The EU is also talking to French pharmaceutical firm Valneva VLS.PA about a potential deal for its COVID-19 vaccine candidate, two EU officials involved in the negotiations said.
Millions of doses of the Valneva vaccine, which started Phase I and II clinical trials in December, have already been booked by Britain. Before applying for approval, vaccines must prove safe and effective in large-scale Phase III trials.
Valneva and the European Commission did not respond to requests for comment.
The EU is also close to signing a contract with U.S. firm Novavax NVAX.O for up to 200 million doses of its COVID-19 vaccine candidate, one of the EU officials said, adding a deal was "imminent".
In December, the European Commission said it had concluded preliminary talks with Novavax, a move that usually precedes the signing of a contract. (Full Story)
Apple and Biogen announce new research study to investigate how Apple Watch can detect declines in cognitive health
Medial research firm Biogen today announced a new collaboration with Apple in the form of a cognitive health research study, powered by iPhone and Apple Watch. The study is trying to identify digital biomarkers that can serve as early indicators of illnesses like Alzheimer’s.
The observational research study will commence later in the year. The companies aim to find patterns in the data collected by sensors in the Apple Watch and iPhone and correlate those to declines in cognitive health function.
If successful, doctors may eventually be able to prescribe treatments earlier in people’s lives, and help reduce the debilitating effects of these kind of mental illnesses.
In the press release, Apple COO Jeff Williams said Apple looks forward to delivering better health outcomes through improved detection of declining cognitive health.
“Working in collaboration with Biogen, we hope this study can help the medical community better understand a person’s cognitive performance by simply having them engage with their Apple Watch and iPhone,” said Jeff Williams, Apple’s chief operating officer. “We’re looking forward to learning about the impact our technology can have in delivering better health outcomes through improved detection of declining cognitive health.”
Biogen CEO Michel Vounatsos said that finding digital biomarkers signalling changes in brain health will “accelerate patient diagnoses and empower physicians and individuals to take timely action”.
The virtual study will likely be rolled out through the Apple Research app. As expected, it will be conducted with privacy in mind. Participants will be told about exactly what data is being collected upfront and can leave the study at any time.
The Apple Research app currently features studies covering heart and movement, women’s health and hearing levels.
Apple first began working with medical institutions back in 2017 with the first Apple Heart Study, run by Stanford researchers. The study was highly successful with participation from more than 400,000 Apple Watch users and led to the release of the irregular heart rate rhythm notifications as an Apple Watch feature available to all.
Ex-Credit Suisse chief Tidjane Thiam launches blank cheque vehicle
Ousted banker joins Spac craze with $250m fund to invest in financial sector
Former Credit Suisse chief executive Tidjane Thiam is raising a $250m special purpose acquisition vehicle to invest in financial services businesses in the developed and developing world, according to people familiar with the matter.
JPMorgan Chase is helping to raise the money after pitching the idea to Mr Thiam, with chief executive Jamie Dimon personally involved, according to these people.
The as-yet-unnamed Spac will be listed in New York and is in discussions with sovereign wealth funds to be anchor backers of the vehicle and several potential board members.
Mr Thiam will be the latest high-profile banker to raise money via a Spac amid a boom in the blank cheque vehicles that has seen the likes of former Citigroup dealmaker Michael Klein and hedge fund manager Bill Ackman raise billions of dollars.
JPMorgan declined to comment. A representative of Mr Thiam was not immediately able to comment.
Spacs, which list on a stock exchange and raise money from investors, use the proceeds to hunt for private companies they can acquire and take public through a reverse merger. Shareholders do not know which company the shell vehicle will target ahead of the deal, so their investment is essentially a bet on those leading the Spac.
A recent all-star cohort of sponsors — which receive a 20 per cent stake in the company as a reward for finding a target — have helped lend legitimacy to a structure that was once relegated to the backwaters of finance and more closely associated with penny stocks.
Other bankers to recently start Spacs are Mr Thiam’s former rival, ex-UBS chief executive Sergio Ermotti, who chairs Investindustrial Acquisition Corp, which filed a $350m US IPO in October. Barclays alumnus Makram Azar’s Golden Falcon Acquisition Corp raised $345m last month on the New York Stock Exchange.
Mr Thiam, a Franco-Ivorian citizen who was previously chief of insurer Prudential, has marketed himself as a person who can take financial services companies in more established countries and connect them to those in emerging markets, one of the people said.
Outside of finance, he has also been linked to political office in France owing to his relationship with President Emmanuel Macron as well as his native Ivory Coast, where last year the Elysée proposed him as a potential member of government ahead of a contentious election.
He faces a regulatory probe in Switzerland over his role in a corporate spying scandal that led to his ousting from Credit Suisse last February.
More banks will be added to the fundraising alongside JPMorgan at the next stage of the New York listing. Credit Suisse, which emerged as one of the leading advisers in the Spac surge last year, is unlikely to be considered, one of the people said.
Trade Chief Lighthizer Urges Biden to Keep Tariffs on China
The trade lawyer who engineered the Trump administration’s economic confrontation with Beijing argues that tariffs get results
WASHINGTON—In his nearly four years in office, U.S. Trade Representative Robert Lighthizer helped move protectionism from the fringes of American policy-making to the core. His advice to the Biden administration: Stay the course.
Keep tariffs on China—all of them—even if that raises prices for U.S. businesses and consumers, he said. Weaken the World Trade Organization so that it can’t overrule U.S. policies, and make it harder for American companies to move overseas despite the cost to their competitiveness.
In an interview, Mr. Lighthizer credited the Trump administration with taking a tough approach toward Chinese trade practices that benefited U.S. workers—ending years of accommodation by previous administrations fearful of angering Beijing.
“We changed the way people think about China,” Mr. Lighthizer said. “We want a China policy that thinks about the geopolitical competition between the United States and an adversary—an economic adversary.”
The 73-year-old Mr. Lighthizer—tall, gravelly voiced and pugnacious—was the engineer who helped steer the Trump administration’s economic confrontation with China. He turned President Trump’s anger at Beijing into a two-year trade war where he deployed tariffs on a scale not seen since the 1930s.
Facing $370 billion in annual U.S. tariffs, China signed a deal a year ago to increase its purchases of U.S. goods and services by $200 billion over two years, open its financial markets and ease pressure on U.S. firms to hand over technology.
The battle had its costs—it rattled global markets, soured Americans’ views toward China and pushed the two economies apart, a cleavage that has deepened as a virus that surfaced in China spread across the U.S., killing more than 370,000. Still the tariffs didn’t lead to the economic disaster that some economists had predicted, although they did increase prices that Americans had to pay for many imported goods.
“We transformed the way people think about trade, and we transformed the way the models are,” Mr. Lighthizer said in an interview. “My hope is that that will continue.”
Mr. Lighthizer’s free-trade critics acknowledge his influence. “He is the most consequential trade representative” since President Kennedy created the position in 1963, said Gary Hufbauer, a Peterson Institute for International Economics senior fellow. “He reversed the disposition toward globalization.”
Mr. Lighthizer’s influence on U.S. economic policy was hardly a given. The U.S. Trade Representative’s office has just 200 employees, compared with the Treasury’s 100,000, and operates essentially as the president’s trade law firm. The trade representative’s power stems directly from his or her relationship with the president.
Mr. Trump made trade a priority and Mr. Lighthizer worked hard to cement his ties to his boss. He hitched rides back to Florida on Air Force One, where he has a home not far from Mr. Trump’s Mar-a-Lago resort and struck up a close relationship with the president’s son-in-law Jared Kushner.
Most important, say Trump officials, Mr. Lighthizer was a persuasive advocate in White House debates and avoided the limelight. He learned the role of discreet staffer from his work decades earlier for Kansas Sen. Robert Dole, who was then the top Republican on the Senate Finance Committee.
“I stay in the trade lane and out of the press,” Mr. Lighthizer remarked at one signing ceremony.
His Senate background, he said, made it especially painful to watch the recent storming of the Capitol by a pro-Trump mob. While he didn’t criticize the president’s role, he said, “For the rest of his administration and for the many months after that [Mr. Trump] has to be an agent of healing.”
President-elect Joe Biden’s economic team shares Mr. Lighthizer’s view of China. But Mr. Biden’s advisers point out that the Trump administration failed to get Beijing to adopt the longer-term reforms it sought, including reducing government support of industry and protecting trade secrets of U.S. companies, in part because it picked fights with U.S. allies at the same time.
In the year since the trade pact was signed, China has fallen far behind on its purchase commitments to the Phase One trade agreement and has doubled down on its statist economic policies.
Mr. Biden plans to shuck unilateral action and sign up allies for what he calls a “united front” against Beijing. That includes leaving the decision on tariffs until consultations with European and Asian partners.
Mr. Lighthizer views the Biden plan with alarm, saying it could let other nations slow or veto U.S. actions and tie up the U.S. in endless, pointless discussions with China. The U.S. and China “started dialogues in the ’90s,” he said. “That did nothing. All of them were just a waste of time.”
Chinese officials argue that they have vastly liberalized their economy, helping U.S. firms and consumers. They also say that their state-led economic model is responsible for turning China into the world’s second-largest economy.
Since the Phase One deal was signed in January 2020, the lead on China policy has shifted to national security officials. Secretary of State Mike Pompeo has looked to deepen relations with Taiwan, which China regards as a renegade province, including starting talks for a bilateral trade deal.
But Mr. Lighthizer blocked that initiative, leading to criticism that he was coddling China in hopes of saving his trade deal. That isn’t the case, he said. There wasn’t enough time to go through the many legal hoops to get a trade agreement, he said. Besides, trade relations with Taiwan are fraught.
“We have a large and growing trade deficit with Taiwan,” he said, which totaled $26.9 billion through November 2020. “We clearly have trade disputes with Taiwan [and] they haven’t been resolved.”
As a longtime steel-industry lawyer, Mr. Lighthizer often sued for tariffs. In office, he initially targeted $50 billion of Chinese goods for levies. That was supposed to equal the annual loss to U.S. companies from technology purloined by China.
Additional tariffs were meant to pressure China and would be largely rolled back when the U.S. was convinced China was carrying terms of the trade deal, Trump officials said.
Although Mr. Lighthizer said Beijing is complying, he still wants the Biden administration to keep tariffs on all $370 billion in Chinese goods—three-quarters of everything China sells to the U.S.
Tariffs get results, he argued, so there is no reason to drop them. The 25% tariffs he slapped on Chinese car imports stopped China from potentially selling millions of vehicles in the U.S., he asserted.
“We’ve protected our automobile industry, our auto parts industry,” Mr. Lighthizer said.
This is all part of what he calls a worker-oriented trade policy. Other parts include stripping the WTO of power to override U.S. trade actions and reworking trade deals so they require more manufacturing in the U.S.
When he renegotiated the North American Free Trade Agreement, for instance, he greatly weakened special arbitration panels American companies use to sue foreign governments over investment disputes.
Those panels should be scrapped, he said, because they make moving factories overseas less risky. “If you’re going to invest in a shaky place, why should the United States basically insure you for free?” Mr. Lighthizer said.
But these protectionist measures also raised the price of imported parts for a swath of American companies, making it more costly to manufacture in the U.S.
“In a globalized world, our companies need to be thinking of selling into other markets,” said Chad Bown, a Peterson Institute trade expert who has closely tracked Mr. Trump’s China policy. Mr. Lighthizer “made it harder.”
His successor as trade representative, House Ways and Means staffer Katherine Tai, has a challenge in shaping policy. Mr. Biden hasn’t put a priority on trade and will be surrounded by aides who have worked with him for decades. In many administrations, China policy is run out of the White House or Treasury with the U.S. Trade Representative playing a secondary role.
Ms. Tai, a Mandarin speaker, headed China enforcement policy at USTR during the Obama administration. A Biden spokesman said “she knows how to make the levers of government work” and she would work closely with the White House on trade, which he called “a key pillar” of Mr. Biden’s economic agenda.
Mr. Lighthizer credits her with helping corral Democratic support for the renegotiated Nafta, called the U.S.-Mexico-Canada Agreement, which passed Congress by a wide margin, unlike nearly all free-trade deals.
“She learned good skills on the Hill,” Mr. Lighthizer said. Those include “how to manage different people who have different objectives and still get things done.”
Bluebird Bio to Spin Off Cancer-Drug Unit
Pioneer in the field of gene therapies will split into one company focused on rare diseases and a second devoted to cancer therapies
Bluebird Bio Inc., BLUE 0.37% a biotech pioneer in the field of gene therapies, plans to split itself in two later this year, spinning off its cancer-drug unit into a new, publicly traded company so it can focus on rare diseases.
Bluebird Chief Executive Nick Leschly will helm the new cancer company and assume a new position as executive chairman of Bluebird. Andrew Obenshain, currently Bluebird’s president of severe genetic diseases, will become its chief executive, the company said.
The separation is expected to close in the fourth quarter, the company said.
“We built this powerful product engine, and the question is: ‘What is the best way to think about the next five to 10 years?’ ” Mr. Leschly said in an interview. “We don’t believe the past is the best way to head into the future.”
The restructuring comes as Bluebird struggles to match its scientific achievements advancing its drug pipeline with commercial success. The Cambridge, Mass., biotech has grappled with painful delays in securing U.S. regulatory approvals and generating revenue from a rare-disease blood drug cleared in Europe.
Bluebird’s stumbles have fueled analysts’ concerns over the company’s operational acumen and a selloff in its shares.
During the past 12 months, Bluebird shares have fallen nearly 47% and the company has shed $1.8 billion in market value. The company posted a loss of $418.8 million in the first nine months of last year. Throughout its 28-year history, the company has accumulated a net deficit of $2.7 billion.
Mr. Leschly said the impetus for the split is the need for increased specialization as the company matures and prepares to bring multiple promising drugs to market. There are significant differences between cancer and rare genetic-diseases when it comes to conducting clinical trials, interacting with regulators and manufacturing at scale, he said.
“You don’t build an oncology company by hiring people who are experts in severe genetic disease, nor do you do vice versa,” Mr. Leschly said. “A lot of this comes down to…priorities and focus.”
Bluebird is one of the biotechnology industry’s pioneers of gene therapy, which help fight disease by replacing defective genes or adding new ones to fight disease. The drugs promise to treat, if not cure, intractable conditions but at a high price.
Bluebird uses a similar technology to deliver drugs for cancer and rare diseases, and housing both units under the same roof made sense as the company built out its pipeline, Mr. Leschly said. For years, Bluebird resisted splitting the units because they complemented each other but now will be stronger apart than together, he said.
“I think we got two aces on our hands here,” said Mr. Leschly, referring to a blackjack strategy. “We’re gonna split the aces.”
Bluebird’s leading cancer treatment, for a blood cancer called multiple myeloma, is under development with Bristol-Myers Squibb Co.
The drug—which uses genetically engineered immune cells to fight tumors—hit a speed bump last May when, the companies said, the U.S. Food and Drug Administration refused to consider approval before receiving additional details on the drug’s manufacturing process.
The companies have since then resolved the issue, and the FDA is scheduled to make an approval decision by the end of March.
The drug could reach annual global sales of $900 million in 2025, according to forecasts by Ronny Gal, a Sanford C. Bernstein & Co. analyst, though it may face stiff competition from rival companies such as Johnson & Johnson that are developing similar treatments.
The new oncology-focused company, which hasn’t yet been named, will also inherit several earlier-stage drugs aimed at treating other blood cancers, such as acute myeloid leukemia and so-called solid tumors that typically affect organs, bones and muscles, Mr. Leschly said. The company’s cancer unit is also working on new approaches to treating cancers such as non-Hodgkin lymphoma.
Bluebird’s rare-disease pipeline is more advanced than the company’s cancer portfolio.
In 2019, European Union regulators approved its drug Zynteglo for the treatment of beta thalassemia, a rare condition in which a defective gene hinders the body’s ability to transport oxygen through the blood. Bluebird’s treatment genetically modifies patients’ stem cells to contain a functional copy of the gene.
Bluebird priced the one-time therapy at €1.6 million, equivalent to $1.96 million, in Europe, and it has proposed allowing governments or insurers to pay over a five-year installment plan, with payments contingent on the drug working.
The company had aimed to start selling the drug in Germany before the end of last year, but the treatments were delayed because of restrictions related to the Covid-19 pandemic, Mr. Leschly said. The company is on the cusp of treating patients in Germany and continues to negotiate reimbursement terms with other European nations, he said.
Bluebird is testing the same drug to treat sickle cell anemia, a life-threatening blood disorder that, in the U.S., largely afflicts Black people.
Bluebird had been planning to seek U.S. approval for the drug in the second half of 2021, but said in November the request would be delayed until late 2022 because of manufacturing requirements requested by the FDA.
Bluebird didn’t disclose financial details of the split but said it intends to capitalize each company with sufficient cash to be successful and create value for shareholders. As of the end of September 2020, Bluebird had cash, cash equivalents and marketable securities of approximately $1.44 billion, according to regulatory filings.
Gapping down
In reaction to earnings/guidance:
- SNN -3.5%, NVRO -3.5%, SPNE -2.7%, NVTA -2.7%, LULU -2.5%, STAA -2.1%, SGRY -0.9%
Select Index ETFs showing early weakness:
- IWM -0.8%, DIA -0.7%, SPY -0.6%, QQQ -0.5%
Other news:
- TWTR -7.6% (Twitter permanently suspends President Trump's personal account)
- BOX -3.9% (proposed private offering of $300 million of convertible senior notes)
- BA -3.8% (issues statement on Sriwijaya Air Flight SJ-182)
Analyst comments:
- GLOB -2.9% (downgraded to Neutral from Buy at Goldman )
- AIN -2.3% (downgraded to Neutral from Outperform at Robert W. Baird)
- MIME -2% (downgraded to Hold from Buy at Jefferies)
- CRK -1.6% (downgraded to Market Perform from Outperform at BMO Capital Markets)
- VIRT -1.6% (downgraded to Underweight from Equal-Weight at Morgan Stanley)
- CRM -1.5% (downgraded to Neutral from Overweight at Piper Sandler)
- CVE -1.2% (downgraded to Equal Weight from Overweight at Barclays)
- AM -1% (downgraded to Mkt Perform from Outperform at Raymond James)
- LPSN -1% (downgraded to Hold from Buy at Jefferies)
Gapping up
In reaction to earnings/guidance:
- BOOT +6.6%, NTUS +6.1%, EXEL +5.2%, PKI +5.2%, FOLD +4.1%, TLYS +3.9%, EXAS +3.6%, AVTR +3.3%, EBS +3%, NSTG +2.3%, GILD +2%, CDNA +1.5%, AZZ +1.2%, NVCR +1%
Other news:
- MESO +70.3% (single dose of Rexlemestrocel-L provides substantial and durable reduction in heart attacks, strokes and cardiac death in patients with chronic heart failure)
- BNGO +24.3% (announces the kick-off of its next-generation cytogenomics symposium, the largest event yet to showcase saphyr's utility in genome analysis for genetic disease and cancer)
- SECO +23.2% (announces receipt of preliminary non-binding "going private" proposal)
- LLY +14.5% (Donanemab slows clinical decline of Alzheimer's disease in "positive" Phase 2 trial)
- ORIC +11.2% (provides corporate update and highlights key 2021 milestones; Three IND/CTA filings for ORIC-533, -944, and -114 expected in 2021)
- NIO +11% (NIO partners with NVIDIA (NVDA) to develop a new generation of automated driving electric vehicles)
- XCUR +10.5% (granted two fast track designations for Cavrotolimod (AST-008) from the FDA)
- WBAI +7.5% (expects to issue ~$14.4 mln worth of its Class A ordinary shares as consideration to acquire bitcoin mining machines owned by the Sellers)
- PASG +7.3% (announces plan to deliver on multiple meaningful catalysts in 2021)
- ATRA +6.8% Presenting at JP Morgan Healthcare Conf)
- PACB +5.2% (SoftBank has taken a 6% stake in PACB, according to Bloomberg)
- BLUE +5.1% (Bluebirdbio to separate oncology business into independent company)
- CYTK +4.3% (FDA granted orphan drug designation to CK-3773274 (CK-274) for the treatment of symptomatic hypertrophic cardiomyopathy)
- BIDU +3.4% (confirms plans to establish an intelligent EV company and form strategic partnership with Geely (GELYY))
- KXIN +3.2% (announces entry into a vehicles supply contract between Haitaoche Limited and China National Vehicles Import & Export Company)
- RYI +2.9% (appoints James Claussen as CFO, effective January 11)
- DYN +2.8% (reports Myotonic Dystrophy Type 1 Program achieves robust RNA Knock down of toxic human nuclear DMPK in preclinical study)
- VXX +2.7% (trading higher with futures softer in pre=mkt)
- BIIB +2.2% (Biogen: Atalanta announced strategic collaborations with Biogen (BIIB) and Roche's (RHHBY) Genentech)
- SYRS +2.1% (announces strategic priorities and expected milestones)
- AVXL +2% (awarded ~$ 1 mln from The Michael J. Fox Foundation for Parkinson's Research to develop ANAVEX2-73 for the treatment of Parkinson's disease)
- RIGL +2% (provides business update )
Analyst comments:
- PLAN +3.3% (upgraded to Overweight from Neutral at Piper Sandler; upgraded to Buy from Hold at Jefferies)
- DDOG +2.1% (upgraded to Buy from Hold at Jefferies)
- CRWD +1.2% (upgraded to Buy from Hold at Jefferies)