Shionogi Pharma, Inc.

Shionogi & Co., one of Japan's leading drugmakers, said in a statement Tuesday that the results of an ongoing late-stage global clinical trial showed that its oral pill treatment for COVID-19 was significantly effective in reducing the spread of the virus. The drug, Ensitrelvir, which is commercially known as Xocova, showed a statistically significant reduction in patients who developed symptoms after home contact with COVID-19, Shionoi said in its statement. The Phase 3 trial, known as SCORPIO-PEP, involved about 2,400 participants in several countries in the U.S., South America, Africa and Asia. The trial results showed that Ensitrelvir was significantly effective in preventing COVID-19 transmission, especially among participants who developed symptoms after close contact with an infected person. It is worth noting, however, that in May this year, Shionogi Pharma had commented that Ensitrelvir had failed to show a significant effect in reducing common COVID-19 disease symptoms compared to a placebo. The results of this study, known as the SCORPIO-HR trial, are in stark contrast to the SCORPIO-PEP trial. Still, in March, the Japanese government fully approved the use of Ensitrelvir. However, while the government bought two million courses of treatment during the pandemic, most of the drugs went unused and will eventually be destroyed, according to media reports. This situation has led to public questioning and discussion about government decision-making and resource allocation.

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Cytotoxic Drugs and HPAPI Manufacturing Market by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, and Key Geographies, Europe, Asia-Pacific and Rest of the World: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering. "Cytotoxic Drugs and HPAPI Manufacturing Market 2022-2035" report features an extensive study of the current market landscape and future potential of the HPAPI and cytotoxic drug manufacturing market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Aided by the ongoing advancements in clinical pharmacology and oncology research, as well as the rising demand for targeted therapies, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have emerged as one of the key areas of interest for researchers and drug developers worldwide. One of the key objectives of the report was to evaluate the current opportunity and the future growth potential of the HPAPI and cytotoxic drug manufacturing market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features a likely distribution of the current and forecasted opportunity across important parameters. In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth. Frequently Asked Questions What are the current opportunities within the HPAPI and cytotoxic drug market? The cytotoxic drugs and HPAPI manufacturing market is presently considered as one of the most powerful and dynamic sectors of the pharmaceutical industry. At present, more than 40% of the total number of drugs are highly potent in nature. Further, around 60% of the HPAPIs are being developed against oncological indications. Considering the upsurge in demand for novel anti-cancer therapeutics, including antibody-drug conjugates (ADCs), high potency compounds have generated significant interest among several researchers and industry stakeholders. What is the need for contract manufacturing organizations (CMOs) in the HPAPI and cytotoxic drug domain? The manufacturing of highly potent APIs and cytotoxic drugs requires an adequate working environment (to prevent cross contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards) and a trained workforce (to satisfactorily handle highly potent materials). In addition, it requires an expensive infrastructure, which is often complex to engineer, install and maintain. As a result, various companies rely on third party service providers to leverage their technologies for manufacturing highly potent and cytotoxic compounds and achieve greater operational flexibility. The inherent expertise of CMOs is believed to be capable of enabling reduction in the time-to-market a product and offer significant cost-benefits. What is the current market landscape and recent trends in the HPAPI and cytotoxic drug contract manufacturing domain? Presently, close to 145 companies have the required capabilities to offer HPAPI and cytotoxic drug manufacturing services across different scales of operation. In addition, several contract service providers are entering into strategic alliances in order to consolidate their presence in this field and enhance their existing capabilities to meet the growing demand for high potency molecules. It is worth mentioning that close to 50% of the expansion activities carried out in this market have been focused on improving the existing manufacturing facilities for highly potent molecules, through the addition of new structures and equipment. What are the key challenges faced by HPAPI and cytotoxic drug CMOs? The primary challenge faced during the manufacturing of highly potent APIs and cytotoxic drugs is related to limiting / altogether preventing cross-contamination of the highly potent molecule with other molecules being produced at the same site. Further, the lack of information related to safe exposure levels and toxicity of new chemical entities can risk the lives of workers and harm the environment. As a result, comprehensive management systems are required for safe handling and containment of highly potent molecules. In addition, proper cleaning techniques and waste treatment systems are extremely essential while producing such compounds. What are the key value drivers in the HPAPIs and cytotoxic drugs contract manufacturing market? The increasing demand for cytotoxic drugs has led to a rise in the number of HPAPIs in the overall pharmaceutical development pipeline. In order to cater to the growing demand for the production of such drug candidates, there is a requirement for safe manufacturing and containment technologies. Even though some pharmaceutical companies have made considerable investments to establish in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial, specifically for small and mid-sized players. How is the revenue generation potential associated with cytotoxic drugs and HPAPI manufacturing market likely to evolve in the coming years? The cytotoxic drugs and HPAPI manufacturing market is projected to grow at a CAGR of approximately 12% in the coming years. Currently, in terms of type of molecule, the market is likely to be driven by highly potent small molecules. However, this trend is expected to change in the foreseen future, as the demand for highly potent biologics, such as cell and gene therapies, increases further. In addition, in terms of scale of operation, majority share of the contract service revenues is expected to be generated by commercial scale manufacturing operations. Specifically, in terms of geography, the cytotoxic drugs and HPAPI manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term. The report features detailed transcripts of interviews held with the following individuals: Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals) Stacy McDonald and Jennifer L. Mitcham (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent) Roberto Margarita (Business Development Director, CordenPharma) Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics) Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research) Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare) Allison Vavala (Ex-Senior Manager, Business Development, Helsinn) Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma) Javier E. Aznarez Araiz (Ex-Business Development, Idifarma) COMPANY COMPETITIVENESS ANALYSIS HPAPI Contract Manufacturers: Company Competitiveness Analysis Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis HPAPI and Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN NORTH AMERICA AbbVie Cambrex Catalent Pfizer CentreOne Piramal Pharma Solutions COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN EUROPE Abzena Aenova CARBOGEN AMCIS Hovione Lonza COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN ASIA-PACIFIC AND REST OF THE WORLD Intas Pharmaceuticals Scinopharm STA Pharmaceutical (a WuXi AppTec company) Syngene Teva API LIST OF COMPANIES AND ORGANIZATIONS AbbVie Abzena ACES Pharma Adare Pharma Solutions ADC Biotechnology ADC Therapeutics ADIENNE Pharma and Biotech Aenova AGC Pharma Chemicals (A subsidiary of AGC Group) Agno Pharma AIMEDBIO Ajinomoto Bio-Pharma Services ALB Technology Alcami Alkermes Almac Alphora Research Altasciences Alvogen Amneal Pharmaceuticals AMPAC Fine Chemicals (A SK pharmteco company) Angelini Fine Chemicals (A subsidiary of Angelini Pharma) ANI Pharmaceuticals Antengene ANVI Pharma Aptuit (An Evotec company) Ardena Arevipharma (Acquired by Yonsung Group) Aspen API Astellas Pharma Astorg AstraZeneca Asymchem Laboratories Aurigene Pharmaceutical Services Avra Laboratories (Acquired by Advent International) Baxter BioPharma Solutions Bio-Synthesis BioTechnique BioVectra BiVictriX Therapeutics BOC Sciences Boehringer Ingelheim Bolt Biotherapeutics Boryung Pharmaceutical Bright Peak Therapeutics Bristol Myers Squibb BrYet Health Bryllan BSP Pharmaceuticals Bushu Pharmaceuticals Byondis Cambrex Capsugel (A Lonza company) CARBOGEN AMCIS (A Dishman Carbogen Amcis Group company) Catalent CellMosaic Celon Laboratories Cerbios-Pharma ChemCon ChemPartner CordenPharma CoreRx Creative Biolabs CritiTech Curia Custom Pharmaceutical Services (A part of Dr. Reddy's Laboratories) Cytopharma Daiichi Sankyo Dalton Pharma Services Dipharma Divi's Laboratories DOTTIKON EXCLUSIVE SYNTHESIS EirGen Pharma (Acquired by OPKO Health) Eisai Eli Lilly Enteris BioPharma (A subsidiary of SWK Holdings) Esteve Eurofins Scientific EVER Pharma Excella (Acquired by Fareva) Exelixis Fabbrica Italiana Sintetici Fareva Farmabios (A PharmaZell Group company) Farmhispania Femtogenix Fermion (A subsidiary of Orion) Flamma Formex (A subsidiary of Biotech Investment Group (BIG)) Formosa Laboratories Fresenius Kabi Frontida BioPharm (Acquired by Adare Pharma Solutions) Fujimoto Chemicals GeneQuantum Healthcare Genmab GENTEC PHARMACEUTICAL GROUP Gilead Sciences Glycotope Goodwin Biotechnology GP Pharm GTP Bioways Gustave Roussy Helsinn Advanced Synthesis Heraeus Hovione ICROM Idifarma (Acquired by Ardena) IDT Australia Iksuda Therapeutics ImmunoGen Indena Ind-Swift Laboratories Intas Pharmaceuticals Janssen Biotech Kodiak Sciences Kohlberg Kyongbo Pharmaceutical (A subsidiary of Chong Kun Dang Pharmaceutical) LakePharma Laurus Synthesis LegoChem Biosciences Levena Biopharma (A subsidiary of Sorrento Therapeutics) Lonza Lotus Pharmaceuticals Lubrizol Life Science MabPlex Mac-Chem (A NMS Group Company) Magle Chemoswed Malladi Drugs & Pharmaceuticals Mayne Pharma McSAF MEDICHEM Merck Mersana Therapeutics Metrics Contract Services MilliporeSigma Minafin Minakem (A subsidiary of Minafin) Mitsubishi Tanabe Pharma Mubadala MuseChem Natco Pharma Navrogen NBE-Therapeutics NerPharMa NJ Bio Normon Novartis Novasep Oasmia Pharmaceutical OEP Pharma Olon Oncotec Pharma Produktion Oxford BioTherapeutics Parabolic Drugs Patheon (Acquired by Thermo Fischer Scientific) PCI Pharma Services Pensatech Pharma Pfanstiehl Pfizer Pfizer CentreOne Pharmacare Premium Pharmaceutics International Pharmascience PharmaZell PILA PHARMA Piramal Pharma Solutions PrasFarma Procos (A subsidiary of CBC) ProJect Pharmaceutics Pyxis Oncology Quadira Biosciences Quotient Sciences Recipharm Recro Pharma Regis Technologies RemeGen Richman Chemical SafeBridge Consultants (Acquired by Trinity Consultants) Sai Life Sciences Sanofi Sartorius ScinoPharm Taiwan Seagen Seattle Genetics SEQENS (Acquired by SK Capital Partners) Shionogi Pharma Siegfried Sigma-Aldrich Fine Chemicals (SAFC) (a Sigma-Aldrich company) SK biotek SK Capital Societal CDMO Sofpromed Somatek SOTIO Biotech STA Pharmaceutical (A WuXi AppTec company) Stason Pharmaceuticals Sterling Pharma Solutions Sutro Biopharma Swedish Orphan Biovitrum (SOBI) SWK Holdings Symbiosis Pharmaceutical Services Synaffix Synbias Pharma Syngene Synthon TBD-Biodiscovery Tergus Pharma Teva API TRIO Pharmaceuticals Tubulis University of Goettingen UPM Pharmaceuticals Vectura Veranova VERAXA Biotech VUAB Pharma (A SAFICHEM company) VxP Pharma Wavelength Pharmaceuticals (A subsidiary of SEQENS) WuXi Biologics ZNZ Pharma For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

GeoVax VP of Business Development/Courtesy of GeoVax Partnering is an important way to grow a business and John Sharkey, Ph.D., newly-hired VP of business development for GeoVax, is well-positioned to identify strong partners. He not only has decades of experience in the U.S. and abroad with large multinational pharmaceutical companies, but he also enjoys relationships with small- and mid-sized companies with diverse technologies. And, as a former consultant to GeoVax, he has hit the ground running. “There are two sources of opportunities, those that are developed internally and those that are available externally,” Sharkey told BioSpace. As VP of business development, he focuses on external opportunities around the world that can be brought in to expand the company’s portfolio relative to its mission. “Our long-term plan is to commercialize in the U.S., yet we have global rights to almost all of our assets,” he said. Sharkey’s biotech career began at Sandoz Pharmaceuticals, a predecessor company to Novartis. He was head of drug delivery in the U.S. at Sandoz and shared, “When the reorganization was occurring to form Novartis, I had the opportunity to go to Europe and work for the organization in business development. “I was fortunate that during those years at Sandoz/Novartis, I worked in a lot of therapeutic areas, including oncology, cardiovascular and ophthalmology. This is unusual for business development,” he said, “and helps in the type of work I do now because I have at least a fundamental understanding of the key issues in those therapeutic areas.” Seeing the Whole Board A glance at Sharkey’s resume shows multinational experience with Novartis and Shionogi Pharmaceuticals as well as positions with small- and mid-sized companies. “I’ve always enjoyed the opportunity to work with colleagues from across multiple cultures and in different parts of the world, doing transactions and meeting people,” he said. “That’s the great part of working for a large, multinational corporation. If you’re in the right position, you get broad exposure to a lot of great people.” When Sharkey considers his career, two triumphs stand out and speak to his perseverance and innovative thinking. Early on, he was head of the technical development team for a particular product, he recalled. “A third-party partner went bankrupt after we had submitted our new drug application. We were able to work with colleagues in Europe to put together a team to work with the [FDA] to allow us to build a brand-new manufacturing facility in Austria to manufacture this product when it was approved.” It was an intense experience, he noted. “I learned a lot of things.” Later, at Novartis, he worked with Genentech to get the ex-U.S. rights for Lucentis, “which turned out to be a very successful product for Novartis’ ophthalmic business,” he said. The challenge was that Genentech viewed Novartis as a competitor. Sharkey, however, succeeded in presenting his company’s product as synergistic. Eventually, he forged his own path, forming his own consultancy, Cogas Consulting, in 2010, where he called on his expertise to help small and mid-sized companies. As a consultant, he was able “to look at a lot of different technologies and therapeutic areas, and help companies early on with their partnering and strategy.” It was as a consultant that he began working with GeoVax. “I bring skillsets that my colleagues may not have,” Sharkey said. For example, “I lived through the development side of the business and have seen products go from development to market. Not a lot of people can say that. That’s not my core competency, but I understand what’s involved. Also, part of my business involved regulatory consulting. I don’t consider myself a regulatory expert, but I probably have a better understanding of the regulatory environment than most and how to engage with it. Hopefully, this (along with my business development expertise) will help GeoVax get to where it wants to be. “We’re a small, smart team and people have to wear a lot of hats,” Sharkey pointed out. In practice, that also entails understanding how regulations vary across the world and identifying partners early on, thereby sharing the workload and minimizing duplicative efforts. “That’s less expensive for everybody and allows a more accelerated timeline,” he said. Taking GeoVax to the Next Level Sharkey noted that one of GeoVax’s objectives in hiring him was to help it become a Phase II company. “That doesn’t simply mean finding Phase II assets and bringing them in,” he pointed out. It requires ensuring those assets advance the company’s goals. Recently, that meant identifying assets that complemented its modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform. To that end, GeoVax acquired a COVID-19 vaccine, CMO4S1, for immunocompromised patients and as a booster to mRNA vaccines. It encodes for both the spike (S) and the nucleocapsid (N) proteins of the virus. Therefore, CMO4S1 elicits an early antibody response and also addresses the highly conserved N portion of the protein, which is good at stimulating the generation of T cells and supporting immune system memory. Consequently, this appears to be an effective way to address viral variants. Both programs for this asset are in Phase II. The company also has immuno-oncology products in Phase I/II and IND-enabling studies, and studies underway for infectious diseases including Ebola and the Zika virus. “We’re transitioning from being a buyer to being a seller, so my focus now is on trying to find (development) partners,” Sharkey reiterated. Attending partnering meetings, including the recent BIO International Convention, “to let people know what we have and what we’re thinking of doing” is a big part of his strategy. “It’s a long process,” he said, and deals tend to be done between people who know each other…who’ve been talking to each other for a while and are aware of the company, its goals and its ability to meet its targets. “Walking up to a booth and talking to a person is what starts a discussion that eventually may lead to a transaction.” Sharkey seems well-equipped to get the conversation started.