Sotradecol FDA Warning
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January 8, 2010
Recently, the Food and Drug Administration's (FDA) Division of Drug, Marketing, Advertising, and Communications (DDMAC) issued a Warning Letter to Bioniche Pharma USA objecting to several web pages that promoted Sotradecol® (sodium tetradecyl sulfate injection). Specifically, these web pages failed to convey any information regarding the risks associated with Sotradecol®, claims on the web pages broadened the approved indications beyond the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves, and the web page overstated the efficacy of Sotradecol®.
Bioniche Pharma USA would like to take the opportunity to provide important corrective information about the safe and appropriate use of Sotradecol®.
Indication and Efficacy:
The web pages misleadingly suggested that Sotradecol® is effective in all sclerotherapy patients and procedures. However, Sotradecol® is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.
Bioniche Pharma's past use of photographs and general claims regarding Sotradecol's® use in the sclerotherapy market should not be interpreted as claims that Sotradecol® may be used in any sclerotherapy patient or that patients may achieve varicose-free legs as a result of treatment with Sotradecol®.
Risk Information:
The web pages did not disclose any important risk information about Sotradecol®. The information is presented below:
Contraindications:
Sotradecol® is contraindicated in:
• patients with previous hypersensitivity reactions to the drug;
• acute superficial thrombophlebitis;
• valvular or deep vein incompetence;
• huge superficial veins with wide open communications to deeper veins;
• phlebitis migrans;
• acute cellulites;
• allergic conditions;
• acute infections;
• varicosities caused by abdominal and pelvic tumors unless the tumor has been removed;
• bedridden patients;
• such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.
Warnings and Precautions:
Sotradecol® should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injections technique. To avoid severe adverse local effects, including tissue necrosis, following extravasation, physicians must use extreme care in intravenous needle placement and use the minimal effective volume at each injection site.
Emergency resuscitation equipment should be immediately available. Allergic reactions including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, 0.5 mL of Sotradecol® should be injected into a varicosity, followed by several hours of observation before administration of a second or larger dose. The physician should be prepared to treat anaphylaxis appropriately.
At least six deaths have been reported with the use of Sotradecol®. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol®. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol®.
One death has been reported in a patient who received Sotradecol® and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in 36-year-old female treated with sodium tetradecyl acetate which was not taking oral contraceptives.
Venous sclerotherapy should not be undertaken if tests (Trendelenberg or Perthers), and angiography show significant valvular or deep venous incompetence because of the danger of thrombosis extension into the deep venous system. Physicians should conduct preinjection evaluation for valvular competency and deep venous potency must be determined by angiography or noninvasive testing such as duplex ultrasound. Physicians should administer slow injections with a small amount (not over 2 mL) of the preparation into the varicosity.
Deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of Sotradecol®. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.
Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriocsclerosis or thromboangiitis obliterans (Buerger's Disease).
Adverse Reactions with Sotradecol®
The following adverse reactions have been reported with the use of Sotradecol®
• Local reactions (pain, urticaria or ulceration) may occur at the site of injections.
• A permanent discoloration may remain along the path of the sclerosed vein segment.
• Sloughing and necrosis of tissue may occur following extravasation of the drug.
• Allergic reactions (hives, asthma, hayfever and anaphylactic shock).
• Mild systemic reactions including headache, nausea and vomiting.
For further information please refer to full prescribing information at the following link here. If you have any questions about this letter or about the use of Sotradecol® please contact Rhonda Noll, Sr. Director of Regulatory Affairs at 1-877-769-6200.
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AngioDynamics Reports Fiscal Second Quarter 2010 Results and Raises Guidance
- Net Sales Increase 10% to $53.5 Million
- NanoKnife® IRE System Net Sales of $700,000
- Net Income Increase of 8% to $3.1 Million, or $0.13 EPS
- Operating Cash Flow of $11.2 Million
- Conference Call Begins Today at 4:30 p.m. Eastern Time
For Immediate Release
QUEENSBURY, N.Y. December 15, 2009 — (NASDAQ: ANGO), a leading provider of innovative medical devices for the minimally-invasive treatment of cancer and peripheral vascular disease, today reported financial results for the fiscal second quarter ended November 30, 2009.
Net sales in the second quarter were $53.5 million, a 10% increase over the $48.5 million reported for the second quarter a year ago. Gross margin was 59.1% compared with 61.3% a year ago, with the decline primarily attributable to lower selling prices for certain products in a competitive pricing environment, higher material costs for certain products and product mix. Operating income was $5.3 million in the quarter compared with $4.9 million a year ago. Net income was $3.1 million, or $0.13 per share, compared with $2.9 million, or $0.12 per share, a year ago.
AngioDynamics generated $11.2 million in cash flow from operations during the quarter. At November 30, 2009, the Company had cash and investments of $74.0 million and long-term debt of $6.9 million.
Oncology/Surgery sales grew 28% to $13.6 million from the second quarter a year ago and included $700,000 in NanoKnife IRE system sales. Peripheral Vascular sales increased by 6% from the second quarter a year ago to $23.2 million, and included $832,000 in sales of the Benephit® renal infusion system acquired from FlowMedica in January 2009. Access sales were $16.7 million in the quarter, an increase of 4% from the second quarter a year ago.
For the six months ended November 30, 2009, net sales were $103.6 million, a 12% increase over the $92.8 million reported for the prior year period; gross margin was 59.6% compared with 61.6% for the prior year; operating income was $8.9 million compared with $8.7 million for the prior year; net income was $5.2 million, or $0.21 per share, compared with $5.1 million, or $0.21 per share for the prior year.
“Our solid second quarter performance was led by strong sales from our Oncology/Surgery business unit and good operating expense control, which combined to offset the impact on our gross margin of product mix and a very competitive pricing environment for many product categories,” said Jan Keltjens, President and CEO. “All Oncology/Surgery products contributed to the exceptional sales growth in this business unit this quarter, and we were particularly pleased to see the initial market interest in our new NanoKnife IRE system. In addition, we continued to gain positive clinical experience with the NanoKnife system as more than 100 patients have been treated with this promising technology.
“As we look ahead, we anticipate the continuation of a challenging pricing environment and are striving to achieve continued solid top line growth, operating efficiencies and expense control to deliver bottom line performance. Based on our first half momentum and planned second half initiatives, today we are raising our guidance for the full fiscal year,” concluded Mr. Keltjens.
Highlights of the quarter, and more recent activities, include the following:
- Stephen J. McGill was appointed Senior Vice President and General Manager, International, a newly created position. Mr. McGill served as Senior Vice President, Global Sales for American Medical Systems and will lead AngioDynamics’ efforts to target and expand its business in the international arena.
- NanoKnife IRE systems continue to be utilized by physicians at various institutions globally who have treated an additional 18 patients since early October. The total number of patients treated to date with the NanoKnife system at nine centers now stands at 104. Of particular note is the treatment of a patient with a pancreatic lesion over three weeks ago. This patient was discharged shortly after the IRE procedure without complication and continues to be free of complications. Procedures have been performed in seven organs (prostate, liver, lung, kidney, bone, pancreas and lymph nodes). In all cases the safety profile for this non-thermal ablation technology remains positive.
- The introduction of a new family of micro-introducer kits and the Total Abscession® nephrostomy drain catheter brought the total number of new products launched during fiscal 2010 to six. The Company remains on track for a total of 11 launches in this fiscal year.
- On November 30, AngioDynamics was added to the MSCI US Small Cap 1750 Index. The MSCI US Small Cap 1750 Index represents a universe of small capitalization companies in the U.S. equity market.
Fiscal 2010 Guidance
The Company updated its outlook for fiscal 2010 to the following:
- Net sales in the range of $214 million to $217 million, an increase of 10-11% over fiscal 2009 net sales (an increase from previous guidance of $211 million to $215 million)
- Gross margin in the range of 59-60% of net sales (a decrease from previous guidance of 61-62%)
- GAAP operating income in the range of $19 million to $21 million (an increase from previous guidance of $18 million to $20 million)
- EBITDA in the range of $31 million to $33 million (an increase from previous guidance of $30 million to $32 million)
- GAAP EPS in the range of $0.46 to $0.48, inclusive of a $0.24 EPS impact from IRE investments (an increase from previous guidance of $0.45 to $0.47)
Conference Call
AngioDynamics management will host a conference call to discuss its second quarter results today beginning at 4:30 p.m. Eastern Time. To participate in the live call by telephone, please dial 1 (877) 941-2332.
In addition, individuals can listen to the call on the Internet by visiting the investor relations portion of the AngioDynamics Web site at http://investors.angiodynamics.com. To listen to the live call, please go to the Web site 15 minutes prior to its start to register, download and install the necessary audio software. In addition, a replay of the call will be available at http://investors.angiodynamics.com.
Use of Non-GAAP Measures
Management uses non-GAAP measures to establish operational goals, and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported non-GAAP EBITDA (income before interest, taxes, depreciation and amortization). Management uses this measure in its internal analysis and review of operational performance. Management believes that this measure provides investors with useful information in comparing AngioDynamics’ performance over different periods. By using this non-GAAP measure, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of Operating Income to non-GAAP measures.
About AngioDynamics
AngioDynamics, Inc. (“AngioDynamics” or the “Company”) is a leading provider of innovative medical devices used by interventional radiologists, surgeons and other physicians for the minimally-invasive treatment of cancer and peripheral vascular disease. The Company’s diverse product line includes market-leading radiofrequency and irreversible electroporation ablation systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at http://www.angiodynamics.com.
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to develop its existing and new products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to integrate purchased businesses as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2009. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. This document may discuss the use of NanoKnife for specific clinical indications for which it is not cleared in the United States at this time.
Please see the investors section of the AngioDynamics for financial tables.
In the News (Homepage Include)
07.15.2010 - AngioDynamics Reports Strong Finish to Fiscal 2010
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ADI's Web Sites are generally not targeted at children under the age of fourteen. We will not knowingly collect information from site visitors in this age group. We encourage parents and legal guardians to monitor their children's Internet usage and to help enforce our Privacy Policy by instructing their children to never provide Personal Information on this Site without their permission.
V. Links to Other Sites
As a resource to our visitors, ADI may provide links to other Internet sites. Please be aware that we do not control other Internet sites and that, in any case, this Internet Privacy Policy does not apply to those Internet sites. We encourage you to read the privacy policy of every Internet site you visit.
VI. Anti-Spam Policy
ADI does not distribute or sell customers' confidential information from our opt-in lists.
Definition of Spam from MAPS – Mail Abuse Prevention System
An email is spam if:
- The recipient's personal identity and context are irrelevant because the message is equally applicable to many other potential recipients; AND
- The recipient has not verifiably granted deliberate, explicit, and still-revocable permission for it to be sent; AND
- The transmission and reception of the message appears to the recipient to give a disproportionate benefit to the sender.
ADI's Commitment:
- AngioDynamics DOES NOT send out unsolicited email (UCE/Spam) (Please note UCE stands for unsolicited commercial email)
- AngioDynamics DOES NOT knowingly do business with any company that participates in sending UCE/SPAM
- AngioDynamics DOES NOT sell or exchange personal information from our opt-in lists.
Rev. December 16, 2009
A Global Reach, A Community Presence
During the last 20 years, AngioDynamics has grown to have a global reach, with facilities in three U.S. states and Great Britain. The company has a new Corporate Headquarters in Albany, N.Y., U.S., and continues to have a major presence in Queensbury, N.Y., U.S., where it also designs, develops and manufactures many of its products. The manufacturing of AngioDynamics’ port systems, electrosurgical devices and needle sets occurs at its Manchester, Ga., U.S., facility, while cutting-edge research and development in the field of radiofrequency tumor ablation is performed in Fremont, Calif., U.S. The manufacture of laser devices takes place in its Cambridge, U.K.
| New York – Global Headquarters 14 Plaza Drive Latham, N.Y. 12110 USA Phone: 1-800-772-6446 +1 (518) 795-1400 Fax: +1 (518) 795-1401 Airport: Albany International (ALB) |
Hotel: Century House 997 New Loudon Road (Route 9) Latham, NY 12110 Directions
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New York – Queensbury Manufacturing Facility Airport: Albany International (ALB) |
Hotels: Hampton Inn & Suites |
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Georgia Airport: Atlanta (ATL) |
Hotels: Springhill Suites Newnan |
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California Airports: |
Hotel: |
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United Kingdom Airports: |
Hotels: De Vere University Arms |
Timeline
Index Page
Patient Resources
At AngioDynamics we are focusing on patient care every day, but we understand that undergoing a procedure is not an everyday occurrence for most patients. You probably have a lot of questions, and we hope that the materials on this page will help answer some of the most common questions about our products and your upcoming procedure. Additionally, we have listed links to the Web sites of several organizations below that you may find helpful during your journey. Please remember these are only tools, and that your physician is best suited to answer your questions.
| National Cancer Institute http://www.cancer.gov |
American Academy of Dermatology http://www.aad.org/forms/pamphlets/ |
| American Cancer Society http://www.cancer.org |
American Academy of Family Physicians http://www.familydoctor.org |
| Mayo Clinic http://www.mayoclinic.com |
Society for Interventional Radiology http://www.sirweb.org/patients |
| WebMD http://www.webmd.com |
NanoKnife™ http://www.nanoknife.com |
| VenaCure EVLT™ http://www.venacure-evlt.com |
LiverTumor.org http://www.livertumor.org |
| Vascular Disease Foundation www.vdf.org |
American College of Phlebology www.phlebology.org |
| Society of Interventional Radiology www.sirweb.org |
American Venous Forum www.venous-info.com |
Mission
To provide benefits to patients by being the leader in design, development, manufacturing and marketing of innovative, proprietary, therapeutic devices used by interventionalists and surgeons for the minimally invasive treatment of peripheral vascular disease, tumor therapy and other, non-vascular disease.
Values
AngioDynamics is deeply committed to improving patient care by ethically serving its customers, shareholders and employees. We value the importance of trust and honesty in all of the relationships that we build. AngioDynamics is dedicated to its pursuit of innovation and tenaciously strives for continuous improvement in every area.
AngioDynamics seeks to add significant value in every interaction with its customers by providing unsurpassed service and the highest quality, best performing products. To accomplish this, AngioDynamics is committed to its employees receiving the highest level of training, and to providing an environment that promotes continual employee growth. All AngioDynamics employees constantly endeavor to be the best and the brightest in the medical device industry.
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About AngioDynamics
Founded in 1988 in Queensbury, N.Y., U.S., AngioDynamics is today a NASDAQ-listed public company. We are a leading provider of innovative medical devices used by interventional radiologists, nephrologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease. Our diverse product line includes market-leading radiofrequency ablation and irreversible electroporation resection systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products.
AngioDynamics has distinguished itself as a dynamic brand in a technologically competitive, high-growth industry, through the company’s consistent ability to successfully develop and bring to market new technologies and products. AngioDynamics believes it is well poised to continue that trend. Looking into the future, the company plans to bring forth a continuing stream of innovations that greatly improve patient care by providing the highest-quality, best-performing products.
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Contact AngioDynamics
| Corporate Office 14 Plaza Drive Latham, NY 12110 Hours of Operation: 8 a.m. to 5 p.m. ET Tel: +1 518-795-1400 Fax: +1 518-795-1401 General e-mail: .(JavaScript must be enabled to view this email address) |
International Office Building 2000 Beach Drive IQ Cambridge Waterbeach Cambridge CB25 9TE Hours of Operation: 9:00-17:30 (Local) Tel: +44 (0)1223 729300 Fax: +44 (0)1223 729329 |
| Customer Service 603 Queensbury Ave. Queensbury, NY 12804 Hours of Operation: 8 a.m. to 6 p.m., Monday - Friday Toll Free Telephone: 1-800-772-6446 (select option 2 for Customer Service) Fax: +1 518-798-1360 .(JavaScript must be enabled to view this email address) |
Physician Clinical Product Questions Contact our clinical specialists by calling 1-800-772-6446, option 5 International Distributors VenaCure EVLT System Distributors Interventional Product Distributors Port & Needle Distributors RFA Distributors |
| Investor Relations Contacts EVC Group, Inc. Jenifer Kirtland Tel: +1 415-896-2005 e-mail: .(JavaScript must be enabled to view this email address) Doug Sherk |