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Old 01-21-2014, 09:07 AM   Nav to Top  #1
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Default IGXT (MC $48 M) FDA DECISION ON FEBRUARY 3 =500%+ Potential !!!

IGXT is one of the Best and Most Undervalued Gem in the Biotech Sector . Market Cap of $48 M for a Company with10 Drugs in Late Stage which all could be on the Market within 3 years is more than Ridiculous .

2 Big Drugs already under review by FDA another 1 NDA filing for "Best in Class" Potency Drug and 1 ANDA filing for CHF will follow within 6 months .

NDA submission for our anti-migraine VersaFilm(TM) product had been accepted for review, with an FDA-assigned PDUFA date of February 3, 2014.
(According to Merck's most recent annual report, sales of Maxalt(R) were $638 million in 2012.)

IntelGenx Announces Submission of ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction
(According to IMS Health, U.S. retail sales of Suboxone(R) Sublingual Film were approximately $1.5 billion in 2012.)

Only 35 M on the float ..IGXT has the Potential to hit $10++ within 2 Year ! GLTA

Intelgenx (IGXT)

Market Cap : $48 M
Cash: $6 M
Price:0.70

Burn-Rate : $2 M a year
Shares Out : 69 M ( 31 M shares are held by Investors )


Mega Product Pipeline
http://intelgenx.com/pipeline/chart.html


New Presentation
http://intelgenx.com/investors/presentations.html


Here is a Summary from he largest Shareholder of IGXT (he sees Tgt of $5-10) !!!

Frankly, my target (first stated in July, 2011) of realizing $3-$8/share from IntelGenx over the
life of the BIPES Fund has never seemed more reason able—the company has put in place more
than enough building blocks to see that kind of sto ck price by the of 2016, as it becomes
recognized as a world leader in the growing area of thin-film drug delivery and development. I
like the fact that my $3 low end corresponds to the already-existing 1-year target of Ram
Selvaraju, a well-respected and sophisticated Wall Street biotech analyst. If the PAR
partnership blossoms into something special (whichis what I expect), the $5-$10 range becomes a real possibility.

1) IntelGenx has a branded drug (ForFivo) which they s
uccessfully negotiated through to
FDA approval. Although ForFivo is not a “big” drug
, royalties and milestones from this
drug should end up covering IntelGenx’s $2million/y
ear operating burn; the industry
credibility that IntelGenx earned just from this ac
complishment should not be
underestimated, because few companies of IntelGenx’
s size are able to get drugs all the
way through the approval process.

2) By the end of 2013, IntelGenx will have successfull
y cleared the equivalent of Phase III
trials in the generic or 505b2 form of 4 branded dr
ugs that together register annual
sales of over $4.5billion. (What we don’t know is
how big a piece of that $4.5billion pie
will IntelGenx’s marketing partners be able to take
...)
3) IntelGenx has partnered with Par Pharmaceuticals—a
large and well-respected generic
drug company—for a generic form of thin-film Suboxo
ne, a drug which currently sells
over $1.5billion/year. With Par as a partner, it i
s reasonable to expect that IntelGenx
should share in sales somewhere in the $100million-
$300million range, allowing it to
generate EPS which should be in the $0.50/share-$1+
/share range from this drug alone

4) It is also a reasonable expectation that Par’s sati
sfaction with IntelGenx’s drug
formulation and development capabilities (proven in
the Suboxone project) means that
IntelGenx should be brought into more Par projects
in the near future. If we see that
happen, it will be fair to say that IntelGenx has b
ecome Par’s de facto partner for thin-
film drug delivery and development, and that IntelG
enx would be a natural takeout
candidate for Par.

5) With an approved drug on the market, proven deliver
y capabilities across 3 delivery
platforms (including thin-film strips), a clinical
pipeline of 7 drugs that includes 2 “post-
PhaseIII” drugs, IntelGenx should be a natural take
out candidate for any number of
generics manufacturers. (I believe that generics ma
nufacturers are being increasingly
drawn to the 505b2 pathway, and are likely to make
acquisitions of 505b2 companies,
as they seek to expand both their product offerings
and their profit margins.) IntelGenx
should also be a takeout candidate for specialty ph
arma companies, and perhaps even
BioDelivery Sciences, if the valuation gap remains
as ridiculous as it currently is.

Both Ram and I share an affinity for IntelGenx’s bu
siness model and proven abilities:

1) IntelGenx primarily uses the FDA’s 505b2 pathway to
approval, which minimizes toxicity
risk and efficacy risk (which is what kills almost
all biotech companies). Efficacy risk and
toxicity risk are minimized because IntelGenx is taking
existing drugs that sell hundreds
of millions (or billions) of dollars a year and mov
ing them onto delivery platforms which
make them better/faster/easier (like what Biovail d
id with Wellbutrin when Biovail
developed Wellbutrin XL).

2 )IntelGenx’s ability to bring a drug all the way thr
ough the FDA’s 505b2 pathway and to
launch an approved drug has been tested and proven.
There are few companies
with an FDA approved drug with a market cap under $
100million
; at US$0.54,
IntelGenx’s market cap is under US$
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Old 01-21-2014, 02:15 PM   Nav to Top  #2
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Major Breakout will start once it breaks the 2.5 year resistance at 0.75
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Old 01-22-2014, 09:09 AM   Nav to Top  #3
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BullInvestor: New Hot Stock Pick (IGXT) Targets Near Term $2-3 Long Term : $5+
IntelGenx (IGXT :$0.69) – Drug Delivery company focused on Oral method with strong pipeline of pharma drugs

Targets: Near term: $2 – $3 /// Long term: $5+

New HOT Stock pick: IntelGenx Corp. (IGXT: $0.69)

IntelGenx has an FDA approved drug (Fortivo XL) on the market and several in pipeline for various indications with multi billion dollar market for some of the other approved drugs on the market for the treatments. Company has many good partnerships in place with companies like PAR Pharma, RedHill BioPharma, Edgemont Pharmaceuticals and others.

IntelGenx is uniquely positioned to capture a huge marketshare given its large portfolio of patents in Drug Delivery Systems. It has 3 key methods:

1) VersaTab – Controlled release tablets
2) VersaFilm – Rapidly disintegrating film
3) AdVersa – Mucoadhesive tablet

Company has NO debt and has sufficient cash for near term giving its current burn rate.
Current capital structure includes:

Shares outstanding: 69 Million
Insider Ownership: 25%

About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx’ development pipeline includes products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic pulmonary fibrosis, allergies and pain management.
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Old 01-22-2014, 01:36 PM   Nav to Top  #4
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Multi year resistance at 0.75 is broken now we will see a major run over $1 quickly .
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Old 02-24-2014, 08:18 AM   Nav to Top  #5
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Default IntelGenx (IGXT) Achieves Positive Bioequivalence Results for Erectile Dysfunction Ve

IntelGenx (IGXT) Achieves Positive Bioequivalence Results for Erectile Dysfunction VersaFilm(TM) Tadalafil Product



SAINT LAURENT, Quebec, Feb. 24, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced the completion of a pilot biostudy with its proprietary VersaFilm(TM) tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug (RLD) tadalafil product.

This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether VersaFilm(TM) tadalafil was bioequivalent as measured by industry standard pharmacokinetic measures of peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that VersaFilm(TM) tadalafil was within an acceptable range of bioequivalency with the RLD on both of these measures.

"The completion of this pilot biostudy confirms that we can continue the development of our VersaFilm(TM) tadalafil product," said Rajiv Khosla, IntelGenx' President and CEO. "We now plan to progress this project, leading to a pivotal bioequivalence study, with the objective of filing a 505(b)(2) NDA with the U.S. Food and Drug Administration."
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Old 02-26-2014, 08:23 AM   Nav to Top  #6
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Default IntelGenx (IGXT) Announces Receipt of Two Additional U.S. Patent Allowances Related

IntelGenx (IGXT) Announces Receipt of Two Additional U.S. Patent Allowances Related to Proprietary Technology




SAINT LAURENT, Quebec, Feb. 26, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced that it has received a Notice of Allowance ("NOA") from the United States Patent and Trademark Office for U.S. Patent Application Serial No. 11/647,033 entitled "Multilayer tablet" which covers the technology used in our hypertension product currently under development. A second NOA has been received for U.S. Patent Application Serial No. 11/782,838 entitled "Controlled-release pharmaceutical tablets" which is related to the drug delivery technology used in Forfivo XL(R), IntelGenx' first FDA-approved product currently commercialized in the U.S. These two NOA's conclude the examination of each U.S. patent application and will result in the issuance of two U.S. patents after administrative processes are completed.

"These two additional NOA's in the U.S. represent yet another important expansion of IntelGenx' patent estate as well as demonstrating the innovative design of our drug delivery technologies," said Rajiv Khosla, IntelGenx' President and Chief Executive Officer. "Our goal is to protect the innovation and commercial potential of the products developed at IntelGenx and these NOA's further strengthen our proprietary position."
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Old 03-03-2014, 08:13 AM   Nav to Top  #7
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Default IntelGenx (IGXT) and RedHill Biopharma Submit Response to FDA CRL for VersaFilm(TM) P

IntelGenx (IGXT) and RedHill Biopharma Submit Response to FDA CRL for VersaFilm(TM) Product for Migraines



SAINT LAURENT, Quebec, March 3, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage drugs, that they submitted a response to the Complete Response Letter ("CRL") of the U.S. Food and Drug Administration ("FDA") for the New Drug Application ("NDA") for their VersaFilm™ Oral Film Product for the treatment of acute migraines.

The companies previously reported on February 4, 2014 that they received the FDA's CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to the anti-migraine VersaFilm™ product's safety and did not require additional clinical studies. IntelGenx and RedHill believe that their response to the FDA addresses all the issues raised in the CRL.

IntelGenx and RedHill will continue working with the FDA on the continuing review of the anti-migraine VersaFilm™ NDA, and will provide additional updates as and when applicable.
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Old 03-11-2014, 08:43 AM   Nav to Top  #8
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Default IntelGenx (IGXT) Reports 2013 Annual Results and Provides Corporate Development Upda

IntelGenx (IGXT) Reports 2013 Annual Results and Provides Corporate Development Update



SAINT LAURENT, Quebec, March 11, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) (the "Company") today announced financial results for its fiscal year ended December 31, 2013 and provided an update on operational developments. All amounts are in U.S. Dollars, unless otherwise stated.

"2013 was a challenging and exciting year for IntelGenx," said Rajiv Khosla, President and CEO of IntelGenx. "We made significant progress with the filing of the NDA for our anti-migraine film and the subsequent filing of an ANDA by our partner, Par Pharmaceutical, for our opioid dependence film. Also, subsequent to the end of the year, in early January, we reached agreement with Par for the development of another two products. One of the challenges throughout 2013 was the disappointing sales performance of Forfivo XL(R), our high strength anti-depressant tablet. We continue to work together with Edgemont Pharmaceuticals, our commercialization partner for this product, to address the Forfivo XL(R) business. At the corporate-level we successfully completed a public offering in December, raising net funds of $3.0 million, which strengthened our cash position at December 31, 2013 to $5.0 million. These funds will enable us to move forward with the next important phase of our development, which is to expand into a new facility and establish a pilot plant for VersaFilm(TM) manufacturing, whilst continuing to further our product portfolio."

Corporate Development Update

Product-related

Anti-depressant tablet, Forfivo XL(R)

Forfivo XL(R), our first FDA approved product, was launched in October 2012 and is being marketed in the United States under the terms of a license agreement between us and Edgemont Pharmaceuticals. Forfivo XL(R) is indicated for the treatment of Major Depressive Disorder ("MDD") and is the only extended-release bupropion HCl product to provide a once-daily, 450mg dose in a single tablet. The active ingredient in Forfivo XL(R) is bupropion, the same active ingredient used in the well-known antidepressant product Wellbutrin XL(R). Prior to the launch of Forfivo XL(R), most patients in the US requiring a 450mg dose of bupropion had been taking multiple tablets to achieve their 450mg dose requirement. With Forfivo XL(R) now available in the US, these patients can simplify their dosing regimen to a single Forfivo XL tablet, once-daily.

The commercialization of Forfivo XL(R) triggered launch-related milestone payments to us of up to $4.0 million, of which $1 million was received in Q1, 2013, and additional milestones upon achieving certain sales and exclusivity targets of up to a further $23.5 million. We also receive tiered, double-digit, royalties on net sales of Forfivo XL(R). We recorded total revenue for Forfivo in 2013 of approximately $492 thousand.

In August, 2013 we announced receipt of a Paragraph IV Certification Letter from Wockhardt Bio AG, advising of the submission of an ANDA to the FDA requesting authorization to manufacture and market generic versions of Forfivo XL(R) 450 mg capsules in the United States. We intend to vigorously enforce our intellectual property rights for Forfivo XL(R) and will pursue all available legal and regulatory pathways in defense of the product, which is currently protected by an issued patent listed in the FDA's Approved Drug Products List (Orange Book).

Anti-migraine Film

In March, 2013 we submitted a 505(b)(2) NDA to the FDA for our novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT(R) orally disintegrating tablets. Maxalt-MLT(R) is a leading branded anti-migraine product manufactured by Merck & Co. The thin-film formulation of Rizatriptan was developed in accordance with the co-development and commercialization agreement with RedHill Biopharma Ltd. using IntelGenx' proprietary immediate release VersaFilm(TM) oral drug delivery technology. In December 2011, we received approval by Health Canada to conduct a pivotal bioequivalence study to determine if our product is safe and bioequivalent with the FDA approved reference product, Maxalt-MLT(R). The trial was conducted in the second quarter of 2012 and was a randomized, two-period, two-way crossover study in healthy male and female subjects. The study results indicate that the product is safe, and that the 90% confidence intervals of the three relevant parameters Cmax, AUC(0-t) and AUC(0-infinity) are well within the 80 -- 125 acceptance range for bioequivalency.

In June, 2013 the FDA assigned a PDUFA action date of February 3, 2014 for the review of the NDA for marketing approval.

Subsequent to the end of the year, in February, 2014 we received a Complete Response Letter ("CRL") from the FDA. A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for our anti-migraine VersaFilm(TM) product primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies. We believe that the majority of issues raised by the FDA were addressed in an amendment submitted by us to the FDA in January, 2014 that has yet to be reviewed.

On March 3, 2014 we announced that we submitted a response to the CRL which, we believe, addresses all the issues raised in the CRL.

Opioid dependence Film

In accordance with a co-development and commercialization agreement with Par, we developed an oral controlled-release film product based on our proprietary VersaFilm(TM) technology. The product is a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The reference listed drug is Suboxone(R) Sublingual Film. A bioequivalent film formulation was developed, scaled-up, and pivotal batches manufactured and tested during a subsequent pivotal clinical study. An ANDA was filed with the FDA by Par in July 2013.

In August, 2013 we learned that, in response to filing of the ANDA, we were 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). We believe the ANDA product does not infringe those or any other patents, and will vigorously defend ourselves in this matter. In accordance with the terms of the co-development and commercialization agreement, Par is financially responsible for the costs of this defense. Since Paragraph IV litigation is a regular part of the ANDA process, we do not expect any unanticipated impact on our already planned development schedule.

Two new (undisclosed) projects

Subsequent to the end of the year, in January, 2014 we announced the signing of another development and commercialization agreement with Par Pharmaceutical, Inc. for two new products.

Under the terms of the agreement, Par has obtained certain exclusive rights to market and sell our products in the USA. In exchange we will receive upfront and milestone payments, together with a share of the profits upon commercialization. In accordance with confidentiality clauses contained in the agreement, the specifics of the product descriptions, platform technologies and financial terms remain confidential.

Corporate

Leadership succession

In April, 2013 we announced that Rajiv Khosla, RPh, PhD, MBA would assume the role of President and Chief Executive Officer, succeeding Horst G. Zerbe, PhD, with effect from January 1, 2014. Dr. Zerbe will remain as Chairman of the Board of Directors and continue to provide expertise in research and development, and manufacturing.

Dr. Khosla held the positions of Chief Operating Officer and Chief Scientific Officer throughout the transitional period of 2013 and was a member of the our Board of Directors for the previous two years. Dr. Khosla has remarkable experience and credentials including, among other senior positions, five years as Vice President of Business Development at Biovail Corporation, a Canadian pharmaceutical company operating internationally. Whilst there, he successfully led the transaction process for more than 75 deal opportunities in a variety of therapeutic areas.

Dr. Khosla holds a Ph.D. in pharmaceutical science, with a thesis on Oral Drug Delivery Technology; an Executive MBA from the Henley Business School in England, a Bachelor of Pharmacy (Honours) from the University of Nottingham, England and is a registered pharmacist in the UK.

Dr. Khosla's biography can be found on our website at IntelGenX.

$3.5 Million Public Offering

In December, 2013 we announced the closing of a registered public offering raising gross proceeds of approximately $3.5 million.

Earlier in the same month we entered into securities purchase agreements with certain accredited investors for the issuance and sale of an aggregate of 7,920,346 shares of its common stock at $0.4419 per share. Additionally, investors received warrants to purchase up to 7,920,346 shares of common stock at an exercise price of $0.5646 per share for a term of five years.

Net proceeds, after deducting the placement agent's fee and other estimated offering expenses payable by us were approximately $3.0 million. We intend to use the net proceeds from the offering for capital investments in VersaFilm(TM) manufacturing equipment, leasehold improvements on a new facility, working capital and other general corporate purposes.

H.C. Wainwright & Co., LLC acted as the exclusive placement agent for the transaction.

Financial Results:

Cash on hand at December 31, 2013 increased to $5.0 million compared with the cash balance of $2.1 million as at December 31, 2012. The increase in cash on hand relates to net cash provided by financing activities of $4.5 million (2012 - $0.4 million), partly offset by net cash used in operating activities of $1.1 million (2012 - $1.6 million), net cash used in investing activities of $0.3 million (2012 - $0.3 million), and an unrealized foreign exchange loss of $0.1 million (2012 - unrealized foreign exchange gain of $0.1 million). The net cash provided by financing activities consists of approximately $3.0 million from a registered public offering that we completed in December 2013, together with approximately $1.5 million in proceeds received from the exercise of warrants and stock options.

We intend to use the net proceeds from the registered public offering for capital investments in VersaFilm(TM) manufacturing equipment, new facility leasehold improvements, working capital and other general corporate purposes.

Accounts receivable totaled $0.1 million as at December 31, 2013 compared with $1.3 million at December 31, 2012. The accounts receivable balance at December 31, 2012 included an amount of $1.0 million related to the launch of Forfivo XL(R)(TM) that was invoiced to our commercialization partner for Forfivo XL(R), Edgemont Pharmaceuticals, in the fourth quarter of 2012. Payment against the invoice was received in February 2013.

Revenue for the year ended December 31, 2013 decreased to $0.9 million from $1.2 million in the previous year. In fiscal 2013, we recorded approximately $0.5 million of revenue related to commercial sales of Forfivo XL(R), compared with a milestone of $1.0 million that was recorded as revenue in 2012 related to the launch of Forfivo XL(R).

Total expenses decreased from $3.5 million in fiscal 2012 to $2.6 million in 2013, representing a reduction of $0.9 million, or 25%. The decrease is primarily attributable to a reduction in R&D expenses that we incurred in 2012 for a) the development of our buprenorphine and naloxone Sublingual Film of approximately $0.7 million, b) the technical transfer of activities in preparation for manufacturing of Forfivo XL(R) to our Contract Manufacturing Organization, Pillar5 Pharma, of approximately $0.3 million (of which, approximately $0.1 million were credited to us in fiscal 2013), and a Product Fee that we paid to the FDA for Forfivo XL(R) of approximately $0.1 million, partly offset by an increase in SG&A expenses attributable to the addition of Dr. Rajiv Khosla to our management team.

The net loss decreased from $2.3 million in fiscal 2012 to a loss of $1.6 million in 2013, and the loss per share decreased from $0.04 per share in 2012 to $0.03 per share in 2013.

About IntelGenx:

IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at IntelGenX.
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Old 04-16-2014, 08:19 AM   Nav to Top  #9
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Default IntelGenx (OTCQX:IGXT) Announces Receipt of an Additional U.S. Patent Allowance Relat

IntelGenx (OTCQX:IGXT) Announces Receipt of an Additional U.S. Patent Allowance Related to Proprietary Technology



SAINT LAURENT, Quebec, April 16, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced that it has received a Notice of Allowance ("NOA") from the United States Patent and Trademark Office ("USPTO") for U.S. Patent Application Serial No. 12/836,810 entitled "Oral mucoadhesive dosage form" which covers IntelGenx' proprietary AdVersa™ mucoadhesive drug delivery technology. This NOA concludes the examination of the U.S. patent application and will result in the issuance of a U.S. patent after the administrative process is completed.

"This patent allowance by the USPTO is another important achievement in protecting the innovation and commercial potential of IntelGenx drug delivery technologies and products," said Rajiv Khosla, IntelGenx' President and Chief Executive Officer. "This NOA is the latest example of how our scientific innovation continues to establish IntelGenx as a leader in pharmaceutical drug delivery."

About IntelGenx:

IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at IntelGenX.
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Old 04-24-2014, 08:14 AM   Nav to Top  #10
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Default IntelGenx (IGXT) and RedHill Biopharma Provide an Update on FDA's Ongoing Review of t

IntelGenx (IGXT) and RedHill Biopharma Provide an Update on FDA's Ongoing Review of the NDA for Migraine VersaFilm(TM) Product



Saint Laurent, Quebec--(Newsfile Corp. - April 24, 2014) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, together with RedHill Biopharma Ltd. (NASDAQ: RDHL; TASE: RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, today reported that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of their response to the Complete Response Letter ("CRL") for the VersaFilm™ Oral Film Product New Drug Application ("NDA") and has requested further clarifications. The VersaFilm™ Oral Film Product is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.

IntelGenx and RedHill (the "Companies") reported on March 3, 2014 that they had submitted their response to the FDA's CRL for the VersaFilm™ Oral Film Product NDA, which had raised questions primarily related to Chemistry, Manufacturing and Controls (CMC). In response, the FDA has requested from the Companies additional CMC data, which the Companies believe they can supply within several weeks based on available information.

The Companies further report that a supplier of raw material for the VersaFilm™ Oral Film Product is currently holding compliance discussions with the FDA, which are independent of RedHill and IntelGenx and are not specific to the VersaFilm™ Oral Film Product. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions.

The Companies believe that FDA approval of the VersaFilm™ Oral Film Product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, IntelGenx and RedHill continue to work with the FDA in order to submit all the data requested, and will provide an update as and when applicable.

About the VersaFilm™ Oral Film Product:

The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt®. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1 billion in 20131.

The product is based on IntelGenx' proprietary "VersaFilm™" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated at approximately 80% of the total migraine patient population2.

About IntelGenx:

IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx’ development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at IntelGenX.

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer and related conditions. RedHill’s current pipeline of proprietary products includes: (i) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study, (ii) RHB-105 - an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; (iii) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals Ltd.; (iv) RHB-103 - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review; (v) RHB-102 - a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting, in advanced development stages for multiple indications and, (vi) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.
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