LEV PHARMACEUTICALS, INC. (OTCBB: LEVP.OB)

Dear Reader,

Don't you just love it when people actually do what they say they are going to do?  We are pleased to report that our feature company has done just that!  As we indicated to you last week, Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB), a biotech company focused on inflammatory diseases, is moving into Phase III clinical trials with its treatment for hereditary angioedema.  Biotech investors know the importance of a Phase III clinical trial in terms of a viable science.  Many products and treatments that sound promising never get to this stage.  Congratulations to LEVP.OB!  Read the fantastic news below.  

You can review our full StockUpTicks profile on LEVP.OB by clicking here
 

About Lev Pharmaceuticals

Press Release 
Source: Lev Pharmaceuticals, Inc.
Tuesday March 15, 4:05 pm ET

NEW YORK--(BUSINESS WIRE)--March 15, 2005--Lev Pharmaceuticals, Inc. ("LevPharma" or the "Company") (OTCBB:LEVP - News) announced today the initiation of a Phase III clinical trial for the treatment of hereditary angioedema ("HAE"). Patient enrollment has begun in the trial designed to test the efficacy of the Company's lead product candidate, C1-esterase inhibitor ("C1-INH"), in treating HAE.

"I share the enthusiasm of the HAE community regarding the advent of the Lev C1 inhibitor study," said Bruce Zuraw, M.D., Professor of Medicine at the University of California San Diego and Principal Investigator of the Phase III trial. "I believe that this treatment modality has the potential to revolutionize the care of HAE in the United States."

The Phase III trial is a multi-center, placebo-controlled, double-blind study designed to examine the use of C1-INH in both treating acute attacks of angioedema and in preventing the onset of such attacks. In 2004 the Company received orphan drug designation from the United States Food and Drug Administration for C1-esterase inhibitor (human) in treating hereditary angioedema. Upon product licensure, orphan drug designation could provide the Company with seven years of marketing exclusivity for its C1-INH product as a treatment for HAE in the United States.

"This Phase III trial represents an important milestone in our program to bring an effective treatment for HAE to the U.S. patient population," said Joshua Schein, Ph.D., the Company's Chief Executive Officer.

HAE is a genetic disorder characterized by episodes of edema (swelling) in the extremities (the hands and feet), the face, the abdomen, and the larynx. There are thought to be 6,000 or more people with HAE in the United States. The majority of patients experience episodes of severe abdominal pain, nausea, and vomiting that is caused by swelling in the intestinal wall. Attacks that involve the face and throat can result in closure of the airway passages, and the mortality rate from untreated airway obstruction has been reported to be over 30% with death most frequently caused by asphyxiation due to airway closure. HAE is caused by a deficiency of C1-INH, and there are currently no approved treatments for acute attacks available in the United States.

LevPharma is developing its C1-INH product through an agreement with Sanquin Blood Supply Foundation ("Sanquin"), an Amsterdam-based not-for-profit organization that provides blood and plasma products and related services, carries out research and provides education, primarily in the Netherlands. Sanquin has been producing and selling successive generations of C1-INH, prepared from human plasma, in the Netherlands for over 30 years for the treatment of HAE. Continuous product development efforts at Sanquin have resulted in the current, highly purified product which has been marketed since 1997. Despite its long record of use in Europe, however, C1-INH, has never been introduced in the United States. Through a supply and distribution agreement with Sanquin, LevPharma has the exclusive right to market and sell C1-INH prepared by Sanquin for the treatment of HAE in North America and certain other geographic regions.

Patients and physicians interested in obtaining more information about the Phase III trial should contact LevPharma directly at 212-682-3096, or visit the Company's website at www.levpharma.com.

About Lev Pharmaceuticals, Inc.

LevPharma is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. LevPharma's product candidates are based on C1-esterase inhibitor ("C1-INH"), a human plasma protein that mediates inflammation and is potentially applicable as a treatment for a range of medical indications. In addition to the treatment of hereditary angioedema, LevPharma is also developing C1-INH for the treatment of acute myocardial infarction, or heart attack, and selective other diseases and disorders in which inflammation is known or believed to play an underlying role.

Legal notice to investors: Certain matters discussed in this news release are "forward-looking statements." These forward-looking statements, which apply only on the date of this release, generally can be identified by the use of forward-looking terminology such as "may," "will," "expects," "intends," "estimates," "anticipates," "believes," "continues" or words of similar import. Similarly, statements that describe LevPharma's future plans, objectives or goals are also forward-looking statements, which generally involve known and unknown risks, uncertainties and other facts that may cause the actual results, performance or achievements of LevPharma to be materially different from those expressed or implied by such forward-looking statements. Such factors may include the following: uncertainties associated with product development, the risk that LevPharma will not obtain approval to market its products, the risk that LevPharma's products will not gain market acceptance, the risks associated with dependence upon key personnel and the need for additional financing.

Contact:

Lev Pharmaceuticals, Inc.
Joshua D. Schein, Ph.D., 212-682-3096
 

Source: Lev Pharmaceuticals, Inc.
 
 

Corporate Summary

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The Lev lead program is the development of C1-INH for the treatment of hereditary angioedema (“HAE”).  HAE is a rare genetic disorder characterized by episodic attacks of edema (swelling) in the extremities, the gastrointestinal tract, and, most seriously, the airway passages.  The disease is caused by a deficiency of C1-INH, and there are approximately 10,000 patients with HAE in the United States. 

Sanquin has been producing and selling successive generations of C1-INH, prepared from human plasma, in the Netherlands for over 30 years for the treatment of HAE.   Continuous product development efforts at Sanquin have resulted in the current, highly purified product which has been marketed since 1997.  Despite its long record of use in Europe, however, C1-INH, has never been introduced in the United States.  Through a supply and distribution agreement with Sanquin, Lev has the exclusive right to market and sell C1-INH prepared by Sanquin for the treatment of HAE in North America and certain other geographic regions.

In the third quarter of 2004 Lev filed an Investigational New Drug Application (“IND”) with the U.S. Food and Drug Administration (“FDA”) to begin a Phase III clinical trial of C1-INH for the treatment of HAE.  Lev intends to initiate this Phase III clinical trial during the first half of 2005.  In July 2004 the company received orphan drug designation from the FDA for C1-esterase inhibitor (human) in treating hereditary angioedema.  Upon product licensure, this designation could provide Lev with seven years of marketing exclusivity for its C1-INH product as a treatment for HAE in the United States.

Lev is also developing C1-INH as a treatment for acute myocardial infarction (AMI), commonly known as heart attack.  AMI is caused by an obstruction of blood flow to the heart, and there are approximately 1,200,000 patients with AMI in the United States annually, resulting in an estimated 500,000 directly attributable deaths. Current treatments for AMI, both surgical and pharmaceutical, are directed at restoring blood flow or preventing further obstruction.  Despite a widespread appreciation for the role of inflammation in AMI in both the scientific and medical communities, no presently available treatments directly target the mechanisms of inflammation.  Based on preliminary animal and clinical data, Lev believes C1-INH may be useful as a treatment for AMI.

The process of inflammation underlies a number of other serious diseases, including gram-negative septicemia and inflammatory bowel disease, and is now also understood to play a role in other disorders previously thought to be unrelated to inflammation, including Alzheimer’s disease and stroke.  As a potent mediator of inflammation, C1-INH has been examined as a potential treatment for some of these diseases, in animal studies, and in a limited number of disorders, in clinical studies as well.  Based on these studies, and on the role C1-INH is known to play in inhibiting key inflammatory pathways, LEV intends to develop C1-INH for certain other diseases and disorders.  Lev management believes the extensive clinical experience with C1-INH in treating HAE in Europe will facilitate its introduction into other clinical indications.
 

Financial Highlights For LEVP.OB

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Last Trade: $1.20    52-Week High  $2.50 (01/03/05) 52-Week Low  $0.15 (05/28/04)

Shares Out (Millions) 76.303  Market Cap (Millions) $128.953 Float (Millions) 1.892

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