Novo Nordisk CEO 'confident' Catalent will resolve Wegovy output problems

 Novo Nordisk Chief Executive Lars Fruergaard Jorgensen said on Friday he was confident Catalent would resolves its problems making Novo's hugely-popular weight-loss drug Wegovy as the company scrambles to boost output to meet soaring demand.

"I am confident in that," Jorgensen said at a Reuters Newsmaker event, when asked about the issues Catalent has had.

Reuters reported in July that Catalent's factory in Brussels that fills Wegovy injection pens had repeatedly breached U.S. sterile-safety rules in recent years and staff had failed to perform required quality checks.

"These are not easy products to produce ... now we are leveraging contract manufacturers and also there is a learning scale, there is a ramp scale," he said, as he held up one of the self-injection pens, which he noted contains a glass vial that must be filled in sterile conditions.

He said very few companies could make such products at scale.

Novo hopes to have a third external facility filling and finishing the injection pens by 2024, Jorgensen said. The Danish drugmaker has previously said it expected to add the third line in the second half of this year.

Even so, it will be "quite some years" before the company can satisfy the whole market for Wegovy, Jorgensen said.

Reuters reported this week that Novo had hired Thermo Fisher as its second contract manufacturer for Wegovy.

Jorgensen reiterated that, given the runaway demand for Wegovy, the "massive" ramp-up of production of the injection pen was unprecedented.

"I think it would probably be hard to find any other examples in drug history of anything that has been ramped as much," he said.

https://www.yahoo.com/news/novo-nordisk-ceo-confident-catalent-095330588.html

GoHealth shares plunge 15% after saying investor group withdrew takeover proposal

 GoHealth (NASDAQ:GOCO) shares fell 15% in early Friday trade after the company announced that reporting persons and CB Stockholders have informed its Special Committee that they are withdrawing their takeover proposal.

The interested parties will no longer pursue the proposed transaction as of the evening of August 24, 2023, according to the filing.

In May, the investor group delivered a non-binding proposal to GoHealth to acquire shares that they do not already own for $20 apiece.

“In response to feedback from the special committee of the Board that it will not pursue a transaction with the Reporting Persons and the Founder Stockholders under the terms set forth in the Proposal, the Reporting Persons and the Founder Stockholders informed the Special Committee on the evening of August 24, 2023 that they would withdraw the Proposal and cease to pursue the Proposed Transaction,” it is said in the filing.

Earlier this month, GoHealth reported its second-quarter results with revenue coming in at $142.8 million, crushing the expected $116.5 million.

https://au.investing.com/news/stock-market-news/gohealth-shares-plunge-15-after-saying-investor-group-withdrew-takeover-proposal-432SI-2957424

Alkermes: Sarissa cuts stake

 Alkermes (ALKS) dropped 4.2% amid a disclosure that activist holder Sarissa Capital Management reduced its stake just below 5%.

https://seekingalpha.com/news/4006426-alkermes-falls-as-activit-holder-sarissa-capital-cuts-stake

Merck Starts Phase 3 Clinical Program for Oral PCSK9 Inhibitor

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, being evaluated for the treatment of adults with hypercholesterolemia. This is the first Phase 3 clinical program for an oral PCSK9 inhibitor. The first participants are now enrolling in two registrational Phase 3 studies evaluating low-density lipoprotein (LDL) cholesterol reduction: CORALreef Lipids and CORALreef HeFH. Merck also plans to initiate a Phase 3 cardiovascular outcomes study, CORALreef Outcomes by the end of 2023.

PCSK9 is a validated target for lowering LDL cholesterol. However, there are no oral PCSK9 inhibitors available to physicians and patients. The Phase 3 CORALreef program follows robust Phase 2b results presented at ACC.23/WCC, in which MK-0616 significantly reduced LDL cholesterol compared to placebo at all doses studied in participants with hypercholesterolemia with a broad spectrum of atherosclerotic cardiovascular disease (ASCVD) risk, including participants on high-intensity statin therapy. MK-0616 was generally well-tolerated.

https://finance.yahoo.com/news/merck-initiates-phase-3-clinical-103000472.html

AstraZeneca becomes first international company to file Medicare drug pricng suit

AstraZeneca (AZN) has joined the legal fight against Medicare drug pricing negotiations, becoming the sixth pharmaceutical company, and first international company, to file suit against US Health Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure.

"We made a very thoughtful decision after participating both willingly and extensively in the rule-making process with CMS," said David Fredrickson, AstraZeneca's EVP of oncology, in an interview with Yahoo Finance. "We really believe that the administrative implementation of the Inflation Reduction Act is running headlong into the progress that has been made to bring new medicines to rare disease and cancer patients."

AstraZeneca called certain provisions of the Inflation Reduction Act, which granted CMS negotiating powers, unconstitutional in its filing, citing the Fifth Amendment.

The company, like others that have filed suit, alleges the Biden Administration is seizing its property in the form of a limited time window to negotiate, and offering no judicial review process once that window closes.

Specifically, Fredrickson said the law counters an older law — the Orphan Drug Act — which spurred innovation for rare diseases in the 1980s. That matters to UK-based AstraZeneca as it boasts a robust portfolio of rare disease and cancer drugs.

"I think today there are very real incentives to pursue orphan drug indications. And to do that, we know that we're going into high risk, low probability science," he said.

Orphan drugs, which treat rare disease affecting smaller segments of the population, are protected from negotiations, but once a second use is found, the countdown to price negotiations begins, Fredrickson explained.

"Today, we're talking about areas where there's precious little research and development taking place," Fredrickson said. "The issue is one of creating incentives to get innovative companies with great science to bring their science into small populations where there's high unmet need."

The IRA negotiations do not apply to drugs with generic or biosimilar competition or for orphan drugs, which are used to treat a single disease.

It also differentiates between small molecule drugs, like pills, which will be granted nine years of exclusivity before negotiations begin, and large molecule drugs, or complex biologics, which have 13 years of exclusivity.

Currently, many drugs are protected by patents for at least 20 years — but that clock begins once the drug is invented, and years of development can eat into the exclusivity time.

"We had to take a look at a percent of our portfolio that we are allocating towards small molecule versus large molecules. That comes into consideration based upon the way in which the legislation is written," he said.

Drug companies have also argued that with no set starting point for price negotiations, it leaves the door open for unreasonably low prices.

"For nearly all drugs, there is no floor. [Becerra] could decide that Medicare should pay only a penny for a particular drug, and the manufacturer would have to sell at that price or assume massive liabilities," AstraZeneca said in its filing.

https://finance.yahoo.com/news/astrazeneca-becomes-first-163049123.html

Ardelyx upped to Overweight from Neutral by Cantor

 Target to $10 from $5

https://finviz.com/quote.ashx?t=ARDX&ty=c&ta=1&p=d

Bayer investor Artisan calls for break up

 Bayer is a "conglomerate" that needs to make major changes including "de-merging" two of its three business arms, investor Artisan Partners (NYSE:APAM) told Reuters on Friday.

Artisan wants the drugs to-pesticides company to demerge its over-the-counter and pharmaceutical units, it said.

"Recently we wrote a letter to the conglomerate Bayer -- and it is a conglomerate," David Samra, founding portfolio manager of Artisan's International Value team, said in an interview.

Bayer has a "whole host of problems" including "too much debt," Samra said.

We suggested "that they cut the dividend to zero because they need the capital to effectively operate and reinvest back in their business," he said, adding that the letter was sent prior to Bayer's earnings results announcement on August 8.

Artisan is Bayer's sixteenth biggest investor, according to Refinitiv data.

Bayer declined to comment.

https://www.investing.com/news/stock-market-news/exclusivebayer-investor-artisan-calls-for-break-up-3161663