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Monday, September 17, 2018

ChromaDex to Partner on Aging Research with Jiangxi Government in China


ChromaDex Corp.(NASDAQ:CDXC), an integrated, science-based, nutraceutical company devoted to improving the way people age with its flagship ingredient NIAGEN® and consumer product TRU NIAGEN®, today announced a strategic partnership for healthy aging research with the Jiangxi Provincial Government, People’s Republic of China.
Wu Zhongqiong, Vice Governor of the People’s Government of Jiangxi Province, commenced the ceremony at the Jiangxi Qianhu State Guesthouse on Thurs., Sept. 13. Additional presentations followed from Madame Wang of Qifeng Food Technology, Dr. Katherine Lo of the Li Ka Shing Foundation, Robert Fried of ChromaDex, and Drs. Charles Brenner and Roger Kornberg of the ChromaDex Scientific Advisory Board.
“We are grateful to have met with the leaders of the great province of Jiangxi and look forward to furthering this relationship,” says ChromaDex CEO Rob Fried. “This is an important first step in our long-term commitment to China.”
“This is a momentous occasion here in Jiangxi,” says Kornberg, who won the Nobel Prize in Chemistry in 2006. “I look forward to the research and progress in the study of aging that will come from this new initiative.”
“I’m thrilled to present the foundational science of nicotinamide riboside (NR) and the safe, evidence-based commercialization of our ingredient to Nanchang and Jiangxi Province,” says Brenner. “The global interest in our technology is exciting, and I look forward to advancing our research and development even further.” Brenner discovered NR and is the Chief Scientific Advisor at ChromaDex.
The initiative will allow Jiangxi to become a foothold for advanced scientific research and business development to solve the problem of aging. The parties continue to discuss the details of the relationship, including their respective contributions to the venture, with the anticipation of finalizing definitive agreements later this year.
In addition to the anti-aging initiative, the ceremony also celebrated the launch of the Food Technology Science Park, in collaboration with Qifeng Food Technology Co. of Beijing, to build a world-class, tech-centric science research complex in Jiangxi.

DOJ Closes Investigation of Sinovac


Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the U.S. Department of Justice (“DOJ”) has closed its investigation, with no charges, into possible violations of the Foreign Corrupt Practices Act related to allegations that certain Sinovac employees made improper payments to Chinese government officials. The closing of the DOJ investigation follows the SEC’s termination of its related investigation, which the Company announced on August 20, 2018.  With the closure of the DOJ’s investigation, the Company is not aware of any pending U.S. government investigations of the Company related to these matters. Sinovac is committed to conducting business in compliance with all applicable laws and cooperated fully with the DOJ. Sinovac will continue in its mission of researching, developing, manufacturing and commercializing vaccines that protect against human infectious diseases.

Array publishes Phase 3 data on melanoma combo


Array BioPharma Inc. (NASDAQ: ARRY) today announced the publication of detailed overall survival (OS) results from the COLUMBUS trial in The Lancet Oncology.
The pivotal Phase 3 trial evaluated the efficacy and safety of the combination of BRAFTOVI+ MEKTOVIcompared to vemurafenib monotherapy in patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation. BRAFTOVI + MEKTOVI reduced the risk of death compared to treatment with vemurafenib [hazard ratio (HR) of 0.61, (95% CI 0.47-0.79, p

Regeneron: FDA to Review EYLEA for Treatment of Diabetic Retinopathy


Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA(aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes.
The target action date for the FDA decision is May 13, 2019.
The sBLA submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). Positive six-month topline results from PANORAMA were announced in March 2018. One-year results from PANORAMA are expected to be shared later this year.
The safety and efficacy of the potential use of EYLEA in DR without DME has not been fully evaluated by any regulatory authority.
EYLEA is administered as a 2 mg intravitreal injection and currently indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, DME, and DR in patients with DME.

Longtime Tobacco Supplier Sees the Future in Cannabis


For a 145-year-old tobacco supplier, the future is in cannabis.
As Canada prepares to legalize marijuana next month, and regulations continue to loosen in the U.S. and other markets, Alliance One International Inc. is the latest company pivoting to pot.
With a valuation just north of $215 million, the North Carolina-based company is banking on the Canadian market to drive growth as tobacco cigarette smoking rates stagnate around the globe. The move comes as investors are pouring billions of dollars into the burgeoning industry, catapulting the value of cannabis stocks.
“Cannabis has been on our mind for some time,” Chief Executive Officer Pieter Sikkel said in an interview. “We could see that consumer tastes are changing.”
As part of its shift, Alliance is changing its name to Pyxus International Inc. as of Wednesday. The company historically has purchased, processed, packaged and shipped tobacco to cigarette manufacturers. It posted sales of $1.85 billion in its most recent fiscal year, returning to growth after three straight years of declines. It carries more than $900 million in debt.
As smoking rates decline, Alliance has been expanding into the market for tobacco vape products. And it now has stakes in two Canadian cannabis companies, in Ontario and on Prince Edward Island. Marijuana will be legal for recreational use by adults in Canada next month.

Constellation Move

Pot stocks have been on a tear since Constellation Brands Inc., the maker of Robert Mondavi wine and U.S. distributor of Modelo beer, announced it was boosting its stake in the Canadian company Canopy Growth, making a $3.8 billion investment. Alliance saw the power of cannabis to juice stock prices firsthand in February when its shares surged after it said it was entering the Canadian market. The stock has more than doubled over the past year.
The shares jumped 36 percent on Tuesday as the company prepared to update investors on its cannabis strategy. In addition to its new name, it changed its stock symbol to PYX.
While a handful of U.S. states allow recreational use, marijuana remains illegal on a federal level and the prohibition has kept many banks, big companies and institutional investors on the sidelines.
So far, the large tobacco companies have mostly stayed away. Universal Corp., an Alliance competitor, saw its shares fall last month when it stopped short of mentioning marijuana during an earnings call. Altria Group Inc., the tobacco giant that makes Marlboro for the U.S. market, said last week that while it intends to “continue to comply with federal law,” it was exploring options and was “mindful of the possibility that in the future cannabis may no longer be illegal under federal law.”
For tobacco companies, a move into cannabis might not be a slam dunk, according to Ken Shea, an analyst at Bloomberg Intelligence. Just as cigarette smokers are moving to non-combustible products like vape pens, cannabis users have embraced edibles and other forms of ingestion beyond smoking, he said. And the market for those products is very competitive, without the barriers to entry that have long boosted existing tobacco companies.
“The opportunity was obvious 20 years ago — you roll up cannabis in a joint and smoke it,” he said. “But smoking probably won’t be the main way people ingest cannabis. It’s declining for the same reason smokers are moving away from combustible devices.”

Bayer shopping 60% stake in Currenta to bidders


Bayer (BAYRY) has hired Morgan Stanley (MS) to shop its 60% stake in Currenta, which operates infrastructure facilities at German chemical complexes, according to Reuters, citing three people familiar with the matter. Currenta could be valued at more than $1.17B or possibly more, one of the sources said, according to Reuters
https://thefly.com/landingPageNews.php?id=2791403

Tandem Diabetes dip attributed to secondary lock-up expiration


Shares of Tandem Diabetes Care are trading lower, which is being attributed to the expiration of a lock-up related to a secondary offering of stock the company announced in August. On August 2, Tandem Diabetes announced a 3.51M share secondary offering of stock that priced at $28.50 per share and raised $100M. Today is the first day some shareholders and company insiders get to sell their shares in the healthcare safety device maker related to that secondary offering, according to Bloomberg data. In morning trading, Tandem dropped $6.54, or 13.7%, to $41.09 per share.