Allergan has acquired worldwide rights to TARIS Biomedical’s lead program LiRIS®, now in Phase II trials for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS), the companies said today. The deal could generate as much as $587.5 million for TARIS from Allergan, which is restructuring its pipeline as it scrambles to fend off a hostile $53 billion takeover bid from Valeant Pharmaceuticals International.
Allergan said the acquisition would enable it to strengthen its urology pipeline, now anchored by its blockbuster drug Botox® (onabotulinumtoxinA), whose numerous indications include second-line treatment for overactive bladder (OAB).
On May 15, France’s Agence Nationale du Securite du Medicament et des Produits de Santé (ANSM) became the latest regulatory agency to approve the new OAB indication. Botox’s eighth approved indication in France covers OAB associated with symptoms including three urgency urinary incontinence episodes within three days, urinary frequency defined as eight or more voids/day in adult patients who don't respond to anticholinergic medication (after three months of treatment) or are intolerant to anticholinergic medication and not responding to a well-controlled physiotherapy.
Botox was approved by the FDA in August 2011 for injection into the bladder muscle for treatment of leakage of urine in adults with overactive bladder due to neurologic disease. And in January 2013, Botox was additionally approved to treat overactive bladder symptoms, such as a strong need to urinate with leakage, urgency and frequency in adults 18 years and older when anticholinergic medication does not work well enough or cannot be taken.
Botox is Allergan’s best-selling product, accounting for nearly one-third of its 2013 sales of $1.98 billion.
TARIS is still recruiting patients for its Phase II trial (NCT01824303), designed to assess if LiRIS at the 400 mg dose is safe and tolerable in women with IC, and to evaluate any change in IC symptoms following LiRIS administration. The first patient was dosed last year. Final data collection date for primary outcome measure is estimated to be in December, with the study projected to be completed in February 2015, according to the trial’s page on ClinicalTrials.gov, last updated on Aug. 6.
Valeant has promised to jettison—by selling or eliminating—all but the late-stage clinical programs of Allergan’s R&D effort, contending in an April 22 statement announcing its first $47.5 billion bid for Allergan that: “Allergan's track record has been largely unproductive over the past 16 years.”
Urology was not included in the therapeutic areas Valeant said it is looking to specialize in, since the statement added: “The new company will continue to fund both companies' late stage development programs, including those in dry eye, diabetic macular edema, glaucoma, migraine, eye whitening, psoriasis, and other dermatology areas.”
LiRIS® uses TARIS-developed technology developed at MIT by serial entrepreneur Robert S. Langer, Sc.D. and Michael J. Cima, Ph.D., who launched the company in 2008. The technology is designed to continuously deliver lidocaine over an extended period directly to the bladder of patients to relieve painful and often debilitating symptoms associated with IC/BPS. The technology is administered to patients via existing, minimally invasive procedures such as catheterization or flexible cystoscopy, and combines three drug-delivery strategies: Osmotic delivery, shape memory technology, and implant retention.
As part of the deal, TARIS spun out intellectual property related to its platform technology, as well as its pipeline programs, to a new company funded by its shareholders.
Allergan agreed to pay TARIS $67.5 million in cash upfront, subject to unspecified adjustments and holdbacks, plus up to $295 million in payments tied to development milestones; and up to $225 million in commercial milestone payments.
“Building on the success of LiRIS® so far, we will now be able to focus our efforts on developing a rich pipeline of applications of our technology, including new treatments for bladder cancer and other areas of unmet need in urology,” Purnanand Sarma, Ph.D., TARIS’ president and CEO, said in a statement.
TARIS’ pipeline effort includes two preclinical compounds TD-210 for non-muscle invasive bladder cancer (NMIBC), and TD-302 for overactive bladder. In October, TARIS launched a collaboration of undisclosed value with AstraZeneca to develop new NMIBC treatments. The companies said at the time that they planned to combine TARIS’ tech platform with targeted cancer therapeutics from AstraZeneca.