Continuing its saga of manufacturing woes, Genzyme has decided to outsource some of the fill and finish work for four of its major drugs to Hospira.

Genzyme also has transferred some of this work, previously done at its troubled Allston Landing, Mass., facility, to its own state-of-the-art plant in Waterford, Ireland.

Because it will take the FDA an estimated six to eight months to approve the fill and finish process for the Genzyme drugs at Hospira, however, this transaction is not expected to jump-start increased production of the four drugs.

In a Form 8-K filed with the Securities and Exchange Commission on Dec. 28, Genzyme said Hospira will perform fill and finish work for Cerezyme, Fabrazyme, Myozyme and Thyrogen at an undisclosed location under a contract that runs through 2015. The agreement also includes an automatic two-year extension unless the collaboration is terminated by either party before Dec. 31, 2015.

No financial terms of the deal were disclosed. Hospira declined to comment for this story.

Headquartered in Lake Forest, Ill., Hospira is a specialty pharma that also performs contract manufacturing work for other biopharma companies. In October, the firm announced the recall of certain lots of the anesthetic propofol and the parenteral nutrition drug Liposyn because of shipments that contained particulate matter believed to have originated from stainless steel equipment used in making the two products ([A#08430110001]).

A Genzyme spokesman said the firm is not disclosing which Hospira facility will do the fill and finish work but specified that it will not be the location involved in the October recall. The companies currently are engaged in technology transfer needed for the FDA approval and commercial manufacture of the four drugs.

Genzyme recently endured its own problems with particles showing up in products. Although no recall was issued, Genzyme notified the medical community in mid-November that certain lots of Cerezyme and Fabrazyme might be contaminated with metal particulates, colored and transparent fibers, rubber-like particles and bits of glass (Also see "FDA Inspection Of Genzyme Plant Finds Lack Of Follow-up, Old Equipment, Poor Personnel Qualification" - Pink Sheet, 30 November, 2009.). That finding followed a six-week shutdown over the summer of the Allston Landing plant due to viral contamination, which led to a shortage of Cerezyme and Fabrazyme, therapies for the rare enzyme replacement disorders Gaucher disease and Fabry disease, respectively.

Some fill/finish work transferred to Irish facility

In a supply update issued Dec. 15, Genzyme noted that it already had moved fill and finish work for 400 unit vials of Cerezyme to its Ireland facility. It also plans to transfer this work for 200-unit Cerezyme vials and other drugs, including Fabrazyme and Myozyme 160 L, to Waterford, the spokesman noted. The agreement with Hospira is intended mainly to increase Genzyme's capacity for providing those products to patients. "We want to preserve our options to have redundant capacity," he explained.

Any Cerezyme and Fabrazyme made since Allston Landing went back into production in late August is being shipped and the initial manufacturing work for those two drugs will continue there. All Myozyme production has been transferred to Belgium. Genzyme anticipates filling all patient need for Cerezyme - the only drug approved in the world for Gaucher - this quarter, and for Fabrazyme - the only FDA-approved product for Fabry - during 2010, Piela said.

Fabrazyme currently is being shipped at 30 percent of demand. Genzyme hopes to ramp up to between 70 percent and 100 percent of demand during the second quarter and plans to update the Fabry community on its progress in February.

Genzyme received a Form 483 from the FDA in mid-November following a five-week inspection of Allston Landing. The report included observations about facilities, systems, process equipment, fill/finish operations, environmental controls, investigations and supporting documentation, and employee training, but did not call for shutting down the plant.

The Cambridge, Mass., biotech says it is undertaking a two-year corrective action plan to address the FDA observations, including hiring a quality compliance consulting firm to help transition the site toward Good Manufacturing Practices and quality compliance.

Potential competitors circling Genzyme

Genzyme has strong incentive to reestablish full supply of Cerezyme and Fabrazyme as other companies are moving forward with potential competitors to the two drugs. UK-based Shire has a Feb. 28 PDUFA date for its Gaucher drug, velaglucerase alfa ( Vela ), and also is working to obtain U.S. approval of its EU-approved Fabry drug, Replagel .

Also in the competition is Israel-based Protalix, which recently licensed its plant-cell derived Gaucher drug taliglucerase ( Uplyso ) to Pfizer for worldwide commercialization (Also see "Pfizer Thinks Small: Partnership With Protalix On Gaucher Drug Eyes Cheaper Plant-Based Production" - Pink Sheet, 7 December, 2009.). To aid Pfizer's efforts, Protalix last month hired Sandra Lauterbach, formerly Genzyme's senior director of global marketing for Fabrazyme, as its VP of sales and commercial affairs. Immediately before joining Protalix, she was VP of marketing, endocrinology, at EMD Serono.

Both Vela and Uplyso are being provided to U.S. patients under emergency early-access programs due to the shortages of Cerezyme and Fabrazyme.

-Joseph Haas (j.haas@elsevier.com)

Genzyme To Contract Out Fill And Finish Responsibilities For Four Drugs To Hospira

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