Angiotech gets a second wave of positive FDA news (ANPI, JNJ, ABT, MDT)
Angiotech Pharmaceuticals (Nasdaq: ANPI) on Thursday got the FDA’s OK to market a next-generation drug-coated stent with partner Boston Scientific (NYSE: BSX), a deal that might help it prop up its declining stent business.
The new Taxus stent is designed for long lesions — situations that typically required the use of multiple stents previously, or in some cases old-fashioned angioplasty. The company says it is a more efficient treatment option for the estimated 8 to 10% of patients with long lesions, and plans to launch the product next month.
The new announcement may help Angiotech deal with brutal stent competition. The company’s royalty revenue from stents fell 40 percent in the first quarter to $17.1 million.
The new longer stent might be of particular use as the company seeks to take market share from Johnson & Johnson (NYSE: JNJ), Abbott Laboratories Inc. (NYSE: ABT) and Medtronic (NYSE: MDT).
The Angiotech stent announcement comes on the heels of an FDA approval last month for the company’s implantable device to prevent pulmonary embolism. It’s a string of good news for a company that earlier this year said might be forced to seek alternate funding or a potential reorganization or debt restructuring due to continued stent market declines.
Late last year, Angiotech was seeking strategic options. At the time, it was not clear that the debt-saddled firm would survive. The stock has since climbed more than 10-fold to more than $1.80 a share . — Mike Tarsala
Angiotech gets a second wave of positive FDA news (ANPI, JNJ, ABT, MDT)
Angiotech Pharmaceuticals (Nasdaq: ANPI) on Thursday got the FDA’s OK to market a next-generation drug-coated stent with partner Boston Scientific (NYSE: BSX), a deal that might help it prop up its declining stent business.
The new Taxus stent is designed for long lesions — situations that typically required the use of multiple stents previously, or in some cases old-fashioned angioplasty. The company says it is a more efficient treatment option for the estimated 8 to 10% of patients with long lesions, and plans to launch the product next month.
The new announcement may help Angiotech deal with brutal stent competition. The company’s royalty revenue from stents fell 40 percent in the first quarter to $17.1 million.
The new longer stent might be of particular use as the company seeks to take market share from Johnson & Johnson (NYSE: JNJ), Abbott Laboratories Inc. (NYSE: ABT) and Medtronic (NYSE: MDT).
The Angiotech stent announcement comes on the heels of an FDA approval last month for the company’s implantable device to prevent pulmonary embolism. It’s a string of good news for a company that earlier this year said might be forced to seek alternate funding or a potential reorganization or debt restructuring due to continued stent market declines.
Late last year, Angiotech was seeking strategic options. At the time, it was not clear that the debt-saddled firm would survive. The stock has since climbed more than 10-fold to more than $1.80 a share . — Mike Tarsala
Medtronic Inc. Paid Surgeon General Accused of Falsifying Reports (MDT)
Medtronic Inc. (NYSE: MDT) has reportedly paid almost $800,000 in consulting fees to a former U.S. Army surgeon accused of falsifying a medical journal study involving one of the company’s products.
The payments were made to Dr. Timothy R. Kuklo, who claimed in the study that the use of a Medtronic bone growth product called Infuse had proved highly beneficial in treating leg injuries suffered by American soldiers in Iraq.
Reports claimed that the Army disclosed that the study was based on false information, and that Dr. Kuklo had forged the names of four other doctors on the study and had cited data that did not match military records.
Colleagues of Dr. Kuklo at the Walter Reed Army Medical Center claimed that he had also overstated the benefits of the Medtronic product.
Medtronic told The Wall Street Journal that the payments were compensation for Kuklo’s work, developing products for the company, training doctors and speaking at company events and that they were not related to the study.
It is legal for military doctors to receive payments from medical product companies, but they are supposed to seek permission from officials. Army officials have said they have not found records to indicate that Dr. Kuklo sought or received such clearance.
Joshua Sherman
Medtronic Troubles May Persist For Some Time (MDT)
Medtronic Inc. (NYSE: MDT) has been hit with a Mutiple-Whammy this week. Lower earnings and a round of layoffs was just the tip of the iceberg. The real issues at stake are a recall, a scandal over falsified study data, and safety notice given. This can all act as a negative catalyst for more than just a few days.
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Medtronic Keeps Buying Companies (MDT)
It seems that M&A continues in the drug and medical equipment markets continues regardless of what is happening throughout the world. Medtronic Inc. (NYSE: MDT) has entered into two separate M&A deals for Venture-backed companies. Normally we would not care, but these were worth a combined total of more than $1 billion.
The first deal was for CoreValve, a maker of medical devices for percutaneous heart valve replacement. This includes a $700 million up-front payment. It could be worth more as it also includes the possibility of milestone-based earnouts. CoreValve was backed by Apax Partners, HealthCap, Maverick Capital and Sofinnova Partners.
Medtronic’s second deal was the acquisition of Ventor Technologies Ltd.. Ventor is an Israeli developer and maker of transcatheter heart valve technologies used to treat aortic valve disease. This deal was valued at $325 million. Medtronic was an original investor in the company already, along with Pitango Venture Capital.
Jon C. Ogg
February 24, 2009
Drug Eluting Stents Vs. Bare Metals Stents Win Again
A new study funded by the Massachusetts Department of Public Health is showing further evidence to support the use of drug eluting stents over bare metal stents in heart attack patients. This study measured stent use specifically in diabetic patients. Drug-eluting stents showed improved outcomes as compared with bare metal stents in diabetics, and no excess adverse events were found with drug-eluting stents in diabetic patients. This data was reported by researchers at the American Heart Association’s Scientific Sessions 2008 in New Orleans. Some of the raw numbers appear marginal, but others are very impressive.
Drug-eluting stents reduced the risk of revascularization, heart attack and death in diabetics as compared with bare-metal stents in the largest observational comparison. The results were presented as a late-breaking clinical trial and is simultaneously published in circulation in the Journal of the American Heart Association.
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Stents Set Up For A Comeback (ABT, BSX, MDT, JNJ, SRDX, ANPI)
Abbott Laboratories (NYSE: ABT) announced after the close today, in a decision we have been waiting on for what feels like forever, that the FDA has approved for the company to begin marketing its XIENCE drug-eluting coronary stent systems.
Boston Scientific (NYSE: BSX) will get to sell basically the same exact stent under a different name. Boston Scientific also has the old Taxus stent. Angiotech (NASDAQ: ANPI) is also Boston’s Taxus stent coating partner for its molecule.
As far as the others, this will get to compete with the Medtronic Inc. (NYSE: MDT) Endeavor stent system as well as Johnson & Johnson (NYSE: JNJ) Cypher stent. Medtronic won the first Stent system approval in February after a 4-year hiatus. SurModics Inc. (NASDAQ: SRDX) is the molecule partner over at J&J for the drug-eluting coatings for teh Cypher stent.
This is being viewed as a key win for Abbott Labs with shares up 1.6% at $55.10 in after-hours trading. The good news is that the dark clouds surrounding stents and drug-eluting stents is starting to lift. The bad news on the topic is that this is now a highly competitive sub-sector in coronary medical technology.
Jon Ogg
July 2, 2008
