Lilly is discontinuing production of Humulin U Ultralente and Humulin L Lente human rDNA-based insulins by the end of 2005 due to declining demand for the products, the company announced July 6.

"Use of these longer-acting insulins has declined by more than 70% over the past five years due to newer insulin therapies that have increased the number of treatment options for patients," Lilly says in a ^FDL-1 'Dear Doctor' letter on the Humulin products.

"Less than 2% of the patients with diabetes who use insulin in the U.S. will be impacted by this discontinuation," the letter states.

Of the 3.5 mil. diabetics in the U.S. that use insulin, Lente and Ultralente are currently used by only 44,000 and 22,000 patients, respectively, the company said.

The firm similarly plans to discontinue production of Iletin II and NPH Iletin II pork insulins due to declining commercial demand.

The two pork insulins are used by approximately 2,000 patients, Lilly said in a separate ^FDL-2 letter on the Iletin formulations.

Labels on all vials of the affected insulin products that are shipped after mid-August will include a statement that they are being discontinued. The company anticipates that product will be available in pharmacies until the end of December.

To aid the transition of patients to other insulin therapies, the firm is distributing "LillyScripts" coupons to prescribers.

The coupons allow patients to obtain a free sample of alternative Lilly insulin products, including Humalog (insulin lispro injection) and Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection).

Lilly's diabetes product portfolio includes the non-insulin products Actos (pioglitazone), which it co-markets with Takeda, and Byetta (exenatide), co-marketed with Amylin.

Lilly said its Iletin insulins are the last animal-based insulins manufactured in the U.S. Patients for whom non-animal insulins are contraindicated may petition FDA for permission to import animal-based insulin for personal use, the agency said.

Although Lilly is citing commercial reasons for discontinuing the four insulin products, the company has encountered manufacturing issues in the past. Sterile diluent for the Humulin and Iletin products has been the subject of several manufacturing-related recalls in recent years due to the presence of particulates.

- Kathleen Michael

Lilly To Discontinue Two Humulins - Ultralente and Lente - By Year-End

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