Cracks in Purdue’s proposed opioid settlement as Arizona backs out

The U.S. state of Arizona withdrew its support for a proposed nationwide opioid settlement with Purdue Pharma LP, saying the maker of OxyContin sought to “undermine material terms of the deal,” according to a court filing on Monday.

Since Purdue filed for bankruptcy protection in September, Arizona is the first state to switch sides in the looming showdown over the privately-held company’s proposed settlement, which it has estimated is worth more than $10 billion.
Purdue reached the deal last month with 24 states and the local governments that have filed the bulk of the more than 2,600 lawsuits against the company.
The lawsuits allege Purdue and its Sackler family owners contributed to a public health crisis by aggressively marketing opioids while downplaying their overdose risks, which contributed to nearly 400,000 deaths since 1999, according to U.S. statistics.
Last week, court filings from states and local governments opposing the settlement asserted that Purdue steered up to $13 billion in profits to the Sackler family, more than triple the amount previously cited in litigation.
A lawyer for some of the Sacklers last week said in a statement that much of the money was paid in taxes and reinvested in businesses that will be sold as part of the proposed settlement.
Arizona’s filing offers little explanation of why the state backed away from its initial support. “At nearly every turn during the course of subsequent negotiations, debtors have sought to undermine material terms of the deal,” it said.
Arizona’s attorney general did not immediately respond to a request for comment. Purdue declined to comment.
U.S. Bankruptcy Judge Robert Drain in White Plains, New York, will consider on Friday Purdue’s request for an injunction to pause the litigation for about nine months. Purdue said it needs time to try to settle the remaining cases.
Purdue also asked Drain to shield the Sacklers from litigation, even though they have not filed for bankruptcy, partly because the family has proposed contributing at least $3 billion towards the settlement.
Opponents of the settlement accused the family of using Purdue’s bankruptcy to shield their wealth from victims.
With Arizona, 25 states now oppose the deal. Kentucky and Oklahoma reached prior settlements with Purdue.
In addition to pursuing a case in state court against Purdue, Arizona is also pursuing a novel lawsuit that it filed directly with the U.S. Supreme Court, saying the unusual move was justified by the national importance of the opioid crisis.

https://www.marketscreener.com/news/Cracks-in-Purdue-s-proposed-opioid-settlement-as-Arizona-backs-out–29351001/

Merck taps 4D pharma for bacterial vaccine R&D project

Merck has teamed up with 4D pharma to develop bacterial strains as vaccines. The deal gives Merck the chance to pick up three candidates against undisclosed indications in return for an upfront fee and up to $347.5 million (€316.2 million) in milestones.
4D landed the deal on the potential of its MicroRx technology. The platform enables 4D to identify strains that have significant effects on humans and target disease pathways that may be modulated by these host-bacteria interactions. 4D is mainly using the approach to go after solid tumors and gastrointestinal diseases, but Merck is interested in a different application of the technology.
“By applying 4D’s MicroRx technology we hope to gain meaningful insights into the role for the host microbiome in modulating the immune response and ultimately protection conferred by vaccines,” Merck’s Daria Hazuda said in a statement.

To gain those insights, Merck is paying an upfront cash payment of undisclosed size for each of the three indications covered by the deal. 4D has also gained the right to make Merck buy $5 million of its stock during the first year of the collaboration, plus a shot at reeling in up to $347.5 million in milestones. The agreement features tiered royalties, too.
Merck will do most of the heavy lifting on any programs that advance out of the lab. 4D will use its MicroRx platform to get the programs—which are at the discovery stage—going, but Merck will take over for development, manufacturing and commercialization.
The agreement adds another facet to the relationship between 4D and Merck. Last year, 4D joined the list of companies to gain access to Merck’s Keytruda for a clinical development program, setting it up to test its live biotherapeutic MRx0518 in combination with the checkpoint inhibitor in patients with solid tumors.
Shares in 4D rose more than 20% after news of the latest Merck deal emerged. The increase added to gains in recent weeks, over which time 4D’s share price has shot up from below £70 to above £120.
https://www.fiercebiotech.com/biotech/merck-taps-4d-pharma-for-bacterial-vaccine-r-d-project

SmileDirectClub hits new lows

Recent IPO SmileDirectClub (SDC -10.6%) has completed a round trip from a brief rally at the end of last week. Shares are now down almost 50% from its $23 offering price on concerns with corporate governance (appearance of self-dealing by Chairman & CEO David Katzman) and the safety and legitimacy of its teledentistry platform.

Analysts at IPO underwriters have been vocal cheerleaders with a bolus of recent Buy ratings in an effort to stem the selling, a futile effort thus far.

https://seekingalpha.com/news/3504535-smiledirectclub-hits-new-lows-11-percent

California bans pharma’s infamous ‘pay-for-delay’ deals

When generic challengers come for a branded med’s patent, drugmakers have in the past chosen to pony up and stall their rivals with an anticompetitive pact better known as “pay for delay.” In an effort to keep drug prices down, California is looking to end the practice.
California Gov. Gavin Newsom signed a new bill Tuesday that will make California the first state to ban pay-for-delay deals in pharma.
The bill, AB 824, will make it unlawful for companies to exchange anything of value in return for a halt to patent challenges from generic drugmakers. That new measure could open the door to a range of civil suits against companies seeking to keep generic competitors off the market.

“California will use our market power and our moral power to take on big drug companies and prevent them from keeping affordable generic drugs out of the hands of people who need them,” Newsom said in a statement.

California’s ban is the most recent regulatory assault on pay-for-delay deals after the U.S. Supreme Court in 2013 freed the Federal Trade Commission (FTC) to challenge brand-name drugmakers’ patent settlements with generics companies. In that 5-3 vote, the court reversed a circuit court’s ruling that shielded the companies from most lawsuits challenging their patent deals.
Soon after that ruling, European regulators rolled up their shirtsleeves in going after pay for delays. In July 2014, the EU fined six companies, including Teva, Mylan and Servier, more than a half-billion dollars for individual pay-for-deal infractions.
With regulators cracking the whip, the FTC reported in 2016 that pay-for-delay deals began to decline in 2014 after a multi-year explosion of such pacts between 2005 and 2012. In 2014, the FTC reported 21 suspected settlements compared to 40 in 2012 and 29 in 2013.
Despite the dip, pay for delays do still happen and often ensnare large-cap pharmas.
In August, a federal judge approved a $65.8 million settlement between Teva’s Cephalon and five plaintiffs on charges the drugmaker incentivized challengers to keep narcolepsy drug Provigil imitators off the market to protect the now-generic drug’s sales.
The civil suit comes four years after Teva agreed to pay out $1.2 billion to settle a Federal Trade Commission probe into similar charges that the Israeli drugmaker promised competitors Mylan and Sun Pharmaceuticals payment for active ingredients and intellectual property—deals that made “no economic sense” for Cephalon beyond stopping competition.

In April, the FTC knocked Impax, concluding the company entered a pay-for-delay deal with Endo to put off copies of opioid painkiller Opana ER.
The agency said Endo controlled the market for the pain drug and gave Impax a “large and unjustified payment” to deter generic competition. Under the deal, Endo agreed to pay Impax more if Opana’s market shrank before the generic launch, the FTC said.
Endo also agreed to hold off on its authorized generic during Impax’s 180-day period of generic exclusivity. The FTC said Impax couldn’t reasonably justify the cash payment that changed hands.
The FTC previously alleged Endo paid Impax $112 million in 2010 to delay its generic until January 2013. In 2017, amid worries about Opana ER’s potential for abuse, Endo pulled the drug off the market at the FDA’s request.
https://www.fiercepharma.com/pharma/california-governnor-inks-bill-banning-pay-for-delay-deals-pharma

Ex-Shire CEO Ornskov emerges as Galderma CEO after $10B Nestlé spinout

As Takeda folds in Shire, two of the Irish rare disease specialist’s former top leaders have found themselves a new home at Nestlé skin health spinoff Galderma.

 

Flemming Ornskov, Shire’s most recent CEO before the Takeda buyout, has taken the reins as Galderma CEO. And Shire’s former finance overseer, Thomas Dittrich, will work alongside him as CFO of Galderma, a company that now holds the title of the world’s largest independent dermatology-focused drugmaker.
Prior to Shire, Ornskov had plenty of experience from his work at Bayer, Bausch & Lomb and Novartis. Dittrich was only Shire’s CFO for a year, but he’s not so new to pharma, either, having previously served a stint at Amgen.

 

 

Meanwhile, Thomas Ebeling, former CEO of Novartis Pharma and Novartis Consumer Health, has become Galderma Chairman, and Sheri McCoy, former Johnson & Johnson vice chair responsible for the pharma and consumer divisions, has also joined as a director. Stuart Raetzman, Nestlé Skin Health's CEO since 2016, has transitioned to a director role.
Consumer giant Nestlé in May confirmed the CHF 10.2 ($10.2 billion) skin health spinoff to a consortium of private investment organizations including EQT Partners, Abu Dhabi Investment Authority’s Luxinva, and PSP Investments, among others.

Ornskov is credited for growing Shire from a relatively small, $4 billion business into one of biopharma’s most prominent rare disease players with $15 billion in revenue in just five years.
He orchestrated Shire’s eventful $32 billion takeover of Baxalta in 2016, which is still one of the biggest pharma M&A transactions in history. And about four years after AbbVie walked out of a $55 billion acquisition deal, Ornskov successfully sold the company to expansion-hungry Takeda for an even larger $62 billion.
Both the Baxalta tie-up and Takeda’s subsequent Shire deal have been challenged by investors, what with the heated competition and risk to Baxalta’s hemophilia business, which previously made up 20% of Shire’s revenue. As Roche’s antibody hemophilia A drug Hemlibra continues its land-grab, and as gene therapies lurk around the corner, other firms’ hemophilia franchises will only be under more pressure.
But that’s not Ornskov’s concern anymore. The new Galderma operates in three business units: aesthetics, prescription and consumer care, with combined revenues of CHF 2.8 billion ($2.81 billion) and about 5,000 employees. In a statement on Oct. 2, the company said it would maintain its current course focused on the “highly attractive” dermatology sector, continue to build its presence in the U.S. and China, and launch new products with an eye on global expansion.
First up, the company on Friday said it had snagged an FDA green light for Aklief, a topical retinoid cream for acne. Its active ingredient, trifarotene, is the first new FDA-approved retinoid molecule in over 20 years, Galderma said. It also stands as the first topical treatment that's been specifically studied and shown efficacy in both facial and truncal acne.
The new cream will add to Galderma’s existing acne solutions, including Epiduo and Differin, both of which contain retinoid drug adapalene. The now-independent Fortworth, Texas-based company said it will launch Aklief in November, and it’s “working closely with payers, provider and pharmacy benefit managers to ensure” its access.
https://www.fiercepharma.com/pharma/ex-shire-ceo-flemming-ornskov-emerges-as-galderma-ceo-after-10b-nestle-spinout

Medtronic Gets FDA Breakthrough Tag for Valiant TAAA Stent Graft System

Medtronic PLC (MDT) said Tuesday it received Breakthrough Device designation from the U.S. Food and Drug Administration for its Valiant TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm.
A TAAA is a complex condition causing a bulging of the aorta, which extends from the chest down into to the abdomen.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies, the company said. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

https://www.marketscreener.com/MEDTRONIC-PLC-20661655/news/Medtronic-Gets-FDA-Breakthrough-Device-Designation-for-Valiant-TAAA-Stent-Graft-System-29350567/

Glaxo Links Up with US Biotech to Target Solid Tumors with Cell Therapy

GlaxoSmithKline PLC (GSK.LN) said Tuesday that it has partnered with San Francisco-based biotechnology company Lyell Immunopharma to develop its cell therapy pipeline, with a special focus on solid tumors.
The five-year collaboration aims at using Lyell’s technology to strengthen the efficacy of its existing cell therapy program, the FTSE 100 drugmaker said.
Glaxo said that it hopes that using Lyell’s technology, it can improve the fitness of T cells, a type of white blood cell.
Unlike other medicines, cell therapies use living cells that are extracted and modified to fight disease. Existing cell therapies on the market, Kymriah and Yescarta, are only approved for blood cancers.
The British company said that so far, T cell exhaustion has posed an obstacle to adapting to cell therapies to solid tumors.
“Lyell is exploring several approaches to improving T cell function and increasing T cell ‘fitness’ to enhance initial response rates in solid tumour cancers and to prevent relapses due to loss of T cell functionality,” said Glaxo’s chief scientific officer and president of research, Hal Barron.
In March 2018, the company sold its gene-therapy division Strimvelis to Orchard Therapeutics PLC. However it retained its cell therapy research program, which was largely based around a collaboration with Adaptimmune Therapeutics PLC which began in 2014.
The lead asset to emerge from the program was GSK3377794, a T-cell therapy currently in phase 2 clinical trial as a potential treatment for relapsed or refractory synovial sarcoma. Glaxo said the asset is also under investigation for a range of other cancers, including non-small cell lung cancer and multiple myeloma.

https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/Glaxo-Links-Up-with-US-Biotech-to-Target-Solid-Tumors-with-Cell-Therapy-29350616/