Indigotindisulfonate sodium

BLUDIGOTM is the first and only indigotindisulfonate sodium injection, USP, drug product approved by the FDA. MARSEILLE, France and COLLEGEVILLE, Pa., July 12, 2022 /PRNewswire/ -- Provepharm, a French company with operations in the United States of America, specializing in the development of pharmaceutical applications, today announced that it has received FDA New Drug Approval for the marketing of its injectable BLUDIGO™ (Indigotindisulfonate Sodium) Injection . BLUDIGO™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. Provepharm filed its application for approval with the FDA in September 2021 and with this new approval, its US affiliate, Provepharm Inc., will market the product directly in the United States of America. Frederick Girard, Provepharm's Chief Medical Officer, said: "BLUDIGOTM is the second product to be granted market authorization by the FDA from Provepharm's R&D group. This new success validates Provepharm's strategy based on a high level of investment in research and development aimed at improving patients' lives and health care professionals' work on a daily basis". In addition, Mary Jane Helenek, Executive VP and COO of Provepharm, Inc., said: "Provepharm is immensely proud of this accomplishment and approval by the FDA. We will soon make this important product available to clinicians in the US." Eighty-two percent of ureter injuries occur during pelvic surgery, and 75% of urinary tract injuries are due to gynecologic surgery [1]. Current estimates of urinary tract injury incidence with all types of gynecologic surgery range from 0.2 to 15 per 1,000 cases [2]. If the damage is not identified during the surgical procedure, it may lead to severe post-surgical complications, notably obstruction fistulae and sepsis, with potential impact on the functional prognosis of the kidney and sometimes on the vital prognosis. These complications lead also to the need for reintervention, sometimes in an emergency. Hence, screening for potential iatrogenic ureteral damage during the initial procedure can provide the surgeons with an opportunity of repairing the damage immediately, which may significantly contribute to the reduction of post-surgical complications. BLUDIGO™ (Indigotindisulfonate Sodium Injection, USP) INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION AND USAGE BLUDIGO™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. CONTRAINDICATIONS BLUDIGO™ is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components. WARNINGS AND PRECAUTIONS Cardiovascular Reactions: Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO™ injection. Interrupt administration if reactions are observed. Hypersensitivity Reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO2 when anesthetized patients are administered BLUDIGO™. USE IN SPECIFIC POPULATIONS Renal Impairment: BLUDIGO™ is not recommended for use in patients with eGFR<30 mL/min. Pediatric Use: The safety and effectiveness of BLUDIGO™ have not been established in pediatric patients. Pregnancy and Lactation: Please consult the Full Prescribing Information before using BLUDIGO™ in a patient that is lactating, pregnant, or may be pregnant. RECOMMENDED DOSAGE The recommended dose for BLUDIGO™ is 5 mL given intravenously over 1 minute. IMPORTANT ADMINISTRATION INSTRUCTIONS Monitor blood pressure and cardiac rhythm during and following the injection. Use immediately after opening ampoule. Withdraw the contents of the ampoule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer with infusion assemblies used with other diluents or drugs. Discard any unused portion. ADVERSE REACTIONS Clinical Trial Experience: The most common adverse reactions (≥ 1%) associated with BLUDIGO™ in clinical trials were: constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. Postmarketing Experience: The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products: Cardiovascular disorders: cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, tachycardia General disorders and administration site conditions: injection site discoloration Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema Please see the full Prescribing Information for additional important safety information. To report SUSPECTED ADVERSE REACTIONS, contact PROVEPHARM Inc. at 1–833-727-6556 or FDA at 1-800-FDA-1088 or . About Provepharm Provepharm Life Solutions is a privately held, global pharmaceutical company based in Marseille, France, specializing in molecule revitalization. Its long-standing expertise in fine chemistry and high investment in R&D allows it to improve the purity of active pharmaceutical ingredients to the highest standards for the development of drug products and medical devices. Provepharm's strategy has already proven successful through the patented development and approval of Provayblue® (methylene blue injection, USP) notably in the European Union and the United States of America. For more information, please visit References: Lee, J.S., Urologic Complications Following Obstetric and Gynecologic Surgery, Korean J Urol 2012;53:795-799, AAGL Advancing minimally invasive gynecology worldwide. AAGL Practice Report: Practice Guidelines for Intraoperative Cystoscopy in Laparoscopic Hysterectomy. Journal of Minimally Invasive Gynecology 2012; 19(4): 407-411 Media Contact Theresa Brogdon (610) 601-8600 [email protected] SOURCE Provepharm Inc.

PDF (205KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Sunao Manabe, Representative Director, President and COO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Koji Ogawa, Corporate Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 https://www.daiichisankyo.com Tokyo, Japan (July 31, 2018) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announces that at a Board of Directors meeting held today a resolution was passed to transfer the domestic manufacturing and sales approvals for 41 long-listed products that Daiichi Sankyo and Daiichi Sankyo’s subsidiary, Daiichi Sankyo Espha Co., Ltd. (hereafter, Daiichi Sankyo Espha), manufacture and sell in Japan to Alfresa Holdings Corporation’s subsidiary, Alfresa Pharma Corporation (hereafter, Alfresa Pharma). Daiichi Sankyo has been working for many years to create innovative pharmaceuticals and continuously deliver top-quality pharmaceutical products, and is now giving priority to the investment of resources in the oncology field toward its 2025 Vision of becoming “a global pharma innovator with competitive advantage in oncology. In addition, Daiichi Sankyo Espha, as a generic drug company, contributes to the medical treatment of people in Japan against the backdrop of a rapidly aging society. Under these circumstances, Daiichi Sankyo has examined the business optimization of domestic long-listed products and judged that the responsibility for their stable provision can continue to be fulfilled by transferring some of Daiichi Sankyo and Daiichi Sankyo Espha’s long-listed products to Alfresa Pharma. In accordance with the resolution, the inventories of a total of 41 products, which comprise 35 of Daiichi Sankyo’s long-listed products and six of Daiichi Sankyo Espha’s long-listed products (book value of ¥3.08 billion as of the end of March 2018), and the rights and obligations pertaining to their domestic manufacturing and sales, will be transferred to Alfresa Pharma from March 2019, for which Daiichi Sankyo and Daiichi Sankyo Espha are expected to receive payment of ¥8.42 billion (excluding the value of the inventories) from Alfresa Pharma. The revenues of the 41 long-listed products being transferred were ¥9.16 billion in the fiscal year ending March 31, 2018. The assets and the manufacturing and sales rights and obligations for 30 of Daiichi Sankyo’s 35 long-listed products will transferred to Alfresa Pharma through a company split effective March 1, 2019, and those for the other products will individually transferred to Alfresa Pharma in order starting from March 2, 2019. The assets and the manufacturing and sales rights and obligations for five of Daiichi Sankyo Espha’s six long-listed products will be transferred to Alfresa Pharma through a company split scheme effective March 1, 2019, and those for the other product will individually be transferred to Alfresa Pharma after March 2, 2019. The 41 long-listed products that Daiichi Sankyo and Daiichi Sankyo Espha are transferring to Alfresa Pharma are as follows. Table: List of 41 Long-listed Products Brand Name Drug Classification by Efficacy Manufacturing & Marketing Reference 1 ATP Agents affecting metabolism, not otherwise categorized Daiichi Sankyo 〇 2 Actosin® Cardiac stimulant Daiichi Sankyo 〇 3 Adsorbin® Antacid Daiichi Sankyo 〇 4 Amisaline® Antiarrhythmic agent Daiichi Sankyo 〇 5 Allergin® Antihistamine Daiichi Sankyo 〇 6 Iscotin® Antituberculous agent Daiichi Sankyo 〇 7 Indigocarmine Function test reagent Daiichi Sankyo 〇 8 Gammalon® Other circulatory organ agent Daiichi Sankyo 〇 9 Chlomy® Antibiotic Daiichi Sankyo 〇 10 Chloromycetin® Antibiotic Daiichi Sankyo 〇 11 Cefmetazon® Antibiotic Daiichi Sankyo 〇 12 Serenal® Sedative, anxiolytic Daiichi Sankyo 〇 13 Somelin® Sedative, anxiolytic Daiichi Sankyo 〇 14 Daipin® Antispasmodic Daiichi Sankyo 〇 15 Tarivid® tablets Synthetic antibacterial Daiichi Sankyo 〇 Tarivid® ear drops Daiichi Sankyo 16 Dopasol® Antiparkinson agent Daiichi Sankyo 〇 17 Tolopelon® Psychoneurosis agent Daiichi Sankyo 〇 18 Droleptan® General anesthetic Daiichi Sankyo 〇 19 Neoiscotin® Antituberculous agent Daiichi Sankyo 〇 20 Neodopasol® Antiparkinson agent Daiichi Sankyo 〇 21 Nelbon® Sedative, anxiolytic Daiichi Sankyo 〇 22 Nor-Adrenalin® Adrenal hormone preparation Daiichi Sankyo 〇 23 Sodium para-aminohippurate Function test reagent Daiichi Sankyo 〇 24 Bal® Antidote Daiichi Sankyo 〇 25 Pyramide® Antituberculous agent Daiichi Sankyo 〇 26 Phenolsulfonphthalein Function test reagent Daiichi Sankyo 〇 27 Forit® Psychoneurosis agent Daiichi Sankyo 〇 28 Liverall® Liver disease agent Daiichi Sankyo 〇 29 Amyl nitrite Vasodilator, antidote Daiichi Sankyo 〇 30 Glucose Saccharide preparation Daiichi Sankyo 〇 31 Gabalon® Antispasmodic Daiichi Sankyo 32 Cortrosyn® Pituitary hormone preparation Daiichi Sankyo 33 Sedrena® Antiparkinson agent Daiichi Sankyo 34 Sepazon® Sedative, anxiolytic Daiichi Sankyo 35 Vitamedin® Mixed vitamin preparation Daiichi Sankyo 36 S・M Digestant Daiichi Sankyo Espha △ 37 Sinlestal® Hyperlipidemia agent Daiichi Sankyo Espha △ 38 Neuer® Peptic ulcer agent Daiichi Sankyo Espha △ 39 Hyamine® External disinfectant Daiichi Sankyo Espha △ 40 Pantosin® Vitamin B preparation Daiichi Sankyo Espha △ 41 Captoril® Hypotensive agent Daiichi Sankyo Espha Brand Name Drug Classification by Efficacy Manufacturing & Marketing Reference 1 ATP Agents affecting metabolism, not otherwise categorized Daiichi Sankyo 〇 2 Actosin® Cardiac stimulant Daiichi Sankyo 〇 3 Adsorbin® Antacid Daiichi Sankyo 〇 4 Amisaline® Antiarrhythmic agent Daiichi Sankyo 〇 5 Allergin® Antihistamine Daiichi Sankyo 〇 6 Iscotin® Antituberculous agent Daiichi Sankyo 〇 7 Indigocarmine Function test reagent Daiichi Sankyo 〇 8 Gammalon® Other circulatory organ agent Daiichi Sankyo 〇 9 Chlomy® Antibiotic Daiichi Sankyo 〇 10 Chloromycetin® Antibiotic Daiichi Sankyo 〇 11 Cefmetazon® Antibiotic Daiichi Sankyo 〇 12 Serenal® Sedative, anxiolytic Daiichi Sankyo 〇 13 Somelin® Sedative, anxiolytic Daiichi Sankyo 〇 14 Daipin® Antispasmodic Daiichi Sankyo 〇 15 Tarivid® tablets Synthetic antibacterial Daiichi Sankyo 〇 Tarivid® ear drops Daiichi Sankyo 16 Dopasol® Antiparkinson agent Daiichi Sankyo 〇 17 Tolopelon® Psychoneurosis agent Daiichi Sankyo 〇 18 Droleptan® General anesthetic Daiichi Sankyo 〇 19 Neoiscotin® Antituberculous agent Daiichi Sankyo 〇 20 Neodopasol® Antiparkinson agent Daiichi Sankyo 〇 21 Nelbon® Sedative, anxiolytic Daiichi Sankyo 〇 22 Nor-Adrenalin® Adrenal hormone preparation Daiichi Sankyo 〇 23 Sodium para-aminohippurate Function test reagent Daiichi Sankyo 〇 24 Bal® Antidote Daiichi Sankyo 〇 25 Pyramide® Antituberculous agent Daiichi Sankyo 〇 26 Phenolsulfonphthalein Function test reagent Daiichi Sankyo 〇 27 Forit® Psychoneurosis agent Daiichi Sankyo 〇 28 Liverall® Liver disease agent Daiichi Sankyo 〇 29 Amyl nitrite Vasodilator, antidote Daiichi Sankyo 〇 30 Glucose Saccharide preparation Daiichi Sankyo 〇 31 Gabalon® Antispasmodic Daiichi Sankyo 32 Cortrosyn® Pituitary hormone preparation Daiichi Sankyo 33 Sedrena® Antiparkinson agent Daiichi Sankyo 34 Sepazon® Sedative, anxiolytic Daiichi Sankyo 35 Vitamedin® Mixed vitamin preparation Daiichi Sankyo 36 S・M Digestant Daiichi Sankyo Espha △ 37 Sinlestal® Hyperlipidemia agent Daiichi Sankyo Espha △ 38 Neuer® Peptic ulcer agent Daiichi Sankyo Espha △ 39 Hyamine® External disinfectant Daiichi Sankyo Espha △ 40 Pantosin® Vitamin B preparation Daiichi Sankyo Espha △ 41 Captoril® Hypotensive agent Daiichi Sankyo Espha (Note): Products marked ○ in the reference column are products subject to the company split scheme of Daiichi Sankyo and products marked △ are products subject to the company split scheme of Daiichi Sankyo Espha. Next, Daiichi Sankyo hereby notifies regarding the Daiichi Sankyo’s company split of 30 long-listed products as follows. Since this is a simple absorption-type company split in which the decrease in Daiichi Sankyo’s net assets is projected to be less than 10% of the total amount of net assets on the last day of the immediately preceding fiscal year and the decrease in Daiichi Sankyo’s net sales is projected to be less than 3% of the total net sales in the immediately preceding fiscal year, this disclosure is made omitting some of the disclosure items and contents. 1. Summary of Daiichi Sankyo’s company split 1) Reason for the company split Because the number of products being transferred in this transaction is large and the number of contracts, etc. related to the products to be transferred is also large, for the comprehensive transfer of the products and each contract, etc., a succession scheme via simple absorption-type company split was selected. 2) Schedule of the company split Board of Directors resolution date (Daiichi Sankyo) July 31, 2018 Contract conclusion date July 31, 2018 Effective date (scheduled) March 1, 2019 Payment date (scheduled) March 1, 2019 Board of Directors resolution date (Daiichi Sankyo) July 31, 2018 Contract conclusion date July 31, 2018 Effective date (scheduled) March 1, 2019 Payment date (scheduled) March 1, 2019 (Note) Since this company split being implemented by Daiichi Sankyo is a simple absorption-type split based on the provisions of Article 784 Paragraph 2 of the Companies Act, it is being implemented without the passage of a resolution at a general shareholders’ meeting. 3) Method of the company split This is a simple absorption-type split with Daiichi Sankyo as the spliting company and Alfresa Pharma as the succeeding company. 4) Contents of allotments pertaining to the company split Upon this company split, Daiichi Sankyo is scheduled to receive an approximately ¥4.2 billion payment from Alfresa Pharma. 5) Treatment of share options and bonds by the company split There will be no changes to the treatment of share options issued by Daiichi Sankyo by this company split. Also, Daiichi Sankyo has not issued any bonds with share options. 6) Capital increase or decrease from the company split There will be no capital increase or decrease caused by this company split. 7) Rights and obligations assumed by the succeeding company Upon this company split, the succeeding company will succeed assets, contract positions, approvals, intellectual property rights and rights and obligations incidental thereto concerning the split business (excluding labor contracts with employees and rights and obligations incidental thereto). However, operating credits and debts that arise until the date the absorption-type split comes into effect (accounts receivable, accounts payable, amounts outstanding, and other monetary transactions) are vested in the splitting company, which is Daiichi Sankyo. 8) Outlook for Fulfillment of Debt Obligations There are no debt obligations borne by the succeeding company under this company split. 2. Approach to Calculating the Contents of Allotments Pertaining to the company Split Since Alfresa Pharma will continue to operate value the split business after this company split, it deemed that adopting the discount cash flow (DCF) method to value the assets based on the future cash flow expected from the split business is appropriate and conducted a calculation using a third party. Alfresa Pharma calculated the business value based on the results of value calculation by the third party and presented the amount to Daiichi Sankyo. In addition to that, comprehensively considering the status of the transferred products at Daiichi Sankyo, and the book value of assets pertaining to the products being transferred, and as a result of discussions and negotiations between the two parties, Daiichi Sankyo finally judged that the amount mutually agreed on is suitable and concluded this absorption-type split contract pertaining to this company split with Alfresa Pharma. No significant increases or decreases are projected in the financial projections that were used as assumptions for the calculation. 3. Outline of the Parties (Splitting Company) 1. Corporate name Daiichi Sankyo Company, Limited 2. Address 3-5-1 Nihonbashi-honcho, Chuo-ku, Tokyo 3. Representative’s title and name Representative Director, President & COO Sunao Manabe 4. Business contents Research and development, manufacture, marketing, etc. of pharmaceuticals 5. Share Capital ¥50,000 million 6. Established September 28, 2005 7. Number of shares issued 709,011,343 shares 8. Fiscal year-end March 31 9. Major shareholders and shareholding ratios (as of March 31, 2018) The Master Trust Bank of Japan (trust account): 8.73% JP MORGAN CHASE BANK 380055: 8.66% Japan Trustee Services Bank, Ltd. (trust account): 7.21% Nippon Life Insurance Company: 5.52% Trust & Custody Services Bank, Ltd. as trustee for Mizuho Trust and Banking Co., Ltd. Retirement Benefit Trust Account re-entrusted by Mizuho Bank, Ltd. 2.22% 10. Financial conditions and business performance in the immediately preceding fiscal year (ended March 31, 2018) international standard (consolidated) Equity attributable to owners of the company ¥1,132,982 million Total assets ¥1,897,754 million Equity attributable to owners of the Company per share ¥1,749.33 Revenues ¥960,195 million Operating Profit ¥76,282 million Profit attributable to owners of the Company ¥60,282 million Basic earnings per share ¥91.31 1. Corporate name Daiichi Sankyo Company, Limited 2. Address 3-5-1 Nihonbashi-honcho, Chuo-ku, Tokyo 3. Representative’s title and name Representative Director, President & COO Sunao Manabe 4. Business contents Research and development, manufacture, marketing, etc. of pharmaceuticals 5. Share Capital ¥50,000 million 6. Established September 28, 2005 7. Number of shares issued 709,011,343 shares 8. Fiscal year-end March 31 9. Major shareholders and shareholding ratios (as of March 31, 2018) The Master Trust Bank of Japan (trust account): 8.73% JP MORGAN CHASE BANK 380055: 8.66% Japan Trustee Services Bank, Ltd. (trust account): 7.21% Nippon Life Insurance Company: 5.52% Trust & Custody Services Bank, Ltd. as trustee for Mizuho Trust and Banking Co., Ltd. Retirement Benefit Trust Account re-entrusted by Mizuho Bank, Ltd. 2.22% 10. Financial conditions and business performance in the immediately preceding fiscal year (ended March 31, 2018) international standard (consolidated) Equity attributable to owners of the company ¥1,132,982 million Total assets ¥1,897,754 million Equity attributable to owners of the Company per share ¥1,749.33 Revenues ¥960,195 million Operating Profit ¥76,282 million Profit attributable to owners of the Company ¥60,282 million Basic earnings per share ¥91.31 (Succeeding Company) 1. Corporate name Alfresa Pharma Corporation 2. Address 2-2-9 Kokumachi, Chuo-ku, Osaka City, Osaka Prefecture 3. Representative’s title and name President & CEO Koichi Shimada 4. Business contents Manufacture, import, export and marketing of pharmaceuticals, diagnostic products, medical devices, pharmaceutical raw materials, etc. 5. Capital ¥1,000 million 6. Established December 14, 1939 7. Number of shares issued 10,000,000 shares 8. Fiscal year-end March 31 9. Major shareholders and shareholding ratios (as of March 31, 2018) Alfresa Holdings Corporation: 100% 10. Financial conditions and business performance in the immediately preceding fiscal year (ended March 31, 2018) Japanese standard Net assets ¥22,945 million Total assets ¥36,528 million Net assets per share ¥2,294.5 Net sales ¥29,677 million Operating income ¥2,155 million Ordinary income ¥2,226 million Net income ¥1,549 million Net income per share ¥154.9 1. Corporate name Alfresa Pharma Corporation 2. Address 2-2-9 Kokumachi, Chuo-ku, Osaka City, Osaka Prefecture 3. Representative’s title and name President & CEO Koichi Shimada 4. Business contents Manufacture, import, export and marketing of pharmaceuticals, diagnostic products, medical devices, pharmaceutical raw materials, etc. 5. Capital ¥1,000 million 6. Established December 14, 1939 7. Number of shares issued 10,000,000 shares 8. Fiscal year-end March 31 9. Major shareholders and shareholding ratios (as of March 31, 2018) Alfresa Holdings Corporation: 100% 10. Financial conditions and business performance in the immediately preceding fiscal year (ended March 31, 2018) Japanese standard Net assets ¥22,945 million Total assets ¥36,528 million Net assets per share ¥2,294.5 Net sales ¥29,677 million Operating income ¥2,155 million Ordinary income ¥2,226 million Net income ¥1,549 million Net income per share ¥154.9 4. Outline of the Split Business Division 1) Business contents of the split division The business to be split on March 1, 2019 by this absorption-type split is 30 long-listed products that Daiichi Sankyo manufactures and sells in Japan (see “Table: List of 41 Long-listed Products,” Page 2-3). 2) Business Performance of Split Division (year ended March 31, 2018) Sales revenues ¥3,386 million Sales revenues ¥3,386 million 3) Split assets and liabilities items and amounts (as of March 31, 2018) Assets Liabilities Item Book value Item Book value Current assets ¥1,154 million Current liabilities ― Fixed assets ― Fixed liabilities ― Total ¥1,154 million Total ― Assets Liabilities Item Book value Item Book value Current assets ¥1,154 million Current liabilities ― Fixed assets ― Fixed liabilities ― Total ¥1,154 million Total ― (Note): The amounts of the split assets and liabilities will be determined considering increases and decreases to the above-stated amounts until the day before the date this company split comes into effect. 5. Status after the company split There will be no changes in the corporate name, address, title and name of representative, business contents, capital, or fiscal year-end of Daiichi Sankyo and Alfresa Pharma upon the completion of the company split. 6. Future Outlook The impact on Daiichi Sankyo’s consolidated performance from this company split is negligible.