FDA grants accelerated approval to Zykadia
SILVER SPRING, Md. — The Food and Drug Administration on Tuesday granted approval to Zykadia (ceritinib) for patients with a specific type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
The drug — an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor — blocks proteins that promote the development of cancerous cells and is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib.
"Today’s approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It also demonstrates the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation program.”
Zykadia is marketed by Novartis, which is based in East Hanover, N.J.
PriceGrabber survey reveals Mother’s Day shopping habits
LOS ANGELES — With Mother’s Day just around the corner, online shopping site and e-commerce platform PriceGrabber released results of its 2014 Mother’s Day Shopping Survey. The survey, conducted from April 3 to April 17, includes responses from more than 3,000 online shoppers.
When the company asked mothers what they wanted for their special day, 44% said they wanted to spend more quality time with family. Gift cards were the next most popular choice at 29%, with 28% of mothers saying they wanted flowers. Jewelry and dining out share the fourth spot at 26%.
What do consumers actually plan to give their mothers this year? The survey revealed that flowers nabbed the top spot at 37%. Quality time with the family and dining out tied as the second most popular choice at 29%. Greeting cards or e-cards came in at 24%, and 19% of respondents said they would be giving gift cards.
The PriceGrabber survey also highlighted the shopping habits of consumers on the hunt for a Mother’s Day gift: 60% of consumers said they would purchase online, with 50% reporting that they would shop from their computer and 10% planning to purchase from a mobile device (defined in the survey as a smartphone or tablet). Forty percent of shoppers will take the brick-and-mortar route when making a purchase.
Energizer to separate into two companies
ST. LOUIS — Energizer Holdings on Wednesday announced that it’s pursuing a plan to divide the company’s household products and personal care divisions into two independent, publicly traded companies.
Household products (batteries and portable lighting products) is expected to produce strong margins and significant cash flows and will be secured by the well-known Energizer and Eveready brands. This division reported annual revenue of $1.9 billion in the 12-month period ending March 31, 2014.
The personal care division is expected to be a leading "pure-play" consumer products company, with a roster of established brand names that includes Schick, Wilkinson Sword, Edge, Skintimate, Playtex, Stayfree, Carefree, O.B., Banana Boat and Hawaiian Tropic. Annual revenue for the personal care division was $2.6 billion in the 12-month period ended March 31, 2014.
"Over the last three years, we have taken a number of important steps to enhance shareholder value, including executing a multi-year cost reduction plan, improving working capital and initiating a dividend," said Ward Klein, CEO. "The Energizer board of directors and management team have continually explored opportunities to improve performance and increase long-term shareholder value and believe that separating the household products and personal care divisions is the next logical step to unlock even greater value for Energizer shareholders. Importantly, as we move through the separation process, the company’s working capital and cost reduction efforts will continue without interruption, and we expect to achieve the full savings projected."
Energizer said creating two public companies brings a wealth of benefits to the standalone business. It expects the household products division will generate value by leveraging its battery and lighting brands to generate significant cash flows, reiterating that its product categories remain important basket builders for retailers. Personal care will build on its stable of leading global products to create value. The personal care category has strong positions in large, developed markets, the company noted.
Once the separation is complete, Klein is expected to serve as executive chairman of the board of standalone personal care. David Hatfield, who is the current president and CEO of Energizer personal care, is expected to serve as CEO of the standalone personal care company. J. Patrick Mulcahy, currently chairman of the board, is expected to serve as executive chairman of the board of standalone household products. Alan Hoskins, currently president and CEO of Energizer household products, is expected to serve as CEO of standalone household products.