Genentech Defends Its Position on Avastin and Compounding Pharmacies
■ In the November/December issue, Retinal Physician reported on the Genentech decision to discontinue Avastin sales by its wholesale distributors to compounding pharmacies. Included in that report was information on the subsequent decision, spurred by highlevel meetings held with representatives from the American Academy of Ophthalmology (AAO) and the American Society of Retinal Specialists (ASRS), by the company to delay this action until Jan. 1, 2008.
More recently, Susan Desmond-Hellman, MD, MPH, president of product development at Genentech, addressed an audience of retinal specialists attending Retina Subspecialty days at the AAO meeting in New Orleans this November.
Dr. Desmond-Hellman defended Genentech's decision and asked the retinal community to understand that, while the company is willing to work to resolve the issues that have been brought to its attention, Genentech faces significant challenges in a highly regulated industry that imposes strict penalties when industry does not comply with regulations.
Dr. Desmond-Hellman remained optimistic throughout her address, saying, "I see this as an opportunity as a step forward to a stronger relationship between Genentech and the ophthalmology community."
Dr. Desmond-Hellman acknowledged the concerns that have been raised regarding the impact Genentech's decision will have on the physicianpatient relationship, the cost of Lucentis, and access to Avastin. Above all, she said, the 2 main points that she wanted to impress upon her audience were:
► Genentech will not interfere with retinal specialists' prescribing choices. Dr. Desmond-Hellman said, "We acknowledge that, even though we never intended for Avastin to be used in the eye, [retinal specialists] are finding a role for it in treating patients. When we made our decision about the compounding pharmacies, our belief then was and our belief now is that physicians will still be able to obtain Avastin."
► Genentech is committed to patient access. Dr. Desmond-Hellman cited the patient-access program in place for Lucentis and stated that the company is working to address areas where it can implement improvements to the program based on feedback from physicians.
However, Dr. Desmond-Hellman added that Genentech "cannot jeopardize our commitment to tens of thousands of other patients who are counting on us to produce the medicines they they need by risking FDA action against us."
In his introduction of Dr. Desmond-Hellman, H. Dunbar Hoskins, MD, executive vice president of the AAO, recalled the initial response from the AAO and the ASRS. "This action by Genentech would severely reduce access to effective therapy for patients with AMD and would stifle the innovation of physicians with offlabel uses, which are the genesis of many of the treatments that we have in ophthalmology and would create a significant safety problem by taking professional pharmacy drug compounders out of the mix," he said.
However, he added, the meetings held with Genentech with representatives from AAO and ASRS have been encouraging.
|■ Ellex 2RT shows promise for early-stage AMD. Ellex Medical Lasers Limited has announced the initial positive clinical results of its continuing study for nonthermal Retina Regeneration Therapy (Ellex 2RT). The company says that the 2RT has demonstrated the potential to improve and stabilize visual acuity, while reducing retinal edema in patients with diabetic maculopathy and macular edema with no apparent damage to photoreceptors.|
At the Retinal Subspecialty Day during the Annual Meeting of the American Academy of Ophthalmology (AAO) in New Orleans this November, principal clinical investigator Peter Hamilton, MD, FRCOph, presented results of the clinical study. "The first phase clinical outcomes have confirmed Ellex 2RT's ability to treat diabetic maculopathy without damaging the neuroretina," he said. "This means that Ellex 2RT may change the way diabetic maculopathy patients are treated and shows potential for intervention in early stage age-related macular degeneration before significant loss of vision has occurred."
Peter Falzon, Ellex CEO, says that the next phase of clinical research will be essential to establishing Ellex 2RT's potential as early-stage therapy for retinal disease. RP