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.”

https://www.fiercebiotech.com/biotech/corbus-nets-over-600-endocannabinoid-related-compounds-planning-to-develop-1-2-per-year

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.

https://www.fiercepharma.com/marketing/eyeing-asia-for-growth-allergan-pours-14-7m-first-medical-aesthetics-center-china

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

Minerva continues rally

Thinly traded Minerva Neurosciences (NERV +8.6%) is up on almost double normal volume. Shares have more than doubled since early March.

Investors appear to be taking positions expecting good news from its ongoing Phase 3 clinical trial evaluating lead drug roluperidone (MN-101) in adults with negative symptoms of schizophrenia. Topline data should be available in H1 2019. According to ClinicalTrials.gov, the estimated primary completion date is December 2019.

Four months ago, data showing cognitive improvements in schizophrenia patients treated with roluperidone were published in a leading psychiatry journal.

Also due in H1 2019 will be topline data from its Phase 2b study of MN-117 in major depressive disorder.

Previously: Minerva Neurosciences’ roluperidone shows treatment effect in schizophrenia patients; shares ahead 13% premarket (May 17)

https://seekingalpha.com/news/3391825-minerva-continues-rally-9-percent

AVROBIO builds on successful IPO

Relatively recent IPO AVROBIO (AVRO +8.6%) has been a star performer since its debut on June 21. Shares are up over 150% from its $19 offer price and up 65% from its opening print of $29.50.

The gene therapy developer’s pipeline includes candidates for Fabry disease, Gaucher, Pompe and cystinosis.

https://seekingalpha.com/news/3391859-avrobio-builds-successful-ipo-9-percent

Canopy Growth Congratulates Canopy Rivers (TSXV:RIV) on Exchange Listing

Canopy Growth Corporation (TSX: WEED) (NYSE: CGC) (“Canopy Growth“) wishes to congratulate the entire team at Canopy Rivers Inc. as they take a leap forward and commence trading today on the TSX Venture Exchange as under the ticker symbol, “RIV”.

Canopy Rivers was founded to diversify Canopy Growth’s cannabis supply streams and quickly evolved into a global strategic growth platform that builds value in its partners by supporting every aspect of a cannabis venture, from licensing and genetics to financial and strategic support leveraging its close relationship with Canopy Growth.

To date, Canopy Rivers has a diverse portfolio of strategic investments including licensed cannabis producers, applicants, an innovative media platform, and a leading European hemp cultivator. This diverse portfolio will expand as new opportunities emerge in the global cannabis industry.

“Canopy Rivers presents a world of opportunity for its partners and for Canopy Growth. It’s the type of relationship that allows us to continue to grow our lead in this incredibly dynamic industry, and we at Canopy Growth couldn’t be more excited for Canopy Rivers to be taking this transformative step into the public markets,” said Bruce Linton, Chairman and co-CEO, Canopy Growth and Acting CEO, Canopy Rivers. “Whether it’s access to new brands, new technologies, differentiated products, first rights to future financing opportunities, and even rights to future full acquisition, Rivers will build value for shareholders, including Canopy Growth by building value for its portfolio partners.”

Canopy Rivers’ management team and Board of Directors bring decades of diverse collective experience in finance, regulated cannabis, retail, media, technology, and more. To learn more about Canopy Rivers and their mission, visit www.canopyrivers.com.

https://www.biospace.com/article/releases/canopy-growth-congratulates-canopy-rivers-tsxv-riv-for-its-listing-on-the-tsx-venture-exchange/