WuXi Biologics in lease agreement for 3rd U.S. facility in global expansion push

WuXi Biologics is in the midst of gung-ho global expansion effort to spread the CDMO’s roots outside of its Chinese home base. Only a month after announcing its first major U.S. investment, WuXi Biologics has now knocked together two major lease agreements in short succession.
WuXi Biologics signed a 10-year lease agreement to occupy a 66,000-square-foot clinical manufacturing facility in Cranbury, New Jersey, that will become its third plant in the U.S., the CDMO said Monday.
The Cranbury facility will eventually employ 100 and will be fully operational by the end of 2020, WuXi said. The facility will include 6,000 liters of bioreactor space along with process development and quality control labs and other supporting functions.

WuXi Biologics’ entry into the Cranbury hub comes quickly after the Chinese CDMO announced plans to occupy two other facilities in the Northeast.

In May, WuXi clinched a deal to build its first U.S. biologics facility at a 46-acre master-planned manufacturing hub dubbed The Reactory in Worcester, Massachusetts.
The two-story, 107,000-square-foot facility will cost $60 million and employ 150 when it is fully operational in 2022, WuXi said in a release. According to the Worcester Telegram & Gazette, the Worcester City Council in January inked a 20-year, $11.5 million tax increment financing plan to coax WuXi, which will be the The Reactory’s first occupant.
WuXi targeted the greater Boston area for its “talented workforce and impressive biotech network,” WuXi Biologics CEO Chris Chen, Ph.D., said at the time.
“We stand ready and able to help our global partners advance their innovative and life-saving ideas,” Chen said. “Together, I am confident that we have much to contribute to the biologics industry and patients worldwide.”
In May, WuXi followed up that big investment with a lease agreement for a 33,000-square-foot process development lab in King of Prussia, Pennsylvania, the CDMO said.

WuXi’s U.S. push is part of its effort to expand globally. In April 2018, WuXi said it would lay out $392 million to build a biologics facility in Dundalk, Ireland, and create a campus of 2.8 million square feet. That project, its first outside of China, has been in the works for several years and snagged support from Ireland’s development agency. The Dundalk plant will eventually employ 400.
In October 2019, WuXi said it would also build a 15,520-square-meter, three-story vaccines manufacturing facility at the Dundalk site. WuXi said it would produce $150 million worth of vaccines a year for 20 years as part of a $3 billion deal with unnamed partner.
Plus, WuXi has expansion plans in Germany; in January, it announced a deal to take over a Bayer plant in that company’s home city of Leverkusen.
WuXi said it would use the facility for its own purposes but also to provide backup supply for Bayer’s hemophilia drug Kovaltry if needed.
https://www.fiercepharma.com/manufacturing/wuxi-biologics-inks-lease-agreement-for-3rd-u-s-facility-global-expansion-push

Costa Rica to resume use of hydroxychloroquine for COVID-19

Costa Rican health authorities said Monday that the country plans to resume its use of hydroxychloroquine to treat coronavirus patients.

The announcement came from Román Macaya, the executive president of the Costa Rican Social Security System (CCSS), even as he acknowledged the drug’s efficacy against COVID-19 has not yet been proven.
“Efficacy is something we have to answer with a clinical study,” Macaya said.
The CCSS had temporarily stopped using hydroxychloroquine for COVID-19 in late May after a study published in The Lancet prompted the World Health Organization (WHO) to do the same.
That study — which indicated that using the drug on hospitalized coronavirus patients could increase their chances of dying — has since come under independent criticism, and the WHO has resumed its own hydroxychloroquine study.
In Costa Rica, all patients — including those with minor symptoms or who are asymptomatic — are offered the option to take hydroxychloroquine upon their diagnosis, as long as they don’t have contraindications to the drug, Macaya said.
The country has provided the drug to coronavirus patients since conferencing with Chinese experts in April, according to Mario Ruíz, Medical Manager of the CCSS.
Costa Rica has a low case fatality rate (.75%), and fewer than 5% of known active coronavirus cases are currently hospitalized.
“We can’t say that’s a result of this medication, but we can’t discard it either,” Macaya said last month. The CCSS has not released data comparing the outcomes of patients treated with hydroxychloroquine to other methods.

On Monday, Macaya suggested that CCSS’s commitment to daily check-in calls for everyone infected with SARS-CoV-2 has helped keep deaths low.
The daily conversations and ongoing symptom tracking ensure that patients are hospitalized at the appropriate time, Macaya said. 

Costa Rica to resume use of hydroxychloroquine for COVID-19 treatment

Legend joins the billion-dollar club

With a $3.2bn valuation ahead of its Nasdaq float – and a market cap that is now 50% higher – Legend Biotech enters the IPO record books.

Genscript certainly timed the flotation of its cell therapy business Legend Biotech to perfection. Shares were listed on Nasdaq a week after impressive data on its lead Car-T project, the J&J-partnered JNJ-4528, were unveiled at Asco, and the presentation surely fanned investor interest in the IPO.
Deliberately timed or not, Legend raised substantially more than initially intended and hit the market with a huge $3.2bn market cap. By Evaluate Vantage’s calculations, this makes it the third-biggest Nasdaq flotation, by this measure, of a research-stage drug developer. That the market for new issues is booming will also have helped, of course.
Legend’s success is also surprising given that new investors only hold around a third of the company, which is based in China and the US. Genscript Biotech, a Hong Kong-listed supplier of biotech products and services, retains a 66% stake in Legend and, presumably, a big say in the spin-off’s future.
This acted as little deterrent to the Legend IPO. After first setting out to raise up to $100m, this was soon hiked to $350m; huge demand then pushed the final offer price to $23, way above the $18-20 indicative range and bringing in a $424m haul. In the two days since floating, the stock has surged another 50%.
Perhaps the most remarkable aspect of the float is that Hong Kong-listed Genscript is capitalised at around $4.3bn, meaning that around two thirds of its valuation is now accounted for by the 66% stake it holds in Legend.
Vantage has identified just eight clinical-stage companies that have floated with valuations above $2bn; a look at where they stand now makes for encouraging reading for Legend’s new investors: all but one are now trading higher.

Still, a similar Vantage analysis last October, done before the Covid-19 opportunity lifted several of these names, tells a different story. At that stage Moderna and Vir were both also trading below their IPO price, with Bridgebio just about staying flat. Whether the pandemic promise is ever realised is far from certain, while the wider stock market revival over the past month has provided most stocks with a boost.
Legend, meanwhile, is highly reliant on JNJ-4528 confirming its promise in phase III. A pivotal trial called Cartitude-2 has been started, but is unlikely to read out before 2022. The Car-T therapy is one of many projects duelling in the highly competitive BCMA-targeting space; early signs of efficacy are at least encouraging (Asco 2020 – J&J sees multiple myeloma responses deepen, May 29, 2020).
Legend is far from a silent partner on this project: a 2017 global development deal saw the two groups agreeing to share costs and profits equally, except in China. The transaction cost J&J a huge $350m up front – Legend’s LCAR-B38M had already generated promising clinical data but JNJ-4528, J&J’s incarnation, had yet to enter the clinic – and the US pharma giant has paid out $110m in milestones since.
Legend has said it will use the IPO proceeds to fund the clinical development and launch of JNJ-4528, build manufacturing facilities and push forward other pipeline projects. But with many of these still very early it is fair to assume that the company’s valuation is largely based on the promise of its lead asset.
Notably, equity analysts covering J&J have yet to append sales forecasts to JNJ-4528, according to EvaluatePharma. Legend will soon boast its own sellside following, of course, and with a market cap now approaching $5bn it seems inevitable that some pretty large numbers will soon emerge.

Legend Biotech’s pipeline

Legend Biotech website

https://www.evaluate.com/vantage/articles/data-insights/other-data/legend-joins-billion-dollar-club

Israel halts coronavirus cellphone surveillance

Israel’s internal security service Shin Bet has halted its cell-phone tracking of coronavirus carriers, an official said on Tuesday, citing the success of alternatives to the controversial method of containing contagions.

Circumventing parliament in March as the coronavirus spread, the Israeli cabinet approved emergency regulations that enabled the use of the Shin Bet technology, usually deployed for anti-terrorism. Privacy watchdog groups have challenged the practice in court as lawmakers considered ratifying it.

An Israeli official said the tracking was stopped following a ministerial meeting on the coronavirus on Monday at which Shin Bet director Nadav Argaman argued that the method was not required as infections taper off under other counter-measures.
“This (tracking) will be renewed only if there is a big outbreak, at which point snap legislation would be required in parliament,” said the official, who requested anonymity.
Israel – with a population of 9 million – has reported 18,091 coronavirus cases and 299 deaths. A limited resurgence prompted Prime Minister Benjamin Netanyahu on Monday to put the brakes on moves to reverse closures of schools and businesses.
https://www.reuters.com/article/us-health-coronavirus-israel-surveillanc/israel-halts-coronavirus-cellphone-surveillance-official-says-idUSKBN23G1MM

U.S. offers $25B in COVID-19 relief to Medicaid-recipient, safety-net hospitals

The U.S. Department of Health and Human Services (HHS) said on Tuesday it would distribute about $25 billion to hospitals that have not previously received relief funds as they grapple with a rise in COVID-19 cases.
The agency said it would provide about $15 billion of the total to hospitals serving patients covered by federal Medicaid program for low-income individuals and children’s health insurance program, and $10 billion to safety net hospitals that treat patients regardless of their insurance status.
The U.S. government has earmarked $175 billion for hospitals and medical providers to meet the increased expenses from rising COVID-19 cases and cover lost revenues due to suspension of medical procedures and routine visits.

The largest for-profit U.S. hospital chains such as HCA Healthcare Inc and Tenet Healthcare Corp appear to be benefiting disproportionately from the relief funds, while smaller hospitals struggle to stay afloat as they await aid, Reuters reported on Tuesday.
The latest funding would include hospitals that did not receive aid from the government’s initial payout of $50 billion, the agency said.
“HHS is using funds from Congress, secured by President Trump, to provide new targeted help for America’s safety-net providers and clinicians who treat millions of Medicaid beneficiaries,” HHS Secretary Alex Azar said in a statement.

HHS has been under media scrutiny for its prior relief fund allocation and the bar has moved higher on the new distributions, wrote Stephens analyst Scott Fidel.
Safety net hospitals will receive between $5 million and $50 million, which will be sent directly to the hospitals via direct deposit. The fund distribution would occur this week, according to the agency.
https://www.reuters.com/article/us-health-coronavirus-hhs/u-s-government-offers-25-billion-in-covid-19-relief-to-some-hospitals-idUSKBN23G2O5

Applied DNA nabs funding to support COVID-19 programs

Applied DNA Sciences (APDN +3.4%) announces that it has secured a $40K grant from National Grid to support the manufacture of COVID-19 tests and vaccine candidates.

National Grid is a U.S. energy company serving more than 20M customers in the Northeast.

https://seekingalpha.com/news/3581602-applied-dna-nabs-funding-to-support-covidminus-19-programs

Royalty Pharma acquires partial royalty interest on Prevymis

Royalty Pharma (RPHA) to acquire a partial royalty interest on Prevymis (letermovir) from AiCuris for $220M.

Prevymis is licensed by Merck, is approved for prophylaxis (prevention) of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant who are at high risk for CMV reactivation.

https://seekingalpha.com/news/3581613-royalty-pharma-acquires-partial-royalty-interest-on-prevymis