Both Congressional Democrats and the pharma industry agree that pending drug pricing legislation is “historic” — they just diametrically disagree on the modifier.
Trade industry group PhRMA’s CEO Stephen Ubl called it an “historic mistake” on Wednesday, joined by Eli Lilly CEO David Ricks, Atlas Venture partner Jean-Francois Formela along with a hematology oncology-leading physician and a metastatic breast cancer survivor in a press conference.
Meanwhile, Senate Democrats lined up their own press conference for later in the day, tapping patient advocacy leaders and AARP CEO Jo Ann Jenkins to offer its history-making take.
“This legislation would be historic, and that’s not an exaggeration,” said David Mitchell, founder of Patients for Affordable Drugs and speaker at the Hill event. “Why historic? For the first time ever, after almost 20 years of fighting, Medicare will be able to use its purchasing power to negotiate lower drug prices for American. For the first time ever, there are going to be curbs on annual drug price increases to limit to no more than the rate of inflation. And for the first time ever, there’s going to be an annual cope on what Medicare Part D beneficiaries pay for our drugs annually.”
While neither side can claim victory for now, the bill sponsors have hinted that passage should be expected as they can use reconciliation and only need a simple majority to pass the bill. The House has also signalled a willingness to return from their summer recess to pass the bill next month.
Senate Dems and Republicans met last week with the Senate parliamentarian to iron out what provisions could be included if they use this short-cut, but senators who are usually on the fence, like Sen. Joe Manchin (D-WV), are now on board.
PhRMA, not surprisingly, sees those provisions differently — with Ubl calling Medicare negotiations “nonsense.”
“An innovative drugmaker has two choices under this bill — accept the government’s price or pay a 95% tax on the sale of that medicine,” he said, adding, “That’s not negotiation, that’s government price setting. Let’s be honest and call it what it is.”
PhRMA is also united in the view that the bill’s provisions, including a cap on the number of years pharmas can independently set drug prices, will stymie innovation, and keyed in on cancer treatments as an example.
Ricks said the bill will affect “decisions we make about how to invest in innovative medicines and those in particular for cancer.”
He outlined two specific effects on a likely decrease in drug development for rare cancers with smaller populations (which cost just as much to develop as those for larger target audiences) and slowing early stage cancer drug development. Cancer drugs are often approved for later-stage use, then move earlier over time and additional research to get to adjuvant uses, he said.
“Manufacturers and investors won’t support that type of sequential development (anymore),” he said.
Another point of contention is the impact on new drug development. The Congressional Budget Office (CBO) estimated the bill would reduce drugmakers’ 1,300 total approvals by about 10 drugs over the next three decades.
Ubl said the CBO “just got it wrong.”
He pointed instead to University of Chicago research earlier this year that estimated 135 fewer drug approvals through 2039 amid its projected drop of $663 billion in R&D spending.
Ricks said, “I would be shocked if the impact of this bill doesn’t result in 15 fewer medicines from Eli Lilly and Co. alone. I think that would imply one every other year that we cancelled because of this. But right now, 40% of our portfolio are small molecules. We’ll need to reevaluate every single one of those projects for viability.”
He also predicted the potential for R&D innovation to leave the US, pointing to the fact that R&D moved from Europe to the US because “Europe has the same harmful policies as embedded in this bill” causing investments to shift.
With Keytruda bulling its way past the $5 billion mark for Q2 sales, you could say that the top execs at Merck can be believed when they say how keenly interested they are in using its cash reserves for new M&A and licensing deals. Just don’t ask what they’re negotiating to buy right now.
The analysts largely tiptoed around the biggest buzz about Merck today: that it’s engaged in discussions to buy Seagen for $40 billion-plus. They’re a polite bunch that needs to be on a first-name basis with CEO Rob Davis. But Davis was willing to emphasize that the pharma giant has the means and the intent to do more deals.
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While Rich Nelson is out as interim CEO of vTv Therapeutics, he will be continuing as the company’s EVP of corporate development as Paul Sekhri takes the mantle of president and CEO on Aug. 1.
In Nelson’s four short months as head of the North Carolina-based biotech, he saw G42 Healthcare, a UAE health tech company, invest in vTv and agree to collaborate on vTv’s Phase III study for a type I diabetes treatment. Prior to Nelson’s stepping in as CEO, Deepa Prasad had served as CEO, though she too was only there for a few months.
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Most pharma TV commercials include a link at the end of the ad, offering a website link for viewers who want more information. It turns out millions of them do. So far in 2022, AbbVie, Novo Nordisk and AstraZeneca are leading the pharma pack with the most engagements garnered, according to data for the first half of 2022 from TV ad tracker EDO.
AbbVie’s Allergan Vuity eyedrops for age-related blurry vision drove the most searches among pharma TV advertising, generating 3.43 million searches after ad runs. That’s more than double the total for the next searched TV ad at No. 2, Novo Nordisk’s Ozempic, which notched 1.7 million, in EDO’s research.
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AstraZeneca CEO Pascal Soriot has been “pruning the tree” for quite some time, cutting a slate of unwanted programs across a range of indications over the last few quarters. And though the chief executive revealed two new cuts on Friday, he said he’s just about ready to put the clippers down and focus on “trying to grow new branches.”
Soriot expects the next couple of years to be “extremely rich in clinical results,” with more than 20 Phase III readouts slated for next year.
Beyond the back and forth of whether Democrats’ drug price negotiation plan is necessary to bring down costs, or just a thinly veiled attempt at price controls, the nuts and bolts of the deal mean pharma companies will inevitably see the tail ends of certain small molecule and biologic sales peter out before they otherwise would have in today’s marketplace.
While the bill’s text is not set in stone, and the Senate parliamentarian may still take issue with the excise tax that CMS will use to ensure companies comply with the negotiated prices, SVB Securities explained to investors how more than a dozen drugs from Eli Lilly, AstraZeneca, AbbVie and J&J, among others, would lose out on some revenue just before their generic competitors hit the market.
AbbVie’s executive team stayed right on track in Q2, with its Skyrizi franchise — now newly approved for Crohn’s — continuing to rack up impressive sales, making up for some unexpected weakness from a stronger dollar. The erosion of the Imbruvica franchise, however, dragged down the stock price $ABBV 5% Friday.
That set the stage for a bullish presentation by CEO Rick Gonzalez, who carefully steered the conversation around the looming loss of US exclusivity with Humira to the formulary discussions now underway that would allow the megabrand to continue to generate revenue in 2023 and 2024, as AbbVie’s newer entries became better established and some hot pipeline picks get a chance to prove themselves in pivotal trials.
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Nine years after doling out $50 million upfront to Merck, it appears AstraZeneca’s work in the WEE1 inhibitor space is over.
The UK Big Pharma has ended two studies of adavosertib, a Phase I trial in solid tumors in combo with PD-1 Imfinzi and a Phase II study testing the drug in patients with ovarian cancer, solid tumors and uterine serous cancer.
The company’s top oncology R&D executive, Susan Galbraith, said WEE1 “remains an important target” but the company has gone in a different direction because AstraZeneca wants a pipeline focused on “products that we think have a greater transformative ability for the treatment of patients with cancer.”
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GSK announced this morning in a London Stock Exchange filing that Laurie Glimcher, president and CEO of the Dana-Farber Cancer Institute, has advised the company of her intention to retire from its board of directors on Oct. 13.
The company did not disclose why Glimcher has decided to move on now after more than five years as a non-executive director, but Glimcher’s appointment heralded a much bigger interest in oncology at GSK, and she’s moving on now as GSK’s R&D chief Hal Barron also hits the exit.
Make way, Dermavant. Two months after the company vowed to upend the plaque psoriasis market with its newly approved vanishing cream, there’s another topical to contend with.
Arcutis Biotherapeutics secured a win on Friday for its phosphodiesterase-4 (PDE4) inhibitor roflumilast, now marketed as Zoryve in plaque psoriasis for children and adults ages 12 and up.
You may recognize roflumilast as the active ingredient in AstraZeneca’s COPD drug Daliresp. PDE4s have long been used to treat skin and other inflammatory conditions, with Otezla being one of the most notable. However, earlier generations carry burdensome side effects, most commonly nausea, diarrhea and vomiting that “really limited the usefulness of PDE4s,” CEO Frank Watanabe said.
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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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