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Hana Biosciences (HNAB) |
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WIKI ANALYSIS
Company Overview
Hana Biosciences Inc. (Public, OTC:HNAB), is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best in-class team, accelerating the development of lead product candidates, expanding its pipeline by being an alliance partner of choice, and nurturing a unique company culture.
Pipeline
HanaBiosciences has a strong Pipeline with Marqibo, Alocrest, Brakiva and Menadione.
Marqibo® (vincristine sulfate liposomes injection, OPTISOME™
A Novel Targeted Nanoparticle-encapsulated Anti-Cancer Compound currently for Acute Lymphoblastic Leukemia (ALL) and Melanoma. Marqibo® has a robust safety database (over 600 patients) and has been extensively evaluated in lymphoid blood cancers such as non-Hodgkin’s lymphoma (NHL) and ALL. Hana has ongoing (or planned) clinical trials which may enable an accelerated approval in 2 indications. Future clinical trial development possible in multiple indications including NHL and melanoma.
Alocrest™ (vinorelbine liposomes injection, OPTISOME™ A Novel Targeted Anti-Cancer Compound for Breast and Lung Cancer. Alocrest™ has completed a Phase I dose-escalation trial demonstrating promising anti-cancer activity as well as acceptable and predictable toxicity.
Brakiva™ (topotecan liposomes injection, OPTISOME™ A Novel Targeted Anti-Cancer Compound for Small-Cell Lung Cancer and Ovarian Cancer. Preclinical data demonstrate the value of Brakiva™ over conventional topotecan.
Menadione Topical Lotion - A Topical Compound for Skin Rash Associated with EGFR Inhibitors. Treatment with EGFR inhibitors such as Tarceva®, Erbitux® and Vectibix® are associated with an acne-form rash involving the face, neck and upper torso in approximately 75% patients. 50% of patients who manifest skin toxicity experience significant discomfort. This results in drug discontinuation or dose reduction in at least 10% and up to 30% of all subjects. Drug delivery is targeted to the normal location of the EGFR-containing skin cells at the dermal/epidermal junction without interfering with EGFR inhibition systemically at the level of the tumor.
Market for Marqibo
Lead asset, Marqibo®, demonstrated compelling efficacy in heavily pre‐treated, adults with Ph(‐) acute lymphoblastic leukemia (ALL) – 35% overall response rate in the 3rd – 6th line treatment setting – 20% complete response rate with impressive median duration and survival
Financing
HanaBiosciences has entered into an Investment Agreement with Warburg Pincus and Deerfield Management for the sale of up to $100 million in preferred stock. Warburg Pincus, the lead investor in the financing, is a new investor in Hana, and Deerfield is the company's largest existing shareholder prior to this financing.
"We are pleased that Warburg Pincus and Deerfield have made such a significant investment in the Company and view it as further validation of the potential of Hana's pipeline of product candidates," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences.
Hana expects that the financing will provide the funds needed to develop Marqibo to approval and commercialization for relapsed/refractory adult ALL patients; to study Marqibo(R) in front-line adult ALL and lymphoma patients; and to unlock the full potential of menadione topical lotion, a first-in-class therapeutic targeted at the dose-limiting skin toxicities in cancer patients taking EGFR inhibitors.
"We are very pleased to be able to provide the financing necessary to advance Hana's promising product pipeline," said Jonathan Leff, a Managing Director of Warburg Pincus. "We look forward to working closely with the company's board and management team to address important unmet needs in oncology."
About Warburg Pincus
Warburg Pincus takes a different approach to investing. Private equity at Warburg Pincus means investing at all stages of a company’s life-cycle: From founding start-ups and fostering growth in developing companies to leading complex recapitalizations or large-scale buy-outs of more mature businesses.
Years of private equity experience, deep industry knowledge, and unparalleled networks of resources and contacts help their investment professionals identify opportunities, attract leading entrepreneurs and management teams, and ultimately grow businesses in today's rapidly changing environment.
The firm's unique, globally-integrated partnership ensures that all of their resources are committed to the success of each portfolio company. Regardless of an investment's stage of development, industry focus or geography — the right people, with the right experience, are available to every entrepreneur and management team.
Before end of 2010, what should drive shareholder value?
- Rolling NDA filling for Marqibo in Adult ALL with priority review expected (6 months).
- Top-line Menadione Topical Lotion proof-of-concept data
- Initiate Phase 2 Menadione Topical Lotion trial
- Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma with an estimated primary completion date of December 2010 (Final data collection date for primary outcome measure).
In 2011, what should drive shareholder value ?
- Seek EU EMA Formal Scientific Advice for Marqibo
- FDA accelerated approval of Marqibo
Conclusion
HanaBiosciences has a strong portfolio and a global issued IP protection until 2021, potential IP through 2026 with Hatch‐Waxman, and additional IP pending. With a NDA filling soon for Marqibo, this oncology biotech company is poised to success in the very near term, thanks to a very good management team and a very strong financial partner behind HanaBiosciences.
HanaBiosciences its:
• Marqibo rolling NDA submission for accelerated approval expected to be initiated by the end of 2010.
• a Multi‐billion dollar worldwide market potential in blood cancers such as adult ALL, lymphomas, myeloma, and childhood ALL
• a Successful recent deep diligence and financing by Warburg‐Pincus and Deerfield resulting in no need for near‐term fund‐raising
• Menadione Topical Lotion, a Phase 2‐ready asset, positioned to follow Marqibo and add value.
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