PRCS JPMorganChaseHQ Healthcare Conference Presentation
Tuck, this is from notes, interviews and the press release.
I would strongly suggest all listen to the PRCS presentation at the JPMorganChaseHQ Healthcare Conference. It can be accessed from the web site URL as follows: praecis.com
Prostate Cancer
PRCS provided an in-depth presentation on the prostate cancer drug (Abarelix Depot) and indicated that the drug should become the standard of care for hormonal treatment of prostate cancer. They expect to take a substantial part of the current $2.5B market. AMGN is moving ahead very rapidly to begin aggressive marketing.
Reasons for success:
It is a single dose compared to other treatments that are two separate dose treatments. Other treatments have FDA warnings and also warnings in Europe. Abarelix should not have this problem.
With 200,000 patient contacts with Abarelix, there have been no adverse events. The safety profile is extremely clean.
It is the only prostate treatment that acts as an inhibitor on follicle stimulating hormones, which apparently also cause cancer to progress.
PRCS has requested and met the conditions for a priority review from the FDA on this drug, but they currently have not heard whether the FDA has granted their request. They should know in a few months.
Endometriosis
PRCS has 365 persons enrolled in Phase II trials. Results are very encouraging. They are now meeting with the FDA on finalizing the Phase III trial, which they expect to begin in Q I 2001. The market size is twice that of Prostate cancer, but they are projecting 1.0B in sales and marketing approval by 2004. There is no competition to this drug.
Lower Back Pain (Latranal)
Dr. Gefter announced that a phase II study of Latranal, its proprietary topical composition for the treatment of localized muscle, tendon or neuropathic pain. The Company intends to enroll 300 patients that suffer from lower back and to begin Phase II trials this month. There is currently no treatment on the market for this indication, and it does treat the disease, not the symptoms. PRCS expects interim results of the study in Q3 2001. The projected market size in $1.0B and marketing approval in 2003.
Alzheimer's disease (Apan)
From the Press Release-(PRCS) also reviewed the results of recent preclinical studies of Apan, the Company's drug candidate in development for the treatment of Alzheimer's disease. The hallmark of Alzheimer's disease is the accumulation of plaque-like deposits in the brain that are composed largely of a peptide called beta-amyloid. A large body of clinical, biochemical and genetic evidence has led to the theory that when beta-amyloid molecules aggregate they become toxic to nerve cells, and that this toxicity leads to the development and progression of Alzheimer's disease. Preclincal experiments have shown that Apan specifically inhibits the aggregation of beta-amyloid and its associated nerve cell toxicity. Alzheimer's disease, and the associated accumulation of beta-amyloid in the brain, is often thought of as a defect in the ability to clear beta-amyloid from the brain into the cerebral spinal fluid (CSF). Both humans and transgenic mice with Alzheimer's disease plaques show increased levels of beta-amyloid in the brain and decreased levels in the CSF. Transgenic mice treated with Apan show significant increases in beta-amyloid levels in the CSF, suggesting that Apan is able to mobilize beta-amyloid in the brain and facilitate its clearance.
Commenting on these results, John H. Growdon, M.D., a Professor of Neurology at Harvard Medical School and a Director of the Alzheimer's Disease Research Center at the Massachusetts General Hospital stated, ``The significant increase in beta-amyloid levels in the CSF of the transgenic mice treated with Apan suggests that this compound could alter the course of Alzheimer's disease by a novel mechanism.''
The Company confirmed the submission to the FDA in December 2000 of an Investigational New Drug Application (IND) for Apan and its expectation of initiating a phase I clinical trial during the first quarter of 2001. This product could be approved and on the market by 2005 according to the company. Sales are estimated at $2.0B. (Sounds pretty conservative)
HGSI
First, PRCS has an agreement with HGSI that they have free access to the HGSI genome database. If PRCS finds a drug lead from this information, they are responsible for validating the target. If the target is validated, then PRCS and HGSI share 50-50 in clinical development costs and sales and marketing profits. The first target is CCR5. PRCS expects to add two additional candidates (submit two additional IND’s) to the clinic prior to the end of this year in addition to the CCR5 (IND already submitted.) They expect the total potential sales from all current and future drug candidates this year to exceed 7.0B.
HGSI/CCR5
CCR5 is the receptor on human lymphocytes that permits the AIDS virus to enter into the cell. PRCS is developing a drug that blocks AIDS from entering the cell by blocking the ability of the AIDS molecule from to attaching to the CCR5 receptor. This is preclinical, and work is progressing in identifying molecules that use the CCR5 receptor.
Additional Preclinical Development Efforts
PRCS gave an overview of its product pipeline, and disclosed that, in addition to its four compounds in clinical development, it currently has seven compounds in preclinical development. The Company briefly discussed several of its preclinical research programs. Those highlighted included a program in inflammatory disease therapeutics targeting NF-kB, a central mediator of inflammation, and a program in HIV therapeutics targeting CCR5, the molecular entry point for the AIDS virus. (They are using technology that is licensed from Dana-Farber.) The Company also provided a brief overview of its Rel-Ease(TM) technology, which has been used to produce abarelix and other compounds in sustained release formulations. The Company discussed its plans to use its Rel-Ease technology to create sustained release formulations of approved drugs, as well as potential products discovered using its proprietary LEAP(TM) technology. |
