Developing and Commercializing a Product: To Partner or Not to Partner?

Apr 26, 2017
By Pharmaceutical Executive Editors
Between 2006 and 2015, 105 companies—the majority of which were in the US—launched a product for the first time, and over 60 percent of those products were originally discovered in universities and small biotech companies.
 
According to a new white paper by Quintiles IMS, The Emerging Pharmaco's Dilemma: Make a deal... or not?, all such pre-commercial companies must make a fundamental decision at some point in the drug development process: is it more advantageous to take the product to market on our own or to partner with an established large pharmaceutical company?
 
Whether for a small or large company, launching a drug successfully is a colossal undertaking, the report reminds us. The legal and regulatory hurdles to approval are constantly changing; the marketplace is ever more competitive and stakeholders’ expectations are ever higher; there is an increasing trend towards patient-focused drug development; and stakeholders are requiring more real-world evidence on how new drugs and technologies impact patients’ quality of life and survival rates in the real world settings.
 
QuintilesIMS’ analysis reveals that about 60 percent of companies launching products for the first time do so as public companies through any of three “Going it Alone” scenarios: 1. developing and commercializing their own product; 2. in-licensing and commercializing the product; and 3. acquiring a company and commercializing its product.
 
The other 40 percent of companies turn to partners—almost half of all partnerships involve large companies, and more than half (55 percent) of co-promotion deals are with large partners.
 
The white paper goes on: “First-time launch companies attempting to bring a product to market on their own face a multitude of challenges, including the need to raise sufficient capital to fund Phase III trials and to either hire in or outsource the talent to manage the clinical trials, prepare regulatory submissions, gain access, and market and sell the approved product.” But, if they can do that, the rewards are high, says the report. “Going it Alone produces twice as many medium-sized companies (those with first-year sales of $101-500 million) than partnering.”
 
The QuintilesIMS’ white paper reveals
  • The funding models for early- vs. late-phase research/commercialization are different. Venture capitalists generally exit deals at the end of Phase II, leaving emerging companies with the need to find new sources of funding. 
  • In terms of first-year sales, Going it Alone appears to be more profitable for the originator than partnering. Going it Alone produces twice as many medium-sized companies in the first year than does partnering. 
  • One of the main short-term benefits of partnering may be in negotiating with payers. Companies Going it Alone are more likely to face payer high rejection rates than those in partnerships. 
  • The long-term benefits of partnering might include support with subsequent launches, ongoing leverage with stakeholders, and greater promotional muscle. 
  • Success for first-time launchers hinges on having a high-value product and access to capital. To be successful, new products have to offer patients better outcomes,.
While it is clear that Going it Alone “delivers higher first-year returns,” partnering with a large pharma company “may provide worthwhile long-term benefits with subsequent products,” the report concludes.
 
To access the QuintilesIMS white paper, click here.
 
 
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