Hana Biosciences Inc. (HNAB-OTC: BB)
Interview with:
Mark Ahn, Ph.D., President and CEO
Business News, Financial News, Stocks, Money & Investment Ideas, CEO Interview
and Information on their Talotrexin (PT-523) for lung cancer and leukemia, IPdR in solid tumors including brian cancers and Ondansetron Lingual Spray (OLS) in clinical trials for chemotherapy-induced nausea and vomiting


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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.

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Biotech and Drugs

Hana Biosciences Inc.

400 Oyster Point Blvd. Suite 215
South San Francisco, CA 94080

Phone: 850-588-6404

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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 Australia.

Company Profile:
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 academia’s 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, we’ve 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. We’ve also established a network of top-ranked collaborators and partners at leading academic institutes who implement the clinical trials. By working with the world’s 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 financing—equity, 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 arena.”


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