FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)
Curator: Aviva Lev-Ari, PhD, RN
UPDATED on 12/10/2019
For an ‘acquisitive’ Gilead, 2020 will be key test for CAR-T plans
Success for Kite, which O’Day made an independent unit, is critical for Gilead. Not only did the California biotech invest a large sum to buy the CAR-T specialist, it’s the most notable bet made on a future outside of drugs for HIV and hepatitis C.
Sentiment on Wall Street has begun to turn against the wisdom of Gilead’s choice, doubting CAR-T will live up to the promise envisioned by O’Day’s predecessors. One analyst went so far as to include the acquisition among the five most value-destroying biopharma deals of the past decade.
Commercially, sales of Yescarta have grown to $334 million through the first nine months of the year, up from $183 million during the same period last year. Still, marketing CAR-T has proved challenging, with hurdles in reimbursement and in-hospital administration particularly acute.
The coming year could prove consequential in shifting Kite’s trajectory higher.
Within the next few weeks, Gilead will ask regulators to approve its second CAR-T cell therapy, a variation of its currently cleared leukemia and lymphoma treatment Yescarta that’s manufactured differently.
A new site in Europe coming online next year could substantially cut times down for Yescarta delivery there, Shaw said. (Globally, Novartis appears better positioned, with sites in Switzerland and France as well as partnerships in China, Japan and Australia.)
Automation of what’s now a mostly manual process will play an important role in CAR-T’s future too, according to Shaw.
“If we get our autologous cell therapy automated very well, you could imagine one day it could be at point of care,” she said. “We don’t want to be disrupted by someone else doing that.”
Disruption could also come in the form of allogeneic cell therapies, which are constructed using donor T cells rather than autologous treatments that use a patient’s own. Numerous clinical hurdles have made that approach more difficult but companies like Allogene — founded by former Kite executives — are moving ahead.
SOURCE
https://www.biopharmadive.com/news/gilead-kite-car-t-christi-shaw-dealmaking/568767/
UPDATED on 5/3/2019
Gilead Sciences tapped new CEO Daniel O’Day in part because of his cancer expertise. But he’s not planning to lead the company’s oncology ramp-up alone.
The Roche veteran intends to bring on a CEO for Gilead’s Kite unit, responsible for key CAR-T drug Yescarta. The new chief will report to O’Day and operate Kite as a separate business unit, JPMorgan analyst Cory Kasimov wrote in a Thursday note to clients.
RELATED: Gilead, looking for cancer sales, swipes Roche pharma chief Daniel O’Day for CEO post
Gilead acquired Kite in 2017 for $12 billion as its hepatitis C revenues, once its bread and butter, crashed. But so far, both Yescarta and Novartis’ rival CAR-T player, Kymriah, have struggled, thanks to a mix of reimbursement and manufacturing challenges.
Kite underperformed expectations once again in the first quarter, with Yescarta’s $96 million in sales for the period checking in below Wall Street consensus of $105 million.
O’Day doesn’t expect to see that trend continue, though. On Gilead’s earnings conference call, he “proclaimed his confidence in cell therapy, noting that it was a critical element of the company’s long term strategy,” Kasimov wrote.
Getting Gilead’s commercial business in order is just one of O’Days three main priorities as he settles into the CEO role, though. After taking the reins March 1, he decided to zero in on strengthening Gilead’s pipeline, in part through M&A. And he’ll also be making organizational tweaks to “ensure the right people are in the right place,” as Kasimov put it.
Gilead is “continuing to scan the entirety” of the M&A landscape and “acknowledges they will continue to ‘look at late stage pipeline,’” while keeping an eye on the company’s areas of expertise—oncology, HIV and hepatitis B and nonalcoholic steatohepatitis, Jefferies analyst Michael Yee wrote to his own clients. And the Big Biotech will be “accelerating internal” candidates in addition to adding bolt-on buys.
RELATED: Gilead executives predict patience—and some deal scouting—from new CEO Daniel O’Day
Unsurprisingly, analysts trained their attention on the call to O’Day’s strategy comments, and “there were literally minimal to no questions about financials,” Yee noted. But that doesn’t mean Gilead turned in a bad quarter. On the contrary, the first quarter was “fairly clean,” he wrote, with revenues of $5.28 billion meeting expectations and earnings per share of $1.76 topping forecasts by 15 cents.
New HIV hotshot Biktarvy stole the show on the revenue side, blowing the $648 million consensus prediction out of the water with $793 million in quarterly sales.
In the quarter, “about 80% of Biktarvy revenue came from switches with 25% from dolutegravir-containing regimens in the U.S.,” Kasimov wrote, referencing key combinations from Gilead’s HIV archrival, GlaxoSmithKline.
UPDATED on 9/7/2017
Here’s the inside account of Gilead’s 11-week sprint to its $12B Kite buyout – ENDPOINTS NEWS
UPDATED on 8/31/2017
Gilead-Kite: A New Transformative Deal For Biotech, AUG 30, 2017
Gilead has made a big bet on new technology in Kite’s immunotherapy platforms and has reduced the number of credible large players in the space.
With a reputation for intense diligence and dynamism in its business development efforts, Gilead’s management team will only bolster the immunotherapy field as it prepares to face off with Novartis, its immediate competitor, and enters squarely in the province of Merck and Bristol Myers Squibb, two of the leaders in immuno-oncology.
Gilead has reinvented the transformative transaction for the sector.
I attended this week the Cambridge Healthtech Institute’s 4th Annual
Adoptive T Cell Therapy
Delivering CAR, TCR, and TIL from Research to Reality
August 29 – 30, 2017 | Sheraton Boston | Boston, MA
The following talks on 8/29/2017 presented the frontier of CAR-T Therapies and Technologies from lab to bed side:
- Building Better T Cell Therapies: The Power of Molecular Profiling
Mark Bonyhadi, Ph.D., Head, Research and Academic Affairs, Juno Therapeutics
- Tricked-Out Cars, the Next Generation of CAR T Cells
Richard Morgan, Ph.D., Vice President, Immunotherapy, Bluebird Bio
- The Generation of Lentiviral Vector-Modified CAR-T Cells Using an Automated Process
Boro Dropulic, Ph.D., General Manager and CSO, Lentigen Technology, Inc.
I covered this event in Real Time for the Press
LIVE – 8/29 – CHI’s Oncolytic Virus Immunotherapy and ADOPTIVE CELL THERAPY, August 28-29, 2017 Sheraton Boston Hotel | Boston, MA
One year ago we published the following:
What does this mean for Immunotherapy? FDA put a temporary hold on Juno’s JCAR015, Three Death of Celebral Edema in CAR-T Clinical Trial and Kite Pharma announced Phase II portion of its CAR-T ZUMA-1 trial
Lydia Ramsey reported on Aug. 28, 2017 that Gilead just handed a revolutionary kind of cancer treatment a $12 billion endorsement.
For Gilead, which is known for its HIV and hepatitis C medications, this is an entirely new area of cancer development.
“The field of cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients,” Gilead CEO John Milligan said in a news release. “We are greatly impressed with the Kite team and what they have accomplished, and share their belief that cell therapy will be the cornerstone of treating cancer.”
In July, a Food and Drug Administration panel voted in favor of approving one of these treatments made by Novartis. One of the panelists called it “most exciting thing I’ve seen in my lifetime.” The FDA is expected to decide whether to approve that therapy, a treatment for pediatric acute lymphoblastic lymphoblastic leukemia, by October.
Gilead won’t have to wait long to see if the FDA will approve Kite’s leading cell therapy, which is called axicabtagene ciloleucel or axi-cel. In November, Kite is expected to get an answer from the FDA regarding its CAR-T treatment for a type of blood cancer called aggressive B-cell non-Hodgkin lymphoma. In data Kite released in February, the company found that out of 101 patients, 36% had a complete response to the treatment after six months.
The one-time treatments won’t come cheap. While companies might price the drug based on how well it works, axi-cel’s price tag could still be $325,000. Analysts expect the therapy to generate $1.7 billion in sales by 2022.
While its axi-cel program is the farthest along, Kite’s also working on another CAR-T cell therapy that’s in clinical trialsto treat multiple myeloma, another form of blood cancer. The company’s also working on cell therapies to treat solid tumors that are still in early clinical trials.
On August 30, 2017, John Carroll writes:
[A]pproval marks a major shift in oncology, with a truly revolutionary approach to treating cancer.
The FDA has approved the world’s first CAR-T therapy, giving a green light to Novartis for Kymriah (tisagenlecleucel) in what regulators themselves describe as an historic event.
The accelerated approval — about a month ahead of the PDUFA date — came through for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia
Novartis, the leader in the field, which will set the price on this therapy and likely those to come. Novartis’ investigators registered a game-changing 83% remission rate in its pivotal study.
CAR-T, though, is also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome with some patients dying from brain swelling in separate studies from the Novartis drug.
Regulators noted that they will require special training for anyone involved in delivering this therapy, while expanding the approval of Actemra (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years of age or older. “In clinical trials in patients treated with CAR-T cells,” the FDA reported, “69% of patients had complete resolution of CRS within two weeks following one or two doses of Actemra.”
Said Joseph Jimenez, CEO of Novartis:
“Five years ago, we began collaborating with the University of Pennsylvania and invested in further developing and bringing what we believed would be a paradigm-changing immunocellular therapy to cancer patients in dire need. With the approval of Kymriah, we are once again delivering on our commitment to change the course of cancer care.”
This approval marks a major shift in oncology, with a truly revolutionary approach to treating cancer. That hasn’t escaped the notice of big players and small, with a host of developers looking to do much better, more safely, with new drugs in the pipeline.
SOURCE
From: “John Carroll [Endpoints News]” <john@endpointsnews.com>
Reply-To: <john@endpointsnews.com>
Date: Wednesday, August 30, 2017 at 11:27 AM
To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>
Subject: BREAKING: FDA ushers in a new era in cancer treatment with ‘historic’ CAR-T approval for Novartis
Novartis’ Canakinumab – NEW Inflammation hypothesis of lung cancer
When researchers looked at the safety profile of canakinumab, they found something amazing — a major reduction in the risk of fatal cancers. This was driven by an effect of the highest dose of the drug to prevent lung cancer. The 300 mg dose reduced the occurrence of lung cancer by 67% and death from lung cancer by 77%. It was Viagra all over again.
SOURCE
In this Revolution and Revelation, Milton Packer explains how safety data can sometimes trump a primary endpoint
by August 30, 2017
https://www.medpagetoday.com/Blogs/RevolutionandRevelation/67605
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