alot of positive weekend sirtex press in us
Alot of positive weekend press appearing in US weekend business sections and health and medicine on advances in treating metastaic liver cancer. Sirtex Medical also highlighted in the prestigious and well-read Medical Technology Stock Newsletter. Sirtex also going to be highlighted in several Journals of American Oncology this coming month. I would not at all be surprised if the company probably waiting and planning a rather large press announcement to the ASX with all these results and then next step is in-licensing deal with big biotech or acquisition. Here are some excerpts from letter. MTSL: May 20, 2006 ISS 256 We are initiating coverage with a strong buy rating on the shares of Australian Biotechnology company Sirtex Medical. We will be following this company with a rather large analysis of the company in a later issue but feel the strong buy rating is warranted on the basis of the timeliness of several very compelling news items that will be forthcoming. Briefly the company is closely held with a float of only 9 million shares out of 56 million fully outstanding shares. Market capitalization is 130 million Australian .The company is involved with a hallmark product that was FDA approved to treat colorectal carcinoma that has metastasized to the liver in 2002. Survival rates in these patients when used with several new chemotherapy drugs have been shown to extend survival times up to 300% compared to chemotherapy alone. After slowly building out the company globally it now has over 75 US treartment centers where the Sir Spheres are administered to patients at the reimbursement rate of $15,000 USD per patient. It recently obtained Australian reimbursement where it administers the Sir spheres at 24 Australian hospitals. European reimbursement is coming shortly in the foreseeable future. The revenues are experiencing rapid expansion and the recent completion of a US maunufacturing facility for their product will increase the already high 85 % gross margins. The company is firmly profitable and is selling at approximated a P.E of 3x 2008 earnings of 82 cents a share at the current $2.45 price Australian. The timeliness of the recommendation is based on foreseeable licencing deals with US biotech companies who share the use of their chemo product with the Sirtex Sir Spheres. We are putting a short term price objective of $6 Australian on the shares. An acquisition of the company is entirely possible as based on the fact that the Sirtex US salesforce is only eleven and growing. In the hands of a global biotech company with a large sales force it is estimated that revenues would be in the 150-160 milllion dollars range currently with EPS of 60 million dollars. Based on EPS of $1.02 and a P.E of 10 this price of acquisition would be be in the $10 range. As Sirtex has collaborations with Aventis-Sanofi, Hoffman La Roche, and Pfizer with Genentech considered to be next, each of these companies would have advantage in owning the company outright. The following recently released announcememt give credence to the timeliness of our recommendation and at the current share price of $2.45 we believe none of this news is factored into the share price and it could rise to $4 and then $6 within 3 months. EFK; 5/20/06 BREAKING CLINICAL NEWS Landmark Study Evaluates Sirtex SIR-Spheres® Microspheres in Patients with Metastatic Liver Cancer
International journal publishes results of largest U.S. study to-date on microspheres
Lake Forest, IL. (May 18, 2006) (WSJ)– A new study, published in the June issue of the International Journal of Radiation Oncology Biology Physics, examines the use of Sirtex SIR-Spheres microspheres in patients with unresectable metastatic liver cancer. According to the study, the use of SIR-Spheres microspheres in patients with advanced liver disease resulted in a median survival of 10.5 months from treatment. Sirtex’s SIR-Spheres microspheres are the only FDA-approved radioactive microspheres for treatment of metastatic liver tumors.
"This truly is a landmark study," says Dr. David Cade, medical director for Sirtex. "The opportunity to examine the efficacy of SIR-Spheres in such a large patient population is a milestone in liver cancer treatment. At Sirtex, we are committed to improving the lives of people with liver cancer, and this study is a major advancement toward providing the best patient care."
Of the nearly 150,000 Americans diagnosed with colorectal cancer every year, at least 80 percent will see their cancer spread to the liver. Less than 20 percent of liver tumors can be surgically resected. Metastatic liver cancer is often fatal, with up to 90 percent of patients dying from liver failure. Microspheres therapy has emerged as a treatment for patients with advanced liver cancer when most other treatment options have failed.
Although Sirtex’s SIR-Spheres microspheres gained FDA approval in 2002, most studies to date have been relatively small in scope. The study published in the International Journal of Radiation Oncology Biology Physics followed 208 patients with unresectable liver metastases. Participants received high doses of radiation via Sirtex SIR-Spheres microspheres. SIR-Spheres microspheres are radioactive polymer spheres that emit beta radiation. Physicians insert a catheter through the groin into the hepatic artery and deliver millions of microspheres directly to the tumor site. The microspheres target the liver tumors, sparing healthy liver tissue.
In the study, participants were divided into two categories: responders and non-responders. Two thirds of study patients were classified as responders (median survival rate of 10.5 months) and one third of patients were non-responders (median survival 4.5 months). Researchers noted that the survival time of patients treated with SIR-Spheres was nearly double the rates of patients treated with systemic chemotherapy. There were no serious side effects reported, leading study authors to conclude that microspheres are a safe and effective treatment for patients with advanced liver disease.
"The ability to offer a patient with advanced liver cancer the possibility of an additional six months or more of life is remarkable," says Dr. Andrew Kennedy, lead author of the study and co-medical director of Wake Radiology Oncology in Cary, N.C. "For those of us using microspheres in our daily practice, we have seen how this therapy increases survival time and improves quality of life for our patients. The results of this study should further illustrate the efficacy of microspheres and encourage more physicians who treat liver cancer to train on the administration of microspheres and offer it to their patients."
Dr. Kennedy presented the findings of the study at the Second Annual Clinical Symposium on Liver Directed Radiotherapy with Microspheres held April 27-28 in Scottsdale, Ariz. Participants in the study were treated at seven different institutions from April 2002 to April 2005. Authors of the study include:
Andrew S. Kennedy, M.D., F.A.C.R.O. Douglas Coldwell, M.D. Charles Nutting, D.O. Ravi Murthy, M.D., F.A.C.P. Daniel E. Wertman, Jr., M.D. Stephen P. Loehr, M.D. Carroll Overton, M.D. Steven Meranze, M.D. Jerry Niedzwiecki, M.D. Scott Sailer, M.D.
Approximately 100 physicians in the United States use Sirtex’s SIR-Spheres microspheres in more than 75 medical centers. The minimally invasive procedure is performed on an out-patient basis with minor side effects.
About SIR-Spheres® Microspheres SIR-Spheres microspheres are radioactive polymer spheres that emit beta radiation. Physicians insert a catheter through the groin into the hepatic artery and deliver millions of microspheres directly to the tumor site. The SIR-Spheres microspheres target the liver tumors sparing healthy liver tissue. Approximately 100 physicians in the United States use Sirtex’s SIR-Spheres microspheres in more than 75 medical centers and the centers are growing.
About Sirtex SIR-Spheres microspheres were developed in the 1980s in Australia and gained FDA approval in March 2002. Sirtex has obtained regulatory approval to market SIR-Spheres microspheres in the United States, European Union, Israel and Australia. The product is marketed in New Zealand, Hong Kong, Malaysia, Singapore and Thailand. Sirtex has major clinical trials with multiple international pharmaceutical companies including Pfizer, Aventis-Sanofi, and Hoffman La Roche. The company is closely held and the founder Dr Bruce Gray has been working in the field over 25 years. For more information, please visit www.sirtex.com.
In The News » Sirtex Presents SIR-Spheres Microspheres Data
BREAKING CLINICAL NEWS
Sirtex Presents SIR-Spheres® Microspheres Data at the American Brachytherapy Society 2006 Meeting
Meeting marks debut of microspheres therapy for liver cancer at annual event
Philadelphia, PA. (May 18, 2006) – New research on Sirtex’s SIR-Spheres® microspheres was presented at the 2006 American Brachytherapy Society’s annual meeting held May 10-12 in Philadelphia. Dr. Andrew Kennedy, co-medical director of Wake Radiology Oncology Services in Cary, N.C., will discuss findings of two studies involving SIR-Spheres microspheres for treatment of advanced liver cancer. Dr. Kennedy’s presentation marks the first time microspheres therapy has been featured at the ABS meeting. Sirtex’s SIR-Spheres microspheres are the only FDA-approved microspheres therapy for metastatic liver cancer.
Dr. Kennedy’s first poster presentation is a retrospective review of 18 patients who received SIR-Spheres microspheres for carcinoid tumors. Standard use of microspheres therapy for carcinoid tumors is to apply once, typically to a single lobe, followed with treatment to the second lobe one month later. Dr. Kennedy evaluated the outcome of treating all tumors during each treatment, a process known as whole liver therapy. A second and third treatment was given to control of large lesions.
Following brachytherapy, participants were monitored with regular laboratory and imaging studies. Eighty-nine percent of patients responded to the treatment, with a median follow-up period of 27 months. Researchers concluded that whole liver and multiple treatments with microspheres brachytherapy are safe and produce a high response rate, even with large tumors.
"We are grateful to Dr. Kennedy for his ongoing microspheres research," says Dr. David Cade, medical director for Sirtex. "Carcinoid tumors are historically difficult to treat. By offering a whole liver approach, this data suggests we are able to treat patients more effectively and increase response rates."
Dr. Kennedy also will present a poster analyzing the current dosing guidelines for SIR-Spheres microspheres. His team compared the current dose planning recommendations with his own dosing formula based on tumor volume and prescribed amount of radioactivity. Though Dr. Kennedy’s formula resulted in 20-30 percent less radioactivity, it enabled a more consistent delivery of microspheres. The reduced activity lowered the risk of radiation-induced liver damage, but did not decrease tumor response.
"Choosing the appropriate microspheres dose is critical," Dr. Kennedy says. "We use this formula in our practice and have had no severe complications or reactions from dosing. The goal is to deliver the most effective dose to the tumor site, but not prescribe too much activity, which can result in liver toxicity or additional disposal concerns for the treating team."
Abstracts on both research papers will be available in the May issue of the journal Brachytherapy. The publication is the official journal of the American Brachytherapy Society.
About SIR-Spheres® Microspheres SIR-Spheres microspheres are radioactive polymer spheres that emit beta radiation. Physicians insert a catheter through the groin into the hepatic artery and deliver millions of microspheres directly to the tumor site. The SIR-Spheres microspheres target the liver tumors sparing healthy liver tissue. Approximately 100 physicians in the United States use Sirtex’s SIR-Spheres microspheres in more than 75 medical centers.
About Sirtex SIR-Spheres microspheres were developed in the 1980s in Australia and gained FDA approval in March 2002. Sirtex has obtained regulatory approval to market SIR-Spheres microspheres in the United States, European Union, Israel and Australia. The product is marketed in New Zealand, Hong Kong, Malaysia, Singapore and Thailand. For more information, please visit www.sirtex.com.
Contact: Andrea Moody Phone: 919-457-0743 Email: [email protected] Breaking News
Sirtex Presents SIR-Spheres(R) Microspheres Data at the American Brachytherapy Society 2006 Meeting; Meeting marks debut of microspheres therapy for liver cancer at annual event.
New research on Sirtex's SIR-Spheres(R) microspheres was presented at the 2006 American Brachytherapy Society's annual meeting held May 10-12 in Philadelphia. Dr. Andrew Kennedy, co-medical director of Wake Radiology Oncology Services in Cary, N.C., ddiscussed findings of two studies involving SIR-Spheres microspheres for treatment of advanced liver cancer. Dr. Kennedy's presentation marks the first time microspheres therapy has been featured at the ABS meeting. Sirtex's SIR-Spheres microspheres are the only FDA-approved microspheres therapy for metastatic liver cancer.
Dr. Kennedy's first poster presentation is a retrospective review of 18 patients who received SIR-Spheres microspheres for carcinoid tumors. Standard use of microspheres therapy for carcinoid tumors is to apply once, typically to a single lobe, followed with treatment to the second lobe one month later. Dr. Kennedy evaluated the outcome of treating all tumors during each treatment, a process known as whole liver therapy. A second and third treatment was given to control large lesions.
Following brachytherapy, participants were monitored with regular laboratory and imaging studies. Eighty-nine percent of patients responded to the treatment, with a median follow-up period of 27 months. Researchers concluded that whole liver and multiple treatments with microspheres brachytherapy are safe and produce a high response rate, even with large tumors.
"We are grateful to Dr. Kennedy for his ongoing microspheres research," says Dr. David Cade, medical director for Sirtex. "Carcinoid tumors are historically difficult to treat. By offering a whole liver approach, this data suggests we are able to treat patients more effectively and increase response rates."
Dr. Kennedy also will present a poster analyzing the current dosing guidelines for SIR-Spheres microspheres. His team compared the current dose planning recommendations with his own dosing formula based on tumor volume and prescribed amount of radioactivity. Though Dr. Kennedy's formula resulted in 20-30 percent less radioactivity, it enabled a more consistent delivery of microspheres. The reduced activity lowered the risk of radiation-induced liver damage, but did not decrease tumor response.
"Choosing the appropriate microspheres dose is critical," Dr. Kennedy says. "We use this formula in our practice and have had no severe complications or reactions from dosing. The goal is to deliver the most effective dose to the tumor site, but not prescribe too much activity, which can result in liver toxicity or additional disposal concerns for the treating team."
Abstracts on both research papers will be available in the May issue of the journal Brachytherapy. The publication is the official journal of the American Brachytherapy Society.
About SIR-Spheres Microspheres
SIR-Spheres(R) microspheres are radioactive polymer spheres that emit beta radiation. Physicians insert a catheter through the groin into the hepatic artery and deliver millions of microspheres directly to the tumor site. The SIR-Spheres microspheres target the liver tumors sparing healthy liver tissue. Approximately 100 physicians in the United States use Sirtex's SIR-Spheres microspheres in more than 75 medical centers.
About Sirtex
SIR-Spheres microspheres were developed in the 1980s in Australia and gained FDA approval in March 2002. Sirtex has obtained regulatory approval to market SIR-Spheres microspheres in the United States, European Union, Israel and Australia. The product is marketed in New Zealand, Hong Kong, Malaysia, Singapore and Thailand. The Sir Spheres are being found to work also synergistacally wit multiple newer generation chemotherapeutic drugs for multiple tumor types that have metastasized to the liver. It is one of the most signifivcant oncology products that have neen developed in the last 10 years in the billion dollars oncology market. For more information, visit www.sirtex.com.
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