WASHINGTON, Sept. 18 (UPI) -- Emerging drugs from Shire, Procter & Gamble, Isis and PDL BioPharma are set to drive the ulcerative colitis market from $656 million to $1.1 billion by 2015, according to an analyst report released Monday.
"Really what is driving that is the high-priced, emerging therapies," Vickie Lai, an analyst with Decision Resources and author of the report, told United Press International.
The biggest one of these is likely to be Shire's Mesavance.
"This stands to make an impressive impact on the market because it has a different dosing schedule," Lai said.
Patients on Mesavance only have to take one or two pills per day versus up to nine per day with some current medications. This could help improve patient compliance and keep the condition in check, which physicians now emphasize because flare-ups may increase the risk of colon cancer, Lai said.
The report projects Shire's drug could generate approximately $300 million in sales by 2015. The drug will primarily steal market share away from the current leaders, including Shire's Pentasa and Proctor and Gamble's Asacol, rather than expanding the market.
Proctor and Gamble has its own new medication in development, RDP-58, that also stands to be a significant player. But it's uptake will be limited because of its side effect profile.
"Physicians are worried about side effects because it affects a part of the immune system that is pretty vital," Lai said. The drug targets the MAP kinase pathway.
Despite these concerns, the drug will do ok and is expected to bring in sales of about $10 million in 2015, the report projects.
Isis' alicaforsen will also see its uptake limited by safety concerns. Lai said the drug is similar to Elan/Biogen Idec's multiple sclerosis treatment Tysabri, which was temporarily taken off the market when it was found to increase the risk of progressive multifocal leukoencephalopathy, a viral infection of the brain that can be fatal.
So "physicians are going to make that link and some might be conservative about prescribing it," she said.
Even with the comparison to Tysabri, alicaforsen still stands to generate sales of $15 million by 2015 because there are limited options for treating this disease and patients and physicians often would rather try a medication before opting for the last resort: surgical removal of the colon.
George Fulop and Mona Ashiya, analysts with Needham, told UPI, Isis has had difficulties finding a development partner for alicaforsen.
The drug "showed promising results" in a phase 2 study, "but the challenge has been for Isis to identify a development partner," Fulop said.
However, alicaforsen isn't what's driving investor interest in Isis, Ashiya noted. Two other drugs in the pipeline -- 301012 for managing high cholesterol and 113715 for diabetes -- garner more interest in the company's stock, which Needham currently rates a buy.
Isis recently presented phase 2 results for these drugs and both looked impressive. The phase 2 trial of 301012 showed the drug safely lowers LDL and total cholesterol after three months of treatment. The 113715 data demonstrated clinical benefits beyond glucose control, including reductions in cholesterol levels.
"We are impressed with the recent clinical data around lead product candidates, ISIS 301012 and ISIS 113715, and we believe additional clinical data from these product candidates in (the second half of this year) will generate investor interest," Ashiya wrote in a research report issued last month.
The fourth ulcerative colitis drug that looks promising is PDL Biopharma's visilizumab, which the company is developing for patients who have not responded to steroids. These patients are typically the sickest.
The drug "only has phase 2 results, so there are still a lot of unanswered questions, but physicians are looking forward to it because these patients are so desperate," Lai said.
Although PDL is targeting a small segment of the patient population, visilizumab stands to rake in $45 million because it is expected to be priced quite high, she said.
