Sharpless to succeed Gottlieb at FDA
National Cancer Institute (NCI) director Ned Sharpless was revealed as the successor to FDA Commissioner Scott Gottlieb, who announced his surprise resignation only a week earlier. Sharpless will take on the role of acting FDA Commissioner, though it's not yet clear if he will stay on beyond an interim capacity. Health and Human Services (HHS) Secretary Alex Azar is vetting candidates for the permanent position.
The speed of the transition surprised many who were expecting a cankerous environment on Capitol Hill to slow down the changing of the guard- but the rapid transition suggests that Gottlieb himself was major factor in the selection. It also reduces the risk of the post staying open through a protracted confirmation process, as it suggests that the administration is willing to apply some resources to ensure a rapid turnaround.
One of the Gottlieb's most lauded virtues as FDA Commissioner was his direct experience and perceived friendliness toward industry, credited with permitting more rapid approvals of innovative products. That industry knowledge should be retained in the form of Sharpless, who co-founded G1 Therapeutics and Sapere Bio.
That industry experience could also prove to be a double-edged sword, as Democrats were quick to suggest during Scott Gottlieb's confirmation hearings that his cosy relationship with biopharma executives could lead to lower regulatory standards. However, recent evidence suggests this won't be a limiting factor, as Gottlieb and Azar- himself an alumnus of Eli Lilly- have already cleared the confirmation hurdle.
But even more important than choosing an interim candidate with industry experience was not choosing one from left field, as the Trump administration had previously hinted at. The news of Sharpless as acting commissioner, rather than an 'outsider' with an anti-regulatory agenda, was sufficient to push up performance in biotech markets.
And although he's on his way out, Gottlieb isn't slowing down on FDA business- he announced new industry guidance late this week intended to modernise clinical trials and support more efficient drug development.
Bristol-Myers Squibb denies defensive strategy
In the face of growing criticism from shareholders, Bristol-Myers Squibb CEO Giovanni Caforio reiterated this week that the company's proposed $74-billion acquisition of Celgene is not designed to fend-off a takeover of the company. This "is not [a] defensive deal," Caforio said, as the drugmaker looks to persuade investors to support the transaction ahead of an April 12 vote.
In a note to investors published late last week, Wolfe Research analyst Tim Anderson suggested that when probed by sell-side analysts, Bristol-Myers Squibb management has so far “stopped short of saying whether there has been any informal indication of interest in Bristol-Myers Squibb by another party, which still leaves open a possible motive for the transaction.”
Anderson added “our belief remains that Bristol-Myers Squibb actions are in fact partly designed to prevent itself from being acquired – whether there was informal interest recently, or whether Bristol-Myers Squibb is merely anticipating this as a future risk, is not clear, however.”
Caforio received an important boost on March 14 when it was announced that US Patent Office's Patent Trial and Appeal Board (PTAB) declined to a request from generics manufacturer Alvogen to review a patent covering Celgene’s Revlimid (lenalidomide), ensuring the myeloma blockbuster is protected until 2023 and removing a small but critical concern about the deal for Bristol-Myers Squibb shareholders.
ViiV builds case for long-acting HIV doublet
Gilead Sciences has maintained its dominant position in the HIV marketplace thanks to a new generation of safer triplet drugs but ViiV Healthcare revealed more Phase III results suggesting that a long-acting injectable doublet may be able to elbow out a seat at the table.
Detailed 48-week results from a pair of pivotal studies (ATLAS and FLAIR) presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) confirmed that ViiV’s cabotegravir plus Johnson & Johnson’s rilpivirine formulated as a once-monthly injection is non-inferior to three-drug regimens on efficacy. More importantly, though, the data should be enough to rebut critical doubts about the doublet’s ability to prevent viral resistance, with similar rates of breakthrough being observed in each arm of the trials.
Susan Swindells, a professor of medicine in the infectious diseases section at the University of Nebraska Medical Center and principal investigator on ATLAS, told FirstWord that she could imagine up to one-quarter of HIV patients being interested in a long-acting injectable alternative to an everyday pill.
Entyvio poised to leapfrog Humira in UC
Takeda Pharmaceuticals is hoping to shake up the ulcerative colitis (UC) treatment paradigm by leveraging newly revealed results from the Phase IIIb VARSITY trial in which its Entyvio (vedolizumab) went head-to-head with AbbVie’s Humira (adalimumab) and won, achieving significantly better remission rates after 52 weeks on the primary endpoint.
Despite having a label that would allow for earlier use, Entyvio has been largely relegated to later lines of therapy in the US by firmly entrenched competitors like the TNF antagonists Humira and Johnson & Johnson’s Remicade (infliximab). Thus, the findings beg the question of whether Takeda can leverage VARSITY to move the anti-alpha4beta7 integrin mAb ahead of other biologics.
Stay tuned for results next week.
FirstWord from the frontlines
Following approval late last week of Roche’s Tecentriq in combination with Abraxane for PD-L1 positive triple-negative breast cancer (TNBC), oncologists snap-polled by FirstWord expect biomarker testing to increase quickly in this disease setting.
Sanofi and Regeneron’s Dupixent has scored another important US approval, this time for moderate-to-severe atopic dermatitis (AD) in adolescent patients aged between 12 and 17 years.
Established as a new gold standard of care for adult AD patients, Dupixent revenues could be significantly boosted by use in this younger cohort. We are snap-polling US dermatologists to get a better understanding of how this may play out.
Keep an eye out for results early next week.
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