By the end of April anyone in the pharmaceutical field must have been exhausted. Not only had some of the biggest mergers in ten years been inked but the only influenza pandemic in three decades was on the loose and threatening widespread mortality around the world. As the year draws to a close the ramifications of these events are still being felt around the world.
The annual influenza season is once again beginning in earnest in some parts of the world and as reports begin to surface that Roche's antiviral Tamiflu may not be as effective as it was once hoped, it is time to reflect on the events of the past 12 months and how we may better protect ourselves against the dangers (both financial and medical) still present as a New Year dawns.
Actelion senior manager for global competitive intelligence Dr Yulia Aspinall says the general economic backdrop and the mega mergers witnessed this year have, and are still, defining the pharmaceutical landscape. "Both are forcing companies to make significant cuts in business operating costs," Aspinall says.
When resources are scarce and patents fast expiring, effective competitive intelligence is paramount to ensuring the success of pharmaceutical firms. In January 2010, experts in the field meet at Arena International's Competitive Intelligence in Pharma event in Nice, France, to discuss such challenges.
One of the hot topics of conversation will be how the mega mergers announced at the start of 2009 will affect 2010's playing field.
Pfizer's takeover of Wyeth kicked off events when it committed $68bn for a company that came with a wealth of vaccines and biologics, including rheumatoid arthritis treatment Enbrel.
Just six weeks later Merck pledged $41bn for Schering-Plough and not more than a week after, Roche brought Genentech into its fold for $47bn. The fact that courtship was en vogue was suitably confirmed.
The Merck-Schering marriage came into effect on 4 November (now the family goes under just the Merck name), ending the company's reliance on the US market for revenue. Its diversified portfolio lifted Merck's shares ever since the news was announced in March to a then low of $20.05 to today's $36.
Its dominance in the cancer market and innovative approach to research caused Roche to become a pest at Genentech's door. Falling drug prices and competition from generic makers cashing in on the loss of patents on blockbuster drugs were all factors in these deals which, according to Aspinall, are unlikely to stop.
As big pharma wakes up to the need to enter the biologics market and mergers gain pace in this space, Aspinall says competitive intelligence will need to play a vital role. "The better you do your homework with competitor assessments the better chance you have to come profitable in the marketplace," she says.
H1N1 – need a tissue?
For mainstream society the H1N1 influenza outbreak was a cause of somewhat serious concern. For big pharma it was an opportunity that had not come about since SARS rocked Asia years before.
As death tolls began to mount and country after country added its name to the "infected" list, drug development firms around the world began to invest assets into producing an antiviral that could stem the tide of what seemed to be an almost unstoppable force.
As of 4 December there have been 8,768 confirmed swine flu deaths worldwide – a sizeable number but a far cry from the one million killed in the Hong Kong flu in 1968.
It has been enough, however, to raise near hysteria among the public and for governments to pledge millions of dollars in the direction of the first effective antivirals out the door.
Roche's Tamiflu and GlaxoSmithKline's (GSK) Relenza led the charge. Tamiflu is in fact ten years old and since its 2009 shoot to fame 68 million people have been prescribed it worldwide.
Roche contested news on the 9 December, however, that it may not be as effective in combating flu-induced illnesses such as pneumonia but governments around the world continue to use the drug as their first line of defence.
As swine flu grabbed the headlines a number of other trials led to important progress in treatments for some of the world's most prevalent diseases, especially for HIV/AIDS. A study by the US Military HIV Program in 16,000 volunteers in Thailand was the first ever trial in which the infection has been prevented. Although there are many strains in varying regions and a cure is still far from being found, it was without doubt a major step.
In addition, a number of anti-cancer drug trials have been making headway and some could prove vital to the hopes of companies about to lose patents. In particular Novartis expects to file for two new approvals of cancer drugs including its first-line cancer treatment drug Tasigna, which could prove to be its saviour once Glivec, its second most popular medicine, loses its patent.
The year ahead is unlikely to be easy but with adequate assessment of competitors' activities and the right products in the pipeline, pharmaceutical firms seem to be turning the corner and shutting the door on the global recession.
For 2010, Aspinall's advice is to build contacts and have a clear strategy. "The main thing you need to do is to develop your network," she explains. "Know your people and who knows what. When you are connecting with people the first thing you need to do is to understand the company objectives."
Without doubt it has been a busy year. Below are some of the biggest stories we have covered during the past 12 months that are set to shape next year's playing field. Click on the headlines below to find out more.
The genetic code for two human cancers has been mapped, signalling a breakthrough in cancer therapy. During the past year big pharma has spent money on finding an effective treatment one of the world's most dangerous diseases.
Europe is on its way to creating the first international biobank but there is still a long way to go. Expect discussions on intellectual property, private/public partnerships and IT infrastructure to develop further next year before a model that will allow access to masses of specimens is decided upon in years to come.
Firm after firm is staking its investment on finding a treatment for rheumatoid arthritis. One of the biggest ones to watch is Wyeth's Enbrel, which earlier in the year received positive results from the latest COMET study.
In December, the EU's new machinery directive came into force across a number of industries and gave little time to adjust to the new rules. How big pharma copes with the new directives on health and safety and certification will be one to watch.