
Roche winning on Perjeta supply, but running short of Boniva
pharmafile | August 20, 2012 | News story | Manufacturing and Production, Sales and Marketing | Boniva, Perjeta, Roche, breast cancer
Roche is getting production for its new breast cancer drug Perjeta back on track after some initial teething troubles, but now says it is facing shortages of osteoporosis therapy Boniva.
Perjeta (pertuzumab) was launched in the US in June for use alongside Herceptin (trastuzumab) and docetaxel in patients with advanced or locally recurring breast cancer that has not previously been treated with chemotherapy, and received its first European approval last week in Switzerland.
The approval by the FDA was granted despite manufacturing problems, which looked set to peg back Roche’s ability to supply the drug.
The cell culture used to make the active ingredient in Perjeta was being compromised by low yields, but Roche says it has now largely resolved the issue.
Perjeta was also endorsed recently by the National Comprehensive Cancer Network (NCCN), which publishes treatment guidelines that are used across the US.
Roche’s drug was given a category 1 classification – the highest available – as the preferred therapy in combination with Herceptin for metastatic breast cancer, which is likely to add to its growth momentum.
Thankfully for Roche, the low yields affected cell culture strains being used in production, but not the master cell line from which they were derived.
“We resolved the issues, and that is also why we are so confident that we can fully supply Perjeta”, commented Roche chief executive Severin Schwann, during the firm’s second-quarter results call.
Meanwhile, Roche also said that manufacturing issues at its facility in Florence, South Carolina – which have impacted the supply of obesity drug Xenical (orlistat) and Mircera (methoxy polyethylene glycol-epoetin beta) for anaemia – are also being addressed.
A block on release of products from the plant into European markets looks set to be relaxed within a couple of months, the company said, which says it has implemented a major remediation programme at the plant to make sure the issues does not recur.
Boniva in short supply
One unanticipated manufacturing issue at Roche, however, is a shortage of its osteoporosis drug Bomvina/Boniva (ibandronate), thanks to lower-than-expected generic competition in the US, according to a FiercePharmaManufacturing report.
Boniva lost patent protection in the US in March and Roche’s subsidiary Genentech was expecting significant levels of generic competition to the drug, which in the end failed to materialise.
“When a generic product did not enter the market, we experienced a stock out due to actual demand exceeding our forecast”, said a company spokesman, who added the firm hopes to be able to meet demand by the middle of September.
Boniva had sales of almost 700 million Swiss francs ($718 million) last year, already down around 22% thanks to generic rivals outside the US.
Phil Taylor
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