SOUTH SAN FRANCISCO, Calif., Nov. 10 Anesiva,Inc. (Nasdaq: ANSV) today announced that the ACTIVE-1 Phase 3 trial evaluatingAdlea(TM), a novel formulation of capsaicin, narrowly missed its primaryendpoint of reducing post-surgical pain versus placebo (p=0.07) followingbunionectomy surgery at four to 32 hours post-surgery. The same measure washighly significant (p=0.004) from four to 48 hours post-surgery. The trialalso achieved a key secondary endpoint of reducing opioid use for Adlea versusplacebo (p=0.012) over the four to 32 hour period. Adverse events weresimilar for both active treatment and placebo groups. Results of a secondPhase 3 trial of Adlea, in total knee replacement surgery, will be announcednext month.
"It is important to note that the four to 32 hour pain measure reflectedthe inpatient period where activity is most restricted," said WilliamHoughton, M.D., Anesiva senior vice president and chief medical officer. "Incontrast, non-weight bearing mobilization increased during the latter period.Thus, the longer duration four to 48 hour measure highlights importantanalgesic potential for Adlea. We expect this to be confirmed in the upcomingACTIVE-2 total knee arthroplasty study which uses the same four to 48 houranalgesic measure as its primary endpoint."
Anesiva has determined that it will cease further commitments to supportZingo commercialization as a result of continued manufacturing challenges andthe need to recall product in the field due to a potential non-safety relatedshelf life issue from a lot of unreleased product. Anesiva plans to seek adevice-oriented partner for this asset. The company will also seek to licenserights to the underlying drug delivery technology to third parties for usewith other medications.
The company plans to meet with its joint venture partners in China todiscuss the future of the relationship. Anesiva will restructure, suspend orcancel Zingo distribution agreements for ex-U.S. territories. In order to winddown ongoing product support obligations, Anesiva will process the withdrawalof Zingo devices from the U.S. supply chain.
As a result of the decision to cease Zingo commercial operations, thecompany has agreed to work with its lenders to accelerate repayment of itsoutstanding $20.0 million loan. In order to preserve its capital, the companywill reduce its staffing to approximately 15 employees and reduce monthlyexpenditures to approximately $2.0 million, pending the results of the AdleaPhase 3 trial in total knee replacement surgery.
"These are difficult but necessary decisions that set a new foundationupon which to rebuild value for Anesiva's stock holders," said Michael L.Kranda, president and chief executive officer. "We look forward to theresults of the Adlea Phase 3 trial in total knee arthroplasty, and pursuingpartnering opportunities for this promising product candidate."
"The Anesiva Board of Directors strongly supports this new direction forAnesiva. We will continue to work closely with the company's management teamto ensure Anesiva has the resources to realize its objectives," said Rodney A.Ferguson, J.D., Ph.D., Anesiva's chairman. "We thank the departing employeesfor their service to the company."
As a result of the foregoing, Anesiva will delay filing its quarterlyreport on Form 10-Q for the quarter ended September 30, 2008. The Form 10-Qwill be filed as soon as reasonably practical and is expected to be filed nolater than November 14, 2008.
Adlea is a highly purified form of capsaicin (derived from chili peppers)that acts on TRPV1 receptors, expressed most densely in C-fiber neurons.Importantly, desensitization of the TRPV1 receptors blocks noxious pain withno effect on adaptive pain or position sense. Adlea generally has a shorthalf-life of 1 to 2 hours. It is undetectable in blood sample analyses after24 hours.
Adlea's short duration of systemic exposure (hours) relative to the longduration of analgesia may offer a safe, additive treatment option in themanagement of orthopedic pain over the days to weeks that patients experienceacute post-surgical pain. Importantly, Adlea appears to have a safety profilethat is largely similar to placebo, in studies performed to date.
Adlea ACTIVE-1 Clinical Trial
The ACTIVE-1 multicenter, double-blind, placebo-controlled trial enrolled301 patients undergoing bunionectomy surgery. Patients were randomized toreceive either a single 4 mL dose of Adlea (0.25 mg/mL) or placebo instilledinto the surgical site immediately prior to wound closure. The primaryefficacy endpoint was a time-weighted pain score (using standard 0 to 10numerical rating system of pain intensity) from four to 32 hours post-surgery.The study also evaluated rescue opioid consumption, pain level from four to 48hours and multiple other secondary endpoints. The study results will besubmitted for presentation at a scientific meeting.
Anesiva, Inc. seeks to be a leader in the development andcommercialization of novel pharmaceutical products for pain management. Thecompany's core product platform is based on Adlea, a novel small moleculeformulation of capsaicin that is currently being evaluated in multipleclinical trials for the management of acute pain following orthopedicsurgeries. Adlea has been shown in previous clinical trials to provideextended pain relief after only a single administration in multipleindications for site-specific, acute and chronic, moderate-to-severe pain.
Anesiva is based in South San Francisco, CA. For more information, go tohttp://www.anesiva.com.
Conference Call Details
Anesiva will conduct a webcast conference call with the investmentcommunity at on Tuesday, November 11, 2008 at 9:00 am Eastern time (6:00 amPacific time). Interested parties can listen to the live conference call bydialing 866-616-3642 (international dial: 660-422-4980) and giving thefollowing conference ID: 73355002, or by logging on to http://www.anesiva.comand going to the Investor Information page. For those unable to participatelive or via the Internet, a replay will be available for seven days after thecall by dialing 800-642-1687 (international dial: 706-645-9291) and giving thefollowing pass code: 73355002. The webcast will be available until thecompany's next quarterly conference call.
This press release includes "forward-looking statements" within themeaning of the Safe Harbor provisions of the Private Securities LitigationReform Act of 1995. Words such as "expect," "may," "achieve," "confirm,""intend," "extend," "plan," "preserve," "will," "seek," "appears," "continue,"and similar expressions are intended to identify such forward-lookingstatements. Forward-looking statements in this press release include mattersthat involve known and unknown risks, uncertainties and other factors that maycause actual results, levels of activity, performance or achievements todiffer materially from results expressed or implied by this press release.Such risk factors include, among others: ability to raise capital, potentialdelays in the commencement and enrollment of Adlea clinical trials and whetherthe Adlea clinical development program will support FDA approval for themanagement of acute pain following orthopedic surgeries. Actual results maydiffer materially from those contained in the forward-looking statements inthis press release. Additional information concerning these and other riskfactors is contained in Anesiva's annual report on Form 10-K for the yearended December 31, 2007, and its most recent filing on Form 10-Q.
SOURCE Anesiva, Inc.