Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze(TM) for Hereditary Angioedema
April 15 2008 - 7:01AM
Business Wire
Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB) today announced that it
has formally submitted its complete response to the U.S. Food and
Drug Administration�s (FDA) complete response (or �approvable�)
letter for the Company�s lead product candidate, Cinryze� (C1
inhibitor). Lev is seeking marketing approval for Cinryze� for both
the acute and prophylactic treatment of hereditary angioedema
(HAE), also known as C1 inhibitor deficiency. A complete response
letter is issued by FDA to request additional information in
connection with its review. In its letter, FDA requested
information with respect to chemistry, manufacturing, and controls
(CMC), as well as additional analyses of existing efficacy data
from the Cinryze� trials. No additional safety information and no
additional clinical trials have been requested to date. In
addition, Lev is scheduled to present to the Blood Products
Advisory Committee (BPAC) on May 2, 2008. Advisory committees
provide FDA with independent advice from outside experts. The BPAC
meeting represents the next stage in the regulatory process for Lev
as the Company continues to work with FDA toward obtaining market
approval for Cinryze�. 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. 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� (C1 inhibitor), is being developed as a
replacement therapy for both the acute and prophylactic treatment
of hereditary angioedema (HAE), also known as C1 inhibitor
deficiency. Cinryze� has been granted orphan drug status for the
acute and prophylactic treatment 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� will not support approval for a biologics license, the
risk that FDA may require us to conduct additional clinical trials
for Cinryze�, the risk that FDA may interpret data differently than
we do or require more data or a more rigorous analysis of data than
expected, the risk that FDA will not approve a product for which a
biologics license has been applied, our heavy dependence on the
success of Cinryze�, our dependence on our suppliers, our
dependence on third parties to manufacture Cinryze�, obtaining
regulatory approval to market Cinryze�, market acceptance of
Cinryze�, maintaining the orphan drug status associated with
Cinryze�, 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.