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DewDiligence

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Re: genisi post# 61378

Friday, 05/02/2008 2:08:52 PM

Friday, May 02, 2008 2:08:52 PM

Post# of 253125
FDA Panel Endorses LEVP’s Cinryze

[The panel meeting nominally pertained to the BLA for the prophylactic HAE indication only; however, it’s reasonable to infer that the positive outcome reflects well on the BLA for the acute indication too. LEVP is up only modestly today because the positive panel vote was widely exepcted from the briefing docs.]

http://biz.yahoo.com/bw/080502/20080502005620.html

>>
Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze™ for Hereditary Angioedema

Friday May 2, 1:32 pm ET

Company to Host Conference Call on Monday, May 5 at 8:30 am EST

NEW YORK & WASHINGTON--(BUSINESS WIRE)--Lev Pharmaceuticals, Inc. (OTCBB: LEVP ) today announced that the Blood Products Advisory Committee to the U.S. Food and Drug Administration (FDA) today voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Cinryze™ (C1 inhibitor) for the prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency.

If approved, Cinryze™ would be the first C1 inhibitor replacement therapy for patients with HAE in the U.S. HAE is characterized by extremely painful, debilitating and sometimes fatal swelling of the extremities, face, genitals, abdomen and laryngeal tract. These attacks, which affect an estimated 10,000 people in the U.S., are usually unpredictable and may be spontaneous or precipitated by emotional or physical stress.

“The advisory committee’s support of Cinryze™ represents an important advancement for HAE patients, caregivers, advocates and physicians who treat this devastating disease,” said Joshua Schein, chief executive officer of Lev. “We look forward to continuing to work with FDA to secure approval of Cinryze™ in order to serve the patients and families who suffer from HAE.”

The FDA had issued a complete response letter (or “approvable” letter) in January, in which the 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 were requested in the FDA’s letter. Lev subsequently filed its complete response to the FDA.

The FDA will review the advisory committee’s recommendations in connection with its consideration of Lev’s BLA.

Conference Call Information

The Company will hold a conference call and audio webcast for investors on Monday, May 5, at 8:30 a.m. Eastern Standard Time (EST). The conference call will be available via live webcast on Lev's website at www.levpharma.com. To participate by telephone, the domestic dial-in number is 866-383-8108 and the international dial-in is 617-597-5343. The access code is 75322162. Investors are advised to dial into the call at least ten minutes prior to the call to register. The conference call will be available via live webcast on Lev's website at www.levpharma.com.

About Cinryze™

Cinryze™ is a plasma-derived C1 inhibitor product that has been studied for the prophylactic and acute treatment of HAE. C1 inhibitor has been used for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.

In the Phase III prophylactic treatment trial, Cinryze™ decreased the normalized number of HAE attacks compared to placebo. The trial had a crossover design with 22 subjects in the efficacy data set. The difference between the number of angioedema attacks during treatment with Cinryze™ and the number during treatment with placebo was statistically significant (p<0.0001). During 12 weeks of prophylactic treatment with Cinryze™, the number of attacks per patient ranged from 0 to 17.6 with a mean of 6.3 (±5.5) and a median of 6 attacks. During 12 weeks of treatment with placebo, the number of attacks per patient ranged from 6 to 20.5 with a mean of 12.7 (± 4.6) and a median of 13.5 attacks. The clinically and statistically significant results for the primary endpoint demonstrating the efficacy of Cinryze™ were supported by statistically significant and clinically meaningful differences in all of the secondary endpoints, with Cinryze™ demonstrating reductions in the severity and duration of attacks, number of days of swelling, and need for open-label Cinryze™ rescue therapy.

In the Phase III acute treatment trial, the median time to the onset of unequivocal relief of symptoms for an acute attack was significantly different between the Cinryze™ group (2 hr) and placebo group (> 4 hr) (p=0.026). The application for the treatment of acute attacks of HAE was not presented before the Blood Products Advisory Committee and is currently under active review at FDA.

Additionally, Cinryze™ has been well tolerated with an adverse event profile no different from placebo. The most common adverse reactions observed have been upper respiratory infection and sinusitis. No drug-related serious adverse events (SAEs), no immunogenicity and no decrease in efficacy have been observed.

As part of Lev's CHANGE trials (C1 inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy), the Company is conducting two open label studies for the treatment and prevention of HAE. Qualifying HAE patients continue to have access to Cinryze™ on a compassionate use basis, free of charge. To date, more than 6,000 doses of Cinryze™ have been administered in all parts of the CHANGE trials with more than a dozen patients having individually received well over 100 doses.

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.
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