Martha Stewart is getting into the marijuana business

Martha Stewart is moving from pots and pans to pot.

The housewares goddess announced Thursday that she’s partnering with marijuana grower Canopy Growth for a new line of CBD-based products for humans and animals.

“I am delighted to establish this partnership with Canopy Growth and share with them the knowledge I have gained after years of experience in the subject of living,” Stewart said in a statement.

“I’m especially looking forward to our first collaboration together, which will offer sensible products for people’s beloved pets.”

Canopy Growth Chairman and co-CEO Bruce Linton sang Stewart’s praises.

“As soon as you hear the name Martha, you know exactly who we’re talking about,” Linton said in a statement. “Martha is one of a kind and I am so excited to be able to work alongside this icon to sharpen our CBD product offerings across categories from human to animal.”

Stewart will also serve as an adviser for the company, which is one of Canada’s major producers.

In 2016, Snoop Dogg, who co-hosts “Martha & Snoop’s Potluck Dinner Party” with Stewart, partnered with Tweed, an Ontario-based subsidiary of Canopy Growth.

So far, the rapper and Tweed have launched three strands under his “Leafs by Snoop” brand: “Sunset,” “Ocean View” and “Palm Tree.”

https://www.marketscreener.com/CANOPY-GROWTH-CORP-16195087/news/Canopy-Growth-Martha-Stewart-is-getting-into-the-marijuana-business-28090095/

Allergan holder Chevedden backs Appaloosa plan to split CEO-chair roles

Appaloosa LP said on Thursday investor John Chevedden was backing the hedge fund’s proposal to split the roles of chairman and chief executive officer at Botox-maker Allergan Plc.

Chevedden, an activist investor who frequently files shareholder rights proposals, had withdrawn his own proposal for Allergan and would support Appaloosa’s, the hedge fund said, adding that this would eliminate unnecessary confusion.

“John Chevedden has worked tirelessly for many years to advance important corporate governance initiatives and we are gratified that he shares our view,” said Appaloosa President David Tepper.

Earlier this month, Tepper stepped up pressure on the botox maker to consider selling itself and splitting the top roles immediately, if management is unable to turn around recent lagging performance.

In response, the drugmaker said implementing Appaloosa’s recommendations would be “highly disruptive” to Allergan’s operations and on Thursday redirected Reuters to its earlier response when asked to comment.

Allergan’s shares, which fell 18.3 pct in 2018, have been lagging those of its peers on account of dropped plans to sell its women’s health unit, a disappointing revenue outlook for 2019 and increasing competition for many of its important drugs.

The company’s fourth-quarter sales fell 5.7 percent, while sales of its second-most important drug, Restasis, fell 17.7 percent.

https://www.marketscreener.com/ALLERGAN-PLC-22497284/news/Allergan-shareholder-Chevedden-backs-Appaloosa-s-proposal-to-split-CEO-chairman-role-28088419/

Marijuana well tolerated among elderly patients; nearly a third reduced opioids

Medical cannabis was well-tolerated among elderly patients and provided significant symptomatic benefits, a retrospective chart review showed.

Adults who were an average age of 81 experienced relief in chronic pain, sleep, neuropathy, and anxiety with medical cannabis, reported Laszlo Mechtler, MD, of Dent Neurologic Institute in Buffalo, New York, and colleagues, in an early-release abstract from the American Academy of Neurology meeting to be held here in May.

Moreover, 32% reduced their opioid pain medication, they added.

At first, about a third of patients experienced adverse effects — mostly sleepiness, balance problems, and gastrointestinal disturbances — but in 13% of patients, those problems resolved when dosages were adjusted.

Similar findings were seen last year in a study published in the European Journal of Internal Medicine, in which elderly patients reported significantly less pain with medical cannabis and more than 18% stopped or reduced opioid analgesics.

In the U.S., people age 65 and older are among the fastest-growing group of cannabis users. To date, 33 states and the District of Columbia have legalized medical marijuana. Ten states also have legalized recreational use, and that’s caused some experts to be concerned about older adults who may self-treat medical problems without guidance.

“Evidence is growing in support of some indications for medical cannabis — pain, for example — and that needs to be weighed against side effects to which older adults may be more vulnerable, like dizziness, somnolence, confusion, and dry mouth,” Joshua Briscoe, MD, of Duke University Medical Center, told MedPage Today. “Older adults should use caution when experimenting with medical cannabis on their own and share the details of such use with their physicians.”

In this study, Mechtler and colleagues analyzed charts of 204 patients from ages 75 to 102 years who used the New York state’s Medical Marijuana Program. They had an average age of 81 and were followed in a neurologic outpatient setting in Buffalo. Of the total sample, 129 were women and 75 were men.

Participants took various ratios of tetrahydrocannabinol (THC) to cannabidiol (CBD) by mouth as a liquid extract tincture, capsule, or in an electronic vaporizer, for an average of 16.8 weeks.

Initially, 34% of participants experienced adverse effects; after adjusting dosages, that figure dropped to 21%. The most common side effects were sleepiness (13%), balance problems (7%), and gastrointestinal disturbances (7%). Due to side effects, seven patients (3.4%) stopped using medical marijuana. The most common ratio of THC to CBD among people who reported no side effects was 1:1.

Overall, 69% of participants experienced symptom relief, largely improvements in pain (49%), sleep (18%), neuropathy (15%), and anxiety (10%).

“With legalization in many states, medical marijuana has become a popular treatment option among people with chronic diseases and disorders, yet there is limited research, especially in older people,” Mechtler said in a statement.

“Our findings are promising and can help fuel further research into medical marijuana as an additional option for this group of people who often have chronic conditions,” he added. “Future research should focus on symptoms like sleepiness and balance problems, as well as efficacy and optimal dosing.”

The study was supported by the Dent Family Foundation.

• Primary Source

  American Academy of Neurology

  Source Reference: Bargnes V, et al “Safety and efficacy of medical cannabis in elderly patients: a retrospective review in a neurological outpatient setting” AAN 2019.

https://www.medpagetoday.com/meetingcoverage/aan/78289

Acceleron treatment of Charcot-Marie-Tooth disease gets FDA orphan tag

In a post on the FDA’s website, Acceleron’s treatment of Charcot-Marie-Tooth disease, efmitermant alfa, received FDA orphan designation.
https://thefly.com/landingPageNews.php?id=2872741

Denali expands antibody discovery deal with AbCellera

Denali Therapeutics has expanded its antibody discovery deal with AbCellera. The agreement tasks AbCellera with generating panels of antibodies for up to eight targets picked by Denali.

AbCellera wrapped up the first phase of its collaboration with Denali last year. That collaboration saw AbCellera search immune responses for naturally derived antibodies with specific binding properties against a neurodegenerative disease target of interest to Denali.

With antibodies discovered by AbCellera now in Denali’s preclinical pipeline, the neurodegenerative disease specialist has firsthand experience of the merits of its partner’s platform and the antibodies it yields. That experience led to the new deal.

“We continue to be impressed with the speed of discovery, the quality and the diversity of the antibodies AbCellera delivers,” Denali COO Alexander Schuth said in a statement.

In expanding the agreement, Denali has secured a source of antibodies against up to eight targets. Denali is paying a technology access fee and funding research, while committing to milestones and royalties, to secure the expanded relationship with AbCellera.

The expansion of the deal comes weeks after AbCellera struck a 10-target deal with Novartis. Talking at the time, AbCellera CEO Carl Hansen framed the Novartis agreement as an inflection point for his antibody R&D shop. Having made its name through single-target deals with GlaxoSmithKline, Merck and Teva, Hansen saw Novartis as the start of AbCellera’s move into “extended access” agreements.

Landing the eight-target Denali deal adds weight to the view that AbCellera is at an inflection point. To support its growing workload, AbCellera moved into a 22,000-square-foot lab last year and plans to grow its headcount from 72 to around 100 by the end of 2019.

For Denali, the AbCellera deal provides it with a source of antibodies as it seeks to stock its pipeline with neurodegenerative disease prospects. Denali’s lead drugs are now in the clinic but it also has a clutch of early-stage programs coming down the pipe.

https://www.fiercebiotech.com/biotech/denali-expands-antibody-discovery-deal-abcellera

Bispecifics player Abpro teams with China’s NJCTTQ in deal worth up to $4B

Abpro is partnering with China-based NJCTTQ to develop new bispecific antibodies using its antibody discovery platform. Under the agreement, Abpro could collect up to $4 billion, which includes $60 million in “near-term R&D funding,” as well as milestone payments and royalties.

Abpro will hold on to the rights for any drugs approved outside of China and Thailand, and NJCTTQ will retain the rights in China, Abpro said in a statement. The pair will use Abpro’s DiversImmune technology, one of two platforms the Massachusetts-based company uses to develop drug candidates. The company was vague about the targets of the collaboration, saying only that they would develop bispecific antibodies, such as T-cell engagers, for immuno-oncology.

“This collaboration further validates our platform’s unique ability to develop best-in-class bispecific T-cell engagers, with significant potential to treat patients living with cancer,” said Ian Chan, Abpro’s co-founder and executive chairman, in the statement. “NJCTTQ has substantial clinical development and commercialization expertise that is highly complementary to our immuno-oncology development platforms as we focus on broadening our pipeline and expanding our ability to treat more patients globally.”

“We intend to pursue additional similar development collaborations that leverage our innovative technology platforms and programs that include commercial rights in key global markets,” Chan added.

This isn’t the first time Abpro has tied up with a Chinese company. In 2016, Abpro signed a $3.5 million deal with Chinese biotech Essex Bio to co-develop monoclonal antibodies. Essex Bio, which specializes in recombinant DNA technology, would retain commercial rights in China, while Abpro would hold them for the rest of the world.

Abpro filed to raise up to $86 million in an IPO last April, hoping the proceeds would fund clinical trials of its lead antibodies for cancer and vascular eye disease in 2019. However, a month later, it put off the IPO, delaying a capital infusion it hoped would support the first clinical trials of those programs.

https://www.fiercebiotech.com/biotech/bispecifics-player-abpro-teams-up-china-s-njcttq-biobucks-deal-worth-up-to-4b

Third Akorn sterile drug plant hit by FDA as new CEO lays out future blueprint

Akorn Pharmaceuticals, which had a $4.3 billion buyout by Fresenius tank last fall, just can’t seem to catch a break.

Just weeks after being hit with an FDA warning letter for its manufacturing operations in Illinois—problems that led to the death of the deal—Akorn today reported that it has received a citation on its third U.S. facility While the four observations were relatively minor, it was a downer on the same day the new CEO Douglas Boothe was telling the market Akorn is ready to move past its regulatory challenges and buyout debacle with Fresenius.

“Our recent financial results reflect the many challenges that have impacted our business of late, including increased competition for many of our generic and promoted products, supply issues, and regulatory and legal challenges,” Boothe said in a statement as the company reported fourth-quarter earnings. “Despite these significant headwinds, we have strong fundamentals to build upon … I look forward to providing updates in the coming months on our go-forward strategy and plan to rebuild value for all of our stakeholders.”

Akorn Thursday reported a 17.6% drop in revenues to $153.4 million for the fourth quarter, attributed in large part to supply shortfalls after the company halted manufacturing to deal with FDA concerns at its Decatur and Somerset, New Jersey  manufacturing facilities. It reported an adjusted net loss to of $0.29 per diluted share, double the loss of $0.14 per diluted share in the same quarter of 2017.

The new Form 483 for Akorn’s sterile drug manufacturing operation in Amityville, New York, was noted in an SEC 8K filing the drugmaker made Thursday. It lists four observations including for a record keeping misstep and failing to do stability testing on time.

It was minor compared to the issues outlined in a 22-page Form 483 for its Decatur, Illinois, plant which preceded a warning letter this year. In that the FDA raised questions about data integrity at the plant, repeat testing of failed batches and other issues that could lead to sterile drug contamination.

Boothe is working to move the company past the failing that doomed the deal with Fresenius. He said in his two months with Akorn, the company has made structural and organizational changes to “emphasize compliance, transparency, and accountability,” at its three U.S. manufacturing facilities. On top of that,  Akorn has decided to “explore strategic alternatives” to divest its India manufacturing facility, the CEO said.

Germany’s Fresenius struck its $4.3 billion buyout offer in 2017, touting the acquisition as a “strategically complementary combination” that would diversify its portfolio and expand its Fresenius Kabi sterile manufacturing capacity. But the deal fell apart last year after Fresenius got tipped off that Akorn violated FDA drug-development standards.

Akorn sued to try to force the deal on Fresenius, but a Delaware judge ruled that the German company was legally entitled to dump the deal. Days later, then-Akorn CEO Raj Rai stepped down.

https://www.fiercepharma.com/manufacturing/a-third-akorn-sterile-drug-plant-spanked-by-fda-as-new-ceo-lays-blueprint-for-a