In my previous article I highlighted three challenges facing the pharmaceutical industry. These challenges focused on the rapidly changing global environment and the important decisions pharmaceutical companies may need to make to remain successful and survive. Navigating the patent cliff, focusing on new therapy areas and mitigating the risks in R&D were identified and explored. One way we have seen the industry address these challenges is to form strategic alliances to jointly develop and commercialise compounds or therapies. A number of products in recent years have been involved in these strategic alliances. This article will explore these in light of the challenges and dive into the healthcare professional (HCP) conversation around these products.
Challenge 1: Patent cliff and blockbusters
In 2007, Pfizer entered into an alliance with Bristol-Myers Squibb (BMS) to develop and commercialise apixaban (Eliquis) – a novel oral anticoagulant (NOAC) discovered by BMS. Jim Cornelius, then chief executive officer of BMS described this alliance as a combination of BMS’s strengths in cardiovascular drugs and Pfizer’s global scale and expertise. Pfizer’s then chairman and chief executive officer, Jeffrey B. Kindler, believed this alliance proved their commitment to pursue pipeline opportunities and that apixaban had the potential to be a best-in-class product. Since then, Eliquis has received FDA approval, has grown in revenue year on year and was the number one prescribed NOAC in 2016. In short, it reached blockbuster status.
Pfizer and BMS invested in direct-to-consumer marketing tactics as well as focusing on specialists and high prescribing primary care physicians. In the online healthcare professional (HCP) conversation, globally 2,315 HCPs posted about Eliquis in the period from March 2018 to April 2019. There is a consistently high level of HCP conversation with peaks occurring with key data releases. This constant feeding of data keeps Eliquis front of mind for HCPs, with a number of individuals sharing their excitement of results and positivity towards Eliquis.
With many pharmaceutical companies including Pfizer reaching patent cliffs, a product like Eliquis could help to maintain profits for a few more years to come as long as it maintains strong growth. In this way, Pfizer and BMS have offset one patent cliff, however another is still to come. Alliances such as these strengthen pharmaceutical pipelines in core therapy areas with high potential for strengthening market leadership. In oncology, for example, companies are collaborating to launch new innovative products. In 2014 Pfizer and Merck KGaA entered into an alliance with Bavencio that has recently been labeled as practice changing by HCPs in renal cell carcinoma. MSD and AstraZeneca’s Lynparza, signed in 2017, has also received positive response from HCPs in ovarian and pancreatic cancer. Alliances in oncology are revealing the shift of pharmaceutical companies towards focused individualised treatments which still offer substantial revenue.
Challenge 2: Small is the new big
The pharmaceutical industry is increasingly focusing on these individualised treatments and the rare diseases sector. Alnylam and Sanofi entered into an RNAi therapeutics rare disease alliance at the beginning of 2014, with fitusiran for haemophilia as one of the compounds included. This alliance is an important building block for Sanofi’s future and strengthens their pipeline in rare diseases, while Alnylam benefits from Sanofi’s global capabilities. Alnylam’s CEO, John Maraganore, said the alliance would help them to accelerate and expand market access for Alnylam’s 5×15 RNAi drugs in clinical development or commercial stages by 2015. Both companies are also able to solidify their presence in rare diseases and gain financial security through the product launch of this key alliance.
Fitusiran is currently in Phase III trials, called the ATLAS programme. Michael Makris, a consultant haematologist, followed news relating to fitusiran, sharing updates throughout the year. At the European Association for Haemophilia and Allied Disorders (EAHAD) meeting in February 2019, data was presented on the efficacy of dosing cessation and resumption of fitusiran due to a pause in a phase II study. HCPs shared posts from this presentation, highlighting the key point as well as asking follow-up questions.
Alnylam and Sanofi have concluded their alliance this year but will continue to work together to develop the products that arose during their time of partnership. Alnylam wishes to move from a clinical development company to a commercial stage company. With a number of their products involved in alliances, these partnerships are one of the ways Alnylam, a US$75 million revenue company, is reaching this goal. Sanofi, a much larger company with a revenue of over US$39 billion, seeks strategic opportunities with companies such as Alnylam in the discovery and development of new products for their pipeline.
Challenge 3: Risk aversion
The diabetes therapy area is growing at a rapid rate with a projected patient increase of 48% by 2045. In order to tackle the challenges in research and development of diabetes treatment, healthcare companies may need to work together. Some of these challenges include decreasing the cycle time in trials, establishing efficient end points and accounting for comorbidities in clinical trials. In an area where therapies are needed as soon as possible, these challenges pose risks to the speed of transition from clinical research to commercial development. As the ideal therapy for diabetes has not been discovered, treatment is constantly benchmarked according to previous options and approved based on non-inferiority or superiority to a placebo. With many diabetes patients located in low to middle income countries, the cost of treatment also poses a risk to patient access and profits for pharmaceuticals entering into the diabetes field. Eli Lilly and Boehringer Ingelheim entered into a strategic alliance in 2011 with a number of type 2 diabetes products. Lilly’s then CEO, John Lechleiter said this alliance would help to strengthen their pipeline and core capabilities as well as “address the upcoming loss of patent exclusivity for several of our products”. For Boehringer this alliance provides stability and financial security as they enter into a new therapy area. Restructuring of this alliance occurred in 2015 to help reduce the complexities of operations in some countries and meet the needs of patients.
The products included in this alliance are Trajenta (linagliptin), Jardiance (empagliflozin), and the combination drugs Jentadueto (linagliptin/metformin HCI), Glyxambi (empagliflozin/linagliptin) and Synjardy (empagliflozin/metformin). Jardiance and Trajenta are the most mentioned products by HCPs globally from this alliance. Jardiance was mentioned in over 1,700 HCP English language posts during the study period while Trajenta appeared in around 450 posts. HCPs discussed the EMPA-REG trial which studied the cardiovascular outcomes of Jardiance (327 mentions over the year from March 2018 to April 2019). HCPs focused mainly on the favourable cardiac outcomes of the trial, while also picking up on other benefits of Jardiance treatment.
HCPs who shared the CARMELINA trial testing non-inferiority of Trajenta to placebo, also highlighted cardiovascular benefits. HCPs shared posts reporting that the trial met its primary end-point.
These alliances show how companies have strengthened their pipelines in therapy areas in which they wish to develop, how they are able to mitigate risks around costs and investment into R&D, as well as gaining access to new markets for commercialisation, leveraging the capabilities of their alliance partners. Companies such as Alnylam are using strategic alliances to assist them in reaching growth goals while Pfizer may enter these alliances to gain innovative pipeline opportunities. These collaborations help customers and patients to access medicines they need at a much faster rate.
In the HCP conversation about alliance products, we see that HCPs share what is important to them in the therapy area, share what their needs or concerns may be and are focused on the value added to their patients, rather than the alliance itself.
As the pharmaceutical industry sets the pace with these alliances, used to jointly develop and commercialise compounds or therapies, it is important to consider how this could shape the industry going into the future.