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FDA approves Eli Lilly orphan drug for gastric cancer

BY Michael Johnsen

INDIANAPOLIS — Eli Lilly on Monday announced that the Food and Drug Administration has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With this approval, Cyramza becomes the first FDA-approved treatment for patients in this setting.

"Lilly Oncology is committed to delivering innovative medicines that extend the lives of people with cancer," stated Richard Gaynor, SVP product development and medical affairs for Lilly Oncology. "Until now, there were no FDA-approved options for patients in this indication. We are pleased that the FDA has approved Cyramza for these patients. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor."

"There is a high unmet medical need in patients with this disease," added Charles Fuchs, principal investigator of the REGARD trial and director, Gastrointestinal Malignancy Program, Dana-Farber Cancer Institute. "This approval represents a meaningful advance for patients and gives those of us who treat them an important new second-line treatment option."

FDA approval of Cyramza marks a pivotal regulatory milestone in Lilly’s research and development program for the molecule, which it acquired when it purchased ImClone Systems in 2008. Cyramza has been granted Orphan Drug Designation by the FDA for this indication. Orphan drug status is given in the U.S. by the FDA’s Office of Orphan Products Development to medicines that show promise for the treatment of rare diseases. Lilly expects to make Cyramza available in the coming weeks and is committed to offering patient assistance programs for eligible patients receiving Cyramza treatment.  

 

 

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Hot Concepts – Consumables

BY Barbara White-Sax

Shifting to ciders

NEW YORK — Anheuser-Busch has introduced a new cider, Johnny Appleseed Hard Apple Cider. The cider is the first wholly new brand from Anheuser-Busch in eight years. The cider category is red hot right now. And with an ABV of 5.5% and made with apple juice sourced from apples in the United States and fine orchards around the globe, this cider is the latest entry in an active category.

IRI data showed that sales of hard cider were $172 million in 2013, compared with bout $35 million in 2009. GuestMetrics, which measures sales in bars and restaurants, said sales volume in the cider category rose about 49% last year from 2012 — another indication that the category should continue to grow.

Johnny Appleseed Hard Apple Cider rolled out in April in 12-oz. glass bottles with a twist-off cap in six-packs and 12-packs. The product also is sold individually in 16-oz. and 25-oz. cans.

Going large with chocolate

WEST CHESTER, Pa. — Mars recently launched a larger version of its classic M&M’s brand. New Mars’ M&M’s Brand Mega Milk Chocolate Candies boast three times more chocolate than regular M&M’s.

The new take on a classic confection is likely to be a home run with consumers. Focus group participants have been asking for larger M&M’s, and consumer testing revealed that 66% of consumers said they would “definitely” or “probably” buy new M&M’S Mega. And, according to Euromonitor and the National Confectioners Association, candy sales are expected to grow in the next five years, “adding more than $6 billion in sales between 2013 and 2018.” Unwrapped, bite-sized confections are one of the high-growth segments.

M&M’S Brand Mega Milk Chocolate Candies are available in two sizes — 1.48-oz. singles and 11.4-oz. medium bags, while M&M’s Brand Mega Peanut Candies are available in 11.4-oz. bags. Singles retail for $1.09, and the suggested retail price for bags is $3.29.

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Consumers increasingly prefer healthier options

BY Barbara White-Sax

Healthy snacks had tremendous growth in 2013. Consumers consistently show a willingness to choose healthier options in the snack aisle, and retailers have responded by including even more healthy options on their store shelves. “A full 48% of consumers said they are willing to pay more for healthier options. That’s an increase of 11 points over the number who said that last year,” said Sally Lyons Wyatt, executive and practice leader of client insights at IRI.

“Across consumables categories, 62% of healthy snack categories grew in volume in 2013,” Wyatt said. Consumers aren’t just saying they want healthier snacks; their purchasing habits are proof of their commitment to better-for-you snacking.

Retailers are making sure that consumers find what they are seeking on their shelves: 60% of consumers say that healthy snacks are easy to find — an 11-point gain versus 2012, according to IRI data. Products that once were found only at Trader Joe’s or Whole Foods are finding their way to drug store shelves, and drug retailers are increasing their organic, natural and gluten-free sections.

Carob/yogurt-coated snacks volume sales were up 26% across all outlets last year, according to IRI. Nutritional snack mixes also had significant growth.

Yogurt, fueled by Greek yogurt, is still the category star. “Yogurt continues to have great sales, with a 3.5% overall volume increase last year,” Wyatt said. “Yogurt delivers multiple benefits because it’s convenient, better-for-you and has a good satiety profile.” Greek yogurt also has contributed to strong dollar sales in the category; dollar sales of yogurt were ahead nearly 30% in drug stores for the 52 weeks ended Jan. 26, according to Wyatt.

“We’re also seeing a huge growth in yogurt drinks and refrigerated smoothies,” Wyatt said. “They are drinkable ways to get nutrition.”

Nutrition is the buzzword behind increased sales of “snack packs” that combine protein (hard-boiled egg, cheese or preserved meats) with other elements (crackers, hummus or carrot sticks) in one convenient package. Wyatt said that while it was too early to tell how significant a category those options from Go Picnic, Hormel and Oscar Meyer will be, she said the segment was “definitely intriguing, since those products are providing variety and delivering against consumer needs.”

A “fruit and vegetable remodel” is driving sales of squeezable fruit, dried fruit snacks and specialty chips. Consumers, challenged with getting enough servings of fruit and vegetables, are open to new ways to get their “five a day.” Squeezable fruit packs are not just for kids anymore; the category saw a dollar sales increase of 74% across all outlets last year.

“We’re seeing a huge increase in snack packs of fresh produce from manufacturers and retailers, but we’re also seeing tremendous growth in squeezable fruit and an explosion of specialty chips, such as kale chips or apple chips, in crazy flavors like chili lime,” Wyatt said. Specialty chips sales were up nearly 18% across all outlets last year.

There’s also been significant growth in the snack bar category led by Kind Healthy Snacks. “They revolutionized the snack bar category,” Wyatt said. “The bars have simple ingredients and are wrapped in clear packaging so consumers can see what they are getting.”

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