Qualifying Notice - CATENA

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Contact: Bureau of Cardiology Allergy and Neurological Sciences

Therapeutic Products Directorate Health Canada
Finance Building, 2nd Floor
101 Tunney's Pasture Driveway
Address Locator 3106B
OTTAWA, Ontario
K1A 0K9

9427-S2826-21

June 9, 2008 (signed)

[employee's name removed]

President
Carexa Inc.
2536 Ridgeside Lane
OAKVILLE Ontario
L6L 6W3

Notice of Compliance with Conditions - Qualifying Notice

Dear [employee's name removed]:

This Notice of Compliance with conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the New Drug Submission for CATENA (idebenone) tablets, Control Number 117672, for its use in the symptomatic management of patients with Friedreich's Ataxia, qualifies to be considered for authorization under the NOC/c Policy. In keeping with the provisions outlined in the NOC/c Policy, the following additional information is required to complete the assessment:

1.   A letter signed by the Chief Executive Officer, or designated signing authority of Santhera Pharmaceuticals (Switzerland), Ltd., indicating that you agree to have this submission considered under the NOC/c Policy. Please be reminded that in agreeing to accept an NOC under the NOC/c Policy, Santhera Pharmaceuticals (Switzerland), Ltd. consents to the posting of the NOC/c-QN on Health Canada's website.

2.   A draft Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority of Santhera Pharmaceuticals (Switzerland), Ltd. having a form and content satisfactory to Health Canada, as indicated in the Guidance for Industry: Notice of Compliance with Conditions, including commitments to provide the following:

Confirmatory Studies

a.   The results of ongoing Study IONIA protocol SNT-III-002, a six month placebocontrolled study in patients with documented diagnosis of Friedreich's Ataxia. The study should confirm the promising efficacy results of the previous study (NICOSIA), conducted in a similar patient population.

This confirmatory study is expected to evaluate the safety and efficacy of CATENA under the proposed conditions of use in the management of patients with Friedreich's Ataxia.

The results of the on-going confirmatory study will be submitted within a timeframe that is agreed upon between Health Canada and Santhera Pharmaceuticals.

b.   Additional long-term data from ongoing open extension studies or studies completed after filing this NDS, which demonstrate the duration / extent of maintenance of treatment benefit and safety of long-term treatment, should be submitted as they become available.

Post Market Safety Monitoring

c.   Periodic Safety Update Reports - for NOC/c Products(PSUR-Cs) on a semiannual basis until two full years of marketing experience has been gained. Then, PSURs will be submitted once a year for the following two years and thereafter at 3-yearly intervals. PSUR-Cs should be prepared in accordance with ICH Guidelines and should include events reported for CATENA under this NOC/c. PSUR-Cs should be submitted in paper and electronic (bookmarked and searchable) formats.

d.   During treatment of FRDA with CATENA, reports of all serious Adverse Reactions (ARs) that occur in Canada and all serious expected and unexpected ARs that occur outside of Canada, should be forwarded within 15 days to Health Canada. One copy should be provided to the Marketed Health Products Directorate and another copy to the Bureau of Cardiology, Allergy and Neurological Sciences in the Therapeutic Products Directorate in accordance with current regulations and guidelines.

e.   Notification and reporting on specific issues of concern as outlined in Section 6.2.4 of the Guidance for Industry, Notice of Compliance with Conditions.

f.   Additional information to be provided in the draft Letter of Undertaking or other regulatory actions for CATENA from any other drug regulatory authority; and a commitment to provide a revised Product Monograph as new information is made available.

3.   A draft "Dear Healthcare Professional Letter" detailing the issuance of a Notice of Compliance under the NOC/c Policy for CATENA when used in the management of patients with Friedreich's Ataxia.

4.   A draft "Fact Sheet" outlining in lay language the potential risks, benefits, and side effects of CATENA when used in the management of patients with Friedreich's Ataxia.

5.   A draft of the Product Monograph which is consistent with the requirements outlined in Section 5.2.1 of the Guidance for Industry, Notice of Compliance with conditions. Please note that, if applicable, a boxed text must appear on the cover page, at the beginning of each major section of the Product Monograph (Parts I, II and III), disclosing the nature of the authorization granted for CATENA and the need to conduct a confirmatory study.

I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidance and policy on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to Guidance for Industry; Notice of Compliance with Conditions) to the outstanding information within 30 calendar days of the date of this letter.

In order to facilitate and to ensure proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to the Submission and Information Policy Division, Therapeutic Products Directorate, Finance Building, 101 Tunney's Pasture Driveway, Address Locator 0201A1, Tunney's Pasture, Ottawa, Ontario, K1A 0K9.

Submission and Information Policy Division
Therapeutic Products Directorate
Health Canada
Finance Building
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9
Address Locator 0201A1

Yours sincerely,

Original signed by
Supriya Sharma, MD MPH FRCPC
Director General

SS/mr