FDA to decide on Avastin before next week
SAN FRANCISCO The Food and Drug Administration will decide by Saturday whether or not Genentech’s cancer drug Avastin will be approved to fight breast cancer as well, according to the Wall Street Journal.
Members of an agency advisory committee voted 5-4 against approval in December. While the FDA isn’t required to follow the panel’s recommendations, it usually does. While it does not seem likely an approval will occur based on the committee’s vote, new reports have stated that two members of the FDA advisory panel have changed their mind to approving the drug, although the FDA has not and will not comment on these reports.
Genentech is looking for approval based on a study it submitted to the FDA that found that using Avastin in combination with Taxol, a breast-cancer drug made by Bristol-Myers Squibb, delayed the growth of patients’ tumors for 11.3 months, 5.5 months longer than Taxol alone. However, despite this, the women on Avastin in the study didn’t live significantly longer than those on Taxol, and they experienced more bad side effects, such as high blood pressure, blood clots and bowel perforation. Six deaths were linked to Avastin’s toxicity, and none to Taxol’s.
A major issue for the FDA advisers was whether slowing cancer for an extra 5.5 months is a benefit that merits market approval. Maha Hussain, an oncologist at the University of Michigan and the chairwoman of the FDA’s Oncology Drugs Advisory Committee, voted that such data don’t clear the bar. But her fellow panel member, Duke University oncologist Gary Lyman, says a 5.5-month halt in tumor growth is the best response he has seen in patients with metastatic breast cancer. “That translates – during whatever time they have left – into better quality of life,” he says.
Genentech is hoping for the approval in order to lift sales of the drug. It had sales of $2.3 billon last year, but the new approval could add an extra $2 billion a year for the company.
FDA approves Abbott’s Simcor for cholesterol
ABBOTT PARK, Ill. The Food and Drug Administration has approved Abbott Laboratories new cholesterol drug Simcor, according to Reuters.
Simcor combines simvastatin, the active ingredient of Merck’s statin drug Zocor that lowers “bad” LDL cholesterol, with Abbott’s Niaspan medicine that raises levels of “good” HDL cholesterol.
Simcor is a follow-up to Advicor, an Abbott combination product already on the market that pairs Niaspan with a less-potent statin known as lovastatin.
Abbott has said it expects sales of the new drug, which also lowers triglycerides to eventually reach $500 million per year.
“There is a clear need for medicines that both raise good and comprehensively lower the bad components of cholesterol,” Christie Ballantyne, one of the lead Simcor researchers, said in a statement.
Fred’s has big plans to improve across-the-board performance, profitability
MEMPHIS, Tenn. Earlier this month, discounter Fred’s announced that, based on an in-depth study of the company’s operations over the last 10 quarters, the discounter has embarked on a strategic plan to improve its performance.
That new strategic plan is heavily rooted in pharmacy.
“We are well positioned with our 296 pharmacists to take advantage of future growth in pharmaceuticals,” Bruce Efird, president of Fred’s, told analysts during a conference call. “It is worth noting that [a] key strength identified by our customers in recent customer research is our pharmacy operations. … Our plan does include accelerated pharmacy [file buys], which have historically provided a higher return on investment.”
As part of the new focus, Fred’s will be concentrating its improvement efforts on its over-performing locations—the chain’s top 50 stores represent 7 percent of Fred’s store base but 40 percent of the chain’s profits, Efird said.
“Our pharmacy teams will execute a similar program in our top 40 pharmacies that generates approximately 45 percent of our pharmacy operating profit,” Efird added. “Currently our front-end sales range from 9 percent to 10 percent higher in stores with pharmacies. This plan includes increasing the number of pharmacies script file buys as well as an aggressive marketing campaign.”
The study revealed that Fred’s has a strong and healthy core store base, and pointed out that upgrading the company’s real estate program will have measurable upside potential.
Specifically, the plan will involve the following elements, all focused on achieving the company’s long-term goal of increasing annual operating margin to 4.5 percent:
- improving the core store performance by closing 75 under-performing locations;
- repositioning and reducing corporate overhead by 10 percent;
- generating $11 million in annualized cash savings beginning in the second half of 2008; and
- initiating multiple merchandising programs to enhance margin and address the changing shift in sales mix.
Of the 75 stores identified for closure, only a handful have pharmacies, company executives told analysts Feb. 7.
Aside from these immediate steps, Fred’s plans to slow capital spending and the rate of new store openings beginning in 2008 in order to focus on growth that is more profitable and that produces a higher return on investment. Fred’s plans to open 18 new stores, 15 with pharmacies, in 2008. “Subsequently upon execution and validation of our transformation plan, we anticipate accelerating our store and pharmacy growth to historic levels,” Efird said.
And Fred’s is not concerned with expanding national chains like Walgreens, CVS and Rite Aid into its core Southeast base, Efird said. “When they come into these rural settings they don’t affect us,” Efird told analysts. “They are [pricey] at the front end and once a customer is accustomed to it, [it does] not match up well with [our present] pricing.”
Separately, Fred’s reported sales of $1.8 billion for the fiscal year ending Feb. 2, representing a 1 percent lift. Comparable store sales for fiscal 2007 increased 0.3 percent.