Intec Pharma is pleased to report the intermediate results of the Phase IIb clinical trial for the second group (out of 3) of advanced Parkinson's disease patients, with the Accordion-Pill-Levodopa product.

An analysis of the results showed that the administration of the Levodopa drug with the Accordion-Pill significantly improved its efficacy.
This improvement was even more substantial than the improvement achieved in the first group of Phase IIb clinical trial. In addition, the administration of the drug with the Accordion-Pill enabled a significant reduction in the number of Levodopa doses per day in comparison to the currently marketed Levodopa products.

The clinical trial was conducted in six medical centers: Sourasky Tel-Aviv Medical Center (Ichilov), Rabin Medical Center (Beilinson), Sheba Medical Center (Tel Hashomer), Rambam Medical Center in Haifa, The Hadassah University Medical Center and Brazilai Medical center. 17 advanced Parkinson's disease patients participated in this study. The patients were treated with the Accordion-Pill-Carbidopa/Levodopa (AP-CD/LD) product for a period of three weeks, and then crossed over (randomized) for a second three week period in which they were treated with their personal currently marketed Carbidopa/Levodopa treatment regimen.  The efficacy of the AP-CD/LD product was tested, in comparison to the current treatment regimen, during 24-hour periods. The primary end-point of the trial was the reduction of Total OFF Time compared to the current treatment regimen. In addition, the safety of the AP-CD/LD was also tested.

The following is an analysis of the main intermediate results as received by the Company prior to this publication:

In 16 patients who completed the study in accordance with the study protocol, a statistically significant decrease in Total Off Time of 1.9 hours (44%) was achieved. With the AP-CD/LD treatment, the Total OFF Time was 2.4 hours compared to 4.3 hours with the current treatment regimen. This result was of statistical significance (P<0.0001). Total Good On Time was increased by 2.1 hours, with the AP-CD/LD treatment (P=0.0001). In addition, a significant reduction (of statistical significance), in the total number of Levodopa daily doses from 6.3 to 3.4 was achieved.

In 12 of these 16 patients (75%), an average reduction of 2.9 hours (55%) of Total OFF Time, over 24-hour period, was achieved. With the AP-CD/LD treatment, Total  Off Time was 2.3 hours compared to 5.2 hours with the current treatment regimen  (P<0.0001). Total Good On Time was increased by 2.8 hours, with the AP-CD/LD treatment (P<0.0001).

With respect to the AP-CD/LD safety, the product once again proved its good safety profile and no significant adverse effects were reported during the study.

The rate of the reduction of Total Off Time, achieved in this group, was twice the rate achieved in the first group of Phase IIb (a reduction of 2.9 hours in comparison to 1.5 hours). The improvement resulted from the extension of the use of the AP-CD/LD from one week to three weeks, which indicates the potential of the AP-CD/LD to dramatically improve the efficacy of the drug following a long term use.

To the Company`s best knowledge, the aforesaid intermediate results are unprecedented, in comparison to the oral Levodopa products which are marketed today. The Company has developed three different strengths of the AP-CD/LD, two of which have been tested so far. The third strength is being tested in the third and last group of Phase IIb, whose results are expected to be published during the fourth quarter of this year.

According to Dr. Peter LeWitt, a Key Opinion Leader for Parkinson Disease, Director of the Parkinson’s disease and Movement Disorders Program at Henry Ford Hospital, Detroit, Michigan USA and the Company's clinical advisor, "These clinical results are consistent with pharmacokinetic evidence that the AP-CD/LD formulation extends anti-Parkinsonian effect of Levodopa in patients with wearing-off. The extent of improvement in “OFF” time (without an increase of troublesome dyskinesias) obtained in this study, indicates a substantial clinically-meaningful effect, with considerable promise for helping a common problem for the advanced Parkinson’s disease patient".

According to the business model of the Company, in the event that the clinical trials shall conclude successfully, the results shall serve as a basis for dialogs on potential collaborations with global pharmaceutical companies. The Company estimates that, should the product be approved for marketing, it shall reach peak annual sales of US$ 800 Million.

The Company estimates that the highly statistically significant results achieved so far shall improve the chances of success in the next phases and may have significant positive implications on the scope, cost and duration of the Phase III clinical trial.

Parkinson's disease
Parkinson's disease is a degenerative disease of the central nervous system, characterized by motor disorders, such as slowed and reduced mobility, involuntary tremors, muscle stiffness, balance disturbances and instability. At the late stages of the disease the patient experiences an overall functional limitation. According to Datamonitor, in 2007 there were approximately 1.45 Million Parkinson's disease patients in the USA, Japan and the 5 major European countries. The drug market for Parkinson's disease in these markets was estimated at approximately US$ 2.2 Billion in 2009 and is estimated to reach US$ 2.9 Billion by 2013.

The disease is caused by an ongoing loss of the brain's ability to produce Dopamine, which is required for normal brain functionality. The most efficient drug for treatment of the Parkinson's symptoms is Levodopa. When the Levodopa reaches the brain, it transforms into Dopamine, whose deficiency causes the disease. Nonetheless, the use of Levodopa is associated with severe motor complications and a need for frequent doses throughout the day, due to significant fluctuations of the drug plasma levels.

The need to develop a formulation which will significantly reduce motor complications associated with Levadopa treatment and daily dosing frequency remained unanswered for decades.
Accordion-Pill-Cabidopa/Levodopa (AP-CD/LD)
AP-CD/LD is a designated oral delivery platform developed by Intec Pharma Ltd. which contains Carbidopa and Levodopa in different doses, for the treatment of the various stages of the disease. The AP-CD/LD is designed to stabilize Levodopa plasma levels and thereby bring about, for the first time, a dramatic reduction in motor complications and reduce the frequency of daily dosing, using oral treatment.

The Company's estimations for future development, expected clinical trials and sales forecasts, with respect to the Company's products, is forward looking information that is based on information in the Company's hands today with respect to drugs development potential and the indications it has received from relevant health care authorities. These estimates may not be realized, in whole or in part, and/or may be realized differently than estimated, as a result of different factors, including failure to reach the objectives of the studies and/or schedules and/or necessary funding for further drug development and failure to obtain regulatory approvals required for further development, failure to reach collaboration with international companies and other factors which are not within the Company's control and the materialization of any of the risk factors that relate to the Company's activities.

Sincerely,

Intec Pharma Ltd.