THIS UNDISCOVERED STOCK HAS HUGE UPSIDE POTENTIAL .PLEASE DO YOUR OWN DD !!!!
Approval will push this stock to 7-10$ !! 10 Drugs in Pipeline !!
Intelgenx (igxt.ob)
Market Cap 16 Mio$
Price : 0,49 $
Shares Out : 33 M ....( CEO owns 11 Mio Shares )
Markman hearing in june // If Positive = STOCK WILL EXPLODE LIKE A SUPERNOVA !!!!
300 Million US$ Market Potential for CPI-300 (antidepressant)-- Approval in 4Q 2010 or early 1Q 2011 !!
Pipeline
IntelGenx Corp. - Products - Product Pipeline
New Presentation...PLEAS READ !!!!!
http://www.intelgenx.com/_assets/pdf...2010-04-27.pdf
In addition, we have a meeting scheduled with FDA in early June to address their complete response letter and clarify the required steps to obtain product approval. Finally, the Markman hearing in respect of the Biovail litigation is also scheduled for early June, and we remain optimistic for a positive outcome. The timing of this acquisition should yield substantial value to the company and its shareholders because we believe it is an excellent product that will become commercialized in the near future."
Objectives for the next 12 Months
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Q2, 2010 Complete pilot study for ED film
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Q2, 2010 Meet with FDA for CRL response (JUNE)
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Q2, 2010 Markman hearing (Biovail litigation) (JUNE) BIG BOOST FOR IGXT
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Q3, 2010 Complete pivotal migraine study
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Q3/Q4, 2010 Respond to FDA CRL letter
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Q4,2010 File ANDA antihypertensive product
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Q1, 2011 Approval of CPI-300 NDA
Buy-Rating by U-Securities
Developments
Intelgenx has announced that they have been issued a patent by the U.S. Patent office (USPTO) for CPI-300, their
sustained release, high dose (450 mg) formulation of Bupropion HCl (Wellbutrin).
Impact
Positive. This solidifies Intelgenx as the Company all current sellers of Bupropion HCl have to negotiate with if
they would like the advantage of having a single dose pill.
Comments
The issuance of this patent puts Intelgenx in the position of having the only approved sustained release, high dose
one pill version of Bupropion HCL. This is very attractive to many existing sellers of generic Wellbutrin for several
reasons:
1. Doctors start patients at lower doses and then titrate them to higher doses. The compliance is higher when
patients take 1 pill versus 2 to 3 pills.
2. Intelgenx uses their proprietary VersaTab technology which can be produced at a significantly lower cost,
making the product more price competitive and profitable at the same time.
Intelgenx received a complete response letter from the FDA on February 8th, 2010, which provided 2 areas that
Intelgenx must address before approval:
1. Commercial manufacturing site: Intelgenx has hired Pillar5 to be their manufacturer and is now running the
necessary batches to gain FDA manufacturing approval. The Company believes that it will be finished
before Q4/2010.
2. Food Effect: The Company believes that this can be addressed through a label adjustment and a postapproval
educational effort. The food effect was observed both in CPI-300 and the reference product
(Wellbutrin). Intelgenx believes that they will have this issue resolved with the FDA in time for an H2/2010 filing and a possible Q4/2010 approval.
The patent issued by the USPTO strengthens Intelgenx�s position regarding any possible new entrants with a
similar dosage and puts them in a strong negotiating position for a commercialization partnership. However, the
current issues with Biovail are ongoing and will prevent Intelgenx from commercializing CPI-300. Intelgenx
believes that these issues could be resolved before final FDA approval in Q4/2010.
Valuation and Recommendation
Intelgenx has strengthened their negotiating position and is getting substantially closer to commercializing their
first major product. A successful approval and launch of CPI-300 will be a substantial revenue opportunity for
Intelgenx and will be strong proof of their technology and business model. This will greatly increase the value of
Intelgenx�s substantial 10 product pipeline. We are maintaining our recommendation with a Speculative Buy
and a target of $1.90
IGXT--Intelgenx
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