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IPHAF News - FDA Advisory Panel June 28th

 Isotechnika just released the following news:

EDMONTON, May 11 /CNW/ – Isotechnika Pharma Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review partner, Lux Biosciences’, New Drug Application (NDA) for voclosporin on June 28, 2010. Voclosporin is proposed for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye.

Lux submitted its NDA on February 4, 2010, seeking approval to market voclosporin in the United States. The FDA accepted the NDA filing for review and granted the NDA priority review on March 30, 2010. The target Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review is August 3, 2010. The FDA is not bound by the Advisory Committee’s recommendation, but may take its advice into consideration when evaluating the NDA for voclosporin.

“With the meeting of the Dermatology and Ophthalmology Drugs Advisory Committee confirmed for June 28, 2010 and the PDUFA date of August 3, 2010, we look forward to value-driving news events in the third quarter, as well as a potential milestone payment of $7.04 million USD, followed by royalty payments on sales in the United States,” said Dr. Robert Foster, President and CEO of Isotechnika Pharma. “The review process in Europe is also underway and expected to be completed by the end of February 2011. If approved, we also look forward to an additional milestone payment and royalty payments for sales of voclosporin in Europe.”

This provides an excellent opportunity for a run-up before June.  IPHAF has been slow to get moving in its run-up and this bumps up our runup by a month.  I currently have a position and I am looking to add another 10K+ shares.  Based on the lack of action in the past month or so, I am not as confident that we will see a huge jump in price, however we should see some action before the panel.  There are not many run-up plays between ASCO and the October FDA plays, so this one fills the gap nicely.

Below you will find my write-up from a few weeks ago.



52 week 0.12 – 0.42
Vol / Avg. 107,220.00/230,000.00
Mkt cap 47.27M
EPS -0.10
Shares 131.31M


Recent News:…closporin.aspx

FDA grants priority review status for Isotechnika Pharma’s voclosporinIsotechnika Pharma Inc. (TSX: ISA) today announced that the New Drug Application (NDA) for the Company’s next generation calcineurin inhibitor, voclosporin, has been accepted for priority review as filed by the U.S. Food and Drug Administration (FDA). The application was submitted by Isotechnika’s partner, Lux Biosciences, Inc.The FDA granted voclosporin with a priority review status which accelerates the review period to six months. The FDA grants a priority review designation to drugs that are considered to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The target date under the Prescription Drug User Fee Act (PDUFA) is August 3, 2010.


“With an active regulatory review process by both the FDA and the EMA, a PDUFA date of August 3rd, and potential EMA approval in the first quarter of 2011, we now have additional validation to the technology, as well as two very important milestones over the next eleven months to drive value in Isotechnika,” said Dr. Robert Foster, President and CEO of Isotechnika Pharma. “FDA approval would result in a milestone payment of $7.04 million USD followed by royalty payments on sales from our partner, Lux. On the back of that we can expect an additional $3.52 million milestone payment from Lux for approval by the EMA, followed by royalty payments.”



Year End Financial Statements December 31 2009 (PDF 232 KB)


Voclosporin a next generation calcineurin inhibitor, has successfully completed a Phase 2b kidney transplant (PROMISE) trial and a Canadian Phase 3 trial for the treatment of moderate to severe psoriasis. An extension to the PROMISE trial and a combined European/Canadian Phase 3 psoriasis (ESSENCE) trial for the treatment of moderate to severe psoriasis are ongoing.

Our partner, Lux Biosciences, initiated pivotal trials of voclosporin in uveitis in February, 2007. The data, announced in March 2009 showed a positive effect on ocular inflammation and a safety profile consistent with the expected use in uveitis. In addition to the uveitis trials, Lux Biosciences has also commenced a Phase 1 trial using the voclosporin ophthalmic solution as a candidate for dry eye syndrome.

Voclosporin has also entered First-in-Man trials as the drug utilized in the CINATRA TM Drug Coated Coronary Stent system developed by the Company’s partner, Atrium Medical Corporation.

TAFA93 is a novel prodrug of the mTOR inhibitor Rapamycin. TAFA93 has been designed to attenuate the unfavorable pharmacokinetics and side effects of Rapamycin which presently limit its broader use. mTOR inhibitors are currently used in the prevention of organ rejection in transplantation, in the treatment of autoimmune and oncological diseases, and as a component of coated stents for the treatment of coronary artery disease. TAFA93 has successfully completed Phase 1 clinical trials.

Drug Market Potential:

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Disclosure: Long IPHAF