Industry news in brief
Eli Lilly and Co. delays starting phase-3 trial
INDIANAPOLIS Officials of Eli Lilly and Co. said they will delay the start of a phase-3 trial of the companys diabetic retinopathy drug, LY333531. Company officials said reasons for the postponement were due to issues related to criteria for initiation of the trial and the number of participants in the study.
The delay will be about 4 to 6 months, company officials said.
B&L Ireland to develop Envision TD system
ROCHESTER, N.Y. Premarket development and production of Bausch & Lombs (NYSE: BOL) Envision TD drug-delivery system will take place at the companys Waterford, Ireland, facility, company officials announced.
Construction is to begin immediately on an addition to the Bausch & Lomb Waterford campus, which now includes a research and development unit and manufacturing lines for soft contact lenses. Of the nearly $15 million investment in Waterford, a portion of the funding will come from Irelands Investment Development Agency, and the remaining funds will come from Bausch & Lomb. The project is expected to add about 30 new jobs at Bausch & Lombs Waterford campus, where about 1,800 people are currently employed.
The Envision TD technology is a project of Bausch & Lomb and Control Delivery Systems, of Watertown, Mass. The companies have agreed to develop ophthalmic products designed to treat a variety of blinding eye diseases.
The Envision TD drug-delivery system is currently in late-stage clinical trials for the treatment of posterior uveitis and diabetic macular edema in the United States, Europe and Japan. Clinical trials for age-related macular degeneration began in January.
The clinical studies for posterior uveitis and diabetic macular edema received fast track status by the U.S. Food and Drug Administration, which grants a speedier regulatory review for promising therapies that address unmet medical needs. Possible commercialization for the first indication is expected in 2004, according to company officials.
Rite Aid accepts Pfizer, Novartis prescription benefit cards
CAMP HILL, Pa. Rite Aid Corp. (NYSE, PCX: RAD) is now accepting the Pfizer Share Card and the Novartis CareCard at its more than 3,500 pharmacies nationwide.
The company has accepted the Glaxo SmithKline Orange Card since Jan. 1, and it began accepting the Pfizer and Novartis cards March 1.
With the Pfizer Share Card seniors pay $15 for a 30-day supply of Pfizer medicines including drugs for conditions that are often left untreated by the elderly like diabetes, high blood pressure, Alzheimers disease, high cholesterol and depression.
The Novartis CareCard provides a 25% discount off the wholesale list price of drugs that Novartis manufactures, including those that treat high blood pressure, Alzheimers disease, high cholesterol and osteoporosis.
The GlaxoSmithKline program offers a 25% discount off the wholesale list price of drugs manufactured by Glaxo including those used to treat congestive heart failure, diabetes, Parkinsons Disease and depression.
To qualify for the programs, patients must be 65 years of age or older with no other prescription coverage and meet certain income guidelines.
Washington State Superior Court approves class action settlement
SEATTLE The King County Superior Court Judge has entered a Final Order and Judgment approving a class-wide settlement in the case of Harris, et al. v. Lexington Eye Institute, Ltd., et al., No. 00-2-26941-2 SEA (State of Washington, King County Superior Court).
Plaintiffs, on behalf of a certified class of Washington consumer/patients, alleged that defendants Lexington Eye Institute of Canada; Focus Eye Care; Dr. Robert Woods; and Trinh Hua, OD, engaged in unfair and deceptive business practices toward their Washington laser eye surgery patients.
As part of the approved settlement, the Defendants agreed not to enforce the Governing Law and Jurisdiction provisions of their consent form that each Washington patient had to sign before laser eye surgery occurred in Canada.
The Governing Law and Jurisdiction provisions of the consent form required that all disputes associated with laser eye surgery performed at Lexington Eye Institute be brought only in Canada and under Canadian law. The settlement thus removes one of the key impediments to Washington patients who have suffered personal injuries caused by the Defendants from obtaining relief for these injuries in their home country and state. For more information about this case, see www.seattleclassaction.com.
Trimedyne sues Lumenis for patent infringement
IRVINE, Calif. Medical device maker Trimedyne Inc. (NYSE: TMED) has filed antitrust and patent infringement claims against rival Israeli firm Lumenis Ltd. (NYSE: LUME).
Trimedyne said it is seeking damages from Lumenis, which it alleges infringed Trimedyne patents relating to medical lasers.
In January, Lumenis filed a lawsuit against Trimedyne also alleging patent infringement.
ASCRS appoints advisory board on LVC education
FAIRFAX, Va. The American Society of Cataract and Refractive Surgery has appointed a medical advisory board to oversee the organizations laser eye surgery education initiative, scheduled to launch in June. The panel, which comprises four ophthalmologists, will advise and support the ASCRS in its endeavor to educate the public about the risks and benefits of laser eye surgery, with a focus on the importance of active discussion between patients and their physicians.
The medical advisory boards function is to review all campaign activity, provide medical expertise, and ensure scientific accuracy. The appointees are: Roger F. Steinert, MD, campaign chair, associate clinical professor of ophthalmology, Harvard Medical School; Stephen S. Lane, MD, clinical professor of ophthalmology, University of Minnesota; Douglas D. Koch, MD, professor of ophthalmology, Baylor College of Medicine, Houston; and R. Doyle Stulting, MD, professor of ophthalmology, Emory University, Atlanta.
The appointment of a medical advisory board is the latest in a series of steps the ASCRS has undertaken to organize the initiative, which will officially launch at the ASCRS annual symposium in June. In November 2001, the organization announced that funding had been obtained through a series of unrestricted educational grants provided by Alcon; Bausch & Lomb; Visx; TLC Laser Eye Centers; IntraLase Corp.; Nidek; Moria; Vision Fee Plan, a division of Capital One Financial Corporation; Refractec; and Katena Products.
Additionally, in December, ASCRS hired Ketchum Public Relations to assist in the campaigns launch and promotion.
IOLs donated for Ridley Day
WEST SUSSEX, England Rayner Intraocular Lenses Limited, has donated a days production of lenses to charity, with half going to Sight Savers International and the other half to Impact Foundation, which will use them to restore sight to people around the world blinded by cataract.
The lenses are donated as part of the 2001 Ridley Day celebrations on November 29, held to mark the worlds first operation to implant an IOL by the late Sir Harold Ridley on Nov. 29, 1949. Mr. Ridley worked closely with Rayner to develop the first IOL more than 50 years ago.
Rayner donated 1,000 PMMA lenses to these two charities.