A release from Merck regarding pediatric studies. This looks like too little too late, IMO, to deal with Agouron and Viracept. It looks like they're having significant difficulties getting crix to kids.
It's nothing if it's not exciting. :-)
NanoSystems and Merck & Co., to Investigate a New Formulation of Protease
Inhibitor, Indinavir, For Treatment of Pediatric HIV Patients
COLLEGEVILLE, Pa., Dec. 19 /PRNewswire/ -- NanoSystems LLC today announced
an agreement with Merck & Co., Inc. to collaborate on the evaluation of an
experimental NanoCrystal(TM) formulation of Merck's HIV protease inhibitor,
indinavir, for the treatment of HIV in pediatric patients and other special
patient groups. Indinavir is indicated in the treatment of HIV infection in
adults when antiretroviral therapy is warranted, and is currently marketed as
Crixivan(R) (indinavir sulfate) in a capsule formulation. Based upon initial
feasibility studies, Merck and NanoSystems believe a NanoCrystal formulation
of indinavir liquid suspension may improve the palatability and administration
of the drug in the treatment of pediatric patients who have difficulty
swallowing solid dosage products.
Merck and NanoSystems hope to demonstrate clinically that the NanoCrystal
indinavir suspension formulation has increased bioavailability compared to
standard suspension formulations in patients. Pediatric liquid suspension
formulations may allow more effective taste masking to facilitate drug
administration to infants and small children.
"This collaboration is intended to address a serious unmet clinical need
in the treatment of HIV in pediatric patients," said Larry A. Sternson, Ph.D.,
President and Chief Executive Officer of NanoSystems. "We are eager to apply
our drug delivery technology in this area to expand the clinical utility of
this highly promising class of anti-HIV drugs."
NanoSystems' NanoCrystal formulations provide a means to improve
bioavailability of drugs with low or poor solubility. The technology is
capable of optimizing drug delivery in a broad range of formats, including
oral, injectable, topical and aerosol dosage formulations. To date, six drugs
incorporating NanoSystems' technology have been tested in human clinical
trials.
Under terms of the agreement, NanoSystems will apply its patented
NanoCrystal drug formulation technology to develop nanoparticle formulations
of indinavir for delivery in a liquid suspension. In return, NanoSystems
receives a licensing fee, a milestone payment, certain research payments, and
royalties based upon product sales after meeting certain thresholds. Further
terms of the agreement were not disclosed.
NanoSystems LLC is applying a proprietary particulate/colloidal technology
to develop improved formulations of both marketed pharmaceutical products and
new chemical entities. NanoSystems is collaborating with a number of
pharmaceutical and biotechnology companies and has license agreements with
Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson, Mimetix Inc.
for an injectable analgesic, and an undisclosed pharmaceutical company for
another respiratory product. |
