Breakthrough designation is inevitableThe FDA won't pass over the opportunity to have a non-BCG dependent treatment against NMIBC. That would be contrary to their mandate to spark innovations and scientific advances so patients can have more options. ImmunityBio is still dependent of BCG as its N-803 molecule is used in combo with BCG. In a separate trial, they're trying to go alone, without BCG but from the combo data, I highly doubt that N-803 alone will deliver good enough efficacy.
That's why we will get this Breakthrough designation, if data from the optimized group keeps delivering good results.
BCG is now a one-supplier manufacturer drug. This cannot go on forever. And there's not any incentive for additional manufacturer to enter BCG production. That's why Sanofi exited this sector in 2018.
Low prices of some lifesaving drugs make them impossible to get https://www.washingtonpost.com/national/health-science/low-prices-of-some-lifesaving-drugs-make-them-impossible-to-get/2019/06/18/abd03190-66bb-11e9-82ba-fcfeff232e8f_story.html
At a time of intense focus on escalating drug prices, BCG shows an unexpected flip side: Prices can be too low to spur companies to produce urgently needed medications.
BCG’s price, which runs about $150 or so a dose, is “too low,” said Benjamin Davies, a urologist at the University of Pittsburgh Medical Center who says he is politically left of center and a frequent critic of high drug prices. He said Merck, the only supplier of the single BCG strain approved in the United States, should raise its price significantly to make the therapy more profitable and attract potential competitors.
Merck has raised the price of the off-patent drug modestly in recent years but has shown little interest in a big hike, perhaps fearing a backlash. After former pharmaceutical executive Martin Shkreli was widely condemned for jacking up the price of an old HIV drug, “manufacturers are sensitive to charges of gouging,” said Rena Conti, a health-care economist at Boston University.
Mike Nally, Merck’s chief marketing officer, said the company isn’t looking to make a big profit on BCG, which is grown on potatoes in a facility in North Carolina. The plant, which has tripled production over the past seven years, is at maximum capacity and any further increase could take years.
With global demand for BCG rising, it would be “healthy” if there were other suppliers, he acknowledged. Lack of industry interest suggests “there’s an element of market failure here.”