Production problems that raised the potential for a shortage of Roche's new cancer drug Perjeta even as it was being launched in June have largely been addressed, CEO Severin Schwan told investors. That allows Roche to get on top of at least one of a number of production issues that have plagued the company.
The FDA gave the nod in June to Roche's ($RHHBY) pertuzumab, brand name Perjeta, developed by its Genentech division, for certain patients with late-stage breast cancer. At the time, Roche said it had enough supplies on hand to get the drug into doctors' hands but Roche and the FDA acknowledged that there were some problems with the cell culture used to make the active ingredient. The agency even said there was a possibility of a shortage.
But in the company's conference call with investors recently, InPharm reports that Schwann said, "We resolved the issues, and that is also why we are so confident that we can fully supply Perjeta."
The cell culture being used in production to make the active ingredient in Perjeta was compromised by low yields, reports InPharm, but the problem did not reach to the master cell line from which they were derived.
Roche also expects to resolve issues at its Florence, SC, plant that have prevented it from releasing obesity drug Xenical and anemia drug Mircera into Europe, InPharm reports. The company hopes to remove the block on those drugs in a couple of months.
But Roche continues to work on returning sufficient supplies of the injectable form of osteoporosis drug Boniva to the market. On July 31, the drug giant told the FDA that it expected to have continuous supplies of the drug to wholesalers in September. In June, Genentech said the injectable form of Boniva would be in limited supply for some weeks because the company had missed its forecast on demand for the product. Last week, a spokeswoman said the company had expected a significant falloff in demand through the year since its patent on the oral dose form of the drug lapsed in March and it now faces generic competition. The falloff didn't happen for the injectable form, however, and so it is now ramping production back up to meet demand.
- read the InPharm story
Out of the box FDA says Perjeta faces shortage challenges
Roche plant spared from sale runs into GMP issues
Roche overestimated generic impact on Boniva demand