Daily treatment with Unigene Laboratories' ($UGNE) oral recombinant parathyroid hormone (PTH) analog increased bone mineral density in postmenopausal women with osteoporosis without the inconvenience of injections. The results were published in Bone.
The company's Phase II study involved 97 women who were given Unigene's oral drug or Forsteo (also known as Forteo), Eli Lilly's ($LLY) injectable synthetic form of PTH.
Why an oral form? Recombinant PTH improves bone mineral density and cuts the risk of bone fracture in osteoporosis, which boosts quality of life, but the regular subcutaneous injections are inconvenient and uncomfortable, meaning that compliance isn't as good as it could be. By making taking the drug less onerous, Unigene's oral PTH analog, which uses its Peptelligence drug delivery technology, could improve the drug's uptake. Peptelligence is an oral and nasal delivery technology and was the subject of a licensing agreement with Tarix Pharmaceuticals last month.
Other companies' approaches in development include the implantable pump from MicroCHIPS (one of Robert Langer's startups), a transdermal patch in development with Zosano Pharma and Asahi Kasei Pharma, and Radius Health's patch that uses 3M's ($MMM) microneedle technology.
Almost exactly a year ago, GlaxoSmithKline ($GSK) pulled out of its agreement with Unigene to develop the PTH product, returning development rights to Unigene, along with a payment of just $8 million from a deal that could have been worth as much as $140 million. This, and declining sales from Fortical, a once-daily nasal calcitonin, may explain why Unigene has announced that it has retained Canaccord Genuity to help it to explore and evaluate its options, which range from partnering to a sale of the business, according to the company.
- read the press release about the Phase II data
- check out the abstract in Bone
- see the press release about Canaccord Genuity