Nastech secures manufacturing contract for new needle free osteoporosis drug
to ramp up manufacturing capacity for a new needle-free drug to
beat osteoporosis, in anticipation of meeting expected global
demand once the product is approved.
Currently in Phase II trials, PTH1-34 contains a naturally occurring human parathyroid hormone (PTH), an important regulator of calcium and phosphorus metabolism, and promises easy and convenient delivery in the form of a nasal spray.
US biotech firm Nastech originally developed the spray and licensed it to P&G in February, in a worldwide development and commercialisation deal that could net Nastech up to $577m (€480m). Nastech has already received a $10m upfront payment and a $7m milestone payment and the latest manufacturing deal will provide further lifeblood to the budding company.
P&G hopes to submit a Food & Drug Administration (FDA) application for the PTH1-34 nasal spray in 2007 and receive approval in 2008 and as part of the new deal Nastech will be responsible for the chemistry, manufacturing and controls (CMC) sections of the FDA regulatory submission.
Once the drug is approved, Nastech will exclusively manufacture the spray from its facility in Hauppauge, New York, and will supply it to P&G at a transfer price that includes an undisclosed manufacturing profit.
"The supply agreement with P&G for PTH1-34 nasal spray attests to the value that our manufacturing and CMC capabilities add to the P&G collaboration as well as our other partnerships," said Steven Quay, chairman, president and CEO of Nastech.
"P&G, a global leader in the osteoporosis pharmaceutical category, continues to demonstrate its ability and commitment to rapidly develop this innovative product."
Affecting more than 150m people around the world, osteoporosis is most commonly found in elderly, post-menopausal women, and associated with an increased risk of hip and vertebral fractures.
Both companies are hoping the new nasal spray will give them the upper hand over injectable alternatives in the $6.2bn osteoporosis drug market, which is tipped to grow 5.3 per cent from 2004 to 2009, according to market research publisher, Research and Markets.
"Although taking treatments via nasal spray is an accepted practice in many areas of health, the osteoporosis treatments via this method are limited," Jackie Parrington of the UK's National Osteoporosis Society told In-Pharmatechnologist.com.
Upsher-Smith' s Fortical and Novartis's Miacalcin are already available as nasal sprays for osteoporosis, however, these drugs contain a different hormone called calcitonin which is not as effective as PTH, said Parrington.
PTH1-34 will have to compete with Eli Lilly's Forteo, a similar PTH drug already in the market but administered by injection, thus making its appeal to patients less strong.
"PTH treatment offers considerable hope for those people with severe osteoporosis, particularly if other treatments have not worked, so if an easier and effective way of delivering PTH treatment can be found then people with severe osteoporosis could benefit greatly," said Parrington.
This is what Procter and Nastech are now betting on, although there are still challenges that need to be addressed in clinical trials, including the fact that prolonged PTH treatment reduces the drug efficacy, before the full potential of this new spray is known.
