Omeprazole

MIAMI and WESTBURY, N.Y., Oct. 28, 2024 /PRNewswire/ -- PL Developments (PLD), a leader in the development, manufacturing, packaging, and distribution of consumer healthcare products, today announced two significant milestones: FDA approval for its Omeprazole OTC ANDA and the successful refinancing of its corporate debt. FDA Approval for Omeprazole OTC The FDA has granted approval for PLD's Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. The product will be manufactured at PLD's facility in Miami, FL, making PLD the only provider of Omeprazole OTC produced in the United States. This achievement underscores the company's extensive capabilities to develop, manufacture, and commercialize some of the most complex products offered in the US consumer healthcare market. "Receiving FDA approval for Omeprazole OTC is a significant achievement for our organization," said Evan Singer, President of PLD. "This accomplishment not only highlights our team's dedication and expertise in bringing complex products to market, but it also reinforces our role as a comprehensive supply partner for our customers. Our goal is to offer a wide assortment of consumer healthcare products that meet the highest standards of quality and reliability. We are committed to delivering value and consistency to our partners in an ever-evolving marketplace." The market for Omeprazole OTC in the United States is robust, with retail sales of approximately $550 million annually. PLD expects to commence commercial shipments of Omeprazole to its clients in early 2025. Corporate Debt Refinancing In addition to this product milestone, PLD today announces the successful completion of its offer to exchange (the "Exchange Offer") $350,000,000 aggregate principal amount of its outstanding 7.750% Senior Secured Notes due 2025 (the "Old Notes") for new PIK Toggle Senior Secured Notes due 2029 (the "New Notes") in an aggregate principal amount of $368,550,000. This strategic move was made possible through improved financial performance and a collaborative effort with key stakeholders. The completion of the Exchange Offer enhances the company's financial flexibility and positions it for continued growth and strategic investments. In addition, we previously entered into a commitment letter with certain holders of the Old Notes pursuant to which we expect to issue and sell to such holders in a private transaction additional New Notes in an aggregate principal amount of $131,450,000 (the "Concurrent Financing"). The proceeds from the Concurrent Financing will be used to repay the remaining amounts of Old Notes outstanding and to pay certain fees and expenses in connection with the Exchange Offer and the Concurrent Financing. "The successful consummation of the Exchange Offer is a strong affirmation of PLD's financial health and growth trajectory," said Asaph Naaman, Chief Financial Officer. "This achievement reflects our focus on operational efficiencies, free cash flow generation, and building strong relationships with external stakeholders. We are now well-positioned to capitalize on future opportunities and continue our upward momentum." The New Notes issued in the Exchange Offer have not been and the New Notes that will be issued in the Concurrent Financing will not be registered under the Securities Act, or any other applicable securities laws. This press release is for informational purposes only and is neither an offer to purchase the Old Notes nor a solicitation of an offer to sell the New Notes. Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and should be evaluated as such. About PLD Founded in 1988 and headquartered in Westbury, NY, PL Developments is a leading developer, manufacturer, packager, and distributor of consumer healthcare products. PLD operates pharmaceutical manufacturing facilities across the United States, encompassing approximately 2 million square feet of real estate and employing 1,800 people. PLD primarily serves US retailers with store brands and Consumer Packaged Goods (CPG) firms with national brands, offering an assortment of more than 450 unique products across several healthcare categories. SOURCE PL Developments WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace Coming off of a busy month, July is looking relatively quiet for the FDA, with only five big target action dates and one pivotal advisory committee meeting. Read below for more. Arcutis Proposes New Atopic Dermatitis Cream for Patients as Young as Six By July 7, the FDA is expected to release its verdict on Arcutis Biotherapeutics’ supplemental New Drug Application (sNDA), seeking approval for a 0.15% formulation of roflumilast cream for the treatment of atopic dermatitis in patients as young as 6 years. Roflumilast is a topical inhibitor of the phosphodiesterase 4 (PDE4) enzyme, which plays a role in increasing the production of pro-inflammatory mediators while dampening the body’s anti-inflammatory mechanisms. A 0.3% formulation of roflumilast is approved under the brand name Zoryve for the treatment of psoriasis in patients 6 years and older. The FDA in December 2023 expanded roflumilast’s indication, allowing its use for seborrheic dermatitis in patients aged 9 and above. Arcutis is backing roflumilast’s atopic dermatitis application with data from three Phase III programs, including INTEGUMENT-1 and INTEGUMENT-2, two identical parallel-group, double-blinded and vehicle-controlled studies. The 0.15% roflumilast cream aced these two studies, hitting four-week success rates of 32.0% and 28.9%, respectively. In January 2024, Arcutis released additional pooled analysis from these two trials, demonstrating that 91.5% of patients treated with 0.15% roflumilast saw an improvement in the Eczema Area and Severity Index, measured at 4 weeks. Roflumilast’s data package also included a Phase II dose-ranging study and a Phase I pharmacokinetic trial. Orexo’s Opioid Overdose Drug Awaits FDA Verdict Orexo AB is proposing its high-dose naloxone drug candidate OX124 as a nasal rescue treatment for opioid overdose. The FDA’s deadline for a decision is July 15. Originally approved under the brand name Narcan, naloxone is a well-known treatment for opioid overdose. Currently available as an injectable and as a nasal spray, it works by competing with opioids for the same receptor sites, thereby undoing and dampening the drugs’ effects. Naloxone is effective at reversing the respiratory depression, hypotension and sedation often seen in patients who overdose on opioids. Orexo’s investigational formulation of naloxone makes use of its “world-class drug delivery platform,” dubbed amorphOX, according to the company’s news release accompanying the acceptance of its NDA. Through amorphOX, Orexo delivers a powder formulation of naloxone that is rapidly absorbed, highly bioavailable and highly stable. AmorphOX also makes naloxone more convenient and easier to use for patients, according to the company, making the product more robust to temperature changes. For instance, its efficacy is unaffected even if stored at freezing temperatures. If approved, Orexo expects to kick off commercial activities in the second half of this year, with a broader retail launch scheduled in early 2025, CEO Nikolaj Sørensen said in a statement. Phathom Pushes Voquezna into Heartburn in GERD The FDA is reviewing Phathom Pharmaceuticals’ application to use its oral drug Voquezna (vonoprazan) for the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD). Its decision is due on July 19. Afflicting around 38 million adults in the U.S., non-erosive GERD is the most common type of GERD and is characterized by reflux symptoms without mucosal erosions in the esophagus. Among its most common signs is episodic heartburn, which typically occurs at night. Patients with non-erosive GERD also suffer from regurgitation and chest pain and often have trouble swallowing. Voquezna, a potassium-competitive acid blocker, works by suppressing acid secretion and acts with preference on parietal cells found in the stomach. This mechanism of action helped the drug win its first FDA approval in November 2023, allowing its use for the treatment of erosive GERD and the relief of heartburn in erosive GERD. The NDA, which Phathom filed in September 2023, is backed by a randomized, placebo-controlled and double-blinded trial with 772 enrolled patients. Results showed that both the 10-mg and 20-mg doses of Voquezna aced the trial's primary endpoint, resulting in a 45% and 44% mean percentage of heartburn-free days over the 4-week treatment period, respectively, whereas this figure was only 28% in placebo comparators. During the study’s 20-week extension phase, the mean percentage of heartburn-free days in the 10-mg and 20-mg treatment groups increased to 62% and 63%, respectively. Alpha Cognition Targets Second Oral Alzheimer’s Drug of the Past Decade By July 27, the FDA is set to release its decision on Alpha Cognition’s NDA for ALPHA-1062, a next-generation acetylcholinesterase inhibitor being proposed for the treatment of mild-to-moderate Alzheimer’s disease. Formulated as a delayed-release oral tablet, ALPHA-1062 is the prodrug of an already-approved acetylcholinesterase inhibitor, galantamine, according to Alpha Cognition. The candidate works through a similar pathway, boosting the activity of acetylcholine on nicotinic receptors and the cholinergic neurotransmission in the central nervous system, in turn inducing cognitive improvements. Compared with galantamine, however, ALPHA-1062 promises a cleaner safety profile. It carries additional benzoyl ester moieties, which allow it to bypass acetylcholine receptors in the gastrointestinal nervous system, thereby avoiding the unwanted stimulation of local neurons and reducing side effects, according to Alpha Cognition’s website. ALPHA-1062’s NDA, which the FDA accepted in December 2023, is supported by studies establishing the bioequivalence of the drug candidate to galantamine. If approved, ALPHA-1062 would be the second oral Alzheimer’s therapy in a decade, according to a February 2024 release from Alpha Cognition. Xspray Tries Again for CML Therapy Dasynoc In February 2024, the FDA accepted Xspray Pharma’s NDA resubmission for Dasynoc (dasatinib), being proposed for the treatment of chronic myeloid leukemia. The regulator’s verdict is due on July 31. According to Xspray’s news release alongside the NDA’s acceptance, Dasynoc is an “optimized version” of Bristol Myers Squibb’s dasatinib, which the pharma sells under the brand name Sprycel. For instance, Dasynoc is unaffected by stomach pH and can be used together with omeprazole, as per Xspray’s website. Dasynoc also has a more consistent uptake pro can be given at lower doses than Sprycel. In July 2023, the FDA rejected Xspray’s initial bid to win approval for Dasynoc. At the time, the regulator accepted the proposed brand name and did not identify deficiencies with the application’s stability and clinical data. Instead, the FDA requested additional information regarding Dasynoc’s dosing in order to avoid confusion among doctors and patients. The regulator also asked for more information regarding a third-party manufacturer. In a February 2024 news release, CEO Per Andersson said that despite the initial rejection, Xspray remains “on track” to launch Dasynoc on September 1, if approved. FDA’s ODAC Convenes to Discuss AstraZeneca’s Imfinzi Regimen in NSCLC On July 25, the FDA’s Oncologic Drugs Advisory Committee will meet to discuss AstraZeneca’s supplemental Biologics License Application for its antibody therapy Imfinzi (durvalumab) for the treatment of resectable non-small cell lung cancer (NSCLC). The panel of external experts will evaluate AstraZeneca’s application for neoadjuvant treatment with Imfinzi and chemotherapy, followed by Imfinzi monotherapy after surgery. The advisory committee will also evaluate whether the pharma should be required to justify Imfinzi treatment before and after surgery. Imfinzi is a monoclonal antibody designed to target and block the PD-L1 protein, in turn inhibiting its downstream signaling cascade. This mechanism hampers cancer cells’ ability to weaken and evade the immune system, while also boosting the body’s innate anti-cancer activity. The FDA first approved Imfinzi in May 2017 for the treatment of advanced bladder cancer. The treatment has since been indicated for several other cancers, including unresectable stage III NSCLC, biliary tract cancer, pancreatic cancer and advanced or recurrent endometrial cancer. In April 2023, AstraZeneca published data from the Phase III AEGEAN study showing that neoadjuvant Imfinzi with chemotherapy, followed by maintenance Imfinzi monotherapy, significantly improved event-free survival in patients with resectable early-stage NSCLC versus chemotherapy alone. The Imfinzi-based regimen also resulted in a significantly higher pathologic complete response. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.