trending Market Intelligence /marketintelligence/en/news-insights/trending/UvAg1nL-Y-WxZxOQ2APMUQ2 content esgSubNav
In This List

Acadia drug relieves dementia symptoms; Roche banks on pipeline for sales growth

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Acadia drug relieves dementia symptoms; Roche banks on pipeline for sales growth

Top news

* Acadia Pharmaceuticals Inc. said its drug pimavanserin extended the time that patients with dementia did not experience hallucinations and delusions before relapsing, meeting the main goal of a late-stage study dubbed Harmony. The company is stopping the study early, based on the recommendation of an independent data monitoring committeee, and is planning to meet with the U.S. Food and Drug Administration regarding a supplemental new drug application submission in 2020.

* Roche Holding AG is banking on its drug pipeline to drive growth in the longer term, CEO Severin Schwan told Reuters. Although the Swiss drugmaker is looking at bolt-on technology M&A, Schwan said the company will not rely on takeovers to fill a revenue growth gap.

Schwan said the company did not expect the U.S. Federal Trade Commission's investigation into the $4.3 billion acquisition of gene-therapy maker Spark Therapeutics — a deal that has faced repeated delays.

* The S&P 500 healthcare sector saw a negative total return of 0.5% in August, making it the fourth-best performing sector when compared to the overall S&P 500 Index, which recorded a decline of 1.6% in the market, according to data compiled by S&P Global Market Intelligence.

SNL Image

On the policy front

* Congress has returned to Capitol Hill after its monthlong recess and faces a jam-packed legislative to-do list, including finishing its efforts to lower Americans' prescription drug costs and end surprise medical bills.

President Donald Trump is also due to unveil his healthcare plan during a speech this month, according to White House Counselor Kellyanne Conway.

Also on Trump's plate is the decision about who he will nominate to permanently lead the FDA — a choice he must make by early November, when the 210-day time limit runs out for Acting Commissioner Ned Sharpless to serve. For now, Stephen Hahn, chief medical executive at MD Anderson Cancer Center in Houston, is Sharpless' top competition.

* A congressional Medicare adviser is developing a value incentive program for post-acute care facilities that could include withholding 5% of payments for facilities that do not meet the program's standards. The new program will use patient outcomes during hospitalizations, successful discharges and Medicare spending per beneficiary as key metrics, policy analysts for the Medicare Payment Advisory Commission said during a Sept. 6 meeting.

* Canada is revamping its drug pricing policies for the first time since 1987 — a move that is expected to slash C$8.8 billion off the pharmaceutical sector's revenues over a decade, Bloomberg News reported. Johnson & Johnson, Merck & Co. Inc., Bayer AG, Boehringer Ingelheim Corp. and Servier Inc. have pushed back on the proposed changes, questioning their constitutionality and arguing that they would limit access to new breakthrough therapies.

M&A and capital markets

* Switzerland-based ADC Therapeutics SA, which develops targeted therapies for cancer, filed for an IPO of up to $150 million on the NYSE.

* Woburn, Mass.-based Frequency Therapeutics Inc., which develops products for hearing loss, eye and skin disorders, gastrointestinal diseases, and diabetes, is planning an IPO of up to $100 million on the Nasdaq Global Market.

Drug and product pipeline

* Eli Lilly and Co. said 68% of 105 pretreated patients with non-small cell lung cancer responded to selpercatinib, also known as LOXO-292, according to results from an early-stage study dubbed Libretto-001.

* Novo Nordisk A/S said it will offer half-priced versions of Novolog — a fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus — in the U.S. beginning Jan. 2, 2020. At the same time, the Danish drugmaker will launch a $99 cash card program for diabetes patients using its analog insulins.

Novo Nordisk is the last to join its competitors Eli Lilly and Co. and Sanofi in launching insulin cost-cutting efforts in the U.S.

* Amgen Inc. said its therapy AMG 510 shrank the tumors of over half of evaluable patients with lung cancer in a small, early-stage study. Follow-up data from the ongoing phase 1 study showed 7 of 13 evaluable patients with non-small cell lung cancer showed a reduction in their tumors — as measured by a metric called partial response — after being given a target dose of 960 milligrams once daily.

* U.S. pricing watchdog Institute for Clinical and Economic Review will assess already marketed ulcerative colitis drugs, including Pfizer Inc.'s Inflectra and Xeljanz, Johnson & Johnson's Remicade and Simponi, and AbbVie Inc.'s Humira. ICER will also evaluate Takeda Pharmaceutical Co. Ltd.'s Entyvio and J&J's Stelara, both of which are under review for U.S. Food and Drug Administration approval.

ICER also plans to further examine FDA-approved cystic fibrosis drugs Symdeko, Orkambi and Kalydeco, all marketed by Vertex Pharmaceuticals Inc. ICER reviewed the medicines in a June 2018 final report that determined that Vertex needed to significantly reduce prices for all three drugs to make them cost-effective.

* The U.S. FDA approved Boehringer Ingelheim's Ofev to treat interstitial lung disease in patients with a rare autoimmune disease called systemic sclerosis.

Operational activity

* Mallinckrodt PLC, along with its subsidiaries, reached a proposed settlement worth $30 million with two Ohio counties in connection with opioid lawsuits. If the settlement agreement is finalized, Mallinckrodt will pay $24 million in cash and $6 million in the form of medicine donations, which include addiction therapy products. In return, all named Mallinckrodt entities will be dismissed with prejudice from the lawsuit.

* Meanwhile, Purdue Pharma LP is in talks with the U.S. Department of Justice to resolve investigations into the company's opioid painkiller OxyContin, The Wall Street Journal reported, citing anonymous sources. Purdue Pharma, which is owned by the Sackler family, proposed to settle the lawsuits against it for $10 billion to $12 billion in August.

* BeiGene Ltd., one of China's largest biotechnology companies, inflated revenue data and overstated research and development costs, New York-based investment company J Capital Research alleged. BeiGene, whose shares slumped nearly 10% in Hong Kong on Sept. 6, denied the accusations, the Financial Times reported.

The day ahead

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

In Asia, the Hang Seng slipped 0.04% to 26,681.40, while the Nikkei 225 inched up 0.56% to 21,318.42.

In Europe, around midday, the FTSE 100 shed 0.57% to 7,240.79, and the Euronext 100 lost 0.06% to 1,081.84.

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.

The Daily Dose has an editorial deadline of 6:30 a.m. ET. Some external links may require a subscription. Links are current as of publication time, and we are not responsible if those links are unavailable later.