Global Blood hit on bearish Feuerstein report

Global Blood Therapeutics (NASDAQ:GBT) slips 5% premarket on light volume on the heels of a bearish report by STAT News’ Adam Feuerstein who cites the risk in securing accelerated FDA approval for sickle cell med voxelotor.

In June, the company reported positive data from a Phase 3 study, the only one it plans to conduct to support its marketing application that will rely on a surrogate endpoint (corporate presentation, slide #24) to demonstrate efficacy, a criterion that the FDA has never approved for sickle cell disease.

Previously: Global Blood -7% despite positive data from sickle cell drug trial(June 27)

https://seekingalpha.com/news/3389981-global-blood-5-percent-premarket-bearish-feuerstein-report

Geron hit on uncertainty with imetelstat with Janssen

Geron (GERN -11.2%), up 22% earlier, is now in the red on more than triple normal volume in apparent reaction to the lack of a decision from Johnson & Johnson on continuing with imetelstat. Investors appeared to be jumping the gun ahead of J&J’s pharma update this morning considering previous guidance that its decision on imetelstat will be made by month-end.

In Johnson & Johnson’s pharma business update this morning, imetelstat was cited under “potential filings” for 2019 – 2021 (slide #15).

JNJ presentation.

Previously: Geron down 13% in early trading on extended timeline for imetelstat study, risk that Janssen will bail (Aug. 1, 2017)

https://seekingalpha.com/news/3390074-geron-11-percent-uncertainty-imetelstat-janssen

Consumers cite health concerns, cost as reasons they eat less meat

Two out of every three participants in a U.S. consumer survey report that they are eating less of at least one type of meat, according to a study from researchers at the Johns Hopkins Center for a Livable Future, based at the Johns Hopkins Bloomberg School of Public Health.

Meat consumption in the U.S. exceeds recommended levels, with significant consequences for public health and the environment. To better understand consumer attitudes and behaviors related to reducing meat consumption, researchers collected survey responses from a nationally representative sample of 1,112 U.S. adults ages 18 and older. The study, conducted in 2015, is thought to be the first of its kind to collect responses from U.S. consumers about the foods they choose to eat instead of meat during meatless meals.

The study was published in the July issue of the journal Public Health Nutrition.

“Many Americans continue to have strong preferences for meat, but this survey adds to a growing body of evidence that a significant portion of the population may be purposefully reducing their meat consumption without becoming vegetarian or vegan,” said Roni Neff, Ph.D., an assistant professor in the Bloomberg School’s Department of Environmental Health and Engineering who led the study and directs CLF’s Food System Sustainability and Public Health Program. “We hope our findings will be useful for the development of awareness campaigns and other interventions geared towards helping consumers reduce their meat consumption in a way that is good for their health, their grocery budgets, and the environment.”

For purposes of the survey, researchers defined meat reduction as eating less red meat, processed meat, poultry or seafood over the last three years. Participants between the ages of 45 to 59 were twice as likely to reduce consumption of one or more types of meat as those 18 to 29-years-old, followed by those over age 60. Women were more likely than men to report reducing meat consumption. Household income was also associated with reduced meat consumption: the lower the income level, the greater the likelihood of reporting reduced meat consumption.

Respondents with incomes lower than $25,000 were more likely to report cutting their overall meat consumption than those with household incomes greater than $75,000. Researchers also observed that the parents of children under age 18 were less likely to reduce their overall meat consumption than non-parents.

The most commonly reported reasons participants gave for cutting meat consumption were cost and health concerns. Few respondents–12 percent each–said they had reduced their meat consumption out of concern for animal welfare or the environment. Key reasons survey participants cited for not reducing meat consumption included the perception that meat is necessary for a healthy diet, and that meals are incomplete or boring without meat. Researchers say these findings reveal opportunities for educating consumers about appealing and nutritious plant-based meals and raising awareness of the environmental impacts of meat production.

The researchers note that the responses offer useful insights into which meat products consumers say they are cutting back on. Fifty-five percent of respondents reported reducing their consumption of processed meat, and forty-one percent reported reducing the amount of red meat in their diets. Of those who reported reducing red and processed meat, 37 percent said they had increased their poultry or seafood consumption. The most commonly reported approach to reducing meat consumption was buying less meat (64 percent), followed by smaller portion sizes (56 percent), meatless meals (42 percent), meatless days (32 percent), and avoiding meat altogether (9 percent).

The study also provides data on what people say they eat in meatless meals. The most frequently reported foods eaten in meatless meals were vegetables, followed by cheese and other dairy products, and eggs. Beans, nuts, tofu, and imitation meats were less frequently eaten during meatless meals, the study found. As a result, opportunities exist for meat reduction campaigns to build consumer interest in eating foods such as beans and nuts as alternatives to meat.

“Our survey results suggest that public health messages on the benefits of reducing red and processed meat consumptionmay be reaching and resonating with many U.S. consumers, but more work remains to be done,” said Neff. “Priorities for meat reduction campaigns should include addressing common misperceptions about meatless meals, and promoting alternatives that consumers enjoy and that are affordable, healthy, and environmentally friendly. They should emphasize that meatless meals can be interesting and taste good, and could also provide resources like recipes with other options.”

 Explore further: ‘Flexitarian’ eating: Part vegetarian, part not

More information: Roni A Neff et al. Reducing meat consumption in the USA: a nationally representative survey of attitudes and behaviours, Public Health Nutrition (2018). DOI: 10.1017/S1368980017004190

https://medicalxpress.com/news/2018-09-consumers-cite-health-meat.html

Calorie counts on restaurant menus have customers ordering less

Bye-bye artichoke dip. Heavyweight appetizers and fatty entrees may not get much love when restaurants list calories on their menus.

In a new study, Cornell University researchers conducted a randomized experiment and found that diners at full service restaurants whose menus listed calories ordered meals with 3 percent fewer calories—about 45 calories less—than those who had menus without calorie information. Customers ordered fewer calories in their appetizer and entree courses, but their dessert and drink orders remained the same.

“Even if you’re an educated person who eats out a lot and is aware of nutrition, there can still be surprising things in these calorie counts,” said co-author John Cawley, professor of policy analysis and management in the College of Human Ecology.

Even the chefs at the restaurants in the study were startled by the high number of calories in some dishes, such as a tomato soup/grilled cheese sandwich combo. “They would have said it was one of the lower-calorie items on the menu,” said co-author Alex Susskind, associate professor of operations, technology and information management at the School of Hotel Administration.

The findings come at a time when most Americans don’t have a precise estimate of how many calories they’re eating, because one-third of their food is prepared outside the home. At the same time, the obesity crisis in America has reached epidemic proportions; the prevalence of obesity in adults has nearly tripled in the past 50 years, to nearly 40 percent of the population in 2016.

In response, many cities, counties and states have passed laws requiring restaurants to include calorie information on their menus. And as of May, it is a nationwide requirement that chain restaurants with 20 or more units post calories on menus and menu boards, as part of the Affordable Care Act of 2010.

To find out how this law affects consumer behavior, the researchers conducted a randomized field experiment in two full-service restaurants. Each party of diners was randomly assigned to either a control group, which received the usual menus, or a treatment group, which got the same menus but with calorie counts next to each item. At the end of the meal, each diner was asked to complete a survey that collected sociodemographic information and attitudes toward diet and exercise. In all, the researchers gathered data from 5,550 diners.

The study also found that diners valued the calorie information. Majorities of both the treatment and control groups supported having calorie labels on menus, and exposure to the calorie counts increased support by nearly 10 percent. “It’s clear that people value this information,” Cawley said.

And there was no downside for restaurants. Their revenue, profit and labor costs were unchanged.

“It’s a cheap policy to put in place, and the fact that there is a reduction in calories ordered makes it appealing,” Cawley said.

 Explore further: Low-calorie restaurant menus: Are they making us fat?

More information: John Cawley et al. The Impact of Information Disclosure on Consumer Behavior: Evidence from a Randomized Field Experiment of Calorie Labels on Restaurant Menus, (2018). DOI: 10.3386/w24889

https://medicalxpress.com/news/2018-09-calorie-restaurant-menus-customers.html

Swedish regulator ends investigation of birth control app

Swedish regulators have closed their investigation of a birth control app after finding that the rate of unwanted pregnancies, which had gained media attention, was actually in line with clinical data.

The Swedish Medical Products Agency said Thursday a review found about 7 percent of women using the Natural Cycles app got pregnant in the first half of the year, equal to the “typical use” failure rate in the clinical study submitted for its European certification.

Authorities launched the probe after reports of unwanted pregnancies drew attention to the Swedish startup.

Natural Cycles last month became the first ever digital contraceptive device to win U.S. Food and Drug Administration marketing approval, underscoring the rapid rise of mobile health applications.

Britain’s advertising regulator ruled in August that the company’s Facebook ad contained misleading claims.

 Explore further: UK regulator says ad for birth control app were misleading

https://medicalxpress.com/news/2018-09-swedish-birth-app.html

Amgen, Sandoz begin biosimilar trial with top-selling Enbrel at stake

A high-stakes case pitting Amgen against Novartis’ Sandoz kicked off in court this week, with potential to change the course of Amgen’s multi-billion dollar Enbrel business and shake up the biosimilars market in the U.S.

A district court in New Jersey will in coming weeks hear arguments from the pharma giants over whether or not patents related to the blockbuster Enbrel are valid and applicable in protecting it from biosimilar competition.

The U.S. biosimilar market has been slow to develop in no small part due to the murky legal foundation set by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), experts said in interviews with BioPharma Dive. Legal squabbling among drugmakers has revved up since the Food and Drug Administration began approving copies of biologics.

Health and Human Services Secretary Alex Azar touched on the hope regulators hold out for the promise of the drugs helping ease healthcare costs at a summit on Thursday on value-cased care, highlighting the still fragile market.

“Nowhere is competition more urgently needed than in high-cost drug areas like biologics,” Azar said.

FDA Commissioner Scott Gottlieb has laid blame on litigation for delaying market access, adding that his agency had approved 11 biosimilars at that time, yet only three were being marketed in the U.S. One of those 11 was Sandoz’s Erelzi (etanercept-szzs), which won approval in September 2015. Three years later, it still hasn’t been launched commercially.

Jefferies analyst Michael Yee said this biosimilar lawsuit is a top development to watch for Amgen and the pharma industry overall heading into 2019.

“This is not widely appreciated by [Wall] Street,” Yee said in a Sept. 9 video. “You are going to start hearing about this, and if Amgen loses there’s downside.”

Enbrel’s profitable rise

After launching in 1998, Enbrel (etanercept) grew into a blockbuster drug for Amgen, gaining additional approvals over the years in plaque psoriasis, psoriatic arthritis and others.

Over the past three years, it’s accounted for between 25% and 30% of Amgen’s total product sales, earning $5.4 billion last year. So far in 2018, the biologic has posted $2.4 billion in sales. The investment bank Leerink forecasts Enbrel to sell $5 billion this year and $4.6 billion in 2019.

Sandoz’s copycat version is a threat to that lucrative revenue stream. A few months after Erelzi’s 2015 OK, Amgen sued on patent infringement grounds.

Amgen’s blockbuster already faces two marketed biosimilars in Europe, which have cut into sales at a rapid rate of 6% per quarter over the past two years, according to Leerink.

Now, a bench trial in New Jersey raises the threat faced by Amgen in the U.S., which accounted for more than 95% of total Enbrel sales last year.

A win for Amgen could help extend its profitable monopoly further into the life of its remaining patents, one of which expires in 2029. For Sandoz, a court victory would find Amgen’s patents invalid or not infringed, potentially clearing the path to U.S. market for its biosimilar without risk of damages.

“This sounds scary,” Yee said. “If Amgen loses the court case in first half of ’19, Sandoz could launch a biosimilar in the face of Amgen and it is not in consensus numbers.”

Déjà vu all over again

This isn’t the first Sandoz v. Amgen biosimilar case of importance.

In June 2017, the Supreme Court shined “a small torch of clarity” on aspects of the BPCIA by weighing in on a previous battle between the two companies, said Dominic Adair, a patent lawyer for Bristows LLP, in an interview.

In that case, the top U.S. court deemed voluntary the so-called patent dance, which describes the process by which both parties exchange information about the biologic and relevant patents. The Supreme Court also said a required 180-day notice of commercial marketing from the biosimilar applicant can happen prior to FDA approval, enabling a quicker launch.

Similar to the previous case, legal experts anticipate ramifications from a new ruling in biosimilars to ripple through the market. What the previous decision was to the patent dance and 180-day period, this case could become for label carve-outs if a ruling is reached.

“Judge Cecci’s decision on the role of label carve-outs would be a first,” patent lawyers Michael R. McDonald and Jordan Engelhardt wrote in a June blog post, “and may have important implications for innovators and biosimilar makers alike in biosimilar litigation.”

Label carve-outs describe the idea that a copycat drug could aim for a single indication of a branded product, potentially side-stepping valid patents on remaining indications.

Enbrel, for example, is approved for five indications. Patents listed in Amgen’s annual filing with the Securities and Exchange Commission include one covering Enbrel’s “methods of treating psoriasis” that runs through August 2019.

“Other biosimilar developers are interested in the label carve-out strategy,” Nicholas Mitrokostas, a partner in the law firm Goodwin Procter’s intellectual property litigation group, told BioPharma Dive. “If the court finds infringement with respect to Sandoz, that could impact what other developers are doing in terms of their own strategies with their own biosimilar products.”

As far as how this case will play out, Yee, the Jefferies analyst, predicted the two drugmakers will reach a settlement for entry in 2023, when Amgen plans to launch a biosimilar to AbbVie’s Humira in the same class of drugs.

Settling to hedge risk of an unfavorable verdict makes it a common outcome in big-stakes pharma litigation where billions of dollars on the line.

Yet, a settlement would avoid clearing up the ambiguity that remains in domestic biosimilar law, while other countries have pushed ahead the U.S.

“The most developed countries like the U.S. are lagging behind the traditionally less well-developed countries in Asia and Europe in terms of developing law in this area,” Adair said.

The chief executive of the Swiss pharmaceutical giant Novartis called the biosimilar space “a tale of two worlds” between the U.S. and Europe in a Feb. 1 earnings call.

“[The U.S.] is a healthcare system that desperately needs biosimilars to be successful to create fiscal space for new medicines,” Vas Narasimhan said then.

Mitrokostas, the Goodwin patent lawyer, said analyzing the case was like “reading tea leaves,”  in part because of a lack of much information and heavy redactions in what is available.

He added a court decision following trial could be expected by early 2019.

“Nobody wants to lose,” Adair said, speaking general on such suits. “They’d rather reach a deal.”

https://www.biopharmadive.com/news/amgen-sandoz-begin-biosimilar-trial-with-top-selling-enbrel-at-stake/532268/

FDA move on e-cigarettes means new risks for Fidelity funds

Fidelity Investments’ bet on a privately held maker of e-cigarettes faces new risks after U.S. health regulators on Wednesday said they are considering a ban on flavored versions of the popular “vaping” products.

Closely held e-cigarette maker Juul Labs and other Silicon Valley start-ups lately have turned up as side bets in portfolios from Fidelity and rivals like T. Rowe Price, as the asset managers look for big paydays once the small companies go public, as Facebook Inc did in 2012.

The U.S. Food and Drug Administration gave the five top-selling e-cigarette brands 60 days to provide plans for keeping their products from being used my minors. Juul, which owns about a 72 percent market share, was targeted by the agency for selling flavors that appear to particularly appeal to minors.

At Boston-based Fidelity, Juul is held in funds including Blue Chip Growth Fund and Fidelity Advisor Series Growth Opportunities Fund. At the latter, a stake in Juul was the largest single holding as of July 31, with a valuation of $45.8 million, or 6.4 percent of net assets, according to a current disclosure on the fund firm’s website.

Fidelity spokeswoman Meghan French declined to comment or make portfolio managers available to comment. But even managers who are fans of Juul have made clear that uncertainty remains.

“The company (Juul) and the industry face a number of social and public policy concerns,” wrote Sonu Kalra, manager of Fidelity Blue Chip Growth Fund, in a quarterly document for investors dated June 30.

However, he and others were mostly bullish on Juul. “A small private investment in Juul Labs also paid off. We saw the value of our non-benchmark position in this leading e-cigarette maker rise along with the growing popularity of tobacco-free smoking,” wrote Growth Opportunities manager Kyle Weaver in the fund’s annual report dated Nov. 30, 2017.

Other non-public companies in the Blue Chip Growth portfolio include ride-hailing company Uber Technologies Inc and Blue Bottle Coffee Inc.

Uber’s chief executive said earlier this month that the company is on track to go public next year. But the company also shows the risks of investing in start-ups not yet tested by public markets, as it faces regulatory scrutiny over several issues, including alleged violations of bribery laws and gender discrimination.

Uber has said it is cooperating with a U.S. Justice Department investigation into possible violations of bribery law. Uber CEO Dara Khosrowshahi in remarks to employees a year ago promised to change its culture after his predecessor Travis Kalanick resigned.

John Bonnanzio, editor of the Fidelity Monitor & Insight newsletter for investors, said that whatever the upside, owning Juul represent business risks, underscored by the FDA action and the difficulty of measuring the impact on a company whose shares are not publicly traded.

Pressure from fund investors could lead Fidelity managers to pull back and decide “this thing isn’t worth the trouble,” he said.

https://www.marketscreener.com/news/FDA-move-on-e-cigarettes-means-new-risks-for-Fidelity-funds–27258295/