By Linda O’Brien, J.D., LL.M.
Eli Lilly and other pharmaceutical companies receive okay for efforts to expedite and increase production of COVID-19 monoclonal antibody treatments.
The Department of Justice has no present intention to challenge proposed efforts by Eli Lilly and Company, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GlaxoSmithKline to exchange limited information about manufacturing facilities that could expedite the production of monoclonal antibody treatments that may safely and effectively treat COVID-19 patients. The Justice Department expressed its position in an expedited business review letter pursuant to its temporary review procedure responding to the COVID-19 pandemic.
The request by the six pharmaceutical companies arose in the context of the ongoing coronavirus pandemic and the federal government support of the accelerated development, manufacture, and distribution of therapeutic treatment and vaccines, such as those incorporating monoclonal antibodies ("mAbs"). The Department letter notes that there are limited number of facilities that can produce monoclonal antibodies targeting COVID-19 on an industrial scale. Waiting for government approval of specific drugs and vaccines before increasing production may delay access to potentially life-saving treatments for several months.
In their request, the pharmaceutical manufacturers indicated that each company was investigating monoclonal antibody agents that may be used to treat COVID-19 and making arrangements for the mass production of those agents if they are approved as safe and effective treatments. The development and calibration in parallel may accelerate and ultimately expand production of the mAb therapeutics.
Specifically, the companies propose to exchange the following categories of information to accomplish this objective:
- technical details regarding a company’s relevant manufacturing facilities, including total potential capacity, technical specifications during which the facilities would be available, and whether the facility is owned by the company or by a third party;
- technical information regarding a company’s manufacturing processes/platforms and/or the manufacturing processes/platforms of their contract manufacturers or their other manufacturing partners; and
- information regarding the source and amount of available raw materials and supplies that are necessary for the manufacture of COVID-19 mAb treatments, but not any information regarding prices or commercial terms of any arrangements for raw materials and supplies.
The companies propose a number of safeguards to reduce antitrust concerns. The safeguards include: (1) limiting the scope of information exchange to only the facilitation of the rapid production of safe and effective COVID-19 treatments; (2) limiting the duration of the information exchange to only as long as necessary to address the COVID-19 crisis; (3) the companies will not make joint decisions on whether to deal with certain customers; and (4) there will no exchange of competitively sensitive information concerning input prices and commercial terms. Based on the companies’ representations, the Justice Department concluded that the proposed collaboration was unlikely to result in collusion or harm to competition in the market for COVID-19 mAb treatments and that it was likely to generate sufficient efficiencies.
"This critical collaboration will help Americans get access to potentially life-saving therapeutics sooner than otherwise would be possible," Assistant Attorney General Makan Delrahim said in the Department announcement. "It also will help preserve Americans’ ability to benefit from the free market competition that drives innovation and access to drugs in the biotech and pharmaceutical industry."
Earlier business review letters. This is the third expedited business review letter regarding efforts to combat COVID-19. The Justice Department’s first letter in April addressed medical supply distributors regarding their collaboration on manufacturing, sourcing, and distributing personal-protective equipment (PPE) and coronavirus-treatment-related medication. The second letter cleared collaborative efforts of AmerisourceBergen regarding distribution of medications and other healthcare supplies to treat COVID-19 patients.
Companies: Eli Lilly and Company; AbCellera Biologics Inc.; Amgen Inc.; AstraZeneca PLC; Genentech, Inc.; GlaxoSmithKline plc
MainStory: TopStory Antitrust AntitrustDivisionNews GCNNews Covid19
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