Outside advisers to the Food and Drug Administration voted 8-6 Thursday in favor of a broader use of Cymbalta on the basis
of studies in lower back pain and osteoarthritis of the knee.
The invalidation of Lilly’s Strattera patent opened the door for as many as 10 companies to sell generic versions of the drug,
which generated U.S. sales of $445.6 million last year as a treatment for attention deficit hyperactivity disorder.
A dozen potential products designed to slow or stop clumps of protein from forming in the brain, a condition linked to the
disease since 1906, have failed in mid- to late-stage testing since 2003.
What a tough week for Lilly. On Aug. 12, a judge struck down the Indianapolis-based drugmaker’s U.S. patent on Strattera,
which might cost the company about $450 million in annual revenue. Then, five days later, Lilly halted clinical trials on
one
of its experimental Alzheimer’s medicines, because patients did worse on the drug than on a placebo.
Approval for the millions of Americans with chronic back or knee pain may add more than $500 million, or 16 percent, to Cymbalta’s
annual sales.
Studies showed that the treatment did not slow the disease's progression. It's just the latest setback for the pharmaceutical
giant, which lost a patent lawsuit over a major drug last week and faces an unprecedented number of patent expirations through
2014.
Eli Lilly and Co. on Thursday lowered its revenue outlook for the year after it lost a patent lawsuit over its attention
deficit hyperactivity drug Strattera. The patent had been set to expire in May 2017. Lilly plans to appeal.
Indianapolis-based drugmaker Eli Lilly and Co. faces such an unprecedented string of patent expirations and an unheard-of
loss of revenue that it’s hard to picture what the company will look like in five years.
Leaders tackle issues ranging from research to cold storage to the future of Eli Lilly and Co.
An experimental medicine for hepatitis C that Lilly helped identify and develop is now on the cusp of market approval, with
analysts predicting as much as $2 billion in annual U.S. sales.
Eli Lilly and Co.’s loss of a patent on one of its blockbuster drugs in court late last month received a collective yawn
from
investors, who have shunned the stock because of five looming patent expirations.
Copenhagen-based health-care company Ascendis Pharma A/S received offers of about $400 million, an unidentified source said.
Ascendis may choose a final bidder by early September.
A U.S. appeals court Wednesday said a lower court was correct to invalidate a patent on the medicine that expires in 2013.
Gemzar generated $1.36 billion in global sales in 2009.
Investors are focused on whether Eli Lilly and Co. can continue dividend payments when patent expirations hit in the new few
years and whether the company's drug development pipeline can replace lost revenue.
Indianapolis-based drugmaker Eli Lilly and Co. recorded profits of $1.3 billion, or $1.22 per share, during the three months
ended June 30,
even after paying $27 million in severance to laid off employees.
Massachusetts-based Alnara Pharmaceuticals Inc. is a privately held company
developing an enzyme-replacement therapy for disorders of the pancreas.
Drugmakers testing experimental Alzheimer’s medicines—including Eli Lilly and Co.—got good news last week
when the National Institute on Aging and the Alzheimer’s Association proposed new guidelines to make earlier diagnoses
of the disease.
The Indianapolis-based drugmaker eliminated 140 information technology jobs in June through retirements, resignations and some cuts. Another 115
cuts will be made this month, and the remainder by the end of the year.
Two Indianapolis giants—Eli Lilly and Co. and Roche Diagnostics—are working hard to pair up drugs and diagnostic
tests to gin up more sales.
Both of Lilly’s late-stage treatments are designed to reduce plaque in the brain called beta amyloid, thought by researchers
to be a main contributor to Alzheimer’s. A drug that stops or reduces memory loss caused by Alzheimer’s may be worth more
than $5 billion
a year, an analyst says, helping Lilly overcome the coming patent losses on several important pharmaceuticals.
