COMUNICADO DE ATAXIAS EN MOVIMIENTO

VIAJE A TENERIFE

Hola a tod@s:

            Desde Ataxias en Movimiento estamos organizando un viaje a la clínica VINTERSOL en Tenerife para la última semana de agosto y la primera de septiembre.

            La clínica está totalmente adaptada y dispone del equipamiento adecuado necesario para personas con movilidad reducida. Además se pueden alquilar triciclos eléctricos u otros medios de ayuda adicionales para quién quiera o los necesite.

El precio por persona en habitación doble compartida es de 1.000€ e incluye:

·        Pensión completa

·        Dos tratamientos individuales a la semana de ½ hora c/u.

·        Dos tratamientos en grupo diarios de ½ hora c/u.

Para acompañantes y familiares el precio es de unos 690 €.

Al margen de la clínica estamos organizando actividades

complementarias como:

·        Equinoterapia.

·        Piragüismo (precio 70€ 4horas).

Ambas actividades se realizan con el material y monitores

cualificados necesarios individualmente.

            Pensamos que es una excelente forma de hacer rehabilitación a la vez que disfrutamos juntos de dos semanas de vacaciones en la playa. Y para poder organizarlo es necesario que los que estéis interesados, mandarle un e-mail a Ana García a anagarfo@... indicando vuestro estado clínico (si utilizáis muletas, andador, silla…) hasta el día 15 de Junio, ya que esta información es necesaria para la correcta organización de todas las actividades, así como la reserva en la clínica.

            Cuando sepamos con certeza quién viene y tengamos todo organizado, os informaremos más detalladamente. Un saludo, y ánimo!!!!!!!!

Hola a todos,
Estoy buscando testimonios de personas SCA2, pasando por CIRAH de Holguín, sobre
sus experiencias antes y después del tratamiento.

Traiga usted mismo! Stéphane LION
28-05-2009

Bonjour à tous,
Je recherche des témoignages de personnes SCA2, étant passées par le CIRAH d'
Holguin, sur leur vécu avant et après traitement.

Portez vous bien !!! Stéphane LION
28-05-2009

----- Original Message -----

From: Cristina/Juan Carlos

To: Marketing

Cc: Gian Piero Sommaruga (casa) ; Ataxia Pakistan ; Svenska_ataxiforeningen ; FARA AUSTRALASIA ; Internaf ; FA_babelFAmily ; FAPG

Sent: Tuesday, May 19, 2009 7:46 AM

Subject: [FA_babelFAmily] Re: [FAPG] ENG: Santhera Press release - Santhera's US Phase III IONIA Trial in Friedreich's Ataxia Misses Primary Endpoint

 

I fear it may cause more delays, please read this:

 

 

http://www.reuters.com/article/rbssHealthcareNews/idUSLJ17257820090519

 

.../...

"This is a huge blow for the company as the outcome of this trial was the basis for the expected filing of the product in the U.S.," WestLB analyst Simon Mather said.
"Moreover the company is now likely to run out of cash during 2010 with an estimated 60 million Swiss francs ($53.81 million) left," Mather said, adding the produce may be withdrawn in Canada since approval there was conditional on positive data from the U.S. trial.
Friedreich's Ataxia is a rare genetic neuromuscular disease that causes the degeneration of an individual's nerve and muscle tissue and results in a loss of muscle control, uncoordinated movements, muscle wasting and thickening of heart walls. Santhera will not stop any clinical trials which can make a difference to the value of the company, but will consider all other options to preserve its cash position, he said.
But it expects that a continuing late stage study in Europe could provide the necessary data to support an application for approval in the United States and so does not plan a new trial, Schollmeier added. ($1=1.115 Swiss Francs) (Editing by Dan Lalor and Mike Nesbit)
.../...

 

 

Juan Carlos

 

2009/5/19 Marketing <marketing@...>

Does this mean that this could cause an extra delay on approval?

 

Deb UK

Jack 11 FA

Teddy 8 months NT

---

From: Gian Piero Sommaruga (casa) [gippi@...]
Sent: 19 May 2009 07:02
To: Ataxia Pakistan; Svenska_ataxiforeningen; FARA AUSTRALASIA; Internaf; FA_babelFAmily; FAPG
Subject: [FAPG] ENG: Santhera Press release - Santhera's US Phase III IONIA Trial in Friedreich's Ataxia Misses Primary Endpoint

 

    

May 19, 2009: Santhera's US Phase III IONIA Trial in Friedreich's Ataxia Misses Primary Endpoint

·         News release IONIA data

Data from second Phase III study expected in the first half of 2010

 

Santhera Pharmaceuticals (SIX: SANN), a Swiss specialty pharmaceutical company focused on orphan neuromuscular diseases, announced today that its US Phase III clinical trial evaluating Catena® for the treatment of Friedreich's Ataxia missed its primary endpoint as measured by the International Cooperative Ataxia Rating Scale (ICARS). The study also did not show statistical significance on the second neurological endpoint, the Friedreich's Ataxia Rating Scale (FARS). On both endpoints, the active treatment arms showed a consistent improvement over baseline and placebo, as seen in prior studies. However, due to a lower than expected effect size combined with the fact that patients on placebo improved unexpectedly, statistical significance could not be achieved in this study population. The safety results were consistent with published data suggesting that Catena® is safe and well tolerated at doses up to 2250 mg/day.

 

The primary endpoint in the IONIA (Idebenone effects On Neurological ICARS Assessments) study compared the effect at six months of two treatment arms with placebo on the baseline ICARS score. For both treatment arms, patients on Catena® improved on average by 2.4 points on the ICARS scale at six months over baseline. This is about half of the improvement seen in the prior US Phase II study named NICOSIA (NIH Collaboration With Santhera In Ataxia) which was used to design the IONIA study. Patients on Catena®, however, improved by only 1.2 points over placebo, because patients on placebo did not deteriorate to the extent expected from the NICOSIA study or as described in the literature. These phenomena combined to produce an effect size that did not reach statistical significance over the six-month study period.

 

Teleconference

At 15.00 CET / 14.00 UKT / 09.00 EST on May 19, 2009, Santhera's management will discuss the IONIA results at a teleconference. Anyone interested in participating may join using one of the following dial-ins (conference ID: 10747196):

         Germany              0692 222 3479 (local call)

         Switzerland          056 580 00 07 (local call)

         United Kingdom    0871 700 0345 (national call) or +44 1452 555 566 (standard international)

         United States       1866 966 9439 (free call)

The teleconference will be available for playback one hour after the presentation ends.

 

"We are of course tremendously disappointed by the IONIA results reported today," commented Klaus Schollmeier, Chief Executive Officer of Santhera. "The study met neither our expectations, nor those of the patients or the investigators. Everybody involved was highly motivated to demonstrate the drug's efficacy again. The results have not dampened our confidence in the drug's potential in Friedreich's Ataxia. Because of its larger patient population and longer study duration, we expect that the ongoing European Phase III MICONOS study will finally provide the efficacy data necessary to support marketing approval in the US and Europe."

 

The design of the ongoing European Phase III trial named MICONOS (Mitochondrial Protection With Idebenone In Cardiological Or Neurological Outcome Study) is different from the IONIA study reported today. The MICONOS study is a twelve-month trial of 232 predominantly adult patients with three active treatment arms against placebo. Enrollment was completed in December 2008 and results are expected in the first half of 2010. If positive, these results will form the basis of filings for a New Drug Application and a Marketing Authorization Application in the United States and Europe, respectively. As a consequence of the IONIA study results, the application for marketing approval earlier filed in Switzerland will be withdrawn.

 

Sue Perlman, Clinical Professor of Neurology at the University of California, Los Angeles and one of the two IONIA study investigators, comments: "I still strongly support the disease-modifying effect of Catena® in Friedreich's Ataxia. I believe it slows the progression of the neurological and cardiac aspects of this condition over time, and I strongly recommend that patients continue in the open-label extension study arm of the Phase III IONIA trial to enable us to gather as much longer term data as possible."

 

"Patients on drug improved over placebo on the primary endpoint (ICARS) in the IONIA study. This is supported by the second neurological endpoint (FARS) which also showed an improvement of treated patients over patients on placebo. In addition, a prespecified responder analysis of the active arms showed effect levels comparable to the NICOSIA study in which 60% of the treated patients showed a clinically meaningful improvement on ICARS. However, due to a larger than expected placebo response rate, statistical significance could not be achieved in this six month trial," said Thomas Meier, Chief Scientific Officer of Santhera. "Therefore, we are eager to see the additional data from the twelve-month MICONOS study as well as our two open-label extension studies. We remain confident in our development programs with Catena® in Friedreich's Ataxia and other neuromuscular and mitochondrial disorders and look forward to the upcoming data from several ongoing clinical trials."

 

About the IONIA Phase III trial

The IONIA (Idebenone effects On Neurological ICARS Assessments) trial was a double-blind, randomized, placebo-controlled Phase III study of six months duration investigating the efficacy, safety and tolerability of two doses of Catena® compared to placebo. The first dose group was 450 mg/day for patients below 45 kg body weight and a corresponding dose of 900 mg/day for patients above 45 kg body weight. The second dose group was 1350 mg/day for patients below 45 kg of body weight and 2250 mg/day for patients above 45 kg. 70 ambulatory Friedreich's Ataxia patients between the ages of 8 and 17 years were recruited into two clinical centers in the US - the Children's Hospital of Philadelphia and the School of Medicine of the University of California, Los Angeles.

 

The primary endpoint was the change in the International Cooperative Ataxia Rating Scale (ICARS), a neurological scale, where the difference between baseline and end of treatment for each of the dosing groups was compared with the change in the placebo group. The IONIA study also investigated Activities of Daily Living parameters (ADL) as well as additional neurological (FARS) and cardiac outcomes. The study incorporated advice provided by the US Food and Drug Administration under Special Protocol Assessment.

 

About the NICOSIA trial

In the Phase II study conducted in collaboration with the US National Institutes of Health named NICOSIA (NIH Collaboration With Santhera In Ataxia), Catena® showed a positive effect in particular on the ICARS as well as the ADL scales. Data from the NICOSIA study demonstrated the drug's significant potential to improve neurological functions after a six-month treatment [1]. 48 patients were recruited at the NIH into three active dosage arms against placebo.

 

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 North America and Europe. The 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.

 

References

[1] Nicholas Di Prospero et al; (2007) Lancet Neurology; 6: 878-886.

 

* * *

About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the discovery, development and commercialization 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's first product, Catena® to treat Friedreich's Ataxia, is marketed in Canada. Data of the second pivotal Phase III trial in Europe are expected for the first half of 2010. The drug has also shown efficacy in a clinical trial as a potential treatment for Duchenne Muscular Dystrophy. For further information, please visit the Company's Web site www.santhera.com.

 

Catena® is a trademark of Santhera Pharmaceuticals.

 

For further information, contact

Klaus Schollmeier, Chief Executive Officer

Phone: +41 (0)61 906 89 52

klaus.schollmeier@...

 

Thomas Meier, Chief Scientific Officer

Phone: +41 (0)61 906 89 87

thomas.meier@...

 

Barbara Heller, Chief Financial Officer

Phone: +41 (0)61 906 89 54

barbara.heller@...

 

Thomas Staffelbach, Head Public & Investor Relations

Phone: +41 (0)61 906 89 47

thomas.staffelbach@...

 

 

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.

 

 

Source: http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200905&newsid=1316083&newslang=en

 

For the USA yes, it means FDA approval will be delayed until the European
MICONOS trial is completed and used for an approval application with the
FDA. No guarantees the FDA will accept it. Reasonable probability the FDA
will accept the European trial results but no guarantees.

For the European sector (which I assume would include the UK) there is no
impact and no delay on Santhera's plans for approval.

Paul

----- Original Message -----
From: "Marketing" <marketing@...>
Sent: Tuesday, May 19, 2009 4:26 AM



Does this mean that this could cause an extra delay on approval?

Deb UK

Well! Such a morning surprise for many of you! Being a night owl and on the
West Coast I actually saw Gian Piero's Email before I went to bed, so it was
a short night as I listened in on the teleconference at 6am PST. So what
does this mean for the FA community? Here's a few off-the-cuff thoughts and
reflections from the conference call. I am sure many others will be shared
as the day rolls on.

  THE CONFERENCE CALL:
  - In all these comments remember this is a company trying to save face on
an important trial failure and trying to make themselves look as good as
they can to their investors.


  - Santhera danced furiously for their investors to convince them this very
high profile and visible trial failure does not mean their company is going
under. They are now pinning FA Idebenone product hopes on the additional
data to be obtained from the "extension study" in which all U.S. phase III
participants who so choose will be given Idebenone and on the European
double-blind study because it has more participants, includes adult
patients, and is twice as long (1 year). They will use a successful result
from the "extension study" and the European trial as a basis for requesting
FDA approval in the USA.


  - They are spending money at a rate of about $2.5M per month.


  - They expect this to be a 10 month setback in their Catena program.


  - They are still evaluating the trial results to better understand the
why's of the failure.


  - A main reason for the failure is that the control group did not decline
in their progression as much as they anticipated, which narrowed the
difference between the control group and the two Catena-taking groups so
that statistically (again as in Phase II) the results aren't significant
enough.


  - They said the placebo effect may have affected the results.
     * One reason they said that is because the control group did not decline
in performance as much as they thought they would (and compared with Phase
II) and some of the control group actually improved.
     * Another reason they suggested was that the USA FA community (that's
us, FAPG, by the way!) saw this trial as the ultimate "high hope" and it may
have helped the placebo effect.


  - In this limited age trial group (8 - 17), looking into the data,
interestingly the more advanced dosed and control FAers had bigger
difference in ICARS and FARS than the "newly" diagnosed dosed and control
FAers. (Maybe either the newly diagnosed participants did not progress
significantly enough over the six months or the placebo effect was stronger
on them for some reason.)



  - They said they do not expect any short term decisions by Canada on their
provisional approval even though it is based on the approval of Catena by
the FDA approval of the USA Phase III trial which now will not happen at
least until after data is collected from the U.S. "extension study" and the
European phase III.


  - They are pulling back their Switzerland request for provisional approval
because Switzerland was also looking at the USA trial results for that
approval.


  - They said that because the European Phase III, MICONOS, has more
participants, is longer and the age of participants is up to 28 years old
they anticipate a successful outcome, which they will then use for USA,
Canadian and Swiss approval efforts.


  - Q&A:
     * Several people asked financial and trial questions.
     * Ron B. asked for a clarification of their comment that the USA  FA
organizations may have influenced the placebo effect and they quickly
withdrew any implied finger-pointing toward FARA or FAPG [whom they didn't
name by organization but who else is there?? ;-) ]




  PAUL'S REFLECTIONS:
  - Santhera is in deep financial doo-doo right now. A single product
company, and that product just failed to convince Santhera and their
investors, let alone the pessimistic USA FDA, that it does anything
statistically significant to help FA.

  - Why did the trial fail? Probably because
     * They used too few participants. It's like flipping a coin and
expecting half to be heads. If you only flip it 4 times you might get 3 or
even 4 heads. The more times you flip the closer to the half-heads result
you are looking for. The European trial hopefully has enough participants.
     * The trial should have been longer. Because of the relatively (compared
to some other disorders/diseases) slow progression of FA, the wide
differences in progression rates among FAers, and any placebo effects take
time to die out,  the statistics failed. A longer trial (like they are doing
in Europe!) will allow the statistics a better chance to show the modest
help Idebenone provides.
     * It is possible the measuring tools, FARS and ICARS, are not able to
measure precisely enough such a modest efficacy. It may be a bit like using
the bathroom scale to measure an ounce of Idebenone powder. I haven't  heard
any commentary on this but it wouldn't surprise me.
     * It is possible that because of the high visibility and hope of this
trial for our young children there was somehow a placebo effect
transmittedunconsciously to these young and impressionable participants.
Santhera will be looking into this more I guess.

  - Does this mean Idebenone does not work? Not at all! It just means that in
hindsight the trial might have been designed differently to get a more
meaningful result. I like Dr. Perlman's affirmation of Idebenone's
helpfulness, "I still strongly support the disease-modifying effect of
Catena® in Friedreich's Ataxia. I believe it slows the progression of the
neurological and cardiac aspects of this condition over time, and I strongly
recommend that patients continue...".

  - Will Canada rescind their provisional approval? Only the Canadian
government knows.

  - Amy posted the free teleconference recording phone number,
1-866-840-0853, and I encourage every parent to go listen to it so you have
first-hand knowledge about this significant happening.

  Regards,

  Paul

May 19, 2009: Santhera's US Phase III IONIA Trial in Friedreich's Ataxia Misses Primary Endpoint

·         News release IONIA data

Data from second Phase III study expected in the first half of 2010

Santhera Pharmaceuticals (SIX: SANN), a Swiss specialty pharmaceutical company focused on orphan neuromuscular diseases, announced today that its US Phase III clinical trial evaluating Catena® for the treatment of Friedreich's Ataxia missed its primary endpoint as measured by the International Cooperative Ataxia Rating Scale (ICARS). The study also did not show statistical significance on the second neurological endpoint, the Friedreich's Ataxia Rating Scale (FARS). On both endpoints, the active treatment arms showed a consistent improvement over baseline and placebo, as seen in prior studies. However, due to a lower than expected effect size combined with the fact that patients on placebo improved unexpectedly, statistical significance could not be achieved in this study population. The safety results were consistent with published data suggesting that Catena® is safe and well tolerated at doses up to 2250 mg/day.

The primary endpoint in the IONIA (Idebenone effects On Neurological ICARS Assessments) study compared the effect at six months of two treatment arms with placebo on the baseline ICARS score. For both treatment arms, patients on Catena® improved on average by 2.4 points on the ICARS scale at six months over baseline. This is about half of the improvement seen in the prior US Phase II study named NICOSIA (NIH Collaboration With Santhera In Ataxia) which was used to design the IONIA study. Patients on Catena®, however, improved by only 1.2 points over placebo, because patients on placebo did not deteriorate to the extent expected from the NICOSIA study or as described in the literature. These phenomena combined to produce an effect size that did not reach statistical significance over the six-month study period.

Teleconference

At 15.00 CET / 14.00 UKT / 09.00 EST on May 19, 2009, Santhera's management will discuss the IONIA results at a teleconference. Anyone interested in participating may join using one of the following dial-ins (conference ID: 10747196):

         Germany              0692 222 3479 (local call)

         Switzerland          056 580 00 07 (local call)

         United Kingdom    0871 700 0345 (national call) or +44 1452 555 566 (standard international)

         United States       1866 966 9439 (free call)

The teleconference will be available for playback one hour after the presentation ends.

"We are of course tremendously disappointed by the IONIA results reported today," commented Klaus Schollmeier, Chief Executive Officer of Santhera. "The study met neither our expectations, nor those of the patients or the investigators. Everybody involved was highly motivated to demonstrate the drug's efficacy again. The results have not dampened our confidence in the drug's potential in Friedreich's Ataxia. Because of its larger patient population and longer study duration, we expect that the ongoing European Phase III MICONOS study will finally provide the efficacy data necessary to support marketing approval in the US and Europe."

The design of the ongoing European Phase III trial named MICONOS (Mitochondrial Protection With Idebenone In Cardiological Or Neurological Outcome Study) is different from the IONIA study reported today. The MICONOS study is a twelve-month trial of 232 predominantly adult patients with three active treatment arms against placebo. Enrollment was completed in December 2008 and results are expected in the first half of 2010. If positive, these results will form the basis of filings for a New Drug Application and a Marketing Authorization Application in the United States and Europe, respectively. As a consequence of the IONIA study results, the application for marketing approval earlier filed in Switzerland will be withdrawn.

Sue Perlman, Clinical Professor of Neurology at the University of California, Los Angeles and one of the two IONIA study investigators, comments: "I still strongly support the disease-modifying effect of Catena® in Friedreich's Ataxia. I believe it slows the progression of the neurological and cardiac aspects of this condition over time, and I strongly recommend that patients continue in the open-label extension study arm of the Phase III IONIA trial to enable us to gather as much longer term data as possible."

"Patients on drug improved over placebo on the primary endpoint (ICARS) in the IONIA study. This is supported by the second neurological endpoint (FARS) which also showed an improvement of treated patients over patients on placebo. In addition, a prespecified responder analysis of the active arms showed effect levels comparable to the NICOSIA study in which 60% of the treated patients showed a clinically meaningful improvement on ICARS. However, due to a larger than expected placebo response rate, statistical significance could not be achieved in this six month trial," said Thomas Meier, Chief Scientific Officer of Santhera. "Therefore, we are eager to see the additional data from the twelve-month MICONOS study as well as our two open-label extension studies. We remain confident in our development programs with Catena® in Friedreich's Ataxia and other neuromuscular and mitochondrial disorders and look forward to the upcoming data from several ongoing clinical trials."

About the IONIA Phase III trial

The IONIA (Idebenone effects On Neurological ICARS Assessments) trial was a double-blind, randomized, placebo-controlled Phase III study of six months duration investigating the efficacy, safety and tolerability of two doses of Catena® compared to placebo. The first dose group was 450 mg/day for patients below 45 kg body weight and a corresponding dose of 900 mg/day for patients above 45 kg body weight. The second dose group was 1350 mg/day for patients below 45 kg of body weight and 2250 mg/day for patients above 45 kg. 70 ambulatory Friedreich's Ataxia patients between the ages of 8 and 17 years were recruited into two clinical centers in the US - the Children's Hospital of Philadelphia and the School of Medicine of the University of California, Los Angeles.

The primary endpoint was the change in the International Cooperative Ataxia Rating Scale (ICARS), a neurological scale, where the difference between baseline and end of treatment for each of the dosing groups was compared with the change in the placebo group. The IONIA study also investigated Activities of Daily Living parameters (ADL) as well as additional neurological (FARS) and cardiac outcomes. The study incorporated advice provided by the US Food and Drug Administration under Special Protocol Assessment.

About the NICOSIA trial

In the Phase II study conducted in collaboration with the US National Institutes of Health named NICOSIA (NIH Collaboration With Santhera In Ataxia), Catena® showed a positive effect in particular on the ICARS as well as the ADL scales. Data from the NICOSIA study demonstrated the drug's significant potential to improve neurological functions after a six-month treatment [1]. 48 patients were recruited at the NIH into three active dosage arms against placebo.

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 North America and Europe. The 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.

References

[1] Nicholas Di Prospero et al; (2007) Lancet Neurology; 6: 878-886.

* * *

About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the discovery, development and commercialization 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's first product, Catena® to treat Friedreich's Ataxia, is marketed in Canada. Data of the second pivotal Phase III trial in Europe are expected for the first half of 2010. The drug has also shown efficacy in a clinical trial as a potential treatment for Duchenne Muscular Dystrophy. For further information, please visit the Company's Web site www.santhera.com.

Catena® is a trademark of Santhera Pharmaceuticals.

For further information, contact

Klaus Schollmeier, Chief Executive Officer

Phone: +41 (0)61 906 89 52

klaus.schollmeier@...

Thomas Meier, Chief Scientific Officer

Phone: +41 (0)61 906 89 87

thomas.meier@...

Barbara Heller, Chief Financial Officer

Phone: +41 (0)61 906 89 54

barbara.heller@...

Thomas Staffelbach, Head Public & Investor Relations

Phone: +41 (0)61 906 89 47

thomas.staffelbach@...

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.

Source: http://www.santhera.com/index.php?docid=212&vid=&lang=en&newsdate=200905&newsid=1316083&newslang=en