Sciele Pharma to Purchase $7 Million Equity Stake in Plethora Solutions LimitedATLANTA, May 24, 2007 (BUSINESS WIRE) -- Sciele Pharma, Inc. (NASDAQ:SCRX) and Plethora Solutions Holding
plc ("Plethora") (AIM:PLE) announced today that they have signed an
exclusive license agreement for the marketing of PSD502 for premature
ejaculation (PE) in the United States together with an agreement for
Sciele to purchase a $7 million equity stake in Plethora. Plethora is
developing innovative products for women's health and male sexual
dysfunction. Plethora has products in clinical development for the
treatment of premature ejaculation, overactive bladder, stress urinary
incontinence, interstitial cystitis and gynecological pain.
Under the terms of the license agreement, Plethora will receive
payments upon achievement of regulatory and sales milestones, and
royalty payments on product sales. Plethora will have co-promotion
rights for urologists in the United States.
PE is the most common form of sexual dysfunction among men. PE is
estimated to affect approximately 25% to 30% of men of all ages
(Laumann et al 1999 JAMA 281 537-44). According to the results of this
survey, approximately 25 million men between the ages of 18 and 59 in
the U.S. experience PE.
PSD502 comprises a unique, proprietary, and rapidly absorbed
formulation of two well-established local anesthetics, lidocaine and
prilocaine, dispensed in a metered dose spray. Plethora has completed
a phase II clinical trial using PSD502, and Plethora is expected to
begin a phase III study in the second half of 2007.
Under the agreement to purchase a $7 million equity stake in
Plethora, Sciele has purchased 1,772,505 new Ordinary Shares in
Plethora at GBP 2.00 per share.
Patrick Fourteau, Chief Executive Officer of Sciele, said, "We are
pleased to take an equity stake and enter into this collaboration with
Plethora as they are developing new products for Women's Health and
sexual dysfunction. This partnership will enable us to further expand
our product pipeline and leverage our sales force. We are enthusiastic
about PSD502, which may provide a potential PE treatment, addressing
an unmet medical need for millions of men."
Steven Powell, Chief Executive Officer of Plethora, said, "We are
delighted to have Sciele as a licensing partner and welcome them as a
shareholder. We look forward to working with Sciele and to updating
our shareholders on progress with licensing PSD502 for premature
ejaculation elsewhere in territories outside the USA."
About Plethora Solutions:
Plethora is focused on the development and marketing of products
for the treatment of urological disorders. The Company has products in
clinical development for the treatment of overactive bladder, stress
urinary incontinence, interstitial cystitis, gynecological pain and
premature ejaculation. In January 2006, Plethora acquired Minneapolis
(MN) based Timm Medical Technologies, Inc. which markets the
ErecAid(R) and Rigiscan(R) products for the treatment of erectile
dysfunction (ED) to urology clinics through a US-based specialty sales
team. Most recently, the ErecAid has been found to be effective for
men that fail Medical Management and for men recovering from
prostatectomy. The Company is headquartered in the UK and is listed on
the London Stock Exchange (AIM:PLE). Further information is available
at www.plethorasolutions.co.uk.
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in
sales, marketing and development of branded prescription products
focused on Cardiovascular/Diabetes and Women's Health. The Company's
Cardiovascular/Diabetes products treat patients with high cholesterol,
hypertension, high triglycerides, unstable angina and Type 2 diabetes,
and its Women's Health products are designed to improve the health and
well-being of women and mothers and their babies. Founded in 1992 and
headquartered in Atlanta, Georgia, Sciele Pharma employs more than 800
people. The Company's success is based on placing the needs of
patients first, improving health and quality of life, and implementing
its business platform - an Entrepreneurial Spirit, Innovation, Speed
of Execution, Simplicity, and Teamwork.
Safe Harbor Statement
This press release contains forward-looking statements that are
subject to risks and uncertainties that could cause actual results to
materially differ from those described. Although we believe that the
expectations expressed in these statements are reasonable, we cannot
promise that our expectations will turn out to be correct. Our actual
results could be materially different from and worse than our
expectations. With respect to such forward-looking statements, we seek
the protections afforded by the Private Securities Litigation Reform
Act of 1995. These risks include, without limitation:
We may not attain expected revenues and earnings. If we are
unsuccessful in obtaining third party payor contracts for our
products, we may experience reductions in sales levels and may fail to
reach anticipated sales levels. If demand for our products exceeds our
initial expectations or the ability of our suppliers to provide
demand-meeting quantities of product and samples, our ability to sell
these products could be adversely impacted. The potential growth rate
for our promoted products may be limited by slower growth for the
class of drugs to which our promoted products belong and unfavorable
clinical studies about such class of drugs. We may encounter problems
in the manufacture or supply of our products, for which we depend
entirely on third parties.
Strong competition exists in the sales of our promoted products,
which could adversely affect the expected growth of our products'
sales or increase our selling costs. We may not be able to protect our
competitive position for our promoted products from infringers.
Altoprev has experienced manufacturing issues; if the issues recur
and cannot be resolved, our ability to acquire the product for sale
and sampling will be adversely affected. Sales of our Robinul product
have been adversely affected by the introduction of knock-off and
generic product.
We may incur unexpected costs in integrating new products into our
operations. If we have difficulties acquiring new products or rights
to market new products from third parties, our financial results could
be adversely impacted. We may be unable to develop or market line
extensions for our products including Sular, Triglide, Fortamet, and
our Prenate Line or, even if developed, obtain patent protection for
our line extensions. Further, introductions by us of line extensions
of our existing products may require us to make unexpected changes in
our estimates for future product returns and reserves for obsolete
inventory. If these risks occur, our operating results would be
adversely affected. Our licensor/supplier can terminate our rights to
commercialize Nitrolingual and the 60 dose size of this product has
not yet met our expectation. Our new Sular formulation is presently
undergoing clinical trial testing. There can be no assurance that the
trial results will be positive, and if they are not, we may not be
able to market and sell our new Sular formulation.
We depend on a small senior management group, the departure of any
member of which would likely adversely affect our business. An adverse
interpretation or ruling by one of the taxing jurisdictions in which
we operate could adversely impact our operating results. A small
number of customers account for a large portion of our sales and the
loss of one of them, or changes in their purchasing patterns, could
result in substantially reduced sales and adversely impact our
financial results. If third-party payors do not adequately reimburse
patients for our products, doctors may not prescribe them. Further,
our business is subject to increasing government price controls and
other healthcare cost-containment measures. Side effects or marketing
or manufacturing problems with our products could result in product
liability claims which could be costly to defend and could result in
the withdrawal or recall of products from the market.
We rely on operational data obtained from IMS, an industry
accepted data source. IMS data may not accurately reflect actual
prescriptions (for instance, we believe IMS data does not capture all
product prescriptions from some non-retail channels). An adverse
judgment in the securities class action litigation in which we and
certain current and former directors and executive officers are
defendants could have a material adverse effect on our results of
operations and liquidity.
If we fail to obtain, or encounter difficulties in obtaining,
regulatory approval for new products or new uses of existing products,
or if our development agreements are terminated, we will have expended
significant resources for no return. Our business and products are
highly regulated. The regulatory status of some of our products makes
these products subject to increased competition and other risks, and
we run the risk that we, or third parties on whom we rely, could
violate the governing regulations; if generic competitors that compete
with any of our products are introduced, our revenues may be adversely
affected.
Some unforeseen difficulties may occur.
The above are some of the principal factors that could cause
actual results to differ materially from those described in the
forward-looking statements included above. These factors are not
intended to represent a complete list of all risks and uncertainties
inherent in our business, and should be read in conjunction with the
more detailed cautionary statements and risk factors included in our
other filings with the Securities and Exchange Commission.
SOURCE: Sciele Pharma, Inc. and Plethora Solutions
Sciele Pharma, Inc.
Joseph T. Schepers, 678-341-1401
ir@sciele.com
or
Plethora Solutions
Steven Powell, 020 7269 8630
or
City/Financial Enquiries - Plethora
Maitland
Brian Hudspith/Liz Morley, 020 7379 5151
or
Scientific/Trade Press Enquiries - Plethora
DeFacto Communications
Richard Anderson, 020 7861 3838