I’m certain that some biopharma brand directors looked upon 2020 with high hopes for a stellar launch. What could go wrong? While no one foresaw the disastrous effects of the COVID-19 pandemic, many other risks can be anticipated—and effective strategies can be put in place right now to mitigate them.
Always Have a Plan B…and C
Next to R&D costs, the financial commitment to launching brands is arguably the next major investment. This money is so considerable and vulnerable that manufacturers should seriously consider an insurance plan. That is, set aside funds to mount alternative promotional campaigns, sketched out in advance. This might not sit well with the existing protocols of the budgeting process. However, if the FDA delays your launch because they feel that your campaign won’t pass muster for its copy and/or visual representations, you’ll be the hero of the day. The usual countermeasure for such a delay is to do a “soft launch,” which means hitting the market with nothing but the package insert. This approach may even work to your advantage in categories such as oncology or neurology, where pure data is what these specialties seek out anyway.
Of course, the worst delay that can happen is an FDA mandate to do an additional trial. In this case, the options are limited. The best approach calls for diverting all funds to answering the request, and suggesting alternative pathways to the most expeditious launch.
If you are lucky enough to be studied in two different indications, and only one is denied, then you can leverage the success of the approved indication by alluding to ongoing studies in the other. When Vioxx and Celebrex approached the launch finish line within a few weeks of each other, Vioxx’s RA indication wasn’t allowed to move forward without additional work. So, it launched without the RA label, but let customers know that RA was in the works—thereby validating its presumed efficacy.
Mitigate Risk by Putting Time on Your Side
Even if the FDA grants approval, they may do so in an unfavorable climate for your brand to have the most robust uptake. Roche received approval for Tamiflu in the early spring—just missing the flu season. Roche delayed the launch until August to better align its therapeutic benefits with the impending winter flu risks.
Conventional wisdom favors first-in-market brands. However, if the brands are breaking new ground in a way that’s uncomfortable for the market protocols to absorb, a delayed launch can create a “watch and wait” scenario to observe how the other brand is faring, adjusting your launch strategy to avoid risks, and pounce on unforeseen opportunities.
Zig When Others Zag
Situations exist where several brands are rushing into the market, their launches clustering around similar dates. For example, the FDA delays your launch, requesting you to do a subset analysis of your data. As a result, you enter the market several months behind. Segmentation is a proven strategy that can out-flank the competition. Instead of following the others’ lead and going for the lion’s share of the population, target a specific segment and own a larger share of that cohort. Position yourself by, say, degrees of disease severity, staking a claim on moderate-to-severe illness, for example, thereby giving the impression that your brand is stronger than the others.
In some instances of a delayed launch yielding first-in-market territory and convenient packaging may offer an advantage. Consumer-friendly dosing delivery vehicles can position your brand as the one to write when mitigating the risk of poor compliance.
Getting the Green Light Earlier
So far, I’ve been discussing situations where the sliding time of launch is delayed. However, another launch consideration is the possibility of an accelerated approval. This is a happy problem to have, indeed, but still a bit of a logistical problem that needs attention. The FDA’s Fast Track Development Program is a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy. Discussions between the manufacturer and the FDA result in a coordinated pathway for a drug to stand ready for a more imminent launch, thus triggering the release of more of the company’s money to the drug’s budget to deliver promotional and educational materials faster than expected.
One recent illustration involves Merck’s drug, Keytruda (pembrolizumab). To achieve an accelerated launch approval, programs from the FDA and NIH (especially during the search for a COVID-19 vaccine) work with the manufacturer to ensure that it has the resources to accomplish the launch safely. In the case of Keytruda, the FDA waived the three typical phases of clinical trials needed to show a drug can prolong lives.
Developed and commercialized by Merck, Keytruda is an immunotherapy targeting PD-L1 that was given approval based on what was basically a larger than usual Phase 1 trial. Essentially, 173 participants received the drug with no control group. Keytruda was able to shrink tumors in about 24% of patients, the FDA said, with the effect lasting at least 1.4 to 8.5 months and continuing beyond this period in most patients. Such advance notice of the accelerated timeline allowed Merck to fast-track the typical launch promotional materials, in a very effective campaign.
Either a launch slow-down or an acceleration, while daunting, doesn’t necessarily forecast bad news for commercialization. By benchmarking your brand’s behavior against these proven strategies, you can make the best of a seemingly unexpected set of circumstances.