Wyeth-Ayerst plans to manufacture the rheumatoid arthritis therapy Enbrel at a West Greenwich, R.I. biopharmaceutical facility purchased from Glaxo.

Glaxo Wellcome is discontinuing the lymphoblastoid interferon alfa-n1 product Wellferon, which was produced at the Rhode Island site.

Wyeth parent American Home Products is purchasing the facility for $60 mil., "conditional on regulatory transfer of various permits." The sale "is expected to be completed by the end of September," Glaxo said. The announcement comes shortly after rumors appeared in the lay press that AHP and Glaxo were in merger talks.

The acquisition of the site will bring expanding Enbrel manufacturing into AHP's purview. The injectable tumor necrosis factor therapy will still be manufactured by Boehringer Ingelheim Pharma in Biberach, Germany and packaged by Cardinal's PCI subsidiary (¹ Also see "Immunex/Wyeth Enbrel Launch Price Is $10,400 Per Year" - Pink Sheet, 9 November, 1998.). Enbrel approval was tied to several post-marketing commitments associated with the German facility.

A U.S. primary production site for Immunex/Wyeth's Enbrel (etanercept) could also facilitate uptake as it adds indications. Enbrel was approved in November 1998 for treatment of moderate to severe RA patients who did not respond to prior antirheumatic therapy.

An indication in juvenile RA followed in May, and a supplemental BLA was filed in July for early, active RA. The firm is conducting Phase II/III trials in chronic heart failure patients. In the first quarter of 1999, the product garnered sales of approximately $60 mil.

The decision to sell the West Greenwich facility emerged from "a strategic review of the commercial and manufacturing viability" of Wellferon, Glaxo said.

Glaxo highlighted declining demand for Wellferon "as alternative treatments become available." By terminating the product, Glaxo will forego capitalizing upon the March 25 clearance of a hepatitis C indication (² Also see "Glaxo Wellferon Launch For Hepatitis C Awaits Manufacturing Change" - Pink Sheet, 5 April, 1999.).

Wellferon generated $30 mil. in revenues in 1998, Glaxo said. While licensed in 40 countries, Wellferon is only actively marketed in four: Spain, Italy, Singapore and Taiwan.

Wellferon was first approved in the U.S. in 1988 for use in hairy cell leukemia and human papillomavirus. In the U.K., the product is also indicated for chronic active hepatitis B and chronic myeloid leukemia.

In the chronic hepatitis C arena, Wellferon competes with Schering-Plough's Intron A (interferon alfa-2b) and Rebetron (interferon alfa-2b/ribavirin). Intron A also carries indications for hepatitis B, hairy cell leukemia, malignant melanoma, condylomata acuminata and AIDS-related Kaposi's sarcoma.

Additional competitors include Amgen's Infergen (interferon alfacon-1), which is indicated as first-line therapy for hepatitis C and for Intron A failures, and Roche's Roferon-A (recombinant interferon alfa-2a) which carries indications for chronic hepatitis C, hairy cell leukemia and KS. A supplemental BLA in malignant melanoma has been pending since August 1997.

Both Schering and Roche are planning filings for pegylated interferon products in 1999-2000. Schering's PEG-Intron A is in Phase III trials as monotherapy and in combination with Rebetol (ribavirin). Roche is conducting a pivotal Phase II study of Pegasys in cirrhotic patients and two Phase III trials comparing Pegasys with the interferon alfa standard dose and induction regimens (³ Also see "Roche Pegasys Once-Weekly Peginterferon Filing Is Set For Early 2000" - Pink Sheet, 28 June, 1999.).

With the Wellferon hepatitis C approval in March, Glaxo said that launch would await implementation of a manufacturing change supplement.

In addition to the West Greenwich facility, the other primary production site for Wellferon is Porrino, Spain. Secondary production sites for Wellferon are located in the U.K.: purification and production of final bulk product take place in Beckenham and filling, labeling and packaging are performed at Dartford.

Glaxo's U.K. production facilities for Wellferon "will also cease manufacture of the product over the next few months, but the other biopharmaceutical manufacturing and development facilities in Beckenham will be unaffected," the company said.

Beckenham activities include manufacture of the digoxin antibody Digibind. Therapeutic Antibodies submitted a PLA Aug. 6 for a competitor, DigiTAB, which Altana will market (⁴ Also see "Therapeutic Antibodies DigiTAb" - Pink Sheet, 16 August, 1999.). Glaxo is also conducting a development program in novel vaccines at Beckenham.

Wyeth-Ayerst To Produce Enbrel At Former Glaxo Wellferon Site

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