NEWS OF THE W EEK
CURBING ANTIBIOTIC USE HEALTH: FDA calls on drug industry to phase out nonmedical uses in animals
T
HE FOOD & DRUG ADMINISTRATION is pro-
SHUTTERSTOCK
Low doses of antibiotics are often used to fatten pigs.
posing that veterinary drug companies voluntarily change the labels on their antibiotics so that growth promotion in food-producing animals is no longer a valid use. The proposal is a response to the agency’s growing concern that the massive use of antibiotics in the agricultural industry is contributing to emergence of antibiotic-resistant diseases in humans. Under the plan, the use of veterinary antibiotics will still be allowed to prevent, control, or treat diseases in food animals, but they will no longer be sold over the counter and must be prescribed by a veterinarian for a specific disease. But the proposal stops short of requiring the animal drug industry to make these changes. FDA believes a voluntary approach will achieve the same result—reduced use of the drugs—faster and with less disruption to the animal agri-
BUYS/BUY-INS April 2012 Sells As traZeneca a stake in development of five Amgen drugs for $50 million. January 2012 Ac quires Micromet, developer of anti body technology, for $1.2 billion. December 2011 Agrees to $400 million payment from Watson to co develop biosimilars. April 2011 Acquires Bergamo, a Brazilian drug company, for $215 million. January 2011 Buys BioVex, developer of an oncolytic vac cine, for up to $1 billion. Source: Amgen
AMGEN WILL BUY PEPTIDE FIRM KAI BIOPHARMACEUTICALS: Acquisition
adds a late-stage therapeutic to the biotech’s pipeline
A
MGEN IS PAYING $315 million for Kai Pharma-
ceuticals, a privately held biotech company developing peptide therapeutics. The deal adds to a string of purchases intended to bolster the big biotech firm’s pipeline and technology portfolio. The centerpiece of the latest acquisition is KAI-4169, a therapeutic peptide for the treatment of hyperparathyroidism in people undergoing dialysis for chronic kidney disease. An intravenous version of KAI-4169, a calcium-sensing receptor agonist, is poised to enter Phase III trials, and Amgen will give Kai a loan before the deal closes to allow the clinical development to move forward. South San Francisco-based Kai is also developing the drug in a transdermal form, which is in earlier-stage trials. Amgen has vast experience in the nephrology market. One of its top-selling drugs, Epogen, is used to WWW.CEN-ONLIN E .ORG
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culture and drug industries than would a formal ban, according to Michael R. Taylor, FDA deputy commissioner for foods, who spoke at an April 11 briefing. The proposal drew mixed reactions from the veterinary drug and food industries. The Animal Health Institute, a trade group that represents veterinary drug manufacturers, says it supports the involvement of a veterinarian when antibiotics are given to food animals. But the National Pork Producers Council says the effort will “disproportionately affect small producers, have a negative effect on animal health, and increase the cost of producing food while not improving public health.” According to the plan, industry will voluntarily phase out use of antibiotics for growth promotion in animals within three years. If a ban on the growth-promoting use were implemented, FDA would likely face decades of litigation and millions of dollars in related costs, Taylor stressed. Moreover, he said, drug companies and animal producers are committed to making the changes. Not everyone is convinced. “We have no reason to believe that the veterinary pharmaceutical industry” will cooperate with FDA on a plan that could reduce industry profits, says Margaret Mellon, senior scientist at the Union of Concerned Scientists, an advocacy group. Likewise, Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, calls the proposal “tragically flawed” because it relies on industry to act voluntarily in the interest of consumers. FDA is accepting comments on the proposal and hopes to finalize it by early next year.—BRITT ERICKSON
treat anemia in people with chronic kidney disease. Epogen sales have fluctuated in the past five years after high doses of the treatment were linked to serious side effects. Furthermore, Epogen is one of several Amgen products expected to encounter competition from biosimilars as early as 2015. Although a path to market for generic versions of biologics is still being worked out in the U.S., competitors are plowing ahead: In January, Hospira launched a Phase III trial of a biosimilar version of Epogen. With biosimilars advancing, Amgen has been using a variety of strategies to bolster its pipeline and technology portfolio, expand its global presence, and do more with a smaller R&D budget. Earlier this month, for example, Amgen sold AstraZeneca a stake in the development of five clinical-stage monoclonal antibodies. That agreement, under which AstraZeneca paid Amgen $50 million up front and agreed to take on a healthy chunk of the costs to commercialize the drug candidates, allows the companies to share the risks of developing new drugs. Analysts are reacting positively to Amgen’s recent spate of deals, all mid-sized mergers and acquisitions (M&A) ranging up to $1 billion in value. “We hope that Amgen will get more aggressive on M&A in the years ahead,” Citigroup biotech stock analyst Yaron B. Werber said in a note to investors earlier this year.—LISA JARVIS
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