Thursday, September 20, 2018
FDA safety review a ‘signal of confidence’ in Acadia drug, says JMP Securities
JMP Securities analyst Jason Butler reiterated a Market Outperform rating and $27 price target on Acadia Pharmaceuticals after the FDA reaffirmed its confidence in Nuplazid safety profile following completion of a comprehensive safety review. Butler sees this as an “important signal of confidence in the drug’s safety profile” and sees this as a clearing event for the stock. He sees these catalysts driving the stock meaningfully higher in the coming months.
https://thefly.com/landingPageNews.php?id=2793419
John Hancock adds fitness tracking to all policies
One of the largest life insurance providers in North America will no longer offer policies that do not include digital fitness tracking.
John Hancock will now sell only "interactive" policies that collect health data through wearable devices such as a smartwatch.Policyholders can earn discounts and rewards such as gift cards for hitting exercise targets.
But critics said the announcement was "creepy" and "dystopian".
Insurance brand Vitality - an international partner of John Hancock - has popularised the idea of "interactive" health and life insurance by offering discounted devices such as the Apple Watch in connection with its policies.
John Hancock launched its first interactive policy in 2015 and will now apply the model across all of its policies.
Activity-tracking devices such as the Apple Watch and Fitbit can record how much exercise somebody is doing and can be used to log dietary choices.
But privacy advocates have warned that insurers could use tracking data to punish customers who fail to meet targets.
"Naturally the American dystopian surveillance state will combine insurance with fat-shaming. Welcome to hell," said Matt Stoller, a fellow at the Open Markets Institute.
John Hancock said customers would not have to log their activities to quality for coverage - but they would not benefit from the discounts if they chose not to.
The company told Reuters it was too early to say whether it was paying fewer claims because of the Vitality programme.
But it said the data it had collected so far suggested that Vitality policyholders lived between 13 and 21 years longer than the rest of the insured population.
https://www.bbc.com/news/technology-45590293
Aurora Cannabis planning US stock listing next month
The frenzy for pot stocks may expand in October as another Canadian company plans to be dual-listed.
Aurora Cannabis said it is planning to list its shares on a major U.S. stock exchange next month.
“Aurora is targeting the month of October to establish a U.S. listing,” a company spokesperson said in an email to CNBC Thursday.
The news was first reported by the Financial Post on Tuesday.
Aurora’s chief corporate officer Cam Battley told the media outlet a new listing will expand the potential investor base for the company to include U.S. institutional investors.
Aurora is currently listed on the Toronto Stock Exchange.
A U.S. dual listing for Aurora would follow Canadian marijuana company Tilray’s successful July IPO on the Nasdaq.
On Wednesday, shares of Tilray rose 38 percent after CEO Brendan Kennedy told CNBC’s Jim Cramer that global pharmaceutical companies must think about partnering with cannabis producers as a “hedge” against the space. Tilray’s stock is up more than 1,100 percent since its July IPO and nearly 500 percent over the past month through Wednesday.
Earlier this week, shares of Aurora rose due to speculation about a major beverage company partnership even though the pot company said there’s no agreement.
Corbus nets over 600 endocannabinoid compounds, plans to develop 1-2 per year
Corbus Pharmaceuticals Holdings has licensed worldwide rights to drug candidates from more than 600 compounds targeting the endocannabinoid system from Jenrin Discovery—which it says will fuel one to two new clinical programs in inflammatory and fibrotic diseases each year, starting in 2020.
Up first is CRB-4001—a CB1 inverse agonist aimed at multiple indications in liver, lung, heart and kidney fibrotic diseases, including NASH, pulmonary fibrosis and more—with plans for a phase 1 safety study in 2019, followed by an NIH-supported, phase 2 first-in-patient study.
The deal included a $250,000 upfront cash payment and up to $18.4 million in milestone payments for each compound developed, plus royalties. In return, Jenrin agreed to not research or develop any compounds intended to modulate any cannabinoid receptor for the next 10 years.
“Securing this extensive portfolio of endocannabinoid system-targeting compounds strongly complements our existing phase 3 lead drug lenabasum,” said Corbus CEO Yuval Cohen, Ph.D., describing Corbus’ CB2 agonist aimed at immune cells in rare inflammatory diseases.
“Our now expanded pipeline is built on robust underlying science based on the endocannabinoid system as a master regulator of inflammation and fibrosis in the body,” Cohen said. The system of neurotransmitters has been linked to the regulation of multiple physiological and cognitive processes.
CRB-4001 was developed in collaboration with the NIH, and was designed to avoid the psychological side effects seen in earlier generations of similar drugs, by making it unable to penetrate the blood-brain barrier. Other potential indications include primary biliary cholangitis, myocardial fibrosis following a heart attack and acute interstitial nephritis, among others.
To help shepherd CRB-4001 and the other compounds in the new endocannabinoid portfolio, Corbus brought on George Kunos, M.D., Ph.D., the scientific director of the NIH’s National Institute on Alcohol Abuse and Alcoholism, to serve on the company’s scientific advisory board as an uncompensated member.
Kunos led the work at the NIH to advance CRB-4001 to clinical testing, including studies in animal models of nonalcoholic fatty liver disease, Type 2 diabetes, diet-induced insulin resistance and Type 2 diabetic nephropathy. Corbus plans to provide more details on the clinical development path of CRB-4001 before the end of the year.
Lenabasum, meanwhile, is being studied in separate phase 3 trials of systemic sclerosis and dermatomyositis, as well as a large phase 2 study of pulmonary exacerbations in cystic fibrosis, funded in part by the Cystic Fibrosis Foundation. In addition, lenabasum, previously known as anabasum, is being evaluated in an NIH phase 2 study for the treatment of lupus.
Corbus estimates a potential annual market opportunity of between about $2 billion and over $5 billion, totaled for those first three indications, in addition to $2 billion to $3 billion in lupus alone.
One of the company’s main competitors could be a CB1-focused drug that Johnson & Johnson obtained last year from Bird Rock Bio, namacizumab, being studied in NASH, Cohen said in a conference call with investors.
“More and more big pharma companies are going to turn their attention to this completely untapped biological system,” Cohen said. “The advantages we have as Corbus—our vision, our nimbleness and now, our patent portfolio—put us ahead of the pack.”
Allergan pours $14.7M into first medical aesthetics center in China
Allergan’s ambition for its medical aesthetics business is to grow to about $8 billion in 2025 from $3.8 billion in 2017 sales, with a big chunk coming from Asia. To achieve that, the U.S. pharma will put a center in Chengdu, China, devoted to letting doctors and potential customers understand what medical aesthetics is all about.
Slated to open in early 2019, the Medical Aesthetics Innovation Center will cost Allergan $14.7 million and will serve as a training center for medical aesthetics practitioners, as well as an education and experience center for consumers.
China and emerging Asian markets in general represent a huge opportunity in Allergan’s eyes. And the company already has its plan for the market laid out.
The company’s international commercial chief, Marc Princen, recently dubbed Asia-Pacific, Middle East and Africa “mission critical” for Allergan to succeed. The reason? About 66% of the world’s middle class will be living there by 2030. These people will look for physical appearance improvements and have the money to pay for them.
According to Princen at the company’s Medical Aesthetics Day event last month, the region will grow to a $2 billion Allergan business by 2025, with a big push into China. The country itself is expected to contribute $1 billion at that time, up from about $180 million in 2017. How does Allergan plan to realize that?
First, it will work to grow sales of its base products, including Botox and Juvederm, and introduce all its new products to the country in the next five years.
Under influence from its neighbor South Korea, where medical aesthetics enjoys nationwide prominence, China’s medical aesthetics industry is expected to reach $13.6 billion in 2018, with an average growth rate of 22.7% from 2015 to 2020, according to a Deloitte report.
In China, Allergan plans to triple its medical aesthetics accounts from about 3,500 and will also help triple the number of trained injectors in the country from the current 5,000, with the new Chengdu center playing a big part in that.
For the new center, Allergan is channeling its resources and extensive clinical experience to improve the skills of an estimated 3,000 Chinese medical aesthetics professionals each year, therefore improving the experience for consumers.
“Allergan is dedicated to improving the diagnosis and treatment skills of Chinese medical aesthetics professionals, so that Allergan products can be better leveraged in serving consumers,” said the company in a release.
On the consumer front, Allergan just unveiled a partnership with China’s e-commerce giant Alibaba’s healthcare branch AliHealth. Hoping to take advantage of over 600 million people within Alibaba’s consumer network, the pair will launch a medical aesthetics platform to educate people and direct them to qualified providers and products.
To cope with the growth, Allergan’s own team also needs to be strengthened as the company plans to expand its sales force in China from 800 to over 1,400 by 2025, said Princen.
Tetraphase: EC grants marketing authorization for XERAVA
Tetraphase Pharmaceuticals announced that the European Commission has adopted the Decision granting marketing authorisation for XERAVA for injection for the treatment of complicated intra-abdominal infections in adults in the European Union. In clinical trials, XERAVA was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem. The European Commission approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use and allows Tetraphase to market XERAVA in all countries in the European Union as well as Iceland, Liechtenstein and Norway. The decision was based on a comprehensive data package which included data from the Company’s phase 3 clinical trials investigating XERAVA in patients with cIAI compared to ertapenem and meropenem. In the first trial, twice-daily intravenous XERAVA met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV ertapenem. In the second trial, twice-daily IV XERAVA met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV meropenem. In both trials, XERAVA was well-tolerated and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.
https://thefly.com/landingPageNews.php?id=2793341
FDA’s Gottlieb worried regular use of pot poses risks to teens
FDA Commissioner Scott Gottlieb says he is more worried about teen usage of marijuana than e-cigarettes, telling CNBC in an interview that he is concerned that more regular use of pot poses new risks. “I’m worried about the inhalation of a product and the risks associated with that. I’m worried about the perception that somehow there’s no risks associated with youth use of the product,” Gottlieb commented. Though he says previous studies have looked at the risks of occasional marijuana use,regular use is increasingly common as it’s legalized, and “I think that’s going to create a different set of risks.” Publicly traded companies in the space include Aurora Cannabis (ACBFF), CV Sciences (CVSI), Canopy Growth (CGC), Cronos Group (CRON) and Tilray (TLRY).
https://thefly.com/landingPageNews.php?id=2793353
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