Elliott has now partnered with a new private equity firm to pursue Athenahealth and is no longer teaming up with Bain, as the two firms appeared to have divergent views on the company’s valuation, said Dealreporter, according to contacts.
Monday, September 24, 2018
J&J talc cancer case in California ends in mistrial
Johnson & Johnson’s latest trial over allegations that its baby powder causer cancer ended in a mistrial, as jurors could not come to an agreement on a verdict, Bloomberg reports. A state judge in Pasadena, California, declared a mistrial after jurors deadlocked on plaintiff Carolyn Weirick’s ask for at least $25M in damages over her mesothelioma, which she claims she developed from asbestos-laced baby powder, the report says.
https://thefly.com/landingPageNews.php?id=2794655
Teladoc to host investor day
Investor Day to be held in New York on September 27 at 10 am. Webcast: https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&referrer=http%3A%2F%2Fir.teladoc.com%2Fnews-and-events%2Fevents-and-presentations%2F&eventid=1819425&sessionid=1&key=12F8758D6016673AE6CF63017702EFA4®Tag=&sourcepage=register
https://thefly.com/landingPageNews.php?id=2794679
Verastem receives FDA approval of Copiktra capsules
Verastem announced that the FDA has approved Copiktra, an oral inhibitor of phosphoinositide 3-kinase, and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. Copiktra is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies. Copiktra also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Use of Copiktra is associated with a boxed warning for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.
https://thefly.com/landingPageNews.php?id=2794681
Arena Pharmaceuticals reports ‘positive’ Phase 2a results for olorinab
Arena Pharmaceuticals announced positive topline results from its Phase 2a trial of olorinab, an investigational, peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 in development for the treatment of gastrointestinal pain. This was a randomized, open-label, 8-week study investigating two doses of olorinab (25 mg and 100 mg) administered TID (three times daily). All patients were diagnosed with quiescent to mild active Crohn’s disease associated with chronic abdominal pain defined as a baseline Average Abdominal Pain Score (AAPS) greater than or equal to4. Fourteen patients were enrolled with a mean baseline AAPS of 5.6. Reductions in pain were seen within the first week of treatment with olorinab and statistically significant improvement from baseline in AAPS was observed at weeks 4 and 8. In the 11 patients evaluable at 8 weeks of treatment (baseline AAPS of 6.0), there was an improvement in AAPS of -4.6 (pless than0.001) from baseline at peak effect (1.5 hours post morning dose). At peak effect, 11 out of 13 patients (85%) with evaluable data at week 4, and 11 out of 11 patients (100%) with evaluable data at week 8, exhibited a clinically relevant improvement (greater than or equal to30% change from baseline) in AAPS. Results in all patients randomized (intent-to-treat) demonstrated 11 out of 14 patients (79%) with clinically relevant improvement at both weeks 4 and 8. The improvement in pain was consistent at both the 25 mg and 100 mg olorinab dose levels and a statistically significant improvement in AAPS was also observed at trough levels (before the morning dose). Olorinab appeared safe and generally well tolerated in this study with no clinically significant changes in heart rate or blood pressure, no psychotropic effects, and no discontinuations due to adverse events.
https://thefly.com/landingPageNews.php?id=2794685
Endo agrees to additional stay of FDA litigation
Endo International announced that it has agreed to an additional stay of its litigation against the FDA until December 31, 2018. The litigation, filed in the U.S. District Court for the District of Columbia in October 2017 by the company’s subsidiaries, Par Sterile Products, LLC and Endo Par Innovation Company, seeks a declaration that FDA’s “Interim Policy” on compounding using bulk drug substances under Section 503 B of the Drug Quality and Security Act of 2013, or DQSA, amendments to the Federal Food, Drug, and Cosmetic Act, or FDCA, is contrary to law because it authorizes bulk compounding of new drugs where the applicable DQSA requirements are not satisfied and because it is fundamentally inconsistent with the plain language and structure of the FDCA statutory regime for introducing new drugs. The litigation also seeks the immediate removal of vasopressin from FDA’s Category 1 nominations list to assure that outsourcing facilities do not engage in bulk compounding of vasopressin-containing drug products under Section 503B. Shortly after Endo commenced the litigation, FDA took initial steps to comply with the DQSA and Endo agreed to FDA’s prior stay requests in January 2018 and April 2018. In August 2018, an outsourcing facility announced it would commence bulk compounding of vasopressin and intervened in the litigation. Endo promptly lifted the litigation stay and filed a motion for preliminary injunction. Seven days after Endo filed its motion, FDA published a proposed clinical need determination for vasopressin in the Federal Register indicating that it “find[s] no basis to conclude that there is a clinical need for an outsourcing facility to compound using the bulk drug substance vasopressin” and initiated a 60-day comment period. If FDA finalizes its proposed clinical need determination following the comment period, bulk compounding of vasopressin will be illegal and subject to FDA enforcement. During discussions between Endo’s and FDA’s respective counsel on September 20, 2018, FDA advised Endo that FDA would commit to use its best efforts to finalize its clinical need determination for vasopressin by December 31, 2018 if Endo agreed to again stay the litigation until such date. Based on FDA’s commitment, Endo agreed to the proposed stay and the parties jointly moved the court for approval on September 21, 2018. The motion was unopposed by the intervenor outsourcing facility. If the court approves the proposed stay, Endo’s motion for preliminary injunction will be held in abeyance and the hearing on such motion that is currently scheduled for October 3, 2018 will be taken off calendar.
https://thefly.com/landingPageNews.php?id=2794171
Amarin claims a big win for its cardio outcomes study
Amarin $AMRN has staked its claim to the next big blockbuster in the cardio space, heralding a clear statistical win on the primary endpoint for its 7-year clinical quest to prove that its industrial strength purified fish oil Vascepa can significantly reduce major cardio threats for a broad swath of patients.
An early preview of the top-line data rolled out at a bleary-eyed time in the morning on Monday pointed a direct arrow at a relative 25% drop in risk for major cardio events — such as death, stroke and hospitalization due to angina — hitting a highly statistical p=<0.001 for the patients in the years-long REDUCE-IT study. And researchers also high-fived each other for a clean safety profile in the same headline data to make the statement.
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The data supported “robust” evidence of its effect across multiple secondary endpoints, according to the company.
The data supported “robust” evidence of its effect across multiple secondary endpoints, according to the company.
Analysts at Jefferies have said that a success here could transform Vascepa into a $2 billion-plus drug. And that number resonated this morning, as Amarin’s share prize zoomed up 234%.
“We are delighted with these topline study results,” said John Thero, president and CEO of Amarin, in a statement. “Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.”
None of this is going to make it easy for the company, though, with a host of angry short investors likely to try whatever it takes to foment a backlash against the data for the last big catalyst of Q3. Company execs still need to survive an 8 am ET call later Monday morning, when they’ll face a grilling about the data, mortality and the implications for this drug.
Further complicating their success, AstraZeneca has its own outcomes study for the rival Epanova ready to read out next year, while GSK’s Lovaza went generic several years ago.
Supporters, though, are swooning.
Patients enrolled in REDUCE-IT had registered an LDL-C level between 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin therapy with a slate of cardiovascular risk factors including: persistent elevated triglycerides between 150-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease or diabetes mellitus and at least one other CV risk factor.
This one has been endlessly debated as the time drew near for the readout. Amarin’s Vascepa — approved more than 4 years ago for hypertriglyceridemia — demonstrated its ability to significantly reduce triglycerides in those patients while influencing biomarkers on inflammation. But as we know from past big cardio studies, that certainly doesn’t necessarily translate into the kind of hard and demonstrable health benefits such that payers are willing to cover much larger mass populations of at-risk members.
REDUCE-IT set out to answer that question, with researchers enrolling more than 8,000 patients so they could compare it as an add-on to statins in reducing instances of major adverse cardiovascular events (MACE) as compared to statin-treated patients plus placebo.
We already know from the recent ASCEND study that popular fish oil products sold in every pharmacy have no clear health benefits, and Amarin has been built on the notion that its highly-purified, omega-3 fatty acid product could distinguish itself from the supplement field. Company execs said that fish oil’s weakness would simply make it easier to prove Vascepa’s value, once the outcomes data were in.
Is it good enough?
Even positive cardio data don’t always translate into commercial opportunity, and analysts now will see whether Amarin has come up with data that are good enough to qualify as the practice-changing event that the company’s backers have insisted would now be in reach.
The difference amounts to a market with millions of potential patients.
Supportive Jefferies analysts who helped build support for the drug’s success recently noted:
Positive REDUCE-IT will be practice changing as it will provide POC that using a highly purified Omega-3 drug (vascepa) in MD patients on stable statins and relatively well-controlled LDL-C (<100mg/dL) contributes to a CV benefit. While LDL-C has decreased over decades, TGs continue to rise. The market needs this type of drug.
But for every advocate, you can count two more who bet against the drug and any upbeat rise in the share price. They won’t retreat without putting up a fight.
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