This is a two-part trial. "Solid tumor" in this protocol means solid tumor excluding hepatocellular carcinoma (HCC).
Part 1: Dose Escalation Phase in subjects with solid tumor (Cohort A) and HCC (Cohort B). The dose will be increased from 45 mg twice a day (BID) with 3+3 cohort method up to the recommended phase 2 dose (RP2D) of pimasertib established as single agent in the global studies for each arm independently.
Part 2: The Maximum Tolerated Dose (MTD) defined in Part 1 will be confirmed in more subjects in Cohort A (N=18) and Cohort B (N=6) separately.
Following the recommendation by the Safety Monitoring Committee, Cohort B was discontinued due to hepatocellular carcinoma (HCC) and there will be no further enrollment of subjects to this cohort. This decision is based upon review of safety and efficacy information.

Start Date30 Sep 2012

Sponsor / Collaborator

Merck KGaA

[+1]

NCT01653743

/ CompletedPhase 3

Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa

This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.

Start Date01 Sep 2012

Sponsor / Collaborator

Merck KGaA

[+1]

100 Clinical Results associated with E. Merck KG

0 Patents (Medical) associated with E. Merck KG

Literatures (Medical) associated with E. Merck KG

10 Feb 2025·Journal of Clinical Oncology

Real-world effectiveness and safety of avelumab first-line maintenance (1LM) treatment in patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Second interim analysis of the AVENUE study.

Author: Gschwend, Jürgen E. ; Hoffman, Jason ; Wang, Lusha ; Lorente, David ; Kostkova, Lenka ; Cremer, Laura ; Molina, Aurea ; Zihler, Deborah ; Goebell, Peter J. ; Brachtel, Anna Leena ; Sultanbaev, Alexander Valerievich

706Background: Avelumab 1LM is standard of care for patients with la/mUC without disease progression after 1L platinum-based chemotherapy (PBC) based on results from the JAVELIN Bladder 100 phase 3 trial. The AVENUE study is evaluating the effectiveness and safety of avelumab 1LM treatment in routine clinical practice in Germany, Spain, Switzerland, and Russia. Previous results showed the acceptable safety profile of avelumab 1LM in a heterogeneous real-world population. Here, we report initial effectiveness data and updated baseline and safety data from the second interim analysis. Methods: AVENUE is a prospective, noninterventional study in patients with la/mUC without disease progression after 1L PBC. Initiation of avelumab 1LM is decided by the treating physician prior to enrollment per local approval. Patients are followed for 36 mo. The primary objective is to evaluate the overall survival (OS) rate at 12, 24, and 36 mo. Secondary objectives include assessment of median OS, progression-free survival (PFS), tumor response, and safety. Results: By data cutoff (May 9, 2024), 177 patients had received avelumab 1LM (median follow-up, 10.0 mo). Median age was 70 years (range, 43-89) and 78% were male. ECOG PS was 0-1 in 89.3%, ≥2 in 5.1%, and not reported (NR) in 5.6%. Primary tumor site was upper or lower tract in 28.2% and 71.8%, respectively. 1L PBC regimen was gemcitabine + cisplatin in 61.0% (split dose in 8.5%), gemcitabine + carboplatin in 36.2%, and other/switch in 3.4%. Number of prior PBC cycles was <4, 4-6, >6, and NR in 12.4%, 84.2%, 2.8%, and 0.6%, respectively. Median time to avelumab 1LM initiation was 6.1 weeks (range, 0.3-80.4) and median treatment duration was 6.0 mo (range, 0.5-30.8). Median OS was not reached (95% CI, 17.0-not estimable) and 6- and 12-mo OS rates (95% CI) were 80.6% (73.9-85.7) and 69.1% (61.1-75.7), respectively. Median PFS was 5.8 mo (95% CI, 4.6-9.1) and 6- and 12-mo PFS rates (95% CI) were 50.0% (42.1-57.3) and 33.1% (25.2-41.2). Disease control rate (assessed up to 6 mo) was 66.9% (95% CI, 58.8-74.3). Treatment-related adverse events (TRAEs) occurred in 57.6%, were grade ≥3 in 15.8%, serious in 15.3%, and led to permanent discontinuation in 10.7%. The most common TRAEs of any grade (≥4.0%) were fatigue (9.6%), hyperthyroidism (5.1%), pruritus (4.5%), and diarrhea (4.0%). Grade ≥3 immune-related AEs and infusion-related reactions occurred in 6.2% and 3.4%, respectively. At last follow-up, 28.8% of patients remained on avelumab, and 34.5% and 8.5% had received second- or third-line treatment (enfortumab vedotin in 21.5% and 2.3%), respectively. Conclusions: Data from the second interim analysis of AVENUE confirm the effectiveness and acceptable safety profile of avelumab 1LM in patients with la/mUC treated in routine clinical practice, consistent with previous studies.

10 Feb 2025·Journal of Clinical Oncology

Real-world effectiveness and safety of first-line (1L) avelumab + axitinib in patients with advanced renal cell carcinoma (aRCC): Primary analysis of the AVION study.

Author: Demey, Wim ; Christopoulou, Athina ; Manzel, Arndt ; Hoffman, Jason ; Wynendaele, Wim ; Kostkova, Lenka ; Timotheadou, Eleni ; Koumarianou, Anna ; Ivanyi, Philipp ; Baklanova, Olga ; Wang, Lusha ; Janssen, Jan ; Androulakis, Nikolaos E. M. ; Merseburger, Axel Stuart ; Brouwers, Barbara Anna Henk ; Garlonta, Victor T.

474Background: In the JAVELIN Renal 101 phase 3 trial, 1L avelumab + axitinib resulted in significantly longer progression-free survival (PFS) and a higher objective response rate (ORR) vs sunitinib in patients with aRCC, with an acceptable safety profile. The AVION study is evaluating the effectiveness and safety of avelumab + axitinib in routine clinical practice in various countries. We report data from the primary analysis. Methods: AVION is a prospective noninterventional study of patients with aRCC receiving 1L avelumab + axitinib in Germany, Greece, Belgium, or Russia. Patients are observed for 24 months. The primary objective is to evaluate the overall survival (OS) rate at 12 months. Secondary objectives include evaluation of OS rate at 24 months, median OS, PFS, ORR, duration of response (DOR), and safety. Results: By data cutoff (Jul 5, 2024), 104 patients were analyzed. Median age was 70 years (range, 37-87) and 70.2% were male. ECOG PS was 0-1 in 92.3%, 2 in 6.7%, and not reported (NR) in 1.0%. International Metastatic RCC Database Consortium (IMDC) risk group was favorable, intermediate, poor, and NR in 26.0%, 45.2%, 12.5%, and 16.3%, respectively. Tumor histology was clear cell, sarcomatoid, and other in 89.4%, 3.8%, and 6.7%, respectively. Prior anticancer treatment included adjuvant drug treatment, surgery (nephrectomy), or radiotherapy in 3.8%, 75.0% (66.3%), and 8.7%, respectively. At data cutoff, avelumab or axitinib treatment was ongoing in 21 (20.0%). Median OS was not reached (95% CI, not estimable [NE]) and the 12-month OS rate was 82.7% (95% CI, 73.5-88.9). Median PFS (95% CI) was 11.3 months (8.1-NE) and 6- and 12-month PFS rates (95% CI) were 72.5% (62.1-80.5) and 48.4% (37.5-58.5), respectively. Among 87 patients with available response data (assessed up to 12 months), ORR was 46.0% (95% CI, 35.2-57.0), comprising complete or partial response in 4.6% and 41.4%, respectively; disease control rate was 79.3% (95% CI, 69.3-87.3); and median DOR was not reached. Treatment-related adverse events (TRAEs) occurred in 67.3% and were grade ≥3 or serious in 20.2% and 14.4%, respectively. TRAEs led to permanent discontinuation of avelumab or axitinib in 6.7% or 9.6%, respectively, and led to death in 1.0%. The most common TRAEs of any grade (≥6%) were diarrhea (19.2%), fatigue (13.5%), hypothyroidism (8.7%), and nausea (7.7%). Follow-up is ongoing. Conclusions: Results from the AVION study are generally consistent with JAVELIN Renal 101 and previous observational studies, demonstrating the effectiveness, safety, and favorable tolerability with low discontinuation rates of avelumab + axitinib in a heterogeneous real-world population.

01 Feb 2025·Food Chemistry

Monitoring of 260 pesticides in extra virgin olive oil and risk assessment for consumers within the framework of the European multiannual control program

Article

Author: Mondello, Luigi ; Rigger, Romana ; Hayenga, Ingrid ; Arena, Alessia ; Zoccali, Mariosimone ; Ferracane, Antonio ; Donnarumma, Danilo

The aim of the present research was to develop and validate a robust analytical method for the monitoring of 260 pesticide residues in Extra Virgin Olive Oil (EVOO) expanding the 185 molecules requested by the multiannual control program. The analytical procedure included an ultrasound-assisted liquid-liquid microextraction followed by low-pressure gas chromatography (LP-GC) and ultra-high-performance liquid chromatography (UHPLC), both coupled to triple quadrupole mass spectrometry. Matrix-matched calibration curves showed good linearity with coefficients of determination greater than 0.999. Accuracy values ranged from 65.5 % to 122.3 % and from 61.1 % to 133.3 % for LP-GC and UHPLC, respectively. The recoveries ranged from 14.0 % to 131.3 %. Fifty commercial EVOO, from Italian and EU production, were analyzed to assess pesticide contamination during the 2021-2023 harvesting seasons. The research focused on evaluating consumer risk by assessing both chronic and acute dietary exposure, using the Pesticide Residue Intake Model developed by EFSA.

News (Medical) associated with E. Merck KG

29 Oct 2024

·www.globenewswire.com

Praxis Bioresearch Obtains FDA Clearance On the IND Application for Its Lead Candidate PRX-P4-003 In Alzheimer’s Disease Apathy

LOS ANGELES, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PRX-P4-003, a gut-activated stimulant, to treat apathy in Alzheimer’s Disease. Previously, an exploratory microdose clinical trial in healthy volunteers demonstrated successful activation of PRX-P4-003 upon oral administration, the intended therapeutic route. “Apathy remains one of the most frequently observed symptoms in the Alzheimer’s Disease with no FDA-approved therapy,” stated Jeffrey Cummings, MD, ScD, director of the Chambers-Grundy Center for Transformative Neuroscience and Professor of Brain Sciences at the University of Nevada Las Vegas, “PRX-P4-003 has chemical properties and preliminary clinical validation that support its potential to build upon the pioneering studies in treating apathy led by the NIH-funded ADMET group.” PRX-P4-003, a selectively bioavailable dopamine and norepinephrine reuptake inhibitor, is a new chemical entity discovered by Praxis Bioresearch. The compound was designed to be activated by pancreatic lipase, an enzyme that is only present in the digestive system. “This is an important milestone for us,” said Sandeep Patil, MD PhD, CEO/Cofounder of Praxis Bioresearch, “I am particularly proud of our team in successfully delivering a high-quality IND package. In the next phase of development, we are deeply committed to demonstrating the effectiveness of our compound in improving the symptoms of apathy in the clinical trials." About PRX-P4-003 PRX-P4-003 is a new chemical entity developed by Praxis Bioresearch that delivers an active isomer of fencamfamine. Fencamfamine is a Schedule IV stimulant that was originally developed and marketed by E. Merck KG, located in Darmstadt, Germany. This prodrug, unlike current stimulants such as methylphenidate and amphetamines, is designed to only be orally active potentially decreasing the risk of abuse. There is a medical need for alternatives to current Schedule II stimulant medications in neuropsychiatric indications as diversion is a significant concern. About Apathy in Alzheimer’s Disease Apathy is the most prevalent neuropsychiatric symptom of Alzheimer’s dementia, affecting nearly 71% of patients over the course of the disease. Apathy has been associated with patient suffering, caregiver distress, and excess disability. There is no approved treatment for apathy in Alzheimer’s Disease. Disclaimer: Research reported in this publication was supported in part by the National Institute of Aging of the National Institutes of Health under Award Number R44AG066378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Contact: info@praxisbioresearch.com

IND

28 Jan 2024

·www.merckgroup.com

Boards of E. Merck KG Newly Elected

Johannes Baillou elected Chairman of the Family Board Professor Dr. Simon Thelen elected Vice Chairman of the Family Board and Board of Partners Dr. Wolfgang Büchele elected Chairman of the Board of Partners E. Merck KG, the company through which the Merck family holds around 70 percent of Merck KGaA, today announced the results of its regular board elections held this past weekend. Johannes Baillou (58) was elected Chairman of the Family Board, which represents the Merck family’s entrepreneurial interests. Baillou has 30 years of Board experience at E. Merck KG. First elected to the Family Board in 1994, he became Vice Chairman of the Board of Partners in 2009 and Chairman in 2014. That year, he was also elected Vice Chairman of the Family Board and Executive Board of E. Merck KG. Johannes Baillou succeeds Dr. Frank Stangenberg-Haverkamp (75), with whom he has worked side by side for ten years and who has reached the mandatory retirement age. He had been Chairman of the Family Board and Executive Board of E. Merck KG since 2014. Professor Dr. Simon Thelen (44) was elected Vice Chairman of the Family Board and Board of Partners of E. Merck KG. He has been a member of the Board of Partners since 2019 and was first elected its Vice Chairman in 2021. Thelen is a physician specializing in hand surgery and an adjunct professor of medicine. “Dr. Frank Stangenberg-Haverkamp has devoted four decades of service to Merck,” said Johannes Baillou. “The partners thank him wholeheartedly for the clarity, courage and care with which he has guided our company and led our family. At the same time, I am delighted that with Professor Dr. Simon Thelen, the next generation of our family is increasingly seizing the opportunity to shape the future of Merck and continuing a practice that is now in the 12th generation. This underscores the family’s unwavering commitment.” In addition to the new Chairman Johannes Baillou, the family elected their 11 further representatives to the Family Board. The Family Board, in turn, elected the nine members of the Board of Partners of E. Merck KG, which is comparable to the supervisory board of a German stock corporation (Aktiengesellschaft) and is composed of family members as well as non-family members. Dr. Wolfgang Büchele (64) was elected Chairman of the Board of Partners. “Dr. Wolfgang Büchele brings a wealth of industrial and entrepreneurial experience. As an external and independent advisor to Merck for the past 15 years in his roles as Chairman of the Supervisory Board of Merck KGaA and member of the Board of Partners of E. Merck KG, he understands our company very well,” said Johannes Baillou. Consequently, Dr. Wolfgang Büchele will step down as Chairman and member of the Supervisory Board of Merck KGaA prior to this year’s Annual General Meeting. The Supervisory Board will elect a new Chair without delay. The following representatives were elected to the Board of Partners: Family representatives: Johannes Baillou (58), Dr. Katharina Kraft (41), Carl Christoph Schweickert (42), Dr. Daniel Thelen (49), Prof. Dr. Simon Thelen (44) External and independent representatives: Dr. Wolfgang Büchele (64), Michael Kleinemeier (66), Dr. Susanne Schaffert (57), André Wyss (56) All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. About E. Merck KG As general partner, E. Merck KG holds around 70 percent of the total capital of Merck KGaA. Shareholders hold the remainder, which is divided into shares. E. Merck KG does not participate in the management of the company, it makes the fundamental entrepreneurial decisions of the Merck Group. The Merck family holds 99.9 percent of the capital of E. Merck KG; the remaining interests are held by the members of the Executive Board of Merck. For more information about the different bodies of E. Merck KG, please click here . About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck generated sales of € 22.2 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

Executive Change

19 Dec 2022

·www.prnewswire.com

Global Cytotoxic Drugs and HPAPI Manufacturing Markets 2022-2035: Increasing Demand has Led to a Rise in the Number of HPAPIs in the Overall Pharmaceutical Development Pipeline

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

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