CHICAGO, Oct. 1 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings,
Inc. (Nasdaq: ADLS), today announced the submission of a new drug application
(NDA) for cethromycin in mild-to-moderate community acquired pneumonia (CAP).
Advanced Life Sciences also entered into debt and equity financing agreements
to strengthen its balance sheet and help fund commitments associated with the
NDA submission and pre-commercialization activities.
CAP is the sixth most common cause of death in the United States. CAP and
other respiratory tract infections are caused by pathogens such as
Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5.6 million
patients in the United States each year, with 10 million physician visits and
2 million hospitalizations occurring annually.
Macrolides and penicillins are currently the front-line treatments for
respiratory tract infections such as CAP. As macrolide and penicillin
resistance grows and has the potential to cause more clinical failures, there
is a need for new antibiotics with unique mechanisms of action that can
overcome this emerging resistance.
"We are excited to make our NDA submission for cethromycin in mild-to-
moderate CAP," said Michael T. Flavin, Ph.D., the Company's chief executive
officer. "Our team has worked tirelessly to complete this important objective
for the cethromycin program. We look forward to advancing the cethromycin NDA
through the FDA review process."
The NDA submission is based on a full clinical development and
manufacturing program for cethromycin. The program included two global Phase
III pivotal studies for the treatment of mild-to-moderate CAP in which
cethromycin was dosed at 300 milligrams once daily for seven days compared to
the standard of care therapy, Biaxin, which was dosed at 250 milligrams twice
daily for seven days. The data from these trials showed that cethromycin was
non-inferior to Biaxin with a similar safety profile. The most common adverse
reactions for cethromycin were taste disturbance, diarrhea, nausea and
More than 5,000 patients have been treated with cethromycin in 53 clinical
trials to date.
In conjunction with the NDA submission, the Company has received a
commitment to increase availability under its loan facility with Leaders Bank
from $4 million to $10 million. The commitment provides that the loan would
mature on January 1, 2011 and contain substantially similar terms and
conditions as the existing loan agreement between Advanced Life Sciences and
Leaders Bank. Advanced Life Sciences has also agreed to issue to Leaders as a
closing fee warrants for the purchase of 65,000 shares of its common stock at
an exercise price of $1 per share. Consummation of the increased loan facility
is subject to entering into definitive agreements and other customary closing
Advanced Life Sciences has also entered into a standby equity distribution
agreement (SEDA) with YA Global Investments, L.P. (Yorkville) for the sale of
up to $15 million of shares of the Company's common stock over a two-year
"The SEDA is an instrument that allows us financial flexibility while we
advance our ongoing regulatory, partnering and pre-commercial activities for
cethromycin," said John L. Flavin President and CFO of Advanced Life Sciences.
"Our ability to choose if, and when, to access funds under the SEDA facility
provides us with flexibility and the potential to minimize dilution for our
Under the terms of the SEDA, Advanced Life Sciences may from time to time,
in its discretion, sell newly-issued shares of its common stock to Yorkville
at a discount to market of 5%. The amount of each advance is generally
limited to $400,000 in any weekly period. Advanced Life Sciences is not
obligated to utilize any of the $15 million available under the SEDA and there
are no minimum commitments or minimum use penalties.
Based upon the Company's currently outstanding shares of common stock, and
options and warrants to purchase common stock, the aggregate number of shares
that Advanced Life Sciences may sell under the SEDA without stockholder
approval is currently limited to approximately 5.3 million shares. Unless
stockholder approval is sought and obtained, the total amount of funds that
ultimately can be raised under the SEDA over the two-year term will depend on
the then-current price for Advanced Life Sciences' stock and the number of
shares actually sold. Advanced Life Sciences' new credit agreement with
Leaders will also contain a covenant limiting the Company's utilization of the
SEDA to $9 million without Leaders' prior consent.
The SEDA does not impose any restrictions on the Company's operating
activities. During the term of the SEDA, Yorkville is prohibited from engaging
in any short selling or derivative transactions related to the Company's
common stock. Advanced Life Sciences issued 393,339 shares of common stock to
Yorkville as a commitment fee in connection with entering into the SEDA.
Advanced Life Sciences also agreed to file with the SEC a registration
statement, the effectiveness of which is a condition to the purchase and sale
of any shares, with respect to common stock issuable under the SEDA.
The Company will discuss today's news in a conference call with investors
at 9:00 a.m. ET today.
Conference Call Details
The conference call will be webcast live over the Internet. To access the
webcast, visit the Investor Relations section of the Advanced Life Sciences
corporate website at http://www.advancedlifesciences.com. Alternatively,
investors may participate in the conference call by dialing 888-679-8018
(domestic) or 617-213-4845 (international). The passcode for the conference
call is 99287584. A replay of the conference call will be available until
October 8, 2008. Callers may access the telephone replay by dialing
888-286-8010 (domestic) or 617-801-6888 (international), passcode 29205976.
Investors are advised to dial into the call at least ten minutes prior to the
call to register. Participants may pre-register for the call at
Pre-registrants will be issued a pin number to use when dialing into the live
call which will provide quick access to the conference by bypassing the
operator upon connection.
Cethromycin has shown higher in vitro potency and a broader range of
activity than macrolides against Gram-positive bacteria associated with
respiratory tract infections, and, again in in vitro tests, it appears to be
effective against penicillin- and macrolide-resistant bacteria. Cethromycin
has a mechanism of action that may slow the onset of future bacterial
resistance. In addition to its utility in CAP, cethromycin is also being
investigated for the prophylactic treatment of inhalation anthrax
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the
discovery, development and commercialization of novel drugs in the therapeutic
areas of infection, cancer and respiratory diseases. The Company's lead
candidate, cethromycin, is a novel once-a-day oral antibiotic in
pre-commercial development for the treatment of respiratory tract infections
including CAP. For more information, please visit us on the web at
Any statements contained in this press release that relate to future
plans, events or performance are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements represent our management's judgment regarding future events. The
Company does not undertake any obligations to update any forward-looking
statements whether as a result of new information, future events or otherwise.
Our actual results could differ materially from those discussed herein due to
several factors including the our ability to obtain and maintain regulatory
approval and labeling of our product candidates; our plans to develop and
commercialize our product candidates; the loss of key scientific or management
personnel; the size and growth of potential markets for our product candidates
and our ability to serve those markets; regulatory developments in the U.S.
and foreign countries; the rate and degree of market acceptance of any future
products; the accuracy of our estimates regarding expenses, future revenues
and capital requirements; our ability to obtain financing on terms acceptable
to us; our ability to obtain and maintain intellectual property protection for
our product candidates; the successful development of our sales and marketing
capabilities; the success of competing drugs that become available; and the
performance of third party collaborators and manufacturers. These and
additional risks and uncertainties are detailed in the Company's filings with
the Securities and Exchange Commission.
SOURCE Advanced Life Sciences Holdings, Inc.