Knobias Clip Report (02-14-2008)
Submitted By Knobias ClipReport
TPTX: CEO Comments on Strategic and Clinical Plans for 2008
The President and CEO of TorreyPines Therapeutics, Inc. (TPTX), Dr. Neil M. Kurtz, presented the Company’s strategic plan for 2008 today in a conference call. The plan calls for the expansion of business development initiatives to evaluate partnership opportunities across the Company’s product pipeline and the streamlining of operations through an expense-reduction program.
“We will conduct a meeting with the FDA in the first half of the year to discuss the efficacy results from the recently completed Phase II clinical trial of tezampanel in acute migraine headache. Depending on the outcome of the meeting, the Company intends to conduct an end-of-Phase II meeting with the FDA in the second half of 2008.
Dr. Kurtz added, “We have no indication from the FDA as to how they view the trial, and we are reluctant to speculate. We believe that the FDA will agree that the 40 mg dose is an effective and safe dose for the treatment of migraines. We would not begin a Phase III trial until we have a partner.”
“We also plan to initiate a Phase II trial of tezampanel in muscle spasticity and rigidity secondary to spinal cord trauma in the second half of the year. In addition, a Phase I trial of NGX426 in a capsaicin model for neuropathic pain is expected to begin in the first half of 2008.”
“The company will seek to begin a Phase II trial of NGX267 in xerostomia, or dry mouth, secondary to Sjogren’s syndrome in the first half of the year. A drug that effectively treats xerostomia and is well tolerated would likely be widely used and have significant market potential. There are also multiple potential indications that include cancer and diabetic patients.”
Sjogren’s syndrome is a chronic disease in which white blood cells attack the moisture-producing glands. The hallmark symptoms are dry eyes and dry mouth, but it is a systemic disease, affecting many organs and may cause fatigue. It is one of the most prevalent autoimmune disorders, striking as many as four million Americans.
Xerostomia can be a symptom of various medical conditions, a side effect of a radiation to the head and neck, or a side effect of a wide variety of medications. It is a common complaint found often among older adults, affecting approximately 20 percent of the elderly. Xerostomia can cause difficulty in speech and eating. It also leads to halitosis and a dramatic rise in the number of cavities, as the protective effect of saliva is no longer present, and can make the mucosa of the mouth more vulnerable to infection.
The Company will implement a plan to streamline operations this year. “We will reduce our workforce by approximately ten employees. This will reduce our operating expenses by $3 million to $4 million on an annual basis. We expect a burn rate in the range of $22 million to $24 million in 2008. I will also assume oversight for our clinical development activities,” stated Dr. Kurtz.
Dr. Kurtz concluded, “I would like to reinforce my enthusiasm for our pipeline. It is not often that a company has product candidates and discovery programs that have shown promise in a variety of disease states, representing large markets with significant unmet medical needs. This allows us to be selective in the opportunities that we pursue internally, while being opportunistic on the partnering front to insure maximum value of our assets for shareholders.”
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