SOURCE: MELA Sciences

MELA Sciences

May 09, 2011 09:27 ET

MELA Sciences Submits a Citizen Petition to FDA Commissioner Calling for Enforcement of Binding Protocol Agreement and FDA Laws and Regulations in PMA Review of MelaFind®

Conference Call Scheduled for 10:00 a.m. EDT

IRVINGTON, NY--(Marketwire - May 9, 2011) - MELA Sciences (NASDAQ: MELA) today announced that it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA or the Agency), requesting that Margaret Hamburg, MD, Commissioner of the FDA, enforce its binding protocol agreement as well as FDA laws and regulations in the review of the MelaFind® pre-market approval (PMA) application.

"MELA Sciences is asking the Commissioner to investigate why her Agency has acted outside its own laws, regulations and guidelines, as described at length in the Citizen Petition," said Joseph Gulfo, MD, President and CEO, MELA Sciences.

Under FDA's regulation (21 CFR § 10.30(e)(2)), the submission of a Citizen Petition obligates the Commissioner to review the issues raised in the petition and respond within 180 days. The petition is a mechanism for raising important issues directly with FDA leadership.

"MELA Sciences took extraordinary steps to ensure that the MelaFind PMA would be reviewed in a transparent and efficient manner," Dr. Gulfo said. "We entered into a binding protocol agreement with the FDA prior to designing our clinical trial. We enrolled more patients into our pivotal study than any prospective trial ever conducted in melanoma detection. We believe we satisfied all of the clinical requirements laid out in the protocol agreement."

"Even with an expedited review and an urgent unmet medical need for better tools to detect melanoma at its earliest, most curable stages, the FDA's review of our PMA has extended nearly two years," Dr. Gulfo noted.

"Despite our requests for a meeting with the FDA following the November 18, 2010 MelaFind Advisory Panel meeting nearly six months ago, we have yet to receive a meeting date with the Agency," Dr. Gulfo continued. "Meanwhile, one American dies from melanoma every hour because early stage melanomas are being missed. We urge Dr. Hamburg and the Agency to enforce the protocol agreement and offer us a fair and transparent review of the MelaFind PMA package."

The MelaFind PMA application is based on the positive results of the company's landmark pivotal study, which included 1,831 pigmented skin lesions from 1,383 patients, making this the largest prospective study ever conducted in melanoma detection. Prior to the start of the study, the company and the FDA entered into a binding protocol agreement to stipulate the study design, including the sensitivity and specificity endpoints that should be used to determine the safety and effectiveness of MelaFind. In February 2011, as a response to public statements made by several members of the Advisory Panel, the company announced that it submitted an amendment to the MelaFind PMA, limiting the indication-for-use to dermatologists.

Earlier this year, PriceWaterhouseCoopers (PwC) released results of a survey showing that medical technology innovation, long centered in the United States, is moving offshore and that U.S. consumers could eventually be the last to have access to innovative medical technology.1 Subsequently, the FDA proposed a new "Innovation Pathway" program for pioneering medical devices, as part of its initiatives "to encourage cutting-edge technologies among medical device manufacturers."2

"While we were delighted to see President Obama and the FDA make a more efficient approval pathway for breakthrough medical devices a key priority, we owe it to patients here in U.S. to do all that we can do to turn the rhetoric of innovation into reality," Dr. Gulfo said. "Our investors have patiently stood by as we have invested more than $100 million into this technology. We firmly believe that MelaFind will be a useful tool to help dermatologists detect melanoma at the earliest most curable stage. I look forward to Commissioner Hamburg's decision and working with the Agency to bring MelaFind to the market and start changing the face of this dreadful disease as soon as possible. I will appreciate her personal attention in this critical matter."

The Citizen Petition delineates many instances in which MELA Sciences believes the Agency has acted outside its own laws, regulations and guidelines throughout the PMA review process, as well as ways in which the binding protocol agreement has been ignored in the PMA review. The company is requesting that the Commissioner enforce the binding protocol agreement and ensure that the PMA review is conducted with fidelity to FDA laws, regulations and guidelines.

A copy of the Citizen Petition submitted to the FDA will be available through the investor relations section of www.melasciences.com. For a direct link, click:
http://phx.corporate-ir.net/phoenix.zhtml?c=191863&p=irol-irhome.

Conference Call Information

MELA Sciences will host a conference call today at 10:00 AM EDT. To participate in the conference call, dial 888-801-6492 and ask for the "MELA Sciences conference call." International callers may dial 913-312-1460. In addition, a live audio of the conference call will be available over the Internet. Interested parties can access the event through the investor relations section of www.melasciences.com. For a direct link, click:
http://phx.corporate-ir.net/phoenix.zhtml?c=191863&p=irol-irhome.

About MELA Sciences, Inc:

MELA Sciences is a medical technology company focused on developing MelaFind®, a non-invasive and objective multi-spectral computer vision system intended to aid in the detection of early melanoma. MELA Sciences designed MelaFind® to assist in the evaluation of clinically atypical pigmented skin lesions, when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma. MelaFind® acquires and displays multi-spectral (from blue to near infrared) and reconstructed RGB digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma, the deadliest form of skin cancer. Although no cure is currently available for advanced-stage melanoma, melanoma is virtually 100% curable if caught early.

MelaFind® Proposed Indications for Use

MelaFind® is indicated for the evaluation of clinically atypical cutaneous pigmented lesions (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 mm, evolving, patient concern, regression, and "ugly duckling"), when a dermatologist chooses to obtain additional information before making a final decision to biopsy to rule out melanoma. MelaFind® is a non-invasive and objective multi-spectral computer vision system designed as a tool to aid dermatologists in the detection of early (e.g., non-ulcerated, not bleeding, or less than 2.2 cm in diameter) melanoma.

MelaFind® is not a screening device and is not indicated for non-pigmented lesions, banal pigmented lesions, lesions that are clinically indentified as definite melanomas, or lesions on special anatomical sites (i.e., acral, mucosal, subungual).

Regulatory Status

The MelaFind® Pre-Market Approval (PMA) application was filed with the FDA in June 2009, received positive FDA Advisory Panel recommendations in November 2010 and is currently under review at the FDA. In February 2011, the Company filed an amendment to the MelaFind® pre-market approval (PMA) application with theFDA, limiting the indication for use to dermatologists. MELA Sciences cannot predict either the timing of the FDA's decision on the PMA application or the outcome. FDA approval is required prior to marketing MelaFind® in the United States.

For more information on MELA Sciences, visit www.melasciences.com.

Safe Harbor

This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and intentions and other statements that contain words such as "expects," "contemplates," "anticipates," "plans," "intends," "believes," "assumes," "predicts" and variations of such words or similar expressions that predict or indicate future events or trends, or that do not relate to historical matters. These statements are based on our current beliefs or expectations and are inherently subject to significant known and unknown uncertainties and changes in circumstances, many of which are beyond our control. There can be no assurance that our beliefs or expectations will be achieved. Actual results may differ materially from our beliefs or expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties facing the company such as those set forth in its reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (the "SEC"). Factors that might cause such a difference include whether the data from our pre-clinical studies and clinical trials is sufficient to support regulatory approval of MelaFind®, whether we are required to provide the FDA with additional data or perform additional testing on MelaFind® or, even if we do receive regulatory approval, whether any such approval is for the indications we seek. Given the uncertainties affecting companies in the medical device industry such as the company, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. The company urges you to carefully review and consider the disclosures found in its filings with the SEC which are available at www.sec.gov and www.melasciences.com.

(1) http://www.pwc.com/us/en/health-industries/health-research-institute/innovation-scorecard

(2) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242629.htm

Contact Information

  • For further information contact:
    For Investors:
    David Carey
    Lazar Partners, Ltd.
    646-871-8485

    For Media:
    Hollister Hovey
    Lazar Partners, Ltd.
    646-871-8485