West Coast Editor
As Indevus Pharmaceuticals Inc. gears up to launch Sanctura XR for overactive bladder, an approvable letter from the FDA for the bladder-cancer drug Valstar - taken off the market in 2002 because of impurities - leaves that compound on track to return to the market late this year or early next.
The specialty pharma company needs to provide the FDA with clarity on validation of manufacturing protocols for Valstar (valrubicin), approved in 1998 for bladder cancer that has not spread but is refractory to bacillus Calmette-Guerin (BCG) treatment, in patients not eligible for surgery.
"It's nothing that requires us to do any additional clinical work," said Brooke Wagner, vice president of corporate communications for Indevus. The firm's stock (NASDAQ:IDEV) closed Friday at $6.76, up 1 cent.
Indevus got Valstar, approved by the FDA in 1998, in the $120 million December buyout of Valera Pharmaceuticals Inc., of Cranbury, N.J., which had bought the drug from Princeton, N.J.-based Anthra Pharmaceuticals Inc. The problems arose when Anthra still owned Valstar, but Anthra lacked resources to fix it, and sold the drug to Valera in 2006.
"It was a stability issue with an inactive ingredient," Wagner explained.
BCG, a somewhat controversial immunotherapy, consists of inactivated Mycobacterium tuberculosis. Patients who have tried two courses of BCG without response have little recourse. "They're faced with cystectomy - removal of the bladder - or, at this moment, nothing else," since Valstar is the only drug approved for BCG-refractory disease, Wagner said.
"It's a relatively small universe," he conceded, though Indevus believes there is potential with Valstar in other stages of bladder cancer that would demand trials. Indevus expects to submit a complete response to the FDA in about two months.
Sanctura XR (trospium chloride) capsules won approval earlier this month, gaining Indevus a $49.9 million milestone payment from co-promotion partner Esprit Pharma Inc., of East Brunswick, N.J. Sanctura XR is designed to improve on first-generation compound's twice-daily dosing, with lower risk of side effects such as dry mouth and cognitive impairment.
Launch date for Sanctura XR is up to Esprit. "They're working on a couple of different tracks," Wagner said. "It's hard for us to give a specific time, because it's beyond our control."
Due for a new drug application filing "in the next couple of weeks," Wagner said, is Indevus' three-month injectable testosterone product, Nebido, for hypogonadism. In June, the firm reported Phase III results showing that 94 percent of patients receiving 1,000 mg of the drug and 86 percent of patients receiving 750 mg ended up with a normal testosterone level, both surpassing the FDA's 75 percent response criteria. For hypogonadism, Indevus already markets Delatestryl (testosterone enanthate).
Nebido "gets a lot of attention from investors because of the market opportunity," Wagner said. "Today, the treatment option is to either take a short-acting injectable, such as Delatestryl, every two to three weeks, or use a topical gel or patch."
Of some 340,000 low-testosterone patients, about 210,000 opt for topical therapy, with 130,000 choosing an injectable. The total market for testosterone therapy amounts to about $550 million, with injectables taking about $50 million.
Among gels, the leader is the Belgian firm Solvay SA's Androgel, though Malvern, Pa.-based Auxilium Pharmaceuticals Inc.'s Testim has been gaining ground. Nebido, Wagner said, will be priced more like the gels than other injectables, which have been on the market for 50 years but are costly. Delatestryl, for example, goes for about $400 per year. Thus, Nebido will offer the advantages of a shot - daily gels are messy and take time to apply and dry - at nearer the cost of a topical therapy.
Rodman & Renshaw initiated coverage of Indevus with a "market outperform" rating earlier this month, predicting that Nebido would be pulling in revenues of $364 million by 2012. The 12-month price target is $10. UBS also started coverage, rating Indevus "buy" with the same price target.
U.S. rights to Nebido, already approved in 75 countries, came from Schering AG, of Leverkusen, Germany (now Bayer Schering Pharma AG). Indevus also sells Vantas for advanced prostate cancer. It's a 12-month hydrogel implant that provides histrelin, a luteinizing hormone-releasing hormone agonist. Another marketed compound is Supprelin LA for central precocious puberty, also a histrelin implant that was gained, along with Vantas, in the Valera buyout.
Also in the pipeline: a Phase III topical microbicide gel called Pro 2000, designed to prevent HIV infection, and a Phase II, six-month octreotide implant for acromegaly. Octreotide is a long-acting octapeptide that mimics somatostatin to block production of growth hormone.