US drug development company Savient Pharmaceuticals has started a major drive to showcase its lead clinical project, the gout treatment Puricase, in both the USA and Europe as it tries to secure partners for the drug.
But while Savient is seeking a US partner to license Puricase (PEG-uricase) in a traditional cash and royalty type agreement, in Europe and elsewhere in the world the company is more interested in forging cross-licensing deals that could bring in new drugs to boost its clinical pipeline, according to Chris Clement, the company’s chief executive.
Savient has high expectations for Puricase, which if its early promise is fulfilled could transform the treatment of gout, but suffered a blow last year after it was forced to drop prosapatide, a drug for HIV-associated neuropathic pain, after disappointing results in clinical testing.
This left the company with just Puricase in clinical development. The drug has just started Phase III testing, with the first patients starting to receive the drug just a few days ago, and if positive Savient could be in a position to file for approval of the drug in the USA as early as next year, with a possible launch in 2009.
Last year’s sale of the Savient biologicals manufacturing business to Ferring has left the company relatively cash rich, with around $90 million in cash, no debt and an ongoing revenue stream from its Oxandrin (oxandrolone) product for AIDS wasting, which had revenues of around $60 million last year, as well as UK-based Rosemont subsidiary, which brings in around $40 million a year from the sale of its oral liquid generics.
Savient also stands to make its first revenues from the first Rosement-branded product in the USA, Soltamox (tamoxifen) for breast cancer, which has just been licensed to Cytogen and should start shipping this quarter.
But while Rosemont is growing nicely at around 12% a year, Savient considers that its branded generics focus lies ‘at the opposite end of the spectrum’ from the company’s core focus on developing specialty pharmaceuticals, and has already been put forward for either a sale or spin-out. Meanwhile, Oxandrin is vulnerable to generic competition, although no company has tried to muscle in on Savient’s position on the drug yet, Clement told PharmaTimes.
So all eyes at the company are on Puricase, both for its sales potential and the leverage it could bring in boosting Savient’s clinical pipeline, and Clement said that discussions with several potential licensing partners are underway.
At the European League against Rheumatism meeting in Amsterdam last week, Zeb Horowitz, Savient’s chief medical officer, told PharmaTimes that there have been no significant advances in the management of gout – a disease in which uric acid levels are elevated in the body, leading to the precipitation of crystals in joints and other parts of the body which in turn cause inflammation and pain – in the last four decades.
Savient’s Phase III programme is designed to show that Puricase can reduce uric acid levels in patients who continue to suffer flares despite being treated with current therapies such as allopurinol. This patient group numbers around 50,000 to 100,000 patients in the USA, and a similar number in Europe.
Puricase is designed to break down uric acid and has already been shown in Phase II studies to alleviate symptoms in patients who have failed allopurinol therapy, and the Phase III trials will compare two-hour intravenous infusions of the drug given either monthly or once a fortnight to placebo.
But there are tantalising suggestions that intermittent treatment with Savient’s drug, with a course given only every few months, could deplete the body’s ‘stores’ of uric acid and provide a long-term treatment benefit, according to Horowitz..
The Phase III programme, comprising two studies (GOUT 1 and GOUT 2), will look at uric acid levels in the blood as its primary endpoint, with control of gout flares among its secondary measurements.
Actually demonstrating a clinical improvement on flares has proved difficult for other newagents, including TAP/Ipsen’s Uloric (febuxostat; in Phase III), said Horowitz, so if Puricase can show a benefit in its Phase III programme, there will be a strong impetus to expand the use of the drug into first-line treatment settings.
Meanwhile, Puricase could have applications in other indications, including organ transplant patients who have an elevated risk of developing gout as a result of treatment with the immunosuppressant cyclosporine. This has an incidence of around 20,000 patients a year, said Horowitz.
It could also play a role in tumour lysis syndrome, a complication of cancer chemotherapy in which uric acid levels in the blood can skyrocket as tumour cells die off. This population numbers around 5,000 patients a year, he noted, but there could be an argument for routine administration of uricase treatment before chemotherapy as a precaution.
Clement noted that the Phase III programme should cost around $17 million to carry out, and can comfortably be funded using Savient’s cash on hand.