A.P. Pharma Receives FDA Complete Response Letter for APF530 |
|
|
|
A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its lead product candidate, APF530, for the prevention of chemotherapy-induced nausea and vomiting (CINV). The CRL describes the following issues that must be addressed.
“We appreciate the FDA’s thorough review of the APF530 NDA,” stated John B. Whelan, A.P. Pharma’s president and chief executive officer. “While disappointed in today’s notification, we believe that the issues raised in the CRL are addressable, and we remain firmly committed to the successful development of APF530, which we believe will fulfill an important unmet need and improve the lives of patients suffering from CINV. In order to allow us time to carefully address the issues raised in the CRL, we are now projecting product launch for the first half of 2014, versus our prior guidance of the second half of 2013.” Conference Call Details A.P. Pharma will host a conference call on Thursday, March 28, 2013 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Interested investors may participate in the conference call by dialing (877) 856-1964 (domestic) or (719) 386-0001 (international) and use participant code 135738. In addition, the live conference call is being webcast and can be accessed on the "Calendar of Events" page of the "Investors" section of the Company's website at www.appharma.com . A replay of the webcast will be posted to this same section of the website available approximately two hours after the call. About APF530 A.P. Pharma's lead product, APF530, is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV, so this indication represents an area of particular unmet medical need. APF530 contains the 5-HT3 antagonist granisetron formulated in the Company’s proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for APF530 because it is widely prescribed by physicians based on a well-established record of safety and efficacy. About A.P. Pharma A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer™ polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks. The Company’s lead product, APF530, is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting. A.P. Pharma resubmitted its New Drug Application (NDA) for APF530 to the U.S. Food and Drug Administration (FDA) in September 2012 and received a Complete Response Letter in March 2013. For further information, please visit the Company's web site at www.appharma.com . Forward-looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the potential approval of APF530 and the potential timing for such approval, if approved at all, the projected timing for the commercial launch of APF530, if approved, as well as risks relating to capital resources and liquidity, satisfactory completion of clinical studies, progress in research and development programs, successful launch and acceptance of new products and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law. |
A.P. Pharma Receives FDA Complete Response Letter
Top 10 Most Recent News Articles
Madrigal Faces Troubling Whistleblower Claims
Whistleblower Complaint Rocks Madrigal Let me tell you, today's chatter isn't for the faint-hearted investor. Madrigal Pharmaceuticals (NASDAQ: MDGL) is under scrutiny, and it's making waves. The gears started turning when their former Senior VP and Head of Clinical Development unloaded a bombshell: he reported dirt on Madrigal's safety and efficacy data for Rezdiffra,...
Continue Reading
Simon® Expands Footprint with Sagefield™ in Nashville
New Ventures in South Nashville You don't often see a development stirring up as much buzz as Simon's latest project, Sagefield™, in South Nashville. This isn't just any run-of-the-mill shopping center. No, Simon is dialing it up a notch, aiming to blend high-end retail, unique dining experiences, and standout design all into one lively spot. For those keeping an eye on...
Continue Reading
Lilly's $3.5B Bet: Next-Gen Obesity Drug Site
Pennsylvania Becoming a Pharma Hub There's a big pharma shuffle happening in the heart of Pennsylvania, folks. Eli Lilly's throwing a whopping $3.5 billion into a new facility in Lehigh Valley, marking it the latest pawn in their larger $50 billion strategy to bolster medicine production right here in the U.S. You talk about commitment, and this investment is no small...
Continue Reading
United Community Rises in Top Banks, Celebrates 10-Year Streak
Celebrating a Decade of Employee Satisfaction Nailing that balance between growth and nurturing a quality workplace—now that's a hard row to hoe for many giants. Yet, United Community has strutted down this path for ten years straight, landing them again on American Banker's 'Best Banks to Work For' list. That kind of consistency screams commitment, don't it? But what's...
Continue Reading
Kroll's Geoeconomic Risk Index: A Financial Sentinel
Diving into Kroll's New Geoeconomic Risk Index When global storms brew, businesses yearn for a reliable compass. In swoops Kroll with its Geoeconomic Risk Index—a new tool aimed at taking the mystique out of geopolitical and economic uncertainties to forecast their impact on businesses' bottom lines. Understanding the Index This isn't just another fancy gadget for the...
Continue Reading
Kargo's Tech Boosts Profit on Seafood Supply Chain
Revolutionizing Seafood Logistics with Kargo You'd think managing seafood shipments would be a simpler gig than charting ocean routes, but think again. Northern Wind, a major player in seafood processing, just proved the power of tech in an old-school business by partnering with a slick AI outfit called Kargo. Their facility in New Bedford, Massachusetts now magically...
Continue Reading
West Virginia's Small Biz Insurance: Risks and Rewards
Insurance: More Than a Safety Net Rolling through Bluefield, West Virginia, you spot these humble small businesses propping up the local spirit—more than just storefronts, they’re the town's heartbeat. But, like any heartbeat, it’s vulnerable to a bunch of risks. That's where insurance steps in, like a cloak of safety keeping the vitals secure. Now, it’s not just...
Continue Reading
Lululemon Faces Legal Flare-Up: Investor Suit Unfolds
Storm's Brewing for Lululemon It ain't all zen at Lululemon these days. Amidst the yoga mats and stretchy pants, shareholders are unrolling lawsuits like it’s the new Pilates fad. A class action's been slapped on Lululemon Athletica Inc. (NASDAQ: LULU) over alleged investor deception, leaving quite a few with bruised portfolios. The Crux of the Lawsuit So, why is the...
Continue Reading
PROYA Skincare Expands to Ulta: A Scientific Ambition
A New Chapter for PROYA Bet you didn't see this one coming: a leading Chinese beauty brand, PROYA, is throwing its hat into the North American skincare ring, rolling out its science-backed skincare line nationwide at Ulta Beauty. The same brand that's been big news across Asia is now setting its sights on the U.S. with a stunning array of products that don't just promise...
Continue Reading
MGS Extends Engagement for BECI Power Line Project
The power game isn't always about flipping switches, my friends. With Midcontinent Grid Solutions (MGS), we're seeing another round of crowd-pleasing playacting as they pump the brakes on the BECI Project. New timeline, new promises—same old story. Investors, environmentalists, and citizens alike are watching this one unfold with a glass of iced tea and crossed fingers....
Continue ReadingTop 5 Most Recently Viewed Articles
Bombardier Celebrates First Challenger 3500 Deliveries
Landmark Deliveries of the Challenger 3500 Bombardier proudly announces a significant achievement with the beginning of deliveries of three state-of-the-art Challenger 3500 aircraft to Aloula Aviation. This event marks a milestone as these are the first Challenger 3500 aircraft registered in Saudi Arabia, showcasing Bombardier's dedication to enhancing global aviation....
Continue Reading
Glenn Fleischman Takes Charge as aytm's Chief Revenue Officer
Glenn Fleischman Takes Charge as aytm's Chief Revenue Officer aytm, a premier agile consumer insights platform for notable brands and organizations, is excited to announce the appointment of Glenn Fleischman as their new Chief Revenue Officer (CRO). This strategic move aims to boost growth and reinforce the company's leading position in the realm of agile market research....
Continue Reading
Class Action Alert for Bitfarms Ltd. Shareholders – Act Now
Attention Bitfarms Ltd. Shareholders Bitfarms Ltd. (NASDAQ: BITF) has been entangled in controversy, leading to a class action that affects many investors. If you acquired shares during a significant time period, it is crucial to be informed about your options and potential next steps. This article serves as an informative guide for those impacted by the fluctuations in...
Continue Reading
Lawsuit Filed Against University Park Church Over Abuse Claims
Legal Action Initiated Against University Park Church Andreozzi + Foote has recently initiated a significant legal action against the University Park Church of Christ, marking an important chapter in the quest for justice for survivors of sexual abuse. This lawsuit, lodged in the Prince George's County Circuit Court, focuses on distressing claims regarding the church's...
Continue Reading
Savaria Corporation Declares New Monthly Dividend Payment
Savaria Corporation's Monthly Dividend Announcement Savaria Corporation (TSX: SIS), a leader in the accessibility industry, has recently made an exciting announcement regarding its monthly dividend policy. The company declared a dividend of 4.67 cents ($0.0467) per common share, highlighting its dedication to delivering value to its shareholders. Details of the Dividend...
Continue Reading