Healthcare Industry News: Lev Pharmaceuticals
News Release - June 26, 2007
Lev Pharmaceuticals, Inc. Announces Completion of Marketing and Sales Management TeamCompany is positioned to build sales force and complete launch preparations
Lead product candidate, C1-INH, to be marketed as Cinryze(TM)
NEW YORK, June 26 (HSMN NewsFeed) -- Lev Pharmaceuticals, Inc. ("Lev" or the "Company") (OTC Bulletin Board: LEVP.OB ) today announced it has completed the formation of its marketing and sales management team. During the past ten months, Lev has been building its commercial team and is now poised to complete launch preparations, including building a sales force, to support the commercialization of its lead product candidate, C1-esterase inhibitor (C1-INH), to be marketed as Cinryze(TM), for the treatment of hereditary angioedema (HAE), if and when approved by the FDA.
"We now have our marketing, reimbursement and sales management team in place and are well positioned to build our sales force and complete launch preparations," said Joe Truitt, Vice President of Sales and Marketing. "We have assembled a very experienced and dynamic commercial team with strong pharmaceutical experience and an impressive track record of success in launching major new products."
Key members of the marketing and sales management team include:
Stephen L. Collins, Executive Director, Distribution and Patient Services. Mr. Collins joined the Company from MedImmune where he last held the position of Senior Director, Managed Care and Customer Operations. Prior to MedImmune, Mr. Collins served as Regional Director of the Managed Care Team for Burroughs Wellcome, a Glaxo SmithKline company.
Paul Firuta, Director, Reimbursement and Managed Care. Mr. Firuta previously served as Director, National Accounts and Reimbursement at OraPharma, a Johnson & Johnson company. Prior to Johnson & Johnson, Mr. Firuta spent nine years at SmithKline Beecham Pharmaceuticals, where he last held the position of Manager, Business Development and Managed Care.
Susanne Heinzinger, Director of Marketing. Previously, Ms. Heinzinger was a Corporate Account Director, Reimbursement for OraPharma, a Johnson & Johnson company. While at OraPharma, Ms. Heinzinger developed and implemented marketing programs for the company's flagship product, ARESTIN®. Prior to Johnson & Johnson, Ms. Heinzinger served as Product Manager at TAP Pharmaceuticals where she worked on the commercial launch for LUPRON DEPOT®.
Mark Collins, National Sales Director. Prior to joining Lev, Mr. Collins spent the past nine years at Guidant, a Boston Scientific company, where he served as Manager, National Accounts in its Cardiac Rhythm Management and Vascular Intervention division. Prior to Guidant, Mr. Collins was Manager, Government Accounts at TAP Pharmaceuticals where he worked on the launch of PREVACID®, a leading heartburn relief medication.
To support the efforts of the marketing and sales management group, Lev has also appointed a product manager, two Corporate Account Directors and two Medical Science Liaisons, each with a track record of success in launching pharmaceutical products.
About Lev Pharmaceuticals, Inc.
Lev is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. The Company's lead product candidate is C1-esterase inhibitor (C1- INH), to be marketed as Cinryze(TM), which it is developing for the acute and prophylactic treatment of hereditary angioedema (HAE), a rare and life- threatening genetic disease. The Company recently announced positive results from the acute portion of its registrational Phase III clinical trial for HAE, designated CHANGE (C1-inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy). In addition, Lev has recently completed the prophylactic portion of the CHANGE trial. Based on the results of the acute study, the Company intends to submit a Biologics License Application (BLA) to the Food and Drug Administration in July 2007. Additionally, the Company intends to submit the data from the prophylactic study, if positive and supportive, as an amendment to the BLA. The Company is also evaluating the development of 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. Lev's C1-INH has been granted orphan drug status for the treatment and prevention of HAE attacks, potentially securing, upon approval, market exclusivity for seven years. The Company has also received fast track designation status from the FDA, which facilitates the development and expedites the review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
For more information about Lev and C1-INH for the treatment of HAE, please contact the Company directly at 212-682-3096 or visit the Company's website at www.levpharma.com.
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 Lev'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 Lev 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 Lev will not obtain approval to market its products, the risk that Lev's products will not gain market acceptance, the risks associated with dependence upon key personnel, the need for additional financing and other risks described in Lev's periodic reports filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations as to such future outcomes and Lev disclaims any obligation to update the forward-looking statements made herein.
Source: Lev Pharmaceuticals
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