Teva expands pipeline

Company inks license agreement to commercialize OncoGenex’s late-stage treatment for cancer

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JERUSALEM, Israel—In a move that enhances its global product pipeline, generic pharmaceutical company Teva Pharmaceutical Industries Ltd. has agreed to a global license and collaboration agreement with biopharmaceutical OncoGenex Pharmaceuticals Inc. to develop and commercialize OGX-011, a Phase III cancer therapy targeted toward inhibiting cancer treatment resistance.

The terms call for Bothell, Wash.-based OncoGenex to receive $60 million upfront, including a $10 million equity investment valuing its stock at $37.38 per share.
OncoGenex will also be eligible to receive up to $370 million in milestone and other payments, along with royalties, according to the companies.

OGX-011, designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance, is expected to be used as adjunct therapy to enhance the effectiveness of chemotherapy. The drug has shown promising results when added to currently available chemotherapies in several tumor types addressing a significant unmet medical need.

The drug is in Phase III clinical trials and is expected to move into late-stage development as a potential prostate and lung cancer treatment in 2010 and 2011, and used as an additional therapy to enhance the effectiveness of chemotherapy, the companies said.

The agreement will further enhance Teva's oncology offerings and strengthen its global branded product pipeline with a promising product candidate entering three Phase III trials involving large patient populations.

OncoGenex spokesman Jason I. Spark, vice president of San Diego, Calif.-based PorterNovelli Life Sciences, says,  "There are two key reasons why OncoGenex partnered with Teva—financial commitment and world-wide commercial priority."

"First, through the partnership, Teva has committed to fund three large and expensive Phase III trials in prostate and lung cancer, in addition to the costs of regulatory approvals and commercialization," Spark says. "The deal allows OncoGenex to maintain significant interest in the development and commercialization, with $370 million in potential development and commercial milestones, mid-teens to mid-twenties in royalties on product sales, as well as an option to co-promote in the U.S. and Canada. Oncogenex's financial obligation is capped at $30 million for development expenses to be paid over three years, and is applicable to reimbursement for its full-time employees working on the OGX-011 development program which may further reduce OncoGenex' burn rate."

Secondly, regarding commercial priority as well as commitment, Teva sees the program as the cornerstone of their oncology franchise, Spark says.

"Teva has the marketing muscle and the capital resources to compete in the branded pharmaceuticals market, has shown tremendous success in marketing Copaxone and has positioned itself as a major player in the specialty pharmaceuticals industry," he adds.
Additionally, OGX-011 "has shown potential to enhance the effectiveness of a variety of cancer therapies that are coming off-patent in the next few years—areas in which Teva already has significant marketing experience and created worldwide marketing opportunities, he says.

Teva could not be reached for comment.

A key aspect of OGX-011 is that it is designed to inhibit the production of the protein clusterin, Spark says. This protein is overproduced in many types of cancers in response to cancer treatments such as chemotherapy, radiation therapy and hormone ablation therapy.

"This overproduction of clusterin is linked to treatment resistance and tumor cell survival," Spark says. "By blocking the production of clusterin, OncoGenex believes that OGX-011 can improve the effectiveness of existing cancer therapies, such as docetaxel treatment in castrate resistant prostate cancer."

OncoGenex and Teva will initially develop OGX-011 as a combination treatment for first- and second-line castrate-resistant prostate cancer, as well as first-line non-small cell lung cancer, he says. The partnership agreement allows for additional indications to be added to the development program in the future.

"OGX-011 is unique among oncology treatments," Spark says. "Despite the body of research implicating clusterin's involvement in tumor cell survival and cancer treatment resistance, clusterin has historically been considered an 'undruggable' therapeutic target because it is primarily a chaperone protein within a cell which helps to prevent cell death. OGX-011 is the first drug candidate to show clinical evidence of reaching the clusterin messenger RNA target within a cell, regulating the clusterin target, suppressing clusterin production and showing clinical potential for therapeutic benefits in prolonged survival and pain palliation."

OncoGenex has not disclosed detailed projections for market potential.

Teva and OncoGenex also plan to collaborate on a global Phase III clinical program, with two Phase III clinical trials expected to be initiated in 2010: a Phase III study for second-line chemotherapy in men with metastatic castrate-resistant prostate cancer (CRPC) and a Phase III study in first-line chemotherapy for metastatic CRPC. An additional Phase III study in first-line treatment of advanced, unresectable non-small cell lung cancer (NSCLC) is intended to be initiated by early 2011.

"We see OGX-011 as a key component of our branded oncology medicines franchise, expanding our pipeline of existing oncology therapeutics and broadening the future available therapies made by Teva for oncology patients and care providers," said Moshe Manor, Teva's Group vice president of global branded products, in a statement. "OGX-011 is supported by compelling data demonstrating the drug's ability to benefit patients on top of several currently available chemotherapies in a number of oncology indications. In addition to prostate cancer, we are particularly enthusiastic about the therapeutic activity seen in the Phase II clinical trial in lung cancer."

The National Cancer Institute estimates that in 2009, approximately 192,280 new cases of prostate cancer would be diagnosed in the U.S. As the most frequently diagnosed cancer among men, one in six men will be diagnosed with prostate cancer during their lifetime, with an estimated 27,360 deaths in the U.S., alone, due to the disease.

The National Cancer Institute also estimates that in 2009, approximately 219,440 new cases of lung cancer would be diagnosed in the U.S. Non-small cell lung cancer accounts for approximately 85 percent of all lung cancer cases. With 159,390 deaths estimated for 2009 in the U.S., lung cancer remains responsible for the most cancer-related deaths in both men and women, representing 28 percent of all cancer-related deaths.

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