Exelixis pullback may create interesting entry point, says Stifel. After Exelixis (EXEL) and partner Roche (RHHBY) announced the Phase 3 IMblaze370 trial did not achieve statistical-significance on the primary efficacy endpoint evaluating the ability of a combination of a MEK inhibitor and anti-PD-L1 to improve overall survival in patients with microsatellite stable metastatic colorectal cancer, Stifel analyst Stephen Willey said he believes attrition in Exelixis shares might create an interesting entry point. The failure of IMblaze370 removes some of Exelixis’ longer-term optionality and he expects topics of RCC growth/competition, label expansion, and longer-term cabozantinib exclusivity to remain core to the story going forward, said Willey who has a Hold rating on the stock. Array BioPharma (ARRY) also has Phase 1/2 development collaborations in place with both Bristol-Myers (BMY) and Merck (MRK) evaluating the MEK/PD-1 hypothesis in earlier-lines of MSS mCRC, noted Willey, who said he would “be opportunistic” on any weakness in its shares. He maintains a Buy rating on Array, which is down 5% in pre-market trading.
Thursday, May 10, 2018
Autolus seeks $100M IPO to take next-gen CAR-Ts deep into the clinic
Autolus has filed to raise $100 million in a Nasdaq IPO. The British biotech wants the cash to bankroll clinical trials of a clutch of next-generation CAR-Ts designed to broaden the use of cell therapies while improving their safety and efficacy.
London-based Autolus has pulled in more than $170 million in venture funding and established itself in the pack of next-generation CAR-T players on the strength of its technologies, many of which aim to address the shortcomings and limitations of existing cell therapies.
Armed with these technologies, Autolus has established a pipeline of therapies designed to extend the persistence of CAR-Ts, reduce toxicity, cut relapses and broaden the list of targets addressable by the cells.
The four Autolus’ candidates in or near the clinic deploy these technologies in an attempt to improve the treatment of acute lymphoblastic leukemia and broaden the use of CAR-Ts to multiple myeloma, peripheral T-cell lymphoma and neuroblastoma. Autolus is yet to generate much clinical data on the assets but aims to establish proof of concept on the anti-CD19 AUTO1 this year.
With the IPO haul set to add to the $129 million Autolus had in the bank at the turn of the year, the biotech expects the proceeds of the listing to take it deep into development. Autolus thinks the IPO will equip it to wrap up phase 1/2 trials of all its current clinical-phase candidates and go on to take two of the assets into late-stage studies. If everything goes to plan, Autolus may advance a drug as far as registration.
Autolus will use some of the IPO monies to prepare for its anticipated first filing. The biotech has developed a semi-automated manufacturing process to support its ongoing trials that it thinks will scale to meet its growing needs. To access the capacity to put that idea to the test, Autolus is set to move into a manufacturing suite at the Cell and Gene Therapy Catapult in Stevenage, U.K., soon.
Further down the line, Autolus plans to set up additional production sites in the U.K. and elsewhere in Europe. When seen in light of Autolus’ ambition to establish its own commercial infrastructure, the production plan shows the biotech’s appetite to grow into a significant standalone business.
That appetite and, as importantly, the ability to raise money to sate it has been lacking in Europe in the past. But with Autolus benefiting from a hospitable private financing environment to raise $173 million before going after the deep pockets of public investors in the U.S., it may have the means to execute the strategy. The first step is to pull off an IPO despite having limited clinical data.
Novartis, Durect renegotiate $293M painkiller deal after phase 3 failure
Novartis has renegotiated its $293 million deal to commercialize Durect’s Posimir postoperative painkiller, cutting its milestone payments following the failure of a phase 3 trial reported last October.
Durect had received $20 million upfront from Novartis’ Sandoz division in May 2017, and was eligible for up to $43 million for achieving development goals, with up to $230 million to follow if the drug goes on to meet sales targets.
But in the PERSIST trial, Posimir (Saber-bupivacaine) missed its primary endpoint of reducing pain in the first two days after surgery, compared to standard bupivacaine. The deal was amended from the $43 million in milestone payments down to $30 million, to be based on FDA approval. Durect remains eligible for the $230 million in sales-based payments, the company said in a statement.
Posimir’s development has not been easy. Durect hopes their formulation of the nonopioid analgesic will provide continuous local pain relief after surgery, through a biodegradable depot placed within the incision that slowly releases the drug over three days.
But in 2014, the FDA handed down a complete response letter to the then-named Posidur, requesting additional clinical safety studies, two years after missing efficacy endpoints in another late-phase trial.
PERSIST would have its own problems: the FDA recommended a series of protocol amendments, including the addition of bupivacaine as a standard control. Durect enrolled 296 patients who underwent minimally invasive gallbladder removal surgery, and while results trended in Posimir’s favor, they were not statistically significant.
The renegotiation also modified the agreement’s termination provisions, including a right for Durect to leave the deal prior to NDA approval. A new fee was added, should Sandoz decide to terminate the agreement for convenience. Previously, Durect said that with last year’s failure of PERSIST, Sandoz had the right to terminate the agreement with 30 days’ notice.
In addition, the amendment now permits either party to develop or commercialize competing products. Sandoz maintains exclusive rights and responsibility to commercialize Posimir in the U.S. following approval.
Astellas to pay Aquinox $25M for regional rights to phase 3 inflammatory pain med
Astellas is paying Aquinox Pharmaceuticals $25 million upfront for regional rights to rosiptor. The deal gives Astellas the right to develop the phase 3 SHIP1 activator in Japan and certain other nations in Asia.
Aquinox thinks rosiptor can reduce inflammation and associated pain by dialing down the PI3K cellular signaling pathway, which is linked to the concentration of pro-inflammatory signaling molecules in tissues. A midphase trial of the drug in patients with bladder pain syndrome/interstitial cystitis (BPS/IC) missed its primary endpoint in 2015. But Aquinox still moved into phase 3 in the indication.
Enrollment in the phase 3 is now complete and Aquinox expects to have top-line data in the third quarter. While waiting on that critical readout, Aquinox has cashed in on the value of the drug in some countries in Asia Pacific.
Astellas is paying $25 million upfront and up to $130 million in milestones for the exclusive rights to rosiptor in all diseases in Japan, South Korea, Australia, Taiwan, Indonesia and Malaysia. China and India are the notable absentees from the list of countries covered by the deal.
Aquinox is set to receive up to $60 million as Astellas clears development milestones. The remaining $70 million is tied to commercial milestones. Astellas is also on the hook for royalties.
Landing the deal gives Aquinox a potential ongoing source of income from a drug that has been on the ropes during its path through the clinic. Aquinox’s stock entered the doldrums in 2015 when it reported the back-to-back failures of rosiptor in midphase BPS/IC and COPD trials. Later that year, Aquinox added a phase 2 mild-to-moderate atopic dermatitis trial to its list of failures.
Success against secondary endpoints enabled rosiptor to bounce back in BPS/IC, leading to the phase 3 trial that is nearing completion. It also led to Astellas’ belief that the drug has a future.
“The agreement fits with our strategy to deliver innovative drugs in therapeutic areas with high unmet medical needs. Rosiptor has a novel mechanism of action, activation of SHIP1,” said Naoki Okamura, chief strategy officer at Astellas, in a statement.
Exelixis-Genentech phase 3 colorectal cancer trial misses primary endpoint
Exelixis (EXEL) announced that IMblaze370, the phase 3 pivotal trial of atezolizumab, an anti-PDL1 antibody discovered and developed by Genentech, a member of the Roche Group (RHHBY), and cobimetinib, an Exelixis-discovered MEK inhibitor, did not meet its primary endpoint. Genentech, Exelixis’ collaborator and sponsor of the IMblaze370 trial, informed the company that the combination of atezolizumab and cobimetinib did not deliver an improvement in overall survival, or OS, versus regorafenib. The IMblaze370 trial evaluated the combination in patients with difficult-to-treat, locally advanced or metastatic colorectal cancer whose disease had progressed or who were intolerant to at least two systemic chemotherapy regimens. The safety profile for the combination appeared consistent with the known safety profile of each individual medicine, and no new safety signals were identified with the combination. Genentech will further examine results from IMblaze370 and plans to present the data at an upcoming medical meeting.
Eagle Pharma Reports Q1 Adjusted Non-GAAP Earnings Per Share Of $0.53
Eagle Pharmaceuticals Inc:
* EAGLE PHARMACEUTICALS, INC. REPORTS FIRST QUARTER 2018 RESULTS
* Q1 ADJUSTED NON-GAAP EARNINGS PER SHARE $0.53
* Q1 EARNINGS PER SHARE $0.17
* Q1 REVENUE $46.6 MILLION VERSUS I/B/E/S VIEW $48.9 MILLION
* Q1 EARNINGS PER SHARE VIEW $0.69 — THOMSON REUTERS I/B/E/S
* EAGLE PHARMACEUTICALS – CASH, CASH EQUIVALENTS WERE $95.7 MILLION, ACCOUNTS RECEIVABLE WAS $53.4 MILLION, AND DEBT WAS $48.8 MILLION AS OF MARCH 31, 2018
* REITERATING 2018 EXPENSE GUIDANCE
* EAGLE PHARMACEUTICALS – REGARDING RYANODEX, EXPECTS TO MEET AGAIN SHORTLY WITH OFFICIALS FROM U.S. MILITARY TO FORMALIZE CLINICAL AND REGULATORY PLANS
* EAGLE PHARMA – DECIDED TO LAUNCH TENTATIVELY APPROVED BENDAMUSTINE HYDROCHLORIDE 500ML SOLUTION, SUBJECT TO RECEIPT OF FINAL APPROVAL FROM FDA
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