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Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Alcami serves pharmaceutical and biotech companies of all sizes for small molecules and biologics, providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid dose drug product manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami`s private equity ownership includes GHO Capital, The Vistria Group, and Ampersand Capital Partners.
Madrigal Pharmaceuticals is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. The Company has advanced its lead candidate, resmetirom, also known as MGL-3196, a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) β-selective agonist, through Phase 2 clinical trials in NASH. Primary and key secondary endpoints were achieved including reduction of liver fat on a sensitive non-invasive imaging test, lowering of multiple atherogenic lipids including LDL-cholesterol and triglycerides, and resolution of NASH on liver biopsy. Based on evidence of broad activity and a favorable safety profile, Madrigal has initiated a Phase 3 clinical study in NASH patients with advanced liver fibrosis, MAESTRO-NASH, in which the primary endpoint after one year of dosing is resolution of NASH and key secondary endpoints include LDL-cholesterol lowering and reduction in liver fibrosis. Clinical benefit in reducing progression to more advanced liver disease, including cirrhosis, is a long-term goal of this trial. A second Phase 3 clinical study, MAESTRO-NAFLD-1, has also been initiated. This 52-week non-invasive study in a broader segment of NASH patients will provide additional safety information to support the NASH indication and will include key efficacy endpoints: LDL-cholesterol lowering, triglyceride lowering, reduction of liver fat as determined by MRI-PDFF, as well as reduction of elevated liver enzymes and reduction in fibrosis biomarkers. This is a non-biopsy study in people with NASH, as documented using non-invasive techniques or historical liver biopsy.
Meda is a leading international specialty pharma company with a broad product portfolio reaching more than 80% of the global pharmaceutical market. Sales at the end of 2014 amounted to more than SEK 15 billion (pro forma SEK 18.7 billion). Meda is thereby the 48th largest pharmaceutical company in the world. At the end of 2014 Meda had 5,202 (3,326) employees, 2,996 (2,009) of which worked in sales and marketing. The company’s main focus is sales and marketing and Meda has its own sales organizations in more than 60 countries. Sales and marketing activities are carried out via distributors in countries where Meda has no representation and globally Meda’s products are sold in more than 150 countries.
Elevar Therapeutics is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar`s lead proprietary drug candidates include rivoceranib (apatinib) and Apealea® (paclitaxel micellar). Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide in numerous cancer indications. Apealea® (paclitaxel micellar) is a non-Cremophor EL based formulation of paclitaxel that received marketing authorization by the European Commission in November 2018, making it Europe`s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Elevar Therapeutics has offices in Utah, California and South Korea.