R&D Trends: Systemic Lupus Erythematosus - Benlysta's FDA approval provides hope for disease treatment, future trial design, and other pipeline candidates
- Published: May 2011
Historical and forecast analysis of the PharmaVitae Universe from 2003 through to 2015. Strategic dynamics within the Universe are segmented by peer set, therapy area, launch/core/expiry configuration and molecule type.
Features and benefits
- Analyze historical and forecast PharmaVitae Universe sales by peer set, therapy area, launch/core/expiry configuration and molecule type.
- Assess the contrasting growth dynamics forecast across PharmaVitae's Big Pharma, Mid-Pharma, Biotech and Japan Pharma peer sets.
- Over 2003–09, the PharmaVitae Universe—comprised of the branded prescription pharmaceutical industry’s leading companies—enjoyed robust sales growth at a CAGR of 7.1%. The forecast period is, however, expected to be significantly more challenging with the Universe forecast a sales CAGR of just 1.3% over 2009–15.
- Compounding this trend has been a difficulty in developing new products, particularly those that can compensate for blockbuster expiries. Those companies insulted from generic competition—or able to gain revenue growth sourced from biologics or the targeting of niche indications and areas of high unmet need will emerge as key growth players.
Your key questions answered
- Assess the outlook for the PharmaVitae Universe through to 2015
- Evaluate the factors that will drive a PharmaVitae Universe sales CAGR of 1.3% over 2009-15, versus a CAGR of 7.1% over 2003-09
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Overview of the PharmaVitae Universe outlook to
Introduction to the PharmaVitae Universe
Industry coverage of the PharmaVitae Universe
The PharmaVitae peer sets
Strategic overview of the PharmaVitae Universe to
The company outlook to
PharmaVitae Universe launch/core/expiry analysis
PharmaVitae Universe molecule type analysis
PharmaVitae Universe M&A analysis
THE BIG PHARMA OUTLOOK TO
Overview of Big Pharma to
Big Pharma prescription pharma sales performance, 2003-
Big Pharma landscape, 2009–
Big Pharma company analysis
Big Pharma launch/core/expiry analysis
Big Pharma therapy area analysis
Big Pharma molecule type analysis
THE MID PHARMA OUTLOOK TO
Overview of Mid Pharma to
Mid Pharma prescription pharma sales performance, 2003–
Mid Pharma landscape, 2009–
Mid Pharma company analysis
Mid Pharma launch/core/expiry analysis
Mid Pharma therapy area analysis
Mid Pharma molecule type analysis
THE BIOTECH OUTLOOK TO 2015KEY FINDINGS
Overview of Biotech to
Biotech prescription pharma sales performance, 2003–
Biotech landscape, 2009–
Biotech company analysis
Biotech launch/core/expiry analysis
Biotech therapy area analysis
Biotech molecule type analysis
THE JAPAN PHARMA OUTLOOK TO
Overview of Japan Pharma to
Japan Pharma prescription sales performance, 2003–
Japan Pharma landscape, 2009–
Japan Pharma company analysis
Japan Pharma launch/core/expiry analysis
Japan Pharma therapy area analysis
Japan Pharma molecule type analysis
Human Genome Sciences and GlaxoSmithKline make history with first new lupus drug for over 50 years
Benlysta's approval by the FDA will send shockwaves through the lupus community, as historically the disease has been a clinical and commercial minefield. Other companies will now be spurred on to continue development of additional lupus drugs, especially those with the same mechanism as Benlysta. With a fairly wide label, Benlysta will help to make lupus the next billion-dollar autoimmune market.
Benlysta (belimumab), a humanized monoclonal antibody (MAb) against the B lymphocyte stimulator (BLyS), is the first systemic lupus erythematosus (SLE) therapy to demonstrate positive Phase III clinical trial data and the first drug to receive regulatory approval for this indication for over 50 years. Specifically, the label states that Benlysta can be used to treat adult patients with active, autoantibody-positive SLE who are receiving standard therapy. While the FDA approval does come with limitations - the drug is not recommended for severe active lupus nephritis or severe active central nervous system lupus, patients who are at the extreme end of disease severity - overall the label is not as restrictive as initially speculated. Benlysta’s prescribing information further indicates that physicians should be cautious when considering treatment in black/African-American patients as the clinical data showed that they were unresponsive to the drug in clinical trials. This is something that the companies will be exploring further in an additional study.
Current treatment of lupus is dictated by organ involvement and severity and is largely treated by off-label medications such as the immunosuppressant CellCept (mycophenolate mofetil; Roche) and the CD20 MAb Rituxan (rituximab; Biogen Idec/Roche). Corticosteroids and antimalarial agents, such as hydroxychloroquine, are also routinely prescribed.
Human Genome Sciences (HGS) and GlaxoSmithKline will begin marketing Benlysta in the US immediately, with a commercial launch anticipated by the end of March. In the EU, Benlysta is expected to receive approval from the European Medicines Agency later in 2011, but this presents a lower commercial opportunity due to the smaller population sizes in this region.
HGS has been building up stock of the drug and has stated that it has about a year's worth of inventory, enough for approximately 50,000 patients. The company will adopt a three-pronged approach to help drive Benlysta's initial post-launch uptake, targeting patients, rheumatologists, and payers. Through addressing payers in this way, HGS aims to facilitate reimbursement prior to receiving a J-code in 2012. HGS has set the annual price of Benlysta at $35,000 per patient, within the range of current therapies used in rheumatoid arthritis and multiple sclerosis.
The authors expects that Benlysta will remain the only marketed US biologic for lupus for at least the next three years. However, there is competition looming with several Phase III agents in development, including UCB's epratuzumab, a CD22 MAb. Other BlyS-targeted biologics in the late-stage lupus pipeline will be encouraged by Benlysta's approval. In Q1 2011, Eli Lilly commenced Phase III trials almost identical to Benlysta's for its BlyS MAb LY2127399, in the absence of any Phase II data. Lilly is also using the SLE Responder Index that HGS Sciences developed for Benlysta.
Nevertheless, Human Genome Sciences' and GlaxoSmithKline's drug has made history, becoming the first lupus drug to be approved for over half a century. While not beneficial for all patients, Benlysta will go on to achieve massive success, and subsequently create the next billion-dollar autoimmune disease market.