This article is Part II of Productive Innovation Index 2016 – White paper: Celebrating the top 30 pharmaceutical companies most successful at bringing innovations to market.
The Productive Innovation Index (PII), now in its sixth year, provides a systematic, objective assessment of how well the top 30 companies perform in successfully bringing new medicines to market.
- Novo Nordisk
Novo Nordisk chooses to operate in diabetes that remains a fiercely competitive therapy area, with three dominant players: Novo Nordisk, Eli Lilly, and Sanofi. The key emergent feature of the market is each individual player attempting to fill any gaps within their diabetes portfolios, whilst leveraging existing access to physicians, and utilising strong sales and marketing forces.
Overall the T2D market will expand due to an increasing patient population and the rise in use of novel therapies at second and third lines with Novo Nordisk maintaining a (shrinking) lead.
Growth of insulin and glucagon-like peptide-1 (GLP-1) receptor agonists over the coming years, is leading the market to expand. Novo Nordisk will continue to lead the diabetes market, while Sanofi, Eli Lilly, and Merck will follow closely behind. The companies will aim to capture growth, driven by an increasing patient population and the rise in use of novel therapies at second and third lines.
Novo Nordisk’s leading agents, Victoza® (GLP-1 agonist in T2D), and Levimir® (insulin used in type 1 diabetes (T1D) & T2D), both show strong growth currently and that 2015 approval of Tresiba® will add to the company’s dominance in T1D.
Notably, it is forecast that Sanofi will supplant Novo Nordisk in 2020 to become the largest player in the Endocrine, Metabolic, and Genetic Disorders market (EM&GD).
Novo Nordisk is aware of its over-dependence on EM&GD and is attempting to leverage and expand its haematology franchise in particular, that currently stands at 11% of turnover.
Note that financial management plays an important part in Novo Nordisk’s high ranking in that the percentage of sales spent on marketing, operating costs, etc., compared to its peer group, indicates a particularly well run and efficient organisation. Given that the basic question underlying the PII is “If I had an early phase asset, to whom would I license it for maximum return?” then this becomes an important consideration.
In purely sales terms, Gilead had a spectacular 2015 reporting $32.2 billion sales compared to $24.5 billion in 2014. Sovaldi®, which had seen the most successful launch in pharma history, actually declined in sales (with increasing competition to come from AbbVie’s Viekira Pak®, Merck’s elbasvir/grazoprevir). This, however, was offset by the uptake of Harvoni® that was launched in late 2014, and Sovaldi® and Harvoni® sales in Japan trebled to nearly $4 billion.
Gilead is already charging ahead this year, planning to roll out a new hepatitis C combo pill that treats genotypes 1-6 of the virus with the FDA granting the medicine a speedy review (final decision expected by the end of June). In addition, pivotal phase III study results and NDAs are planned throughout 2016 across both liver disease and HIV/ AIDS.
Focus on other therapeutic areas is lower key, but impressive data were published for Zydelig® in second-line chronic lymphocytic leukemia (CLL). A FDA indication was gained in pulmonary arterial hypertension for Letairis®. Phase II and III studies were announced across several inflammatory conditions.
The company is being cautious in terms of future sales projections, however, citing competition and increased payer pushback whilst highlighting that future growth will be driven my partnerships and acquisitions.
Given its short timespan to date and aggressive programme of launches, it is not surprising that Gilead’s portfolio is characterised by new products. This is evaluated within the PII by the Freshness Index rankings: The Freshness Index 2010-15 is the percentage of 2015 sales generated by products launched from 2010 onwards, similarly for Freshness Index 2012-15. These are known as FI10-15 and FI12-15 respectively and Gilead’s scores are nearly 69% for both. To put this into context, the average FI scores across all the PII companies are 29% and 16%.
At first glance, the acquisition of Pharmacyclics delivers on two fronts for AbbVie: it reduces the company’s dependency on revenues from Humira® (the world’s best selling drug), which is set to face biosimilar challenges and also expands its presence in oncology, specifically CLL and other haematological cancers.
This may prove to be complex and expensive, particularly as Johnson & Johnson already owns 50 percent of the drug Imbruvica®, into which much of Pharmacyclics’ value is effectively tied.
As stated, AbbVie’s oncology pipeline strengthened with the purchase of Pharmacyclics and the company has now received three FDA Breakthrough Therapy Designations for venetoclax across CLL and acute lymphoblastic leukaemia (ALL), plus a Priority Review in multiple myeloma for Empliciti®.
AbbVie still has faith in Humira® and is continuing the process of generating additional indications, and also building on its already 90-country wide coverage by pushing more and more into emerging markets.
It has also strengthened its position in Parkinson’s disease with the approval of Duopa®; with a novel delivery system aimed at late stage patients who currently have limited treatment options.
The company’s Viekira Pak® continues to carve out Hepatitis C subpopulations and was recently granted a priority FDA review in patients with compensated cirrhosis.
AbbVie’s host of positive data in late stage studies across oncology and immunology, for both novel and launched compounds, indicates that its policy of novel launches and maximising penetration of existing brands will continue.
Biogen’s Tecfidera®, which launched in the US in early 2013, is set to overtake Novartis’ Gilenya® as the leading product in multiple sclerosis (MS) due to a balance of efficacy and tolerability that makes it an ideal first-line treatment option. Tecfidera® carries no contraindications, and the only monitoring requirement is for a recent complete blood count test. This positions Tecfidera® favourably against Gilenya® and Tysabri®, which carry notable safety uncertainties and onerous monitoring regimens.
Already dominant in treating MS with Tecfidera®, Tysabri® and interferons, Biogen is now looking at reversing or repairing MS changes with an innovative phase II study of anti-LINGO-1, an antibody intended to stimulate regrowth of the myelin sheath.
The company’s commitment to CNS continues with phase III assets in Alzheimer’s disease, MS and spinal muscular atrophy (SMA), and earlier stage studies in Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
The oncology franchise, current at $1.3 billion, looks to expand particularly by expanding the indication range of obinutuzumab.
Biogen’s commitment to replenishing and supplementing its portfolio is reflected in its Freshness Index rankings. Biogen’s FI10-15 and FI12-15 respectively scores near 43% for each (versus average scores of 29% and 16% across all the PII companies).
Source: IDEA Pharma.