SEC Report:
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October 15, 1999
TULARIK INC (TLRK)
S-1 Filing (SEC form S1)
Tularik is engaged in the discovery and development of a broad range of novel and superior orally available drugs based on gene regulation. Building on our scientific strengths, we intend to become a world-class pharmaceutical company. Our broad range of programs includes cancer, cytomegalovirus, known as CMV, diabetes, obesity, inflammation, immune disorders, hypercholesterolemia and bacterial diseases and a class of targets known as orphan nuclear receptors, all of which represent large commercial markets. We have diversified our drug discovery and development efforts not only across a large number of diseases, but also across multiple promising targets and drug candidates for these diseases. Our product pipeline includes two cancer drug candidates in clinical testing, one cancer drug candidate for which an investigational new drug application, known as an IND, has been filed, one preclinical anti-CMV drug candidate and 14 early and advanced drug leads in our other programs.
Gene regulation is the selective activation and deactivation of genes within a cell and is fundamental to the development or progression of most diseases. Our drug discovery approach, which is based on gene regulation, is amenable to the discovery of small molecule, orally available drugs. These drugs are well suited for the treatment of chronic diseases requiring the daily administration of medications over many years. We also selectively pursue drug candidates with mechanisms of action other than gene regulation.
Our drug discovery and development expertise includes molecular biology, biochemistry, structural biology, chemistry, pharmacology and clinical development. To complement our internal capabilities, we collaborate with world-renowned scientists and clinicians and with leading pharmaceutical companies. We believe that our integration of biology, chemistry and pharmacology enhances our ability to find novel gene regulating drugs and that our drug discovery and development efforts are highly efficient and productive. To date, we have:
. identified numerous validated targets and other novel proteins that
regulate the expression of disease-causing genes;
. established more than 80 biochemical and cell-based assays for high
throughput screening, known as HTS;
. conducted more than 15 million drug screens using a library of more than
500,000 distinct compounds and natural products;
. identified seven compounds that are early leads, seven compounds that are
being optimized by chemists, one compound that is in preclinical
development, one anti-cancer drug candidate for which we have filed an
IND application and one anti-cancer drug candidate that is in phase 1
clinical trials; and
. obtained a license for an anti-cancer drug candidate that we expect to
enter phase 2 clinical trials in 2000.
We have commenced or are preparing for clinical trials of three cancer drug candidates, lometrexol, T138067, which we refer to as T67, and T900607, which we refer to as T607. Our most advanced drug candidate is a novel antifolate called lometrexol, which we recently licensed from Eli Lilly. The utility of antifolates as anti-cancer agents has been proven by methotrexate, an antifolate drug used extensively in the treatment of several tumor types. We expect to commence phase 2 trials of lometrexol in 2000. T67 acts on tubulin, the cellular target for known cancer drugs Taxol and vincristine. In contrast to these agents, T67 retains its activity against tumor cells that are multiple drug resistant, or MDR, and is able to cross the blood brain barrier. To date, 23 patients have been enrolled in phase 1 trials of T67. Pending successful completion of these phase 1 trials, phase 2 trials of T67 will be initiated in several tumor types, including brain tumors. T607, an analog of T67, also targets tubulin and is active against MDR positive tumors. Animal studies indicate that T607 is distinguished from T67 in that T607 has a reduced ability to cross the blood-brain barrier, which may make it suitable for the treatment of different tumor types than T67. We recently filed an IND for T607.
We intend to commercialize drugs independently and through collaborations with pharmaceutical partners. To assist in the commercialization of some of our products, and to fund research and development activities, we have established and will continue to pursue collaborations with selected pharmaceutical and biotechnology companies. We currently have corporate collaborations in six of our research programs: with Knoll relating to obesity; with Japan Tobacco, or JT, relating to orphan nuclear receptors; with Roche Bioscience relating to inflammation; with JT relating to obesity/diabetes; with Taisho relating to immune disorders; and with Sumitomo relating to hypercholesterolemia. We have retained significant rights to independently market products resulting from most of our programs, including worldwide commercialization rights to our cancer, bacterial diseases and CMV programs and North American commercialization rights in four of our externally funded programs. As of June 30, 1999, we had received a total of $108.8 million from our current and former corporate collaborators, including $95.8 million in research funding and $13.0 million from equity purchases.
As of September 30, 1999, 44 U.S. patents based on our discoveries had been issued or allowed. In addition, as of that date, we had 47 patent applications pending in the United States and had filed several corresponding foreign patent applications.
Tularik was incorporated in California in 1991 and reincorporated in Delaware in 1997. |
