Relief for Chinese biotechs as BIOSECURE Act delayed

 Legislation in the US that could have a dramatic impact on the businesses of five biotechs with links to China has been left out of a key bill, introducing a delay that will likely extend into the next administration.

The BIOSECURE Act, which will prohibit businesses in the US from contracting with various Chinese firms on national security grounds, has not been included in a defence budget bill viewed as probably the last chance to pass the bill in 2024 before Congress goes on recess.

In its current form, the BIOSECURE Act would prohibit the federal government from contracting with, or providing grants to, companies that do business with a “biotechnology company of concern.” It specifically mentions five biotechs – WuXi AppTec and WuXi Biologics, as well as BGI Group and its subsidiaries MGI Tech and Complete Genomics.

It failed to make it onto the amendments of the mammoth $886 billion National Defense Authorisation Act (NDAA), a basket of legislation that also includes provisions for aid to Ukraine and received strong bipartisan support in the House of Representatives last week and has now been sent to Outgoing President Joe Biden to sign.

Shares in WuXi AppTec, WuXi Biologics, and MGI Tech all rose on the back of the latest twist in a meandering legislative tale that was widely expected to reach its conclusion this year.

The US House voted in favour of the proposed legislation in September by 306 to 81 votes, easily reaching the two-thirds majority needed to keep the Act in play, although there has been pushback from House Democrats who have opposed naming companies directly in the legislation.

The bill has already been progressively watered down since its first iteration amid concerns that it would disrupt the biopharma sector by raising costs, potentially lead to loss of access to some medicines, and disproportionately affect smaller biopharma companies and start-ups, which are less likely to be able to bid for contracts with alternative suppliers than their larger counterparts.

Changes in recent months include the introduction of a waiver programme that can be applied in certain circumstances and a grandfathering clause that would give companies until 2032 to sever ties with the Chinese firms.

If the BIOSECURE Act doesn’t make it through before President-Elect Donald Trump takes office, it expires and the new administration would have to re-activate it, which is by no means certain.

https://pharmaphorum.com/news/relief-chinese-biotechs-biosecure-act-delayed

ASH: Regeneron plays its PNH hand

 Regeneron will have a tough job taking on AstraZeneca’s big-selling Ultomiris in the market for paroxysmal nocturnal haemoglobinuria (PNH) therapies – but new biomarker data suggests it could have a shot.

Updated results from the ACCESS-1 trial comparing combination therapy with pozelimab and cemdisiran (poze-cemdi) to Ultomiris (ravulizumab) indicate that Regeneron’s duo may be able to achieve and maintain greater disease control, as measured by lactate dehydrogenase (LDH) levels.

The data – shared at the American Society of Haematology annual congress – showed that, in PNH patients previously untreated with complement inhibitors, 96% of those treated with poze-cemdi achieved adequate LDH control, compared to 80% of the arm treated with AZ’s drug, over 26 weeks of follow-up. Normalisation of LDH levels was seen in 93% and 65% of patients, respectively.

Ultomiris is a complement C5 inhibitor that has become a mainstay of PNH treatment, helping it become a $2.8 billion product in the first nine months of 2024. It offers reduced dosing frequency compared to its predecessor Soliris (eculizumab), which added just over $2 billion to AZ’s revenues in the same period.

Like AZ’s drugs, pozelimab is a C5 inhibitor, but is co-administered with cemdisiran, an investigational siRNA therapeutic developed with Alnylam under a $1 billion alliance agreed in 2019 that reduces circulating levels of C5 in the blood. Regeneron says this makes the combination a first-in-class prospect for PNH – a rare disease that destroys red blood cells. LDH is released when the red blood cells break down, so serves as a surrogate marker for anti-PNH therapies.

Poze-cemdi also has the distinction of being administered subcutaneously, while Ultomiris needs to be given using an intravenous infusion.

“C5 inhibitors are widely considered the mainstay of PNH treatment, but a proportion of patients still do not achieve adequate control of intravascular haemolysis, may experience residual anaemia, and may feel significant treatment burden, as many of these therapies require clinic or home visits for intravenous delivery,” said ACCESS-1 trial investigator Christopher Patriquin, of the University of Toronto.

He added that the combination achieved “complete, rapid, uninterrupted, and durable inhibition” of C5 and noted that, if additional data reinforces these findings, poze-cemdi could “help transform what may be possible for many people with PNH.”

Regeneron and Alnylam are now waiting for the results of a second cohort in ACCESS-1 comparing poze-cemdi with Soliris, and are also running trials of the combination in other complement-mediated diseases, including generalised myasthenia gravis (gMG) and geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Pozelimab has already been approved for marketing by the US FDA under the Veopoz trade name for the treatment of adult and paediatric patients aged one year and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease, which is an ultra-rare disorder leading to life-threatening blood clots. Soliris is currently used off-label to treat CHAPLE.

https://pharmaphorum.com/news/ash-regeneron-plays-its-pnh-hand

Bausch + Lomb dips on rumour of failing takeover talks

 Shares in ophthalmology specialist Bausch + Lomb (B+L) have lost almost 10% of their value on a report that a joint takeover bid for the group is in trouble.

The Financial Times has said that investment group Blackstone – which formed a partnership with TPG to explore a possible acquisition of B+L earlier this year – is uncomfortable with the valuation that the eyecare company is putting on its business.

Citing people familiar with the matter, the FT reports that Blackstone is likely to drop out of the consortium, reducing the chances of a deal going through.

It was reported in October that the two private equity (PE) firms had partnered on a potential bid for B+L, which sells contact lenses as well as ophthalmic pharmaceuticals, intraocular lenses, and eye surgery products, and made revenues of $4.15 billion last year.

PE players are thought to be the most likely acquirers for the business, as other players in the ophthalmology market that might be interested – such as Alcon and Johnson & Johnson – could face antitrust resistance to a takeover.

Reports of Blackstone and TPG's interest sparked speculation that a deal could emerge at $25 per share, valuing B+L at between $13 and $14 billion. Shares in the NYSE-listed company were $18.72 in pre-market trading at the time of writing, valuing the company at around $7.25 billion.

There have been rumours for several months that Bausch Health (formerly Valeant Pharmaceuticals), B+L's debt-ridden parent company, which retains an 88% ownership stake in its business, is looking at strategic options, including a sale of the company. In July, it was forced to refute claims in the press that it was considering bankruptcy or insolvency proceedings.

Bausch Health ended the third quarter of this year with $21.5 billion of debt and, in October, ratings agency Fitch said that a separation from B+L – resulting in the loss of the eyecare unit's operating and financial stability – would create "significant risk to [Bausch Health's] credit profile."

Despite that, Bausch Health's main shareholders – who include funds run by billionaire investors Carl Icahn and John Paulson – are reported to have been pushing for a sale of B+L. They are also on the board of B+L and a sale would give them a larger stake in the more profitable ophthalmology business.

Around $10 billion of Bausch Health's debt is due towards the end of 2027, and a B+L sale would allow it to retire a considerable portion of it.

According to the FT report, Bausch Health's efforts to spin off B+L as a listed company have faced pushback from creditors worried about its impact on the parent company's balance sheet.

https://pharmaphorum.com/news/bausch-lomb-dips-rumour-failing-takeover-talks

Wray Resigns

 Before President-elect Donald Trump could say "You're Fired!" - FBI Director Christopher Wray has resigned.

While Wray's departure was always in the cards, the move comes two days after Sen. Chuck Grassley (R-IA) wrote an 11-page letter to Wray asking him to step down, accusing him of mismanagement and "failure to take control of the FBI."

"These failures are serious enough and their pattern widespread enough to have shattered my confidence in your leadership and the confidence and hope many others in Congress placed in you," wrote Grassley.

Developing...

https://www.zerohedge.com/political/fbi-director-chris-wray-resigns

Grifols Seeks to Calm Investors With €1.3 Billion Debt Placement

 

Grifols SA raised €1.3 billion ($1.4 billion) in a private debt placement, as the Spanish drugmaker seeks to reassure investors about its ability to manage borrowings.

The notes were issued at 7.125% and are due in May 2030, with proceeds earmarked mostly to fully redeem notes due February next year and repay loans due in November, the company said in a regulatory filing late Wednesday. It also announced an 18-month extension of an existing revolving credit facility, to May 2027.

https://www.bloomberg.com/news/articles/2024-12-11/grifols-seeks-to-calm-investors-with-1-3-billion-debt-placement

Watch: Congressman Warns Iranian Mothership Lurking Off Coast Responsible For NJ Drone Scare

 Republican Congressman Jefferson Van Drew of New Jersey, a member of both the House Judiciary Committee and the Transportation and Infrastructure Committee, told Fox News' Harris Faulkner around noon that government sources have informed him that mysterious drones in New Jersey skies at night originate from an Iranian "mothership" stationed off the US East Coast. 

"Here's the real deal Harris .... and I've gotten to know people. And from very high sources, very qualified sources, and very responsible sources... I'm going to tell you the real deal: Iran launched a mothership - probably about a month ago that contains these drones and is off the US East Coast," Van Drew said. 

Van Drew continued, "Know that Iran made a deal with China to purchase drones - motherships and technology to go forward. The sources I know are good." 

He emphasized, "These drones should be shot down," adding the military "is on alert with this." 

Our coverage of the situation: 

• Nov. 19: Spy Drones? "Unusual Activity" Reported Over Morris County, New Jersey, Near Military Research Facility
• Dec. 3: Mysterious 'Car-Sized Drones' Over New Jersey Prompt FBI Investigation

A resident of Montville, NJ, claimed one of these 'truck-sized drones' crashed on Beverwck Road. 

This is all taking place in what is supposed to be some of the world's most controlled airspace, second only to Baltimore-Washington airspace.

Since no one believed the aliens invading NJ narrative, we're back to Iran-China World War III. 

https://www.zerohedge.com/geopolitical/watch-congressman-warns-iranian-mothership-behind-nj-drone-scare-urges-military-action

Pharmacies prevail in appeal of $650-million opioid award in Ohio

 Ohio’s top court ruled on Tuesday that pharmacy chain operators CVS

, Walmart and Walgreens could not be held liable for fueling an opioid epidemic in two counties in the state that won a $650.9-million judgment against them.

The Ohio Supreme Court held on a 5-2 vote, opens new tab that a state law barred Lake and Trumbull counties’ claims that the dispensing of addictive pain medications by the pharmacy chains created a public nuisance that the companies should be forced to address.

Justice Joseph Deters, writing for the majority, said the court recognized that the deadly epidemic had touched the lives of people throughout Ohio and “undoubtedly has far-reaching consequences for their communities and for the state as a whole.”

“Creating a solution to this crisis out of whole cloth is, however, beyond this court’s authority,” Deters wrote.

He said an amendment to the Ohio Products Liability Act that the state legislature adopted in 2007 barred all common-law public nuisance claims based on the sale of products that seek compensation from a product’s manufacturer or supplier.

Representatives for the companies and counties did not immediately respond to requests for comment.

The case was the first the three pharmacy operators had faced at trial of the thousands of lawsuits filed by states and local governments against drugmakers, distributors and pharmacies over the U.S. opioid addiction epidemic.

A federal jury in Cleveland concluded in 2021 that an oversupply of addictive pain pills and the diversion of those opioids to the black market created a public nuisance in the counties, and that the pharmacies helped cause it.

U.S. District Judge Dan Polster, who oversees the federal litigation over the opioid epidemic, ordered CVS, Walmart and Walgreens following the trial to pay a combined $650.9 million to help the two counties address, or abate, the harms caused by the epidemic.

The companies appealed, prompting the 6th U.S. Circuit Court of Appeals last year to ask the Ohio Supreme Court to review the matter, saying it raised “novel and unresolved questions” of state law that it should address first.

https://www.cnbc.com/2024/12/10/pharmacies-prevail-in-appeal-of-650-million-opioid-award-in-ohio.html