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- FIRST IN CLASS RENIN INHIBITOR TO TREAT HYPERTENSION -
- VALIDATION OF SPEEDEL'S LEADERSHIP IN RENIN INHIBITION -
Basel/Switzerland and Bridgewater NJ/USA, 06 March 2007
Speedel (SWX: SPPN) welcomes today's announcement by Novartis
that
the US Food and Drug Administration (FDA) has approved
SPP100
(aliskiren, Tekturna[1]) to treat hypertension both as
monotherapy
and in combination with other anti-hypertensives. The approval
was
based on data from more than 6,400 patients with high blood
pressure
in numerous clinical trials. SPP100 is the first-in-class once
daily
oral direct renin inhibitor that Speedel successfully
developed
through Phase I and II clinical trials before Novartis exercised
its
license-back option in 2002.
Dr. Alice Huxley, CEO, commented: "We are delighted that SPP100
has
been approved in the US as the first in a new class of medicines
for
high blood pressure in over a decade. This is a wonderful example
of
a win-win partnership between big pharma and small biotech, and we
are confident that Novartis will ensure the market success of
Tekturna given the drug's profile and Novartis' position as the
global leader in cardiovascular therapies."
Dr. Huxley continued: "This approval validates Speedel's
long
standing commitment to renin inhibition as the potential
gold
standard therapy for treatment of hypertension and other
related
disorders. Hypertension is a leading cause of cardiovascular
disease,
the world's No. 1 killer. Speedel remains at the forefront
of
research and clinical development of next generation renin
inhibitors
with SPP635 in Phase IIa and SPP1148 in Phase I."
In clinical trials, SPP100 produced double-digit reductions in
blood
pressure sustained for a full 24 hours, reaching its maximum
lowering
effect within 2 weeks. It was generally well tolerated at
the
approved doses of 150mg and 300 mg once daily.
Clinical trials have also shown that SPP100 further reduced
blood
pressure when used in combination with many common high
blood
pressure therapies, including angiotensin converting
enzyme
inhibitors (ACE inhibitors), angiotensin receptor blockers
(ARBs),
calcium channel blockers (CCBs) or the diuretic
hydrochlorothiazide
(HCTZ).
Novartis is also conducting a large outcome trial programme to
evaluate the potential long-term effects of SPP100 and direct
renin
inhibition beyond high blood pressure.
In September 2006, SPP100 was also submitted by Novartis to the
European Medicines Agency (EMEA) for review in the European Union.
The proposed brand name for SPP100 outside the US is Rasilez[1].
Speedel believes that SPP100 has a five year lead over the next
generation of renin inhibitors being developed in the industry.
Speedel's own family of renin inhibitors includes SPP635 currently
in
Phase IIa with results due in the second half of 2007, followed by
SPP1148 which started Phase I in Q12007, and the SPP800 series
currently in late-stage pre-clinical profiling.
About SPP100 (aliskiren, Tekturna)
SPP100 (aliskiren, Tekturna) is the first-in-class oral
renin
inhibitor. The development of SPP100 is the result of over 20
years
of research on renin. Renin is the key enzyme at the top of the
Renin
Angiotensin System (RAS), one of the key regulators of
blood
pressure. The RAS is a cascade, starting with renin, leading
to
angiotensin I and finally to angiotensin II. Angiotensin-
converting
enzyme inhibitors (ACE-Is) and angiotensin II receptor
antagonists
(ARBs) have been developed to block this system "down stream"
and
have shown clinical efficacy in patients with hypertension and
other
cardiovascular diseases.
By inhibiting renin at the top of the RAS, SPP100 decreases
the
system's activity, as measured by Plasma Renin Activity. PRA
is
believed to be very important in end-organ protection (e.g. heart
and
kidney). PRA is an independent and direct surrogate marker
for
several cardio-renal diseases, such as myocardial infarction
and
chronic renal disease. Renin inhibitors lower PRA whereas
most
current leading anti-hypertensive drug classes such as ACE-Is
and
ARBs increase PRA levels.
Speedel in-licensed SPP100 from Novartis in 1999 and
successfully
completed 18 clinical trials, through Phase I and II in about
500
patients and healthy volunteers. Based on the results
generated
during this programme, Novartis exercised a license-back option
in
2002, and in March 2004 Novartis started trials with SPP100 in
Phase
III as monotherapy for hypertension and in Phase IIb as
combination
therapy. Regulatory approval was given by the US FDA in March
2007
and a regulatory submission was made by Novartis in the EU during
Q3
2006.
Speedel believes that it is the first company to
establish
successfully a clinical proof of concept in Phase II and to
have
developed and filed for patent protection a commercially
viable
manufacturing process for a renin inhibitor, an area of
industry
research for over 20 years. In a Phase II study of 200
patients
conducted by Speedel, it was demonstrated that SPP100
achieves
dose-dependent blood pressure reduction. The study also showed
that
150mg and 300mg SPP100 once daily were comparable to Losartan
100mg,
which is double the starting dose of this ARB (Stanton,
Jensen,
Nussberger, O'Brien, Hypertension.2003; 42: 1137-1143).
About Speedel
Speedel is a public biopharmaceutical company that seeks to create
value for patients, partners and investors by developing
innovative
therapies for cardiovascular and metabolic diseases. Speedel is a
world leader in renin inhibition, a promising new approach with
significant potential for treating cardiovascular diseases. Our
lead
compound SPP100 (aliskiren, Tekturna[1]), the first-in-class renin
inhibitor, was in-licensed from Novartis in 1999 and licensed-back
to
Novartis Pharma in 2002 for further development and
commercialisation; SPP100 was approved by the FDA in the US in
March
2007, and filed by Novartis with the EMEA in the EU in Q3 2006.
Our
pipeline covers three different modes of action, and in addition
to
SPP100, includes SPP301 in Phase III (on hold), SPP200 in Phase
II,
SPP635 in Phase Il, SPP1148 in Phase I and several pre-clinical
projects.
Speedel develops novel product candidates through focused
innovation
and smart drug development from lead identification to the end of
Phase II. We either partner with big pharma for Phase III and
commercialisation in primary-care indications, or we may ourselves
complete Phase III development in specialist indications.
Candidate
compounds for development and the company's intellectual property
come from our late-stage research unit Speedel Experimenta and
from
in-licensing. Our team of approximately 70 employees, including
over
30 experienced pharmaceutical scientists, is located at our
headquarters and laboratories in Basel, Switzerland and at offices
in
New Jersey, USA and Tokyo, Japan.
In January 2007 the company raised gross proceeds of CHF 55.5
million
(approximately EUR 34.3 million or USD 44.5 million) through a
convertible bond issue. In March 2006 the company raised gross
proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m)
through the public offering of 500,000 treasury shares.
Previously,
as a private company, we raised gross proceeds of CHF 239 million
(approximately EUR 154 million or USD 183 million) from private
placements of equity securities and two convertible loans and we
have
had total revenues, principally from milestone payments, of CHF
57.7
million (approximately EUR 37 million or USD 44 million). The
company's shares were listed in September 2005 on the SWX Swiss
Exchange under the symbol SPPN.
Forward looking statements
This press release includes forward-looking statements that
involve
substantial risks and uncertainties. These forward-looking
statements
are based on our current expectations and projections about future
events. All statements, other than statements of historical facts,
regarding our strategy, future operations, future financial
position,
future revenues, projected costs, prospects, plans and objectives
of
management are forward-looking statements. The word "may" and
similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying
words. We may not actually achieve the plans, intentions or
expectations described in these forward-looking statements and you
should not place undue reliance on them. There can be no assurance
that actual results of our research and development activities and
our results of operations will not differ materially from these
expectations. Factors that could cause actual results to differ
from
expectations include, among others: our or our partners' ability
to
develop safe and efficacious products; our or our partners'
ability
to achieve positive results in clinical trials; our or our
partners'
ability to obtain marketing approval and market acceptance for our
product candidates; our ability to enter into future collaboration
and licensing agreements; the impact of competition and
technological
change; existing and future regulations affecting our business;
changes in governmental oversight of pharmaceutical product
development; the future scope of our patent coverage or that of
third
parties; the effects of any future litigation; general economic
and
business conditions, both internationally and within our industry,
including exchange rate variations; and our future financing
plans.
Ends
Nick Miles
Director Communications & Investor Relations
Speedel
Hirschgässlein 11
CH - 4051 Basel
Switzerland
T +41 (0) 61 206 40 00
D +41 (0) 61 206 40 14
F +41 (0) 61 206 40 01
M +41 (0) 79 446 25 21
E nick.miles@speedel.comwww.speedel.com
Frank LaSaracina
Managing Director
Speedel Pharmaceuticals Inc
1661 Route 22 West
P.O. Box 6532
Bridgewater, NJ 08807
United States of America
T +1 732 537 2290
F +1 732 537 2292
M +1 908 338 0501
E frank.lasaracina@speedel.comwww.speedel.com