Mid-sized pharma Biogen and Celgene expanding fast


Biogen Idec grew revenues by 40 per cent – or $9.7 billion – in 2014, on the back of strong performances from multiple sclerosis (MS) drugs Tecfidera and Tysabri, plus the company's entry into haemophilia with two treatments.

Interferon revenues for the year, including Avonex and Plegridy, were $3.1 billion, with two-thirds of these sales in the US. Tecfidera revenues were $2.9 billion, followed by Tysabri at about $2.0 billion.

Fourth quarter revenues for the company hit $2.6 billion, an increase of 34 per cent compared to the same period in 2013.

The undoubted star of the show was Biogen's new oral multiple sclerosis treatment Tecfidera. The drug achieved sales of $2.9 billion for 2014, only its second year on the market, with revenues growing more than threefold from the previous year.  The drug's stellar performance put it just ahead in revenue terms compared to one of its close rivals among new MS drugs, Novartis' Gilenya.

Calling 2014 a "remarkable" year for the company, CEO George Scangos said there would be continued focus on novel biology for challenging diseases in 2015.

In December 2014, Biogen reported positive interim data from the phase 1b trial of BIIB037 for the treatment of Alzheimer's disease, finding a statistically significant reduction in beta amyloid plaque in the brains of Alzheimer's patients, an improvement in two measures of cognition, and an acceptable safety profile.

In January 2015 the company announced positive top-line results from the phase II acute optic neuritis (AON) RENEW trial in which treatment with anti-LINGO-1 showed evidence of biological repair of the visual system.

It is also set to acquire UK-based Convergence Pharmaceuticals, which holds an innovative portfolio of candidates for neuropathic pain, including CNV1014802, in development for trigeminal neuralgia, a chronic orphan disease.

Further strengthening its R&D capabilities, Biogen has announced several collaborations since the start of 2015, including a $30 million strategic alliance with Columbia University to look into genetics discovery research, and with San Raffaele Hospital of Milan, Italy, to develop gene therapy for both haemophilia A and B.

Samsung Bioepis, the joint venture between Samsung Biologics and Biogen, has just received European Medicines Agency acceptance and validation of its marketing application for its biosimilar of arthritis/psoriasis treatment Enbrel (etanercept), marking the compound as potentially the first biosimilar version of etanercept to be approved in the EU.

Biogen has also entered a partnership with Google[x] Life Sciences to explore drivers of MS disease progression through investigational technologies and methods, such as novel sensor platforms, advanced laboratory science, and bio-analytical tools.

Strong growth for Celgene

Similarly, Celgene reported strong growth with an 18 per cent increase in total revenue for the year 2014, at $7.67 billion, compared to $6.49 billion for the previous year. Fourth quarter total net product sales increased 19 per cent to just over $2 billion, compared to $1.72 billion in Q4 2013.

Chairman and CEO Bob Hugin said 2014 had been an outstanding year for the company, placing it ready to exploit "a great opportunity for 2015 and beyond".

R&D highlights from the year included a positive opinion for haematology drug Revlimid in December from the EMA's Committee for Medicinal Products for Human Use (CHMP) for continuous treatment in adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation. A submission for its use for newly diagnosed multiple myeloma (NDMM) to the US FDA is under review, with the regulator giving a Prescription Drug User Fee Act (PDUFA) goal date of 22 February. It is also under review in Japan, with a decision expected in 2015.

Following publication of data from the phase III trial MDS-005 of Revlimid in patients with red-blood cell transfusion dependent low-risk myelodysplastic syndromes last year, a submission to the FDA is planned in 2015.

Celgene is also initiating a phase III trial of Revlimid in newly diagnosed diffuse large b-cell lymphoma patients in the first quarter of 2015.

Full year Revlimid sales were $4,980 million, up 16 per cent.

In December, a submission was made to the EMA for approval of Vidaza in elderly acute myeloid leukaemia (AML), with an opinion from the CHMP expected by the end of 2015. Sales of Vidaza in the US dropped significantly in 2014 following generic competition since September 2013.

In oncology, the CHMP adopted a positive opinion for Abraxane in combination with carboplatin for first-line treatment of non-small cell lung cancer (NSCLC), with a decision expected from the European Commission by the end of Q1 2015. In December, it was approved in Japan for use in unresectable pancreatic cancer, where it is already approved for metastatic gastric cancer, breast cancer and NSCLC. Full-year sales were $848 million, an increase of 31 per cent.

The EC granted marketing authorisation for Otezla for moderate-to-severe chronic plaque psoriasis in patients who could not have other systemic therapy. It was also approved alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for active psoriatic arthritis who had had no success with a prior DMARD therapy. Additional regulatory decisions are expected in 2015. Full-year sales were $70 million, buoyed by the psoriatic arthritis indication and significantly accelerated in the fourth quarter following the US approval for psoriasis.

For 2015, the company expects total net product sales of $9,000 million-$9,500 million, including Revlimid net sales in the range of $5,600 million-$5,700 million and Abraxane net sales of $1,000 million-$1,250 million.

By 2020 Celgene has a target of net product sales in excess of $20,000 million, with the haematology franchise expected to surpass $14,800 million, oncology products to reach over $2,200 million, and the inflammation and immunology portfolio over $3,000 million.


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2 February, 2015