Drug Delivery Technology

established safety record, and then
move our programs forward with a
higher degree of confidence in our
ability to meet the profile.
Q: How is Depomed’s
AcuForm technology
different from other
technologies? What are the
clinical benefits of
products delivered with
AcuForm?

A: Our AcuForm technology is a unique gastric retentive oral tablet that consists of swellable polymers. Upon contact with gastric fluids, the tablet increases in size by a factor of 3X and is retained in the stomach over 6 to 8 hours. No residuals are retained after the tablet fully disintegrates and is removed with the stool. While it sounds simple, there actually have been very few gastric retentive technologies successfully applied to marketed products. Different approaches have been tried unsuccessfully, such as accordions or tablets that adhere to the gastric lining. AcuForm technology is also a proven technology as evidenced by the hundreds of thousands of patients who have used it successfully with our two marketed drugs GLUMETZA and Proquin XR. Clinical benefits include a more efficient delivery of drugs preferentially absorbed in the upper

gastrointestinal tract, and resulting dosing convenience, improved tolerability, and compliance. Our best examples are our gabapentin extended-release formulations DM- 1796 for neuropathic pain and DM- 5689 for menopausal hot flashes. Patients are trying to maximize the window of absorption and overcome the saturable pumps by taking large doses of immediate-release gabapentin 3 to 4 times a day, typically without optimal success because patients have trouble achieving target dose levels because of the high side effects seen with immediate-release formulations. Our formulations, however, are retained in the stomach above the site of absorption and deliver gabapentin slowly as a once-daily dose, and thus reduce side effects as we have seen in our previous clinical trials.

Q: What is Depomed’s
strategy in utilizing its
AcuForm technology?
Partnering its technology
with other companies or
developing its own
proprietary products?
A: We are still in the development
stage with our late-stage clinical
pipeline, but our long-term goal is to
use DM-5689 (indicated for hot
flashes and to which we retained full
rights) as a centerpiece of a portfolio
of women’s health products. So we

do leverage our technology to
develop proprietary products. In fact,
all our marketed and pipeline
products are based on our AcuForm
technology. However, we are open to
and actively looking to broaden our
technology base because we believe
that an internal technology is the
most cost-effective and efficient
development engine to generate new
products. We do want to avoid the
“licensing trap” in which you are
dependent on in-licensing new
products and constantly risk
overpaying for the assets.
We made a strategic decision to exit
the fee-for-service model and avoid
doing feasibility studies for partner
companies. Nonetheless, we are
looking to consummate deals in
which we license our technology for
compounds to be developed by a
partner in exchange for an up-front,
milestone, and royalty payments, and
rights retained for our women’s
health franchise. This structure
allows us to minimize our internal
development efforts while generating
additional cash. The best example is
our recent deal with Covidien in
which we licensed our technology for
the development of four products
while receiving $4 million up-front,
up to $64 million in development
milestones, royalty on sales, plus
promotion rights in the OB/GYN
field.