- SPP100 (Aliskiren) on Track for US Regulatory Submission in Early 2006 -
BASEL, Switzerland and BRIDGEWATER, N.J., Sept. 20 /PRNewswire-FirstCall/
-- Speedel Holding Ltd (SWX: SPPN) is very pleased with the positive Phase III
clinical results in hypertension released today by Novartis on SPP100
(Aliskiren) as a monotherapy and in co-administration with the diuretic
hydrochlorothiazide (HCTZ). Speedel welcomes the news that Novartis is on
track for its first regulatory submission of SPP100 in the US in early 2006
and in the EU in the fourth quarter of 2006. These submissions will be for
SPP100 as a monotherapy treatment, together with data supporting
co-administration with other anti-hypertensive therapies, based on trials from
over 8,000 patients. These latest results reconfirm the previous findings from
clinical studies conducted by Speedel. SPP100 is the first-in-class once daily
oral renin inhibitor being developed for the treatment of hypertension.
Speedel in-licensed the compound from Novartis and successfully developed
SPP100 through Phase I and II before Novartis exercised a license-back option
in 2002.
Dr. Alice Huxley, Speedel CEO, stated: "We are delighted to see the
consistent and strong performance of SPP100 in these latest Novartis Phase III
trials. It is encouraging to witness the depth and breadth of the clinical
programme being run by Novartis to bring this novel first-in-class therapy to
market. Hypertension is one of the largest and growing unmet medical needs
across the world and SPP100 potentially offers benefits over current
therapies, particularly for improved protection of end-organs such as the
heart and kidneys."
On 20 September, 2005 at an R&D update meeting in London, Novartis
disclosed the latest results of two Phase III dose-ranging placebo controlled
clinical trials of SPP100 as monotherapy(1). This data showed:
-- Full 24 hour blood pressure (BP) lowering with excellent reduction in
early morning BP
-- Clinically significant reductions in BP across all doses
(75,150,300,600 mg once daily)
-- Consistent BP lowering across all studies
-- Excellent safety and placebo-like tolerability up to 300mg
-- Excellent blockade of the RAS(2) and potential for improved end-organ
protection as once daily therapy
Another Phase III trial in which SPP100 was co-administered with the
diuretic hydrochlorothiazide (HCTZ)(3) showed the following results:
-- Overall significant additional BP lowering with the co-administration
of SPP100 and HCTZ compared to the individual therapies
-- Excellent responder rates(4) of SPP100 in co-administration with HCTZ
-- Very good safety and tolerability in all co-administration doses of
SPP100 with HCTZ
Speedel notes that this co-administration data builds on Speedel's
clinical findings about the benefits of combination therapy shown in 2001 and
2002 in pilot clinical studies with SPP100 in co-administration with an ARB,
as well as with an ACE-I (angiotensin converting enzyme inhibitor) or a
diuretic. All three studies showed the potential for beneficial effects of
SPP100 with these three different classes of blood pressure modulators while
maintaining the placebo-like safety profile of SPP100.
Novartis also disclosed today that:
-- Data are to be presented in 2006 from clinical trials combining the
use of SPP100 with an ACE-I and a CCB (calcium channel blocker)
-- Data will begin to be reported in the second half of 2006 from three
surrogate outcome studies to support the potential improved end-organ
protection of SPP100
-- Starting in Q2 2006 three major outcome morbidity and mortality
studies will commence to ensure an extensive profiling programme of
SPP100 compared to other anti-hypertensives, with data expected to be
available from Q4 2011
Novartis R&D update 20 September 2005 webcast
Presentation slides with the data from these Phase III trials will be
available via a webcast today at 13:00 UK / 14.00 CET on the website
http://www.novartis.com/investors .
About SPP100 (Aliskiren)
SPP100 (Aliskiren) 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 (ACE) inhibitors 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.
Inhibition of renin, articulated as 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. It is only
a Renin Inhibitor that lowers PRA efficiently whereas most current leading
anti-hypertensive drug classes such as ACEIs 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. Phase III trials are ongoing in the US, EU,
and Japan, with first regulatory submission in the US planned for early 2006
and in the EU for Q4 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's co-administration studies
The three pilot clinical studies conducted by Speedel in 2001 and 2002
investigated the safety and efficacy of SPP100 in co-administration with the
ACE-inhibitor (ramipril), the diuretic (hydrochlorothiazide - HCTZ) and the
ARB (irbesartan), in hypertensive patients. All three studies were open label
and blood pressure effects were assessed by 24-hour Ambulatory Blood Pressure
Monitoring.
About Hypertension
Hypertension is a common disorder in which blood pressure is abnormally
high, placing undue stress on the heart, blood vessels and other organs such
as the kidney and the brain. Blood pressure is determined in two phases as the
heart contracts and relaxes. Systolic blood pressure represents the force that
blood exerts on the walls of arteries as the heart contracts to pump out
blood. Diastolic blood pressure represents the force as the heart relaxes to
allow the blood to flow into the heart.
Due to its wide prevalence and impact on cardiovascular health,
hypertension is a major cause of disease and death in Europe and North
America. More than one in three Europeans and North Americans over the age of
35 suffers from hypertension -- but for the vast majority of patients who
undergo hypertension treatment, the causes of high blood pressure are unknown.
More than 40 % of patients undergoing treatment with current therapies do not
reach targeted blood pressure levels, and so there is a considerable unmet
medical need.
The latest potential therapeutic agents for hypertension are renin
inhibitors. Renin is an enzyme produced in the kidneys in response to reduced
renal perfusion. Through a cascade of biological events, renin acts to bring
about sodium retention, an increase in blood pressure, and restoration of
renal perfusion, which shuts off the signal for renin release. For
hypertensive individuals, renin inhibitors are currently being investigated as
a therapy that may provide benefits over current therapies to reduce blood
pressure, decrease salt retention and may protect end organs such as the
kidney, heart and brain.
(1) Study A1201 in 455 hypertensive patients and Study A2308 in 672
hypertensive patients.
(2) Renin Angiotensin System
(3) Study A2204 in 2,776 hypertensive patients
(4) % of patients who obtain a decrease in BP > 10mmHg or reach a
diastolic blood pressure < 90mmHg
About Speedel
Speedel is a 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), the first-in-
class renin inhibitor, is partnered with Novartis for Phase III development
and commercialisation in hypertension with filing for registration expected in
2006. Our pipeline covers three different modes of action, and in addition to
SPP100, includes SPP301 in Phase III, SPP200 in Phase II, SPP630 and SPP635 in
early 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. Since
being founded in 1998, we have raised gross proceeds of CHF 239 million
(approximately EUR 154 million or USD 191 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 46 million). The company's shares were listed on the SWX Swiss
Exchange under the symbol SPPN on 08 September 2005.
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.
SOURCE Speedel Pharmaceuticals Inc.
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Related links:
http://www.speedel.com
http://www.novartis.com/investors
CONTACT:
Nick Miles, Director Communications &
Investor Relations for Speedel, +41-61-206-40-00, or
+41-0-61-206-40-14, or +41-79-446-25-21, - fax, +41-61-206-40-01
- mobile, nick.miles@speedel.com; Frank LaSaracina, Managing
Director of Speedel Pharmaceuticals Inc., +1-732-537-2290, or
+1-908-338-0501 - mobile, +1-732-537-2292 - fax,
frank.lasaracina@speedel.com
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