Transcript Document

Founding of Tularik
Qu i c k Ti m e ™ a n d a TI FF (U n c o m p re s s e d ) d e c o m p re s s o r a re n e e d e d to s e e th i s p i c tu re .
Tularik was founded in 1991 based on a dream that dream took shape
during a series of fly-fishing trips to western Alaska made over a
period of years by Tularik's founders, Dave Goeddel, Bob Tjian and
Steve McKnight. On the banks of the river for which the company
was later named, an idea emerged that became the basis for the
Tularik Biopharmaceutical Company. The vision was to create
medicines that treat a broad range of serious human diseases by
regulating gene expression. These medicines would be small
molecules -- administered orally, convenient for patients to use and
easy to manufacture. Tularik is presently a 429 person enterprise
dedicated to this vision.
Tularik Inc.
Qu i c k T i m e ™ a n d a T IFF ( Un c o m p re s s e d ) d e c o m p re s s o r a re n e e d e d to s e e th i s p i c tu re .
1120 Veterans Boulevard,
South San Francisco, CA 94080
(tel) 650.825.7000; (fax) 650.825.7303
Mission Statement
Advances in the field of molecular biology, some of which are
based on the insights of Tularik's founders, have led to the
recognition that inappropriate gene expression is a causal factor
in nearly every major human disease. Tularik is a pioneer in the
application of gene regulation biology to the discovery and
development of new drugs. The power of Tularik's approach lies
in its applicability to all disease categories.
TLRK (Nasdaq) decade stock performance
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TLRK (Nasdaq) 12 month stock performance
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At 52 week high (3.61 - 11.90), current 11.01, P/E = -5.21,
Drug Pipeline: 4 Candidates in Clinical Trials
Tularik's drug discovery system is broadly applicable to a wide range of diseases. Its
focus is on diseases that represent large markets that are underserved by current
therapeutic products. The pipeline is concentrated in three broad disease areas:
Cancer, Immunology, and Metabolic Disease.
Tularik's integrated platform is highly productive. Scientists are employing a biologybased approach to drug discovery that frequently succeed in identifying multiple
targets in a single gene regulation pathway. An integrated screening and lead
optimization strategy has apparently identified high-quality lead compounds.
Because the majority of leads act on targets for which there are no currently
marketed therapeutics, they provide opportunities for producing first-of-class drugs. A
benefit of the program diversity is thsat it provides a hedges against drug
development risks. Tularik has identified lead compounds for 27 of company-validated
targets. Thirteen of these lead compounds are being optimized by medicinal
chemists and 6 are currently viewed as IND candidates. Tularik expects to file IND
applications for one or more advanced leads in 2003, and to promote an equal
number of optimized leads to "IND-candidate" status. The company publicizes that
their pipeline will be replenished with new leads that will emerge this year from its
research efforts.
Metabolic Disease: T131
Type 2 Diabetes According to the American Diabetes Association, nearly 17 million
Americans have diabetes. Diabetes develops when the body can not effectively
control the level of sugar (glucose) in the blood. When diet and exercise are not
effective in controlling blood sugar levels in people with type 2 diabetes, oral
medication(s), insulin injections or a combination are needed. According to Deutsche
Bank estimates, the market for oral anti-diabetic drugs is expected to grow from over
$5 billion in 2001 to $11.5 billion in 2005.
Program Status In January 2003, Tularik initiated Phase 1 clinical testing to
evaluate the safety and pharmacokinetic profile of T131, a drug candidate to treat
type 2 diabetes. T131 activates PPAR (peroxisome proliferator-activated receptor
gamma), a target involved in the body’s ability to respond to insulin. The randomized,
double-blinded, dose-escalation trial is being conducted in healthy adult volunteers in
the United Kingdom. Current drugs that activate PPAR including Actos TM and
Avandia TM had combined sales in 2001 of $1.5 billion. T131 has a novel chemical
structure and interacts with PPAR differently from currently approved drugs. Animal
studies comparing T131 to Avandia TM demonstrates that T131 has superior potency,
equal efficacy and an excellent safety profile. T131 does not cause cardiac
hypertrophy or a decrease in hematocrit, and causes less weight gain than Avandia
TM in animal models. Tularik retains exclusive worldwide commercialization rights.
Inflammatory Disease: T487
Inflammation Under normal circumstances, inflammation is a defensive response
to injury and infection. The process begins with the recruitment of leukocytes from
the circulatory system to the site of damaged or infected tissue. Excessive or
prolonged accumulation of leukocytes can lead to inflammatory conditions, including
rheumatoid arthritis, inflammatory bowel disease, psoriasis, multiple sclerosis and
asthma.
Program Status Tularik hasinitiated a Phase 1 clinical trial to evaluate the safety
and pharmacokinetics of T487. T487 is a small molecule designed to inhibit the
chemokine activity underlying inflammatory diseases by binding to a single chemokine
receptor without impairing other important immune system functions. T487 is
expected to reduce inflammation in conditions such as rheumatoid arthritis,
inflammatory bowel disease and psoriasis. In preclinical models, T487 showed
activity against certain inflammatory conditions and exhibited strong oral
bioavailability, high potency and excellent selectivity with little or no pronblematic side
effects. Tularik retains worldwide intellectual property and commercialization rights to
T487
Cancer: T67, T607
Hepatocellular Carcinoma: HCC is a tumor type that is on the rise in the United
States, principally in relation to the spread of hepatitis C infection. The National Cancer
Institute estimates that HCC is the most common cancer in some other parts of the world.
There are currently no approved systemic chemotherapeutic agents to treat HCC and
surgical resection is feasible in a small percentage of patients.
Program Status: Two drug candidates are in clinical development, T67 and T607. The
most advanced candidate, T67, is a small molecule that binds irreversibly to ß- tubulin, a
proven anti-cancer drug target. In Phase 1 and Phase 2 clinical trials, T67 showed activity
against hepatocellular carcinoma (HCC; aka, primary liver cancer). Tularik expects to
initiate a pivotal Phase 2/3 trial program in HCC in 2003. The phase 2/3 trial is expected to
include approximately 750 1st line HCC patients and will be performed at numerous centers
across the U.S., Europe and Asia. The study design will compare survival in patients who
receive T67 every week to doxorubicin. T607 is a structural analog of T67, but, differs from
T67 in that T607 does not cross the blood brain barrier and has a different tissue distribution
profile. This may be a desirable feature for treatment of certain tumors. In Phase 1 trials,
Tularik observed a partial response in HCC with T607 , suggesting a mechanism of action
shared by T67. Tularik is currently conducting Phase 2 clinical trials of T607 in patients with
esophageal cancer, gastric cancer, HCC and ovarian cancer. Tularik discovered T67 and
T607 and retains worldwide rights to both drug candidates.
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Cancer Continued: DRUG DISCOVERY
Cancer Gene Discovery In addition to 2 drug candidates in
its oncology clinical development program, Tularik has an
ongoing cancer gene discovery effort that intends to discover
the full set of amplified oncogenes--genes that play a primary
role in causing cancer. This research is producing potentially
important new anti-cancer drug targets, against which the
company intends to develop small molecule leads. Tularik
has entered into a collaboration with Medarex, Inc. to
develop therapeutic antibodies against three targets
discovered in the cancer genomics program.
Product Development Rights and Partnering