IRVINE, Calif. and LEXINGTON, Mass. – Aug. 13, 2014 – Allergan Inc. (NYSE: AGN) (“Allergan”) and TARIS Holdings LLC today announced that Allergan has closed a transaction to acquire worldwide rights to TARIS Biomedical’s® (“TARIS”) lead program, LiRIS®, which is currently in Phase 2 trials for the treatment of interstitial cystitis / bladder pain syndrome (IC/BPS). Allergan paid $67.5 million in cash upfront, subject to certain adjustments and holdbacks. Allergan has also agreed to pay up to an aggregate of $295 million in development milestone payments and up to an aggregate of $225 million in commercial milestone payments. Prior to the closing of this transaction, TARIS spun out certain assets, including pipeline programs and intellectual property related to TARIS’ platform technology, to a new company funded by TARIS shareholders.
“Allergan has a longstanding history of delivering stockholder value by developing innovative medical treatments that address unmet medical needs,” said David E.I. Pyott, Chairman of the Board and Chief Executive Officer, Allergan. “Our work to develop BOTOX® (onabotulinumtoxinA) as a second-line treatment for overactive bladder (OAB) has made a significant difference for patients who suffer from this chronic condition. The acquisition of LiRIS® is an important addition to our growing urology pipeline and, if approved, will provide a local treatment for interstitial cystitis / bladder pain syndrome, which is a debilitating bladder condition.”
“This transaction is a win for patients, for our shareholders and employees, and for the future potential of our core delivery technologies,” said Purnanand Sarma, Ph.D., President and CEO of TARIS. “Allergan is an ideal partner for advancing LiRIS® because of its team’s expertise in drug delivery technologies, specialty product development and commercialization in the urology market. We are confident that Allergan will enable LiRIS® to reach patients who do not have effective options that adequately address their disease. 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.”
About LiRIS® and Interstitial Cystitis
LiRIS® incorporates proprietary technology developed by TARIS designed to continuously deliver lidocaine over an extended period directly to the bladder of patients with interstitial cystitis / bladder pain syndrome (IC/BPS) to relieve the painful and often debilitating symptoms associated with this disease. IC/BPS is a complex bladder disease associated with significant bladder pain and disability, including in some patients lesions in the bladder, so-called Hunner’s lesions. Patients also suffer from increased urinary urgency and frequency. IC/BPS may dramatically impact quality of life, including loss of work and reduced personal relationships and intimacy.
About Allergan, Inc.
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 11,700 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. For more information regarding Allergan, go to: www.allergan.com.
About TARIS Biomedical®
TARIS Biomedical® is a clinical-stage specialty pharmaceutical company focused on developing a pipeline of innovative treatments for bladder diseases. Current therapies for these conditions are characterized by limited efficacy and/or systemic side effects. The TARIS Biomedical delivery platform is designed to improve treatment by providing controlled, sustained delivery of a drug directly to target tissues. The TARIS technology was developed by internationally renowned scientists from the Massachusetts Institute of Technology: Robert Langer and Michael Cima. Based in Lexington, Massachusetts, TARIS Biomedical is backed by leading venture capital firms Flagship Ventures, Flybridge Capital Partners, Polaris Partners and Third Rock Ventures. For more information, visit www.tarisbiomedical.com.
BOTOX® (onabotulinumtoxinA) Important Information Indication
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into the bladder muscle and used to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities
Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not take BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.
Please see next page for additional Important Safety Information. IMPORTANT SAFETY INFORMATION (continued)
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo. Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX®.
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® with certain other medicines may cause serious side effects.
Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past. Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti- platelets (aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements by Mr. Pyott and Dr. Sarma, and other statements regarding the potential of the LiRIS® program and Allergan’s urology pipeline. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan’s expectations and projections. Risks and uncertainties include, among other things, general industry, pharmaceutical and medical device market conditions; potential safety and efficacy challenges and concerns; challenges related to achieving regulatory approval from the FDA on a timely and cost-efficient manner; technological advances and patents attained by competitors; inconsistency of treatment results among patients; potential difficulties in manufacturing; challenges related to new product marketing, such as the unpredictability or market acceptance for new products and/or the acceptance of new indications for such products; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by Allergan, as well as Allergan’s public filings with the SEC, including the discussion under the heading “Risk Factors” in Allergan’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan’s press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
Media contact for TARIS Biomedical:
MacDougall Biomedical Communications
Media contact for Allergan: