JERUSALEM, Israel, November 6, 2012 – Teva Pharmaceutical Industries Ltd. announced today that additional data from the Phase III clinical program for QNASL® (beclomethasone dipropionate) Nasal Aerosol will be presented at the 2012 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Anaheim, CA on November 8-13, 2012. QNASL® is a recently approved "dry" nasal aerosol corticosteroid that treats seasonal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older.
Findings from one clinical study being presented at the meeting highlight the nasal symptom improvement and efficacy profile of QNASL® in children ages 6-11 with seasonal allergic rhinitis (SAR), while others reinforce ocular safety, appropriate dosing and device performance.
On March 23, 2012, the U.S. Food and Drug Administration (FDA) approved QNASL®. The product became available to patients by prescription in April 2012, making it the first marketed nonaqeous or "dry" nasal aerosol product in a category that reports annual sales of $2.5 billion. QNASL® is delivered as a once-daily, nonaqueous aerosol that uses an environmentally friendly propellant (HFA) and contains a built-in dose counter.
"QNASL has provided an alternative therapy for patients suffering from allergic rhinitis," said Dr. William Storms, MD, practicing allergist, clinical professor at the University of Colorado Health Sciences Center and founder of the William Storms Allergy Clinic in Colorado Springs, CO. "The dry mode of delivery of QNASL, along with the performance and functionality of the device, offers patients a safe and effective way to manage and control their nasal allergy symptoms. The data to be presented at ACAAI this year further demonstrate the efficacy profile of QNASL, especially among the pediatric population and confirm the product's ocular safety profile in adolescents and adults."
The following QNASL® (beclomethasone dipropionate) data will be presented during poster sessions on Saturday, November 10 from 12:30 – 1:30 p.m. PST and Sunday, November 11 from 12:00 – 1:00 p.m. PST in Hall C (first floor) of the Anaheim Convention Center at the ACAAI Annual Meeting:
- #P314: Device and Integrated Dose Counter Performance of Beclomethasone Dipropionate Nasal Aerosol During Daily Use
- #P329: Nasal Symptom Improvement Following Once-Daily Treatment With Beclomethasone Dipropionate Nasal Aerosol (80 µg or 160 µg) in Children With Seasonal Allergic Rhinitis
- #P330: Efficacy, Safety, and Optimal Dose Selection of Beclomethasone Dipropionate Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis
- #P331: Evaluation of Ocular Safety Following Long-Term Treatment With Beclomethasone Dipropionate Nasal Aerosol in Subjects With Perennial Allergic Rhinitis
- #P325: Nasal Deposition of Beclomethasone Dipropionate Nasal Aerosol Versus Fluticasone Propionate and Mometasone Furoate Aqueous Nasal Sprays
"The data to be presented at ACAAI provide additional evidence that QNASL is a generally well-tolerated and effective treatment option for people suffering with seasonal and year-round nasal allergies," said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. "We are committed to the development of novel therapies to help the millions of Americans who suffer from allergic rhinitis effectively manage and control their burdensome symptoms."
ABOUT ALLERGIC RHINITIS
Allergic rhinitis (AR) is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, runny nose and nasal congestion. For many AR patients, nasal congestion or a stuffy nose may be the most frequent and bothersome symptom. According to a recent survey, patients suffer considerable discomfort during allergy attacks, such that nearly two out of five (38 percent) said their discomfort was not tolerable without relief. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR.
In the U.S., the prevalence of AR has increased during the past three decades; it is recently estimated at 20 percent in the general adult and adolescent populations. Of those Americans affected with AR, approximately 20 percent have SAR, 40 percent have perennial allergic rhinitis (PAR) and 40 percent have a combination of the two (i.e., PAR with seasonal exacerbation) depending on the allergen sensitivity. Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimate of $11.2 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences and 3.5 million lost work days per year are attributed to AR. In addition, the presence of co-morbidities such as asthma and sinusitis further increase AR-related treatment costs.
ABOUT QNASL® (BECLOMETHASONE DIPROPIONATE)
QNASL® Nasal Aerosol is a prescription corticosteroid medication that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. It is administered as a nonaqueous or "dry" spray delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant. QNASL® Nasal Aerosol contains beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When QNASL® Nasal Aerosol is sprayed into the nose, it helps reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing. It is not known whether QNASL® Nasal Aerosol is safe and effective in children under 12 years of age.
Visit http://qnasl.com/Content/pdf/pi.pdf for full prescribing information.
IMPORTANT SAFETY INFORMATION
In clinical studies, nosebleeds and nose ulcers were more common in patients treated with QNASL Nasal Aerosol than patients who received placebo. Some nosebleeds were more severe in patients treated with QNASL Nasal Aerosol than in patients who received placebo. Tell your healthcare provider if you start to have nosebleeds or nasal ulcers after using QNASL Nasal Aerosol.
Thrush (Candida), a fungal infection in your nose, mouth, or throat may occur. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
You should avoid using QNASL Nasal Aerosol until your nose is healed if you have a sore in your nose, you have had recent surgery on your nose or if your nose has been injured, because QNASL Nasal Aerosol may cause slow wound healing.
Some people who use corticosteroids may have eye problems such as increased pressure in the eye (glaucoma) or cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use QNASL Nasal Aerosol.
Serious allergic reactions can happen in people taking QNASL Nasal Aerosol. Stop using QNASL Nasal Aerosol and call your healthcare provider right away or get emergency help if you experience shortness of breath or trouble breathing, skin rash, redness, swelling, severe itching, or swelling of your lips, tongue or face.
People are more likely to get infections if they have immune system problems or use drugs, including corticosteroids, which may weaken the body's ability to fight infections. Avoid contact with people who have infections like chickenpox or measles while using QNASL Nasal Aerosol. Speak to your healthcare provider before using QNASL Nasal Aerosol if you have tuberculosis or untreated fungal, bacterial, or viral infections, or eye infections caused by herpes. Symptoms of an infection include: fever, pain, aches, chills, feeling tired, nausea and vomiting.
A condition in which the adrenal glands do not make enough steroid hormones may occur. Symptoms can include tiredness, weakness, dizziness, nausea and vomiting. Tell your healthcare provider if you experience these symptoms.
Children taking QNASL Nasal Aerosol should have their growth checked regularly, since corticosteroids may slow growth in children.
The most common side effects with QNASL Nasal Aerosol are nasal discomfort, nosebleeds, and headache.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of QNASL (beclomethasone dipropionate) Nasal Aerosol. For more information, ask your healthcare provider or pharmacist.
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.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is a world leading generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
The following discussion and analysis contains forward-looking statements, which express the current beliefs and expectations of management. Such statements involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition from the introduction of competing generic equivalents and due to increased governmental pricing pressures, the effects of competition on sales of our innovative medicines, especially Copaxone® (including competition from innovative orally-administered alternatives as well as from potential generic equivalents), potential liability for sales of generic medicines prior to a final resolution of outstanding patent litigation, including that relating to our generic version of Protonix®, the extent to which we may obtain U.S. market exclusivity for certain of our new generic medicines, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), our ability to achieve expected results through our innovative R&D efforts, dependence on the effectiveness of our patents and other protections for innovative medicines, intense competition in our specialty pharmaceutical businesses, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based medicines, our potential exposure to product liability claims to the extent not covered by insurance, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, adverse effects of political instability and adverse economic conditions, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, the impact of continuing consolidation of our distributors and customers, the difficulty of complying with U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority requirements, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, the termination or expiration of governmental programs or tax benefits, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2011 and in our other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update any forward-looking statements or other information contained in this report, whether as a result of new information, future events or otherwise.