NEWS - New PTH product for osteoporosis close to launch

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New PTH product for osteoporosis close to launch

Rheumawire

March 14, 2006

Zosia Chustecka

Salt Lake City, UT - A new product for use in the treatment of osteoporosis

is approaching launch, having received a nod for approval in both the EU and

the US in recent days. The product is recombinant parathyroid hormone (PTH)

from NPS Pharmaceuticals and will have the brand name Preos in the US and

Preotact in Europe, where it will be marketed by Nycomed.

In Europe, the product has a positive opinion from the Committee for

Medicinal Products for Human Use (CHMP), which is the last step before

approval by the European Medicines Agency. The company hopes that the

marketing authorization, which is valid for all 25 member states of the

European Union, will be issued during the second quarter of 2006 and expects

to be ready to launch as soon as it is received.

In the US, the product has an approvable letter from the Food and Drug

Administration, but the agency has also requested additional clinical

information and expressed concern over hypercalcemia associated with the

proposed daily dose of the product. NPS said in a press release that it has

requested a meeting with the FDA to discuss these concerns and to determine

whether existing clinical information is sufficient or whether additional

studies will be needed. No further information is available at this time,

the company told rheumawire, and so it is uncertain exactly when a US launch

may be expected.

The new product is very similar to the parathyroid hormone product already

available for osteoporosis, teriparatide, marketed as Forteo by Lilly. In

fact, the only difference between the two is a few amino acids-the new

product is a full-length version of PTH, whereas teriparatide is missing one

last fragment. Both products are injectable once-daily preparations, and

Forteo is expensive; both of these factors are seen as disadvantages in the

osteoporosis market, where oral bisphosphonate products with convenient

once-weekly and now also once-monthly formulations are available.

Clinical data from TOP study

The approval applications in both the EU and the US are based on clinical

data from the Treatment of Osteoporosis with PTH (TOP) study, an 18-month

trial conducted in postmenopausal women with osteoporosis. Some details of

this study were presented last fall at the American Society for Bone and

Mineral Research 2005 meeting.

Dr Greenspan (University of Pittsburgh, PA) and colleagues reported

data showing that the new PTH product significantly reduces the incidence of

vertebral fractures and, in particular, significantly decreases the risk of

a first vertebral fracture. All of the women participating in the study had

low bone mass, and some had already had a vertebral fracture when they

enrolled (n=471), but most did not (n=2056). In this much larger cohort, the

incidence of a first vertebral fracture was 2.08% in the placebo group vs

0.67% in the PTH-treated group, a relative risk reduction of 68% (95% CI

0.14-0.75, p=0.006). In the smaller group of women who had already had a

vertebral fracture, the incidence of a further vertebral fracture was 8.94%

in the placebo group vs 4.24% in the PTH group, a relative risk reduction of

53% (95% CI 0.23-0.98, p=0.040).

Greenspan et al report that PTH was generally well tolerated, with headache,

dizziness, and nausea reported more frequently in the drug-treated group

compared with placebo. There was also a higher incidence of hypercalcemia

(28.3% vs 4.7% in the placebo group), but this led to discontinuation of

therapy only in 0.5% of the PTH-treated group, they comment.

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org