By one of those delicious coincidences, Gilead was formed in 1987 with the mission of treating and curing viral diseases and only 2 years later Hepatitis C was announced as a new disease. And the rest, as they say, is history.
I’ve been a fan of Gilead for a long time now, loving its mix of new kid on the block brashness, its ambition in wanting to own the spaces in which it operates, willingness to buy in expertise when needed (it purchased Pharmasset in 2012, including its candidate sofosbuvir), get rapid approvals (submitted in April 2013, FDA approved sofosbuvir In December 2013) and then commercialize the heck out of brands (it launched sofosbuvir as Sovaldi at the beginning of 2014 and generated $2,3B sales in its first quarter alone, the best launch in pharma history).
Sometimes though, your heart can be stolen by a paramour who is as not brash and exciting but is more staid but just does everything right. This was reinforced by Biogen this month gaining the top position in IDEA Pharma’s Pharmaceutical Innovation Index, an independent view of how successfully the top 30 companies bring products to market and then commercialize them (see later for further details).
When I think Biogen, I see MS (multiple sclerosis) . Understandable, given that more than 90% of Biogen’s revenue continues to come from MS, with Biogen’s Tecfidera continuing to fight it out with Novartis’ Gilenya for market leadership.
Already strong in treating MS with interferons, Biogen launched Tysabri in 2004 with impressive efficacy data but cases of progressive multifocal leukoencephalopathy (PML), a serious and rare viral infection of the brain, caused it to be pulled almost immediately. Undaunted, Biogen, in consultation with the FDA, carefully built a Risk Evaluation and Mitigation Strategies (REMS) program which saw Tysabri returned to the market in 2006 in a way that saw patients who could, and could not, receive Tysabri being clearly identified.
2010 and 2011 saw the launch of Novartis’ Gilenya in the US and EU respectively but Biogen retaliated with Tecfidera (dimethyl fumarate) in 2013, possessing 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.
Biogen consolidated further in MS in 2016 by launched Zinbryta which it will co-market with AbbVie. However, major threats are looming in MS, including Roche's Ocrevus (ocrelizumab) and Celgene's ozanimod, with both firms predicted to become major market players, although Biogen has reacted smartly by acquiring MT-1303 (with the same mechanism of action (MoA) as ozanimod) for just $60 million in up-front payments from Mitsubishi Tanabe.
Analysts and KOLs feel that although Tecfidera will lose share to Ocrevus, ozanimod and Sanofi’s Aubagio (teriflunomide), it will remain the market leader in a disease area currently worth over US$18 billion and growing at 6.5% year on year.
Somewhat uncharacteristically, Biogen undertook a high risk strategy in 2016, albeit with the laudable aim of totally owning MS with a brand new approach to treating the disease. Unfortunately, looking at reversing or repairing MS changes with an innovative Phase 2 study of anti-LINGO-1, an antibody intended to stimulate regrowth of the myelin sheath, the agent did not meet the primary endpoint of the SYNERGY trial as well as its secondary efficacy endpoint. So, instead of totally owning MS, it now merely dominates it!
Biogen’s commitment to replenishing and supplementing its portfolio and planning for patent loss is reflected in its Freshness Index rankings with its 5 and 3 year scores being 53% and 47% respectively (versus average scores of 22% and 11% across all the PII companies), ranking it 4th and 3rd in the 2 categories. (The Freshness Index is a major KPI in the PII and measures the percentage of the year’s sales generated by products launched in the last 3 and 5 years.) The anti-LINGO-1 study failure and looming MS competition highlights the need for Biogen to expand into new therapeutic areas and the company has responded admirably.
Gavyza was approved in 2016 for follicular lymphoma (having already been approved for chronic lymphocytic leukaemia) which should drive growth of the currently small oncology franchise.
In addition, the company continues to progress its Phase 3 assets in Alzheimer’s disease, non-Hodgkin’s lymphoma and spinal muscular atrophy, and earlier stage studies in Parkinson’s disease and amyotrophic lateral sclerosis (ALS) in a clinical portfolio highly regarded by analysts.
Biogen has worked quietly and efficiently on dominating its home MS market and at the same time looking to widen its portfolio. Having divested its non-core haematology business, Biogen surprised many observers by looking to leverage its manufacturing and commercial capabilities and scientific expertise through Samsung Bioepis, its joint venture with Samsung Biologics that develops, manufactures and markets biosimilars as well as through other strategic contract manufacturing partners. Under its commercial agreement with Samsung Bioepis, Biogen will market and sell Benepali, an etanercept biosimilar referencing Enbrel, and Flixabi, an infliximab biosimilar referencing Remicade, in the E.U. Enbrel and Remicade represent >$20 billion sales globally, primarily in rheumatoid arthritis and other autoinflammatory diseases.
This willingness to maximise existing success, broaden its portfolio and indication base, and the ambition to supplement its pure R&D focus with a commercially driven move into biosimilars sees Biogen rise 5 places in the PII to top the table for the first time.*
Move over Gilead, I have a new favourite pharma company…
* More about the Pharmaceutical Innovation Index (PII)
PII celebrates the top 30 pharmaceutical companies most successful at bringing innovations to market
By gathering and ranking KPIs on sales, financial metrics, clinical and regulatory efficiency, and Freshness Index, amongst others, the PII attempts to answer the following question:
If two companies each had the same NCE at the same stage of development (say end of phase I), which company would do the best job of commercializing the product?
Visit www.ideapharma.com/pii to:
- View the PII table published this month
- Request a copy of the PII White paper which gives an in-depth review of the top 10 ranked companies (plus the major risers and fallers)