|Vascular Files Patent Infringement Complaint Against Boston Scientific; Tesaro Demonstrate Activity in Ovarian and Breast Cancer|
|By Staff and Wire Reports|
|Thursday, 16 May 2013 19:20|
Vascular Solutions (Nasdaq: VASC) announced it has filed a patent infringement complaint in the U.S. District Court for the District of Minnesota against Boston Scientific Corporation (NYSE: BSX). The complaint alleges that Boston Scientific has infringed three patents owned by Vascular Solutions concerning rapid exchange guide extension technology by manufacturing and selling its Guidezilla™ guide extension catheter which received 510(k) clearance in March 2013. Vascular Solutions is seeking an injunction against Boston Scientific prohibiting the manufacture and sale of its Guidezilla catheter as well as damages for lost profits and legal costs.
U.S. Patents 8,048,032, 8,142,413 and 8,292,850, comprising 60 claims in total and having an initial filing date of May 2006, were issued by the U.S. Patent & Trademark Office to Howard Root, et. al. and assigned to Vascular Solutions concerning rapid exchange guide extension technology. These patents form the basis for Vascular Solutions' GuideLiner® catheter, the first and until now only rapid exchange mother-and-child guide extension catheter. Since its launch in 2009, the GuideLiner catheter has been described by prominent interventional cardiologists as an "indispensable tool," a "game-changing device," and a catheter that "makes impossible cases possible."
"Boston Scientific's Guidezilla is one of the most blatant plagiarisms of a patented medical device that I have ever encountered," said Howard Root, Chief Executive Officer of Vascular Solutions. "Virtually every substantive aspect of our GuideLiner product and patents, from the design to the dimensions to even the exact words used in the product's deployment instructions, has been misappropriated by Boston Scientific and applied to their Guidezilla catheter. We do not take the initiation of patent litigation lightly, but this is exactly the type of conduct that patents were intended to protect – a small medical device company creating a completely new and innovative product only to be flagrantly violated by a knock-off brazenly marketed by the world's largest interventional cardiology company. We intend to move quickly to stop this violation of our rights."
TESARO (Nasdaq: TSRO), an oncology-focused biopharmaceutical company, announced final results from a Phase 1 trial of niraparib, an inhibitor of poly ADP-ribose polymerase (PARP), will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. These results include anti-tumor activity and safety data for 100 patients with solid tumors, including 49 patients with high grade serous ovarian cancer (HGSOC) and twelve patients with breast cancer. Full, updated results relating to the abstract will be provided during the investigators' poster presentation on June 4, 2013.
"We are pleased that these data confirm the preliminary results presented at ASCO in 2011, and support advancement of niraparib into Phase 3 trials," stated Dr. Mary Lynne Hedley, President of TESARO. "We remain on track to begin enrolling patients in a Phase 3 trial in the ovarian cancer maintenance setting by mid-year, and to initiate a Phase 3 trial in patients with breast cancer during the second half of 2013."
Investor Briefing - TESARO will host an investor briefing in Chicago on Sunday, June 2 at 6:15 PM local time in conjunction with the ASCO annual meeting. At this briefing, TESARO management will review niraparib clinical data, discuss development plans in ovarian and breast cancer and answer questions from analysts and investors. This event will be webcast live and archived for 30 days at www.tesarobio.com.
ASCO Data Presentation Details - Final Results of the Phase I Trial of Niraparib (MK4827), a Poly(ADP)ribose Polymerase (PARP) Inhibitor Incorporating Proof of Concept Biomarker Studies and Expansion Cohorts Involving BRCA1/2 Mutation Carriers, Sporadic Ovarian and Castration Resistant Prostate Cancer (CRPC), Poster #2513, June 4, 2013 from 8:00 AM to 12:00 PM; 11:30 AM discussion
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