SPEEDEL RECEIVES FIRST COST-OF-GOODS SAVINGS FOR SPP100
-Novartis confirms it is using Speedel's manufacturing process for
SPP100-
Basel/Switzerland and Bridgewater NJ/USA, 29 November 2007
Speedel Holding Ltd (SWX: SPPN) today announced it has received from
Novartis the revenue report regarding SPP100 (Tekturna/Rasilez[1])
for the three months ending 30 September 2007. Consequently Speedel
has updated its revenues and now confirms that it has earned a total
of CHF 621,000 for the third quarter 2007 compared to management's
best estimate of CHF 571,000 previously announced with its financial
results.
After publishing its results on 14 November and in line with the
licensing agreement, Speedel has received from Novartis the revenue
report regarding SPP100 for the third quarter. This report includes
details on the royalties due to Speedel from Novartis reported net
sales of USD 9 million for SPP100 in the US and Europe. This report
also includes for the first time details on the cost-of-goods savings
which Novartis has achieved for product sold during the third
quarter, using the chemical synthesis route developed by Speedel and
licensed to Novartis in 2002. A small portion of the product sold by
Novartis in the third quarter was reported to be eligible for the
savings on cost-of-goods stipulated in the licensing agreement.
Alice Huxley, CEO, stated: "We are glad that Novartis have now
confirmed their use of the manufacturing process developed by Speedel
for SPP100. It is encouraging to see the first fruits of our major
technical breakthrough which enabled the first renin inhibitor to
come to market. We look forward to being in a position to report to
the investment community every quarter an increasing revenue stream
attributable to this component of our agreement with Novartis, as one
may expect the manufacturing efficiencies for SPP100 to further
improve going forward."
Although Novartis has provided Speedel with a revenue report for Q3
which includes details on the cost-of-goods component for that
period, no comparable data for the first and second quarters of 2007
is yet available to us. Furthermore, Novartis have now indicated
their willingness to discuss the terms and conditions of Speedel's
audit of data supplied by Novartis with the quarterly revenue reports
pertaining to the cost-of-goods component under the licensing
agreement signed in January 2000. On this basis, Speedel remains
confident that these two items will be resolved amicably in due
course.
Speedel will update its financial results for the first nine months
when the company reports its full year 2007 results on 07 March
2008.
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 (Tekturna/Rasilez[1]), 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 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 II, SPP200 in Phase II, SPP635 in
Phase Il, SPP1148 in Phase I, SPP676 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 80 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 255 million
(approximately EUR 157 million or USD 204 million) from private
placements of equity securities and two convertible loans including
the conversion premiums. 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 -
[1] Tekturna/ Rasilez ® are Novartis trademarks
For further information please contact
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.com
www.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.com
www.speedel.com