Novo Nordisk’s diabetes pill Rybelsus to be covered by Express Scripts

Novo Nordisk’s new diabetes pill, Rybelsus, will be covered by Express Scripts Holding Co, one of the largest U.S. pharmacy benefit managers, the Danish drugmaker said on Friday.

Pharmacy benefit managers act as middlemen in the drug supply chain, and negotiate discounts on drugs on behalf of health insurers.

Depending on the discounts drugmakers are willing to provide, pharmacy benefits managers make decisions about which drugs to include in coverage plans.

https://www.reuters.com/article/us-novo-nordisk-usa/novo-nordisks-diabetes-pill-rybelsus-to-be-covered-by-express-scripts-idUSKBN1ZG0MB

NMC independent committee taps FBI ex-boss Freeh in Muddy Waters fight

Private healthcare provider NMC Health, hurt by short-selling by Muddy Waters, said on Friday an independent review committee looking into the matter had hired FBI ex-boss Louis Freeh.

NMC, the United Arab Emirates’ largest private healthcare provider, launched an independent review of its finances last month after short-seller Muddy Waters questioned the value of its assets and cash balance while announcing a short position.

Since Muddy Waters’ claims were launched on Dec. 17, NMC has lost 2.4 billion pounds ($3.14 billion) of its share value, or 44%.

Its shares leapt 6.4% on Friday to 1,533 pence, leading London’s bluechip index, after news that Freeh, who probed BP oil spill claims payouts, would take charge of the investigation.

Short selling involves borrowing an asset and selling it with the aim of buying it back at a cheaper price for profit. Muddy Waters, founded by American Carson Block, is known in financial markets for declaring short equity positions on the basis of its in-house research.

Muddy Waters also questioned the value of NMC’s reported profits and debts. The short-seller also said in a research note that NMC’s asset purchase prices and capital expenditures were inflated.

NMC has called the report “false and misleading” and has defended its position.

The company suffered another setback after the attack by Muddy Waters as two major shareholders launched a discounted share sale in NMC earlier this month.

The healthcare firm’s vice-chairman Khaleefa Al Muhairi and its second-largest shareholder Saeed Al Qebaisi together sold NMC shares worth 375 million British pounds ($490.54 million) and a source told Reuters that the sale price factored in context around Muddy Waters.

FBI HEAVYWEIGHT

NMC said the independent committee has also hired Freeh’s risk management firm FGIS to look at the allegations.

“The committee chose Freeh Group to provide a completely independent, unbiased, comprehensive and transparent report that will address all of these allegations,” Jonathan Bomford, chairman of the independent review committee, said.

Freeh, who ran the Federal Bureau of Investigation from 1993 until June 2001, has handled multiple high-profile probes including possible misconduct by a lawyer involved in settlement payments to those affected by the Gulf of Mexico spill in 2010.

However, his tenure as director of the FBI also attracted criticism.

The strongest backlash of Freeh’s tenure came from the commission that investigated the Sept. 11, 2001 attacks on the World Trade Centre and the Pentagon.

The NMC committee intends to publish findings of its review before NMC reports its 2019 results.

Muddy Waters did not immediately respond to a request for comment outside U.S. business hours.

https://www.marketscreener.com/BP-PLC-9590188/news/NMC-independent-committee-taps-FBI-ex-boss-Freeh-in-Muddy-Waters-fight-29851817/

Bayer close to Roundup settlement: Mediator

Bayer is close to settling more than 75,000 cancer claims related to its Roundup herbicide, mediator Ken Feinberg told Bloomberg in an interview, saying he was “cautiously optimistic” a deal could be reached in about a month.

Feinberg was quoted as saying that the number of cases had grown to between 75,000 and 85,000 and “maybe more”. Bayer in October said it was now facing 42,700 U.S. plaintiffs blaming its glyphosate-based weedkillers for their cancer.

Feinberg declined to discuss terms of the possible settlement.

Bayer has ruled out withdrawing from the market in the U.S., saying regulators and extensive research have found glyphosate to be safe.

A spokesman for Bayer said: “The number reported by Bloomberg includes potential plaintiffs with unserved cases and is a speculative estimate about the numbers of plaintiffs who might be included in a potential settlement.”

He added: “The number of served cases as reported on a quarterly basis remains significantly below 50,000.  Bayer does not report or speculate about potential plaintiffs with unserved cases.”

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-close-to-Roundup-settlement-mediator-tells-Bloomberg-29851727/?countview=0

Court OKs Insys bankruptcy plan

A Delaware court has approved a bankruptcy plan for Insys Therapeutics (OTCPK:INSYQ), the first company to file for Chapter 11 protection over opioid epidemic-related legal exposure.

Unsurprisingly, shareholders will be wiped out. Most creditors will only receive only about eight cents on the dollar.

https://seekingalpha.com/news/3532577-court-oks-insys-bankruptcy-plan

I-MAB prices IPO at $14

I-Mab (IMAB) has priced its initial public offering of 7,407,400 American Depositary Shares (“ADSs”), every 10 ADSs representing 23 ordinary shares of the Company, at $14.00 per ADS, for expected gross proceeds of ~103.7M.

Underwriters’ over-allotment is an additional 1,111,110 ADSs.

The ADSs will begin trading today on Nasdaq under the symbol “IMAB”.

https://seekingalpha.com/news/3532626-i-mab-prices-ipo-14

Novo Nordisk: FDA Approves New Indication for Ozempic

Novo Nordisk AS (NVO) on Thursday said the U.S. Food and Drug Administration approved a new indication for Ozempic, or semaglutide, to “reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.”

Novo Nordisk said the FDA’s decision was based on results from the SUSTAIN 6 trial, a two-year study examining “the cardiovascular safety of adding Ozempic or placebo to standard of care in adults with type 2 diabetes and established cardiovascular disease.”

“There is a well-established link between cardiovascular disease and type 2 diabetes. It’s one of our biggest concerns with type 2 diabetes because even when patients reach their blood sugar targets, the risk of a major adverse CV event remains,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “Today’s milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease.”

Ozempic is already indicated for use by certain patients to improve blood sugar and reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease, the company said.

https://www.marketscreener.com/NOVO-NORDISK-AS-1412980/news/Novo-Nordisk-Says-FDA-Approves-New-Indication-for-Ozempic-29850639/

Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020 – CFO

Eli Lilly and Co aims to announce roughly one $1 billion (765 million pounds) to $5 billion (3.8 billion pounds) deal every quarter in 2020, its chief financial officer told Reuters, as the U.S. drugmaker looks to build up its pipeline of future products.

It will focus largely on earlier stage opportunities across key therapeutic areas including oncology, pain, immunology, and neurology, CFO John Smiley told Reuters in an interview at the JP Morgan Healthcare conference in San Francisco earlier this week.

Eli Lilly has been on a deal-making spree in recent years in a bid to increase products and sales in core franchises as older blockbuster medicines, such as diabetes treatment Humalog, face generic competition and pressure to lower prices.

Last week, it announced a $1.1 billion deal to buy dermatology products maker Dermira Inc. With the purchase, Lilly will acquire Dermira’s experimental treatment for atopic dermatitis, a serious form of eczema, which is in late-stage testing, as well as an approved medicated cloth to treat excessive armpit sweating.

“We are looking at Dermira-like opportunities targeting assets in the $1 billion to $5 billion range,” Smiley said. “We’d like to be doing something in the range of one per quarter or so.”

In 2018 and 2019, it announced several deals for cancer companies, including an $8 billion acquisition of Loxo Oncology. U.S. regulators in 2018 approved Vitrakvi, Loxo’s first commercial medicine, which treats a wide variety of cancers triggered by a rare genetic mutation.

In a presentation to investors this week, Lilly Chief Executive David Ricks said most of its deals will be in the cancer space, but that other therapeutic areas remain of strong interest as well.

While the company is still looking at late-stage assets, Smiley said the most opportunity for shareholders is in drugs in earlier stages of development.

Deals could include licensing agreements, outright acquisitions, or other structures, he added.

In its most recent earnings call, Lilly forecast a higher-than-expected profit for 2020, citing growing demand for its newer medicines including diabetes drug Trulicity and Taltz for psoriasis and other related autoimmune diseases.

However, sales of Trulicity and other newer medicines have been crimped by high rebates and discounts drugmakers pay to middlemen, such as pharmacy benefit managers, in order to make sure patients have access to their products.

https://www.marketscreener.com/DERMIRA-INC-18138387/news/Dermira-Eli-Lilly-targets-quarterly-deals-of-1-billion-5-billion-in-2020-CFO-29850571/