Conference Call Scheduled for Thursday, January 31, 2008 at 8:30
a.m. ET
NEW YORK--(Business Wire)--Lev Pharmaceuticals, Inc. (OTCBB:LEVP.OB) announced today that it
has received a complete response letter from the U.S. Food and Drug
Administration (FDA) related to its biologics license application
(BLA) for Cinryze(TM) (C1 inhibitor) for both the acute and
prophylactic treatment of hereditary angioedema (HAE), or C1 inhibitor
deficiency.
A complete response letter is issued by the FDA in order to
specify additional information the agency requires to complete the
review of the BLA. In its letter regarding Cinryze(TM), the FDA has
requested information with respect to chemistry, manufacturing, and
controls (CMC), as well as additional analyses of existing efficacy
data from the Cinryze(TM) trials. While no new clinical trials were
requested in this letter, no assurances can be given that additional
clinical studies will not be requested in the future or on the timing
of any further FDA action.
"We believe we can address the FDA's questions in a timely manner
and hope to secure approval for Cinryze(TM) in mid-2008," said Joshua
Schein, chief executive officer of Lev. "Given the safety and efficacy
data from our clinical trials, we remain confident in our ability to
bring Cinryze(TM) to patients that are suffering from this
debilitating and life-threatening disease."
As part of Lev's CHANGE trial (C1 inhibitor in Hereditary
Angioedema Nanofiltration Generation evaluating Efficacy), the Company
is conducting two open label studies for the treatment and prevention
of HAE. Qualifying HAE patients will continue to have access to
Cinryze(TM) on a compassionate use basis, free of charge. To date,
more than 4,000 doses of Cinryze(TM) have been administered in all
parts of the CHANGE trials with more than a dozen patients having
individually received well over 100 doses.
Additionally, Cinryze(TM) has been well tolerated with an adverse
event profile no different from placebo. The most common adverse
reactions observed have been injection site rash and lightheadedness.
No drug-related serious adverse events (SAEs), no immunogenicity and
no decrease in efficacy have been observed.
C1 inhibitor has been used for more than 35 years in Europe to
treat patients with C1 inhibitor deficiency.
The Company will hold a conference call and audio webcast for
investors on Thursday, January 31, at 8:30 a.m. Eastern Time (ET). The
conference call will be available via live webcast on Lev's website at
www.levpharma.com. To participate by telephone, the domestic dial-in
number is 888-713-4214 and the international dial-in is 617-213-4866.
The access code is 81142253. 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 by clicking on the following link:
http://phx.corporate-ir.net/playerlink.zhtml?c=130944&s=wm&e
=1752456. (Due to its length, this URL may need to be copied/pasted
into your Internet browser's address field. Remove the extra space if
one exists.)
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. The webcast will be
available for replay approximately two hours after the end of the
webcast.
In addition, the Web cast is also available through Thomson's
investor portals. Individual investors can listen to the call at
www.earnings.com, Thomson's individual investor portal, powered by
StreetEvents. Institutional investors can access the call via
Thomson's password-protected event management site, StreetEvents
(www.streetevents.com).
About Hereditary Angioedema
HAE is a rare, severely debilitating, life-threatening genetic
disorder caused by a deficiency of C1 inhibitor, a human plasma
protein. This condition is the result of a defect in the gene
controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the
natural regulation of the contact, complement, and fibrinolytic
systems, that when left unrestricted, can initiate or perpetuate an
attack by consuming the already low levels of endogenous C1 inhibitor
in HAE patients. Patients with C1 inhibitor deficiency experience
recurrent, unpredictable, debilitating, and potentially life
threatening attacks of inflammation affecting the larynx, abdomen,
face, extremities and urogenital tract. While there is no approved
therapy for acute HAE attacks in the U.S., C1 inhibitor has been used
in Europe to treat HAE for more than 35 years. There are estimated to
be 10,000 people with HAE in the United States.
For more information on HAE, visit the U.S. HAE Association's
website at: www.haea.org.
About Lev Pharmaceuticals, Inc.
Lev is a biopharmaceutical company focused on developing and
commercializing therapeutic products for the treatment of inflammatory
diseases. Lev's lead product candidate, Cinryze(TM) (C1 inhibitor), is
being developed as a replacement therapy both for the treatment and
prevention of Hereditary Angioedema (HAE), also known as C1 inhibitor
deficiency, a rare, severely debilitating, life-threatening genetic
disorder. In 2007, Lev met both primary endpoints in its pivotal U.S.
Phase III clinical trial for the acute and prophylactic treatment of
HAE, achieving clinical and statistical significance. Cinryze(TM) has
been granted orphan drug status for the treatment and prevention of
HAE, potentially securing, upon approval, market exclusivity for seven
years. Additionally, Lev is in the process of prioritizing its C1
inhibitor development platform for the treatment of selective other
diseases and disorders in which inflammation is known or believed to
play an underlying role.
For more information about Lev, C1 inhibitor, or HAE, please
contact Lev directly at 212-682-3096, or visit Lev's website at
www.levpharma.com.
Forward Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. All statements, other
than statements of historical facts, included in this press release
regarding our plans and objectives of management are forward-looking
statements. We may not actually achieve the plans, intentions or
expectations disclosed in our forward-looking statements and you
should not place undue reliance on our forward-looking statements.
Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements we make. Various important factors could cause actual
results or events to differ materially from the forward-looking
statements that we make, including risks related to new information
arising out of clinical trial results, the risk that the safety and/or
efficacy results of existing clinical trials for Cinryze(TM) will not
support approval for a biologics license, the risk that the FDA may
require us to conduct additional clinical trials for Cinryze(TM), the
risk that the FDA may interpret data differently than we do or require
more data or a more rigorous analysis of data than expected, the risk
that the FDA will not approve a product for which a biologics license
has been applied, our heavy dependence on the success of Cinryze(TM),
our dependence on our suppliers, our dependence on third parties to
manufacture Cinryze(TM), obtaining regulatory approval to market
Cinryze(TM), market acceptance of Cinryze(TM), maintaining the orphan
drug status associated with Cinryze(TM), the risks associated with
dependence upon key personnel, and our ability to obtain additional
funding to support our business activities. These and other risks are
described in greater detail in the "Risk Factors that May Affect
Results" section of our filings with the SEC. Our forward-looking
statements do not reflect the potential impact of any future
acquisitions, mergers, dispositions, joint ventures or investments we
may make. We do not assume any obligation to update any
forward-looking statements.
Investor:
Lev Pharmaceuticals
Jason Tuthill, 212-850-9120
jtuthill@levpharma.com
or
Media:
WeissComm Partners
Katherine Stueland, 312-208-0320
kstueland@wcpglobal.com
Copyright Business Wire 2008
