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These excerpts taken from the HALO 10-K filed Mar 14, 2008. Current
Products and Product Candidates
We have two marketed products and multiple product candidates
targeting several indications in various stages of development.
The following table summarizes our lead clinical products and
product candidates:
Cumulase is an ex vivo (used outside the body)
formulation of rHuPH20 to replace the bovine enzyme currently
used for the preparation of oocytes prior to IVF during the
process of intracytoplasmic sperm injection, in which the enzyme
is an essential component. We launched Cumulase in the European
Union and the United States in June 2005.
Hylenex is a human recombinant formulation for rHuPH20 to
facilitate the absorption and dispersion of other injected drugs
or fluids. When injected under the skin or in the muscle,
hyaluronidase can digest the hyaluronic acid gel, allowing for
temporarily enhanced penetration and dispersion of other
injected drugs or fluids. We received approval from the Food and
Drug Administration, or FDA, for Hylenex in December 2005. In
February 2007, we entered into an expanded collaboration
agreement with Baxter under which Baxter fills and finishes
Hylenex and holds it for subsequent distribution.
Chemophase, our lead oncology product candidate, is an
investigative chemoadjuvant designed to enhance the transport of
chemotherapeutic agents to tumor tissue, potentially increasing
diffusion in tissues without affecting vascular permeability.
Chemophase is being developed for potential use in the treatment
of patients with superficial bladder cancer. In April 2006, we
commenced patient enrollment in our Chemophase Phase I/IIa
clinical trial. In September 2007, we completed enrollment in
our Phase I/IIa clinical trial.
Enhanzetm
Technology, a proprietary drug enhancement system using rHuPH20,
is our broader technology opportunity that can potentially lead
to proprietary partnerships with other pharmaceutical companies.
We are currently seeking partnerships with pharmaceutical
companies that market or develop drugs requiring or benefiting
from injection via the subcutaneous or intramuscular routes that
could benefit from this technology. In December 2006, we
signed our first Enhanze Technology partnership with Roche. In
September 2007, we signed our second Enhanze Technology
partnership with Baxter.
Table of Contents
Current Products and Product Candidates We have two marketed products and multiple product candidates targeting several indications in various stages of development. The following table summarizes our lead clinical products and product candidates:
Cumulase is an ex vivo (used outside the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection, in which the enzyme is an essential component. We launched Cumulase in the European Union and the United States in June 2005. Hylenex is a human recombinant formulation for rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We received approval from the Food and Drug Administration, or FDA, for Hylenex in December 2005. In February 2007, we entered into an expanded collaboration agreement with Baxter under which Baxter fills and finishes Hylenex and holds it for subsequent distribution. Chemophase, our lead oncology product candidate, is an investigative chemoadjuvant designed to enhance the transport of chemotherapeutic agents to tumor tissue, potentially increasing diffusion in tissues without affecting vascular permeability. Chemophase is being developed for potential use in the treatment of patients with superficial bladder cancer. In April 2006, we commenced patient enrollment in our Chemophase Phase I/IIa clinical trial. In September 2007, we completed enrollment in our Phase I/IIa clinical trial. Enhanzetm Technology, a proprietary drug enhancement system using rHuPH20, is our broader technology opportunity that can potentially lead to proprietary partnerships with other pharmaceutical companies. We are currently seeking partnerships with pharmaceutical companies that market or develop drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology. In December 2006, we signed our first Enhanze Technology partnership with Roche. In September 2007, we signed our second Enhanze Technology partnership with Baxter.
Table of ContentsThis excerpt taken from the HALO 10-K filed Mar 9, 2007. Current
Products and Product Candidates
We currently have two FDA-approved products, Cumulase and
Hylenex. We also have one product candidate, Chemophase, which
is currently in clinical development. All of our other product
candidates are in the research or pre-clinical stage of
development. We received a CE (European Conformity) Mark for
Cumulase in December 2004 and FDA clearance in April 2005. We
launched Cumulase in the European Union and in the United States
in June 2005.
During March 2005, we filed a new drug application
(“NDA”) for the spreading agent Hylenex. Other
manufacturers have FDA approved products for use as spreading
agents, including ISTA Pharmaceuticals, Inc. (“ISTA”),
with an ovine (ram) hyaluronidase,
Vitrase®,
Amphastar Pharmaceuticals, Inc., with a bovine (bull)
hyaluronidase,
Amphadasetm,
and Primapharm, Inc. also with a bovine hyaluronidase,
Hydasetm.
The FDA has
Table of Contents
determined that Amphadase, Hydase, Hylenex and Vitrase are
distinct new chemical entities and hence afforded five years of
market exclusivity. The five year market exclusivity precludes
identical new chemical entity products from being marketed for a
period of five years. As each of these products is established
as distinctly different new chemical entities, the marketing
exclusivity granted does not prohibit the marketing of the
products. During December 2005, we received FDA approval for our
Hylenex NDA.
During June 2005, we submitted an investigational new drug
application (“IND”) in order to begin clinical testing
of our Chemophase product candidate. We received authorization
to initiate clinical testing of Chemophase in August 2005, and
we commenced patient enrollment in our initial clinical protocol
under this IND in October 2005. In March 2006, we completed
enrollment in our Chemophase Phase I clinical trial. In
April 2006, we commenced patient enrollment in our Chemophase
Phase I/IIa clinical trial.
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