Congenital Lobar Emphysema

DUBLIN, June 15, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping dexlansoprazole 30 mg capsules, a generic version of Takeda's Dexilant®. This additional dosage strength rounds out the product family, now with both 30 mg and 60 mg delayed-release capsules. "We're proud to provide this high-quality, affordable generic medication to appropriate patients," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "The dexlansoprazole product family strengthens our portfolio and our reputation as a reliable supplier." Dexlansoprazole is a proton pump inhibitor with a novel delivery system approved for the treatment of erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). According to IQVIA™, Dexilant® 30 mg sales were approximately $45 million for the 12 months ended April 30, 2023. Dexilant® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria. PPIs, including dexlansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products. WARNINGS AND PRECAUTIONS Dexlansoprazole Delayed-Release Capsules, 60 mg, contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Presence of Gastric Malignancy: In adults, symptomatic response to therapy with dexlansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy. Acute Tubulointerstitial Nephritis (TIN): TIN has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms, from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia). Discontinue dexlansoprazole and evaluate patients with suspected acute TIN. Clostridium difficile-Associated Diarrhea: Published observational studies suggest that PPI therapy like dexlansoprazole may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated. Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs. Discontinue dexlansoprazole delayed-release capsules at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. Cutaneous and Systemic Lupus Erythematosus (CLE and SLE): CLE and SLE have been reported in patients taking PPIs. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. SLE is less commonly reported than CLE in patients receiving PPIs. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving dexlansoprazole delayed-release capsules, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Cyanocobalamin (Vitamin B12) Deficiency: Daily treatment with any acid-suppressing medications over a long period of time (eg, longer than three years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. Hypomagnesemia and Mineral Metabolism: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (eg, diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically. Interactions with Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. Interaction with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients. Fundic Gland Polyps: PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated. Risk of Heart Valve Thickening in Pediatric Patients Less Than Two Years of Age: Dexlansoprazole is not recommended in pediatric patients less than two years of age. ADVERSE REACTIONS Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. Patients 12 to 17 years of age (≥5%): headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause adverse effects on fetal bone growth and development. Pediatrics: Based on data with lansoprazole, dexlansoprazole is not effective in patients with symptomatic GERD 1 month to less than 1 year of age and nonclinical studies have demonstrated adverse effects in juvenile rats. INDICATIONS AND USAGE Healing of Erosive Esophagitis (EE): Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of EE for up to eight weeks. Maintenance of Healed Erosive Esophagitis and Relief of Heartburn: Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks. Please click for Full Prescribing Information. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Sims, any statements relating to product launch, commercialization, sales, supply or distribution, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. SOURCE Endo International plc

US specialists' lack of satisfaction with current treatment options in cutaneous and discoid lupus paves the way for advanced pharmacological agents to disrupt the market EXTON, Pa., May 8, 2023 /PRNewswire/ -- According to the Lupus Foundation of America, approximately two-thirds of people with the autoimmune condition systemic lupus erythematosus (SLE) will develop some type of skin disease, called cutaneous lupus erythematosus (CLE). Skin disease in lupus can cause rashes or lesions, most of which will appear on the sun-exposed areas of the body. While some patients suffer from CLE along with other systemic lupus symptoms like joint pain and fatigue, others with the condition have symptoms limited only to the skin. A more serious condition called discoid lupus erythematosus (DLE) occurs in over half of CLE cases, where disk-shaped, round lesions appear on the skin, often producing scarring and skin discoloration. Despite recent advances in the treatment of SLE and lupus nephritis (LN) in the form of AstraZeneca's Saphnelo (anifrolumab), GSK's Benlysta (belimumab), and Aurinia's Lupkynis (voclosporin), substantial unmet needs still exist within the CLE and DLE space, according to recent Spherix research conducted in collaboration with more than 100 U.S. treating rheumatologists and dermatologists in March 2023. Three-quarters of both specialists note an extremely high unmet need for new pharmacological treatment options in CLE, with rheumatologists expressing a significant need for therapy options in discoid lupus specifically – higher, in fact, than for both lupus and lupus nephritis. Specialists in the study cohort elaborated: "We need more safe and effective treatments. Nothing works right now." – Dermatologist "We need steroid-sparing drugs that work faster and better than what we have, with fewer side effects." – Rheumatologist "We need drugs to suppress the disease, minimize flares and prevent scarring." – Rheumatologist "We need a targeted non-steroid therapy with minimal worrisome side effects." – Dermatologist There are currently no specific FDA-approved therapies for cutaneous lupus erythematosus (CLE) or discoid lupus erythematosus (DLE) – conditions which mostly affect women and people of color. Rheumatologists and dermatologists rely on topical therapies (e.g., topical steroids, topical calcineurin inhibitors, and topical retinoids), DMARDs (e.g., hydroxychloroquine, mycophenolate mofetil, methotrexate), and/or or biologics such as Benlysta (belimumab), Saphnelo, and rituximab which are used to treat systemic lupus erythematosus (SLE). Spherix Global Insight's Market Dynamix™ Cutaneous Lupus Erythematosus service focuses on this evolving market, where a paradigm shift is expected within the next few years. The service includes access to annual reports based on survey responses from community-level physicians, in addition to qualitative feedback from key opinion leaders (KOLs) and treating physicians, on their understanding and management of the condition (with and without systemic involvement), its diagnosis, pharmacological treatment, co-management between specialties, unmet needs, and the promising pipeline including Bristol Myer Squibb's Sotyktu (deucravacitinib, approved for plaque psoriasis), Biogen's litifilimab, Horizon's daxdilimab, Sanofi's eclitasertib, Gilead's GS-5718, Merck's enpatoran, among others. About Market Dynamix™ Market Dynamix is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. About Spherix Global Insights Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company's unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers. A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology. To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter. Spherix Global Insights Contacts Ryan Rex, Insights Director, Rheumatology [email protected] Scott Upham, Corporate Communications [email protected] NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement by any company, brand, or product aforementioned. SOURCE Spherix Global Insights

May 25th, 2023 at 11:00 AM ET (Virtual Event) WALTHAM, Mass. & MONTREAL--(BUSINESS WIRE)-- Ventus Therapeutics, a biopharmaceutical company utilizing structural biology and a proprietary computational chemistry platform to identify and develop differentiated small molecule therapeutics across a broad range of diseases, announced today that it will host its inaugural Program Spotlight on VENT-03 on May 25th, 2023 at 11:00 AM ET. The virtual event will feature VENT-03, a first-in-class cGAS inhibitor in development for lupus and other inflammatory disorders. cGAS, a highly sought-after target, is an innate immune sensor of nucleic acids that, when aberrantly activated, leads to auto-inflammation and tissue damage. The pathway has been clinically validated in systemic lupus erythematosus (SLE) and is implicated in a wide range of immunological and neuroinflammatory conditions. Ventus has demonstrated proof-of-mechanism with its portfolio of cGAS inhibitors in multiple disease models. Despite significant efforts across the industry over the past decade, VENT-03 will be the first cGAS inhibitor to advance to the clinic, demonstrating Ventus’ ability to drug a target that has been undruggable to date and has the potential to significantly improve treatment options for patients. As part of the event, Ventus scientists, together with Dr. Victoria Werth, Professor of Dermatology and Medicine at Penn Medicine, will discuss the biology of the cGAS pathway and its importance in immunology. They will also review the current treatment landscape and the potential of VENT-03 as an effective treatment for SLE and present the clinical development plan for VENT-03, including an overview of Ventus’ differentiated translation to the clinic. A live question and answer session will follow. To register for the event, please click here. About cGAS cGAS is an intracellular pattern recognition receptor that is activated after binding to double-stranded DNA (dsDNA) in the cytoplasm. dsDNA in the cytoplasm is generally associated with cellular dysfunction, as seen in multiple diseases such as systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE), and dermatomyositis (DM). cGAS activation leads to cGAMP formation, activation of STING and downstream expression of type I interferons such as IFN-α, -ß and -κ, leading to pronounced inflammation and tissue damage. This pathway also leads to the expression of several other proinflammatory cytokines such as CXCL10. Genetic mutations that lead to the aberrant activation of cGAS/STING in humans are known to cause severe infant onset Aicardi-Goutières Syndrome (AGS) and genetic forms of chilblain lupus, demonstrating the relevance of the pathway in human diseases. Given that the pathophysiology and presentation of these genetic diseases have significant similarities with idiopathic complex diseases such as SLE, CLE, and DM, these diseases represent highly compelling opportunities for treatment with a cGAS inhibitor. About Ventus Therapeutics Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation, and neurology. The Company’s proprietary drug discovery platform, ReSOLVE™, gives it the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. Ventus’ first target screen was conducted in 2020, which led to the nomination of three development candidates in 2022, including: VENT-03, a potential first-in-class cGAS inhibitor; VENT-02, a brain-penetrant NLRP3 inhibitor; and VENT-01, a peripherally restricted NLRP3 inhibitor. These programs exemplify Ventus’ unique discovery capabilities and focus on first- and best-in-class programs for multi-indication immunology targets with franchise potential. For more information, please visit and engage with Ventus on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements about future expectations, plans, and prospects, including, but not limited to, statements related to the anticipated benefits of Ventus’ business strategy, pipeline programs, drug discovery platform, and financial position. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to the risks and uncertainties inherent in Ventus’ business, which include, without limitation, the timing, progress, and results of preclinical and clinical studies involving its development programs; the results of its earlier studies not being predictive of future results; its ability to enhance the ReSOLVE™ platform; its ability to continue to obtain funding for its operations and to implement its business strategy; the impact of the COVID-19 pandemic on its business; anticipated developments related to its competitors and its industry; the performance of third-party service providers, including suppliers, manufacturers, and CROs; and its ability to obtain, maintain, and protect its intellectual property. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ventus undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or otherwise.