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FDA-approved generic provides cost-effective option for treating cancer LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer. Now available in the U.S., Cyclophosphamide for Injection, USP is the newest addition to Fresenius Kabi’s broad portfolio of generic oncology injectables that help make cancer therapies more affordable and accessible. This press release features multimedia. View the full release here: Cyclophosphamide is now available from Fresenius Kabi. (Photo: Business Wire) “The introduction of Cyclophosphamide for Injection adds another critical treatment to our broad and leading oncology portfolio that offers lower-cost options for treating cancer,” said John Ducker, president and CEO of Fresenius Kabi USA. Supplied as a 500mg, 1g, and 2g single-dose vials of lyophilized powder, the drug can be administered intravenously or orally. Fresenius Kabi offers all lyophilized presentations of cyclophosphamide currently in the market. Cyclophosphamide for Injection, USP is available through distributors or direct from Fresenius Kabi. About Cyclophosphamide for Injection, USP Cyclophosphamide for Injection is an alkylating drug indicated for the treatment of: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. IMPORTANT SAFETY INFORMATION Cyclophosphamide for Injection is contraindicated in patients with hypersensitivity to cyclophosphamide and with urinary outflow obstruction. Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections - Severe immunosuppression may lead to serious and sometimes fatal infections. Close hematological monitoring is required. Urinary Tract and Renal Toxicity - Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur. Exclude or correct any urinary tract obstructions prior to treatment. Cardiotoxicity - Myocarditis, myopericarditis, pericardial effusion, arrhythmias and congestive heart failure, which may be fatal, have been reported. Monitor patients, especially those with risk factors for cardiotoxicity or pre-existing cardiac disease. Pulmonary Toxicity - Pneumonitis, pulmonary fibrosis and pulmonary veno-occlusive disease leading to respiratory failure may occur. Monitor patients for signs and symptoms of pulmonary toxicity. Secondary malignancies have been reported in patients treated with cyclophosphamide-containing regimens. Veno-occlusive Liver Disease - Fatal outcome can occur. Embryo-Fetal Toxicity - Can cause fetal harm. Advise female patients of reproductive potential to avoid pregnancy. Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . Nursing Mothers: Discontinue drug or nursing. Females and males of reproductive potential: Counsel patients on pregnancy prevention and planning. Renal Patients: Monitor for toxicity in patients with moderate and severe renal impairment. This Important Safety Information does not include all the information needed to use Cyclophosphamide for Injection, USP safely and effectively. Please see the full prescribing information for Cyclophosphamide for Injection, USP at . About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, clinical nutrition and technologies for infusion and transfusion. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn and Facebook.

Data demonstrates compelling clinical activity, highlights adagrasib potential as monotherapy in solid tumors Clinical data also presented at the ASCO Plenary Series: April 2023 Session Data follows recent inclusion of KRAZATI® (adagrasib) in NCCN Guidelines for CNS Cancers SAN DIEGO, April 26, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, announced today the Journal of Clinical Oncology published in a Rapid Communication data indicating adagrasib, a potent and selective KRASG12C inhibitor, is well tolerated and demonstrates meaningful clinical activity in patients with pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), and other solid tumors harboring a KRASG12C mutation. Rapid Communications are reserved for publications deemed to represent timely and late breaking research that may have an immediate impact on patient care. In addition, findings were presented last week at the April session of the American Society of Clinical Oncology (ASCO) Plenary Series Program. This publication follows the recent inclusion of KRAZATI® (adagrasib) in the National Comprehensive Center Network (NCCN) Guidelines for Central Nervous System (CNS) Cancers for patients living with previously treated KRASG12C-mutant non-small cell lung cancer (NSCLC) and CNS metastases. The Phase 2 data of the KRYSTAL-1 study demonstrates the potential of adagrasib as a monotherapy in patients with unresectable or metastatic KRASG12C-mutated solid tumors beyond NSCLC and colorectal cancer (CRC). The data presented was based on confirmed blinded, independent, central review (BICR) responses. This is the largest Phase 2 dataset evaluating KRAS G12C mutated solid tumors other than non-small cell lung cancer and colorectal cancer. The enrolled and treated population (n=63) included 21 PDAC, 12 BTC, 9 appendiceal adenocarcinoma, 4 gastroesophageal/esophageal adenocarcinoma, 3 small bowel adenocarcinoma, 5 ovarian adenocarcinoma, 4 unknown primary, 3 endometrial adenocarcinoma, 1 breast adenocarcinoma and 1 glioblastoma. The median prior lines of systemic therapy was two. Results showed an objective response rate (ORR) of 35% for the overall cohort. In patients with PDAC, ORR was 33%; for patients with BTC, ORR was 42%. Notably, findings demonstrate the safety pro adagrasib is aligned with previously reported data in patients with pretreated NSCLC and CRC. These findings demonstrate a meaningful improvement relative to the historically reported standard of care for PDAC and BTC. For patients with previously treated metastatic PDAC, current standard of care (gemcitabine + nab-paclitaxel or liposomal irinotecan + 5FU/leucovorin) has resulted in limited ORR (3-16%).1-2 In a biomarker-unselected BTC patient population, the ABC-06 phase 3 trial investigating FOLFOX in the second-line setting reported an ORR of 5%.3 "We are thrilled to see the results of this Phase 2 study, which demonstrate a marked improvement on the current standard of care for patients with unresectable or metastatic KRASG12C-mutated solid tumors, including PDAC, BTC, other gastrointestinal (GI) and non-GI tumors, where few treatment options exist. It is particularly encouraging to see meaningful clinical activity in pancreatic and biliary tract cancers tumors," said Shubham Pant, M.D., M.B.B.S., The University of Texas MD Anderson Cancer Center. "The data indicates that adagrasib has the potential to be an effective treatment for KRASG12C-mutated solid tumor types in addition to NSCLC and CRC." "We're pleased to share this data which demonstrates meaningful clinical activity in KRASG12C-mutated tumor types in addition to NSCLC and CRC, indicating a potential path to regulatory approval for adagrasib in additional indications," said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics, Inc. "We look forward to continuing to advance adagrasib as a potential best-in-class treatment option for patients harboring a KRASG12C mutation." The primary endpoint for the Phase 2 cohort of the KRYSTAL-1 study was objective response rate. Secondary endpoints included duration of response, progression-free survival, overall survival and safety. Findings were presented last week at the April session ASCO Plenary Series Program as a data presentation (Abstract 425082) titled, "KRYSTAL-1: Activity and Safety Of Adagrasib (MRTX849) In Patients With Advanced Solid Tumors Harboring A KRASG12C Mutation." The full abstract for the presentation can be found here: Program Guide – ASCO Meeting Program Guide. The full Journal of Clinical Oncology article can be found here. About KRAZATI® (adagrasib) In the U.S., KRAZATI was approved by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints. KRAZATI was reviewed under the FDA Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Mirati submitted a Marketing Authorization Application (MAA) in the EU in May 2022. In 2021, adagrasib achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. For Prescribing Information, visit Mirati.com/KRAZATI_USPI Adagrasib continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer. For more information, visit Mirati.com/science. KRAZATI (adagrasib) U.S. Indication KRAZATI is indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). About Mirati Therapeutics, Inc.® Mirati Therapeutics, Inc.® is a commercial stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer. For more information about Mirati, visit us at Mirati.com or follow us on Twitter, LinkedIn and Facebook. Forward Looking Statements This press release includes forward-looking statements regarding Mirati's business, financial guidance and the therapeutic and commercial potential of KRAZATI® (adagrasib), sitravatinib (TAM receptor inhibitor), MRTX1719 (MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and MRTX1133 (selective KRASG12D inhibitor), Mirati's technologies and Mirati's other products in development. Any statement describing Mirati's goals, expectations, intentions or beliefs, financial or other projections, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Mirati's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Mirati's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Mirati. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Mirati's programs are described in additional detail in Mirati's annual report on Form 10-K, and most recent Form 10-Q, which are on the Securities and Exchange Commission and available at the SEC's Internet site ( ). These forward-looking statements are made as of the date of this press release, and Mirati assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Mirati Contacts Investor Relations: ir@mirati.com Media Relations: media@mirati.com References 1. Wang-Gillam A, Hubner RA, Siveke JT et al. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall analysis and characteristics of long-term survivors. Eur J Cancer 2019. 108:78-87 2. Huffman BD, Basu Mallick A, Horick NK, et al. Effect of MUC5AC Antibody (NPC-1C) administered with second-line gemcitabine and nab-paclitaxel on the survival of patients with advanced pancreatic ductal adenocarcinoma. JAMA Network Open 2023;6(1)e2249720 3. Lamarca A, Palmer DH, Singh Wasan H, et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3 open-label, randomised, controlled trial. Lancet Oncol 2021;22:690-701 Company Codes: NASDAQ-SMALL:MRTX

MONTREAL, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Sunshine Biopharma Inc. (NASDAQ: “SBFM”), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today issued a letter to shareholders from Dr. Steve Slilaty, Chairman and CEO of the Company. Dear Fellow Sunshine Biopharma Shareholders, On behalf of Sunshine’s Board of Directors, our senior management team, and employees, we are delighted to have you as our shareholders and as valued stakeholders of our corporate family. I am writing this letter to provide you with some of the important developments that have occurred at Sunshine over this past year and some insights into what we see ahead. 2022 has been a transformative year for the Company despite some challenging headwinds with the economy and financial markets. On February 17, we completed an $8 million public offering and up-listed to NASDAQ. Shortly thereafter on March 14, we completed a private placement for total gross proceeds of another $8 million and on April 28 we closed a third offering for $19.5 million in gross proceeds. These offerings, together with additional funds of approximately $12 million received from the exercise of warrants included in the aforesaid offerings, enabled us to expand our proprietary drug development program and complete a key acquisition which set us on the path of becoming a fully-integrated biopharma company. In April, 2022, we announced our biopharma pipeline developments for mRNA molecules capable of destroying multidrug resistant cancer cells grown in culture. The cytotoxicity tests were performed on a variety of cancer cells including multidrug resistant, breast, ovarian, and pancreatic cancer cells. Soon after announcing these findings, the Company filed a provisional patent application for composition and utility subject matter pertaining to the structure and sequence of these mRNA molecules in the United States. These mRNA molecules bear the laboratory designation K1.1. During the early summer as the transmissibility of the Covid Omicron variants became more widespread we expanded our collaboration with the University of Arizona to accelerate the development of our novel PLpro inhibitors for our anti-Coronavirus treatment program. In October 2022 we announced what we consider to be our crown achievement of 2022, our acquisition of a Canadian generic pharmaceuticals company, Nora Pharma Inc., with sales of approximately $14 million. Sunshine Biopharma now has over 50 generic prescription drugs on the market in Canada with plans to grow further throughout North America and potentially other markets around the world. We have vigorously pushed forward with our oncology K1.1 mRNA development program by entering into a key collaboration arrangement with a leading lipid nano-particle (LNP) formulation company in North America. Our LNP collaboration partner is currently preparing two LNP formulations for our antineoplastic K1.1 mRNA (K1.1a and K1.1b). We had previously demonstrated that K1.1 mRNA is capable of destroying cancer cells in vitro, including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Parallel studies using normal human cells (HMEC) showed that K1.1 mRNA had little or no cytotoxic effects. Beginning in March, 2023, our partner generated K1.1-LNP formulations will be used to conduct in vivo studies on xenograft mice expressing the in vitro tested human cancers as well as liver cancer. Should these mice studies prove successful, the Company can advance relatively rapidly to conducting human trials. The LNP formulated K1.1 mRNA can be readily adapted for delivery into patients using the recently gained knowledge from the mRNA vaccine technology. We believe we have a solid foundation to move the Company forward into 2023 and beyond. Our objectives going forward will be focused on: Achieving profitability on a priority basis; andContinuing to invest in our proprietary drug development program. On a personal note, I am excited about what we’ve accomplished in 2022 and look forward to what the future holds as we solidly navigate the Company through 2023 and beyond. As a scientist, my overarching life’s mission is to make the world a healthier place for all. On behalf of Sunshine Biopharma and our more than 40 employees, I would like to thank all of our shareholders and supporters. We appreciate the confidence you have placed in us and look forward to providing further updates as our progress continues. Wishing you an enjoyable Holiday Season and a healthy, happy, and prosperous New Year! Very Truly Yours, Dr. Steve Slilaty Chairman & CEOSunshine Biopharma Inc. Safe Harbor Forward-Looking Statements This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma, Inc. (the “Company”) that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company’s drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company’s filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company’s most recent SEC filings. For Additional Information: Sunshine Biopharma Contact:Camille Sebaaly, CFODirect Line: 514-814-0464camille.sebaaly@sunshinebiopharma.com Sunshine Biopharma Media Contact:Christine PetragliaTraDigital IRDirect Line: 917-633-8980investors@sunshinebiopharma.com