Cancer Prevention Pharma And Mallinckrodt Complete Licensing Deal

Cancer Prevention Pharmaceuticals, Inc., a private biotech company developing novel therapeutics to prevent cancer and other diseases, has signed a license agreement with Mallinckrodt Pharmaceuticals, through its Sucampo AG subsidiary, granting Mallinckrodt exclusive North American commercialization rights to Cancer Prevention’s lead drug candidate, CPP-1X/sul.

In April 2018, U.K.-based Mallinckrodt had exercised its option to the license agreement, and paid Cancer Prevention $10 million to support the pivotal Phase 3 clinical trial of CPP-1X/sul in patients with the orphan disease familial adenomatous polyposis (FAP).

Results from the FAP Phase 3 clinical trial are expected in the first half of 2019. FAP is a genetic disease that typically develops into colon cancer. There are no approved pharmaceutical treatments and no other drugs in late-stage clinical development.

Under the terms of the license agreement, Mallinckrodt paid Cancer Prevention a $5 million license fee. In addition, following commercialization of the product, Cancer Prevention and Mallinckrodt will share profits equally on all North American sales of the drug.

Cancer Prevention also is eligible to receive up to an aggregate of $185 million from Mallinckrodt, dependent upon achievement of other clinical development and sales milestones, subject to a reduction of up to $15 million related to amounts provided by the company in advance of entering into this agreement. Each party will be reimbursed for its R&D expenses from future product profits.

Cancer Prevention maintains all global rights to CPP-1X/sul outside North America.

In connection with the transaction, Cancer Prevention signed a service agreement with Mallinckrodt to assist with completing the FAP Phase 3 pivotal trial and certain activities supporting the preparation, filing and review of the NDA in the United States. Cancer Prevention expects to be compensated for the services with additional R&D payments of up to approximately $10 million.

The current standard of care for FAP requires patients to undergo the progressive removal of the colon and rectum, ongoing endoscopies of the gastrointestinal tract, and additional surgery throughout life. FAP has been designated an orphan indication in the U.S. and Europe, occurring in about 1 in 10,000 people, with an estimated 30,000 cases in the U.S.

Last year the U.S. Food and Drug Administration granted CPP-1X/sul Fast Track designation, which provides a streamlined path to commercialization if approved.

The randomized, double-blind Phase 3 trial of CPP-1X/sul will determine if the combination of eflornithine plus sulindac is superior to either of the drugs as single agents in delaying time to the first occurrence of an FAP-related event.

https://bit.ly/2OG0oRX

Inspire Medical 2Q business highlights

Inspire Medical Systems, Inc. (INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (OSA), reported financial results for the quarter ended June 30, 2018.

Recent Business Highlights

• Revenues of $10.9 million in the second quarter of 2018, an 81% increase over the same quarter last year and provides full year 2018 revenue guidance to be in a range of $42.8 million to $44.0 million
• Activated 15 new U.S. medical centers in the second quarter of 2018, bringing the total to 168 U.S. medical centers implanting Inspire therapy
• Aetna issued a policy decision to provide coverage to its approximately 22 million members for Inspire therapy
• Received approval from Japan’s Ministry of Health, Labour and Welfare for Inspire therapy to treat moderate to severe OSA in Japan

“We are extremely pleased with our continued strong growth in revenues in the second quarter,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems.  “These results demonstrate the strong and growing adoption of Inspire therapy by physicians and patients as a highly differentiated solution for the treatment of moderate to severe obstructive sleep apnea.  In order to drive further growth, we are focused on increasing patient flow at existing medical centers, training and activating new medical centers, and adding territory managers in the U.S.”

“We were also excited to recently receive a positive national coverage decision for Inspire therapy from Aetna, a leading U.S. health plan that provides coverage for approximately 22 million members,” continued Mr. Herbert. “The team continues to focus on establishing reimbursement, both with positive coverage policies as well as supporting centers on obtaining individual prior authorization approvals.”

https://yhoo.it/2vMRivO

eHealth started at buy by Chardan

Target $40

https://bit.ly/2Bj3TvW

Buffett boosts his Teva stake as turnaround plan yields results

Analysts may have their concerns about Teva’s growth prospects, but Warren Buffett apparently still likes what he sees at the Israeli drugmaker.

The billionaire’s holding company, Berkshire Hathaway, upped its stake in the generics giant in the second quarter to 43.2 million shares, according to a regulatory filing. Those shares were worth more than $1 billion as of June 30, The Street notes.

Teva investors were pleased with the news, and they sent shares skyward in response.

Buffett’s move comes as Teva’s new management works to dig the company out of serious debt, in part with a $3 billion cost-cutting program that’s proved popular with analysts and investors. Despite the progress on that front, though, the company’s shares still took a hit after Teva’s second-quarter earnings announcement, a slip Wells Fargo analyst David Maris attributed to shareholders expecting too much too soon.

“We believe the stock sold off for a variety of reasons, but if we had to choose a primary reason it would be because expectations were running high into the quarter,” he wrote in a note to clients at the time.

Others, such as RBC Markets’ Randall Stanicky and Jefferies’ David Steinberg, have expressed worries about Teva’s longer-term revenue outlook, despite an ongoing rollout of CNS drug Austedo and a forthcoming launch for closely watched migraine candidate fremanezumab.

“There may not be much significant new revenue contribution beyond Austedo and fremanezumab until Teva’s earlier-stage pipeline in biologics and biosimilars reaches the market in 5-6 years or more,” Steinberg wrote earlier this month.

Still, the restructuring—which will claim 14,000 positions when all is said and done—is doing its job, and Teva is even ahead of schedule in that department, CEO Kåre Schultz said on the company’s second-quarter earnings call. And that fact has left some industry watchers, such as Credit Suisse analyst Vamil Divan, M.D., feeling positive about the stock.

He and his colleagues “remain optimistic” about the “ongoing turnaround story,” he wrote recently.

Berkshire first reported that it had put its money behind Teva back in February, when it said it had grabbed 18.9 million American depositary receipts worth close to $358 million.

https://bit.ly/2MRRQXT

Changing How We See The World

One of the most important findings in psychology is that people make important changes in their lives when they are in the midst of deep emotional experience.  Simply talking with a coach, counselor, or therapist doesn’t in itself lead to profound change.  Rather, it’s when we experience things strongly that our existing views of the world are shaken up.  That shake up opens us to new ways to view ourselves, others, markets, and the future.

This is one of the reasons important change can occur when people “hit bottom”.  It’s when everything has gone wrong and we’re in despair that we’re willing to make a complete overhaul in what we do.  Therapists refer to this as “corrective emotional experiences.”

But it’s not just negative experience and setbacks that can help us see and do things differently.  Sometimes powerful positive experiences have the same impact.  One example is the experience of awe:  when we are so inspired by something positive that it becomes a part of us and changes our perspectives going forward.  In a new article, I describe recent research into awe and how experiences of awe literally renew our energy and help us become more successful.

A theme I have never heard expressed in conventional trading psychology is that markets–and participation in markets–can become sources of awe.  That is, they can be awe-inspiring.  When we perceive the vast complexity of markets and so immerse ourselves that we perceive a meaningful pattern, it’s as if we’re catching a glimpse of the universe.  It’s not an ego thing at all, strutting about and proclaiming your “conviction” in an idea.  Rather, it’s standing back and absorbing all that is happening and allowing ideas and themes to come to you.

Trading with your ego ultimately depletes our energy, as we take too many P/L dings.  Trading with a sense of openness and awe can give us energy.  It can be inspiring.  And that inspiration and awe can help us change how we see the world–it becomes a *positive* corrective emotional experience.  Many traders become frustrated with markets and fight what is happening.  How different it is to experience markets as awe-some!

Further Reading:

 

How Awe Can Renew Our Lives

https://bit.ly/2OFPyLS

Weed-Killing Carcinogen Glyphosate Found In Children’s Foods

The known carcinogen and infamous weed killing chemical glyphosate has just been found in breakfast foods marketed for children. A new study has discovered trace amounts of the most widely used herbicide in the country in oats, granolas, and snack bars.

Concern over glyphosate has continued to grow in the United States in recent years.  Although the chemical may be safe in some amounts to spray on weeds if certain safety precautions are taken, it is probably a lot more dangerous if it’s ingested by a child. Most disturbing, however, is the fact that thirty-one out of 45 tested products had levels of glyphosate that were higher than what many scientists consider safe for children.

The study, which was conducted by the non-profit Environmental Working Group (EWG) found that many of the breakfast foods marketed to children contain glyphosate.  “I was shocked,” said Dr. Jennifer Lowry, who heads the Council on Environmental Health for the American Academy of Pediatrics. Although not much is known about the effects of the chemical on children, parents and doctors are concerned. “We don’t know a lot about the effects of glyphosate on children,” Lowry said. “And essentially we’re just throwing it at them.”

“We’re very concerned that consumers are eating more glyphosate than they know,” said Scott Faber, vice president of government affairs at EWG, according to CBS News. Faber has been working to improve food safety standards for more than a decade. He said he and his team at EWG conducted the study which included a lab test involving “45 samples of products made with conventionally grown oats.” The researchers found glyphosate, which is the active ingredient in the Monsanto weed-killer Roundup, in all but two of the products.

EWG used it’s own very stringent standards of safe levels of glyphosate when testing the products, which should also be noted. Because of that, in response to EWG’s study, Monsanto said, “even at the highest level reported… an adult would have to eat 118 pounds of the food item every day for the rest of their life in order to reach the EPA’s limit” for glyphosate residues. Just last week, in fact, a jury in California ordered Monsanto to pay one man $289 million in damages after his lawsuit claimed the company’s weedkillers caused his cancer. EWG’s Faber is skeptical of EPA’s glyphosate limits.

The World Health Organization says glyphosate is a “probable carcinogen,” and California lists it as a chemical “known to the state to cause cancer.” Monsanto continues to dispute the claim that the chemical is carcinogenic, saying in a statement, “glyphosate does not cause cancer” and “has a more than 40-year history of safe use.”

As the debate over glyphosate’s safety continues, it isn’t likely to see tests on the stuff cease anytime soon. And Faber isn’t the only person concerned over its possible carcinogenic effects.  “It is time now for them to step up and do their jobs to ban glyphosate,” said Zen Honeycutt, who heads Moms Across America, a group formed to raise awareness about toxic exposures. “We want to trust that what is in the grocery store is safe and the shocking reality is that in many cases it’s not,” Honeycutt said.

https://bit.ly/2Mmr0Le

Aldi is going granola to compete with Whole Foods

Aldi is synonymous with low-cost food staples, canned goods and no frills shopping.

But the German grocer is hoping a shift to trendy, natural foods will help it grow its market share in the United States. Last week, it announced the next phase of an aggressive growth initiative that will include a larger emphasis on natural foods.

The question is: Will shoppers choose Aldi over Whole Foods for healthy fare?

No doubt, says Diane Sheehan, an analyst with Kantar Consulting. High-end retailers, she says, are too focused on premium shoppers. But in today’s competitive grocery environment, everyone “expects good deals on quality products.”

“Those retailers continue to be underestimating Aldi and are doing it to their own detriment,” she said.

That gives Aldi an opportunity to invite shoppers to try its new veggie noodles, organic meats, sliced fruits and guacamole cups. The goal is expand its fresh food selection by 40%. But there are potential pitfalls to the healthy food strategy.

Aldi, which has been in the United States for more than four decades, operates as a private label retailer, similar to Trader Joe’s. It largely sells its own line of in-house brands.

There’s a strong possibility that Aldi will run into issues expanding its in-house line of products into trendy, natural foods, says RJ Hottovy, a senior retail analyst at Morningstar.

Interior of an Aldi.

“Even though they will be marketing these products under their own private label brands, there are still a limited number of suppliers who produce these types of products, which can lead to shortages or unpredictable pricing,” he said.

Sheehan also cautions Aldi about not cannibalizing its existing stores by building new stores too close to old ones. The company is spending $5 billion to build 700 new US stores and remodel another 1,800 over the next four years.

Overall, Sheehan thinks Aldi’s prolific expansion is a good idea. “[It] enforces how strong Aldi is right now and [that] it’s in it to win it,” she said.

As a privately held company, Aldi doesn’t report earnings. But it pulled in $84.9 billion in global revenue in 2016 making it the 8th biggest retailer in the world, according to a Deloitte analysis. Walmart (WMT) is in first place, pulling in $486 billion, followed by Costco (COST) ($118 billion) and Kroger (KR) in third place ($115 billion).

Competitors will be keeping a close eye to see if Aldi’s brand recognition improves and its smaller stores attract more busy people. “Aldi is reinforcing that small, simple and convenient is just as valuable as having thousands of products,” Sheehan said.

A typical Aldi is 10,000 square feet — much smaller than an average Whole Foods, which ranges between 25,000 and 50,000 square feet. A sprawling Walmart can be more than 100,000 square feet.

As part of its expansion, existing Aldi stores will also get a brighter lights, bigger aisles, less-cluttered shelves and more refrigeration space. It’s also launching meal kits and offering more alternative milks, like soy and almond.

But it lags in e-commerce and grocery delivery, areas in which competitors like Amazon’s Whole Foods and Kroger are thriving. It recently started delivery groceries in some cities through the shopping app Instacart.

Digital offerings, however, might be more important than trendy food and lots of stores.

“2018 is an inflection point year because we see a lot of movement with online grocery platforms, meal kits services and this,” Hottovy told CNN. “There’s a lot of change.”

https://cnnmon.ie/2PgvYXR