Sunday, Jun 2, 2019

Xolair (omalizumab) Significantly Reduced Nasal Polyps and Congestion Symptoms in Adults With Chronic Rhinosinusitis With Nasal Polyps in Two Phase III Studies

The Phase III POLYP 1 and POLYP 2 studies of Xolair in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) with inadequate response to intranasal corticosteroids met both co-primary endpoints and key secondary endpoints

In both studies, Xolair showed a safety profile consistent with previous FDA-approved indications

CRSwNP impacts up to 4 percent of people worldwide, and the prevalence increases with age

South San Francisco, CA -- June 2, 2019 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline data from two Phase III multicenter studies evaluating Xolair^® (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to intranasal corticosteroids. The POLYP 1 and POLYP 2 Phase III trials met both co-primary endpoints and key secondary endpoints. Xolair, an injectable biologic medicine designed to target and block immunoglobulin E (IgE), was shown to be well tolerated and the safety profile was consistent with that observed in previous studies in people with moderate to severe allergic asthma and chronic idiopathic urticaria.

“The results from these pivotal studies provided further support that IgE plays a role in inflammatory and respiratory conditions, and showed that Xolair reduced the size of nasal polyps and associated symptoms that impact these patients’ quality of life,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We plan to discuss these results with the FDA with the goal of bringing this new treatment option as soon as possible to people who do not experience relief with the current standard of care.”

The co-primary endpoints of POLYP 1 and POLYP 2 were change from baseline in Nasal Polyp Score (NPS) and change from baseline in average daily Nasal Congestion Score (NCS) over 24 weeks. Xolair demonstrated statistically significant and clinically relevant improvements in both of these co-primary outcomes. Patients enrolled in the study included those with and without a history of surgery.

Key secondary endpoints were met, including improvement in smell, post-nasal drip (posterior rhinorrhea score), runny nose (anterior rhinorrhea score) and the Sino-Nasal Outcome Test-22 (SNOT-22) health-related quality of life assessment.

CRSwNP is the inflammation of the nose and paranasal sinuses with the presence of nasal polyps on the lining of the nasal sinuses or nasal cavity.

Additional findings from these trials will be presented at an upcoming scientific congress.

About POLYP 1 and POLYP 2

POLYP 1 and POLYP 2 are replicate Phase III studies designed to determine the efficacy and safety of Xolair compared with placebo in adult patients with CRSwNP who have had an inadequate response to standard of care treatment. Both trials were randomized, multicenter, double-blind and placebo-controlled. POLYP 1 involved 138 patients, and POLYP 2 involved 127 patients. The primary outcomes for both trials were change from baseline in average daily Nasal Congestion Score at week 24, and change from baseline in Nasal Polyp Score to week 24. Patients in the studies were administered either Xolair or placebo by subcutaneous injection every two to four weeks.

About Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Chronic rhinosinusitis with nasal polyps (CRSwNP) is the inflammation of the nose and paranasal sinuses with the presence of noncancerous lesions (nasal polyps) on the lining of the nasal sinuses or nasal cavity. It is possible to have a single polyp or several and the size of the polyps can vary from microscopic to several centimeters. Symptoms can include nasal blockage/obstruction, nasal congestion, nasal discharge, facial pain/pressure and reduction in or loss of smell. CRSwNP is diagnosed by physical examination with endoscopy. The condition is associated with asthma and aspirin sensitivity.

About Xolair

Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. Genentech is a leading biotechnology company that discovers, develops, manufacturers and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies.

Xolair U.S. Indication

Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat:

• Moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens.
• Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.

Xolair is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.

Important Safety Information

The most important information patients should know about Xolair is that a severe allergic reaction called anaphylaxis can happen when a patient receives Xolair. The reaction can occur after the first dose, or after many doses. It may also occur right after a Xolair injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Patients must go to the nearest emergency room right away if they have any of these symptoms of an allergic reaction:

• wheezing, shortness of breath, cough, chest tightness or trouble breathing
• low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety or feeling of “impending doom”
• flushing, itching, hives or feeling warm
• swelling of the throat or tongue, throat tightness, hoarse voice or trouble swallowing

The patient’s healthcare provider will monitor the patient closely for symptoms of an allergic reaction while they are receiving Xolair and for a period of time after the patient’s injection. The patient’s healthcare provider should talk to the patient about getting medical treatment if they have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.

Patients must not receive Xolair if they are allergic to omalizumab or any of the ingredients.

Before receiving Xolair, patients must tell their healthcare provider about all of their medical conditions, including if they:

• have a latex allergy or any other allergies (such as food allergy or seasonal allergies). The needle cap on the Xolair prefilled syringe may contain latex.
• have sudden breathing problems (bronchospasm)
• have ever had a severe allergic reaction called anaphylaxis
• have or have had a parasitic infection
• have or have had cancer
• are pregnant or plan to become pregnant. It is not known if Xolair may harm a patient’s unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Xolair passes into breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive Xolair.

Patients must tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Receiving Xolair

• Xolair should be given by a healthcare provider in a healthcare setting.
• Xolair is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
• In asthma patients, a blood test for a substance called IgE must be performed prior to starting Xolair to determine the appropriate dose and dosing frequency.
• In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
• Patients must not decrease or stop taking any of their other asthma or hive medicine unless their healthcare providers tell them to.
• Patients may not see improvement in their symptoms right away after Xolair treatment.

Possible Side Effects of Xolair

Xolair may cause serious side effects, including:

• See, “What is the most important information I should know about Xolair” in the Xolair Medication Guide at http://www.xolair.com regarding the risk of anaphylaxis.
• Cancer. Cases of cancer were observed in some people who received Xolair.
• Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive Xolair. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by Xolair. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
• Fever, muscle aches, and rash. Some people who take Xolair get these symptoms 1 to 5 days after receiving a Xolair injection. If a patient has any of these symptoms, they must tell their healthcare provider.
• Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving Xolair. The patient’s healthcare provider can test the patient’s stool to check if they have a parasite infection.
• Heart and circulation problems. Some people who receive Xolair have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by Xolair.

The most common side effects of Xolair:

• In adults and children 12 years of age and older with asthma: pain especially in the arms and legs, dizziness, feeling tired, skin rash, bone fractures and pain or discomfort of the ears.
• In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds.
• In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain and upper respiratory tract infection.

These are not all the possible side effects of Xolair. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at 888-669-6682.

Please see full Prescribing Information, including Medication Guide at http://www.xolair.com for additional Important Safety Information.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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