Unfortunate.
I agree about the close. However I am not liking it one bit. I was trying to get more for 2 weeks and had to pay more than I planned. 1 year of this going nowhere until I get ready for a big purchase. Grrr.
Most bio runup traders take their basis off the table prior to results. Only investors do not. As the fear of results approaches they get scared and run.
Why do you say that? Does that mean you think they will expire worthless because data will not come till after the 18th, or just because IV is so high?? Just curious about your logic. TIA
I am selling them not buying them.
From your perspective it is the end of the story. I am trying to calculate Theta decay and looking at some option ideas that rely heavily on exactness.
For example if you could see the future and knew that the news would come out COB on 01-18 or after, then you could make a killing on premium with the IV this high. If someone tries to catch a little premium selling JAN covered calls and positive data hits before 01-18 it would result in a premium gain (with positive data) but not near as great of a gain if it was after.
If anyone knows exactly which CC the time to prepare/release data is discussed specifically, I would appreciate anyone pointing me to it. I will try to listen to the most recent one first. TIA. Hope everyone has a great New Year!
Ahh I don't recall how long he said or which CC he said that on. The market seems to think late Jan or early Feb:
http://seekingalpha.com/article/1065041-option-strategy-for-celsion-s-liver-cancer-results
Hey bio, where are you getting 8 days? Thanks in advance. I was thinking late Jan (after op ex) based on the options skew. Was not sure if some more concrete heads up had been given or 8 days was a guess.
Actually that is not right. The IV would drop huge after the results are released but we can not know exactly to what level. Current IV is crazy high at like 366%. Also deeper ITM options lose time value. So I am not sure what it would be exactly without actually calculating it with think or swim.
Correct. about 16.40. eom