Heart attack drug back on track after manufacturing issues

By Emilie Reymond

- Last updated on GMT

Related tags: Manufacturing

Biotech contract manufacturer Diosynth and PDL Biopharma have
extended their agreement for the commercial supply of PDL's heart
attack treatment Retavase (reteplase), a move that signals the end
of manufacturing issues PDL experienced with the drug.

The resumption comes a few months after PDL announced it had to halt the commercial production of the drug because of manufacturing issues with "one of its contract manufacturers", without naming which.

At the time, the company said the drug was being manufactured through a multi-step process, including custom materials from Diosynth, Centocor and Roche, although indicated that all the manufacturing would eventually be migrated to Diosynth.

Therefore, the recent announcement of an extended supply agreement between PDL and Diosynth suggests that Diosynth was the contract manufacturer involved and that the production of Retavase by Diosynth has now been restarted after it managed to resolve either some or all of the manufacturing issues.

Diosynth refused to comment on the matter, while Centocor and Roche were unavailable for comment.

During the first six months of 2006, PDL's contract manufacturer for Retavase experienced excess costs related to manufacturing difficulties as a result of higher than expected batch failure rates.

"The manufacturing of this product is complex, time-consuming and expensive and historically subject to periodic batch failure because of the complexity of the manufacturing process,"​ said PDL back in September.

"As a result, we and that contract manufacturer have agreed to temporarily cease Retavase manufacturing and run three test batches under change order to extensively sample and analyse the process prior to making potential improvements."

PDL said at the time that it was discussing with its contract manufacturer about an amended supply agreement in connection with these higher than expected batch failure rates.

This manufacturing resumption is good news for PDL just a few weeks before it announces its fourth quarter results. The firm took a hit in the second quarter of 2006 due to a $2.5m (€1.9m) charge associated with analysing and improving the Retavase manufacturing process, which had a negative impact of 6 per cent of the firm's margins in that period.

The company also expected to incur additional expenses during the remainder of 2006 related to resolving these manufacturing issues of approximately $2m.

Although PDL said it currently has enough inventory of Retavase to meet commercial demand through mid-2008, its inability to reduce batch failure rates and timely and efficiently manufacture Retavase could have been harmful for the company.

What remains to be seen is whether PDL can get back on its feet with Retavase, despite fierce competition from other biotech companies, a decline in the thrombolytic market and plummeting sales.

Related topics: Contract Manufacturing & Logistics, QA/QC

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