PROLOR Biotech: We'll Partner Our hGH Product At An Inflection Point
Scientists at Washington University in St. Louis, Missouri were studying two hormones - human Chorionic Gonadotropin (hCG) and Luteinizing Hormone (LH) – when they made a discovery that explained why hCG remains longer in the body than LH, notwithstanding their near-identical nature. What these Scientists discovered, says PROLOR Biotech (NYSEAMEX:PBTH) President Shai Novik, is a small sequence that they called ‘Carboxyl Terminal Peptide’, or CTP, attached to the end of the longer lasting hormone, hCG.
Today, CTP is the technology that underlies PROLOR’s lead product candidate – longer-acting human growth hormone (hGH), which is in Phase II clinical development for both children and adults. Novik says the company expects to launch a Phase III study of the compound in adults later this year and would expect top-line results roughly one year later – around the same time as results from the ongoing Phase II study of the same compound in children. The same CTP technology PROLOR is developing in hGH has already been validated, Novik contends, as Merck (NYSE:MRK) received EU approval for ELONVA®, a longer-acting version of follicle stimulating hormone (FSH), in 2010. ELONVA® is based on the same CTP technology. As it happens, the pharmaceutical giant has rights to use CTP in four proteins with all other rights belonging to PROLOR.
As the company’s hGH product approaches registration studies, PROLOR intends on partnering a product that would contend for a $3 Billion a year market. “Our strategy would probably be to partner with a large company that has a significant presence in that market – at least for distribution”, answers Novik on the question of strategy. According to analysts, any of the large pharmaceutical companies currently offering a daily hGH injection could express interest in a once-weekly alternative. Names to watch in this segment include Pfizer (NYSE:PFE), Novo Nordisk (NYSE:NVO), Merck, Novartis (NYSE:NVS), Roche-Genentech (OTCQB:RHHBY), and Eli Lilly (LLY). Some reports have even gone as far as saying that PROLOR could be a takeover target because of overwhelming interest in the company’s hGH product-candidate alone.