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DISCOVERY LABORATORIES, INC.
EXHIBIT 99.1
FOR IMMEDIATE RELEASE:
Company Contact: Investor Contact:
John G. Cooper Harvey Goralnick/Brad Meyer
SVP/CFO FOCUS Partners LLC
215-340-4699 212-752-9445
Info@discoverylabs.com dsco@focuspartners.com
Discovery Laboratories & Esteve Expand Relationship to Develop
and Commercialize Surfaxin(R) in Europe
Doylestown, PA -- March 7, 2002 -- Discovery Laboratories, Inc. (Nasdaq: DSCO),
a late-stage specialty pharmaceutical company leveraging its platform technology
in humanized lung surfactants to develop potential novel respiratory therapies
and pulmonary drug delivery products, today announced a significantly expanded
alliance with Laboratorios Del Dr. Esteve S.A ("Esteve") for the development,
marketing and sales of Surfaxin throughout Europe, Central America and South
America. This expanded collaboration supersedes existing sublicense and supply
agreements between Discovery and Esteve in October 1999, which limited the
European territory to Southern Europe.
Through the alliance, Esteve will market Surfaxin for respiratory distress
syndrome (RDS) in premature infants, meconium aspiration syndrome (MAS) in full
term babies, and acute lung injury/acute respiratory distress syndrome
(ALI/ARDS) in adults. Currently, Discovery is conducting two phase 3 clinical
trials for RDS, a phase 3 trial for MAS and a Phase 2 trial for ARDS. In
addition, the new arrangement anticipates an opportunity for Esteve to negotiate
licenses for the development and marketing of future Discovery products in the
above territories.
The agreement provides for an up-front licensing fee to Discovery of $500,000, a
purchase by Esteve of $4 million of Discovery's common stock at $4.867 per share
(a 50% premium to the trailing 30 day average determined as of March 4, 2002),
and milestone payments to be made to Discovery tied to attaining specific
regulatory approvals for Surfaxin. Additionally, Esteve will sponsor clinical
trial costs for ALI/ARDS to obtain European Agency for the Evaluation of
Medicinal Products (EMEA) approval for marketing in Europe. Under the prior
arrangement, Esteve had provided support for Discovery's multinational clinical
trials for RDS and MAS in Europe. Discovery retains manufacturing rights and, as
part of the collaboration, Esteve has agreed to an exclusive supply agreement,
whereby, they will purchase Surfaxin drug product from Discovery. Discovery will
receive, as a potential ongoing revenue stream, a transfer price based on sales
of Surfaxin by Esteve and/or its sublicensee(s).
- more-
Antoni Esteve, Ph.D., Esteve's Director of Scientific and Commercial Operations,
commented, "Esteve is very proud to expand our collaboration with Discovery.
Over the last several years, we have increased our confidence in the significant
potential of humanized surfactants to improve therapies for the treatment of
babies suffering from respiratory disorders, adults suffering from acute
respiratory distress syndrome, and the downstream possibility of aerosolized
surfactants treating a broader range of respiratory diseases and as a drug
delivery platform. Our additional investment in Discovery supports this
confidence and gives Esteve the opportunity to broaden our product portfolio for
the medical communities we serve."
"We have worked closely with Esteve since 1999 and they have been an excellent
partner," said Robert J. Capetola, Ph.D., President and Chief Executive Officer
of Discovery. "Expanding our relationship to now include all of Europe was a
natural progression for us. Esteve has a superb reputation of marketing
innovative pharmaceuticals, and we are pleased to be represented by their
professional team to effectively market and distribute Surfaxin to the critical
care hospital community. In combination with our recent Quintiles Transnational
collaboration, Discovery now has in place the sales and marketing infrastructure
to bring Surfaxin to the critical care markets in Europe, the United States and
Latin America. Discovery will establish and maintain the global brand strategy
for Surfaxin, while our collaborators will be responsible for regional
implementation. Our objective is to have a uniform, recognizable
Discovery/Surfaxin image visible to the critical care markets throughout the
world. Meanwhile, Discovery will record a significant share of the revenues, and
in the case of the United States, Discovery should generate margins typical of a
fully-integrated specialty pharmaceutical company."
Human lung surfactants are substances naturally present in the lung tissue and
are essential to the lungs' ability to absorb oxygen. Discovery's Surfaxin is
the first humanized peptide-based surfactant that mimics the human surfactant
protein B, considered physiologically the most important of the four major
proteins found in human lung surfactants.
RDS in premature infants is a breathing disorder in which the lungs of infants
do not stay open due to an insufficient amount of surfactant, which is produced
naturally in normally developing infants as their lungs mature. Approximately
270,000 cases of RDS in premature infants occur in the developed world annually.
MAS results when a full-term baby inhales meconium, a material produced in the
intestine of a full-term baby before birth. Severe respiratory distress is a
result and there are currently no approved therapies anywhere in the world.
Approximately 60,000 cases of MAS occur in the developed world annually.
ALI/ARDS is a life-threatening disorder for which there are currently no
approved therapies anywhere in the world. ALI/ARDS is characterized by an excess
of fluid in the lungs and decreased oxygen levels in the patient. One prominent
characteristic is the destruction of surfactants. These conditions are caused by
events such as smoke inhalation, near drowning, industrial accidents and other
traumas and illnesses including pneumonia and septic shock. Because there are no
approved treatments, the mortality rate can range from 35% to 50%. There are
estimated to be between 150,000 and 250,000 ALI/ARDS patients per year in each
of the U.S. and Europe. The current standard of care includes placing patients
on mechanical ventilators in intensive care units. Surfaxin is intended to
re-establish the lung's capacity to absorb oxygen.
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About Esteve
Privately owned, Esteve is one of the largest pharmaceutical corporations in
Southern Europe. With a turnover of EURO 561 million in 2001, its own products
distributed in more than 80 markets worldwide, patents granted in more than 40
countries, and employing more than 2,000 people, it is committed to research and
international expansion as a key to its future and continued growth.
About Discovery Laboratories
Discovery Laboratories, Inc. is a specialty pharmaceutical company leveraging
its platform technology in humanized lung surfactants to develop potential novel
respiratory therapies and pulmonary drug delivery products. Surfaxin, the
Company's lead product, is currently in two pivotal Phase 3 multi-national
clinical trials for Respiratory Distress Syndrome (RDS) in premature infants, a
Phase 3 clinical trial for Meconium Aspiration Syndrome (MAS) in full-term
infants, and a Phase 2 clinical trial for Acute Lung Injury/Acute Respiratory
Distress Syndrome (ALI/ARDS) in adults. Aerosol formulations of the Company's
surfactant technology are being developed in an effort to treat other
respiratory conditions, including asthma and chronic obstructive pulmonary
disease, and as a novel pulmonary drug delivery vehicle to efficiently deliver
drugs to the respiratory tract that are currently delivered orally or by
injection. To serve the critical care marketplace, the Company is developing a
dedicated sales and marketing capability through a collaboration with Quintiles
Transnational Corp for the US, and has a commercialization alliance with
Laboratorios Del Dr. Esteve S.A for Europe and Latin America. Interested parties
can receive corporate updates by sending their email addresses to
dsco@focuspartners.com. More information about Discovery Laboratories is
available on the Company's Web site at www.discoverylabs.com.
This press release shall not constitute an offer to sell or a solicitation of an
offer to buy any securities of the Company. To the extent that statements in
this press release are not strictly historical, including statements as to the
Company's business strategy, outlook, objectives, plans intentions, goals,
future financial conditions, future collaboration agreements, the success of the
Company's product development, or otherwise as to future events, such statements
are forward-looking, and are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. The forward-looking statements
contained in this release are subject to certain risks and uncertainties that
could cause actual results to differ materially from the statements made. Among
the factors which could affect the Company's actual results and could cause
results to differ from those contained in the forward-looking statements
contained herein are the risk that financial conditions may change, the risk
that the Company will not be able to raise additional capital or enter into
additional collaboration agreements, risks relating to the progress of the
Company's research and development and the development of competing therapies
and/or technologies by other companies. Those associated risks and others are
further described in the Company's periodic filings with the Securities and
Exchange Commission including the most recent reports on Form 10-KSB, 8-K and
10-QSB, and amendments thereto.
Statements in this press release regarding Esteve and Discovery have been made
by each respective company and are that company's sole responsibility.
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