Par Pharmaceutical Exhibit 99.1
Contacts:
Stephen J. Mock
Cecelia C. Heer
Par Pharmaceutical Companies, Inc.
(201) 802-4000
PAR PHARMACEUTICAL ANNOUNCES EQUITY INVESTMENT
IN OPTIMER PHARMACEUTICALS
PAR ENTERS INTO JOINT DEVELOPMENT AND COLLABORATION AGREEMENT WITH OPTIMER
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COMPANIES TO COLLABORATE IN THE DEVELOPMENT AND MARKETING
OF ANTIBIOTIC, PAR-101;
PAR-101 REPRESENTS PROMISING ADDITION TO PAR'S EXPANDING PIPELINE OF
NEW DRUG CANDIDATES
SPRING VALLEY, NEW YORK, MAY 3, 2005 - Par Pharmaceutical Companies, Inc.
(NYSE:PRX) today announced that it has entered into a purchase agreement to
acquire a 16 percent equity interest in Optimer Pharmaceuticals, Inc. Optimer is
a privately held biotechnology company located in San Diego, California. The
company was founded in 1998 by Michael Chang, Ph.D., Professor Chi-Huey Wong of
Scripps Research Institute and Professor Samuel Danishefsky of Memorial
Sloan-Kettering Cancer Center.
Par and Optimer have also entered into a joint development and collaboration
agreement for the compound now known as PAR-101. PAR-101 is a narrow-spectrum
antibiotic with potent activity against CLOSTRIDIUM DIFFICILE (C. DIFFICILE). It
is orally active, with minimum systemic exposure, and is being developed for the
treatment of C. DIFFICILE-associated diarrhea (CDAD), the leading cause of
institutional enteric infections. Currently, there is no satisfactory treatment
for CDAD. PAR-101 has been granted Fast-Track status by the U.S. Food and Drug
Administration, and is now in Phase IIa clinical studies, with Phase IIb trials
expected to commence in the second half of 2005. If all proceeds well with the
product's development and regulatory review, Par believes that PAR-101 could be
available commercially as soon as 2008.
"Working closely with our accomplished colleagues at Optimer, we look forward to
demonstrating the utility of PAR-101 in addressing a significant, unmet medical
need," said Shankar Hariharan, Ph.D., executive vice president and chief
scientific officer of Par. "We are excited to add this new compound to Par's
expanding roster of new drug candidates in clinical development.
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"CDAD imposes significant costs on society both in terms of human suffering and
economics. We believe that PAR-101 has the potential to become an important
addition to the physician's armamentarium for treating this debilitating
infection," Dr. Hariharan added.
"We are proud and excited to have Par as our development and marketing partner,"
said Dr. Michael Chang, president and chief executive officer of Optimer. "We
believe that this collaboration will significantly expedite the
commercialization of PAR-101."
In the U.S., as many as 10 percent of all patients hospitalized for more than
two days are afflicted with CDAD. C. DIFFICILE infection is currently the most
common cause of nosocomial diarrhea, often adding up to two weeks to the length
of patient hospitalization. This can add as much as $10,000 to $15,000 to the
cost of a hospital stay. CDAD is also implicated in the majority of cases of
antibiotic-associated colitis, which is one of the leading causes of morbidity
and mortality among elderly debilitated patients. The rising incidence of CDAD
has been attributed to the increasingly frequent prescription of broad-spectrum
antibiotics for hospitalized patients.
PAR-101 is a novel macrocyclic antibiotic that is produced by fermentation. Its
narrow-spectrum activity is highly selective for C. DIFFICILE, thus preserving
gut microbial ecology, an important consideration for the treatment of CDAD. It
is believed that PAR-101 has the potential to address resistance to existing
therapies and increasing recurrence rates of CDAD. Recurrence rates of CDAD are
20 to 25 percent with existing therapies, representing a significant unmet
medical need. According to the Centers for Disease Control and Prevention, a
virulent new strain of C. DIFFICILE has been linked to an eightfold increase in
mortality in some outbreaks in the U.S. and Canada.
TERMS OF THE AGREEMENT
Under the terms of the agreement, Optimer will fund all expenses associated with
the clinical trials of PAR-101. Par will be responsible for clinical
development, and, if successful, Par will submit the New Drug Application for
the product. All legal and regulatory responsibilities also reside with Par. If
ultimately cleared for marketing, Par will manufacture and market PAR-101. Par
has exclusive rights to market, sell and distribute the product in the U.S. and
Canada. Par will pay Optimer a royalty on sales of the product. Par has an
option to extend the joint development and collaboration agreement to include up
to three additional drug candidates from Optimer's pipeline.
Optimer Pharmaceuticals, Inc. (San Diego, California, www.optimerpharma.com) is
an emerging biotechnology company focused on the research and development of
anti-infective products to treat serious bacterial infections. Optimer's core
drug discovery technologies are licensed from Scripps Research Institute and
Memorial Sloan-Kettering Cancer Center. The company has a solid portfolio of
preclinical and clinical stage antibiotic compounds. Optimer's other compound in
clinical development is prulifloxacin, a novel, broad-spectrum fluoroquinolone
antibiotic.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic
pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and
its recently acquired subsidiary, Kali Laboratories, Inc. The company is also
developing an additional line of branded pharmaceutical products for specialty
markets and expects to introduce the first of these in 2005. Par currently
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manufactures, markets or licenses more than 85 prescription drugs. For press
release and other company information, visit http://www.parpharm.com.
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Certain statements in this press release constitute "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995. To
the extent any statements made in this news release contain information that is
not historical, these statements are essentially forward-looking and are subject
to risks and uncertainties, including the difficulty of predicting FDA filings
and approvals, acceptance and demand for new pharmaceutical products, the impact
of competitive products and pricing, new product development and launch,
reliance on key strategic alliances, uncertainty of patent litigation filed
against us, availability of raw materials, the regulatory environment,
fluctuations in operating results and other risks and uncertainties detailed
from time to time in the Company's filings with the Securities and Exchange
Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
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