Genentech delays Avastin ban for wet-AMD US biotechnology company

Genentech will delay a plan which would make it harder to repackage its Avastin (bevacizumab) cancer drug as a cheaper, alternative treatment for wet, age-related macular degeneration (wet-AMD).

In early October 2007, Genentech said it would ban purchases of Avastin by US independent compounding pharmacies, which currently divide vials of the medicine as a replacement for Lucentis (ranibizumab) in wet-AMD, which is the leading cause of blindness in the elderly.

Genentech posted a letter on its company website, saying it would postpone the ban until the beginning of 2008. The original ban was to start at the beginning of November 2007.

The company proposed the ban after senior executives met with the American Academy of Ophthalmology and American Society of Retina Specialists. The postponement, says Genentech, will allow doctors time to develop transition plans.

Genentech revealed, however, that it would reinstate its supply of Avastin to compounding pharmacies, if the FDA authorised the company to do so. The FDA had raised concerns about the off-label use due to sterility issues, added Genentech.

Many doctors use Avastin off-label to treat wet-AMD because Lucentis costs more than USD 2,000 per treatment, while Avastin only costs around USD 150.

As Lucentis is so expensive, and because pharmacoeconomic concerns are high on the US Federal government agenda, the FDA may indeed authorise continued off-label use of Avastin for elderly patients who may not be able to afford Lucentis on their health insurance schemes.

Analyst comment

At the beginning of 2007, Genetech advised that sales trends for Lucentis, which was approved in 2006 for wet-AMD, should be viewed with caution since prescribing patterns had yet to be established.

Genentech reported Lucentis sales of USD 198m in Q3 FY07, a decline of 5.3 per cent on Q2 FY07.

On 17 October, Caris & Company analysts lowered their FY08 Lucentis sales expectations from USD 850m to USD 742m. The analysts believe this was related to data from the phase III PRONTO trial, which demonstrated that patients only required 5.6 injections in the first year, when Lucentis was used as needed, compared with monthly injections.

Despite the slowdown, the analysts added that the long-term outlook for Lucentis was attractive given the drug's potential in diabetic macular oedema. The market could be as large as that for age-related macular degeneration.