Virus spreads to more Chinese cities, President Xi says containment is priority

An outbreak of a new coronavirus has spread to more Chinese cities, including the capital Beijing and Shanghai, authorities said on Monday, and a fourth case has been reported beyond China’s borders.

China’s National Health Commission confirmed that the virus, which causes a type of pneumonia, can pass from person-to-person, the official Xinhua News Agency said.

President Xi Jinping said curbing the outbreak and saving lives was a top priority as the number of patients more than tripled and a third person died.

Adding to the difficulties of containing it, hundreds of millions of Chinese will be traveling domestically and abroad during the Lunar New Year holiday that starts this week.

Authorities around the globe, including in the United States and many Asian countries, have stepped up screening of travelers from Wuhan, the central city where the virus was first discovered.

“Wuhan is a major hub and with travel being a huge part of the fast approaching Chinese New Year, the concern level must remain high. There is more to come from this outbreak,” said Jeremy Farrar, a specialist in infectious disease epidemics and director of the Wellcome Trust global health charity.

Authorities confirmed a total of 217 new cases of the virus in China as of 6 p.m. local time (1000 GMT) on Monday, state television reported, 198 of which were in Wuhan.

Five new cases were confirmed in Beijing and 14 more in Guangdong province, the report said. Another statement confirmed a new case in Shanghai, bringing the number of known cases worldwide to 222.

“People’s lives and health should be given top priority and the spread of the outbreak should be resolutely curbed,” President Xi was quoted as saying by state television.

The virus belongs to the same family of coronaviruses as Severe Acute Respiratory Syndrome (SARS), which killed nearly 800 people globally during a 2002/03 outbreak that also started in China.

Its symptoms include fever and difficulty in breathing, which are similar to many other respiratory diseases and pose complications for screening efforts.

Zhong Nanshan, a respiratory expert and head of the health commission team investigating the outbreak, confirmed that two cases of infection in Guangdong province were due to human-to-human transmission, Xinhua said. Some medical staff have been infected, it added, but gave no number.

BEYOND BORDERS

South Korea on Monday confirmed its first case, a 35-year-old Chinese national who had traveled from Wuhan, the fourth patient reported outside China.

Last week, two cases were reported in Thailand and one in Japan. All three involved people from Wuhan or who recently visited the city.

A report by London Imperial College’s MRC Centre for Global Infectious Disease Analysis estimated that by Jan. 12 there were 1,723 cases in Wuhan City with onset of related symptoms. Chinese health authorities have not commented directly on the report.

“This outbreak is extremely concerning. Uncertainty and gaps remain, but it is now clear that there is person to person transmission,” Farrar said.

The World Health Organization said on Monday “an animal source” appeared most likely to be the primary source of the outbreak and that some “limited human-to-human transmission” occurred between close contacts.

China’s state council reiterated the government will step up prevention efforts and find the source of infection and transmission channels as soon as possible, state television said on Monday.

Shares in pharmaceutical firms and mask makers in China surged Monday because of the outbreak.

“Who knows how many people who have been to Wuhan may be unaware that they have already been infected?,” said one commentator on Chinese social media platform Weibo

The state-run Global Times newspaper said in an editorial the government needs to disclose all information and not repeat the mistakes made with SARS. Chinese officials covered up the SARS outbreak for weeks before a growing death toll and rumors forced it to reveal the epidemic.

“Concealment would be a serious blow to the government’s credibility and might trigger greater social panic,” the editorial said.

https://www.reuters.com/article/us-china-health-pneumonia/virus-spreads-to-more-chinese-cities-president-xi-says-containment-is-priority-idUSKBN1ZJ001

Jazz Pharma’s Sunosi OK’d in Europe

As expected, the European Commission approves Jazz Pharmaceuticals’ (NASDAQ:JAZZ) Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure.

Two months ago, the advisory group CHMP adopted a positive opinion backing approval.

The company in-licensed the dual-acting dopamine and norepinephrine reuptake inhibitor from Aerial Biopharma LLC in 2014.

https://seekingalpha.com/news/3532890-jazz-pharmas-sunosi-okd-in-europe

JPM: Glaxo sees enormous Shingrix potential, but supply gap still in the way

GlaxoSmithKline’s Shingrix has generated blockbuster sales quickly after its launch, but numbers touted by the drugmaker this week show the size of the remaining opportunity—and how much supply constraints have held the rollout back.

Glaxo estimates about 115 million people in the U.S. alone are eligible for the shingles vaccine, which requires two doses two to six months apart. The company has reached about 11 million with at least one dose, execs said at the annual J.P. Morgan Healthcare Conference, meaning there are still more than 100 million eligible recipients in the U.S. alone.

In 2018, during its first full year on the market, Shingrix passed the $1 billion mark as the launch roared to life. During the first nine months of 2019, sales reached $1.67 billion.

Shingrix won U.S. approval in October 2017, and, days later, the Centers for Disease Control and Prevention vaccine advisers recommended it for adults 50 and older with healthy immune systems. That strong recommendation caught the U.K. drugmaker unprepared to met demand.

The rollout has surpassed early expectations, but supply constraints have forced GSK to limit deliveries. With its current manufacturing network, GSK can produce “high-teen millions” of doses per year, but that isn’t even meeting U.S. demand. It’s far short of what’ll be needed to fuel a global rollout.

The company is “looking everywhere” to increase capacity, but it’s started to hit a “bottleneck,” GSK’s vaccines president Roger Connor told FiercePharma at JPM. Connor, who previously ran GSK’s pharma manufacturing, took the company’s top vaccines post in 2018.

While GSK is making incremental gains—the company recently pledged a $100 million investment in Montana—GSK’s main capacity expansion will come in the form of a new plant slated to come online in 2024, Connor said. When the drugmaker opens the plant, it expects a “tens of millions” increase in dose capacity.

The complex supply chain features multiple sites at multiple locations around the world, and it’s further complicated by the fact that the vaccine is made up of two components—the antigen and the adjuvant, Connor said.

Before it can open the new site, GSK is doing what it can with current supply. The drugmaker has prioritized people who have received their first dose, and it’s moved to increase supply visibility through an online tracker. The company isn’t yet advertising in the U.S.

As for future launches around the world, those will mostly have to wait as the company is taking a “thoughtful” approach to the global rollout.

“We don’t want to launch and let down our patients and the markets where we have launched first,” he added. “We’ll take our time and do it appropriately.”

Of course, GSK has big ambitions for the vaccine in the years to come. It’s planning to kick off “phased launches” in China and Japan and is also exploring the shot in people under 50 with compromised immune systems. The vaccine will be a growth driver for “years to come,” Connor said.

https://www.fiercepharma.com/vaccines/jpm-gsk-s-shingrix-has-stormed-out-gate-despite-supply-limitations-but-there-s-plenty

Celltrion plans to launch a biosimilar each year for next decade

There are plenty of pharma companies outlining their strategies for the new decade this week at the JP Morgan Healthcare conference, and South Korea’s biosimilars specialist Celltrion was no exception.

Celltrion’s chairman Jung Jin Seo said the company expects to launch a biosimilar every year until 2030, building on its portfolio of already-approved drugs.

Biosimilars are near-copies of biologic drugs, and Celltrion was the first to successfully market a biosimilar of a monoclonal antibody in 2013.

Before its version of Johnson & Johnson/MSD’s Remicade (infliximab) was approved in Europe in 2013, there were doubts as to whether it was even possible to get near-copies of such a complex molecule past regulators.

But Celltrion’s infliximab biosimilar, branded as Remsima, proved a huge hit in Europe and a whole string of other antibody biosimilars have followed, taking market share in the EU and in some cases.

There has also been some success in the US although some biosimilar launches have been delayed because of patent issues.

Since then other companies have also got in on the action – South Korean rival Samsung Bioepis is establishing itself as a biosimilars specialist, while companies such as Amgen, Pfizer, and Teva are also players.

Celltrion cited figures from IQVIA showing that Remsima has overtaken Remicade’s market share, and has around 59% of the market.

Celltrion’s Truxima, a biosimilar of Roche’s cancer drug rituximab, and Herzuma referring to the Swiss firm’s breast cancer drug Herceptin (trastuzumab) have also got the lion’s share of their respective markets.

The company’s strategy is to offer a value-added version of its biosimilars, such as its subcutaneously administered version of Remsima.

This offers a more convenient treatment option than the originator, taking minutes to administer instead of hours and was approved in rheumatoid arthritis in Europe late last year.

Celltrion has applied for an extension of the marketing authorisation to cover the inflammatory bowel disease indication, with an approval expected in mid-2020.

Ho Ung Kim, head of the medical and marketing division at Celltrion Healthcare said, “As a ‘first mover’, Celltrion Healthcare has gained extensive experience in the biopharmaceutical field and is now ready to initiate a direct sales model.

“Celltrion Healthcare has set up its own sales network and overseas offices in 14 countries throughout Europe to secure price competitiveness, and strives to lead the global tumour necrosis factor alpha (TNF-α) inhibitors market with its innovative infliximab Remsima SC, which is projected to be worth approximately $50 billion.”

Celltrion plans to launch a biosimilar each year for next decade

AstraZeneca Prostate Cancer Supplemental Drug Gets U.S. Approval

AstraZeneca PLC (AZN.LN) said Monday that its supplemental new drug application for Lynparza has been accepted and granted priority review in the U.S. by the Food and Drug Administration for patients with metastatic castration-resistant prostate cancer.

The pharmaceutical company said that the Prescription Drug User Fee Act date is set for the second quarter of 2020.

The London-listed company said that Lynparza is also aimed at patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, which have progressed following prior treatment with a new hormonal agent.

Results of the PROfound trial showed Lynparza significantly reduced the risk of disease progression or death by 66%, it added.

Prostate cancer is the second-most common cancer in men, with an estimated 1.3 million new cases diagnosed world-wide in 2018 and it is associated with a significant mortality rate, AstraZeneca noted.

https://www.marketscreener.com/ASTRAZENECA-4000930/news/AstraZeneca-Prostate-Cancer-Supplemental-Drug-Gets-U-S-Approval-29862325/

AstraZeneca liver cancer treatments win orphan FDA status

Two AstraZeneca (NYSE:AZN) cancer drugs received have orphan status for treatment of liver cancer by the FDA, a designation that may eventually speed progress to approval.

The special status was granted to Imfinzi, a lung cancer treatment, and tremelimumab, which has been tested in a combination in a variety of cancers.

Lynparza, another Astra drug, was also given FDA priority review for a severe form of prostate cancer, the company said separately.

https://seekingalpha.com/news/3532874-astrazeneca-liver-cancer-treatments-win-orphan-fda-status

Revolution Medicines Maps Out an IPO to Reach Cancer’s Frontiers

Cancer research has revealed proteins known to play a role in the disease, but with no known way of stopping what they do. In pharmaceutical parlance, they’re “undruggable.”

Revolution Medicines is trying to drug the undruggable with small molecules that block the signaling pathways these proteins use to help cancer grow and thrive. With one of its experimental therapies now in early-stage testing under a partnership with a large pharmaceutical company and more compounds in the pipeline, the Redwood City, CA, biotech is preparing to go public to finance its research.

In documents filed with securities regulators late Friday, Revolution set a preliminary $100 million target for its IPO. The company has applied for a Nasdaq listing under the stock symbol “RVMD.”

Revolution is developing drugs for what it calls “frontier targets,” proteins that support cancer but have no drug that blocks them. In cases where there is an FDA-approved drug, the therapy doesn’t fully suppress what the protein does to help cancers grow. Revolution is developing drugs to specifically target RAS and mTOR, two signaling pathways that play a role in helping tumors.

RAS proteins act like molecular switches that control the signaling systems regulating cellular growth. In normal cells, these proteins receive and obey the signals that switch them from the active state to the inactive state. But when RAS gets stuck in the active state, these proteins drive cells to become cancerous.

In order for a drug to block a protein, it needs to bind to a site somewhere on the molecule. RAS proteins pose the challenge of lacking druggable binding pockets for a drug, Revolution says in its filing. The company’s technology addresses that problem by using a second protein, which it calls a chaperone, to form a pocket. That druggable pocket is where Revolution’s small molecule drugs are intended to bind to a RAS protein.

Revolution says it is developing small molecule drugs that target multiple types of the active form of the RAS protein, which it calls RAS(ON). It expects to nominate its first RAS(ON) drug candidate this year, according to the filing. The company adds that it believes its approach could treat diverse RAS mutations encompassing colorectal, pancreatic, and non-small cell lung cancer, among others.

Revolution’s most advanced drug, RMC-4630, blocks SHP2, a protein in the RAS signaling pathway. The drug is currently in Phase 1/2 testing with partner Sanofi (NYSE: SNY), and in the IPO filing, Revolution reports preliminary data from that study. As of Nov. 6, 2019, 63 of the 66 patients enrolled in the study had received the drug. In addition to dosing data, Revolution reported early signs that RMC-4630 shows anti-tumor activity against non-small cell lung cancer that has the KRAS mutation, one of the RAS(ON) targets of the company. In one patient, the volume of tumors was reduced by 45 percent.

Sanofi is reimbursing Revolution for most of the research costs of RMC-4630. Through the end of the third quarter of 2019, Sanofi had paid Revolution $83.5 million, which includes the upfront payment to start the alliance plus R&D expenses, according to the filing. The California biotech says it will use the IPO proceeds to fund development of other RAS drugs, bringing them through the preclinical work needed to support an application to start tests of “one or more” of them in humans. The company will also use the new cash to develop RMC-5552, a preclinical compound that addresses the mTOR pathway.

Revolution launched from venture capital firm Third Rock Ventures five years ago. At that time, the startup’s focus was developing new medicines from natural products—compounds found in nature that have therapeutic properties. Revolution’s lead program was an antifungal drug.

As the company continued to work with the natural products technology it licensed from the University of Illinois at Urbana-Champaign, Revolution also made progress in cancer applications, CEO Mark Goldsmith told Xconomy in 2018. Revolution raised additional financing to continue that research and eventually returned the antifungal compound to the Illinois scientist who discovered it. In Revolution’s IPO filing, the biotech says its RAS(ON) drugs and mTORC1 inhibitors are “inspired by natural products.”

Revolution’s research is bolstered by assets from Warp Drive Bio, a biotech that it acquired in 2018. Warp Drive was also developing RAS drugs. At the time of the acquisition, executives declined to offer financial details about the all-stock deal. But Revolution’s IPO filing reveals that it offered shares valued at $69 million.

That Warp Drive deal also turned Sanofi into a Revolution shareholder. As one of Warp Drive’s shareholders, the French pharmaceutical giant was issued shares in Revolution as part of the acquisition. According to the IPO filing, Sanofi’s stake in Revolution is 7.8 percent.

Revolution has raised more than $211 million, most recently a $100.2 million Series C financing last summer. The filing shows that Third Rock Ventures is the company’s largest shareholder, owning a 28.8 percent stake, followed by The Column Group at 18.6 percent.

https://xconomy.com/san-francisco/2020/01/17/revolution-medicines-maps-out-an-ipo-to-reach-cancers-frontiers/