ISIP News, be interesting to see how it "plays" (and OT: SI sure is slow right now, hope we're not about to see it crash as the market opens)...
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Tuesday January 18, 8:06 am Eastern Time
Company Press Release
SOURCE: Isis Pharmaceuticals, Inc.
Isis Pharmaceuticals, Inc. Announces Restructuring and Expense Reduction Plan; Company Has Approximately 3 Years of Cash Under the New Operating Plan
CARLSBAD, Calif., Jan. 18 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) today announced a restructuring plan to reduce expenses and focus resources on the development of antisense drugs with significant commercial potential. As a result of heightened focus and initiatives to conserve resources, the company will reduce its workforce by nearly 40%. Under the restructuring plan, Isis has cash and committed funds sufficient to support activities for nearly three years. The company expects to make significant progress toward its primary goals of commercializing antisense drugs and building shareholder value in that time frame.
The unexpected failure of the company's pivotal clinical trial of ISIS 2302, an antisense inhibitor of ICAM-1, in Crohn's disease prompted the restructuring of the company. Isis has not yet determined whether it will pursue further development of ISIS 2302 in Crohn's.
``Given the large body of data showing the value of antisense in creating new drugs, our confidence in the technology remains strong, despite the results of the pivotal trial in Crohn's disease,' said Stanley T. Crooke, M.D., Ph.D., Isis' Chairman and CEO. ``We are committed to bringing antisense drugs to the market for the benefit of patients and our shareholders. Under our new operating plan we have prioritized our programs and will concentrate on developing the key assets that have maximum potential to build near-term shareholder value.'
The company has identified the following products and programs as highest priority: ISIS 2302, targeting ICAM-1, in a topical formulation for psoriasis; ISIS 3521 and ISIS 2503, targeting PKC-alpha and Ha-ras respectively, each in several cancer tumor types; ISIS 14803, in Hepatitis C; ISIS 104838, targeting TNF-alpha, in inflammatory diseases including rheumatoid arthritis and Crohn's; ISIS 107248, targeting VLA4 in Multiple sclerosis and inflammatory diseases; antisense research and development programs; the Ibis drug discovery platform; and antisense target validation programs. The company will complete its studies in an enema formulation of ISIS 2302 for ulcerative colitis and ISIS 5132 for cancer.
Going forward, Isis expects to be in a solid financial position based on reasonable assumptions for committed cash and revenue and with the implementation of cost cutting measures called for in the new operating plan. Including $24 million in equity financing, $50 million in committed funds from partners and approximately $55 million in cash at year-end 1999, and with reasonable assumptions about new sources of cash, the company believes it has sufficient resources to fund activity for more than three years. Net cash use is expected to decrease significantly in 2000 compared to 1999, due in part to the reduction in workforce.
Isis' goals for 2000 - 2001 include 1) advancement of antisense drugs for at least two indications beyond Phase II; 2) demonstration of clinical safety and efficacy in antisense drugs for at least two indications; 3) continued demonstration of antisense activity in animals; 4) initiation of clinical trials with ISIS 104838; 5) completion of at least one major Ibis deal; 6) achievement of oral bioavailability of ISIS 104838 in animals; and 7) balancing partnerships, product rights and dilution.
Partnerships will continue to be key value drivers for the company. ``Our relationship with Elan Corporation, plc. is an excellent example of a how we can leverage our technology with a single partner,' said Dr. Crooke. ``Clearly, the success we've enjoyed in the first program, oral formulation development of our TNF-alpha inhibitor ISIS 104838, paved the way to the second collaboration with ISIS 14803 for Hepatitis C Virus that we announced earlier this month. We are making substantial progress with ISIS 104838 developing an orally bioavailable, commercializable solid dose form. We expect to file an IND for the IV formulation of ISIS 104838 later this year and for the oral formulation in 2001. We are equally enthusiastic about pursuing a Hepatitis C drug with Elan's Medipad drug delivery technology. The deals with Elan are beneficial to Isis as they provide a means of funding the development of two new antisense drugs and, perhaps more importantly, funding and creating the platform for patient-friendly formulations of antisense drugs.
``Our partnership with Astra-Zeneca has progressed in a similar manner,' added Dr. Crooke. ``Our collaboration to discover and develop cancer drugs is just one year old. As we announced last week, they have chosen to expand this relationship to include Isis as their partner for target validation.
``In addition to antisense partnerships,' continued Dr. Crooke, ``we have the potential to begin forming significant partnerships for our new Ibis technology. Ibis is a second proprietary drug discovery platform that has germinated from our expertise in RNA. The Ibis approach to drug discovery involves the creation of small molecules that bind to RNA, which represent new and unique drug targets. To date, the development of this technology platform has been funded by grants from the Defense Advanced Research Projects Agency. We believe the technology has now matured enough to be of interest to major pharmaceutical partners and we look forward to exploiting this platform to the benefit of patients and shareholders.
``The pursuit of revolutionary drug discovery technologies is challenging and risky, yet we are steadfast in our belief that what we are accomplishing is of significant value, particularly as Isis is the undisputed leader in both antisense and Ibis technology platforms,' concluded Dr. Crooke. ``We believe that our plan will enable us to realize added value as we focus on bringing products through the clinic and commercialization, validating antisense, and leveraging our solid financial position and scientific expertise.'
The company will host a live video webcast and conference call today available to the public at 1:00 p.m. Eastern time to review the new operating plan. The video webcast can be accessed at www.streetfusion.com by clicking on ISIP Isis Pharmaceuticals, Inc, under ``Special Events' either at the scheduled time for the live broadcast or following the event for 60 days. Attendees are advised to visit the website in advance and download the free RealPlayer software that is needed to view the web cast. If you need any assistance downloading RealPlayer, please contact the StreetFusion ``help desk' at 617-542-0621. The live event is also available via conference call at 800-837-5476 in the U.S. or 212-676-5390 internationally. A replay of the call will be available for 72 hours following the event at 800-633-8284 in the U.S. or 858-812-6440 internationally, with the reservation number 14059815#. Complete details on accessing the live and archived event are available at the company's website, www.ISIP.com. |
