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Monday, Oct 29, 2007
Wednesday, Oct 31, 2007 (updated paragraph six)
Genentech recently informed the retinal community that our company would no longer allow compounding pharmacies to purchase Avastin® (bevacizumab), a Genentech-manufactured drug, from authorized wholesale distributors. Avastin is an infused medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with certain forms of cancer, though some ophthalmologists have been using it to treat various ocular diseases, including neovascular (wet) age-related macular degeneration (AMD).
The decision we communicated was not made lightly. In fact, it was guided by our company's strong commitment to take actions that are scientifically and clinically sound and in the best long-term interest of patients, while at the same time adhering to government regulations and remaining mindful of the retinal community's views.
We understood that some would disagree with our decision to stop supplying Avastin to compounding pharmacies and would accuse Genentech of making profit, not patients, its priority. Genentech's decision was not motivated by a desire for increased profits. We did not and do not expect that this change in policy toward compounding pharmacies will lead to any increase in LUCENTIS® (ranibizumab injection) sales. Further, we expect Avastin to be available and that physicians will continue to prescribe it for ocular indications.
A series of FDA actions contributed to our decision. First, the FDA raised concerns related to the sterility and repackaging of the drug for ocular use in a Warning Letter to a compounding pharmacy. Subsequently, during a routine inspection of our South San Francisco manufacturing facility, FDA inspectors raised concerns related to the ongoing ocular use of Avastin, because it is not manufactured for that use. In order to resolve the concerns raised by the FDA, we destroyed four batches of Avastin deemed unsuitable for use in the eye due to a higher visual inspection standard. (These lots would have been entirely suitable for its approved use as an intravenous cancer medication.) The action resulted in the loss of more than 350,000 vials of Avastin with a market value of more than $200 million. The implication of this event was that future supplies of Avastin would likewise be at risk of having to be destroyed. In our judgment, these FDA actions — and the potential for future similar actions — necessitated a change in our policy toward compounding pharmacies.
Genentech and the retinal community share a commitment to patients and have been working to help ensure the transition does not unduly impact patient care. To this end, Genentech senior executives met with American Academy of Ophthalmology (AAO) and American Society of Retina Specialists (ASRS) leadership to discuss the company's decision and areas for collaboration. Among the outcomes of that conversation was our agreement to make January 1, 2008, rather than November 30, 2007, the date on which Genentech discontinues the supply of Avastin to compounding pharmacies. We made this change so that affected physicians will have sufficient time to develop and implement transition plans to assure that patient care is not adversely affected. Genentech also agreed that it would reinstate its supply of Avastin to compounding pharmacies if the FDA gave the company legal and regulatory authorization to do so. Further, we discussed ways to establish an even more effective access program for non-AMD patients who seek anti-VEGF therapy.
While we can't be certain of the precise effects of any of the differences between Lucentis and Avastin, it is important to emphasize that Lucentis is purposefully different in fundamental ways from Avastin. While both drugs target and inactivate VEGF (Vascular Endothelial Growth Factor), Lucentis was engineered from the outset, because of the proposed limited space available within the eye, to bind more tightly to its target. (In fact, it binds more than ten-fold more tightly than does Avastin.) To reduce the theoretical possibility of increased inflammation in the eye, the apparent pro-inflammatory components of the antibody, present within Avastin, were removed. Finally, to facilitate the movement and distribution of Lucentis throughout the eye, and to reduce its time of circulation in the serum (where one seeks to minimize the drug's concentration, relative to the eye), the size of the molecule was reduced by more than 65 percent; this change results in a reduction of serum half-life of more than 100-fold.
It is important to highlight that Genentech has always believed that no eligible patient should go without one of our approved medicines due to financial barriers alone and that the necessary steps to obtaining assistance should be as easy as possible. Specific to Lucentis, we offer The LUCENTIS Commitment™, a comprehensive support program dedicated to facilitating timely reimbursement. In addition, the Genentech Access to Care Foundation (GATCF) provides Lucentis at no cost not only to qualified patients with wet AMD, but also to qualified patients with other ocular diseases that can lead to blindness. Genentech is working in conjunction with GATCF to make the process more efficient and to speed patient access to treatment. You should expect to see process improvements implemented by year-end. We look forward to working with the ASRS and AAO to identify other opportunities for improving the ease of access to and speed of patient assistance programs.
If physicians or patients have any questions related to our access and reimbursement services, please contact us toll-free at 1-866-724-9394.
For more than 30 years, Genentech has been and remains committed to high standards of integrity in contributing to the best interest of patients. We believe our current course of action underscores that commitment, and ensures that patients and physicians will continue to have access to safe and effective treatments.