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Alchem awarded 5-year Contract for "Drug Formulation and Manufacturing Program"

Description of Requirement: The NIH Clinical Center (CC), Pharmacy Department, Investigational Drug Management and Research Service (IDMRS); the Office of Research Support and Compliance (ORSC); and the Office of Logistics and Acquisition Operations (OLAO) are partnering to establish a suite of multiple award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts that, together, will constitute the Drug Formulation and Manufacturing Contracts (DFMC). The DFMC will allow NIH ICs to hire contractors to conduct the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational New Drug (IND) enabling studies, and clinical trials.

The goal of the contracts is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug compounds. Throughout the period of performance of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. Additionally, unless otherwise requested any assigned research must be performed in compliance with, all current FDA, World Health Organization (WHO), and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to current good manufacturing practices (cGMP) as may be applicable. Contract Award Dollar Amount: IDIQ Maximum $45,000,000.

https://www.fbo.gov/spg/HHS/NIH/OoA/75N98019R00005/listing.html

Alchem awarded 5-year Contract for "CRO Support for NCATS Medicinal Chemistry for Lead Optimization"

The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development. The objective of this contract is to support the DPI drug development programs by identifying preclinical drug candidates with improved efficacy, optimized ADME properties, and minimal predicted toxicity. One of the DPI program requirements is to efficiently identify preclinical development candidates for rare and neglected diseases. To accomplish this endeavor, DPI has a need for a team of chemists; pharmacologists; absorption, distribution, metabolism, and excretion (ADME)/pharmacokinetics (PK) experts; and toxicologists working closely together to perform medicinal chemistry lead optimization.

While this Contract will be primarily in support of the DPI drug development programs. The Government reserves the right to allow other drug development programs at NIH to solicit task order proposals. As such, this Contract is not limited to rare or neglected disorders. Contract Award Dollar Amount: $17,887,012.

https://www.fbo.gov/spg/HHS/NIH/NIDA-01/N01TR-19-2007/listing.html

Alchem Laboratories Supporting Sixteen Active Clinical Programs and Awarded New DOD/NCI Contracts in 2018

•     Awarded a new DOD contract W81XWH-18-D-0028-to support the U.S. Army Medical Research Acquisition Activity with “Non-Personal Services for Experimental Therapeutics Medicinal Chemistry Tasks”

•     Awarded two new five-year contracts in the second half of 2017 with the National Cancer Institute 

•     Successfully conducted 140 cGMP batches to support over twenty different government and commercial projects

•     Two different topical drug products manufactured in its new clinical manufacturing building to support Phase 1 and 2 clinical trials

•     Products manufactured by Alchem over the last five years in 16 active clinical programs at the beginning of 2018

March 2, 2018 — Alchem Laboratories Corporation, a contract manufacturing organization located in Alachua, Florida dedicated to excellence in custom synthesis, today announced support of clinical programs and new DOD/NCI contracts for 2018. DOD contract W81XWH-18-D-0028-awarded in January supports the U.S. Army Medical Research Acquisition Activity with “Non-Personal Services for Experimental Therapeutics Medicinal Chemistry Tasks.” This contract was awarded to procure, synthesize, or purify potential antimalarial drug candidates for the Walter Reed Army Institute of Research. Alchem Laboratories was also awarded two new five-year contracts with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Contract HHSN261201700007I “Synthesis of Non-GMP Small Molecules” was awarded September 13, 2017 to synthesize, purify, characterize, and submit to the Drug Synthesis and Chemistry Branch (DSCB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), NCI, target compounds of high purities and small libraries of analogs of lead compounds. Contract HHSN261201700020C “Manufacture of Bulk Chemicals and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies” was awarded July 31, 2017 to support DTP and NCI’s Experimental Therapeutics Program (NExT) to facilitate the transition of novel drug discoveries into clinical trials of new cancer therapeutic agents. These projects have been funded in whole or in part with Federal funds from NCI, NIH, Department of Health and Human Services, under Contract No. HHSN261201700007I (100% Federally funded up to $7,777,665.00) and Contract No. HHSN261201700020C (100% Federally funded up to $2,814,764.00).

“I am proud of the team and progress we have made over the past year. We have achieved critical milestones, with 140 cGMP batches successfully manufactured to support over twenty different government and commercial projects” said Jim Talton, President and CEO. “Twelve of 16 of the active clinical studies currently underway are led by the NCI, which Alchem has been supporting through multiple R&D contracts for over fifteen years. In 2018, we also will continue to work toward rolling scale-up of our GMP clinical manufacturing facility expansion, which is a cornerstone of our long-term strategy to support multiple development programs simultaneously through phase 2/3 clinical studies and commercial production” Talton stated.

About Alchem Laboratories (www.alchem.com)
Alchem can be a value-creating partner for both established and start-up pharmaceutical companies by providing qualified infrastructure and trained personnel for all stages of drug development including design and synthesis of novel compounds, synthesis of analogs of lead compounds, process development and optimization, analytical method development and validation, stability studies for drugs and intermediates, cGMP manufacturing of APIs and products for clinical studies, and documentation for all stages of drug development. Our partners and collaborators include the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), the National Institute of Standards and Technology (NIST), the U.S. Army Medical Research Acquisition Activity (USAMRAA), the U.S. Department of Agriculture (USDA), the Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (ICP), Gemphire Therapeutics, Inc. (NASDAQ: GEMP), Cerenis Therapeutics Holding SA (CEREN.PA), Brickell Biotech, Inc., FLUCEL LLC, Nanopharmaceutics, MRIGlobal, Pace Analytical Labs, Southern Research, and the University of Florida UF|INNOVATE - Sid Martin Biotech.