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Macrochem Acquires Option To License Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infection, from Genaera

Geschrieben am 10.07.2007 - [Nächster Artikel]

Wellesley Hills, Massachusetts (ots/PRNewswire) -

- Broadens late-stage product development portfolio building on
lead product candidate EcoNail in Phase 2 trial for onychomycosis

MacroChem Corporation (OTCBB: MACM) today announced that it has
signed an exclusive option to acquire exclusive worldwide license
rights for drug uses of pexiganan, a novel, small peptide
anti-infective for topical treatment of patients with mild diabetic
foot infection (DFI), from Genaera Corporation (Genaera).

"We believe this is a unique opportunity for MacroChem to broaden
its product portfolio with a product that has already completed two
Phase 3 clinical trials. It also fits our strategic focus and
complements our lead product candidate, EcoNail(TM) for treatment of
nail fungus currently in a fully enrolled Phase 2 trial and
progressing on track with an interim assessment of clinical data
later this year after all patients have been treated for twenty four
weeks," said Robert J. DeLuccia, President and CEO of MacroChem.

Clinical trials with pexiganan previously conducted by Genaera
include two Phase 3 trials submitted in a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) in 1998. At that time,
outstanding issues with CMC (Chemistry, Manufacturing and Controls)
and an FDA request for one additional controlled trial precluded
approval.

Mr. DeLuccia further noted, "We would be pleased to have pexiganan
in our hands since we believe that, if approved, it would be welcomed
by physicians and patients for the treatment of diabetic foot
infection. In recent years, there have been many advances in the
manufacturing of peptides, a better understanding of the treatment of
diabetic foot infection, improvements in clinical trial design and
execution, and more clarity concerning regulatory requirements for
topical anti-infectives with the potential market being even more
attractive than before."

WELLESLEY HILLS, Massachusetts, July 10 /PRNewswire/ --

He added, "There continues to be a very large and growing
incidence of diabetes and, as a result, a growing number of diabetic
foot infections in the U.S. Diabetic foot ulcers in the approximately
20 million diabetics in the US alone are a major concern and burden
to both patients and healthcare system. There is also a lack of
effective topical anti-infectives to treat diabetic foot infection.
Accordingly, we believe that pexiganan could fill an important unmet
medical need for a topical anti-infective treatment and provide a
significant commercial opportunity in an addressable market of
approximately 3.5 million diabetic foot infections annually."

The option agreement gives MacroChem a 90-day exclusive right to
enter into a license agreement with Genaera. MacroChem paid Genaera
US$250,000 on execution of the option agreement.

Both EcoNail and pexiganan would be developed to treat diseases of
the foot predominantly treated by the same prescribing specialists,
namely podiatrists. Both products would potentially be of interest to
a larger number of physician specialists and primary care physicians
as well. EcoNail is the company's patented lacquer which contains the
antifungal econazole and MacroChem's enhancer SEPA(R). Patients
participating in the EcoNail study will receive 48 weeks of treatment
and will undergo efficacy assessments using standard criteria of nail
appearance and mycology. However, the Company will collect and
evaluate 24-week interim data later this year. This trial was
specifically designed, with the assistance of well-known
onychomycosis experts, to address three important objectives: to
assess early signs of efficacy, to maintain robust clinical endpoints
in the full study, and, if successful, to facilitate advancement to
Phase 3 as soon as possible.

About MacroChem

MacroChem Corporation is a specialty pharmaceutical company with
two clinical development stage products containing our proprietary
enhancer, SEPA(R): EcoNail, to treat fungal infection of the nail and
Opterone(R), to treat male hypogonadism. In addition to our SEPA
technology, we are also evaluating applications for MacroDerm(TM),
our patented series of polymers that impede penetration of active
ingredients through the skin. For more information visit our website,
http://www.macrochem.com .

Forward-Looking Statements

With the exception of historical information contained in this
press release, the matters described herein are forward-looking
statements that involve risks and uncertainties. MacroChem's actual
results may differ significantly from the results discussed in the
forward-looking statements. Factors that might cause such a
difference include, but are not limited to, those discussed or
referred to in the section entitled "Risk Factors" in MacroChem's
Annual Report on Form 10-K, as well as those discussed elsewhere
therein, and include, without limitation, risks regarding product
development, the timing and results of clinical trials, the
regulatory approval process, capital requirements, financial
condition, patent protection and dependence on third parties for
development and licensing arrangements. Readers are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. MacroChem undertakes no obligation to
update publicly any forward-looking statements, whether as a result
of new information, future events or otherwise. For more information
visit our website, http://www.macrochem.com .


MacroChem Corporation: Bernard Patriacca - VP/CFO +1-781-489-7310
Investor Relations: The Investor Relations Group, Inc.
Jordan Silverstein/Christine Berni +1-212-825-3210
Media: The Investor Relations Group, Inc.
Bill Douglass +1-212-825-3210


Web site: http://www.macrochem.com

ots Originaltext: MacroChem Corporation
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Bernard Patriacca, VP-CFO of MacroChem Corporation, +1-781-489-7310;
or Investors, Jordan Silverstein or Christine Berni, +1-212-825-3210,
or Media, Bill Douglass, +1-212-825-3210, all of The Investor
Relations Group, Inc. for MacroChem Corporation
 
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