Sovereign Pharmaceuticals LLC

ALPHARETTA, Ga., Oct. 1, 2024 /PRNewswire/ -- This ADHD Awareness Month, we stand with the ADHD community. Alora Pharmaceuticals, LLC, the largest U.S. manufacturer of methylphenidate medications,1 recognizes that ADHD impacts various aspects of daily life, from school to work to personal time. This month, let's all commit to increasing awareness and understanding of ADHD while fostering a more supportive environment. ADHD is among the most prevalent neurodevelopmental disorders in children and can be a lifelong disorder, with symptoms emerging in childhood and persisting into adulthood. Recognizing the signs of ADHD is an important step in obtaining a diagnosis.2 According to the Centers for Disease Control and Prevention (CDC), approximately 10.2% of children in the U.S., ages 3 to 17, have been diagnosed with ADHD.3 According to the National Institutes of Health (NIH), the percentage of adults with ADHD is estimated to be around 4-5%.4 These statistics indicate that millions of children and adults in the U.S. are living with this condition. Medication, along with behavioral therapy, is often used in ADHD treatment.2 Stimulants, like RELEXXII ®, are fast-acting and among the most well-known and frequently utilized medications for ADHD. The CDC states that 70-80% of children with ADHD experience a reduction in symptoms when using stimulant medications.5 "Raising awareness about ADHD is vital in breaking down barriers and fostering understanding. Accurate diagnosis and effective management are crucial for improving patient outcomes and quality of life. At Alora Pharmaceuticals, we strive to provide the resources and support needed to empower individuals with ADHD to reach their full potential," stated Shannon Faught, CCO of Alora Pharmaceuticals. For more information on RELEXXII® please visit relexxii.com. For Important Safety Information visit relexxii.com/isi. For full Prescribing Information, including BOXED WARNING, visit relexxii.com/pi. For U.S. residents only. About Alora Pharmaceuticals, LLC. Alora Pharmaceuticals, LLC is the parent company of six specialty pharmaceutical and pharmaceutical manufacturing companies. Headquartered in Alpharetta, GA, Alora is the parent company of the following organizations that comprise the Alora Family of Companies: Avion Pharmaceuticals, Acella Pharmaceuticals, Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories, and Vertical Pharmaceuticals. For media inquiries or for more information about Alora's efforts to address the nationwide ADHD treatment supply shortage, please contact Alora Pharmaceuticals, LLC: 1880 McFarland Parkway, Suite 110, Alpharetta, GA 30005; 1-678-325-5189. Relexxii® is a registered trademark of Vertical Pharmaceuticals, LLC. References: 1. Data on file, Osmotica Pharmaceuticals. 2. 3. 4. 5. SOURCE Alora Pharmaceuticals , LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ALPHARETTA, Ga., Dec. 19, 2023 /PRNewswire/ -- Alora Pharmaceuticals, LLC, the parent company of Vertical Pharmaceuticals, LLC, announced today the commercial availability of Relexxii® (methylphenidate hydrochloride extended-release tablets). Relexxii is a once-daily central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and in pediatric patients 6 years of age and older.1 With the introduction of Relexxii, patients and health care professionals will have an additional branded ADHD treatment option from which to choose. Continue Reading Once-daily Relexxii is now widely available in flexible dosing options that support a more tailored treatment approach throughout the ADHD treatment journey: 18-mg, 27-mg, 36-mg, 45-mg, 54-mg, 63-mg, and 72-mg. This line of once-daily strengths has been specifically designed to support targeted titration to help achieve the lowest effective dose and to help mitigate the need for multiple daily pills. Once-daily Relexxii strengths are offered in 9-mg increments, yielding two "in-between" doses of 45-mg and 63-mg. Available in flexible dosing options that support a more tailored treatment throughout the ADHD treatment journey. Post this Relexxii once-daily dosing is made possible by Alora Pharmaceutical's Osmodex® Drug Delivery Technology, which allows the medication to be released at a controlled rate throughout the day. With the immediate-release drug layer dissolving within one hour of administration, patients get the medicine they need quickly — and for up to 24 hours — with each daily dose. In a study of 60 healthy volunteers, once-daily dosing of Relexxii 72-mg demonstrated bioequivalence to twice daily dosing of Concerta® (methylphenidate HCI) 36-mg tablets.2 "Alora Pharmaceuticals recognizes the importance of reliability when it comes to ADHD medications. Our mission of manufacturing supply to address the nationwide shortage is unwavering. With Relexxii, we can offer the consistency of a branded treatment for individuals affected by ADHD. Alora Pharmaceuticals remains committed to ensuring that patients have access to affordable medications that they need", stated Harold (Art) Deas, CEO of Alora Pharmaceuticals, LLC. To learn more about Relexxii or to find patient support resources, please visit . For Full Prescribing Information, including BOXED WARNING, please visit . About Alora Pharmaceuticals, LLC Alora Pharmaceuticals, LLC is the parent company of six specialty pharmaceutical and pharmaceutical manufacturing companies. Headquartered in Alpharetta, GA, Alora is the parent company of the following organizations that comprise the Alora Family of Companies: Avion Pharmaceuticals, Acella Pharmaceuticals, Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories, and Vertical Pharmaceuticals. For media inquiries or for more information about Alora's efforts to address the nationwide ADHD treatment supply shortage, please contact Alora Pharmaceuticals, LLC: 1880 McFarland Parkway, Suite 110, Alpharetta, GA 30005; 1-678-325-5189. Relexxii® is a registered trademark of Vertical Pharmaceuticals, LLC. Osmodex® is a registered trademark of Acella Holdings, LLC. Concerta® is a registered trademark of ALZA Corporation. References: 1. Relexxii (methylphenidate hydrochloride extended-release tablets) package insert. Vertical Pharmaceuticals, LLC; 2023. 2. Data on file, Osmotica Pharmaceuticals US LLC. SOURCE Alora Pharmaceuticals , LLC

In connection with closing, AcelRx received approximately $2.7 million from Alora Pharmaceuticals and Aguettant AcelRx announces full repayment of its senior loan with Oxford Finance HAYWARD, Calif., April 5, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the closing of its divestment of DSUVIA® to Alora Pharmaceuticals (Alora). In connection with the closing of the transaction, AcelRx received a total of approximately $2.7 million from Aguettant and Alora. On March 14, Alora agreed to acquire all assets related to DSUVIA, including inventories, equipment and intellectual property in exchange for consideration at closing of $1.1 million, a 15% royalty on commercial sales of DSUVIA, 75% royalty on sales of DSUVIA to the Department of Defense and up to $116.5 million in sales-based milestones. In connection with the closing, AcelRx also decided to fully repay its senior loan with Oxford Finance, leaving the company debt-free after the closing of the transaction. "As previously announced, we are thrilled to begin the new chapter of AcelRx focused on our late-stage development product portfolio. We are confident we found the right partner in Alora to accelerate the commercialization and fully realize the potential of DSUVIA for our shareholders. Our complete attention is now directed towards the approval of Niyad™ and Fedsyra™, both of which we believe will address a clear unmet need for physicians and generate long-term value for AcelRx," stated Vince Angotti, Chief Executive Officer of AcelRx. About AcelRx Pharmaceuticals, Inc. AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's lead product candidate, Niyad is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. AcelRx is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, with an expected NDA filing in the first half of 2023, and PFS-02, a pre-filled phenylephrine syringe with an expected NDA filing in 2024. This release is intended for investors only. For additional information about AcelRx, please visit . About Nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that will be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC) and acute pancreatitis. About DSUVIA (sufentanil sublingual tablet), 30 mcg DSUVIA®, branded as DZUVEO® in Europe, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DSUVIA/DZUVEO was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA/DZUVEO is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile, when delivered sublingually, avoids the high peak plasma levels and short duration of action observed with IV administration. DZUVEO has been approved by the European Medicines Agency and Aguettant markets the drug in Europe. For more information, including important safety information and black box warning for DSUVIA, please visit . About Alora Pharmaceuticals, LLC Alora Pharmaceuticals, LLC is the parent company of six specialty pharmaceutical and pharmaceutical manufacturing companies. Alora is headquartered in Alpharetta, GA. Alora is the parent company of the following organizations that comprise the Alora family of companies, Avion Pharmaceuticals, Acella Pharmaceuticals, Osmotica Pharmaceuticals, Sovereign Pharmaceuticals, Trigen Laboratories and Vertical Pharmaceuticals. Forward-looking statements This press release contains forward-looking statements based upon AcelRx's current expectations. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "potential," "believe," "expect," "expects," "expected," "create," "created," "anticipate," "may," "will," "enable," "should," "seek," "approximately," "intends," "intended," "plans," "planned," "planning," "estimates," "benefits," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to AcelRx's product development activities and ongoing commercial business operations; (ii) risks related to AcelRx's commercial partner's success; (iii) risks related to the ability of AcelRx and its business partners to implement development plans, launch plans, forecasts and other business expectations; (iv) risks related to unexpected variations in market growth and demand for AcelRx's and its business partner's commercial and developmental products and technologies; (v) risks related to AcelRx's liquidity and our ability to maintain capital resources; (vi) AcelRx's ability to retaining its listing on the Nasdaq exchange; and (vii) risks relating to our ability to obtain regulatory approvals for our developmental product candidates. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC) and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. View original content to download multimedia: SOURCE AcelRx Pharmaceuticals, Inc. Company Codes: NASDAQ-NMS:ACRX