When it comes to soporific pharmaceutical agents, Pfizer actually has the upper hand — at least when compared to its rival Moderna.
In the past four years, Pfizer’s Lyrica (pregabalin) has gone from $6 billion in annual sales to more than $3 billion in annual sales — and the sales momentum may well increase going forward.
Lyrica, an increasingly popular treatment for fibromyalgia and chronic pain, was approved in 2006 for fibromyalgia and chronic pain. Since then, the company has made long-term marketing and promotion a top priority to market the drug. It is one of the first treatments in the US (and was one of the first in Europe) to have a dose treatment that was regularly swallowed to decrease the effects of new clinical trials. As a result, Lyrica is the most popular treatment for chronic pain, accounting for 80 percent of its sales.
But Lyrica does not even hold a candle to Moderna’s lead drug, Sarepta Therapeutics’ (pronounced as “sara-tra-tmy-ah) M923, a treatment for Duchenne muscular dystrophy (DMD). It is being prepared for a Phase 3 trial, which indicates promising prospects of an FDA approval.
The upside for patients with dystrophin deficiency is that there are few current treatments available to treat muscle loss and deterioration. M923 is designed to prevent the muscle weakening that the disease causes. According to a recent report from Global Data, Dynamex, which is developing a product, LytxD, to prevent muscle loss in patients with progressive muscular dystrophy, has estimated that only 13% of patients with dystrophin deficiency are on therapy. It predicts that M923 will have “near-term” market penetration in markets outside the US.
Moderna has gone through several years of development with no positive results from clinical trials. In 2008, the company reported positive results from a Phase 1/2 clinical trial of mRNA to treat progressive muscular dystrophy. A year later, preliminary results from the Phase 2 trial came back positive, showing that patients with multiple types of muscular dystrophy showed significant benefits after receiving the treatment. In 2011, its attempts to modify mRNA to treat ALS were largely unsuccessful, and it ceased development of that therapeutic for other diseases.
In 2017, it announced positive results for a Phase 1/2 trial that showed clinical benefit for Parkinson’s disease, non-cancer pain, epilepsy, and schizophrenia. And this year, the company began early stages of development for treatments for late-stage Alzheimer’s disease and multiple sclerosis. M923 is an early stage product, and could face similar clinical challenges to those that the other clinical trials faced. It is most promising in the treatment of DMD, but the company would need to conduct large additional clinical trials before securing an FDA approval.
Moderna offers a traditional big pharma approach to drug discovery — rather than developing drugs from scratch, it taps established and efficient discovery tools, such as recombinant DNA technology, to turn vast libraries of genetic data into individual drugs. It then commercializes those drug candidates and either brings them to market or licenses its medicines to third parties. Although the company has not yet achieved commercial sales, it has a $2.7 billion market cap.
One major obstacle to developing new innovative drugs is that most companies with applications for large-scale clinical testing are currently in cost-cutting mode. Because these companies have been hobbled by a prolonged period of depressed stock prices, Moderna has been able to move faster through early-stage clinical trials, often with negative results and delays. Its product pipeline remains only at its early stages.
But Moderna has the stronger financial base to make a strong investment in research and development than its corporate competitors in the near term. Pfizer is not in a strong position with regard to research and development, given that it is pouring a significant portion of its recently-exited tax savings into a $14 billion buyout of Allergan that turned the once-leading player in generic-drugs into a niche global player.
Moderna has also made aggressive moves to diversify its operations, becoming a platform company for RNA-targeted therapies for various types of disorders, including diseases such as NASH (nonalcoholic steatohepatitis) and other diseases for which excessive fat accumulation is a major cause of disease.
When it comes to defending its strength, Moderna may have the most to gain from Pfizer’s moves.