Big news this week in pharma! the Trump administration appointed Dr. Ned Sharpless as the interim director of the FDA after Former commissioner Scott Gottlieb suddenly stepped down last week. Sharpless is currently the director of the National Cancer Institute and apparently Gottlieb’s first choice as a successor. It is expected that with his background as a physician/scientist, the FDA will sustain its recent regulatory efficiency and industry-friendly lean. Despite some turbulence, the FDA bestowed a fast review to Sanofi/Regeneron immunology collaboration Dupixent in sinusitis with nasal polyps following excellent data in phase 3 trial. This would make it the only biologic in the therapeutic area. The FDA also gave a thumbs up to Roche’s Tecentriq in triple negative breast cancer in combination with Abraxane making it the first immunotherapy in breast cancer. The decision has been met with optimism from the physician community. Tecentriq will also hold sole share of the breast cancer market for now, away from PD1/PDL1 competitors Keytruda and OPDIVO, which have a firm grip on other potential therapy areas.
Merck was recently forced to curtail their distribution of the bladder cancer medication TICE BCG following increased demand for the product. With no other companies looking at entering the market and following Sanofi’s exit from the market in 2016, patients may be forced to resort to partial bladder resection or a total removal of the bladder and most of the sexual organs as an alternative treatment. Furthermore, Merck expects to be limited in its ability to provide a steady supply of medication through 2019 and extending potentially into 2020. Former Pfizer CEO Ian Read saw a significant drop in his pension package, indicative of transfer of leadership. He was offered a massive jump in pay in 2017 to stay at the helm of the pharma giant. This amount has dropped significantly, as he has shifted to the role of executive chairman and passed the title of CEO off to COO Albert Bourla. During his time as CEO, Read played a role in the slimming down the company and refocusing on the development of high value prescription medications. With the change in leadership, it is expected Bourla will rely primarily on Pfizer’s own pipeline to drive growth rather than looking for acquisitions.
The drugs topping Medicare part D spending have also been released. The leaders of the list were both drugs that had seen an increase in price recently. The top spot belonged to Celgene’s cancer drug Revlimid. Second place went to the next generation anticoagulant Eliquis produced by Pfizer. Both drugs garnished over 3 billion dollars in part D spending. The releasing of the spending information is an effort on the part of government to maintain transparency with drug prices. Despite pushing back over the development of an international drug price index by the Trump administration, the industry remains relatively open to suggestions regarding reducing drug prices.
The Indian drug maker Lupin has once again found itself in hot water with FDA following the arrival of a 25 page form 483. Although Lupin doesn’t expect this to hurt its supplies or its revenue stream, it is an indication of a failure to follow through on fixes after instructions given in previous form 483s. A Biocon/Mylan biosimilar plant was also handed a form 483, however this one is relatively minor and includes only two observations from the FDA, especially compared to Lupin’s form 483, which received 11 observations. Acadia Pharmaceuticals’ practices for the marketing of Nuplazid are under the magnifying glass of the justice department. The company recently handed off documentation regarding Nuplazid marketing follow the demands from the department. Acadia looks to remain cooperative but states that the probe will place a significant drain on resources.