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8-K - FORM 8-K - Innovation Pharmaceuticals Inc.ctix_8k.htm

 EXHIBIT 99.1

 

September 15, 2016

 

My Fellow Cellceutix Shareholders,

 

Yesterday, news was released that Allergan plc (NYSE: AGN) has agreed to acquire Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE) for $21.00 in cash (a 159% premium to the value of VTAE shares on Tuesday) for a total transaction value of approximately $639 million.  First off, we’d like to congratulate Vitae on the acquisition offer.

 

With the acquisition, Allergan would take control of Vitae’s two clinical drug candidates, VTP-43742, an oral therapy for psoriasis and other autoimmune disorders, and VTP-38543, a drug candidate for the treatment of atopic dermatitis (eczema).  The former has completed a Phase 2a proof-of-concept trial in patients with moderate to severe psoriasis and Vitae plans to initiate a 16-week Phase 2b trial during the fourth quarter. VTP-38543 is currently in a Phase 2a proof-of-concept trial evaluating treatment in patients with mild to moderate eczema. 

 

I share this with you because it exemplifies the premium that the industry is placing on new, oral psoriasis drugs, even those in mid-stage development.  I’m not in the business of analysis, but it seems to me that Allergan values VTP-43742 at more than our total market capitalization.  As such, we see a tremendous market opportunity with Prurisol and greatly look forward to initiating our Phase 2b trial in patients with moderate to severe psoriasis with emphasis on the Psoriasis Area and Severity Index (PASI). We’ve just advanced substantial start-up payments to vendors towards the trial, an action that we feel will continue to grow shareholder value.

 

I wish to point out that Dr. Bertolino is now introducing Prurisol to large pharmas, most of which are embracing it for the first time.  We believe that the path to a large financial deal is generation of comparably encouraging data in Phase 2b as recently seen in our completed Phase 2a trial.

 

Prurisol, our oral drug in development for treating psoriasis

 

We have completed the Phase 2a trial evaluating multiple dosing levels of Prurisol in mild to moderate psoriasis patients and  the trial successfully met its primary endpoint.  More details on the trial are provided at: http://cellceutix.com/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint/#sthash.s7T0r6y3.DKbIw1B9.dpbs.

 

In our Phase 2b trial, which we anticipate to commence in the fourth quarter, we are increasing the dosing levels of Prurisol to 300mg and 400mg in the treatment arms, compared to the highest dosing of 200mg in the completed study.  Further, we will be treating patients with moderate to severe psoriasis and focus on PASI scoring, in order to provide appropriate data for Phase 3 planning.  It is our belief that the higher dosing levels in patients with more severe psoriasis will deliver an even stronger therapeutic effect, as suggested by data from patients with moderate psoriasis in the 200mg cohort of the completed Phase 2a trial.

 

Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements   involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.