The U.S. Federal Trade Commission (FTC) voted 3-2 to accept a proposed consent order allowing North Chicago-based Abbvie Inc.’s $63 billion acquisition of Allergan plc, of Dublin. Under the consent decree, which the two companies signed in March, Allergan will divest brazikumab, an IL-23 inhibitor in development to treat autoimmune diseases, to Astrazeneca plc, of Cambridge, U.K. Allergan also will divest Zenpep (pancrelipase replacement therapy), a treatment for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, and pancreatic enzyme preparation Viokace (pancrelipase) to Nestle SA, of Vevey, Switzerland. The FTC vote followed a 10-month global investigation of the anticompetitive aspects of the acquisition, including more than 40 interviews and a review of more than 430,000 documents. In his dissenting statement, Commissioner Rohit Chopra called the acquisition an “unlawful takeover” and said the divesture to Nestle is “risky and concerning,” given that the company currently markets no prescription drugs. The majority countered that, saying, “The claim that Nestlé lacks significant pharmaceutical experience is simply false. Nestlé has been involved in the pharmaceutical industry for over 40 years, in various iterations.” Chopra also took issue with the fact that the consent order is a windfall for Astrazeneca, since it requires Allergan to give back the rights to a “major drug development project,” which Astrazeneca can license again or shelve. Chopra’s opposition isn’t limited to the Abbvie/Allergan deal. The FTC’s “default strategy of requiring merging parties to divest overlapping drugs is narrow, flawed and ineffective,” he said. “It misses the big picture, allowing pharmaceutical companies to further exploit their dominance, block new entrants, and harm patients in need of life-saving drugs.” Noting that Chopra and Commissioner Rebecca Kelly Slaughter are generally opposed to pharmaceutical mergers, the FTC’s majority hit back at Chopra, saying “his dissent makes misleading claims about the staff’s investigation, the state of competition in the pharmaceutical industry and the Commission’s enforcement record in this industry.” The next step is for the FTC to publish the consent order in the Federal Register, kicking off a 30-day comment period.
In a whistleblower complaint filed Tuesday with the U.S. Office of Special Counsel, Rick Bright said he wants his job back as director of the Biomedical Advanced Research and Development Authority (BARDA) and a full investigation into his involuntary transfer in April from that position to the NIH. When asked on the complaint form why he thought the transfer was retaliatory, Bright wrote, “I insisted on scientifically vetted proposals, and I pushed for a more aggressive agency response to COVID-19. My supervisor became furious when Congress appropriated billions of dollars directly to my office, and when I spoke directly to members of Congress.” The complaint specifically accuses Bright’s supervisor, Robert Kadlec, the head of the Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response, of violations of the law or regulations, gross mismanagement, gross waste of funds, abuse of authority, substantial and specific danger to public health and to public safety, and censorship related to scientific research. An attachment to the complaint said HHS officials were already “gunning” for Bright, partly because of his early warnings about COVID-19, but suggested that his transfer was triggered by the publication of a media article for which HHS officials suspected he was the source. The article raised concerns about the use of hydroxychloroquine and chloroquine as COVID-19 treatments and safety issues about supplies of the drugs being imported from facilities in India and Pakistan that had not been inspected by the FDA. In addition to confirming information the reporter received from other sources, Bright gave the reporter “emails between HHS officials that were not privileged or classified or otherwise legally restricted from dissemination, which discussed the drug’s potential toxicity and demonstrated the political pressure to rush these drugs from Pakistan and India to American households,” according to the attachment. The statement noted that on the day Bright was removed from his position at BARDA, the FDA issued a warning that hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.
The U.S. SEC this week charged a Chinese couple, Zhuobin Hong and Caixia Jiang, in an $8.5 million insider trading scheme involving Sagent Pharmaceuticals Inc. The complaint, filed in a federal district court in California, alleges that Hong and Jiang traded Sagent securities in advance of a July 11, 2016, announcement about the company's acquisition based on confidential information they received from a friend and neighbor whose company competed in the bidding process to acquire the Schaumburg, Ill.-based firm. The couple, who were living in California at the time but have since returned to China, allegedly made the trades through accounts held in the names of relatives in China, according to the SEC. Between November 2015 and June 2016, the accounts amassed more than 1 million shares of Sagent stock. On several trading days, the couple’s purchases made up more than 20% of the total trading volume in Sagent stock for the day. They sold the shares immediately following the announcement that Sagent was being acquired by Nichi-Iko Pharmaceutical Co. Ltd., of Tokyo.
The SEC temporarily suspended trading for three drug companies this week citing questions about the accuracy and adequacy of information they released about the development status of WP-1122, a prodrug of 2-DG (2-deoxy-D-glucose), as a potential treatment for COVID-19 and the ability to expedite regulatory approval of the drug. Trading for WPD Pharmaceuticals Inc. (OTCMKTS:WCOTF), of Vancouver, British Columbia, Moleculin Biotech Inc. (NASDAQ:MBRX), of Houston, and CNS Pharmaceuticals Inc. (NASDAQ:CNSP), of Houston, will be suspended through May 15. Last month, Moleculin announced a pre-print article, submitted by researchers at the University of Frankfurt to Nature Research, in which scientists reported that "blocking glycolysis with non-toxic concentrations of 2-DG prevented SARS-CoV-2 replication in Caco-2 cells." Moleculin CEO Walter Klemp said the report was "the breakthrough we were looking for," though it came "from an unexpected source." Shares of Moleculin climbed 125.7% to $1.27 on the news.
The U.K.’s National Institute for Health and Care Excellence (NICE) Wednesday released another COVID-19 rapid guideline. This one is on treating COVID-19 patients who have acute kidney injury (AKI). Citing emerging evidence that the coronavirus might directly harm the kidneys, the guideline stressed the need to monitor hospitalized patients for AKI.
Addressing difficulties Australian providers are facing in obtaining supplies of radiopharmaceuticals from a licensed manufacturer in a timely manner during the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) added a new exemption to its regulations that allows specified individuals within public and private hospitals and public institutions that don’t hold a manufacturing license to manufacture radiopharmaceuticals or radiopharmaceutical active ingredients for the treatment of a patient in another state or territory. The TGA said it will review the exemption when the “current COVID-19 circumstances change.”