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The CEO’s Blog — Garo H. ArmenRSS Feeds
I have always believed in open and transparent dialogue in which to share observations and opinions about the company. Given that we live in an age of instant and global communication, my hope is that this blog will encourage connectivity between our constituencies and enable me to respond directly to your comments and questions.Through this forum, my intention is to share the direction of the company, increase the understanding of our business, and provide insights and lessons learnt since our inception. Periodically, I will also provide my commentary on developments affecting the industry and how they relate to Antigenics.
Jul 31, 2008Antigenics Earnings Call This morning we announced our second quarter 2008 financial results. Enclosed is my script from the call outlining the company’s recent activities and the progress being made around our core technologies. View full posting and legal disclaimer | View Comments
Jun 25, 2008Antigenics Update Since our announcement that Oncophage was approved in Russia, I have received lots of inquiries from concerned stakeholders, and rightfully so, as to why our stock price is below the levels prior to approval of our personalized cancer vaccine. Unfortunately, I don't know the answer and there are certainly no fundamental reasons that I am aware of which could account for this. On a more positive note, we continue to make steady progress for the launch of Oncophage in Russia. There are a number of administrative procedures (such as distributor agreements as well as placing freezers in hospitals, etc.) that are being attended to with the highest sense of urgency by our team here and in Russia. This continuous effort will help us prepare for the launch of Oncophage in Russia before the end of the year. View full posting and legal disclaimer | View Comments May 01, 2008Antigenics Earnings Call This morning we announced our first quarter 2008 financial results. Enclosed is my script from the call outlining the company’s recent activities and accomplishments. Garo Armen As I’m sure you are all aware, Antigenics recently announced the approval of Oncophage in Russia for the treatment of renal cell carcinoma, or RCC, patients at intermediate-risk for recurrence. This is the most substantive accomplishment in our company’s history as we start our transition from a biotech R&D company to a commercial entity. We are proud to be among the very few biotech companies ever to bring to market the product that the company was founded on. Even more importantly, this is the first ever formal regulatory approval of a patient-specific therapeutic cancer vaccine. Now patients with nonmetastatic RCC will have an approved treatment option post-surgery and that too is the first ever anywhere in the world. View full posting and legal disclaimer | View Comments April 08, 2008Oncophage receives its first regulatory approval This morning we announced that Oncophage is registered in Russia for patients with intermediate-risk kidney cancer – representing an important therapeutic advancement for patients at risk for disease recurrence. The Russian medical system is advancing at an incredible rate, with a number of state-of-the-art facilities and skilled medical professionals already in place. A number of key questions about how we anticipate commercializing Oncophage in Russia come to mind, but before addressing them, let me comment on what we have accomplished. Ever since we announced our Russian filing we have been reminded about the fact that there has been little or no precedent for such approval on a number of grounds: (1) first approval of a novel therapeutic in Russia which has not yet been approved elsewhere; (2) first approval of a personalized cancer vaccine anywhere in the world; and (3) acceptability of data from a subset analysis. While these are all valid points, what is fundamental is that there could be no innovation in any field if one only pursued that for which there is precedence. View full posting and legal disclaimer | View Comments January 25, 2008Why I believe in Antigenics I have spent much of the past six months traveling to Russia and Europe meeting with key opinion leaders in the fields of oncology and urology; working on the details of a potential launch of Oncophage in Russia; and seeking to raise funds to support these operations. Last week we announced that Antigenics raised $26.1 million through a private placement of common stock and warrants. I am particularly gratified that our investors represent a sophisticated group of institutions with substantial expertise in health care. I have received a number of questions as to why I decided to invest $5.1 million, and the simple answer is: my belief and confidence in the company. View full posting and legal disclaimer | View Comments August 2, 2007Antigenics files for Oncophage® approval in Russia Why did Antigenics decide to first file Oncophage for registration in Russia? I have carefully considered this question over the last 12 months. When we first discussed this idea with several individuals, whose opinions I trust implicitly, their first reaction was also “Why Russia?” They made me feel somewhat unpatriotic! The issue was how could a product that has been developed by a US company at a cost of nearly $500 million be first introduced in Russia? The simple answer is that Russia currently offers a more promising commercial pathway for patients to have access to Oncophage than the US. Clearly we are driven by our conviction that our vaccine, Oncophage, provides significant and meaningful improvement in an important subset of kidney cancer patients. This subset is believed to be the logical target for cancer vaccines – a conclusion shared by key experts around the world. In spite of this, however – and this is a big “however” – subset analysis does not conform to the strict statistical standards as currently applied to the drug approval process in the US, irrespective of how logical the subset and how significant the benefit to the patients may be. View full posting and legal disclaimer | View Comments June 25, 2007QS-21 and Oncophage® Following Antigenics’ recent announcement that GlaxoSmithKline is launching a Phase 3 study in lung cancer evaluating its MAGE-A3 therapeutic cancer vaccine, GSK stated on Monday 18th June during a GSK oncology seminar that the first patient is expected to enroll in September. How does this benefit Antigenics? This represents one of more than 20 QS-21 containing vaccines currently in development by Antigenics’ licensees. Currently a profitable product, our license and supply agreements for QS-21 provide revenues for Antigenics and royalties post-commercial launch for at least 10 years thereafter, irrespective of patent expiries. Therefore, GSK’s new Phase 3 trial – the largest lung cancer trial ever conducted, enrolling 2,270 patients at 400 centers in 37 countries – could generate additional royalties for Antigenics in a near-term timeframe. View full posting and legal disclaimer | View Comments March 30, 2007Yesterday afternoon, an advisory panel of the US Food and Drug Administration (FDA) voted 13-4 in favor of approval of Dendreon’s prostate cancer vaccine, Provenge. This is a landmark event in the emerging field of cancer vaccines, demonstrating not only the clinical potential of this class of treatments but also signs of increasing regulatory flexibility that may help other promising cancer vaccines reach patients in a reasonable timeframe. As committee member Francesco Marincola, an immunologist with the National Institutes of Health, noted, “This opens up a whole new field of vaccine therapy that is very promising.” Provenge and Antigenics’ cancer vaccine Oncophage are both patient-specific. Provenge is a cell-based therapy comprised of the patient’s own dendritic cells (specialized immune cells) that are processed to display a ‘shared’ antigen that is common to 95 percent of prostate cancers. Evaluation in late-stage prostate cancer patients shows a survival benefit of about 4.5 months. Oncophage is a sterile protein preparation comprised of the unique ‘antigenic fingerprint’ purified from the patient’s own tumor cells. It is being evaluated to prevent disease recurrence in earlier-stage kidney cancer patients, which has the potential to have a longer-lasting effect on survival compared with the current paradigm of treatments primarily for later-stage cancer patients. Like most therapeutic cancer vaccines, both Provenge and Oncophage are regarded as generally safe and well tolerated. Below I’ve outlined some key points about yesterday’s positive panel vote on Provenge and the implications for our clinical development plans for Oncophage. View full posting and legal disclaimer | View Comments March 07, 2007Presenting at the Cowen Health Care Conference We put out an announcement this morning regarding my upcoming presentation at the Cowen conference next Tuesday, March 13, at the Boston Marriott Copley Place at 3:15 p.m. During the presentation, I will cover how new developments underpinning the global vaccine business are transforming the industry and how Antigenics expects to participate in this significant growth through our pipeline of proprietary products as well as through our adjuvant QS-21, which is being used by major players in the vaccine marketplace:
I will also cover our investigational chemotherapeutic product Aroplatin, which is finishing Phase 1 trials. Our homepage also lists reports from brokerage houses and consulting firms outlining how a new generation of preventative and therapeutic cancer vaccines are creating a new and vibrant vaccine business. Many of our collaborators are the leaders in this emerging field of new generation of vaccines and we are excited about the opportunities this presents for Antigenics through multiple products and platforms. I look forward to seeing those of you attending the conference or having you listen to the webcast. View full posting and legal disclaimer | View Comments February 26, 2007Last week we announced our 2006 year-end financial results and corporate update, in which I outlined the expected growth in cancer vaccines, the hints of potential positive regulatory change and highlights from the company’s pipeline. I welcome your comments and look forward to engaging directly in a dialogue with you. In 2006, Antigenics solidified its position in the growth of the emerging vaccine market. The vaccine marketplace is now proclaimed as the highest growth segment of the pharmaceutical market for the next 10 years in recent reports published by several prominent brokerage houses and consulting firms. In addition, and more specifically for cancer vaccines, there are hints of potential positive regulatory change. An indication of this was a recent two-day workshop held jointly by the US Food and Drug Administration (FDA) and the National Cancer Institute (NCI). During this workshop, the NCI director stated, “We have to make rather dramatic changes on how we are going to do drug approvals in the future” – a reference made specifically about the approval of cancer vaccines. |
