Takeda Pharmaceutical Co Ltd has agreed to sell a portfolio of
over-the-counter and prescription drugs marketed in the Asia Pacific
region to South Korea’s Celltrion Inc for $278 million, it said on
Thursday
Takeda, Japan’s biggest drugmaker, will get $266 million upfront in
cash and up to an additional $12 million in potential milestone
payments, the company said.
The portfolio to be sold to Celltrion includes OTC and pharmaceutical
products marketed mainly in Australia, Hong Kong, South Korea, and
elsewhere in Asia, it said.
Takeda will continue to manufacture the products and supply them to Celltrion.
The Japanese company pledged to dispose of $10 billion in non-core
assets following its $59 billion purchase of Shire Plc completed last
year, which left it saddled with debt.
Prior to Thursday’s announcement it had divested $7.7 billion in
non-core assets so far, with the latest deal being the sale of OTC and
prescription products to Denmark-based Orifarm Group for about $670
million.
Nikkei Business reported last month that Takeda is looking to sell
its Japanese OTC business for around 400 billion yen ($3.72 billion).
After Takeda reported full-year earnings on May 13, Chief Executive Christophe Weber said “we are not an OTC company.”
https://www.marketscreener.com/CELLTRION-INC-40742914/news/Japan-s-Takeda-to-sell-some-Asia-focused-drugs-to-Celltrion-for-278-million-30756542/
Thursday, June 11, 2020
U.S. cannot shut down economy again, Treasury’s Mnuchin says
The United States cannot let the coronavirus shut down its economy
again, U.S. Treasury Secretary Steven Mnuchin said on Thursday, adding
that more than $1 trillion in rescue funds will flow into the economy
over the next month.
Mnuchin, speaking on CNBC television, said he was prepared to go back to Congress for more money to support the economy, but additional funds would be targeted to sectors with the most need, including hotels, restaurants, travel and entertainment firms.
The Treasury chief, who has been the Trump administration’s point man for negotiating rescue programs, said that he was confident that COVID-19 infection spikes in certain areas could be dealt with due to improvements in testing, contact tracing and ample hospital capacity.
“We can’t shut down the economy again. I think we’ve learned that if you shut down the economy, you’re going to create more damage and not just economic damage,” he said, adding that this includes other problems.
Mnuchin said of the $3 trillion in coronavirus rescue spending approved by Congress this year, only about $1.6 trillion has filtered through the economy so far.
“Over the next month, you’re going to see over another $1 trillion pumped into the economy, that’s going to have a big impact,” Mnuchin said. The Federal Reserve’s Main Street Lending program for mid-size businesses is just getting started and “we’re prepared to go back to Congress for more money to support the American worker,” he added.
Asked if he was considering more aid to states, Mnuchin said that would be subject to negotiations with Congress.
Mnuchin added that due to an extension of forgivable Paycheck Protection Program loans to 24 weeks, he expects many restaurants that had previously been reluctant to seek loans will come forward to take up a significant portion of the program’s remaining funds.
https://www.marketscreener.com/news/U-S-cannot-shut-down-economy-again-Treasury-s-Mnuchin-says–30757775/?countview=0
Mnuchin, speaking on CNBC television, said he was prepared to go back to Congress for more money to support the economy, but additional funds would be targeted to sectors with the most need, including hotels, restaurants, travel and entertainment firms.
The Treasury chief, who has been the Trump administration’s point man for negotiating rescue programs, said that he was confident that COVID-19 infection spikes in certain areas could be dealt with due to improvements in testing, contact tracing and ample hospital capacity.
“We can’t shut down the economy again. I think we’ve learned that if you shut down the economy, you’re going to create more damage and not just economic damage,” he said, adding that this includes other problems.
Mnuchin said of the $3 trillion in coronavirus rescue spending approved by Congress this year, only about $1.6 trillion has filtered through the economy so far.
“Over the next month, you’re going to see over another $1 trillion pumped into the economy, that’s going to have a big impact,” Mnuchin said. The Federal Reserve’s Main Street Lending program for mid-size businesses is just getting started and “we’re prepared to go back to Congress for more money to support the American worker,” he added.
Asked if he was considering more aid to states, Mnuchin said that would be subject to negotiations with Congress.
Mnuchin added that due to an extension of forgivable Paycheck Protection Program loans to 24 weeks, he expects many restaurants that had previously been reluctant to seek loans will come forward to take up a significant portion of the program’s remaining funds.
https://www.marketscreener.com/news/U-S-cannot-shut-down-economy-again-Treasury-s-Mnuchin-says–30757775/?countview=0
Myriad Genetics tumbles on continued COVID-19 pressures
Myriad Genetics (MYGN -13.0%)
is down on double volume, the largest price plunge since early
February, as COVID-19 disruptions continue to pressure test volumes,
pricing and reimbursement.
Bloomberg Intelligence’s Jonathan Palmer believes
that volumes in its flagship hereditary cancer business could drop 70 –
75% in fiscal Q4 due to slack demand for elective testing, adding that
it appears doubtful that its GeneSight depression test will live up to
expectations and the integration of its prenatal testing unit has been
“challenging.”
https://seekingalpha.com/news/3582361-myriad-genetics-tumbles-on-continued-covidminus-19-pressures
Hospital operators lead healthcare losers on COVID-19 doubts
Hospital groups are solidly in the red, leading
the selloff in the healthcare sector, on concerns about reopening shifts
amid more reports of rising COVID-19-related hospitalizations.
Selected tickers: Universal Health Services (UHS -6.6%), Surgery Partners (SGRY -15.2%), SunLink Health Systems (SSY -1.3%), Select Medical Holdings (SEM -9.0%), Tenet Healthcare (THC -8.5%), Community Health Systems (CYH -3.5%), HCA Healthcare (HCA -5.9%), Humana (HUM -3.1%), iShares U.S. Healthcare Providers ETF (IHF -3.7%)
https://seekingalpha.com/news/3582357-hospital-operators-lead-healthcare-losers-on-covidminus-19-doubts
Novo Nordisk acquires AstraZeneca spinoff for as much as $2.1B
Novo Nordisk (NVO -0.6%) has acquired Corvidia Therapeutics, a developer of therapies for cardio-renal diseases spun off from AstraZeneca (AZN -2.0%), from venture capital shop Sofinnova Partners for as much as $2.100B.
The deal includes an upfront payment of $725M plus up to $1.375B in milestones.
Corvidia’s lead candidate is IL-6 inhibitor ziltivekimab for
reducing the risk of major adverse cardiovascular events (MACE) in
patients with chronic kidney disease who have atherosclerotic
cardiovascular disease and inflammation.
Sofinnova was the company’s sole seed investor in 2015 and has remained the largest shareholder to date.
The transaction will not impact NVO’s 2020 earnings guidance nor its share buyback program.
https://seekingalpha.com/news/3582352-novo-nordisk-acquires-astrazeneca-spinoff-for-much-2_1bMost Early COVID-19 Clinical Trials Poorly Designed
An analysis of clinical trials of potential treatments for COVID-19
suggests that most clinical trials registered between January and March
this year have significant design flaws that will limit their long-term
usefulness.
Of 201 trials registered with ClinicalTrials.gov or the WHO international trial registry before 26 March this year, a third exclude clinical endpoints, almost half were designed to recruit 100 patients or less and more than 70% were open label.
“Because of these weaknesses, many of these studies are likely to yield only preliminary evidence,” commented Hemalkumar Mehta, PhD, an assistant professor at Johns Hopkins University Bloomberg School of Public Health and lead author of the study, which was published in the journal BMJ Open.
“Given the urgency of identifying definitive evidence on potential COVID-19 treatments, this is an instance where we wish we did not have to say ‘further research is needed’ because of basic trial design shortcomings and small trials.”
Mehta and co-authors acknowledge the exceptional circumstances of the pandemic and the need for fast answers to the scientific problems it poses, but highlight that small, open-label trials without clearly defined endpoints only have limited statistical use and are subject to bias.
Instead, they advocate the use of randomized study designs for better accuracy and long-term benefit to patients, although they recognize that these trials are often more expensive and require strong scientific leadership to be successful.
“We understand the urgency of clinical research on COVID-19, but this is a time when we need rigorous science to inform policy and clinical decision-making,” explained co-author and G. Caleb Alexander, MD, a professor at the Bloomberg School of Public Health.
“Any treatment that is ultimately deemed safe and effective via robust trials could potentially be used by millions of people.”
Overall, the analysis showed that of the 201 trials, 87.6% were based in China (49.8%) or in the USA (37.8%). A total of 92 drugs and antibody-rich plasma were being tested in the trials, although most of the drugs were already approved for treatment of diseases or health problems other than COVID-19 such as infection with other viruses, malaria, autoimmune diseases or cancer. Only eight products or combinations of products were new.
Although randomized trials were more common than non-randomized trials, with 152 having some form of randomization, the majority of the trials in this group were open label with only 55 trials including at least single blinding to help minimize investigator bias.
Most of the trials analyzed in this study were registered in February and March, with registrations rising rapidly between early March and 26 March. Notably, as of the beginning of June, the number of COVID-19 related trials on these registries has risen to more than 2000.
“This study provides early evidence of the benefits of global registries to characterize urgent clinical trial research questions now under investigation,” conclude the authors. “Used wisely by active researchers, these registries can help to identify the most promising avenues for developing new therapies, avoid unnecessary duplication and define unanswered questions that inevitably arise from early research.”
Of 201 trials registered with ClinicalTrials.gov or the WHO international trial registry before 26 March this year, a third exclude clinical endpoints, almost half were designed to recruit 100 patients or less and more than 70% were open label.
“Because of these weaknesses, many of these studies are likely to yield only preliminary evidence,” commented Hemalkumar Mehta, PhD, an assistant professor at Johns Hopkins University Bloomberg School of Public Health and lead author of the study, which was published in the journal BMJ Open.
“Given the urgency of identifying definitive evidence on potential COVID-19 treatments, this is an instance where we wish we did not have to say ‘further research is needed’ because of basic trial design shortcomings and small trials.”
Mehta and co-authors acknowledge the exceptional circumstances of the pandemic and the need for fast answers to the scientific problems it poses, but highlight that small, open-label trials without clearly defined endpoints only have limited statistical use and are subject to bias.
Instead, they advocate the use of randomized study designs for better accuracy and long-term benefit to patients, although they recognize that these trials are often more expensive and require strong scientific leadership to be successful.
“We understand the urgency of clinical research on COVID-19, but this is a time when we need rigorous science to inform policy and clinical decision-making,” explained co-author and G. Caleb Alexander, MD, a professor at the Bloomberg School of Public Health.
“Any treatment that is ultimately deemed safe and effective via robust trials could potentially be used by millions of people.”
Overall, the analysis showed that of the 201 trials, 87.6% were based in China (49.8%) or in the USA (37.8%). A total of 92 drugs and antibody-rich plasma were being tested in the trials, although most of the drugs were already approved for treatment of diseases or health problems other than COVID-19 such as infection with other viruses, malaria, autoimmune diseases or cancer. Only eight products or combinations of products were new.
Although randomized trials were more common than non-randomized trials, with 152 having some form of randomization, the majority of the trials in this group were open label with only 55 trials including at least single blinding to help minimize investigator bias.
Most of the trials analyzed in this study were registered in February and March, with registrations rising rapidly between early March and 26 March. Notably, as of the beginning of June, the number of COVID-19 related trials on these registries has risen to more than 2000.
“This study provides early evidence of the benefits of global registries to characterize urgent clinical trial research questions now under investigation,” conclude the authors. “Used wisely by active researchers, these registries can help to identify the most promising avenues for developing new therapies, avoid unnecessary duplication and define unanswered questions that inevitably arise from early research.”
Most Early COVID-19 Clinical Trials Poorly Designed
Lantern Pharma prices IPO at $15
Lantern Pharma (LTRN) has priced its IPO of 1.75M common shares at $15.00/share, for gross proceeds of $26.25M.
Underwriters’ over-allotment is an additional 262,500 shares.
Trading kicks off today.
Closing date is June 15.
https://seekingalpha.com/news/3582158-lantern-pharma-prices-ipo-15
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