Boston Globe / April 18, 2001 / By Naomi Aoki, Jeffrey Krasner and Anthony Shadid
The U.S. system for handling and transporting grain -- an infrastructure that has evolved over a century -- probably can not handle separating biotech crops from non-biotech crops, said James A. Bair, vice president of the North American Millers Association.
While well equipped to move huge quantities of grain, "it's not a good system for differentiating intrinsic traits," Bair said yesterday at a meeting of food processors and food industry representatives in Washington.
The discovery last year of StarLink, an unapproved variety of genetically engineered corn, highlighted the difficulties in separating crops with different traits. StarLink, which was not approved for human consumption, showed up in taco shells and other food products, requiring costly recalls.
Bair predicted that the difficulty in separating biotech and non-biotech crops would mean that food free of genetically engineered ingredients would become more expensive and harder to find in the next five to 10 years.
Schering-Plough Corp. has asked the U.S. Food and Drug Administration to broaden the uses for Clarinex, the successor to blockbuster allergy drug Claritin, to cover both seasonal and perennial allergic rhinitis.
The company received an "approvable" letter in January from the FDA indicating that Clarinex 5 mg tablets will probably be approved for the treatment of seasonal allergic rhinitis and is awaiting final regulatory approval.
In the meantime, the company has asked to expand the breadth of the approval to allergic rhinitis. The broader heading would cover the seasonal allergies to pollens and molds as well as yearlong allergies to dust mites and animal dander.
If granted, the broader approval could benefit Sepracor Inc., the Marlborough company that helped develop Clarinex.
Doubts still linger, however, about the new version of the allergy drug. Some analysts question whether Clarinex is better than its predecessor, saying it could face stiff competition from less-expensive allergy drugs and from generics when the patent for Claritin expires.
Shares in Sepracor closed up $1.94 to $39.95 on the Nasdaq Stock Market yesterday. The shares have fallen 50 percent this year. Shares in Schering-Plough closed up 31 cents to $36.76 on the New York Stock Exchange. The shares have fallen 35 percent this year.
Genzyme General yesterday announced that DaVita Inc., which operates a large chain of dialysis centers and hospital dialysis services, will start providing its patients with Renagel.
The move could further accelerate sales of Renagel, which helps control the phosphorus level in the blood of dialysis patients. In February, Genzyme estimated Renagel would generate revenues of between $120 million and $130 million this year.
Genzyme General, a unit of Genzyme Corp. of Cambridge, said that about 25,000 of DaVita's 41,000 patients may end up using Renagel. "DaVita's decision is further validation that Renagel is fast becoming a standard component of dialysis treatment," Mike Raab, general manager of Genzyme General's Renal Program, said in a statement.
Dialysis is a process that mechanically purifies the blood of patients with poor kidney function. But while dialysis removes most waste products from the blood, it cannot reduce high levels of phosphorus. Elevated phosphorus levels, in turn, can cause heart disease, bone disease, and other complications. Genzyme says other phosphorus binders on the market use calcium, which Genzyme says can hurt patients. Makers of calcium-based phosphorus binders have disputed those claims.
DaVita, based in Torrance, Calif., operates 486 dialysis stations in 32 states and Washington, and provides dialysis services in 285 hospitals.
Genzyme acquired Renagel through its $1 billion acquisition of GelTex Parmaceuticals Inc. last year. Renagel is considered a key product for the firm, which has been heavily dependent on the drug Cerezyme, which is used to treat Gaucher disease.
Genzyme shares are highfliers in a largely dismal market for biotech firms. The company's shares yesterday rose $5.42 to close at $105.46. Over the past 12 months, the shares have jumped from $40.75, an increase of about 160 percent.
