Staff Writer

Allergan Inc. expanded its urology portfolio, purchasing worldwide rights to Ser-120, a Phase III nasal spray for nocturia developed by Serenity Pharmaceuticals LLC.

Privately held Serenity has been flying under the radar since its founding in 2006. The Milford, Pa.-based company is backed by high net worth individuals and insiders, so it has no need to fundraise or otherwise seek publicity, CEO Samuel Herschkowitz told BioWorld Today.

Even Serenity's website is password-protected, but Herschkowitz revealed a bit about the biotech's strategy, which involves licensing drugs that were too toxic or otherwise difficult to administer and applying a combination of reverse engineering and drug delivery to fix their problems. He likened the approach to that of Agouron Pharmaceuticals Inc. (now part of Pfizer Inc.), which took a toxic protease inhibitor and reverse engineered it for better receptor saturation with less toxic buildup.

Ser-120 is a small molecule that targets a receptor in the kidney to reduce the volume of urine output in patients with nocturia, a urological disorder characterized by frequent night-time urination. Nocturia is commonly associated with overactive bladder and benign prostatic hyperplasia, and Herschkowitz said the drugs approved for those conditions have not been particularly effective in addressing nocturia.

Herschkowitz declined to specify whether Ser-120 was a new or existing compound, but he said multiple Phase III trials are well under way. He also declined to say whether approval would be pursued through a new drug application or through the 505(b)(2) pathway. No data on the compound has been published.

But despite the lack of details available about Ser-120, Allergan apparently liked what it saw. The Irvine, Calif.-based firm agreed to pay $43 million up front and up to $122 million in milestones, as well as royalties, for worldwide rights in all indications except pediatric bedwetting.

Allergan is best known for eye care and for Botox (onabotulinumtoxin type A), the anti-wrinkle drug that garnered $1.3 billion last year. Botox also is approved for cervical dystonia, certain eye muscle problems, eyelid spasms and excessive sweating, and last month it gained approval for upper limb spasticity.

But Allergan has been busy building a urology franchise. The firm markets overactive bladder drug Sanctura XR (trospium chloride), which it acquired in its $370 million buyout of Esprit Pharma Inc. in 2007.

Sanctura sales were only $65.6 million last year, but Allergan recently teamed up with Quintiles Transnational Corp. for co-promotion to primary care doctors in the U.S. Allergan's own sales force for the drug focuses on urologists.

Behind Sanctura, Allergan has bladder cancer drug EOquin (apaziquone) partnered with Spectrum Pharmaceuticals Inc., which is working its way through two Phase III trials.

Additionally, the firm is studying Botox in Phase III trials for overactive bladder secondary to neurological conditions, Phase II trials for idiopathic overactive bladder and Phase II trials for lower urinary tract symptoms associated with benign prostatic hyperplasia.

In addition to its deal with Allergan, Serenity has a partnership with CPEX Pharmaceuticals Inc. on a Phase II intranasal urology drug. Herschkowitz said additional deals have not been disclosed.

Shares of Allergan (NYSE:AGN) slid 7 cents to close at $65.25 on Thursday.