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Novartis Completes Purchase of Minority Interest in Alcon PDF
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Companies
Thursday, 10 July 2008
Novartis AG and Nestle S.A. recently announced that they have completed the first step purchase and sale of 74 million shares of Alcon, Inc. (NYSE: ACL) common stock currently owned by Nestle pursuant to the agreement dated April 6, 2008 between Novartis and Nestle. With the completion of the first step transaction, Nestle remains Alcon's majority shareholder with approximately 52% of Alcon's issued capital and Novartis now owns a minority stake in Alcon equal to approximately 24.85% of Alcon's issued capital.

As a result of Novartis' minority investment in Alcon, the Alcon board of directors expands from eight to ten directors. James Singh, Nestle's executive vice president and chief financial officer, and Daniel Vasella, M.D., Novartis' chairman and chief executive officer, are the new Alcon directors. The expansion of the board and the election of Singh and Vasella were approved by shareholders at Alcon's 2008 annual general meeting.

In addition to this minority investment, the April 6, 2008 agreement provides Novartis with a call option to purchase Nestle's remaining Alcon common shares. The agreement also provides Nestle with a put option to sell its remaining Alcon common shares to Novartis. These options commence on January 1, 2010 and expire on July 31, 2011. If either of these options are exercised, and subject to the agreement's closing conditions (including regulatory approval), Novartis would become the majority shareholder of Alcon with approximately 77% of its issued shares.

Source: Alcon
 
Hope for patients with end-stage glaucoma PDF
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Ophthalmology and Optometry
Wednesday, 09 July 2008
Ophthalmologists can honestly give their end-stage glaucoma patients hope, says a study led by Jason W. Much, M.D. The findings break new ground in an under-researched area and will help ophthalmologists evaluate, counsel and care for patients with visual field loss due to end-stage glaucoma."Relentless progression to (complete) blindness is not the norm in treated patients," says Dr. Much. "Patients should be encouraged that treatment is not futile. They may retain their visual acuity for many years and be able to perform simple tasks of daily living and enjoy reading and hobbies."

The researchers reviewed charts of 64 patients (84 eyes) with end-stage glaucoma cared for by ophthalmologists at the University of Pennsylvania Medical Center from 1992 to 2004. All subjects were U.S. residents; most were black and had POAG. At the study baseline, the majority of patients had 20/50 visual acuity or better along with loss of most of their visual field, defined as being able to see less than a 10 degree radius from the center of the eye's focus. Because of the decreased field of vision, these patients were all considered legally blind at the onset of the study. Fifty-six percent of eyes had had trabeculectomy and 71 percent had had laser trabeculoplasty (removal of part of the trabecular meshwork via laser). The average IOP,controlled by treatment , was 15.36 mmHg throughout the study period. At the study conclusion point, only eight in 84 eyes had 20/200 visual acuity---meaning the ability to see objects clearly and in detail was severely compromised--and in some of these eyes the loss may have resulted from progressive cataract. Few eyes suffered complete blackout of their central visual field because of glaucoma. These findings on maintenance of visual acuity were particularly encouraging in a study population that was predominantly African-American and therefore at higher risk for glaucoma progression.
 
Akorn Receives FDA Approvable Letter for Akten® Ophthalmic Gel 3.5% PDF
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Companies
Wednesday, 09 July 2008
Akorn, Inc. (NASDAQ: AKRX) recently announced the receipt of an FDA approvable letter for Akten® Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product. The approvable letter identified several minor CMC deficiencies that must be addressed and rectified before final approval is granted. The majority of these items have been addressed in the previous submissions to the FDA. The remaining response will be submitted to the FDA very soon. No additional clinical data is required.

Additionally, prior to approval, product labeling must be finalized. Akorn have received proposed labeling from the FDA and will submit final printed labeling.

Source: Akorn
 
Large-scale U.S. Medicare patient study evaluates glaucoma surgeries PDF
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Ophthalmology and Optometry
Tuesday, 08 July 2008
The claims records of 14,491 U.S. Medicare beneficiaries diagnosed with glaucoma who received one of three incisional surgeries--- primary trabeculectomy (PT), trabeculectomy in the presence of scarring from previous ocular surgery or trauma (TS), or implantation of a glaucoma drainage device (GDD)---between 1994 and 2003 were analyzed by Frank A. Sloan, PhD, and colleagues. "Incisional" indicates that incisions were used to accomplish the procedure. Similar procedures that use laser tools rather than incisions were not assessed in this study. Surgical treatment may be used when IOP medications become ineffective or other factors make surgery the best option. Because some studies had suggested that performing GDD earlier in complicated glaucoma cases might provide benefit with fewer adverse outcomes, Dr. Sloan's group decided to compare GDD to PT and TS outcomes in a large, national Medicare population.

The three surgeries are designed to improve the drainage of fluid from the eye to reduce IOP. In trabeculectomy (both PT and TS), a small portion of the trabecular meshwork is removed to increase fluid flow, and in GDD a tiny implanted shunt is used to bypass the trabecular meshwork and redirect fluid flow. These incisional techniques have benefitted millions of glaucoma patients who otherwise might be blind or have very low vision. Study patients were at least 68 years of age but not older than 96 during the period analyzed. A number of important case-mix and demographic factors were controlled for by the study design. Patients' Medicare claim records were analyzed to determine post-surgery rates of severe or less severe outcomes, the need for additional glaucoma-related surgery, or progress to low vision or blindness. Records for follow up at one, two, and when available, six years post-surgery were also analyzed.

The study found that, although adverse outcomes were uncommon for all three surgeries, rates of severe outcomes, less severe outcomes, and progression to low vision or blindness were higher for persons who received GDD than for those who received PT or TS. Also, adverse outcome rates related to trabeculectomy were somewhat higher at six-year follow up than other studies have reported. Patients treated with GDD were more likely to progress to legal blindness. Although the study population was diverse (Medicare patients who represented all areas of the U.S. and a range of ethnicities), the patients treated with GDD were disproportionately African-American, a group at higher risk than other ethnicities of developing glaucoma-related blindness.

This large study demonstrates that most of the differences in outcomes for PT, TS and GDD may be due to disease severity in the patients treated, rather than to differences in the techniques, devices, or surgeons involved in treatment, Dr. Sloan says. "As we move forward, we might expect to see a decrease in complication rates for these surgeries," he concludes.

Source: Ophthalmology
 
Allergan Intents to File FDA Application for Treatment to Stimulate Natural Eyelash Growth PDF
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Companies
Tuesday, 08 July 2008
Allergan announced recently that it intends to file a New Drug Application by end of the third quarter of 2008 with the U.S. Food and Drug Administration (FDA) for bimatoprost, a synthetic prostaglandin analog, as a treatment to stimulate eyelash growth. Allergan has completed its clinical trial program demonstrating that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth.

"Our exploration of bimatoprost as an eyelash growth enhancer reflects our continuing commitment to offer innovative medical aesthetic treatments that are science-based, with the clinically proven safety and efficacy that consumers have come to trust Allergan to provide," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "We are pleased with the results of our clinical program and believe this innovative product, if approved, could meet a significant and currently unmet demand in the medical aesthetic marketplace."

The global mascara market is presently estimated to be $3.7 billion annually.(1) If approved by the FDA for eyelash growth, which Allergan currently anticipates in 2009, the company estimates global peak sales of bimatoprost for this indication could exceed $500 million per year. Allergan has exclusive U.S. and foreign patents on the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate natural eyelash growth. If approved by the FDA, Allergan's bimatoprost product for eyelash growth will be available by prescription only to consumers in the United States.

"The development of this innovative product stems from our 60-year expertise and leadership in prescription eye care products," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "As the largest medical aesthetics company worldwide, we are particularly pleased with the prospect of bringing to market yet another science-based medical treatment that fits into our overall facial aesthetics product portfolio and further reflects our commitment to the Science of Rejuvenation(TM)."

Source: Allergan
 
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