Shaman rises again?
P.T. Barnum said it best, 'there's a sucker born every minute'.
From Keiretsu News - January, 2004
keiretsunews.com
PS Pharmaceuticals
Progress Since PS Pharmaceuticals Presented to Keiretsu Forum
PS has adhered to the product timeline presented to Keiretsu Forum in August 2003. With a product that has been in multiple clinical trials and has a substantial volume of both pre-clinical and clinical data, the corporate partnering process requires a lengthy due diligence period. Since the presentations to Keiretsu, numerous meetings have been held with potential partners. We are rapidly completing the due diligence process with several companies and hope to enter discussions of deal terms in the near future. We have also begun the work, which must be completed prior to meeting with the FDA regarding the final development of SP-303 for the HIV indication. We have contracted with a CRO specializing in statistical analysis to assist us in completing the final study report for the previously completed Phase III trial. A significant amount of work has already been performed to clean up the final database. Once the analyses have been completed by the outside CRO, we will arrange for a meeting with the FDA; the meeting is on target for the first quarter of 2004.
PS Pharmaceuticals Company Overview
PS Pharmaceuticals is a private enterprise founded two years ago to focus on the final development and commercialization of a late-stage gastro-intestinal product for the treatment of diarrhea frequently observed in patients with HIV. This product may also benefit a large segment of the population (upwards of 20%) that suffers chronically from a disease that to date has no satisfactory treatment, Irritable Bowel Syndrome (IBS). Based on its unique anti-secretory mechanism, the product that has the potential to save the lives of million of children around the world (in a way that is financially rewarding to the investors in PS). The product is termed SP-303, a naturally occurring product sustainably harvested and purified from the latex of the plant Croton lechleri of the family Euphorbiaceae, a tree widely available in multiple South American countries.
The origins of SP-303 trace to traditional healers in the Amazon Basin rain forest, who tapped the pulsing red latex of Croton lechleri (commonly known as Sangre de Drago, or Dragon’s Blood), to treat various gastro-intestinal symptoms, including the dramatic dysentery experienced by cholera sufferers.
Between 1992 and 1999, SP-303 demonstrated both safety and efficacy in over 1,200 humans in clinical trials for Traveler’s Diarrhea and AIDS Diarrhea; however, due to financial constraints, pharmaceutical development of SP-303 was halted in January 1999 prior to finishing final study reports for the Phase III trial or filing an NDA (a New Drug Application) with the FDA.
PS Pharmaceuticals was founded in 2002 to purchase the rights to SP-303 and to take it back into pharma development, simultaneously pursuing a comprehensive proof of concept clinical program for the blockbuster indication of Irritable Bowel Syndrome and finishing the program for the HIV-associated diarrhea indication, the fastest and lowest risk route to market (~2 years). The dual clinical pathway supports a strategy of generating product revenues and off-label usage as soon as possible, while finishing the full clinical development program for IBS (a potential multi-billion dollar indication).
Market
HIV/AIDS patients historically have suffered tremendously from parasitic and infectious diarrhea. Although antiretroviral therapy has reduced the incidence of infectious diarrhea in HIV/AIDS patients in the western world, the incidence of diarrhea remains high in this treated patient population. It is believed that the diarrhea observed in these patients is now mostly associated with the HIV infection itself or caused by antiretroviral therapy, particularly protease inhibitors. Sales projections for the US market with this indication are greater than $100 mm.
Irritable Bowel Syndrome is a very large disease, ranking second only to the common cold as a cause of lost work time. In addition, the disease accounts for approximately 3 million physician visits in the United States each year, costing the U.S. Healthcare system more than $30 billion annually (Source: Novartis press release dated October 22, 2002). The Company estimates that the market in the United States alone could be over $4 billion for a safe and effective diarrhea IBS product.
In the year 2001, over 5 million children under five years of age living in developing countries died of dehydration caused by diarrhea. Diarrhea in children is a major market opportunity in the US, with approximately 35 million episodes per year in children under five years old. Aside from oral rehydration therapy, there are no safe therapeutic options in this patient population. An effective product for the pediatric population could have a significant impact on the morbidity and mortality produced by diarrhea in the developing world. PS is working on innovative public/private partnerships to make SP-303 accessible to the dramatic need in the developing world, while leaving the western market opportunity intact for appropriate return on investment. In addition, a significant portion of this funding will go to the manufacturing of SP-303, benefiting both the pediatric and adult development programs.
The mechanism of SP-303 (and anecdotal reports of beneficial usage) would also support SP-303 for the diarrhea side-effects and symptoms caused by Inflammatory Bowel Disease/Crohn’s Disease, chemotherapy, and antibiotic, anti-depressant, and other drug usage.
Unique Differentiators and Company Strategy
Unique Differentiators:
PS Pharmaceuticals has secured initial funding and has recruited a powerful team The Company will be led by its President, Dr. Barry Quart. Dr. Quart was most recently with Pfizer where he served as Senior Vice President, Pfizer Global R&D and the Director of the La Jolla Laboratories. Dr. Quart was also President of R&D at Agouron where he was instrumental in the development of Viracept, the largest selling HIV protease inhibitor in the world, which moved from laboratory bench to NDA in 38 months. Dr. Quart has been instrumental in the approval of over 10 drugs including paclitaxol, didanosine, stavudine, and sotalol. Kimberly J. Manhard has joined the Company as VP of Regulatory Affairs. Ms. Manhard previously was VP of Regulatory Affairs at Exelixis and worked with Dr. Quart at both Agouron and Bristol Myers-Squibb.
The team also displays an important continuity factor in key areas. Lisa Conte is the founder of both Shaman and PS Pharmaceuticals. She has raised over $200 mm to bring this technology to market, as well as germinates the pathways to get SP-303 to the forgotten populations in developing countries in a responsible manner. Dr. Steve King, VP of Ethnobotany and Conservation, has worked on the long-term sustainable supply of the raw plant material from which we extract SP-303 for over a decade. He’s a fluent Spanish speaker who has lived in the Amazon basin. And Dr. John Chow, head of manufacturing, has been working on the pharmaceutical grade manufacture of SP-303 since 1997.
Outside consultant review
An independent due diligence review of the clinical and regulatory data associated with SP-303 was conducted by Dr. Allen Mangel, who developed Lotronex at GSK and directed the final development of Rifaximin for Traveler’s Diarrhea at Salix Pharmaceuticals. Dr. Mangel has concluded that, “SP-303 is ultimately very likely approvable for the treatment of Traveler’s Diarrhea.” In addition, in an exploratory statistical analysis in patients with HIV/AIDS, “across multiple endpoints in patients with diarrhea at baseline, SP-303 showed a substantial treatment effect as compared to placebo.” Finally, “a good logic exists that SP-303 could improve bowel function including urgency in diarrhea-predominant IBS patients.” The full report is available upon request.
Inventory of raw material and library of opportunities The Company has developed a sustainable supply of raw plant material and has substantial quantities of inventory of raw latex, intermediates and finished SP-303 on hand (i.e., commercial value of ~$40 mm for the HIV market). In addition to SP-303, PS has a library of over 2,300 plants, 344 of which have exhibited significant antiviral activity.
Strong patent position
The Company has composition of matter patents in the United States, Japan, Canada, Australia, United Kingdom and the Netherlands for SP-303. In Europe, PS plans to file the MAA through the Centralized Procedure, which provides a 10-year window of exclusivity for new chemical entities. In addition, the Company has also filed a patent for enteric-coated formulations of SP-303 worldwide, and has received such patent approval in New Zealand and Taiwan.
Company Strategy
Rather than raising the funds needed to go it alone, the PS strategy is a lower risk-partnering program.
The Company intends to have final clinical development and commercialization of the product funded by and/or conducted by a corporate partner. The Company is currently pursuing three types of partnership discussions:
An overseas partner, who would potentially fund development activities in return for overseas rights (such as Asian rights) and potentially profit sharing.
A large pharmaceutical company, seeking worldwide rights in return for traditional compensation (up-front payment, milestones, royalties)
A specialty pharmaceutical company, mostly focused on near-term revenue with a high probability of success (i.e.—AIDS-diarrhea indication), while collaborating on large pharma partnering strategy for ultimate IBS indication (we do not intend to “split” indications among partners)
A good product will prevail in spite of a difficult past. Late stage safe products that work are hard to come by.
Contact Information
Lisa Conte, Founder & CEO
(650) 616-1902
lconte@pspharma.com |
