At Press Time
Abbott Labs to Acquire AMO
Stockholders to Receive $22 Per Share in Cash.
By Jerry Helzner, Senior Editor
■ Advanced Medical Optics (AMO), the company behind WhiteStar phaco technology, the Tecnis IOL, The VISX excimer laser and IntraLase laser-cut flaps for LASIK, is about to become a part of healthcare products giant Abbott Labs.
Abbott Labs and AMO have announced a definitive agreement for Abbott to acquire AMO for $22 per share in cash, for a total transaction value of approximately $2.8 billion, including estimated net debt at the time of closing. Prior to the announcement on Jan. 12, AMO shares were trading for just under $9 a share. Abbott, with 2008 sales of approximately $30 billion, had no significant presence in the ophthalmic marketplace.
Based in Santa Ana, Calif., AMO became an independent company in 2002 after being spun off from Allergan. The company is comprised of three segments: cataract surgery, laser vision correction and eyecare products. Globally, AMO holds the number one position in LASIK surgical devices, the number two position in the cataract surgical device market and the number three position in contact lens care products.
In recent years, AMO has made major investments in laser vision correction by acquiring VISX, the world leader in excimer lasers and IntraLase, the leader in laser flap-cutting technology for LASIK.
"With AMO, Abbott is enhancing and strengthening its diverse mix of medical device businesses and gaining a leadership position in another large and growing segment," said Miles D. White, chairman and CEO of Abbott. "Additionally, Abbott's significant global presence will help drive growth opportunities for this business, especially in international markets, where favorable demographics are driving demand for advanced eyecare procedures and products."
"This transaction underscores the fundamental value of the AMO franchise, the talent and expertise of our global team, and the strength of our product offering, pipeline and strategy to provide refractive vision care for people of all ages," said Jim Mazzo, chairman and chief executive officer, AMO, who will be remaining with Abbott as president, AMO.
AMO achieved more than $1 billion in sales in calendar 2008. Abbott said the buyout would have no significant effect on earnings in 2009 and would add to profit in 2010.
Buehler Is Named Alcon CEO
■ The world's largest eyecare company will have a new leader on April 1.
Alcon, Inc. said that Kevin Buehler will become president and chief executive officer of the company on that date. Cary Rayment will retire as president and CEO but will remain a director and the (non-executive) chairman of the board. Buehler will also be nominated as a board member.
Buehler, 51, has had a 24-year career with Alcon. He is currently senior vice president, global markets and chief marketing officer of Alcon Laboratories, Inc., a subsidiary of Alcon, Inc. In this capacity, he is responsible for all aspects of the company's Surgical, Pharmaceutical and Consumer groups, and is integral in the development and execution of corporate strategy.
"I am delighted and excited to have the opportunity to lead Alcon and our 15,000 employees into the future," said Buehler. "Alcon is well-positioned as the leader in our industry, and I will do all that I can to build on that sound foundation."
Rayment, 61, has been president and chief executive officer of Alcon since October of 2004 and chairman since May 2005. During that time, he has been credited with leading the company to solid gains in sales and earnings and expanding Alcon's leadership of the eyecare industry.
"I have the utmost confidence in Kevin's ability to successfully lead this organization." said Rayment. "I look forward to continue working with the board on the strategic opportunities of Alcon's business."
The change in Alcon company leadership comes during a time when majority ownership of Alcon is transitioning from international food giant Nestlé to Novartis. Novartis already owns approximately 25% of Alcon and has an option to buy another 52% from Alcon and achieve majority owner status by 2011.
PROFILE: How Bascom Palmer Does It
Voted Number One in Eye Care for Last 5 Years.
By René Luthe, Senior Associate Editor
■ Last July, U.S. News & World Report again named the University of Miami Miller School of Medicine's Bascom Palmer Eye Institute the nation's best in eye care in the magazine's annual Best Hospitals survey — making it the fifth consecutive year Bascom Palmer has won the honor. How does the Institute consistently earn such accolades? Apparently, through a commitment to ceaseless improvement and innovation in ocular medicine.
Earlier in 2008, Bascom Palmer was given another honor for its efforts. The Institute and two other branches of the University of Miami Miller School of Medicine received a $4.8 million grant from the U.S. Department of Defense in recognition for its innovative work in clinical and scientific medical practices. Bascom Palmer's share was $2 million. The money will fund the Institute's Center of Ophthalmic Innovation, which combines medicine, science and engineering to conduct critical vision research and find solutions that improve ocular health.
According to Bascom Palmer, the grant will support research in areas of particular importance to the Department of Defense, including traumatic eye injury and visual restoration, ophthalmic imaging and telemedicine.
Other research initiatives include finding ways to block the death of retinal ganglion cells in diseases such as glaucoma and ischemic optic neuropathy, as well as ways to regenerate them. Jeffrey L. Goldberg, M.D., Ph.D., explains that one approach involves novel nano-technology.
"We are using special magnetic nano-particles to encourage optic nerve regeneration," Dr. Goldberg says. "We are actually coating the magnetic nano-particles with drugs or proteins that help retinal ganglion cells survive and grow after injury, and then we're using magnetic fields to direct the nano particles to bind to the retinal ganglion cells. The ultimate goal is to use magnetic fields to pull retinal ganglion cell axons, which are their projections down the optic nerve, to actually pull them through the injured optic nerve and encourage them to regenerate back to their targets in the brain."
Bascom Palmer completed a major project when it expanded its Palm Beach Gardens facility in 2006.
Another approach involves the use of adult human retinal stem cells. Dr. Goldberg reports that his researchers are taking them from patients and coaxing them into retinal ganglion cells, as well as other retinal neurons that die in degenerative diseases such as macular degeneration. "These are still preclinical," Dr. Goldberg says. "We're testing these in animal models of optic nerve injury, of glaucoma models. We're getting ready to study them in retinal degeneration models, so, for example, that would be relevant to retinitis pigmentosa."
Noted retinal specialist Philip J. Rosenfeld, M.D., Ph.D., is currently involved in nine prospective studies of therapies to treat wet AMD. These include the PrONTO study, which investigates OCT imaging of patients with wet AMD treated with Lucentis injections, and a phase 2/3 dose-ranging trial to establish the safety and efficacy of intravitreal injections of anti-VEGF pegylated aptamer.
Another sign of Bascom Palmer's vitality is the new Palm Beach Gardens facility. Launched in late 2006, the $22 million campus features a state-of-the-art refractive surgery center that looks onto a 50-seat amphitheater. "It actually has a curtain that draws back so that you can do on-site seminars and observation and training as surgery is being done," says Tony Garand, chief operating officer at Palm Beach Gardens. "We've got Grand Rounds that we present there and link up with audio-visuals in Miami."
The ambulatory surgery center there is the first surgery center associated with the University of Miami. A third building on the site has not yet been developed, Garand reports, but will eventually be dedicated to research and clinical purposes.
Garand attributes Bascom Palmer's many successes to its physicians. "I think they do an outstanding job of medical care, I think they do an outstanding job with patient care, I think they do an outstanding job with research."
| IN THE NEWS |
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| ■ Allergan eyelash treatment. You can soon expect inquiries from patients seeking aesthetic eyelash enhancement, thanks to a consumer ad campaign about to commence in support of Allergan's new drug Latisse (topical bimatoprost 0.03%), which it says is the first science-based hypotrichosis therapy to win FDA approval. Already successful as the glaucoma drug Lumigan, bimatoprost can enhance the length, thickness and darkness of eyelashes, Allergan says. The company expects the drug to generate 9 million inquiries this year in the U.S. Consumers will be prompted to visit www.latisse.com to find a doctor. Its sales effort will include ophthalmologists, optometrists, dermatologists, plastic surgeons and even OB/GYNs. Available only by prescription, Latisse is a once-daily treatment applied directly to the base of the upper eyelashes with a single-use-per-eye disposable applicator rather than instilled as an eye drop; this method prevents all but 5% of the dose typical in Lumigan use from reaching the ocular surface. Allergan says this keeps any IOP lowering to less than 1 mm Hg. Latisse users can expect to experience longer, fuller and darker eyelashes in as little as 8 weeks, with full results in 16 weeks, based on a double-blind, placebo-controlled study of 278 patients. Using a new 4-grade rating scale developed for the study called the Global Eyelash Assessment, 78% of treated patients experienced at least a 1-grade improvement by 16 weeks. Side effects (predominantly hyperemia, itching and skin hyperpigmentation) occurred in less than 4% of patients, Allergan says. Although the precise mechanism of action is unknown, bimatoprost activates prostaglandin receptors in hair follicles and is thought to increase the percent of lashes in, and duration of, the anagen or growth phase. To maintain effect, continued treatment is required. Latisse is shipping now and should be available nationwide by the end of March. ■ Tecnis multifocal gets FDA OK. The FDA has approved AMO's Tecnis Multifocal IOL, which has already been in use internationally for several years. AMO says that its unique design gives patients superior near vision and reading speed, as well as exceptionally high spectacle independence, with nearly nine out of 10 patients reporting that they never wear glasses after surgery. AMO also reports that in clinical trials the Tecnis Multifocal has provided high-quality vision for near, far and intermediate distances, day or night, with 95% of patients satisfied with the vision provided by the lens. In addition, the company says the Tecnis Multifocal is the first and only pupil-independent, non-apodized fully diffractive aspheric lens designed to correct the two highest-order aberrations — spherical and chromatic. ■ Next-generation ReSTOR IOL approved. Alcon's +3.0 D add power AcrySof IQ ReSTOR IOL, introduced in many international markets in 2008, is now approved in the U.S. Clinical trials included a 3-month follow-up exam of near, intermediate and distance acuities. The percentage of patients who achieved 20/20 or better at all three distances with the ReSTOR +3.0 D was nearly fourfold the rate of patients who received the control lens, AcrySof IQ ReSTOR +4.0 D. The clinical studies also showed a high rate of patient satisfaction, with more than 95% of patients stating that they would have this lens implanted again. ■ ISTA NDA approved. ISTA Pharmaceuticals says that its New Drug Application for Bepreve (bepotastine ophthalmic solution) has been accepted for review by the FDA. The company is seeking approval for Bepreve as an eyedrop treatment for ocular itching associated with allergic conjunctivitis. ISTA says its phase 3 clinical studies with Bepreve demonstrated highly statistically significant reductions in the primary endpoints of ocular itching. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and on additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. ISTA says there were no serious ocular adverse events reported in patients dosed with Bepreve. ■ Statins linked to eye problems. A recent study of 256 patients by the Oregon Health & Science University indicates that statin drugs taken to reduce cholesterol may cause one of three types of muscular eye disorders. Researchers looked at reports of diplopia, ptosis and ophthalmoplegia in the databases of the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization and the FDA. Statins have been known to cause systemic muscle problems in some patients, but this is the first research linking statins directly to muscle problems of the eye. Statins can prevent muscle tissue from repairing and regenerating normally. Other muscular problems experienced by statin users include muscle aches, pain, inflammation, weakness and tissue deterioration. The eye disorders the researchers found were rare, occurring in 0.1% of patients, but those patients taking gemfibrozil (another cholesterol-lowering drug) at the same time as statins were at a higher risk (0.5% to 2.5%). Of the 256 patients reported on, 23 lost eye range of motion, eight had ptotic upper eyelids and 18 experienced both diplopia and ptosis. All symptoms disappeared after they stopped taking statins. The study was unable to determine which eye muscles were involved from the database information or how long it took for them to fully recover. OM |
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