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Hana Biosciences, Inc.
(OTC: HNAB) is a South San Francisco, CA-based biopharmaceutical company that acquires,
develops, and commercializes innovative products to advance cancer care. Hana Biosciences is offering hope to individuals
suffering from cancer with their Talotrexin
(PT-523) in lung cancer and leukemia, IPdR in solid tumors
including brain cancers, and Ondansetron Lingual Spray (OLS) in clinical trials for
chemotherapy-induced nausea and vomiting.
Biotech and Drugs
Hana Biosciences Inc.
400 Oyster Point Blvd. Suite 215
South San Francisco, CA 94080
Mark Ahn, Ph.D.,
President and CEO
Lynn Fosse, Senior Editor
June 2, 2005
Mark J. Ahn, Ph.D. is President and Chief Executive Officer of Hana Biosciences, Inc.
(HNAB), a South San Francisco, CA-based biopharmaceutical company which acquires,
develops, and commercializes innovative products for the treatment of important unmet
medical needs in cancer and immunological diseases.
Prior to Hana, Dr. Ahn served as Vice President,
Hematology and corporate officer at Genentech, Inc. where he was responsible for
commercial and clinical development of the Hematology franchise which surpassed $1 billion
in revenues, achieved the #1 oncology therapeutic position in the US, and was recognized
as the #1 sales and marketing team in the biopharmaceutical industry in by Product
Management Today. Prior to Genentech, Dr. Ahn held a series of positions of increasing
responsibility at Bristol-Myers Squibb Company, Amgen, Inc and FMC Corporation in
strategy, general management, sales & marketing, business development, and finance. He
also served as an officer in the U.S. Army.
Dr. Ahn is a Henry Crown Fellow at the Aspen
Institute, founder of the Center for Non-Profit Leadership, and a member of the Board of Trustees
for the MEDUNSA (Medical University of South Africa) Trust. Dr. Ahn also serves on the
Board of Directors of Transmolecular, Inc., a neuroncology company.
Dr. Ahn received a BA in History/Economics and an MBA
in Finance from Chaminade University. He was a graduate fellow in Economics at Essex
University, and has a Ph.D. in Business Administration from the University of South
Hana Biosciences, Inc. (OTC: HNAB) is a South San Francisco, CA-based biopharmaceutical
company that acquires, develops, and commercializes innovative products to advance cancer
care. The company is committed to creating value by building a world-class team,
accelerating the development of lead product candidates, expanding its pipeline by being
the alliance partner of choice, and nurturing a unique company culture. Additional
information on Hana Biosciences can be found at www.hanabiosciences.com.
CEOCFO: Dr. Ahn, what
attracted you to Hana, and what has changed under your leadership?
Dr. Ahn: Hana concentrates exclusively in oncology. We
know where to look in academia and research institutes to find the most promising
compounds with validated targets and known mechanisms of action. Our business model allows
us to identify promising compounds, acquire them and develop them with less risk than that
of other companies.
What initially attracted me to the company was the
promise of moving an interesting molecule that was developed and discovered at the Dana
Farber Cancer Institute at Harvard University called Talotrexin. Talotrexin is being
developed for the treatment of lung cancer, cervical cancer, and acute leukemia. This
discovery was begging for focused attention in moving it efficiently from the lab to the
clinic and to the commercial market. Talotrexin is a great opportunity for collaboration
with academia and part of a business model that we conceived, as well as a solid
foundation that we could build additional products into our pipeline. To date, we have
brought in three products, two of which we have already brought into the clinic and we are
moving our third product into the clinic this Summer.
The best part of our company, however, is our people pipeline--our team of dedicated
people dedicated to advancing cancer care and making a difference in the lives of patients
we serve. Having worked in large companies, I can truly say that the best part of being an
entrepreneur is the gift of working with people you like and respect. We have terrific
people from academia and from large biopharmaceutical companies that have a great talent
for being able to select and develop promising molecules that can make a difference in
improving current standards of cancer care.
CEOCFO: Are these all in
the area of cancer?
Dr. Ahn: Yes. Our business model is to focus on cancer
exclusively. I call it the CNN strategy for oncology -- all oncology all the time. To
leverage our oncology focus, the second thing we want to do is diversify our risks. For
example, we brought in multiple technology platforms where most companies focus on one
platform. Our observation is that academias enduring expertise is to find targets
and optimize product leads in the laboratory. This is where we come in. Our team is set up
to execute translational development and commercialization. That is, to bridge the gap
between a promising lead and the manufacturing, regulatory, clinical and commercial
challenges necessary to bring new drugs to the market.
This is a detailed process. For example, we conduct toxicology work to make sure the
compound is safe in a variety of animal models and tissues. Then we write the regulatory
and clinical trial documents to make sure that public safety is protected and that we are
providing patient benefit. That work, collectively called translational development, is in
kind of a hole right now; a hole that we have built the company on because venture
capitalists and large companies that do licensing work, want to see the translational
development work completed before they invest heavily in specific molecules.
We also noted that the largest valuation multipliers have been between the lab and the
clinic and early phases of clinical trials. Our thought was that since this is an
inherently risky business, by utilizing multiple platforms a single failure will not tip
the company overboard. This assumes, of course that we do a good job selecting molecules.
In other words, by having separate platforms, we manage our unique risk and have a higher
chance of overall success at the enterprise level.
The third part of our business model is to have
multiple sources of financing. In our first sixteen months of operations, weve
raised about $18 million in equity. Additionally, we have about $12 million dollars in
grant support, which help leverage our development without diluting equity. Furthermore,
they provide third-party validation of the technology.
CEOCFO: How do you
decide which drug to choose?
Dr. Ahn: Cancer development is about choices because
the context for drug development and regulatory approval is empirical medicine. Making
choices of which compounds to acquire and what to do with those compounds is the lifeblood
of our business model. We have a small and talented team, whose members have left very
successful careers to come together at Hana and develop what we believe is a sustainable
market opportunity to build value for patients and investors.
For example, our vice president and Chief Medical
Officer, Dr. Greg Berk, who was hematologist/oncologist and clinical scientist at on Cornell
University for 13 years where he worked on leading drugs such as Avastin, Rituxan, and
Gleevec. Another example is Fred Vitale, our vice president of Business Development, has a
long history of successfully commercializing and partnering products with biotechnology
and large pharmaceutical firms.
CEOCFO: Will you give us
a sense of where you are on the projects, of which you are most interested?
Dr Ahn.: Talotrexin (PT-523) is a novel non-classical
antifolate that is a water-soluble, nonpolyglutamatable analogue of aminopterin.
Talotrexin (PT-523) exhibits 10-fold higher affinity to its target enzyme DHFR
(dihydrofolate reductase) than MTX (methotrexate) and utilizes the membrane-bound
transporter (RFC) 10-fold more efficiently than MTX. In addition, it is 10 to 100 fold
more potent than MTX against a wide variety of in pre-clinical studies. The results of
these studies suggest that Talotrexin (PT-523) has the potential to significantly enhance
the treatment of patients with cancer and autoimmune diseases. Thus, Phase I trial in
solid tumors, Ph I/II in NSCLC (non-small cell lung cancer), and a Ph II trial in ALL are
ongoing. Ph II trials in cervical, endometrial, ovarian cancers are forthcoming.
IPdR is a novel oral prodrug of IUdR being developed as a radiation therapy
sensitizer for the treatment of brain cancers. IPdR is converted to IUdR by a hepatic
aldehyde oxidase. Intravenously administered IUdR has demonstrated efficacy and survival
advantage in a Phase II clinical trial, but has unacceptable gastrointestinal and
myelotoxicities. Because of the low concentration of aldehyde oxidase in the small
intestine and bone marrow, IPdR treatment may avoid previously observed toxicities with
intravenous IUdR. Preclinical studies in a variety of models demonstrated that oral IPdR
possesses a superior efficacy and toxicity profile versus IUdR. Thus, a Phase I trial in
solid tumors will be conducted at the Case Western Reserve University and Phase I/II
trial in glioblastoma multiforme will commence in 2005.
Ondansetron Lingual Spray (OLS) is a novel delivery system that utilizes the vast and
highly absorptive surfaces of the oral mucosa to deliver ondansetron directly into the
bloodstream, thus achieving therapeutic levels in a shorter period of time than
conventional oral dosage forms. Ondansetron is a selective blocking agent of the seratonin
5-HT3 receptor and is widely accepted as the standard of care to prevent
chemotherapy-induced nausea and vomiting. Ondansetron LS may provide a more rapid delivery
of ondansetron to prevent nausea and vomiting as compared to current oral forms by
avoiding the "first-pass effect" -- since drug delivery via the oral mucosa
avoids degradation in the gastrointestinal tract and metabolism by liver enzymes. Hana
licensed the exclusive rights to develop and commercialize Ondansetron LS in the US and Canada
from NovaDel Pharma, Inc. Pilot clinical trials were completed earlier this year and the
pivotal registration trial will commence in 2005.
CEOCFO: How do you stay
focused when you are working with so many projects?
Dr. Ahn: It is about making sure we have a great team
with outstanding hematology/oncology backgrounds that are experts in their respective
field and building a culture of people committed to the success of one another. Weve
also established a network of top-ranked collaborators and partners at leading academic
institutes who implement the clinical trials. By working with the worlds leading
experts we improve our success rate and the odds of introducing important new drugs to
help cancer patients
CEOCFO: Why should
potential investors be interested now and what should they realize about the company that
they may not notice at first?
Dr. Ahn: Hana Biosciences is a new company in the
biopharmaceutical small cap space. We are tightly focused in oncology to capture
efficiencies and economies of scale, with a management team with extensive experience in
oncology research, development and commercialization. We have built a diversified,
development stage business model reduces risk by building on known mechanisms of action,
acquiring clinical development stage products and technology platforms, and creating near
term OLS sales enhances our sustainability. In addition, we are leveraging investment with
multiple sources of financingequity, grants, near term revenues.
We are living in a spectacular period in which
biological insights will lead to new and better medicines to advance cancer care. Hana
Biosciences will be a leader among emerging biopharmaceutical companies in the cancer
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