A healthy and clear vision is important to the quality of our life. Good eyesight not only allows us to enjoy life but also makes it complete.
Working on the development and commercialization of innovative eye therapies is QLT Inc. This Canadian biotechnology company made its initial public offering in September 1986 at C$2.50 per share. The company is publicly traded on the Nasdaq under symbol (QLTI) and on the Toronto Stock Exchange under symbol (QLT.TO).
For readers who are new to QLT, here's brief overview of the company and its upcoming events to keep an eye on...
The company has one commercial product, Visudyne, for the treatment of wet age related macular degeneration, or wet AMD for short, developed in partnership with Novartis AG (NVS). QLT has exclusive U.S. rights to sell and market Visudyne in the U.S. Visudyne, which was approved by the FDA in 2000, is sold in over 80 countries worldwide.
QLT's revenue includes sales of Visudyne in the U.S. and the royalties collected from Novartis from the sale of Visudyne outside the U.S.
In 2010, Visudyne worldwide net sales, which dropped 14.2 percent to $90.6 million, included $22.6 million in U.S. sales. Because of an amended Visudyne agreement with Novartis, in 2010, QLT booked higher sales of net product revenue of $31.1 million and $13.6 million of royalties from Novartis.
In the second quarter ended June 30, 2011, global Visudyne sales rose 4.3 percent to $25.4 million. Sales in the U.S. were $6.5 million, up 2.0 percent while sales outside the U.S. were $18.9 million, up 5 percent from the prior year quarter.
The company's current active investigational products include, Latanoprost Punctal Plug Drug Delivery System (L-PPDS) under phase II for the treatment of Glaucoma, and QLT091001 under phase I for the treatment of Leber Congenital Amaurosis and Retinitis Pigmentosa.
L-PPDS is a minimally invasive drug delivery system that delivers Latanoprost to the eye through controlled sustained release to the tear film. Latanoprost is already approved by the FDA for reducing intraocular pressure in patients with glaucoma or ocular hypertension. Latanoprost, also known by the brand name of Xalatan manufactured by Pfizer Inc. (PFE), lost patent exclusivity in March 2011. The drug fetched annual sales of $1.6 billion in 2010.
IMS Health estimates that the U.S. market for glaucoma eye drop treatments is roughly $2.0 billion annually, despite the poor compliance associated with the current eye drop therapies. L-PPDS is designed to provide a more effective, convenient and reliable treatment alternative to eye drops for glaucoma patients.
A phase II study to assess the effectiveness of L-PPDS in reducing intraocular pressure in patients based on 4 weeks of treatment with L-PPDS vs. baseline values is currently underway. The results of this trial are expected to be available this quarter. (3Q). According to QLT, even if the phase II study is positive, L-PPDS will not advance to a later stage trial but rather another phase II trial would be conducted for further clinical evaluation.
Apart from glaucoma, the second indication for which QLT's punctal plug drug delivery system was evaluated was for the treatment of allergic conjunctivitis through the sustained release of Olopatadine, an antihistamine. Interim results from a phase II trial of O-PPDS (olopatadine punctal plug delivery system) released in February of this year, demonstrated that there were no significant differences between the O-PPDS and placebo-PPDS subjects with respect to reduction in the signs and symptoms of allergic conjunctivitis. In light of the disappointing results, QLT has stopped O-PPDS study for the time being.
Yet another clinical development program of QLT is QLT091001, a synthetic retinoid replacement therapy, for the treatment of LCA (Leber Congenital Amaurosis), a rare and disabling childhood blindness. QLT091001 is being developed by QLT in partnership with privately-held Retinagenix LLC.
In May of this year, QLT announced positive preliminary results from its phase 1b proof-of-concept clinical trial of QLT091001 for LCA. According to the study results, treatment with QLT091001 resulted in clinically meaningful improvement in either or both visual acuity and visual fields in 8 of the 12 LCA subjects. With the company recruiting two additional LCA patients in the study, with a total of 14 subjects, enrollment has been completed.
The company is in talks with the FDA and the European Medicines Agency to finalize the design and protocol requirements for a pivotal trial of QLT091001 for LCA. The company is working towards reaching an agreement on the more detailed requirements for its regulatory and registration pathway for QLT091001 by the end of this year. The company hopes to advance QLT091001 for LCA to a registration trial in 2012.
QLT091001 is also being evaluated as a potential treatment for Retinitis Pigmentosa, a hereditary retinal diseases demonstrating clinical features similar to LCA. The company is currently enrolling patients in the QLT091001 trial for Retinitis Pigmentosa, and expects to have a total of 14 Retinitis Pigmentosa patients in the trial by year end.
Last December, QLT091001 received orphan drug designation from the FDA for the treatment of LCA (Leber Congenital Amaurosis) and RP (Retinitis Pigmentosa). In February of 2011, QLT091001 received positive opinion from the EMA COMP (Committee for Orphan Medicinal Products) for the treatment of LCA and RP. Positive opinions by the COMP precede official designations of QLT091001 as an orphan drug by the EMA.
There are no FDA or EMA approved therapeutic treatments for Leber Congenital Amaurosis and Retinitis Pigmentosa. Based on market research, the company has pegged the treatment eligible LCA patient population for QLT091001 at 1,000 to 2,000 patients worldwide, and the potential treatment eligible RP patient population at less than 15,000 patients worldwide.
A quick look at the company's balance sheet...
QLT's revenue stream includes Visudyne sales and related royalties. In the second quarter ended June 30, 2011, the total revenue was $12.7 million, up 2.5 percent from the year-ago comparable quarter, due to higher Visudyne sales worldwide. The company incurred a wider net loss of $6.14 million or $0.12 per share in the second quarter of 2011, compared to a loss of $1 million or $0.02 per share in the year-ago quarter.
The company has a share buyback program in place that was approved last December to repurchase up to 3.62 million shares over a period of 1 year. Under this program, as of June 30, 2011, QLT has repurchased about 1.6 million shares at an average price of $6.98 per share, for a total cost of $10.9 million. The company has no long-term debt and has a consolidated cash balance of $201.1 million.
The 52-week price range of QLT is $5.34 to $8.87 on the Nasdaq and C$5.51 to C$8.53 on the TSX.
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