Our Launch-Time Menu

As of Sept. 1, FDA’s CDER has approved 39 novel drugs. But, as we know, long before approval, plans are set in motion to successfully launch drugs into the market. Depending on the therapeutic need, these plans can range from complex delivery logistics, to creative advertising campaigns, to elevated scientific meetings, to supporting patients through access programs. Each brand launch has its own unique story, and in this Product Launch issue, we highlight five products, all approved in 2019, and showcase what is now their early brand journey (see coverage by following the links below).

The brands are chosen with input from the Pharmaceutical Executive Editorial Advisory Board. In alphabetical order, they are:

• Oxbryta, from Global Blood Therapeutics, is a breakthrough drug for sickle cell anemia approved late November 2019. Oxbryta is the first drug to treat the root cause of sickle cell anemia rather than just managing symptoms, in a once-a-day tablet formulation. Net sales surpassed Wall Street analysts’ predictions, making Oxbryta’s story a clear choice.
• Skyrizi, from AbbVie, was approved in April 2019 for severe plaque psoriasis. Based on Phase III data that showed it could clear skin lesions by 90% in up to three quarters of patients within a week, the drug’s strong advertising presence in a large patient population, and sales of $300 million in Q1 2020 are the reasons for Skyrizi’s inclusion.
• Spravato, Janssen Pharmaceuticals’ drug for major depressive disorder (MDD) was approved in March 2019. Based on a form of the “party drug” ketamine, Spravato was the first treatment for MDD to win approval in years. Delivered as a nasal spray for use with oral antidepressant treatments, its launch story includes a NICE rejection against the backdrop of a lack of new therapies in mental health.
• Vascepa, from Amarin, was approved in December 2019, making it one of the two latest approvals to launch in the COVID era. Vascepa was approved on a priority review by FDA to reduce cardiovascular risk and mortality for patients who are already managed on statins. Based on EPA, which is found in fish oil, Vascepa’s launch story combines patient education to a large consumer public familiar with omega-3s, but lacking knowledge on the difference between taking supplements for health prevention vs. treating an inherently dangerous medical disease.
• Zolgensma, Novartis’s gene therapy approved inMay 2019 for spinal muscular atrophy. Though the most expensive therapy currently on the market, the value proposition coupled with its scientific breakthrough make the Zolgensma story a compelling read.

Lisa Henderson

As some of our stories will highlight, are the challenges of product launch and prescription sales during COVID. For some, launch became an exercise of pivoting and execution in ways that, while maybe under exploration at the time, were largely unfamiliar to all stakeholders. In this article, the theme of launching a product during the pandemic was discussed.

Other companies have also gone on record about their launch challenges, including Paratek Pharmaceuticals’ efforts one-year into the launch of its antibiotic NUZYRA , and at the end of April, Immunomedics’ launch of breast cancer drug Trodelvy, as discussed by its CFO/CBO Usama Malik here.​

We are glad that these executives choose to share their experiences with you on our website. We are also happy to announce that our recent virtual conference is now available complementary to watch on-demand. Just register first to view these sessions here. The conference focused on physician education and reaching doctors during and after COVID-19 and featured presentations and discussion with pharma speakers from Pfizer, Eli Lilly, and AstraZeneca.

Clearly, COVID touches on every topic we regularly cover, and that will be evident in the upcoming months. Next month, our October issue will focus on Hub Services and one of the core capabilities of supporting patients. It’s evident these organizations that support pharmaceutical companies and physicians’ efforts to get prescription medicines to patients in a safe and educational manner were effected, but not fazed, during COVID.

As for pharma professionals, they remain focused on patients and family. Whether its patient safety during COVID, more time spent with family for executives, or the business goals of gaining on therapies for patients and families, there is a common thread that keeps this industry humming at all times.

Lisa Henderson is Pharm Exec’s Editor-in-Chief. She can be reached at lhenderson@mjhlifesciences.com.