Takeda to divest certain Latin American assets for $825M

Continuing its plan to divest ~$10B in non-core assets aimed at reducing its leverage, Takeda Pharmaceutical Company (TAK +1.5%) has agreed to sell a portfolio of over-the-counter and prescription products sold in Latin America to Brazil’s Hypera S.A. for $825M.

The line-up of ~18 medicines generated ~$215M in sales in fiscal 2018.

The transaction, the company’s fifth divestment over the past 12 months, should close in H2.

https://seekingalpha.com/news/3547523-takeda-to-divest-certain-latin-american-assets-for-825m

VBI Vaccines commences mid-stage study of therapeutic cancer vaccine

The first patient has been dosed in a Phase 2a clinical trial evaluating VBI Vaccines’ (VBIV +8.3%) VBI-1901, a therapeutic cancer vaccine candidate, in patients with first-recurrent glioblastoma multiforme, the most aggressive type of brain cancer.

Participants will receive VBI-1901 in combination with GlaxoSmithKline’s (GSK +3.2%) immunomodulatory adjuvant system AS01_B or a granulocyte-macrophage colony-stimulating factor (GM-CSF).

The estimated primary completion date is October.

https://seekingalpha.com/news/3547530-vbi-vaccines-commences-mid-stage-study-of-therapeutic-cancer-vaccine

FDA OKs ANI Pharma dementia med

The FDA approves ANI Pharmaceuticals’ (ANIP -5.1%) Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg, a generic version of Teva Pharmaceutical Industries’ (TEVA) Namenda XR, approved in the U.S. in June 2010 for Alzheimer’s disease-related dementia (Forest Laboratories).

Per IQVIA, the U.S. market is ~$127M.

https://seekingalpha.com/news/3547533-fda-oks-ani-pharma-dementia-med

Trump presses U.S. Federal Reserve to cut rates

U.S. President Donald Trump on Monday reiterated his call for the U.S. central bank to lower interest rates, tweeting that the Federal Reserve has been “slow to act” and should be more aggressive.
Trump’s comments did not mention the ongoing coronavirus outbreak but come as investors continued to fret following last week’s global market slide amid the outbreak and looked toward a possible global interest rate cut.
https://www.reuters.com/article/us-usa-trump-fed/trump-presses-u-s-federal-reserve-to-cut-rates-idUSKBN20P2AB

COVID-19 detected in saliva of infected patients

Traces of COVID-19 was detected in the saliva of 11 of 12 patients infected with the virus, suggesting that saliva may be a “promising, noninvasive specimen” for the diagnosis, monitoring and infection control of the virus, according to a study published in Clinical Infectious Diseases.
“Saliva specimens can be provided easily by asking patients to spit into a sterile bottle. Since no invasive procedures are required, the collection of saliva can greatly minimize the chance of exposing healthcare workers to 2019-nCoV,” Kelvin Kai-Wang To, clinical associate professor at the University of Hong Kong’s department of microbiology, and colleagues wrote. “We have tested 2019-nCoV in saliva from patients with suspected 2019-nCoV infection based on clinical and epidemiological criteria as outlined by the Centre for Health Protection of Hong Kong. Here, we report the results of the saliva testing.”
To and colleagues collected saliva a median of 2 days (range, 0-7 days) after hospitalization from 12 patients in Hong Kong with lab-confirmed COVID-19. Samples were collected by asking patients to cough out saliva from their throat into a sterile container, with 2 mL of a viral transport medium added to the sample. They conducted a viral culture of each sample. Virus-induced cytopathic effects were then studied daily for up to 7 days.
Patients examined were aged from 37 to 75 years, with a median age of 62.5 years. There were five female and seven male patients.

Traces of COVID-19 was detected in the saliva of 11 of 12 patients infected with the virus, suggesting that saliva may be a “promising, noninvasive specimen” for the diagnosis, monitoring and infection control of the virus.

COVID-19 was detected in the saliva of 11 of 12 (91.7%) of the patients, and viral loads were highest in the earliest specimens for five (83.3%) of the patients.
“The presence of 2019-nCoV in patients’ saliva suggests the possibility of salivary gland infection,” the researchers wrote. “However, it should be noted that saliva specimens not only contain saliva secreted from major or minor salivary glands but also contain secretions coming down from the nasopharynx or coming up from the lung via the action of cilia lining the airway. Further studies are required to delineate the sources of 2019-nCoV in saliva.” – by Eamon Dreisbach
Disclosures: The authors report no relevant financial disclosures.
https://www.healio.com/infectious-disease/emerging-diseases/news/online/%7B7d347043-f342-474f-8cd6-60ecf6372c13%7D/covid-19-detected-in-saliva-of-infected-patients

Pfizer, Eli Lilly: FDA Accepts Regulatory Submission for Tanezumab

Pfizer Inc. and Eli Lilly & Co. on Monday said the U.S. Food and Drug Administration accepted their biologics license application for their non-opioid pain drug tanezumab.
The drug makers said the application covers 2.5-milligram doses of tanezumab administered subcutaneously for patients with chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics.
Pfizer and Eli Lilly said the FDA set a target action date for December, and that the agency plans to hold an advisory committee meeting to discuss the application.
Pfizer and Lilly in 2013 formed a worldwide collaboration to develop and commercialize tanezumab, part of an investigational class of non-opioid chronic pain medications known as nerve growth factor inhibitors.

https://www.marketscreener.com/ELI-LILLY-AND-COMPANY-13401/news/Pfizer-Eli-Lilly-FDA-Accepts-Regulatory-Submission-for-Tanezumab-30092823/

ECB Ready to Cut Rates, Purchase Assets to Offset Epidemic

A senior European Central Bank official signaled Monday that the bank was prepared to cut interest rates or buy assets to support the eurozone economy against the impact of the coronavirus, a shift in tone that suggests mounting concern in Frankfurt over the widening economic fallout.
Speaking in London, ECB Vice President Luis de Guindos warned that the spread of the virus could hurt the eurozone’s exports to China, a major overseas market, while disrupting businesses’ supply chains and curbing demand for services in Europe.
“We remain vigilant and will closely monitor all incoming data. The Governing Council stands ready to adjust all its instruments, as appropriate, to ensure that inflation moves towards its aim in a sustained manner,” Mr. de Guindos said.
Investors are watching closely for how the ECB will respond to an infection that is spreading rapidly through a region already buffeted by trade wars, geopolitical tensions and messy negotiations around Brexit. Stock market indexes in Italy and Germany, two of the nations most affected, have fallen around 15% over the past two weeks, with Italy’s blue-chip index trading more than 3% lower on Monday.
Mr. de Guindos’s comments echo Federal Reserve Chairman Jerome Powell, who signaled on Friday that the U.S. central bank was prepared to cut interest rates to cushion the economy against the effects of the virus.
Unlike the Fed, the ECB has little room to cut interest rates because its key rate is already below zero, at minus 0.5%. The ECB also restarted a controversial bond-buying program in September in an effort to stimulate the region’s weak economy.
The euro jumped against the dollar in recent days, partly reflecting diminishing expectations that the ECB will follow the Federal Reserve in cutting interest rates, analysts said.
Jens Weidmann, the head of Germany’s conservative central bank, cautioned Friday against any immediate policy move by the ECB, even as he warned that Germany’s economy would be hurt by the spread of the virus.

https://www.marketscreener.com/EURO-BRITISH-POUND-EUR-4593/news/ECB-Ready-to-Cut-Rates-Purchase-Assets-to-Offset-Epidemic-Suggests-Official-Update-30094012/