Antigenics Responds to Column
Re: Antigenics' Pipeline Looks Like a No-Go
To the editor:
After reading your June 13 article, Antigenics' Pipeline Looks Like a No-Go, I thought it would be appropriate to introduce myself and address the opinions outlined in your article.
Let me say from the outset that I am very disappointed Antigenics (AGEN:Nasdaq) was not contacted for comment. Going forward, I hope the company will have an opportunity to address questions posed by RealMoney.com.
There are several points in the story that I feel compelled to address:
"The best chances for acceptance are in Europe, where Oncophage faces competition in a fragmented market."
Renal cell carcinoma (RCC) affects approximately 60,000 patients in the U.S. and Europe. The American Cancer Society estimates that there will be approximately 36,000 new cases of kidney cancer in the U.S. in 2005, and about 12,660 people will die from the disease this year. As you may know, RCC accounts for about 85% of all kidney-related tumors.
Physicians and patients in the U.S. and Europe face limited options. The current standard of care for patients with non-metastatic RCC consists of a nephrectomy, meaning the surgical removal of the kidney, followed by observation. Once the kidney is removed, if the disease returns, there are no treatment options left for the patient.
Your assumption about the market being fragmented is incorrect. In fact, the patient pathways are well defined; we have identified the key centers across the globe; the value of the U.S. market alone is approximately $500 million; and there is a high unmet medical need in the adjuvant setting.
Unfortunately, you do not provide any reasons behind why Europe offers Antigenics a better chance for approval. To obtain regulatory approval in the U.S. or Europe, our Phase 3 RCC trial must be carefully controlled, well designed and demonstrate that Oncophage is safe and effective. Our current trial is designed to show that patients being treated with Oncophage have a statistically significant benefit in recurrence-free survival over patients in the observation arm. We expect to announce top-line results from this trial by year-end.
"I do not see a viable future business for Antigenics with its current late-stage product pipeline."
As you know, Oncophage is in Phase 3 clinical trials in both RCC and melanoma. Oncophage has been granted FDA fast track and orphan drug designations in both indications. The RCC trial, taking place at 132 centers worldwide and involving more than 800 patients, is the most extensive study of adjuvant therapy in patients with RCC to date, as well as the largest clinical trial of any patient-specific treatment tested.
In Phase 2, AG-858 (referenced in the article as HSC-858) is a personalized therapeutic cancer vaccine for the treatment of chronic myelogenous leukemia (CML). The current standard of care for CML is treatment with Gleevec, a product with sales in excess of $1 billion.
In addition to our ongoing clinical trials, this year we will be filing a new IND for AG-707 (genital herpes) and a new protocol to initiate a Phase 1 study of Aroplatin (advanced solid malignancies). The incidence rate for genital herpes in the U.S. is 45 million with approximately 400,000 new cases per year. With limited treatment options -- four marketed products that treat symptoms only -- the market is valued at $2 billion in US sales.
Aroplatin is a third-generation platinum chemotherapeutic structurally similar to oxaliplatin, a Sanofi-Aventis product that is projected to sell in excess of $1 billion this year. In our laboratory studies comparing Aroplatin to oxaliplatin, we showed that Aroplatin suppressed tumor growth, caused a reduction in tumor size, and provided a 50% increase in survival as compared to control animals. This data represents a five-fold improvement to results seen from the oxaliplatin arm of the study.
Oncophage has also been studied in other cancers, including colorectal cancer, non-Hodgkin's lymphoma, pancreatic cancer and gastric cancer. Data from these trials have been published in peer-review journals and presented at oncology conferences around the world.
I believe the article fails to consider the true value behind our pipeline. The applicability of our core technology is transferable across many disease settings including oncology, infectious diseases and autoimmune disorders such as multiple sclerosis and Type 1 diabetes. Adding to our blockbuster potential with Oncophage, we believe that Aroplatin has advantages for the treatment of certain cancers when compared with current platinum-based chemotherapeutics.
"While this sounds like a great idea, it may not be, for several reasons -- not the least of which is that product processing logistics are challenging, margins lower and distribution channels nonstandard. As a result, securing a commercialization alliance with a major pharma company, a move that is usually accomplished by phase II clinical trials for other therapeutics, is difficult."
In this paragraph, I feel you have potentially misled readers on how Oncophage will be manufactured and distributed. There are a finite number of medical centers in the U.S. and Europe that perform nephrectomies. After the physician removes the kidney, the tumor material is frozen and sent to our facility in Lexington, Mass. for processing, using a well-established delivery service.
The assertion on lower margins is incorrect. We have published our costs, which are similar to or below the costs of most biologics.
In conclusion, I understand the comments made in your article are opinions. But as a result of not contacting Antigenics for comment, your story is regrettably flawed on several key points.
Regards,
Sunny Uberoi, vice president of corporate communications, Antigenics, New York. (Received June 17, 2005) |
