Published: 07:00 24.07.2008 GMT+2 /HUGIN /Source: Santhera
Pharmaceuticals Holding AG /SWX: SANN /ISIN: CH0027148649
July 24, 2008: Santhera Receives First Product Approval: Health Canada
Approves Catena® for Treatment of Friedreich's Ataxia
Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical
company focused on neuromuscular diseases, announced today that Health
Canada has approved with conditions SNT-MC17/idebenone for the treatment
of Friedreich's Ataxia. Health Canada's decision is the first marketing
authorization worldwide for any Friedreich's Ataxia therapy. The new
drug will be marketed in Canada under the brand name Catena®. Santhera
has established a wholly owned Canadian subsidiary, Santhera
Pharmaceuticals (Canada), Inc. recently incorporated in Montréal,
Quebec, to address the needs of Canada's several hundred patients with
this rare and severely progressive muscle disease. Launch of Catena is
anticipated for the end of October 2008.
In clinical studies submitted to Health Canada as part of the approval
process, Catena showed statistically and clinically relevant
improvements in Friedreich's Ataxia patients, as measured by Activities
of Daily Living scores as well as cardiac and neurological functions.
The approved product labeling allows for the treatment of symptoms of
Friedreich's Ataxia. Two doses are approved: a starting dose of
450 mg/day for patients below 45 kg body weight and 900 mg/day for
patients above 45 kg body weight whereby treating physicians have an
option to dose up to 1,350 mg/day for patients below 45 kg body weight
and up to 2,250 mg/day for patients of more than 45 kg body weight if
needed. Under the conditions of the Notice of Compliance with
Conditions, Santhera has agreed to submit additional data from its
ongoing phase III clinical trial in the United States to confirm the
efficacy of the therapy.
Klaus Schollmeier, Chief Executive Officer of Santhera said: "We are
very pleased about this market authorization by the Canadian authority.
Health Canada concluded that the data presented were promising enough to
allow Catena's approval for the benefit of patients now while requiring
confirmatory efficacy data when they become available. Today's approval
is a major milestone for the Friedreich's Ataxia community in Canada and
elsewhere. For the first time, physicians will be able to offer patients
an approved, safe and efficacious therapy to treat their devastating
disease." He continued: "This first marketing authorization marks a
significant event for our Company, one that has been our goal since the
inception of Santhera in 2004. Today, Santhera's vision of offering
therapies for orphan indications is becoming reality. The entire team at
Santhera is energized by this success and is even further encouraged to
work towards approvals in other regions."
MJ Roach, VP Marketing & Sales and Santhera's General Manager for North
America, commented: "Canada's marketing authorization provides an
excellent foundation to establish a medical and marketing platform in
North America for the treatment of rare neuromuscular diseases in
general and for Friedreich's Ataxia in particular. The Canadian market
will also provide valuable insights for launching the product in the
United States, once the ongoing clinical trial is completed and the
product is approved. We look forward to working with physicians in
Canada who prescribe Catena to Friedreich's Ataxia patients."
Update on ongoing phase III clinical trial
In the United States, the IONIA (Idebenone effects On Neurological ICARS
Assessments) phase III trial has currently enrolled 41 patients. It was
agreed with the US Food and Drug Administration under a Special Protocol
Assessment process to recruit a minimum of 51 patients but to include
more patients if available. Given the current prospects for patient
availability, Santhera and its US clinical investigators believe that
the final study will include about 60 to 65 patients.
Conference call
At 19.00 CET / 18.00 UKT / 13.00 EST on July 24, 2008, Santhera will
host a conference call. Anyone interested in participating may join the
teleconference facility using the following dial-in in Switzerland
+41 52 267 07 36. The conference call will be recorded for playback and
is available one hour after the conference call ends and for 20 days
under +41 52 267 07 00 (reference no. 668713).
About Friedreich's Ataxia
Friedreich's Ataxia is a rare but severe genetic neuromuscular disorder
that results in the degeneration of an individual's nerve and muscle
tissue. This disorder causes loss of muscle control, uncoordinated
movements, muscle wasting and thickening of heart walls which frequently
leads to a shortened life span. Friedreich's Ataxia affects both
Caucasian males and females equally and it is estimated that about
20,000 patients suffer from the disease in both North America and
Europe. Average life expectancy for Friedreich's Ataxia patients is
limited to approximately 35 to 50 years.
The disorder results from a genetic defect in the gene encoding for
frataxin. Reduced levels of this protein ultimately result in impaired
energy production in mitochondria, the cells' energy production centers,
and elevated oxidative stress. Tissues that have the highest need for
energy, in particular nerve and cardiac tissues, are primarily affected
by frataxin deficiency resulting in pathological changes in heart muscle
anatomy and function and loss of nerve cells.
About Catena®
Catena may be useful in the symptomatic management of patients with
Friedreich's Ataxia. The drug is believed to increase the supply of
energy to cells in the body. Additionally it has antioxidant properties
and may protect the cells in the body which are damaged by the disease.
Catena® is a trademark of Santhera Pharmaceuticals, registered in Canada
and the United States.
About Notice of Compliance with Conditions
A Notice of Compliance with Conditions (NOC/c) is an authorization to
market a drug in Canada issued by Health Canada, indicating that the
sponsor has agreed to undertake additional studies to confirm the
clinical benefit of the product. A market authorization under the NOC/c
policy allows Health Canada to provide earlier market access to
potentially life-saving drugs. Eligibility for an NOC/c is restricted to
promising new drug therapies intended for the treatment, prevention or
diagnosis of serious, life-threatening or severely debilitating diseases
or conditions for which a) there is no alternative therapy available on
the Canadian market or, b) where the new product represents a
significant improvement in the benefit/risk profile over existing
products. Once a sponsor provides satisfactory evidence of the drug's
clinical effectiveness, and all the conditions agreed upon have been
met, Health Canada will remove the conditions associated with market
authorization in favor of a full approval.
* * *
About Santhera
Santhera Pharmaceuticals (SWX:SANN) is a Swiss specialty pharmaceutical
company focused on the discovery, development and marketing of
small-molecule pharmaceutical products for the treatment of severe
neuromuscular diseases, an area of high unmet medical need which
includes many orphan indications with no current therapy. Santhera
currently investigates three compounds in five clinical-stage
development programs. The Company's first product, SNT-MC17 (INN:
idebenone) has received a marketing approval with conditions from Health
Canada to treat Friedreich's Ataxia and will be marketed under its brand
name Catena. The product is also under review by health authorities in
the EU and in Switzerland for the same indication, while in the United
States a pivotal phase III trial is recruiting patients.
SNT-MC17/idebenone has also shown efficacy in a phase II clinical trial
as a potential treatment for the indication Duchenne Muscular Dystrophy.
For further information, please visit www.santhera.com.
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52
klaus.schollmeier@santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.com
Disclaimer/Forward-looking statements
This communication does not constitute an offer or invitation to
subscribe for or purchase any securities of Santhera Pharmaceuticals
Holding AG. This publication may contain certain forward-looking
statements concerning the company and its business. Such statements
involve certain risks, uncertainties and other factors which could cause
the actual results, financial condition, performance or achievements of
the company to be materially different from those expressed or implied
by such statements. Readers should therefore not place undue reliance on
these statements, particularly not in connection with any contract or
investment decision. The company disclaims any obligation to update
these forward-looking statements.
News release Approval Canada
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Therapy passions, simple but overwhelmingly strong, have governed my life: the longing for love, the search for knowledge, and unbearable pity for the suffering of mankind.
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