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Wednesday, February 5, 2020

Biogen up 18% on reported favorable patent ruling for Tecfidera

Biogen (BIIB +17.5%) jumps on modestly higher volume in apparent response to or in anticipation of a favorable ruling from the USPTO’s Patent Trial and Appeal Board regarding a challenge to a key patent protecting top selling MS drug Tecfidera (dimethyl fumarate). A decision was expected no later than tomorrow, February 6.
Would-be generic competitor Mylan N.V. (MYL +2.9%) is challenging the validity of the patent, which, if successful, would erase eight years of exclusivity in the U.S.
Tecfidera accounted for ~30% of the company’s sales last year.
https://seekingalpha.com/news/3538715-biogen-up-18-on-reported-favorable-patent-ruling-for-tecfidera

BARDA OKs additional funding for development of Spero antibiotic

The U.S. Biomedical Advanced Research and Development Authority (BARDA) has exercised its option under a 2018 contract to provide an additional $15.9M of funding to Spero Therapeutics (SPRO -2.1%) to support the development of tebipenem HBr for the treatment of complicated urinary tract infections (cUTI), a Fast Track- and Qualified Infectious Disease Product-tagged indication in the U.S.
A Phase 3 study, ADAPT-PO, is ongoing with topline data expected in Q3.
Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is an oral carbapenem antibiotic marketed in Japan by Meiji Seika Pharma Co., Ltd. for infections related to pneumonia, otitis media (ear infection) and sinusitis in children.
https://seekingalpha.com/news/3538623-barda-oks-additional-funding-for-development-of-spero-antibiotic

Tesla tumbling after confirming China deliveries delay

Tesla (NASDAQ:TSLA) confirms deliveries scheduled for early February in China will be delayed due to the coronavirus outbreak. Execs expects the production line to catch up once the outbreak gets better and the Shanghai factory is reopened, although that timetable is unclear.
The EV automaker has been relatively immune from broad concerns over a reeling Chinese economy as investors and analysts focus on the long-term picture.
Wedbush is out with a note this morning in that vein. “We are currently modeling ~20K deliveries in the key China region for the March quarter. In our opinion the current situation is more bark than bite as the aggressive trajectory of Giga 3 production and demand out of Shanghai look very strong out of the gates and the potential to hit 150k units/demand out of this region over the next year still remains intact,” forecasts analyst Dan Ives.
https://seekingalpha.com/news/3538550-tesla-tumbling-after-confirming-china-deliveries-delay

Test of Gilead remdesivir in coronavirus patients to start tomorrow in China

China’s state-run Xinhua News Agency reports that healthcare providers at Wuhan’s Jinyintan Hospital will begin treating the first group of severe coronavirus cases with Gilead Sciences’ (GILD -2.2%) remdesivir tomorrow. A total of 761 patients will receive therapy.
Chinese authorities have OK’d the start of clinical trials.
https://seekingalpha.com/news/3538631-testing-of-gileads-remdesivir-in-coronavirus-patients-to-start-tomorrow-in-china

Phase 1 trade deal ambiguity gives China ample room for coronavirus delays

The United States’ expected “export boom” to China in the aftermath of the Phase 1 trade deal will be delayed, as China battles the rapidly spreading coronavirus, White House economic adviser Larry Kudlow said on Tuesday.

Chinese factories, cities and transport links are shut as Beijing fights the spread of the virus, dampening domestic demand for everything from oil to consumer goods.
Under the trade deal, Beijing agreed to boost its U.S. purchases by $200 billion over two years, a massive increase that many analysts said was overly ambitious before the virus emerged.
PURCHASE TARGETS
In the text of the agreement, Beijing has pledged https://www.reuters.com/article/us-usa-trade-china-details-factbox/whats-in-the-us-china-phase-1-trade-deal-idUSKBN1ZE2IF to buy $76.7 billion of additional U.S. goods and services, on top of a 2017 baseline, in the 12 months that started Jan. 1, 2020, although the agreement doesn’t formally take effect until Feb. 15, 2020.
It specifies an additional $123 billion in Chinese purchases for the second year, 2021.
Included in the first-year target are increases of $32.9 billion in U.S. manufactured goods purchases, $12 billion for agricultural products, $18.5 billion for energy and $12.8 billion for services.
The deal deliberately does not spell out when during the year these goods should be purchased, in part because Beijing insisted that market demand dictate purchase timing.
It says, “The Parties acknowledge that purchases will be made at market prices based on commercial consideration and that market conditions, particularly in the case of agricultural goods, may dictate the timing of purchases within any given year.”
The deal text contains a disaster clause, yet to be formally invoked by Beijing, to allow for delays: “In the event that a natural disaster or other unforeseeable event outside the control of the Parties delays a Party from timely complying with its obligations under this Agreement, the Parties shall consult with each other.”
CONSULTATIONS
The form these consultations should take is not specified in the text.
Enforcement of the agreement relies heavily on a bilateral process, with each side setting up an enforcement office to monitor compliance with the deal and to field complaints from companies or other parties.
Any disputes in implementing the terms of the agreement, including meeting China’s purchase targets, will progress up a chain of officials over a 90-day period, from the working level, to vice ministers and ultimately to U.S. Trade Representative Robert Lighthizer and Chinese Vice Premier Liu He.
If a dispute cannot be resolved, the complaining party can levy tariffs in proportion to the damage caused by complaint.
China, however, would be prohibited from responding in kind to any punitive U.S. tariffs. Beijing’s only recourse in that cause is to quit the agreement.
Lighthizer has said the structure, which includes twice yearly consultations with Liu, is aimed at resolving any disagreements bilaterally. He has eschewed third-party dispute resolution mechanisms in trade agreements.
The USTR “has not received any requests from China’s government to discuss changes in China’s purchase commitments due to the coronavirus outbreak,” a spokeswoman said.
The Trump administration considers trade and the coronavirus separate issues, White House senior adviser Kellyanne Conway said Wednesday. In the public health meetings she has been in, she said she’s never “heard the word trade mentioned a single time.”
With wide swaths of China’s economy on lockdown, implementation of the trade deal “will take a back seat” said Wendy Cutler, a former deputy U.S. trade representative.
“The best thing the United States can do at this point is be compassionate and recognize this and accept it, and not make abrasive comments on what we expect,” Cutler told a trade conference in Washington.
Cutler said that it is unlikely that virus-prompted delays would let China “off the hook” for its purchase agreements, and Washington and Beijing would find a way forward.
“There is a heavy incentive on both sides for this agreement to work,” she said.
https://www.marketscreener.com/news/Explainer-Phase-1-trade-deal-ambiguity-gives-China-ample-room-for-coronavirus-delays–29946231/

Adidas closes ‘considerable’ number of stores in China due to coronavirus

German sportswear company Adidas on Wednesday said it was temporarily shutting a “considerable” number of its stores in China due to the coronavirus outbreak.

The company said the fast-spreading virus was having a negative impact on its business but added that it could not yet assess to what extent.
Adidas has about 12,000 outlets in China, including franchise stores.
Adidas saw sales growth slow to 11% in China in the July-September period from 14% in the second quarter.
Several retailers have warned that coronavirus is taking its toll, including Nike Inc and Hugo Boss, which have both closed some stores in China.
Adidas’s German rival Puma said that factories will remain closed until Feb. 10.
“We have so far not been informed of any production or shipment delays. A number of stores – both owned and operated and partner stores – remain closed for the time being due to local regulations”, a Puma spokesman said.
“It is too early to comment on the effects of these closures”, he added.
The group cancelled or postponed all Puma events in China in February including training and marketing meetings and put travel restrictions in place. Its Shanghai office remains closed until February 9.

https://www.marketscreener.com/news/Adidas-closes-considerable-number-of-stores-in-China-due-to-coronavirus–29944055/?countview=0

Alleviating age-related cognitive decline by activating immune cells

Interleukins IL-33 and IL-5 are major culprits in the inflammatory responses associated with asthma. But researchers at Albany Medical College just found that leveraging the ability of these two signaling molecules to link to a type of immune cell in the brain might alleviate age-related cognitive decline and help treat neurodegenerative diseases.
The class of immune cell is called group 2 innate lymphoid cells (ILC2s). In a new study published in the Journal of Experimental Medicine, the scientists reported that treating old mice with IL-33 to activate ILC2 or use IL-5—which is a product of ILC2 activation—improved cognition among the animals.
In healthy mice, ILC2s were recently found in the meninges—the membranes that line the skull and enclose the brain and spinal cord. These cells were shown to be activated and help healing after spinal cord injury. “However, whether ILC2s also reside in other parts of the central nervous system, and how they respond to aging, was unknown,” Qi Yang, the new study’s co-corresponding author, said in a statement.
Yang and colleagues examined the brains of mice of different ages. They found that in aged mice, ILC2s made up about 50% of all immune cells in a complex cerebral structure called the choroid plexus. But there were only a few in young mice. An analysis of choroid plexus tissue also revealed that ILC2s exist in large numbers in elderly people.
Choroid plexus produces cerebrospinal fluid and acts as a barrier that blocks toxins from entering the central nervous system. It’s close to the hippocampus, a part of the brain that’s crucial to learning and memory functions.

ILC2s in aged mice brains were largely inactive. To determine whether they would be able to proliferate, the researchers treated mice with IL-33, a known ILC2 activator. As a result, the ILC2s significantly expanded, and the researchers noted that they expressed high amounts of Ascl2 and Hif1a, the transcription factors that promote the renewal and survival of neurons. ILC2s in older mice also survived longer than did those in younger rodents.
What’s more, aged mice that received pre-activated ILC2 or IL-33 showed significantly enhanced performance in tests that measured the animal’s cognitive functions, such as spatial memory, the team reported. “Together, these data provide direct evidence that activated ILC2 can improve the cognitive function of aged mice,” the researchers wrote in the study.
The team went on to examine the specific effector molecules by which activated ILC2 work to improve cognitive function. They tried giving the mice either IL-5 or IL-13, two signaling molecules ILC2s produce. While IL-13 has been shown to promote spatial learning and memory in young mice, IL-5’s effects on cognition were unknown.
Surprisingly, it was IL-5, not IL-13, that improved elderly animals’ performance in tests. The team found that treatment with IL-5 increased neurogenesis and reduced neuroinflammation, which probably explains why they showed better cognitive function.

Neurodegenerative diseases and age-related dementia represent huge unmet medical needs, so scientists have been searching for new pathways to combat them. A team led by Brown University scientists previously found that widely used HIV drug lamivudine might be repurposed to treat age-related disorders by limiting the activity of a virus-like mechanism that gives rise to an inflammatory immune response.
In 2018, a collaboration between the University of Virginia and Virginia Tech found that meningeal lymphatic vessels, which connect the brain and the immune system, could be targeted for Alzheimer’s and age-related dementia.
The Albany Medical College team believes ILC2s in the aged brain are also promising targets for treating age-related cognitive decline and neurodegenerative diseases.
“Our work has thus revealed the accumulation of tissue-resident ILC2 cells in the choroid plexus of aged brains and demonstrated that their activation may revitalize the aged brain and alleviate aging-associated cognitive decline,” said Yang.
https://www.fiercebiotech.com/research/alleviating-age-related-cognitive-decline-by-activating-immune-cells