FirstWord Lists: Pharma's largest pipeline opportunities

Based on analyst consensus forecasts compiled by FirstWord, there are nine late-stage pipeline products either launched, or expected to be, this year or next that are anticipated to generate blockbuster revenues by 2016.

Biotech dominance

Notably – although perhaps not surprisingly – the list is dominated by biotech rather than Big Pharma players, with Gilead Sciences' hepatitis C therapy GS-7977 expected to generate the highest sales by 2016 by some margin. Biogen Idec – via its oral multiple sclerosis treatment BG-12 – and Medivation – due to the prostate cancer therapy enzalutamide – also feature prominently.

Current consensus forecasts suggest that GS-7977 will deliver global sales of $3.7 billion in 2016, just two years after launch. Revenue estimates reflect the potential game changing nature of GS-7977, which is widely expected to become a key component in the first all-oral hepatitis C treatment regimen. Gilead has certainly paid for the privilege; GS-7977 was acquired with the rest of Pharmasset for around $11 billion late last year, making it the most expensive purchase of a clinical stage company.

Movement into hepatitis will expand Gilead's focus beyond HIV, where the company has enjoyed great success in recent years; a second key pipeline launch – the quad regimen Stribild – will help to maintain a market leading position but will cannibalise sales of existing HIV treatments.

Biogen Idec's BG-12 is expected to become the second oral MS treatment to reach the market, with a PDUFA date in late December. Despite the availability of Novartis’ Gilenya – also on track to become a blockbuster based on its first-half 2012 sales performance – leading neurologists interviewed by FirstWord believe that BG-12 will emerge as the first-line therapy choice and number one future therapy for MS; a status driven by its impressive efficacy and robust side effect profile.

Enzalutamide – which will be co-marketed with Astellas – should become Medivation’s first approved product with a PDUFA date set for November. Initial clearance will be in post-chemotherapy prostate cancer patients but, like its closest competitor – Johnson & Johnson’s Zytiga – subsequent approval in pre-chemotherapy patients is expected to grow revenues further.

Zytiga has driven dramatic market expansion in prostate cancer – fuelled by better than expected data presented at this year’s ASCO meeting – and enzalutamide is expected to accelerate this momentum. Many analysts believe the Medivation product to be the slightly more effective drug, which has a better chance of showing a statistically significant survival benefit as its study is larger and provides for a longer duration of therapy.

An extended FDA review and recently scheduled advisory committee meeting have not dampened analyst expectations for Novo Nordisk’s long-acting insulin product Tresiba, which is expected to launch in either late 2012 or early 2013. Set to compete against Sanofi’s multi-billion dollar Lantus franchise, Novo Nordisk will be hoping to gain a label that allows for differentiation, with analysts citing the potential for superior hypoglycaemia data.

Big Pharma

Big Pharma’s presence on the list is limited to three players, one of which – Roche – has pursued a notably different strategy from its peer set rivals over the past decade and a half. The Swiss drugmaker is represented by two new products that are expected to enhance its portfolio of oncology-focused monoclonal antibodies. Perjeta and trastuzumab emtansine (T-DM1) are both indicated for HER2-positive breast cancer, a disease segment where Roche is already the clear market leader. Addition of Perjeta to Herceptin therapy will both add cost and prolong treatment duration; a commercial win-win.

FirstWord has written heavily about Pfizer’s tofacitinib in recent weeks; the product is viewed as a key catalyst for the company at this post-Lipitor juncture. Initial approval will only occur in anti-TNF failure patients, but such has been the success of these biologic products, tofacitinib is expected to rapidly achieve blockbuster status. Longer-term growth will potentially be driven by extension into the second- and front-line settings.

Currently forecast to launch in 2013, Relvar is expected to further enhance GlaxoSmithKline’s position in the respiratory market, effectively as a once-daily version of its Seretide/Advair franchise. The UK drugmaker has recently announced pivotal-stage, top-line results, with full data expected to be unveiled later this year.

A contentious blockbuster candidate

The other product on this list – Vivus' recently approved obesity treatment Qsymia – is arguably the most contentious blockbuster candidate. By the same notion, however, it is perhaps the most intriguing product on the list.

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