Merck KGaA CEO Stefan Oschmann told Bloomberg in a television interview that demand for semiconductor solutions is high. The CEO reiterated that the business will return to sustainable growth in 2019, according to Bloomberg.
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Friday, February 1, 2019
OptumRx to cover migraine drugs from Amgen, Eli Lilly
An OptumRx client note viewed by Reuters reveals that new migraine drugs from Amgen (AMGN) and Eli Lilly (LLY) are listed as preferred treatments on its lists of covered drugs, according to Caroline Humer. Teva Pharmaceutical’s (TEVA) rival drug, Aimovig, is excluded on one list from the PBM owned by UnitedHealth (UNH) and patients can pay more for it in some cases on a second list, Reuters added
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https://thefly.com/landingPageNews.php?id=2857923
Crunch time for ImmunoGen as phase 3 readout looms for lead antibody-drug
2019 could be a pivotal year for antibody-drug conjugate specialist ImmunoGen as it tries to draw a line under past challenges with phase 3 data for lead drug mirvetuximab soravtansine.
Within the next few months, ImmunoGen should report the results of its FORWARD I trial of the wholly owned folate receptor alpha-targeting ADC in platinum-resistant ovarian cancer, which aims to displace chemotherapy as the go-to treatment in these patients.
Analysts at Jefferies say they are “leaning positively on the outcome of the trial”, which could lead to an FDA approval in 2020 and—if all goes to plan—U.S. sales of around $774 million in 2032, with another $233 million possible from ex-U.S. royalties.
ImmunoGen has one of the longest histories in the biotech sector, having been incorporated way back in 1981, so it has been a long haul towards sustainable revenues and profits for the company’s investors as it approaches the end of its fourth decade of operations.
The last couple years have also been a little mixed for ImmunoGen’s ADC pipeline, with a late-stage failure of Bayer-partnered mesothelioma drug anetumab ravtansine in 2017 and the loss of Sanofi as a partner for its anti-LAMP1 candidate last year. On the plus side, it also signed new partnering deals with Jazz Pharma and Debiopharm.
Jefferies is expecting data from FORWARD I to read out in the first half of the year, and said the trial will give ImmunoGen more than one shot on goal.
The study is comparing mirvetuximab to the most commonly used second-line chemotherapies—Johnson & Johnson’s Doxil (pegylated liposomal doxorubicin), topotecan and paclitaxel—and the best outcome will be a significant improvement in median progression-free survival (mPFS) for the ADC across the whole patient population.
If that doesn’t happen, ImmunoGen could still move ahead with registration if mirvetuximab is shown to be better than the comparators in a subset of patients with high levels of folate receptor alpha (FRα) expression. FRα is overexpressed on ovarian and several other epithelial cancers, and the majority of the FORWARD I cohort are high expressers.
From data generated with the ADC to date, Jefferies think that it has a reasonable chance of showing a two month or more advance on mPFS which should be enough for FDA approval, given that the current second-line chemotherapies typically only extend life for three to four months.
It is worth noting, however, that a couple of other FRα-targeting drugs have failed at the last hurdle in refractory ovarian cancer, including Merck and Endocyte’s vintafolide and Eisai/Morphotek’s farletuzumab.
Nevertheless, ImmunoGen reported positive preliminary results with mirvetuximab and Merck’s PD-1 inhibitor Keytruda (pembrolizumab) at last year’s ESMO which seemed to indicate a benefit for the combination over the ADC alone, which adds to the optimism about the program.
“We see use in combination in earlier lines of therapy as upside to our estimates,” said the Jefferies analysts.
Anti-rejection drug rapamycin shows promise in liver cancer
Scientists at the University of Pittsburgh School of Medicine were studying the cells that surround the liver’s central vein when they made a serendipitous discovery. Cells with a mutation in a gene called β-catenin also made high levels of the mTOR protein—a fault that they believe could promote the development of cancer.
Since there are already mTOR inhibitors on the market, including anti-rejection drug rapamycin, they wanted to dig deeper to learn whether those drugs could be repurposed in liver cancer. So they created a mouse model of liver cancer with mutations in the β-catenin and MET genes, creating animals with tumors that are similar to more than 20% of liver cancers in people.
When they fed the mice rapamycin, the tumors shrunk. When they added a MET inhibitor, the cancers almost disappeared completely, the Pitt researchers reported in the journal Cell Metabolism.
Inhibiting mTOR has been tried before in liver cancer but with little success. A 2016 trial in 525 patients with the disease, for example, found little difference in survival between patients given mTOR inhibitor sirolimus after liver transplantation versus patients who received a different sort of anti-rejection drug. The Pitt researchers believe their results argue for a more refined approach, targeting mTOR inhibitors to patients whose liver tumors have both β-catenin mutations and an addiction to the mTOR protein.
By studying the mouse models of liver cancer that they created, the scientists discovered that β-catenin uses an enzyme called glutamine synthase to activate mTOR. “Activating mTOR kicks up the protein-making factories in these cells, giving them the resources to divide and grow,” saidsenior author Satdarshan Monga, M.D., professor of pathology and director of the Pittsburgh Liver Research Center at Pitt, in a statement.
Rapamycin analogs are already approved and on the market to treat a range of cancers, including renal cell carcinoma and HER2-negative breast cancer. The crowding of the market for mTOR inhibitors in oncology may have prompted AstraZeneca’s recent decision to drop its midstage candidate vistusertib, in spite of promising data in a range of cancers.
At the very least, Pitt’s Monga believes his team’s findings argue for an approach whereby liver cancer patients who undergo transplants are given rapamycin as the preferred anti-rejection medicine over other choices.
“Current liver cancer therapies increase the likelihood of survival only by 3 or 4 months, so taking a precision medicine approach to identify the right patient could allow us to repurpose existing drugs to improve treatment success,” he said.
The next step for the Pitt researchers is to plan a clinical trial testing rapamycin as a treatment for liver cancer and as a way to prevent recurrences in patients who have received liver transplants.
J&J Erleada trial stops early on good news, new prostate cancer nod eyed
Johnson & Johnson is counting on Erleada to carry the prostate cancer baton as Zytiga battles generics. And it just got one step closer to a new indication.
Wednesday, the New Jersey drugmaker said investigators had cut short a phase 3 study of Erleada in combination with androgen deprivation therapy in patients with metastatic, castration-sensitive prostate cancer (mCSPC) after the combo showed it could significantly stave off disease progression and extend patients’ lives. Based on the results, an independent data monitoring committee recommended placebo-plus-ADT patients switch over into the Erleada group.
Now, the pharma giant will submit those results for presentation at an upcoming medical meeting, and in the meantime, it’s planning to file for approval in mCSPC this year, it said.
A green light for Erleada would add to its first indication, a nod in nonmetastatic castration-resistant prostate cancer that brought it to the market last February. There, it’s battling Pfizer and Astellas’ Xtandi—also known as Zytiga’s longtime nemesis—which picked up its own go-ahead in July. Despite Erleada’s head start, Xtandi has a sizeable lead in the market, Pfizer said this week, pegging Xtandi’s share at quadruple Erleada’s.
A new approval would also bring in patients from the castration-sensitive group who aren’t currently eligible for Zytiga. The elder drug is OK’d only in high-risk patients, while Erleada’s newest data applies to a broader patient pool.
All in all, analysts expect Erleada to eventually cross the blockbuster barrier but not to show up its predecessor. Barclays analyst Geoff Meacham has projected $1.3 billion in peak sales, which is less than half of the $2.71 billion Zytiga pulled in over the first nine months of 2018.
Meanwhile, looking to dodge the impact of Zytiga generics on Xtandi’s original market—metastatic castration-resistant prostate cancer—Pfizer and Astellas are going after new indications, too. Executives are looking ahead to two key trials in hormone-sensitive prostate cancer, a market Angela Hwang, president of Pfizer’s biopharmaceuticals group, called the one “we’re really excited about.”
Takeda hits FDA snag on Ninlaro, but its growth still helps drive revenue hike
In Takeda’s last quarterly report as a separate company from Shire, things seem to be going its way—key drugs are growing nicely, Shire integration is on track, and cash-raising sell-offs are underway, executives said.
But all is not rosy. Takeda’s rising multiple myeloma star and key growth driver Ninlaro just hit a snag at the FDA.
The Japanese pharma said on Friday that it decided to withdraw an application to expand Ninlaro’s use as a maintenance therapy in post-transplant patients, after conversations with the FDA showed that the agency wants to know how long Ninlaro can extend patients’ lives, data that Takeda doesn’t yet have.
“After only 31 months of median follow-up, there were not enough deaths accrued in the study to assess any significant difference in overall survival, or even in fact imply a trend,” Christopher Morabito, Takeda’s head of R&D portfolio strategy, said during a conference call on Friday.
Morabito admitted that the speed bump shouldn’t have been a surprise, because the FDA previously telegraphed that overall survival (OS) data is a critical endpoint for their final analysis. Celgene’s Revlimid, for example, is one of the drugs that faced that hurdle.
Only two months ago at the American Society of Hematology annual meeting, Takeda touted data showing Ninlaro could cut the risk of disease progression or death by 28% compared with placebo. Ninlaro data has also indicated it could be safer than its blockbuster predecessor Velcade, and that it could be “a very good combination partner with other classes,” Jay Humphrey, VP of U.S. marketing, told FiercePharma at the time.
Full OS data for myeloma maintenance therapy could take years to accumulate, if Revlimid’s case is any indication. A meta-analysis published in the Journal of Clinical Oncology in 2017 turned up a seven-year survival rate of 62% among post-transplant patients on the Celgene drug. Morabito said Takeda will be in active talks with regulators “as to how much OS data they need to see to feel comfortable with the endpoint.”
Takeda can’t yet predict when it will be able to resubmit the app, Morabito said, though he assured investors another study that involves newly diagnosed patients who haven’t undergone a transplant remains on track, with readouts expected in the second half of 2019.
Ninlaro has been a new favorite at Takeda since Velcade dropped off the patent cliff. In the quarter that ended in December, Ninlaro sales rose 33.2%, to 17.1 billion Japanese yen ($157 million). Another important growth driver is bowel disorder therapy Entyvio: During the first nine months, Entyvio added 194.4 billion Japanese yen to Takeda’s top line, up 35.1%. These two drugs helped Takeda deliver 4.8% revenue growth over the three quarters.
Takeda wrapped up its $58 billion deal to acquire Shire in January, but it won’t be until next quarter that Shire’s numbers are consolidated with Takeda’s. Sell-offs to raise cash for paying down deal-related debt, however, are already under way. Takeda just announced on Monday that it would sell 21 assets, including its old Osaka headquarters building, and aims to rack up 38 billion yen in sale proceeds by the end of March.
CEO Christophe Weber has also said the company would look to sell up to $10 billion worth of noncore assets to fill the huge debt hole it incurred from the Shire buyout. Takeda has drawn a line around five key areas it wants to keep: gastroenterology, oncology, neuroscience, rare diseases, and plasma-based therapies and vaccines, which together represent 75% of the combined business, according to CFO Costa Saroukos. “All other areas are noncore, basically,” he said.
Executives again stressed their focus on a smooth integration and driving down its net debt/EBITDA ratio to 2.0x in the midterm. “At the moment, it’s very much about … keeping the business momentum and not disrupting our R&D and pipeline momentum,” Weber said.
Bristol-Myers yanked its Celgene bid days before deadline—and got a better price
On Dec. 10, Bristol-Myers Squibb made what it said was its final offer to acquire Celgene. But it turns out that wasn’t the case. It ended up scoring a better deal instead.
Just days before a Jan. 2 deadline Bristol-Myers itself had set for wrapping up an agreement, the New Jersey drugmaker pulled that proposal—$57 in cash and one BMS share for each Celgene share—citing Celgene’s sinking share price.
In its place, it traded some of the cash for a contingent value right, which would pay off only if three Celgene pipeline drugs made it to market. The revised per-share bid? $50, one BMS share and the CVR, tying future cash payments to regulatory approvals for MS candidate ozanimod and CAR-T prospects JCAR017 and bb2121.
Celgene took the bait. And that yielded the $74 billion buyout the two companies inked in the early hours of Jan. 3.
Conversations among the company’s executives, which began all the way back in early 2017, help illustrate why. 2018 wasn’t an easy year for the sector in general, but it was particularly unkind to both Bristol-Myers and Celgene. Investor worries over Opdivo’s lung cancer future and Revlimid’s patent cliff plagued the two players and their share prices.
And those “significant risks to both companies” prompted BMS CEO Giovanni Caforio and Celgene CEO Mark Alles to make haste, the recently released deal proxy (PDF) shows. Executives negotiated through December with a “strong desire to announce a transaction by January 2, 2019,” it says.
One thing that helped the timeline? A lack of other interested parties. Celgene reached out to just one other drugmaker it thought “would have a strategic fit with Celgene that was as strong as that between Celgene and Bristol-Myers Squibb, as well as the scale to enable it to present a proposal that could be competitive with Bristol-Myers Squibb’s,” the proxy said. And when that company said no, Celgene quit searching.
“Outreach to additional parties presented a significant unfavorable risk of a leak that would be damaging to Celgene and the prospects of a transaction with Bristol-Myers Squibb, and therefore would not be advisable,” its executive committee decided.
Now, Bristol-Myers and Celgene have a tie-up they say will make their combined company the field’s No. 1 oncology drugmaker, backed by Opdivo and Revlimid—and, they hope, a couple of CAR-T entrants. It’ll also put the combined company among the top five immunology and inflammation players, they contend.
Meanwhile, though, industry watchers still want answers on how the merger will drive sustained revenue and earnings growth down the line. Late last month, analysts pointed to lower-than-expected revenue growth guidance from Bristol-Myers and grilled the company’s management for answers.
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