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Updated: Arbitrator awards $157M to Soon-Shiong’s ImmunityBio in dispute with Sorrento

Sorrento Therapeutics’ yearslong battle with NantCell and NANTibody has come to an arbitration award, but additional legal proceedings centered around…

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Sorrento Therapeutics’ yearslong battle with NantCell and NANTibody has come to an arbitration award, but additional legal proceedings centered around a “catch-and-kill” scheme remain pending.

On Friday, the arbitrator in the dispute between Sorrento and NantCell and Immunotherapy NANTibody LLC issued an award that grants contractual damages and pre-award interest.

The arbitrator awarded NantCell (part of billionaire Patrick Soon-Shiong’s ImmunityBio) nearly $157 million and NANTibody close to $17 million. Post-award, prejudgment interest will accrue at 9% per annum, according to an SEC filing sent in by Sorrento.

Sorrento doesn’t agree with the ruling.

Henry Ji

“The Company believes the Award was wrongly decided and is evaluating next steps, including, among other things, potential grounds to vacate, modify, or correct the Award under applicable law,” Sorrento wrote in the SEC filing, signed by Henry Ji, the biotech’s chairman, president and CEO.

Meanwhile, in an SEC filing later Monday morning, ImmunityBio said it will seek the award in a timely manner.

“This decision by the arbitrator is final and binding on the parties, and we intend to pursue confirmation of the award promptly. After obtaining a judgment, we intend to pursue vigorously the collection of the award and applicable interest from Sorrento, but we make no assurances that we will receive the full amount or with respect to the timing of our receipt of funds,” ImmunityBio wrote in part in its filing with the SEC.

Sorrento now has no more obligations under its exclusive license agreement with NANTibody, according to the biotech’s SEC document. Sorrento and a subsidiary from Soon-Shiong’s network of Nant companies set up Immunotherapy NANTibody as a joint venture in 2015. Per the Dec. 2 SEC filing, Sorrento holds 40% of the outstanding equity of NANTibody.

Regarding a tie-up with NantCell, which is now known as ImmunityBio under the wings of repeat biotech entrepreneur Soon-Shiong, Sorrento still has the ability to receive potential future royalties on net sales of an anti-PD-L1 antibody that it “previously delivered” to NantCell.

Endpoints News has reached out to Sorrento and will update accordingly.

Other arbitration remains pending. That includes Sorrento seeking “several hundred million dollars in damages for alleged breaches” of a stock sale and purchase agreement from 2015 between Sorrento and NantPharma regarding the drug Cynviloq. An arbitrator decision is anticipated later this year, Sorrento wrote in the SEC filing.

Sorrento is working on multiple immunotherapy programs and has a slate of Covid-19 projects in the works across diagnostics, antibodies, antivirals and an mRNA vaccine. In the early months of the pandemic, Ji told a Fox News reporter the biotech had an “exceptionally potent antibody” and that the crisis would be over.  The stock skyrocketed. But investors and ethicists were taken aback by the claims — the antibody had never been tested in patients, let alone mice.

Soon-Shiong, who for years has touted a moonshot quest for changing the cancer treatment landscape and was reportedly on the list of potential NIH chiefs under President Donald Trump’s watch, also caused a stir in the Covid-19 arena with his attempts to get the ear of White House leaders and get his company’s vaccine into trials.

Sorrento’s pain subsidiary went public last month via a blank check deal.

Meanwhile, ImmunityBio awaits an FDA decision on its first BLA accepted for review. By May 23, 2023, the agency will determine whether to greenlight ImmunityBio’s N-803 for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease.

Editor’s note: This story was updated to include information from an ImmunityBio SEC filing from Monday morning.

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International

Your Lululemon Faves May Not be Around for Long

A sportswear giant is accusing lululemon of patent infringement.

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A sportswear giant is accusing lululemon of patent infringement.

The Gucci loafers. The Burberry  (BBRYF) trench coat. When it comes to fashion, having a unique design is everything. This is why brands spend millions both creating and protecting their signature looks and the reason, as in the case of Adidas  (ADDDF) , extricating a brand's design from creators who behave badly is a costly and difficult process.

There is also the constant effort to release new styles without infringing on another group's style. This week, sportswear giant Nike  (NKE) - Get Free Report filed a lawsuit accusing lululemon  (LULU) - Get Free Report of infringing on its patents in the shoe line that the Vancouver-based activewear company launched last spring.

After years of selling exclusively clothing, accessories and the odd yoga mat, lululemon expanded into the world of footwear with a running shoe it dubbed Blissfeel last March. These were soon followed by training shoe and pool slide styles known as Chargefeel, Strongfeel -- all three of the designs (including a Chargefeel Low and a Chargefeel Mid design) have been mentioned in the lawsuit as causing "economic harm and irreparable injury" to Nike.

Nike's History Of Suing Lululemon Over Design

The specific issue lies in the technology used to build the shoes. According to the lawsuit filed in Manhattan federal court, certain knitted elements, webbing and tubular structures are too similar to ones that had been used by Nike earlier.

Nike is keeping the amount it hopes to receive from lululemon under wraps but is insisting the company infringed on its patent when releasing a shoe line too similar to its own. Lululemon had previously talked about how its shoe line "far exceeded" its leaders' expectations both in terms of sales and ability to expand.

In a Q1 earnings call, chief executive Calvin McDonald said that the line "definitely had a lot more demand than we anticipated."

Nike has already tried to go after lululemon through the courts once before. In January 2022, it accused the company of infringing on six patents over its at-home Mirror Home Gym. As the world emerged out of the pandemic, lululemon has been billing it as a hybrid model between at-home and in-person classes. 

The lawsuit was also filed in the U.S. District Court in Manhattan but ultimately fizzled out.

When it comes to the shoe line lawsuit, Lululemon has been telling media outlets that "Nike's claims are unjustified" and the company "look[s] forward to proving [their] case in court."

Lululemon

Some More Examples Of Prominent Design Battles

In the fashion industry, design infringement accusations are common and rarely lead to high-profile rulings. While Nike has gone after the technology itself in both cases, lawsuits more often focus on the style or pattern on a given piece.

Shein, a China-based fast-fashion company that took on longtime leaders like H&M  (HNNMY)  and Fast Retailing  (FRCOF) 's Uniqlo with its bottom-of-the-barrel pricing, has faced numerous allegations from smaller and independent designers over the copying of designs -- in some cases not even from fashion designers but artists painting in local communities.

"They didn't remotely bother trying to change anything," U.K.-based artist Vanessa Bowman told the Guardian after seeing her painting of a local church appear on a sweater on Shein's website. "The things I paint are my garden and my little village: it’s my life. And they’ve just taken my world to China and whacked it on an acrylic jumper."

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Government

McDonalds President Says It Might Be ‘Impossible’ to Operate in These Key States

The Fast Food Accountability and Standards Recovery Act is ruffling fast-food industry feathers.

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The Fast Food Accountability and Standards Recovery Act is ruffling fast-food industry feathers.

While the pandemic accelerated both discussions and movement of businesses, talk of how California's high tax rates and liberal leadership has made it "impossible" to do business in the state is anything but new. So are alarm-raising statements about how big business is fleeing the Golden State en masse.

In 1933, one state official wrote that "if we set up a tax on one of their supercolossal $7,000,000 productions, [the movie industry] would no doubt transfer their operations to" Florida. Similar fears of a business exodus to Nevada pushed local legislators to give a property tax break to equipment manufacturers in the 1960s.

More recently, Elon Musk told the audience at the All In Summit in Miami that the Golden State had "gone from a land of opportunity to the land of taxes, over-regulation and litigation." He had earlier moved the Tesla  (TSLA) - Get Free Report offices from the Silicon Valley to Austin, Texas at the end of 2021.

This Is What McDonald's Has Against California

While discussions around the tech exodus took place throughout much of 2020 and 2021, a new discussion has begun around an industry that exists in every state in the country: the fast food business.

In the fall of 2022, the state passed what shortens to the FAST bill -- the Fast Food Accountability and Standards Recovery Act could require fast-food restaurants to pay workers up a minimum wage of $22 an hour with an annual raise of 3.5%.

While initially passed, the law has faced significant pushback both from the industry and local voters. A referendum vote has been set to November 2024 and implementation is blocked until that takes place.

Industry leaders have predictably been very vocal against the law. In an open letter from January 25, McDonald's USA President Joe Erlinger wrote that it "makes it all but impossible to run small business restaurants."

"Under the FAST Act, an unelected council of political insiders, not local business owners and their teams, would make big decisions about crucial elements of running a business, fracturing the economy in the process," Erlinger wrote while adding that paying fast-food workers such a wage could raise the cost of eating at a McDonald's by as much as 20%.

Justin Sullivan/Getty Images

Another State's Worker Movement Is Also Causing A Headache For McDonald's

While California has led the pack with fast-food worker protection movements, Virginia followed with a similar bill just six months later. This month, it introduced Virginia's House Bill 2478.

While not committed to a specific minimum wage, the passed law would require a council of state legislators, elected officials, industry representatives and fast-food workers to get together and regularly oversee worker conditions and compensation.

With both a Republican governor and Republican-controlled house, the bill is extremely unlikely to pass in Virginia in the near future. That said, it still managed to ruffle the feathers of McDonald's leadership -- in the same open letter, Erlinger also takes aim at Bill 2478 as an example of what can happen if California sets an example and, in his words, "this one-sided style of democracy is mimicked elsewhere."

"Just last week, a Virginia legislator imported from California introduced a near-identical piece of legislation that state leaders now have an opportunity to stop in its tracks," Erlinger wrote. "And no doubt, they'll keep looking for backdoors in California."

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Government

EY Eyes Comeback for Biopharma M&A

EY noted that the total value of biopharma M&A in 2022 was $88 billion, down 15% from $104 billion in 2021. The $88 billion accounted for most of the…

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A recent trickle of mergers and acquisitions (M&A) announcements in the billion-dollar-and-up range suggests that biopharma may be ready to resume dealmaking this year—although the value and number of deals isn’t expected to return to the highs seen just before the pandemic.

2022 ended with a handful of 10- and 11-figure M&A deals, led by Amgen’s $27.8 billion buyout of Horizon Therapeutics, announced December 13. The dealmaking continued into January with three buyouts announced on the first day of the recent J.P. Morgan Healthcare Conference: AstraZeneca agreed to acquire CinCor Pharma for up to $1.8 billion, while Chiesi Farmaceutici agreed to shell out up to $1.48 billion cash for Amryt, and Ipsen Group said it will purchase Albireo Pharma for $952 million-plus.

Biopharmas generated about $88 billion in M&A deals in 2022, down 15% from $104 billion in 2021. The $88 billion accounted for most of the $135 billion in 124 deals in the life sciences. The number of biopharma deals fell 17%, to 75 deals from 90. The other 49 deals totaling $47 million consisted of transactions in “medtech,” which includes diagnostics developers and companies specializing in “virtual health” such as telemedicine. [EY]
EY—the professional services firm originally known as Ernst & Young—recently noted that the total value of biopharma M&A in 2022 was $88 billion, down 15% from $104 billion in 2021 [See Chart]. The $88 billion accounted for most of the $135 billion in 124 deals in the life sciences. That $135 billion figure is less than half the record-high $313 billion recorded in 2019, including $261 billion in 70 biopharma deals.

The number of biopharma deals fell 17% to 75 deals from 90. EY’s numbers include only deals greater than $100 million. The other 49 deals totaling $47 million consisted of transactions in “medtech,” which includes diagnostics developers and companies specializing in “virtual health” such as telemedicine.

We expect this to be a more active year as the sentiment starts to normalize a little bit,” Subin Baral, EY Global Life Sciences Deals Leader, told GEN Edge.

Baral is not alone in foreseeing a comeback for biopharma M&A.

John Newman, PhD, an analyst with Canaccord Genuity, predicted last week in a research note that biopharma companies will pursue a growing number of smaller cash deals in the range of $1 billion to $10 billion this year. He said rising interest rates are discouraging companies from taking on larger blockbuster deals that require buyers to take on larger sums of debt.

“We look for narrowing credit spreads and lower interest rates to encourage larger M&A ($50 billion and more) deals. We do not anticipate many $50B+ deals that could move the XBI +5%,” Newman said. (XBI is the SPDR S&P Biotech Electronic Transfer Fund, one of several large ETFs whose fluctuations reflect investor enthusiasm for biopharma stock.)

Newman added: “We continue to expect a biotech swell in 2023 that may become an M&A wave if credit conditions improve.”

Foreseeing larger deals than Newman and Canaccord Genuity is PwC, which in a commentary this month predicted: “Biotech deals in the $5–15 billion range will be prevalent and will require a different set of strategies and market-leading capabilities across the M&A cycle.”

Those capabilities include leadership within a specific therapeutic category, for which companies will have to buy and sell assets: “Prepared management teams that divest businesses that are subscale while doubling down on areas where leadership position and the right to win is tangible, may be positioned to deliver superior returns,” Glenn Hunzinger, PwC’s U.S. Pharma & Life Science Leader, and colleagues asserted.

The Right deals

Rising interest and narrowing credit partially explain the drop-off in deals during 2022, EY’s Baral said. Another reason was sellers adjusting to the drop in deal valuations that resulted from the decline of the markets which started late in 2021.

Subin Baral, EY Global Life Sciences Deals Leader

“It took a little bit longer to realize the reality of the market conditions on the seller side. But on the buyer side, the deals that they were looking at were not just simply a valuation issue. They were looking at the quality of the assets. And you can see that the quality deals—the right deals, as we call them—are still getting done,” Baral said.

The right deals, according to Baral, are those in which buyers have found takeover targets with a strong, credible management team, solid clinical data, and a clear therapeutic focus.

“Rare disease and oncology assets are still dominating the deal making, particularly oncology because your addressable market continues to grow,” Baral said. “Unfortunately, what that means is the patient population is growing too, so there’s this increased unmet need for that portfolio of assets.”

Several of 2022’s largest M&A deals fit into that “right” category, Baral said—including Amgen-Horizon, Pfizer’s $11.6-billion purchase of Biohaven Pharmaceuticals and the $6.7-billion purchase of Arena Pharmaceuticals (completed in March 2022); and Bristol-Myers Squibb’s $4.1-billion buyout of Turning Point Therapeutics.

“Quality companies are still getting funded one way or the other. So, while the valuation dropped, people were all expecting a flurry of deals because they are still companies with a shorter runway of cash that will be running to do deals. But that really didn’t happen from a buyer perspective,” Baral said. “The market moved a little bit from what was a seller’s market for a long time, to what we would like to think of as the pendulum swinging towards a buyers’ market.”

Most biopharma M&A deals, he said, will be “bolt-on” acquisitions in which a buyer aims to fill a gap in its clinical pipeline or portfolio of marketed drugs through purchases that account for less than 25% of a buyer’s market capitalization.

Baral noted that a growing number of biopharma buyers are acquiring companies with which they have partnered for several years on drug discovery and/or development collaborations. Pfizer acquired BioHaven six months after agreeing to pay the company up to $1.24 billion to commercialize rimegepant outside the U.S., where the migraine drug is marketed as Nurtec® ODT.

“There were already some kind of relationships there before these deals actually happened. But that also gives an indication that there are some insights to these targets ahead of time for these companies to feel increasingly comfortable, and pay the valuation that they’re paying for them,” Baral said.

$1.4 Trillion available

Baral sees several reasons for increased M&A activity in 2023. First, the 25 biopharma giants analyzed by EY had $1.427 trillion available as of November 30, 2022, for M&A in “firepower”—which EY defines as a company’s capacity to carry out M&A deals based on the strength of its balance sheet, specifically the amount of capital available for M&A deals from sources that include cash and equivalents, existing debt, and market cap.

That firepower is up 11% from 2021, and surpasses the previous record of $1.22 trillion in 2014, the first year that EY measured the available M&A capital of large biopharmas.

Unlike recent years, Baral said, biopharma giants are more likely to deploy that capital on M&A this year to close the “growth gap” expected to occur over the next five years as numerous blockbuster drugs lose patent exclusivity and face new competition from lower-cost generic drugs and biosimilars.

“There is not enough R&D in their pipeline to replenish a lot of their revenue. And this growth gap is coming between 2024 and 2026. So, they don’t have a long runway to watch and stay on the sidelines,” Baral said.

This explains buyers’ interest in replenishing pipelines with new and innovative treatments from smaller biopharmas, he continued. Many smaller biopharmas are open to being acquired because declining valuations and limited cash runways have increased investor pressure on them to exit via M&A. The decline of the capital markets has touched off dramatic slowdowns in two avenues through which biopharmas have gone public in recent years—initial public offerings (IPOs) and special purpose acquisition companies (SPACs).

EY recorded just 17 IPOs being priced in the U.S. and Europe, down 89% from 158 a year earlier. The largest IPO of 2022 was Prime Medicine’s initial offering, which raised $180.3 million in net proceeds for the developer of a “search and replace” gene editing platform.

Another 12 biopharmas agreed to SPAC mergers with blank-check companies, according to EY, with the largest announced transaction (yet to close at deadline) being the planned $899 million merger of cancer drug developer Apollomics with Maxpro Capital Acquisition.

“For the smaller players, the target biotech companies, their alternate source of access to capital pathways such as IPOs and SPACs is shutting down on them. So how would the biotech companies continue to fund themselves? Those with quality assets are still getting funded through venture capital or other forms of capital,” Baral said. “But in general, there is not a lot of appetite for the biotech that is taking that risk.

Figures from EY show a 37% year-to-year decline in the total value of U.S. and European VC deals, to $16.88 billion in 2022 from $26.62 billion in 2021. Late-stage financing rounds accounted for just 31% of last year’s VC deals, down from 34% in 2021 and 58% in 2012. The number of VC deals in the U.S. and Europe fell 18%, to 761 last year from 930 in 2021.

The decline in VC financing helps explain why many smaller biopharmas are operating with cash “runways” of less than 12 months. “Depending on the robustness of their data, their therapeutic area, and their management, there will be a natural attrition. Some of these companies will just have to wind down,” Baral added.

M&A headwinds

Baral also acknowledged some headwinds that are likely to dampen the pace of M&A activity. In addition to rising interest rates and inflation increasing the cost of capital, valuations remain high for the most sought-after drugs, platforms, and other assets—a result of growing and continuing innovation.

Another headwind is growing regulatory scrutiny of the largest deals. Illumina’s $8 billion purchase of cancer blood test developer Grail has faced more than two years of challenges from the U.S. Federal Trade Commission and especially the European Commission—while Congress acted last year to begin curbing the price of prescription drugs and insulin through the “Inflation Reduction Act.”

Those headwinds may prompt many companies to place greater strategic priority on collaborations and partnerships instead of M&A, Baral predicted, since they offer buyers early access to newer technologies before deciding whether to invest more capital through a merger or acquisition.

“Early-stage collaboration, early minority-stake investment becomes increasingly important, and it has been a cornerstone for early access to these technologies for the industry for a long, long time, and that is not changing any time soon,” Baral said. “On the other hand, even on the therapeutic area side, early-stage development is still expensive to do in-house for the large biopharma companies because of their cost structure.

“So, it is efficient cost-wise and speed-wise to buy these assets when they reach a certain point, which is probably at Phase II onward, and then you can pull the trigger on acquisitions if needed,” he added.

The post EY Eyes Comeback for Biopharma M&A appeared first on GEN - Genetic Engineering and Biotechnology News.

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