Two companies that are seeking to compete with Irvine-based Edwards Lifesciences Corp. in the less-invasive replacement heart valve market have had a busy month.
Minneapolis-based Medtronic Inc. received Food and Drug Administration approval about two weeks ago to use its locally developed Medtronic CoreValve for patients who have severe aortic stenosis and are at high risk for surgery. The condition is a narrowing of the body’s main artery that puts sufferers at risk of heart attack.
Medtronic, which employs about 700 people in Orange County, received its initial CoreValve approval earlier this year for patients who are too ill or frail for traditional open-heart surgery.
Regulators’ decision to approve the new CoreValve usage came after a clinical trial on high-risk patients had superior clinical outcomes compared to open-heart surgery for aortic valve replacement a year after implant. People who suffer from severe aortic stenosis tend to be 80 and older.
Wells Fargo & Co. analyst Larry Biegelsen, who follows Medtronic and Edwards, said in a client note that the FDA approval was in line with Medtronic’s guidance about the timing of CoreValve’s approval and how it might fare.
Edwards and Medtronic settled a long-running patent battle in May that could lead to a $1 billion injection of money into Edwards’ coffers; the settlement also keeps CoreValve on the U.S. market.
Separately, Irvine-based CardiAQ Valve Technologies Inc. said this month that it filed a federal lawsuit against a competitor in the less-invasive heart valve market and is seeking an injunction against it over development and commercialization.
CardiAQ alleges in its complaint that Vancouver-based Neovasc Inc. improperly used its proprietary technology to develop the Tiara less-invasive mitral heart valve. CardiAQ also alleges fraud, breach of contract, and unfair and deceptive trade practices.
It said in its complaint that Neovasc approached it in 2009 and offered support services to help CardiAQ develop a minimally invasive implantable mitral valve. CardiAQ said it then proceeded to “openly share its intellectual property, proprietary designs, development updates, prototypes and other confidential information” with Neovasc after signing a confidentiality agreement.
CardiAQ alleges that Neovasc recently disclosed that it began its internal transcatheter mitral valve program in 2009, the same time the company was working with CardiAQ.
Neovasc said in a recent news release that it hadn’t received the complaint, but that based on its “understanding of the unproven allegations, [we believe] the lawsuit to be groundless and without merit.”
Generic Latisse on the Way
Irvine-based Allergan Inc. had a legal setback this month when the U.S. Court of Appeals ruled a pair of patents covering its eyelash-growing drug Latisse are invalid.
The ruling sets the stage for generic versions of Latisse to come to market. Swiss drug maker Novartis SA and Toronto-based generic drug company Apotex Inc. are gearing up to sell their versions of Latisse, which came about after Allergan researchers found that the active ingredient in the Lumigan glaucoma drug stimulated eyelash growth.
The court found that the eyelash growth was a “known potential side effect” of glaucoma treatment, thus rendering Allergan’s patent claims invalid.
Wall Street disagreed on the impact of the ruling.
Analyst David Buck of the Buckingham Research Group in New York City called Latisse “a relatively small drug for Allergan,” which has annual sales of about $6.2 billion. Latisse accounted for $100 million, or 2%, of that in 2013.
David Maris of BMO Capital Markets told industry newsletter FiercePharma that
the invalidated patents could cost Allergan $151 million in sales in 2018, with peak sales falling in the range of $150 million to $200 million.
Griffin-American Buys Atlanta Office
Newport Beach-based real estate investor Griffin-American Healthcare REIT III Inc. bought a medical office building in suburban Atlanta. A purchase price wasn’t disclosed.
DeKalb Professional Center in Lithonia has 19,000 square feet of space. It was built in 2008 and is 81% leased to four tenants, including the Emory Clinic, which is attached to Emory University.
Griffin-American bought the center from McWhirter Realty Partners LLC in Smyrna, Ga.
Bits & Pieces
The Washington, D.C.-based Association for Professionals in Infection Control and Epidemiology held its annual conference this month in Anaheim. Topics discussed included dealing with organisms resistant to multiple drugs, and systematic approaches to infection prevention. … New York-based Integro Insurance Brokers acquired Newport Beach-based employee benefits firm Lugo & Associates Insurance Services Inc. for an undisclosed price. Lugo’s focus includes group health insurance in small- and medium-sized markets.
