Zosano Pharma, Inc. Announces Publication of Positive Phase 2 Study of Its ZP-PTH Patch for Osteoporosis Therapy

FREMONT, Calif.--(Business Wire)--
Zosano Pharma, Inc., a privately held pharmaceutical company developing products
using a novel transdermal delivery technology, announced publication in the
current issue of the Journal of Clinical Endocrinology and Metabolism of results
from a positive phase 2 study of its rapid-delivery transdermal patch (ZP-PTH)
for the treatment of postmenopausal osteoporosis. The study by authors Felicia
Cosman, Nancy E. Lane, Michael A. Bolognese, Jose R. Zanchetta, Pedro A.
Garcia-Hernandez, Karen Sees, James A. Matriano, Kim Gaumer, and Peter E.
Daddona is titled "Effect of Transdermal Teriparatide Administration on Bone
Mineral Density in Postmenopausal Women." The article is currently available
online and will be in the January 2010 issue.

In the 165-patient study, the authors concluded that daily administration of
ZP-PTH (teriparatide) for 24 weeks resulted in a significant gain in bone
mineral density (BMD) of the lumbar spine over placebo (p<0.001) and that the 40
mcg coated transdermal patch increased total hip BMD compared to both placebo
and FORTEO 20 mcg subcutaneous injection (p<0.05).

"We are pleased to have the study published in this highly respected
peer-reviewed journal and are encouraged that ZP-PTH has demonstrated gains in
lumbar spine bone mineral density relative to FORTEO®," commented Gail Schulze,
Zosano`s board chair and CEO, "ZP-PTH combines an established bone forming
agent, with Zosano`s rapid-delivery, user-friendly microprojection patch
technology, and can offer patients an alternative to daily injections in a safe,
effective and convenient treatment for osteoporosis. We continue to lay the
groundwork for our pivotal phase 3 clinical study and in parallel are advancing
a number of strategic partnering discussions."

About the Study:

The Phase 2 study was a randomized, multi-center, blinded, multi-dose trial
designed to determine safety and efficacy of the ZP-PTH rapid-delivery patch for
the treatment of osteoporosis. ZP-PTH uses Zosano`s unique transdermal
microprojection technology being developed as an alternative to daily
injections, to deliver PTH 1-34, teriparatide (PTH), a compound proven to
stimulate formation of new bone and reduce the risk of fractures.

The primary objective of the study was to assess safety and evaluate the effect
of three doses of ZP-PTH on lumbar spine bone mineral density (BMD) after 24
weeks relative to placebo in postmenopausal women with osteoporosis. Secondary
study objectives were to evaluate the effect of three doses of ZP-PTH on total
hip, femoral neck and forearm BMD relative to placebo and injectable FORTEO®.

The study enrolled 165 patients between 50 and 81 years of age with severe
osteoporosis and was conducted at 13 sites across North and South America.
Subjects were randomized to one of five treatment groups: ZP-PTH 20 mcg, 30 mcg,
40 mcg, or ZP placebo patch or Forteo® 20 mcg injection. All study participants
were taught self-administration techniques and thereafter self-administered
their medication. The ZP-PTH or placebo patch was applied to the lateral
abdomen, alternating left and right sides on a daily basis and worn for 30
minutes, and the Forteo®
20 mcg/daily injection was administered in the abdomen or thigh.

Study participants were assessed monthly for six months after randomization. BMD
measurements of common osteoporosis sites were performed at baseline and at six
months. An additional BMD measurement of the lumbar spine was performed at a
three-month visit.

The primary efficacy variable was the mean percent change from baseline in
lumbar spine BMD at week 24 of dosing for active ZP-PTH patch treatment groups
compared to ZP placebo patch.

The study results demonstrated that daily administration of all three doses of
ZP-PTH for 24 weeks resulted in a significant gain in BMD of the lumbar spine
over placebo (p<0.001). The ZP-PTH 40 mcg patch, which effectively delivers 16
mcg of PTH, was similar to the Forteo® 20 mcg injection, in mean percent change
from baseline in lumbar spine BMD (4.97% versus 3.55%). Treatment with ZP-PTH 40
mcg also showed a significant increase in total hip mean percent change from
baseline in BMD (+1.33%) compared to placebo (-0.634%) and FORTEO® (0.094%),
both at p<0.05. All ZP-PTH doses were well tolerated with no systemic adverse
events different from FORTEO®. There were no clinically significant sustained
occurrences of hypercalcemia in any treatment group.

About Osteoporosis

Osteoporosis is a disease characterized by low bone mass and the deterioration
of bone tissue, leading to bone fragility and an increased susceptibility to
fractures. While any bone can be affected, fractures of the hip, spine and wrist
are especially common. Osteoporosis is a major public health issue, affecting
55% of people 50 years or older in the U.S.(1) Approximately 80% of those
affected are women.(2) By 2025, experts predict that osteoporosis-related
fractures will be responsible for an estimated $25.3 billion in medical
costs(3), an economic burden comparable to other major chronic diseases.

About Zosano Pharma, Inc.

Zosano Pharma, Inc. is a privately held pharmaceutical company focusing on the
development of its lead clinical program, the ZP-PTH rapid delivery patch for
the treatment of osteoporosis. ZP-PTH is being developed as an alternative to
daily injections and is based on Zosano`s novel transdermal delivery technology
which can deliver peptides, proteins, small molecules and vaccines by permeating
the skin`s outer layer and ensuring significant therapeutic effect. This proven
proprietary technology offers many key benefits, including efficacy and safety
comparable to approved injectables, needle-free and pain-free delivery, a
self-administered patch, rapid onset of action and room temperature storage.
Zosano`s transdermal delivery technology has been clinically tested in more than
400 patients with four different peptides and a vaccine. Zosano aims to develop
products both independently and through strategic licensing and co-development
arrangements. Founded in 2006 as an ALZA Corporation spin-out led by Nomura
Phase4 Ventures, Zosano is funded by New Enterprise Associates, Nomura Phase4
Ventures, HBM BioVentures and ProQuest Investments. For more information, please
visit www.zosanopharma.com.

(1) (2) (3) Source: National Osteoporosis Foundation

Zosano Pharma, Inc.
John Vuko, CFO, 510-745-1297
jvuko@zosanopharma.com

Copyright Business Wire 2009