Speedel Holding Ltd (SWX: SPPN) announced that it be overjoyed
via the FDA esteem of a second goods contain SPP100 (aliskiren)
inside the USA all for the conduct of hypertension. The approval
be announced by Novartis who is liable for commercialisation of this
most primordial in genus aim renin inhibitor.
Tekturna HCT 1 (aliskiren and hydrochlorothiazide) have be voted
for by the US Food and Drug Administration in fit of a
single-tablet capacity of two soaring blood coercion medicine -
Tekturna 2 (aliskiren), the first brand new type of high blood
pressure tablets in higher than a decade, and the diuretic
hydrochlorothiazide (HCT)3.
This is the first regulatory approval of a single-tablet
combination analysis involving Tekturna, set as Rasilez 4
uncovered the US, which has been shown to equivalently degrade
blood
pressure for 24 hours and beyond5.6 HCT, sometimes call a
"water pill", is one of the supreme commonly-used high blood pressure
medicines7.
Dr Chris Jensen, Head of Scientific Affairs, aside: "Hypertension
is frozen a imperfectly glut bug in spite of popular therapy.
This combination of a new mode of motion such as the first direct
renin inhibitor effective a standard diuretic should confer a
carrying great weight new treatment preference for patients and
mortgage their agreement." Alice Huxley, CEO, stated: "This
approval is an influential tread send for the rapidly increasing
approval of aliskiren in the open market. One third of
antihypertensive prescription in the US be documentary for HCT as
a combination or as monotherapy. This is the second approved
product containing our cranium merged SPP100 and we foresee more
combination products to be modern." The two medicines here
single-tablet combination diligence both in divergent ways to
lower blood pressure, with clinical notes showing that the
combination of Tekturna and HCT submit greater blood pressure
reduction than any element alone8.
Single-tablet combination such as Tekturna HCT run a broad
outlook high blood pressure admin by reducing the numeral of
pills society take daily9.Tekturna HCT is approved for patients
not controlled by either medicine alone10.
The US approval of Tekturna HCT was substructure by the sideways
of clinical trial involving more than 2,700 patients treated with
Tekturna and HCT11.
Speedel in-licensed SPP100 from Novartis in 1999 and delightedly
completed 18 clinical trials, through Phase I and II in almost
500 patients and well volunteers. Among them, Speedel conduct the
first glorious pilot clinical tribunal with the combination of
aliskiren and HCT. Based on the grades generate during this
schema, Novartis exercise a license-back option in 2002.
Regulatory approval of Tekurna, known as Rasilez outside the US,
was given by the US FDA in March 2007 and by the EU in August
2007.
Speedel subsequent equals renin inhibitors With three new renin
inhibitors in clinical development, Speedel continue to assemble
its ripened pipeline by leveraging its adroitness and quality in
renin inhibition. This inventive mode of action has been validate
by the 2007 approval of SPP100 (Tekturna/Rasilez) in the US, EU
and Switzerland where on earth it is market by Novartis in these
market. Both Speedel and Novartis lately win the Wall Street
Journal Gold Award for Technology Innovation, which was given to
the agreed scheme for their work in unearth and sprouting SPP100
as an ahead of its time therapy for hypertension. Speedel is
developing a people of next generation direct renin inhibitors,
and in for a moment has three compound in the clinic: SPP635 in
Phase IIa, SPP676 in Phase I and SPP1148 in Phase I.
Growing worldwide gusto menace of high blood pressure The Lancet
published an editorial on 17 August 2007 which stated: "The risk
of becoming hypertensive during lifetime exceed a staggering 90%
for a creature in a developed pastoral." The editorial also
observed that: "The gradually common combination and relationship
of flabbiness, diabetes, hyperlipidaemia
and high blood pressure, if departed raw for as powerfully drawn
out, lead to cardiovascular disease, embrace, renal bomb,
dementia, and ultimately leave-taking. Worldwide, the ballpark
numeral of adults with hypertension was 972 million in 2000; 639
million dwell in developing country. By 2025, the sated number is
scheduled to mushroom to 1.56 billion." 12 About SPP100
(aliskiren, Tekturna/Rasilez13) SPP100 (aliskiren,
Tekturna/Rasilez) is the first-in-class oral direct renin
inhibitor. The development of SPP100 is the arise of completed 20
years of research on renin. Renin is the rate-limiting enzyme at
the high point of the Renin Angiotensin System (RAS), one of the
manhandle toggle regulator of blood pressure. The RAS is a burst,
starting with renin, influential to angiotensin I and before i go
to angiotensin II. Angiotensin-converting enzyme inhibitors
(ACE-Is) and angiotensin II receptor antagonists (ARBs) savour
been developed to standing traffic this policy "down stream" and
have shown clinical efficacy in patients with hypertension and
other cardiovascular disease.
v Visceral leishmaniasis (VL), also agreed as kala azar , is the
dominant sombre form of the microbe, which, if untainted, have a
mortality rate of almost 100%. It is characterized by unusual
bout of pig`s ear, indiscriminate counterbalance annihilation,
tightness of the spleen and liver, and anaemia.
Direct renin inhibitors lower PRA whereas most current leading
anti-hypertensive drug classes such as ACE-Is and ARBs increase
PRA level.
Speedel consider that it is the first company to create
successfully a clinical confirmation of generalization in Phase
II and to have developed and profile for chief document
protection a commercially viable buying preparation for a renin
inhibitor, an interest of industry research for over 20 years. In
a Phase II research of 200 patients conducted by Speedel, it was
demonstrated that SPP100 get done dose-dependent blood pressure
moderation. The study also show that 150mg and 300mg SPP100 once
afternoon by day be comparable to Losartan 100mg, which is double
the intermediate starting dose of this ARB (Stanton, Jensen,
Nussberger, O'Brien, Hypertension.2003; 42: 1137-1143).
About Speedel Speedel is a nonspecific population
biopharmaceutical company that seek to discover effectiveness for
patients, partner and depositor by developing innovative
therapies for cardiovascular and metabolic diseases.
Speedel is a world ringleader in renin inhibition, a promising
new mind-set with significant approaching for treat
cardiovascular diseases. Our lead compound SPP100
(Tekturna/Rasilez14 ), the first-in-class direct 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 by the EMEA in the EU in August 2007. Our
pipeline wrapper three opposing mode of action, and also as to
SPP100, include SPP301 in Phase II, SPP200 in Phase II, SPP635 in
Phase Il, SPP1148 and SPP676 in Phase I and several pre-clinical
project.
Speedel develop novel product nominee through assured freshness
and stylish drug development from lead christening to the secure
of Phase II. We either partner with hulking great pharma for
Phase III and commercialisation in primary-care indication, or we
may ourselves do Phase III development in connoisseur
indications. Candidate compounds for development and the
company's learner chattels come from our late-stage research
wedge Speedel Experimenta and from in-licensing. Our squad of
generally 80 team, with over 30 veteran pharmaceutical
scientists, is positioned at our headquarters and laboratories in
Basel, Switzerland and at office in New Jersey, USA and Tokyo,
Japan.
In January 2007 the company make higher gross proceeds of CHF
55.5 million (approximately EUR 34.3 million or USD 44.5 million)
through a convertible union aspect. 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 reserves
allotment. Previously, as a sheltered company, we raised gross
proceeds of CHF 255 million (approximately EUR 157 million or USD
204 million) from private placement of equity securities and two
convertible loan including the rendition premium. We have have
total revenues, principally from milestone payments, of CHF 57.7
million (approximately EUR 37 million or USD 44 million). The
company's shares were downstairs in September 2005 on the SWX
Swiss Exchange beneath the crest SPPN.
Forward appearance confirmation This wring giving out includes
forward-looking statements that call for great risks and
uncertainties. These forward-looking statements are based on our
current expectations and overhang about projected measures. All
statements, bar statements of historical facts, on the speciality
of our strategy, future operation, future trade and industry
duty, future revenues, projected costs, prospects, strategy and
objectives of management are forward-looking statements. The
synonym "may" and impossible to tell apart expressions are in
beyond a shadow of a disbelief to identify forward-looking
statements, although not all forward-looking statements cover
these identify libretto. We may not in fact achieve the plans,
intention or expectations describe in these forward-looking
statements and you should not place undue assumption on them.
There can be no self-possession that actual results of our
research and development goings-on and our results of operations
will not fluctuate materially from these expectations. Factors
that could convey actual results to differ from expectations
consist of, among others: our or our partners' skill to tumble
into place safe and efficacious products; our or our partners'
ability to achieve favourable results in clinical trials; our or
our partners' ability to get your paw on marketing approval and
market acceptance for our product candidates; our ability to
enter into future assistance and license agreements; the impact
of bout and powered transaction; current and future regulations
affecting our commercial; change in governmental slip of
pharmaceutical product development; the future range of our
patent coverage or that of third party; the effects of any future
litigation; general monetary and business provisos, both
worldwide and within our industry, including exchange rate
instability; and our future fund plans.
References: 1 Tekturna HCT is a Novartis trademark 2
Tekturna/Rasilez are Novartis trademark 3 Tekturna HCT US
Prescribing Information 4 Tekturna/Rasilez are Novartis
trademarks 5 Oh BH, Mitchell J, Herron JR, et al. Aliskiren, an
oral renin inhibitor, provide dose-dependent efficacy and
uninterrupted 24-hour blood pressure adjust in patients with
hypertension. J Am Coll Cardiol 2007;49:1157-1163.
6 Sica D, Gradman AH, Lederballe O, et al. Aliskiren, a novel
renin inhibitor, is well put up with and has sustained
BP-lowering effects alone or in combination with HCTZ during
long-term (52 weeks) treatment of hypertension. Eur Heart J
2006;27(Suppl):121 P-797 7 Chobanian AV, Bakris GL, Black HR et
al. and the National High Blood Pressure Education Program
Coordinating Committee. The seventh fairy-tale of the Joint
National Committee on blocking, recollection, evaluation, and
treatment of high blood pressure. Hypertension 2003; 42:1206-1252
8 Villamil A, et al. Renin inhibition with aliskiren provides
chemical addition antihypertensive efficacy when nearly new in
combination with hydrochlorothiazide. Journal of Hypertension
2007, 25: 217-226 9 Boolell M, Glasspool J. Cardiovascular
Disease Health
Burden, Treatment Benefits and Challenges: Need for Partnership.
Health & Productivity Management Vol 5, No 4 December 2006, p
11-14.
10 Tekturna HCT US Prescribing Information 11 Tekturna HCT US
Prescribing Information 12 The Lancet: 2007; 370:539 13
Tekturna/Rasilez are Novartis trademarks 14 Tekturna/Rasilez are
Novartis trademarks Speedel Holding Ltd
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