Vipoma

BOCA RATON, Fla. and RICHLAND, Wash., March 14, 2023 /PRNewswire/ -- PharmaLogic Holdings Corp. ("PharmaLogic" or "the Company"), a contract development and manufacturing organization and radiopharmaceutical manufacturer, today announces the signature of a Master Services Agreement with Viewpoint Molecular Targeting, Inc., a wholly-owned subsidiary of Perspective Therapeutics, Inc. ("Perspective") (NYSE AMERICAN: CATX), for the development and production of theranostic candidates VMT-01 and VMT-α-NET. The radiopharmaceuticals are currently in development for the diagnosis and treatment of metastatic melanoma and neuroendocrine tumors (NETs), respectively. Under the terms of the agreement, PharmaLogic will produce and supply doses of VMT-01 and VMT-α-NET for use in Perspective's early-stage clinical trials. This will complement the existing radiopharmaceutical GMP capability that Perspective already has at its mid-west site. Scott Holbrook, PharmaLogic's Chief Strategy Officer and General Manager, stated, "Targeted alpha therapy (TAT) with Pb-212 labeled radioligands offers one of the most exciting platforms for novel cancer therapy within the rapidly expanding precision radiotherapy ecosystem. The expertise of Perspective Therapeutics and PharmaLogic are well aligned to yield a successful collaboration around VMT-01 and VMT-α-NET." "We are delighted to select PharmaLogic as a trusted CDMO partner at this important juncture of the Viewpoint's clinical development journey," said Thijs Spoor, Perspective Therapeutics' CEO. "Radiopharmaceutical diagnostic imaging and therapeutic agents have a limited shelf life from time of manufacture to patient administration in the clinical setting. PharmaLogic's domain expertise in radiopharmaceuticals and broad national distribution footprint helps address our need for specialty radiopharmaceutical manufacturing at the highest level. As we have been given the safe to proceed authorizations from the U.S. Food and Drug Administration, we look forward to commencing enrollment of the Company's two image guided alpha-particle therapy studies at multiple clinical trial centers around the country. Furthermore, we look forward to reporting preliminary results from the clinical trials later in the year." "PharmaLogic is excited to partner with Perspective Therapeutics on the production and distribution of these personalized alpha-particle theranostics," said Chris Parr, PharmaLogic's Vice President of Radiochemistry and Technical Operations. "We value Perspective's scientific leadership in this area and believe it aligns perfectly with our mission of delivering clinically relevant precision medicine products to patients in the communities we serve." About PharmaLogic Holdings Corp. PharmaLogic is a world-class contract development and manufacturing organization specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other malignancies. In addition to an established and reliable network of radiopharmacies, PharmaLogic has decades of expertise in drug development from discovery, through manufacturing and commercialization. The Company seeks to take the lead in the advancement of radiopharmaceutical technology for the benefit of patients worldwide. For more information, visit: About Perspective Therapeutics Perspective Therapeutics, Inc., formerly known as Isoray, Inc., is a medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. Perspective Therapeutics is the sole producer of Cesium-131 brachytherapy seeds and has a proprietary technology that utilizes the isotope lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Perspective Therapeutics is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments. Perspective Therapeutics' melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs are entering Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. For more information, please visit their website at . Safe Harbor Statement Statements in this news release about Perspective Therapeutics, Inc.'s ("Perspective") and its wholly-owned subsidiary Viewpoint Molecular Targeting, Inc.'s ("Viewpoint," and together with Perspective, the "Company") future expectations, including: the functionality and capabilities of the Company's therapies including its targeted alpha-particle radiotherapy and its theranostic candidates VMT-01 and VMT- α-NET; the potential size of the commercial market for the Company's treatment programs; the Company's expectations, beliefs, intentions, and strategies regarding the future; and all other statements in this news release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing the Company of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as whether the alpha-particle therapy studies referred to in this news release are conducted on the anticipated timelines or are successful; the ability to raise ongoing capital to fund added costs of research and development related to the Company's business; the ability of the Company to manage growth and successfully integrate its businesses; whether the Company can maintain its key employees; the risk that the recent merger disrupts current plans and operations; the outcome of any legal proceedings that may be instituted against the Company following consummation of the merger; whether the Company's anticipated product pipeline is achieved; whether additional studies are released that reinforce the results of the studies discussed in this presentation; whether the anticipated benefits of the Company's therapies are realized; training and use of the Company's products; market acceptance and recognition of the Company's products; the Company's ability to enforce its intellectual property rights; whether ongoing patient results are favorable and in line with the conclusions of clinical studies and initial patient results; successful completion of future research and development activities; whether we, our distributors, and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell, and use our products in their various forms; the procedures and regulatory requirements mandated by the FDA for animal trials, human trials, clinical studies, Phase I and II approvals, fast track approvals, and 510(k) approval and reimbursement codes; changes in applicable laws and regulations; and other risks detailed from time to time in the Company's reports filed with the SEC. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. For more information regarding risks and uncertainties that could affect the Company's results of operations or financial condition, please review the definitive Proxy Statement filed on November 7, 2022, and our Form 10-K filed on September 28, 2022, with the SEC. Company Codes: AMEX:CATX

SAN FRANCISCO, CA / ACCESSWIRE / September 29, 2022 / Napo Pharmaceuticals, Inc. ("Napo"), the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the activation by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for Napo's NP-300, a novel drug product candidate for the symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral and parasitic infections including Vibrio cholerae, the bacterium that causes cholera. "We were very pleased to hear from the FDA that they have completed their review of our IND application for NP-300 and concluded that Napo may proceed with its proposed phase I clinical trial for the drug. Following the completion of the phase I trial, the Company will be positioned to initiate the next stage of our clinical development program for cholera-related diarrhea when our development team has the requisite resources and bandwidth to initiate the additional required trials," said Lisa Conte, Jaguar's president and CEO. "We are grateful for the partial financial support from the National Institute of Allergy and Infectious Diseases (NIAID) to support the NP-300 preclinical program." Cholera is an acute diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae. Although cholera is an orphan indication in the United States, it is estimated that, worldwide, 1.3 to 4 million cholera cases and 21,000 to 143,000 cholera-related deaths occur each year, according to the Centers for Disease Control and Prevention of the U.S. Department of Health & Human Services. Approximately one in 10 of infected persons will have severe disease characterized by profuse watery diarrhea, vomiting, and leg cramps. In these people, rapid loss of body fluids leads to dehydration and shock. Without treatment, death can occur within hours. Cholera is now endemic in many countries outside the United States. The largest cholera outbreak in recorded history occurred recently in Yemen. According to Oxfam, the number of cholera cases in Yemen in 2019 was the second largest ever recorded in a country in a single year, surpassed only by the numbers in Yemen in 2017. NP-300 is a novel oral botanical drug product that is sustainably derived from the Croton lechleri tree, the same source as that for crofelemer, and is planned to be developed under the FDA's Botanical Guidance. As stated on the FDA's website, crofelemer is currently one of only two drugs that have been approved under the FDA's Botanical Guidance definition of a botanical drug product. Upon completion of the requisite development activities to support the New Drug Application (NDA) and subsequent approval of NP-300 by the FDA for the symptomatic relief and treatment of diarrhea from cholera, the Company intends to pursue a Tropical Disease Priority Review Voucher ("TDPRV") under the FDA's financial incentive program to develop NP-300 for this indication. Priority review vouchers are transferable, and in past transactions by other companies have sold for values ranging from $67 million to $350 million, which provides for a potential immediate return on investment upon approval of NP-300 for the cholera-related diarrhea indication. About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health. For more information about Jaguar Health, please visit . For more information about Napo Pharmaceuticals, visit . Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's expectation that it will pursue a TDPRV related to the proposed cholera-related diarrhea indication for NP-300. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: Peter Hodge Jaguar Health, Inc. phodge@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View source version on accesswire.com:

VERO BEACH, Fla., Sept. 6, 2022 /PRNewswire/ -- QOL Medical, LLC, a ground-breaking, rare disease pharmaceutical company, announced today that the United States (U.S.) Food & Drug Administration (FDA) approved Sucraid® single-use containers for patients more than 33 lb (15 kg) with Congenital Sucrase-Isomaltase Deficiency (CSID). Currently, Sucraid® (sacrosidase) Oral Solution is the only pharmaceutical treatment for CSID in children and adults. Sucraid® is an enzyme replacement therapy for genetically determined sucrase deficiency, which is part of CSID. Sucraid® helps the breakdown and absorption of sucrose (table sugar) from the intestine, which relieve the gastrointestinal symptoms of CSID. Now Sucraid® is available in both Sucraid® multi-dose bottles and Sucraid® single-use containers. More information can be found at . "If untreated, patients living with this chronic condition suffer from debilitating symptoms. We are always looking for ways to improve their quality of life. These new single-use containers will make it easier for them to manage their medication," said Weng Tao, MD, PhD, COO of QOL Medical, LLC. "FDA's approval of Sucraid® single-use containers, with three-day room temperature stability, offer greater convenience for CSID patients on the go." People with CSID are unable to properly digest sucrose (table sugar), which is found naturally in many fruits and vegetables, as well as added to many processed foods. In adolescents and adults, CSID has been characterized by symptoms of chronic abdominal pain, gas, loose stools, and diarrhea, which overlap with common irritable bowel syndrome (IBS) symptoms. In infants, CSID classically presents as explosive watery diarrhea, failure to thrive, diaper rash, irritability, and acidic stools. Important Safety Information INDICATION Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). IMPORTANT SAFETY INFORMATION FOR SUCRAID® (SACROSIDASE) ORAL SOLUTION Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away. Sucraid® does not break down some sugars that come from the digestion of starch. You may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict starch in your diet. Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain, or glycerin (glycerol). Tell your doctor if you have diabetes, as your blood glucose levels may change if you begin taking Sucraid®. Your doctor will tell you if your diet or diabetes medicines need to be changed. Some patients treated with Sucraid® may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred. Check with your doctor if you notice these or other side effects. Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency. NEVER HEAT SUCRAID® OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Do not mix Sucraid® with fruit juice or take it with fruit juice. Take Sucraid® as prescribed by your doctor. Normally half of the dose of Sucraid® is taken before a meal or snack and the other half is taken during the meal or snack. Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit FDA.gov/medwatch or call 1-800-FDA-1088. Click here to read our full prescribing information Sucraid® PI. About QOL Medical, LLC QOL Medical is a specialty biopharmaceutical company dedicated to improving clinical outcomes and overall quality of life for patients with rare diseases. QOL Medical is a patient-centric company founded in 2003 to focus on the acquisition and commercialization of orphan and gastrointestinal products in underserved markets. Learn more at . Sucraid® is a registered trademark of QOL Medical, LLC. All rights reserved. Corporate Contact: QOL Medical, LLC 3405 Ocean Drive Vero Beach, FL 32963 Phone: 866-469-3773 Fax: 772-365-3375 Email: info@qolmed.com