FDA OKs Vanda Pharma's Hetlioz for rare developmental disorder

 

• The FDA has signed off Vanda Pharmaceuticals' (NASDAQ:VNDA) Hetlioz capsules and the liquid formulation of Hetlioz for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS), a rare inherited disorder characterized by mild-to-moderate intellectual disability, delayed speech and language skills.
• HETLIOZ is the first FDA-approved medication for patients with SMS.
• SMS is a developmental disorder that is caused by a small deletion of human chromosome 17p.
• The nod for HETLIOZ for the treatment of nighttime sleep disturbances in SMS is based on a single placebo-controlled efficacy study in this rare disorder, which studied both adults with SMS taking the HETLIOZ capsule and children with SMS taking the liquid formulation. The safety profile of HETLIOZ in this study was similar to those seen in HETLIOZ studies previously conducted for the treatment of Non-24-Hour Sleep-Wake Disorder, and was similar between adults and children with SMS.
• HETLIOZ capsules, for adults with SMS, will be immediately available and the HETLIOZ LQ liquid formulation, for children with SMS, is expected to be available in the first quarter of 2021.
• https://seekingalpha.com/news/3640715-fda-oks-vanda-pharmas-hetlioz-for-rare-developmental-disorder-shares-up-9

Bayer sets up cell and gene platform to foster purchased biotech firms

 Bayer said it was setting up an organisation within its healthcare division to speed up and support cell and gene therapy development, following recent takeovers.

The new platform will provide services such as research, manufacturing, clinical development and project management to support the new business.

Bayer acquired cell and gene therapy companies BlueRock Therapeutics and Asklepios Biopharmaceutical in 2019 and 2020, respectively.

https://www.reuters.com/article/us-bayer-celltherapy/bayer-sets-up-cell-and-gene-platform-to-foster-purchased-biotech-firms-idUSKBN28C0U1

JD Health IPO examines value of China’s big tech

 JD.com is offering a timely reminder of why big technology firms are valuable to Beijing. The e-commerce giant’s healthcare arm has priced shares in its initial public offering at a reasonable 13 times sales. The $3.5 billion deal is set to be the biggest IPO in Hong Kong this year after an abrupt regulatory halt to the debut of Ant, the Alibaba payments affiliate, in November. As Chinese officials also scrutinise competitive practices of internet platforms, the healthcare sector underscores a symbiotic relationship.

The pandemic has boosted demand for digital, contactless medical services. JD Health International was China’s largest online retail pharmacy by revenue in 2019, according to its prospectus, and was the first to offer online appointments for Covid-19 nucleic acid tests. Daily online consultations leapt to nearly 90,000 in the first half of 2020, almost six times more than the same period last year. The company’s topline grew 33% year-on-year in 2019 and accelerated to 76% in the six months of 2020, roughly the same pace of its closest rival, $39 billion Alibaba Health Information Technology, in its interim period. The bulk of JD Health’s business is in direct sales of medicines and other products. Other services include an over-9,000-merchant-strong online marketplace and digital marketing.

Assume JD Health’s enterprise value reaches $28 billion at the high-end of the range, after subtracting some $486 million in cash and cash equivalents as of June. Its roughly $2.2 billion in revenue for trailing twelve months implies a sales multiple of nearly 13 times, below Alibaba Health’s 18 times and in line with Ping An Healthcare and Technology, which runs the Good Doctor app, per Refinitiv data. Alibaba Health has more annual active users and turned a net profit in the six months ended September, while JD Health was loss-making in the first half of this year.

It’s a smart area for JD.com and its peers to tap into: China’s National Development and Reform Commission supports the buildout of internet healthcare in a country where overcrowded hospitals and long wait times are a problem. Given the sensitive nature of the sector, there will perhaps also be less regulatory surprises than there have been of late in e-commerce and payments. Big traditional companies in China have long served official goals, and it helps internet companies to play the part too.

https://www.reuters.com/article/us-jd-hlth-intl-ipo-breakingviews/breakingviews-healthcare-ipo-examines-value-of-chinas-big-tech-idUSKBN28C097

Interpol warns COVID-19 vaccines could be targeted by criminals

 The Interpol global police co-ordination agency warned on Wednesday that organised criminal networks could be targeting COVID-19 vaccines, and could look to sell fake shots.

Interpol, which is headquartered in France, said it had issued a global alert to law enforcement across its 194 member countries, warning them to prepare for organised crime networks targeting COVID-19 vaccines, both physically and online.

“As governments are preparing to roll out vaccines, criminal organisations are planning to infiltrate or disrupt supply chains. Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures, which could pose a significant risk to their health, even their lives,” said Interpol secretary general Juergen Stock.

https://www.reuters.com/article/us-health-coronavirus-interpol/interpol-warns-that-covid-19-vaccines-could-be-targeted-by-criminals-idUSKBN28C166

UK first country to authorize Pfizer-BioNTech vaccine for emergency use

 

• Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have won permission for emergency use of their COVID-19 vaccine in Britain, with two doses three weeks apart required for protection. First in line are frontline health care workers and nursing home residents, followed by older adults.
• Calling the U.K. decision "a historic moment," Pfizer CEO Albert Bourla said, "we are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world."
• Other countries aren't far behind: The U.S. and the EU also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna (NASDAQ:MRNA), and a similar nod by the FDA is expected as early as next week.
• While the U.K. has ordered enough Pfizer vaccine for 20M people, it's unclear how many will arrive by year's end and adding to the distribution challenges is that it must be stored at ultra-cold temperatures.
• British regulators also are considering another shot made by AstraZeneca (NASDAQ:AZN) and Oxford University.
• The shots made by Pfizer and BioNTech have been tested in tens of thousands of people and early results suggest the vaccine is 95% effective at preventing COVID-19. The vaccine has also been tested in only a small number of children, none younger than 12, but there's no information on its effects in pregnant women.
• https://seekingalpha.com/news/3640670-u-k-becomes-first-country-to-authorize-pfizer-biontech-vaccine-for-emergency-use

Mexico set to sign Pfizer vaccine deal

 Mexico’s government was due to sign a contract on Wednesday with pharmaceutical company Pfizer for the delivery of its coronavirus vaccine, Deputy Health Minister Hugo Lopez-Gatell said on Tuesday.

Pfizer has submitted the details about its vaccine to Mexico’s health regulator, Cofepris, and the country’s foreign minister last month said the government expects the vaccine to reach Mexico in December.

Lopez-Gatell said the contract with Pfizer, which developed its vaccine with German partner BioNTech SE, is expected to be signed by Health Minister Jorge Alcocer, and the Finance Ministry was making plans to ensure Mexico sets aside enough money to pay for the Pfizer and other vaccines.

Mexico’s contract with Pfizer will include ways to minimize the challenges associated with its vaccine, which requires that it be transported and stored at -70 degrees Celsius (-94 F).

“The contract that will be signed tomorrow includes provisions for its distribution to be as close to the point of use so that the period of deep freezing is shortened, the distance to be covered is shortened,” Lopez-Gatell said.

He said Mexico’s military will help with the vaccination process.

https://www.reuters.com/article/us-health-coronavirus-mexico-tally-vacci/mexico-set-to-sign-pfizer-vaccine-deal-on-wednesday-idUSKBN28C08P

U.S. CDC to shorten COVID-19 quarantine to 10 days

 The U.S. Centers for Disease Control and Prevention will soon shorten the length of self-quarantine recommended after potential exposure to the coronavirus to 10 days, or 7 days with a negative test, a federal spokesperson said on Tuesday.

CDC currently recommends a 14-day quarantine in order to curb the transmission of the virus.

https://www.reuters.com/article/us-health-coronavirus-usa-cdc-quarantine/u-s-cdc-to-shorten-covid-19-quarantine-to-10-days-federal-spokesperson-idUSKBN28C05D