Lev Pharmaceuticals Signs Agreements with CuraScript, CVS Caremark, and FFF Enterprises...

Wed Jun 4, 2008 12:48pm EDT

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Lev Pharmaceuticals Signs Agreements with CuraScript, CVS Caremark, and FFF Enterprises to Support Cinryze(TM) Commercialization

    Company Also Announces Plans for LevCare(TM) Program Providing
     Support Services to Hereditary Angioedema Patients and Their
NEW YORK--(Business Wire)--
Lev Pharmaceuticals, Inc. ("Lev" or the "Company") (OTCBB:LEVP)
announced today that it has entered into multi-year agreements with
CuraScript, CVS Caremark, and FFF Enterprises to serve as its
specialty pharmacy, specialty distribution and patient services
partners to support the U.S. commercialization of Cinryze(TM) (C1
inhibitor, (human)), the company's investigational treatment for
hereditary angioedema (HAE), also known as C1 inhibitor deficiency.

   Lev also announced plans to launch LevCare(TM), a program designed
to ensure that patients have ready access to Cinryze(TM) once it
becomes commercially available in the U.S. HAE is a rare, severely
debilitating, life-threatening genetic disorder caused by a deficiency
of C1 inhibitor, a human plasma protein. On May 2, 2008, U.S. Food and
Drug Administration's (FDA) Blood Products Advisory Committee voted
unanimously that there is sufficient evidence of safety and efficacy
to support the approval of Cinryze(TM) for the prophylactic treatment
of HAE. Cinryze(TM) is currently under review by the FDA.

   "By employing a 'limited distribution model' through the
comprehensive, coordinated and integrated services of CuraScript, CVS
Caremark, FFF Enterprises and LevCare(TM), we will be well positioned
to provide patients with broad access to Cinryze(TM) pending FDA
approval," said Judson Cooper, Lev's chairman. "We believe this proven
specialty pharmaceutical model will facilitate favorable reimbursement
coverage for and rapid uptake of Cinryze(TM) upon commercialization."

   CuraScript and CVS Caremark will provide specialty pharmacy and
specialty distribution services that deliver Cinryze(TM) directly to
patients, clinics and physicians. FFF Enterprises will serve as Lev's
3PL (Third Party Logistics) provider and specialty distributor to
supply Cinryze(TM) to hospitals, clinics and physicians. LevCare(TM),
which will be administered by TheraCom, a division of CVS Caremark,
will provide support services to patients and physicians, such as
benefit coverage investigations, prior authorizations, case management
and broad-based reimbursement assistance.

   About Hereditary Angioedema

   HAE 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 U.S.

   Additional information on HAE can be obtained from the U.S.
Hereditary Angioedema Association 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
(human)), is being developed as a replacement therapy for hereditary
angioedema (HAE), also known as C1 inhibitor deficiency. Cinryze(TM)
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

   About CVS Caremark

   CVS Caremark is the largest provider of prescriptions in the
nation. The company fills or manages more than 1 billion prescriptions
annually. Through its unmatched breadth of service offerings, CVS
Caremark is transforming the delivery of health care services in the
U.S. The company is uniquely positioned to effectively manage costs
and improve health care outcomes through its 6,300 CVS/pharmacy
stores; its pharmacy benefit management, mail order and specialty
pharmacy division, Caremark Pharmacy Services; its retail-based health
clinic subsidiary, MinuteClinic; and its online pharmacy, CVS.com.
General information about CVS Caremark is available through the
Investor Relations portion of the Company's website at
http://investor.cvs.com, as well as through the pressroom portion of
the Company's website, at www.cvs.com/pressroom.

   About CuraScript

   CuraScript, Inc. is a wholly owned subsidiary of Express Scripts,
Inc., one of the nation's largest Pharmacy Benefit Managers (PBM's).
As an experienced leader in the specialty pharmacy industry,
CuraScript specializes in providing specialty medications and support
to individuals with chronic illnesses requiring these complex,
high-cost therapies. CuraScript employs over 2,500 team members and is
headquartered in Orlando, Florida.

   About FFF Enterprises

   FFF Enterprises, a privately held corporation, is the largest and
most trusted distributor of plasma products, vaccines and other
biopharmaceuticals in the U.S. Founded in 1988, FFF is celebrating its
20th year with more than a billion dollars in 2007 annual sales and an
impeccable safety track record. FFF's Guaranteed Channel Integrity(TM)
ensures that products are purchased only from the manufacturer and
shipped only to healthcare providers, protecting patients and
manufacturers from counterfeit risks and pricing irregularities
inherent in secondary and gray market channels. FFF's proprietary
technologies, Verified Electronic Pedigree(TM) and Lot-Track(TM),
provide verification of this secure channel. FFF's ability to move
rapidly in a dynamically changing marketplace allows the creation of
new opportunities for our customers through innovative vehicles for

   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 FDA may
require us to conduct additional clinical trials for Cinryze(TM), 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(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.

Lev Pharmaceuticals
Jason Tuthill, 212-850-9130
WeissComm Partners
Katherine Stueland, 312-208-0320

Copyright Business Wire 2008