Category: Uncategorized
October 11, 2002

News Release: QLT And Novartis Ophthalmics Launch Phase III Program To Treat Skin Cancer

QLT Inc. (QLT TSX) and Novartis Ophthalmics, the eye health unit of Novartis announced the start of patient enrollment in two phase III clinical trials using photodynamic therapy (PDT) with verteporfin for the treatment of multiple basal cell carcinoma.

The trials are designed to determine the safety and efficacy of using verteporfin with PDT to eliminate multiple basal cell carcinoma. Approximately 180 patients will be enrolled in two randomized, multi-centered, placebo-controlled trials at 19 centers in North America. The design of the phase III program is based on the results of a randomized phase II clinical study conducted at four centers with 421 tumors treated in 54 patients. The phase II trial demonstrated the preliminary safety and efficacy of verteporfin at three different light doses in patients with non-melanoma skin cancer with multiple lesions. The group of patients exposed to the highest light dose had the best response rate with 98% of the assessed tumors showing a complete clinical response six months after initial treatment.

'Photodynamic therapy using verteporfin has a high probability of success and offers clear advantages over existing treatments because it is a non- invasive procedure that can treat multiple tumors simultaneously,'said Mohammad Azab, M.D., QLT Inc.'s senior vice president, clinical and medical affairs. 'Randomized phase II results showed a 98% clinical response rate with a good cosmetic outcome.'

'We are very excited that verteporfin, in addition to ocular indications, also showed promising results for patients suffering from multiple basal cell carcinoma. This may further extend usage of verteporfin for the benefit of patients,'said Luzi von Bidder, head of Novartis Ophthalmics.

Marketed by Novartis Ophthalmics as Visudyne(R), verteporfin is the therapy of choice in some forms of wet age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50. Visudyne has been developed by QLT and Novartis Ophthalmics and is available in more than 60 countries.

About the treatment

Photodynamic therapy treatment is designed to treat tumors on or just under the surface of the skin and on the lining of the internal organs. As opposed to other standard non-melanoma skin cancer therapies, the therapy may have the added advantage of being able to treat multiple tumors at once with little or no scarring.

As a treatment for skin cancer, verteporfin is injected into the patient intravenously and within two hours selectively concentrates in the tumor. Activation of verteporfin by a non-thermal light emitting diode (LED) at a wavelength of 689 nm at the tumor site produces a cytotoxic form of oxygen that destroys the cancer cells. Local pain and discomfort at the treatment sites are among the most common adverse effects but can be well controlled with oral pain relief medication.

Disease overview

The two most common forms of non-melanoma skin cancer are basal cell carcinoma and squamous cell carcinoma. Basal cell carcinoma accounts for an estimated 75 percent of all skin cancers and is the most common cancer in humans. The disease typically develops on sun-exposed areas such as the head and neck and is slow growing.

The most common warning sign of skin cancer is a change in the skin's appearance, especially a new growth or sore that doesn't heal. Basal cell carcinomas typically look like small red or pearl-colored lumps that may crust over, ulcerate or bleed.

Background on the companies

QLT Inc. (NASDAQ: QLTI; TSE:QLT) is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialized two products to date, including Visudyne therapy which is the largest selling ophthalmology product ever launched. For more information, visit our web site at www.qltinc.com

Novartis Ophthalmics: With world-wide headquarters in Bulach, Switzerland, Novartis Ophthalmics is a global leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of glaucoma, age-related macular degeneration, eye inflammation, ocular allergies and other diseases and disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. The North American headquarters is based in Atlanta, Georgia. Novartis Ophthalmics has production sites in Switzerland, France and Canada. For more information, visit www.novartisophthalmics.com or www.novartisophthalmics.com/us.

Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com

Visudyne(R) is a trademark of Novartis AG.

QLT Inc. is listed on The Nasdaq Stock Market under the trading symbol 'QLTI'and on The Toronto Stock Exchange under the trading symbol 'QLT.'

Certain statements in this press release, which can be identified by language such as 'will be', 'may have', 'has a high probability of'or similar expressions, constitute 'forward-looking'statements of QLT and Novartis AG within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Such statements include, but are not limited to, those with respect to the probability of success of this treatment and the expected advantages which this treatment will offer, those setting out the anticipated number of patients to be enrolled in the study and the expected number of centres at which the study will be conducted, and those with respect to the expectation that adverse affects can be well controlled with oral pain relief medication. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: levels of patient enrollment, actual results from the trials, timing of the trials and additional information and other factors as described in detail in QLT Inc.'s Annual Information Form on Form 10-K and recent and forthcoming quarterly reports on Form 10Q, Novartis AG's Form 20-F, and other filings with the US Securities and Exchange Commission and Canadian Securities Regulatory authorities. Forward-looking statements are based on our current expectations and QLT and Novartis AG are not obligated to update such information to reflect later events or developments.

CONTACT: TEL: (604) 707-7000 QLT Inc.: Vancouver, Canada

FAX: (604) 707-7001 Therese Crozier

Tamara Hicks

TEL: (770) 905-1020 Novartis Ophthalmics, North America:

FAX: (770) 905-1510 Duluth, Georgia, USA, Jan McClure

TEL: +41 1 864 15 69 Novartis Ophthalmics, World-wide:

FAX: +41 1 862 03 83 Bulach, Switzerland,

Sabine Ciccotosto

WEBSITE This email address is being protected from spambots. You need JavaScript enabled to view it.