GlaxoSmithKline: Return To Growth
GlaxoSmithKline continues to accelerate new product sales momentum and bolster the company’s pharmaceuticals, vaccines and consumer healthcare businesses.
GlaxoSmithKline plc
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Brentford, Middlesex
TW8 9GS, United Kingdom
Telephone: +44 (0)20 8047 5000
Website: gsk.com
Best-Selling Products
| Product | 2015 Sales | 2014 Sales |
|---|---|---|
| Advair/Seretide | $5,626 | $6,464 |
| Infanrix, Pediarix | $1,120 | $1,266 |
| Triumeq | $1,116 | $87 |
| Epzicom, Kivexa | $1,067 | $1,174 |
| Avodart | $1,004 | $1,230 |
| Flovent/Flixotide | $952 | $1,073 |
| Ventolin | $948 | $1,016 |
| Tivicay | $899 | $431 |
| Hepatitis Vaccines | $825 | $853 |
| Lamictal | $812 | $812 |
| Augmentin | $807 | $876 |
| Rotarix | $637 | $575 |
| Synflorix | $582 | $608 |
| Boostrix | $547 | $485 |
All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2015: £1.5284.
Financial Performance
| 2015 | 2014 | |
|---|---|---|
| Revenue | $36,564 | $35,162 |
| Net income | $12,796 | $4,327 |
| Diluted EPS | $2.63 | $0.87 |
| R&D expense | $5,441 | $5,273 |
| 1H16 | 1H15 | |
|---|---|---|
| Revenue | $19,504 | $17,592 |
| Net income | $(214) | $12,461 |
| Diluted EPS | $(0.05) | $2.59 |
| R&D expense | $2,603 | $2,566 |
All sales are in millions of dollars except EPS, and were translated using the Federal Reserve Board’s average rate of exchange in 2015: £1.5284
Despite decreasing sales of GlaxoSmithKline’s all-time best-selling medicine Advair/Seretide, the company is undergoing a growth trajectory. GSK made substantial progress during 2015 to accelerate new product sales growth, integrate new businesses in Vaccines and Consumer Healthcare, and restructure its worldwide Pharmaceuticals business. As a result, the Group is well-positioned to return to core earnings growth during 2016, with full-year core EPS percentage growth anticipated to be 11-12 percent CER (constant exchange rate).
A new chief executive officer will help GSK remain concentrated on the execution of the Group’s strategy to drive growth and performance during 2017 and beyond. Existing CEO Sir Andrew Witty is set to retire from the company on March 31, 2017, after being at the helm since May 2008.
CEO Sir Andrew Witty
Emma Walmsley, currently CEO of GSK’s Consumer Healthcare division, was tapped in September 2016 as GSK’s CEO Designate. She will join GlaxoSmithKline’s Board of Directors effective Jan. 1, 2017. GSK Consumer Healthcare, one of the world’s largest consumer health companies, was established during 2015 following completion of GlaxoSmithKline’s three-part transaction with Novartis.
“I am delighted and honored to be appointed GSK’s next CEO,” Ms. Walmsley stated. “GSK is a company that leads both in science and in the way it does business. We have momentum in the Group and as the demand for medical innovation and trusted healthcare products continues to rise, we have the opportunity and the potential to create meaningful benefits for patients, consumers and our shareholders. I’m looking forward to working with Andrew and other leaders over the next few months to ensure a smooth handover and to develop plans for 2017 and beyond.”
GSK has established three world-leading businesses: Pharmaceuticals, Vaccines and Consumer Healthcare. The company has a strong portfolio of innovative products with a presence in more than 150 markets. On a 2015 pro-forma basis, Pharmaceuticals accounted for 58 percent of revenue, Consumer Healthcare represented 26 percent and Vaccines contributed 16 percent.
According to management, R&D innovation underpins all three businesses. In November 2015, the Group profiled to investors an R&D portfolio of ~40 assets concentrated on Oncology, Immuno-inflammation, Vaccines, HIV and Infectious diseases, Respiratory and Rare diseases. Of the ~40 assets, 80 percent have the potential to be first in class.
Each of the three businesses is supported by proprietary technologies and manufacturing capabilities in fields such as devices, adjuvants, bio-electronics and formulations. The Group strives to improve returns from its R&D innovation by striking a balance between pricing and volume generation.
Executives have outlined a series of expectations for GSK’s performance during the five-year period from 2016-2020. Expectations include Group core EPS growing at a CAGR of mid-to-high single digits on a CER basis; the U.S. introduction of a generic alternative to Advair that was factored into the Group’s assessment of its future performance; and paying an annual ordinary dividend of 80 pence for each of the years 2015-2017.
Performance & Outlook
For calendar-year 2015, GSK delivered further progress against its strategy with sales of £24 billion (+6%), core EPS of 75.7p (-15%) and total EPS of 174.3p, +>100% CER. Across the three businesses, Pharmaceuticals generated £14.2 billion, down 7 percent (-1% pro-forma); Vaccines produced £3.7 billion, up 19 percent (+3% pro-forma); and Consumer Healthcare accounted for £6 billion, up 44 percent (+6% pro-forma).
According to the company, £2 billion of new product sales in 2015 were driven by HIV (Tivicay and Triumeq), Respiratory (Relvar/Breo, Anoro, and Incruse) and Meningitis vaccines (Menveo and Bexsero). A new biologic treatment for severe asthma, Nucala, was introduced to the marketplace at the end of 2015. Based on 2015 results, new product sales were anticipated to reach the company’s £6 billion target up to two years earlier (2018 versus 2020). Additionally, 2016 core EPS percentage growth was projected to reach double digits (CER).
As of early February 2016, GSK’s integration and restructuring program was on schedule, with £1 billion incremental annual cost savings delivered in 2015 for costs of £1.9 billion. GSK was on schedule to deliver £3 billion of annual cost savings by year-end 2017.
For the first six months of 2016, Group turnover rose 11 percent in Sterling terms and 6 percent CER on a reported basis to £12.76 billion ($19.5 billion). During the 2016 first half, Pharmaceuticals sales increased 1 percent year-over-year, Vaccines improved 16 percent and Consumer Healthcare advanced 16 percent, with each business still reflecting the impact of the Novartis transaction.
The three-part transaction consisted of GlaxoSmithKline acquiring Novartis’ global Vaccines business (excluding influenza vaccines) for an initial cash consideration of $5.25 billion; the creation of a new world-leading Consumer Healthcare joint venture with Novartis in which GSK has majority control and an equity interest of 63.5 percent; and the divestment of its Oncology business for an aggregate cash consideration of $16 billion.
GlaxoSmithKline’s three-part transaction with Novartis – an innovative deal anticipated to accelerate GSK’s strategy of becoming a simpler, stronger and more balanced platform for long-term growth – was completed on March 2, 2015. As a result, the Group’s reported first-half 2016 financials included six months of sales of the Vaccines and Consumer Healthcare products acquired from Novartis and excluded the former GSK Oncology business. The first-half 2015 results included sales of the GSK Oncology products for the two-month period ended March 2 and sales of the acquired Vaccines and Consumer Healthcare products for the four months after that date.
On a pro-forma basis for first-half 2016 results, Group turnover rose 5 percent. Pharmaceuticals improved 4 percent, Vaccines rose 12 percent and Consumer Healthcare went up 6 percent compared to the one-year-earlier period. Sales of New Pharmaceutical and Vaccine products amounted to £1.87 billion in first-half 2016 ($2.86 billion), representing a year-over-year improvement of £1.16 billion.
Pharmaceuticals revenue equaled £7.47 billion ($11.41 billion), increasing 1 percent versus the 2015 first-half term, but adjusting for the disposal of the Oncology business to Novartis, rose 4 percent pro-forma. First-half 2016 HIV sales improved 50 percent year-over-year. Total Respiratory sales decreased 1 percent, primarily reflecting a 25 percent downturn in Seretide in Europe, and the continuing transition globally of the Respiratory portfolio to newer products. U.S. Respiratory sales went up 4 percent and were flat in International. Sales of New Pharmaceutical Products in the first half of 2016 totaled £1.62 billion ($2.48 billion), a Sterling increase of £999 million, which more than offset the Sterling decrease in Advair/Seretide sales of £205 million ($313 million). Sales of Established Products dropped off 11 percent in first-half 2016, impacted by decreases in all regions, including the impact of market reforms and the continued reshaping of the business in China and the impact of biennial price revisions in Japan.
Vaccines sales during the first two quarters of 2016 rose 16 percent on a reported basis and 12 percent pro-forma to £1.84 billion ($2.82 billion). On a reported basis, the US grew 5 percent, Europe increased 28 percent and International advanced 15 percent. Growth benefited from the phasing of various tenders in International combined with the strong performance of the Meningitis franchise – particularly in the US and Europe – partly offset by an unfavorable comparison with first-half 2015 CDC stockpile movements in numerous products.
Consumer Healthcare sales for first-half 2016 grew 16 percent on a reported basis to £3.45 billion ($5.27 billion), with the US increasing 17 percent, Europe rising 20 percent, and International improving 13 percent. On a pro-forma basis, sales grew 6 percent year-over-year, with growth spurred by strong performances in Oral health and Wellness power brands across every region.
“The second quarter’s performance reflects further strong execution of the Group’s strategy and our ability to allocate capital effectively across our three businesses to improve returns,” Sir Andrew Witty commented. “Momentum across the Group is being driven by growth in new product sales, continued cost control and delivery of restructuring and transaction benefits. We have also made good progress in research and development, and in the second half of 2016, expect to complete key regulatory filings for Shingrix, Closed Triple, Benlysta SC and sirukumab.”
Shingrix is a non-live, adjuvanted, subunit (HZ/su) vaccine candidate being developed to help prevent herpes zoster and its complications. Shingrix combines glycoprotein E, a protein found on the varicella zoster virus (VZV) that causes shingles, with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen.
The closed triple therapy combines three medicines – the inhaled corticosteroid (ICS) fluticasone furoate (FF), the long-acting muscarinic antagonist (LAMA) umeclidinium (UMEC), and the long-acting beta2-adrenergic agonist (LABA) vilanterol (VI) – delivered once per day in GSK’s Ellipta inhaler. The closed triple combination therapy FF/UMEC/VI is being studied for advanced chronic obstructive pulmonary disease.
During September, the company announced the submission of regulatory filings in the US and Europe for Benlysta (belimumab) for approval as a subcutaneous formulation in patients with active, autoantibody-positive systemic lupus erythematosus. Already on the market as an intravenous injection, Benlysta first-half 2016 sales totaled £143 million ($219 million), accounting for 24 percent year-over-year CER growth.
The human anti-interleukin (IL)-6 monoclonal antibody sirukumab is undergoing development for treating adult patients with moderately to severely active rheumatoid arthritis (RA). In September, GSK announced that the drug was filed for marketing approval in the US and EU. Sirukumab is being jointly developed for RA as part of a collaboration with Janssen Biologics (Ireland).
In outlining the expectations for 2016 and the five-year period through 2020, Group management has made certain assumptions about the healthcare sector, the different markets in which GSK operates and the delivery of revenue and financial benefits from its current portfolio, pipeline and restructuring programs.
During the 2016-2020 time frame, GSK expects additional sales decreases of Advair/Seretide. The U.S. launch of a generic version has been factored into GSK’s assessment of its future performance. Management assumes no premature loss of exclusivity for other key products during the five-year period. The Group’s expectation of at least £6 billion of revenue each year on a CER basis by 2020 from products introduced in the last three years includes contributions from the current pipeline asset Shingrix. According to GSK leadership, this target is now anticipated to be met up to two years earlier. The Group additionally expects volume demand for its products to grow, especially in Emerging Markets.
The Group’s expectations assume successful delivery of GSK’s integration and restructuring plans during the 2016-2020 period. Material costs for investment in new product launches and R&D have been factored into the expectations provided. The expectations are based on constant currencies and assume no material change to the Group’s effective tax rate.
In addition, during September as the United Nations General Assembly took place in New York, GSK set out a series of steps to further address emerging global health challenges. These challenges include supporting immunization for refugees; tackling the continued increase of antimicrobial resistance; and preparing for future public health threats or pandemics. These pledges build on the company’s long-standing and comprehensive commitments to delivering innovative medicines and vaccines and widening access to them; and will support the ambitious Global Goals to improve health, prosperity and sustainable development by 2030.
Deals & Collaborations In 2016
Aligned with GSK’s strategy of simplification via concentrating on core therapeutic areas, the company during September announced a series of deals with Aspen. GSK is divesting its anesthesia portfolio to Aspen for £180 million in addition to milestones of up to £100 million. The companies also entered into parallel agreements to terminate their collaboration in Sub-Saharan Africa and for Aspen to exercise its option to obtain GSK’s remaining thrombosis business in certain retained markets.
GSK announced a deal with Verily Life Sciences, an Alphabet company, in early August to form Galvani Bioelectronics. The new jointly owned company will be based in the UK and will enable the R&D and commercialization of bioelectronic medicines. GSK will hold a 55 percent equity interest in Galvani and Verily will maintain 45 percent. The parent companies will contribute existing intellectual property rights and an investment of up to £540 million for seven years, subject to successful completion of various discovery and development milestones.
A relatively new scientific field, bioelectronic medicine aims to tackle a wide array of chronic diseases using miniaturized, implantable devices that can modify electrical signals that pass along nerves in the body, including irregular or altered impulses that occur in many illnesses. GSK has been active in this area since 2012 and believes certain chronic conditions such as arthritis, diabetes and asthma could potentially be treated with these devices.
GSK entered into an exclusive, global license deal with Janssen Sciences Ireland UC (Janssen) for CNTO 7160 during July covering all therapeutic fields. The anti-IL-33R monoclonal antibody is undergoing phase I clinical development. The biological therapy prevents interleukin-33 from binding to the ST2 receptor (IL-33R) and could be applicable to a wide spectrum of severe asthmatic populations. There is strong human genetic evidence and target biology linking the IL-33 pathway to asthma and regulation of inflammatory cells regarded as important in asthma, including neutrophils and eosinophils.
GSK assumed all development, manufacturing and commercialization activities globally with the exception of the ongoing phase I study, which Janssen will continue to run until completion. Janssen receives up to £175 million comprising an upfront payment, as well as development and first commercial sales milestones, in addition to tiered royalties on sales and further considerations contingent on future sales performance.
In July, GSK announced £275 million of new investments at three of its UK manufacturing facilities to boost production and support delivery of its latest innovative respiratory and large molecule biological medicines. The vast majority of these products will be for export to worldwide markets.
In other facility news, GSK opened a £56 million state of the art manufacturing site in the United Kingdom during April. The new facility was in response to demand for GSK’s portfolio of respiratory medicines delivered by the innovative Ellipta inhaler. The multi-dose dry powder inhaler (DPI) was developed to deliver GSK’s portfolio of once-daily respiratory medicines. Ellipta inhaler is the result of more than a decade of design and development by a team of 200-plus scientists and engineers.
GSK agreed on a strategic collaboration with Miltenyi Biotec during March. The collaboration unites GSK’s expertise in developing cell and gene therapy-based treatments with Miltenyi Biotec’s worldwide leadership in cell processing and related technologies in cell therapy. The companies seek to optimize the manufacture and delivery of such personalized therapies using increased automation and leading-edge processing technology.
GSK is building a cell and gene therapy R&D platform to underpin development of novel therapies in oncology and rare diseases – two of the company’s core research fields. This plan reflects management’s belief in cell and gene therapy’s potential as a significant treatment approach for tackling the underlying cause of serious disease.
In February news, ViiV Healthcare completed two previously announced transactions to acquire Bristol-Myers Squibb’s late-stage HIV R&D assets and its portfolio of preclinical and discovery-stage HIV research assets. ViiV is a worldwide specialist HIV company established during November 2009 by GlaxoSmithKline and Pfizer, with Shionogi joining in October 2012.
“As a result of these transactions, ViiV Healthcare now has one of the most robust HIV pipelines in the industry,” stated Dominique Limet, CEO of ViiV. “The assets that we have acquired complement our existing portfolio and could lead to new medicines and combinations addressing a broad range of treatment and prevention needs of people living with HIV.”
ViiV acquired late-stage HIV R&D assets from Bristol-Myers Squibb for an initial upfront payment of $317 million followed by development and first commercial sale milestones of up to $518 million, as well as tiered royalties on sales. ViiV additionally acquired Bristol-Myers Squibb’s preclinical and discovery-stage HIV research business for an upfront payment of $33 million, followed by development and first commercial sales milestones of up to $587 million, and further consideration contingent on future sales performance.
In early February, GSK and Adaptimmune Therapeutics plc announced that the companies had expanded the terms of their strategic collaboration. The revised agreement accelerates Adaptimmune’s lead clinical cancer program, an affinity enhanced T-cell immunotherapy (GSK3377794) targeting NY-ESO-1 toward pivotal trials in synovial sarcoma. Adaptimmune is a leader in the use of T-cell receptor (TCR) engineered T-cell therapy to treat cancer.
Adaptimmune and GSK initially announced a strategic collaboration and licensing pact during June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program via clinical proof of concept, and, on exercise, will assume full responsibility for the program.
At the onset of 2016, ViiV Healthcare formalized a collaboration with Janssen Sciences Ireland UC for the phase III investigation and commercialization of the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for treating HIV-1 infection. The long-acting formulations of cabotegravir (CAB LA) and rilpivirine (RPV LA) are being studied as an injectable maintenance treatment for patients who have achieved viral suppression. As part of the agreement, the companies intended to begin a phase III program to evaluate the efficacy, safety and tolerability of the long-acting, two drug injectable regimen during mid-2016.
This collaboration marks the second development agreement between GSK and Janssen. The two companies during June 2014 both entered into an agreement to develop and commercialize a single-tablet combining ViiV Healthcare’s integrase strand transfer inhibitor (INSTI) dolutegravir (branded as Tivicay) and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (marketed as Edurant). A phase III clinical trial program to evaluate the safety and efficacy of the medicines as maintenance treatment of HIV-1 infection started during May 2015.
Product Approvals & Pipeline Updates In 2016
GlaxoSmithKline’s R&D portfolio of ~40 assets is anticipated to drive the company’s long-term performance, with multiple development milestones expected throughout 2016 and 2017. During that time frame, up to 10 regulatory submissions are expected to include Shingrix (shingles vaccine), sirukumab (RA), Benlysta SC (lupus) and ICS/LABA/LAMA (COPD). Also anticipated were up to 10 Phase III starts including cabotegravir (HIV), daprodustat (anemia) and Men ABCWY vaccine. During 2016/2017, up to 20 Phase II starts in Immuno-inflammation, Oncology, Respiratory and Infectious diseases have been projected. As of early 2016, GSK’s estimated R&D rate of return maintained at 13 percent.
The New England Journal of Medicine (NEJM) in September published detailed results from a randomized phase III study (ZOE-70) of Shingrix. The investigational shingles vaccine demonstrated 90 percent efficacy in adults aged 70 years and older that is maintained for at least four years. The clinical trial, from which headline results were reported in October 2015, demonstrated that the two-dose candidate shingles vaccine had 90 percent efficacy (95% confidence interval: 84-94%) compared to placebo in people over 70 years old. Vaccine efficacy was maintained across the various age groups included in the trial, ranging between 90 percent in people aged 70-79 years (95% confidence interval: 83-94%) and 89 percent in those aged 80 years and above (95% confidence interval: 74-96%). GSK was on track to submit regulatory applications during 2016.
Additional studies to evaluate the ability of Shingrix to help prevent shingles are under way in healthy people aged 50 and older and in adults with compromised immune systems. These trials will provide additional information with respect to the efficacy and safety profile of the vaccine candidate as well as its ability to stimulate immune responses in other populations and in specific circumstances.
GSK announced the regulatory filing of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in September. The MAA is seeking approval of a subcutaneous formulation of sirukumab for treating adult patients with moderately to severely active rheumatoid arthritis. Specifically, the MAA is intended for approval of sirukumab in combination with methotrexate in rheumatoid arthritis patients who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs (DMARDs) and as a monotherapy in these patients for whom treatment with methotrexate is inappropriate.
Marketing clearance is being sought for the subcutaneous form of sirukumab in two presentations: a single-dose prefilled syringe and a single-dose autoinjector. The data to support the filing are based on a comprehensive phase III clinical development program involving 3,000-plus patients.
GSK revealed during June that a pivotal global phase III study investigating subcutaneous sirukumab in adult patients with moderately to severely active RA met both co-primary end points. All major secondary endpoints were additionally met with statistical significance for each dose of sirukumab versus placebo (p<0.001 for all measures across both doses).
A regulatory submission to the United States Food and Drug Administration was also on schedule for 2016. As of September, sirukumab had not been approved as a treatment for any indication anywhere worldwide.
In other September news highlights, GlaxoSmithKline and Innoviva announced the presentation of further data from the pivotal phase III FULFIL trial with the investigational closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) in patients with COPD. The trial, for which headline results were reported during June 2016, met both of its co-primary endpoints. At 24 weeks, there was a clinically meaningful and statistically significant (p<0.001) benefit for FF/UMEC/VI in lung function, measured as mean change from baseline in trough FEV1 (171mL, 95% confidence interval [148, 194]) and health-related quality of life, measured as mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) total score (-6.6 units for closed triple versus -4.3 units for budesonide/formoterol, difference of -2.2 units, 95 percent confidence interval [-3.5, -1.0]). Also, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50 percent on closed triple and 41 percent on budesonide/formoterol (odds ratio 1.41; p<0.001).
GSK’s plans are on track for regulatory filings of the closed triple combination therapy for COPD in the United States and Europe by year-end 2016.
ViiV Healthcare during August announced the beginning of a phase III program to support regulatory submissions for a two-drug regimen of dolutegravir and lamivudine (branded as Epivir) for treating HIV-1 infection in adults who have not received prior antiretroviral therapy. The phase III program consists of two identical trials (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus lamivudine with a three-drug regimen of dolutegravir combined with the fixed-dose tablet tenofovir/emtricitabine (marketed as Truvada). The trials together will include 1,400 men and women living with HIV and are being carried out at research centers in Europe, Central and South America, North America, South Africa and Asia Pacific.
Dolutegravir is used in combination with other antiretroviral agents for treating HIV. Integrase inhibitors are able to block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is additionally responsible for establishing chronic infection. Tivicay is approved in more than 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.
Lamivudine is a nucleoside analog used in combination with other antiretroviral agents for treating HIV infection. The drug is available in branded and generic forms.
The US Food and Drug Administration approved a supplemental New Drug Application for dolutegravir 10mg and 25mg oral tablets in June. The approval lowers the weight limit from at least 40kg to at least 30kg, in patients ages 6 to less than 12 years old, for treating HIV-1 in children and adolescents. Dolutegravir, in line with the previous label, now is available for use in two pediatric populations: pediatric patients weighing at least 30kg living with HIV-1 who are treatment naïve (not previously treated) and who are treatment experienced (previously treated), as long as they have not taken an integrase inhibitor.
During July, GSK provided an update on the company’s response to the Zika virus disease outbreak. Since the outbreak started in the Americas during late 2015, GSK has been assessing how it can best help to respond, according to its leadership. The company took months to assess the feasibility of beginning a Zika vaccine discovery program, based on GSK’s novel vaccine technology platforms which management believes could be suitable for working on this target.
After the feasibility assessments were concluded, GSK has been preparing research studies that will evaluate a new vaccine technology for Zika known as SAM (self-amplifying mRNA) in collaboration with the Vaccine Research Center at the National Institutes of Health (NIH) in the United States. GSK executives believe that this novel technology may have the potential to induce protective immunity against Zika. This project is based at the newest GSK Vaccine R&D Center located in Rockville, Md.
The European Commission during June approved Strimvelis, the first ex-vivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID (Severe Combined Immunodeficiency due to Adenosine Deaminase deficiency). A child born with ADA-SCID does not have a healthy, fully-functioning immune system and thus is unable to fend off everyday infections.
Strimvelis (autologous CD34+ cells transduced to express ADA) is the first corrective gene therapy for children to be awarded regulatory approval anywhere worldwide. Strimvelis is indicated for treating patients with ADA-SCID for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.
The ADA-SCID gene therapy was initially developed in Milan by Ospedale San Raffaele (OSR) and Fondazione Telethon through their joint San Raffaele Telethon Institute for Gene Therapy (SR-Tiget). Strimvelis was taken forward by GSK via a strategic collaboration formed during 2010 between GSK, OSR and Telethon. Within the collaboration GSK – working with the biotech company MolMed S.p.A – has applied its expertise in product development to optimize, standardize and characterize a manufacturing process that was previously only suitable for clinical studies into one that has been shown to be robust and suitable for commercial supply.
The Japanese Ministry of Health, Labour and Welfare granted approval for Nucala (mepolizumab) during March as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately controlled with standard treatment. Nucala represents the first medicine in a new class of anti-interleukin-5 (IL-5) biologic therapies. Nucala is available in Japan for adults and adolescents aged 12 years or older. US marketing clearance was granted in December 2015, marking the first approval of an anti-IL-5 treatment anywhere in the world.
IL-5 plays a significant role in regulating the function of eosinophils, which are inflammatory white blood cells known to be important in asthma. The medicine is administered as a 100-milligram fixed-dose subcutaneous injection once per month.
GlaxoSmithKline during early February announced the filing of a supplemental Biologics License Application (sBLA) to the U.S. FDA for FluLaval Quadrivalent. The influenza vaccine is already approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older. The submission seeks an expanded indication for children 6 months through 35 months old. The sBLA filing is based on one Phase III pivotal trial and three supportive clinical studies conducted in children 6 months through 35 months of age.
