Lyrica Generics Launch, But Pfizer Has Been Bracing For The Hit
Executive Summary
The first generic versions of Pfizer's blockbuster pain medicine pregabalin have launched in the US. Pfizer has guided investors the company will return to growth in 2020 after cycling through the loss.
The first generic versions of Pfizer Inc.'s blockbuster pain medicine Lyrica (pregabalin) launched in the US after the US Food and Drug Administration approved several generics on 19 July. The loss of marketing exclusivity for Lyrica will be a substantial hit to Pfizer, which generated $4.62bn from sales of the drug in 2018. It was the company's second best-selling drug behind the pneumococcal vaccine Prevnar 13.
Nonetheless, the generic entry had been expected; with Pfizer accordingly trying to prepare investors for a challenging 2019. CEO Albert Bourla guided investors at the beginning of the year to anticipate flat or slightly declining revenues in 2019 before the company returns to growth in 2020.
More details of the launch’s impact on 2019 revenues will likely come during Pfizer's second quarter sales and earnings call scheduled for 30 July. The generic approvals appear to have come a few weeks later than expected, since Pfizer had advised investors it would cycle through the loss by 30 June 2020. Pfizer obtained an extra six months of exclusivity for Lyrica after securing a pediatric extension in November 2018.
Investors will be closely monitoring Pfizer's second quarter financial results for continued growth of Prevnar 13, the oncology drugs Ibrance (palbociclib) and Xtandi (enzalutamide), and the rheumatoid arthritis pill Xeljanz (tofacitinib). Pfizer is relying on those drugs and others to see it through the loss of Lyrica.
Investors also will be eager for an update on the launch of Vyndaqel and Vyndamax, two formulations of tafamidis approved in May for a rare cardiovascular disease, cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). (Also see "Pfizer Wins Tafamidis Approval; Now It Will Need To Build The Market" - Scrip, 6 May, 2019.) The drug could be a potential blockbuster, but Pfizer has warned investors to expect a slow ramp as the company builds the market and awareness for the disease.
Some investors have been hoping Pfizer might make a commercial-stage acquisition to patch over the loss of Lyrica, but Bourla has talked about building the pipeline through M&A rather than the commercial portfolio. (Also see "Pfizer's Business Development Transition: From "Revenues Now" To Pipeline Development" - Scrip, 30 Apr, 2019.)
Nine Firms Launch Generic Pregabalin
Among the generic versions of Lyrica approved by the FDA are drugs manufactured byAlembic Pharmaceuticals Ltd., Alkem Laboratories Ltd., Amneal Pharmaceuticals LLC, Dr. Reddy's Laboratories Ltd., InvaGen Pharmaceuticals Inc., MSN Laboratories Pvt. Ltd., Rising Pharmaceuticals, Sciegen and Teva Pharmaceutical Industries Ltd.. According to the FDA, the nine firms received approval for generic pregabalin 75mg, 100mg, 150mg, 200mg, 225mg and 300mg capsules, with all except Alkem and Teva also approved for the lower-strength 25mg and 50mg versions. Numerous other companies hold tentative approvals for generic pregabalin.
Lyrica is one of the biggest generic commercial opportunities in 2019, particularly when it comes to traditional small molecules. (Also see "Going Generic: Big Brands Poised To Lose Marketing Exclusivity In The US In 2019 " - Scrip, 15 Mar, 2019.) Other big branded drugs losing marketing exclusivity this year include GlaxoSmithKline PLC's Advair (salmeterol/fluticasone), a high barrier-to-entry respiratory drug, and biologics like Roche's Avastin (bevacizumab) and Herceptin (trastuzumab), the first biosimilars of which launched from Amgen Inc./
Allergan PLC on 18 July. (Also see "US Market For Therapeutic Cancer Biosimilars Will Be Tested By Mvasi, Kanjinti Launches" - Scrip, 19 Jul, 2019.)
Pfizer is eyeing its own opportunity with biosimilar versions of Avastin and Herceptin, named Zirabev and Trazimera, respectively. The biosimilars were both approved by the FDA recently and could launch by the end of the year, Pfizer has said, although it has not outlined the exact timeline.
Partners Amgen and Allergan launched their biosimilar versions at risk, meaning before the patent litigation was fully resolved, which poses financial risks but could also trigger the launch of other biosimilars. (Also see "How Risky Is Amgen's At-Risk Launch Of Herceptin, Avastin Biosimilars?" - Pink Sheet, 21 Jul, 2019.) Investors and general industry watchers will be eager to hear more from Pfizer about a potential launch timeline.