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Avella joins limited-distribution network for orally administered cancer drug

BY Alaric DeArment

PHOENIX — Avella Specialty Pharmacy will be included in the limited-distribution network for a cancer drug made by Genentech, Avella said Tuesday.

The specially pharmacy company said it would be included in the network to sell Tarceva (erlotinib), an orally administered drug used to treat non-small cell lung cancer and pancreatic cancer. Genentech will shift distribution of Tarceva to a select group of pharmacies starting July 1 to align its distribution with that of similar cancer drugs.

"Being included in such an elite group of suppliers is a testament to our business model in the oral oncology market," Avella VP of business development Leslie Yendro said. "Manufacturers like Genentech recognize Avella’s ability to serve patients in all 50 states and to provide high-touch patient services and reliable product data to ensure maximum drug effectiveness."

 

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More companies focus on innovation, marketing, report finds

BY Alaric DeArment

WASHINGTON — Consumer packaged goods companies and retailers that sell their products have managed to stay strong despite economic difficulty, according to a new report.

The 2013 financial performance report, "Growth Strategies: Unlocking the Power of the Consumer," conducted by the Grocery Manufacturers Association and PwC, found that despite overall slowing net sales growth rates in 2012, food, beverage and household product companies had respective sales growth of 7%, 5.5% and 3.2%.

"This report shows that in the midst of a challenging economy, the food, beverage and consumer products industry continues to show great resiliency," GMA president and CEO Pamela Bailey said. "By providing consumers with innovative products and convenient, cutting-edge shopping experiences, CPG companies are well-positioned to enhance consumer loyalty and profitability."

The report found that the companies performing best identify consumers, engage with them and focus on innovation to reach them directly, showing how digital channels, adoption of mobile technology and marketing directly to consumers are rewriting the rules of retailing and CPG manufacturing.

Findings in the report, the 17th of its kind, included $1.1 trillion in retail sales last year, including $568 billion at grocery stores. Many companies are embracing the need for product innovation and understanding consumer and market needs as part of their research and development activities. Meanwhile, bottom performers are starting to hold onto their cash, meaning they could be ready to start making more investments in research and development and marketing to launch new products.

"CPG companies that engage with consumers directly through digital channels and build out their direct-to-consumer processes will have the best advantage for creating new growth," PwC U.S. leader for retail and consumer industry Steven Barr said. "Fifty-two percent of U.S. consumers are already buying directly online from brands they trust, proving that CPG companies now have far greater opportunities to walk alongside their shoppers in real time while driving sales of existing and new products."

More than 40% of CPG companies plan to sell products directly to consumers this year, compared with 24% last year, finding direct-to-consumer as an effective means for testing new products and reaching out to new consumers faster and more effectively.

 

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With nuanced ruling on ‘pay for delay,’ Supreme Court hands generics partial resolution

BY Jim Frederick

Half a loaf, the saying goes, is better than none. For the generic drug industry, that means that the Supreme Court handed it a partial victory Monday by ruling that “pay for delay” patent settlements between brand name and generic drug companies aren’t necessarily illegal and should be considered on a case-by-case, “rule of reason” approach by the Federal Trade Commission, which staunchly opposes the practice.

The high court’s decision, reported June 17 by Drug Store News, means that pioneer and copycat pharmaceutical makers are free to continue pursuing the controversial legal settlements of patent-infringement lawsuits that can delay the introduction of generic versions of some big-selling branded drugs in return for a cash payment or other compensation. Those agreements often involve “reverse payments” to the generic company — or an agreement by the brand company not to launch its own “authorized generic” version of the drug in question — in exchange for the generic company’s agreement to delay launch of its first-to-market version of the drug. Such settlements are not “presumptively unlawful,” the Supreme Court ruled in a 5-3 decision (Justice Samuel Alito didn’t participate in the ruling).

But the court’s ruling doesn’t really settle much. Justices essentially threw the legal uncertainties and antitrust questions surrounding reverse payments and pay-for-delay back to the lower courts.

In an online report Monday, the Los Angeles Times called the court’s decision “a middle-ground position” that leaves the door open for the FTC to challenge in court any settlement between branded and generic drug makers that involves a lot of money changing hands. To wit: “A ‘large and unjustified’ payment to settle a patent dispute can trigger an antitrust claim against the brand-maker,” the Times noted.

The issue is far from simple or black-and-white. The FTC, not to mention some retail pharmacy groups and the American Medical Association, argue that pay-for-delay settlements violate antitrust laws and end up costing consumers and health plans billions of dollars in higher drug costs by delaying generic competition. But industry trade groups like the Generic Pharmaceutical Association and the Pharmaceutical Research and Manufacturers of America — not to mention the big health research firm IMS Health — say the practice actually gets many copycat drugs to market sooner and helps lower overall spending for pharmaceuticals.

“Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired, including the top-selling medicines Lipitor, Effexor and Lamictal,” says GPhA’s Ralph Neas, president and CEO.

Who’s right? Let us know your opinion by clicking on the comment button below.

 

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