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Lev Pharmaceutical announced today that it has entered into a letter agreement with the Sanquin Blood Supply Foundation (Sanquin), authorizing Lev to file for European marketing authorization of its lead product candidate, Cinryze(TM) (C1 inhibitor (human)), for the treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency
NEW YORK, NY, USA | July 1, 2008 | Lev Pharmaceuticals, Inc. (Lev or the Company) (OTCBB:LEVP) announced today that it has entered into a letter agreement with the Sanquin Blood Supply Foundation (Sanquin), authorizing Lev to file for European marketing authorization of its lead product candidate, Cinryze(TM) (C1 inhibitor (human)), for the treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency.
In addition, Lev has received notification from the European Medicines Agency (EMEA) that it is eligible to submit an application for Cinrzye(TM) for Community Marketing Authorization through the centralized European registration procedure.
Cinryze(TM) is manufactured in Europe by Sanquin using a state-of-the-art nano-filtration purification process under a distribution and manufacturing services agreement with Lev. Under its agreement with Sanquin, Lev currently holds the exclusive rights to market and distribute Cinryze(TM) for the treatment of HAE in North America. Lev is presently in discussions with Sanquin to expand its authorized territory to include certain European countries. Sanquin has been manufacturing C1 inhibitor for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.
Lev intends to submit its application to the EMEA in the fourth quarter of 2008. No assurances, however, can be given that Lev will ultimately be granted European rights to Cinryze(TM) or that the EMEA will approve any application for Community Marketing Authorization filed by Lev.
Cinryze(TM) Regulatory Status
On May 2, 2008, the Blood Products Advisory Committee (BPAC) to the U.S. Food and Drug Administration (FDA) voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Cinryze(TM) for the prophylactic treatment of HAE. The data from Lev's acute treatment trial was not presented before the BPAC and is currently under active review at FDA.
On May 6, 2008, Lev announced that FDA accepted for review Lev's complete response submission for Cinryze(TM) targeting an action date of October 14, 2008.
Open Label Extension Update
Lev continues to provide patients with access to Cinryze(TM) through its ongoing open-label acute and prophylactic trials. Currently, there are 67 patients taking Cinryze(TM) on an acute basis and 65 patients taking Cinryze(TM) prophylactically as a replacement therapy for HAE attacks. In addition, 26 patients are self-administering Cetor(R), Sanquin's C1 inhibitor product, under a special importation program.
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 www.levpharma.com.
SOURCE: Lev Pharmaceuticals, Inc. |
