EffRx Signs Expansion of Licensing Deal with Nycomed Pharma for Its Novel Effervescent Osteoporosis Drug EX101; Additional Upfront and Milestone Payments of Up to US $15 Million
Under the terms of the agreement, EffRx will receive from Nycomed additional upfront and milestone payments of up to US$15m. This brings the total for all territories to US$74m in upfront and milestone payments. EffRx will in addition be granted double-digit royalties on future sales of EX101. Nycomed will also sponsor the necessary additional studies required for marketing approval in its territories. The licensing deal now covers the whole world except USA, Japan, South African countries and a few other minor markets.
EX101 is currently in late stage clinical trials. Earlier trials indicate that EX101 has the potential to be “Best in Class” oral bisphosphonate according to EffRx scientists. Final approval and launch in USA is expected in 2010 while submission for European approval is expected by end of 2009.
The growing global osteoporosis market is presently valued at about $7bn per annum.
“We are really pleased with this extended collaboration with Nycomed. EffRx has received strong global demand for EX101, especially in several emerging markets, and we believe that Nycomed is the right company to maximize the penetration in these markets. Our focus will now be to support Nycomed in any area we can be of assistance and at the same time find the right partner for EX101 in USA and Japan,” commented Christer Rosén, Chairman and CEO of EffRx.
Notes to editors
About EffRx
EffRx, Inc. is a drug delivery company that utilizes value-added drug delivery technologies to improve the performance of established pharmaceuticals. The company applies its technologies to well-established, proven compounds to develop reformulated products with reduced gastrointestinal side effects, better absorption, and faster onset of action. EffRx develops novel prescription and OTC pharmaceuticals at relatively low development cost and risk, shorter time to market and with premium pricing compared with generics.
EffRx exploits a number of drug delivery technologies, notably soluble effervescent formulations, granules for immediate dispersion, and fast-melt lozenges with an effervescent layer. These technologies are applied to established high volume drugs with large market potential in various therapeutic areas.
EffRx currently has an extensive pipeline of product candidates, with three products in active development. The most advanced product is EX101 (effervescent alendronate), for the treatment of osteoporosis. Also in development is a bi-layer tablet for the treatment of xerostomia.
EffRx is headquartered in Jupiter, Florida, USA.
For additional information, please visit the website www.effrx.com.
About Nycomed
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.
Its R&D is built to be open for partnerships as in-licensing is a cornerstone of the company’s growth strategy.
Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS, and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed will further strengthen its position in key Asian markets.
Headquartered in Zurich, Switzerland, the company generated in 2008 total sales of € 3,4 billion and an adjusted EBITDA of € 1,2 billion.
For more information visit www.nycomed.com
About EX101
Bisphosphonate tablets (Fosamax, Actonel, Boniva etc.) has for years been associated with upper gastrointestinal problems. This in turn has resulted in poor compliance and increased cost for society.
EX101 addresses these issues by:
There is no tablet to swallow, only a good tasting (strawberry) solution
Soluble Form means there is no tablet to lodge in the esophagus; EX101 is fully rinsed into the stomach
EX101 is administered in half the volume (120 ml) compared with label instructions for bisphosphonate tablets
Gastric Imaging and pH Telemetry Study demonstrates
Reduced stomach acid after dosing EX101
Alendronate never present under acidic conditions
Well documented “heartburn” issues can thereby be alleviated
Imaging & pH Telemetry Study provide supportive data to eliminate or reduce vertical wait time
EX101 shows high absorption consistency compared with Fosamax tablets
About Osteoporosis
Regarded as the “Silent epidemic”.
Osteoporosis, which literally means "porous bone", is a disease in which the density and quality of bone are reduced. As the bones become more porous and fragile, the risk of fracture is greatly increased. The loss of bone occurs "silently" and progressively. Often there are no symptoms until the first fracture occurs.
Facts and Figures:
Osteoporosis affects an estimated 75 million people in Europe, USA and Japan
1 in 3 women over 50 will experience osteoporotic fractures, as will 1 in 5 men
In women over 45 years of age, osteoporosis accounts for more days spent in hospital than many other diseases, including diabetes, myocardial infarction and breast cancer
A 50 year old woman has a 2.8% risk of death related to hip fracture during her remaining lifetime, equivalent to her risk of death from breast cancer and 4 times higher than that from endometrial cancer
It is estimated that in Europe, 179,000 men and 611,000 women will suffer a hip fracture each year and that the cost of all osteoporotic fractures in Europe is provisionally €25 billion
From 1990 to projections in 2050 the number of hip fractures for women and men aged 50-64 in Latin America will increase by 400%. For age groups older than 65 the increase will be a staggering 700%
There is a range of drug treatment available for postmenopausal osteoporosis. Different studies have consistently shown that, depending on the drug and the patient population, treatment reduces the risk of vertebral fracture by between 30-65% and of nonvertebral fractures by between 16-70%
Poor compliance by patients with drug therapies for osteoporosis over a year leaves them at risk for fractures and higher healthcare costs
Contact:
EffRx, Inc., Jupiter Christer Rosén, CEO, +1-561-308-7780 crosen@effrx.com or
Jaap Uittenbogaard, CFO, +1-561-622-0321 juittenbogaard@effrx.com