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Bayer plummets after Monsanto cancer ruling; Alnylam rare drug wins FDA approval


Essential IR Insights Newsletter Fall - 2023

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Bayer plummets after Monsanto cancer ruling; Alnylam rare drug wins FDA approval

Top news

* Bayer AG's shares plunged more than 10% after its newly acquired unit Monsanto Co. was ordered to pay $289 million in damages over allegations that its glyphosate-based weedkiller Roundup caused cancer in a school groundskeeper. As of 1:28 p.m. CEST, Bayer's shares were down 13.59% to €80.67. This was the largest fall in the German agrochemical company's stock prices in almost seven years, Bloomberg News noted.

* The U.S. Food and Drug Administration approved Onpattro, Alnylam Pharmaceuticals Inc.'s RNA-based treatment of a peripheral nerve disease caused by a rare genetic disorder. Onpattro, or patisiran, is the first approved treatment of adult patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis, or hATTR amyloidosis. The average annual list price for the drug will be $450,000, or $9,500 per vial, based on an average of 2.7 vials administered on an average of 17.5x per year.

* Reps. Kathleen Rice, D-N.Y., and Tom Reed, R-N.Y., want all lawmakers on Capitol Hill barred from serving on the boards of publicly traded companies following the arrest last week of one of their colleagues, Rep. Chris Collins, R-N.Y., on insider trading charges.

* Meanwhile, the U.S. FDA plans to standardize its drug safety assessments — a move Commissioner Scott Gottlieb said would create more efficiency and provide more transparency about regulators' approach.

* Senate Finance Committee Chairman Orrin Hatch, R-Utah, and House Energy and Commerce Committee head Greg Walden, R-Ore., raised concerns last week about the potential economic impacts of the Trump administration's proposed rule to eliminate the safe harbor protections that allow pharmacy benefit managers and health plans to secure rebates from drugmakers.

On the policy front

* A new proposed rule change for the accountable care organization shared savings program is already receiving criticism from healthcare provider associations, with one even claiming the changes would create havoc and cause ACOs to quit the program. The National Association of ACOs, a nonprofit organization that represents the groups of healthcare providers, came out strongly against the proposed rule hours after it was announced by the U.S. Centers for Medicare and Medicaid Services.

* Republican Gov. Charlie Baker of Massachusetts last week signed the first-ever legislation in the U.S. that would help improve diagnosis and treatment of Alzheimer's disease, which affects 120,000 residents in the state and 5.7 million people across the country, The Boston Globe wrote.

* The Ministry of Public Health of the Democratic Republic of the Congo confirmed four new cases of Ebola virus near the town of Mangina in the country's North Kivu province, raising the outbreak total to 21 cases, Reuters reported. Officials are preparing to deploy an experimental vaccine by Merck & Co. Inc. called mAB114, Steve Ahuka, a virologist at the National Institute for Biomedical Research in the capital, Kinshasa, told Reuters.

* The Centers for Disease Control and Prevention last week unveiled a new graphic novel with the aim of educating America's youth about infectious diseases, including influenza.

M&A and capital markets

* Chinese drug developers Suzhou Kintor Pharmaceuticals Inc. and Frontier Biotechnologies Co. Ltd. are exploring IPOs on the Hong Kong Stock Exchange, insiders told Bloomberg News. The offerings, which could raise $300 million for each company, would take advantage of the recently relaxed listing rules for biotechnology companies.

* Glass Lewis & Co. recommended that shareholders vote to approve health insurer Cigna Corp.'s $54 billion acquisition of Express Scripts Holding Co., making it the second shareholder advisory firm to support the deal, Bloomberg News reported.

Glass Lewis' recommendation follows that of Institutional Shareholder Services, which also backed the merger. In contrast, activist investor Carl Icahn is encouraging Cigna shareholders to vote against the deal, calling it a "travesty."

Drug and product pipeline

* Shire PLC and Shionogi & Co. Ltd. are seeking Japanese approval to expand the indication of their drug Intuniv to include adults with attention deficit hyperactivity disorder.

* A second Chinese company has been flagged by the European Medicines Agency after low levels of a cancer-causing substance were again detected in batches of valsartan, the main ingredient in certain high blood pressure and heart drugs. The EMA said valsartan manufactured by Zhejiang Tianyu Pharmaceutical Co. Ltd. was determined to contain low levels of an impurity known as N-nitrosodimethylamine.

* Amicus Therapeutics Inc. said the U.S. FDA granted accelerated approval to its medicine Galafold to treat Fabry disease, a rare genetic disorder.

Operational activity

* China's Wuhan Institute of Biological Products Co. Ltd. was punished too lightly for manufacturing violations it committed in 2016, Xinhua News reported, citing inspectors who revisited a previous investigation into the vaccine maker. Wuhan was fined in 2017 for producing substandard DPT vaccines, which prevent diphtheria, pertussis and tetanus.

* Canadian drugmaker Aralez Pharmaceuticals Inc. is winding down its operations following a strategic review of the business and selling its main assets in transactions valued at $250 million. As part of the process, Aralez is also filing for bankruptcy protection in Canada and the U.S. to continue operating as usual as it searches for buyers for its other assets.

Other features

* The Wall Street Journal highlights the limited impact of oncology-related projects and cancer applications by International Business Machines Corp.'s artificial intelligence system called Watson.

* The Financial Times features several startup biotech companies such as Diurnal Ltd., Tissue Regenix Group PLC and Bangladesh Export Import Co. Ltd., whose investors would have to wait before these companies could bring their products to the market and make profits.

* Opioid abuse by pregnant women is becoming worse across the U.S., Bloomberg reported citing the Morbidity and Mortality Weekly Report published by the U.S. Centers for Disease Control and Prevention.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, the Hang Seng was down 1.52% to 27,936.57. The Nikkei 225 retreated 1.98% to 21,857.43.

In Europe as of midday, the FTSE fell 0.51% to 7,628.81, and the Euronext 100 slipped 0.43% to 1,057.93.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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