GSK receives prestigious Prix Galien USA award for SHINGRIX

GSK today announced that SHINGRIX, a vaccine indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older, has been awarded the 2019 Prix Galien USA Award for Best Pharmaceutical Product. Prix Galien is the world’s leading recognition of innovation and excellence in medical products and devices that improve the human condition. SHINGRIX was selected from 22 nominees by an evaluation committee composed of 12 renowned leaders from the biomedical industry and academia, including four Nobel Laureates. Last week, SHINGRIX was also awarded the Prix Galien in Germany in the Primary Care category.

Following US approval of SHINGRIX in 2017, the vaccine has created a paradigm shift in the prevention of shingles, helping to protect millions of people from the disease and its potentially debilitating symptoms. Prix Galien recognized the antigen-adjuvant combination in the vaccine formulation that delivers more than 90 percent efficacy in those 50+ years of age. The composition of SHINGRIX harnesses innovative technology to address immunosenescence – the natural, age-related decline in the function of the immune system – and levels of protection in the older adult population. The insights generated during the development of SHINGRIX may also open up new avenues for advancing vaccine technologies and could lead to the development of a new generation of higher-efficacy vaccines for aging adults.

Roger Connor, GSK Vaccines President said, “It is a great honor for SHINGRIX to receive the prestigious Prix Galien Award. This award recognizes the importance of vaccines in healthcare and is the result of more than 20 years of innovation by GSK’s researchers and the significant scientific advancement in the field of vaccinology. Shingles is a debilitating disease and we are proud that SHINGRIX is able to help prevent many patients, especially older populations with a diminished immune system, from suffering from this disease, today and in the future.”

In the US, there are more than one million new cases of shingles diagnosed each year resulting in considerable morbidity and pain.1 More than 99 percent of those aged over 50 years old are infected with the varicella zoster virus, and one in three Americans will develop shingles in their lifetime. This risk increases to one in two for adults aged over 85 years.^[i]

ZEJULA^® (niraparib), a once daily, oral PARP inhibitor developed by Tesaro, a GSK company, was also shortlisted alongside SHINGRIX in the Best Pharmaceutical Product category.

About shingles

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox.[ii] Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.[iii] As people age, the cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation.^2,[iv]

Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks. The pain associated with shingles is often described as burning, shooting or stabbing.4,[v] Even once the rash is gone, a person can experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years.² PHN is the most common complication of shingles, occurring in 10 to 18 percent of all shingles cases.2,[vi]

There are an estimated 1 million cases of shingles in the United States each year.² More than 99 percent of those over 50 years old are infected with VZV and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older.2,5

About SHINGRIX

SHINGRIX is given intramuscularly in two doses. The second dose should be administered anytime between 2 and 6 months after the first dose.

Important Safety Information for SHINGRIX

• You should not receive SHINGRIX if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of SHINGRIX
• The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach
• SHINGRIX was not studied in pregnant or nursing women. Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding
• Vaccination with SHINGRIX may not protect all individuals

Ask your healthcare provider about the risks and benefits of SHINGRIX. Only a healthcare provider can decide if SHINGRIX is right for you.

About Zejula (niraparib)

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development program by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial as monotherapy maintenance treatment in patients with first-line ovarian cancer (PRIMA), data from this study were recently presented at the European Society for Medical Oncology Congress (ESMO) clinical meeting, a Phase 3 study as a first-line triplet maintenance treatment in ovarian cancer (FIRST), and a Phase 2 study of niraparib combined with bevacizumab maintenance treatment in advanced ovarian cancer (OVARIO).

Several combination studies are also underway, including trials of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (TOPACIO). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

Indication

Zejula is a prescription medicine used for the:

• maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, when the cancer comes back. Zejula is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
• treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with:
  • a certain “BRCA” gene mutation, or
  • a positive laboratory test, and whose cancer was in response to treatment with platinum-based chemotherapy, and who have progressed more than 6 months after the last treatment.
  • Your healthcare provider will perform a test to make sure that Zejula is right for you.
• It is not known if Zejula is safe and effective in children.

Important Safety Information

Zejula may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with Zejula. MDS or AML may lead to death.

Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with Zejula. They can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:

• Weakness
• Feeling tired
• Weight loss
• Frequent infections
• Fever
• Shortness of breath
• Blood in urine or stool
• Bruising or bleeding more easily

Your doctor will do blood tests to check your blood cell counts before treatment with Zejula. You will be tested weekly for the first month of treatment with Zejula, monthly for the next 11 months of treatment, and from time to time afterward.

High blood pressure is common during treatment with Zejula, and it can become serious. Your doctor will check your blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and as needed thereafter during your treatment with Zejula.

Before starting to take Zejula, tell your doctor about all of your medical conditions, including if you:

• Have heart problems
• Have high blood pressure
• Are pregnant or plan to become pregnant. Zejula may harm an unborn baby and may cause loss of pregnancy (miscarriage)
  • If you are able to become pregnant, you should use effective birth control (contraception) during treatment with Zejula and for 6 months after taking the last dose of Zejula
  • If you are able to become pregnant, your doctor may perform a pregnancy test before you start treatment with Zejula
  • You should tell your doctor right away if you become pregnant
• Are breastfeeding or plan to breastfeed
  • Zejula may harm your baby. You should not breastfeed your baby during treatment with Zejula and for 1 month after taking the last dose of Zejula

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Zejula include the following:

Changes in the amount or color of your urine. If you have certain side effects, then your doctor may change your dose of Zejula, temporarily stop, or permanently stop treatment with Zejula.

These are not all the possible side effects of Zejula. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Prescribing Information, available at Zejula.com.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2018.

 GSK enquiries:

[i] Cohen et al. Herpes Zoster. N Eng J Med. 2013;369:255-63.

[ii] Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30.

[iii] Gnann et al. Clinical practice. Herpes zoster. N Eng J Med. 2002;347(5):340-6.

[iv] Johnson RW et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic Advances in Vaccines. 2015;3(4):109-120.

[v]  Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96.

[vi] Yawn et al. Health care utilization and cost burden of herpes zoster in a community population. Mayo Clin Proc. 2009;84(9):787-94.

[vii] The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.