Shares of Insys Therapeutics Inc. INSY, +34.05% shot up 27% in very active afternoon trade Thursday, after the company said earlier that its epinephrine nasal spray was granted fast track designation from the Food and Drug Administration as an investigational treatment for anaphylaxis, which is a life-threatening allergic reaction. Volume spiked to 5.6 million shares, compared with the full-day average of about 480,000 shares. The company said that in a previous clinical trial, Insys’s product showed promise as a potential “needle-free, non-invasive and easy-to-use alternative” to intramuscular injection. “The receipt of Fast Track designation represents a significant milestone for Insys and our clinical development of this novel drug-device combination,” said Steve Sherman, senior vice president of regulatory affairs for Insys. “We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon as possible.” The stock has now rallied 5.4% year to date, while the S&P 500 SPX, -0.44% has tacked on 8.9%.
Thursday, August 30, 2018
Reata Gets $30M Milestone Payment From Kyowa Hakko Kirin
Reata Pharmaceuticals, Inc. (Nasdaq:RETA), a clinical-stage biopharmaceutical company, today announced that it has received a $30 million milestone payment from its licensee, Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin), following the initiation of AYAME, a Phase 3 clinical trial to assess the efficacy and safety of bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease in Japan.
In December 2009, Reata granted Kyowa Hakko Kirin the exclusive license to develop and commercialize bardoxolone in renal disease and certain other indications in Japan, China, Taiwan, South Korea, and Southeast Asia. Last year, Kyowa Hakko Kirin reported positive results from the Phase 2 TSUBAKI trial of bardoxolone in patients with type 2 diabetes and chronic kidney disease. The pivotal AYAME trial began in May of this year and will enroll an estimated 700 diabetic kidney disease patients, with an estimated study completion date of March 2022. Kyowa Hakko Kirin is also collaborating with Reata in Japan on the ongoing Phase 3 CARDINAL trial of bardoxolone for the treatment of Alport syndrome, a severe, hereditary form of chronic kidney disease.
Drug firms drop lawsuit to keep Neb. from using their products in executions
Two pharmaceutical manufacturers will suspend their legal fight to prevent Nebraska from using their products in lethal injection executions.
Fresenius Kabi filed a notice Wednesday in U.S. District Court for the voluntary dismissal of a lawsuit that unsuccessfully tried to keep Nebraska from using drugs that the company believed were its in the Aug. 14 execution of Carey Dean Moore. Sandoz Inc. withdrew a motion to intervene in the same lawsuit.
Both companies made a late attempt to keep the state from going ahead with Moore’s execution, arguing that they would suffer serious financial harm if their products were linked to a lethal injection.
Nebraska carried out its first lethal injection using diazepam, fentanyl, cisatracurium and potassium chloride. Fresenius Kabi presented evidence that the potassium chloride was its product, while Sandoz argued that the cisatracurim could have been made at one of its plants.
Lawyers with the state argued that prison officials obtained the drugs legitimately, and the state refused to halt the execution.
The state’s supply of potassium chloride will expire Friday, and the cisatracurium expires Oct. 31. Although prison officials have said they are working to obtain fresh supplies, they also recently said they have no immediate source to replace the drugs.
Like many drug companies, Fresenius Kabi and Sandoz require their suppliers to sign contracts preventing the sale of their products for use in capital punishment.
Just days before the execution, Senior U.S. District Judge Richard Kopf denied a restraining order sought by Fresenius Kabi. The judge said he would not frustrate the will of Nebraska voters, 61 percent of whom voted in 2016 to overturn a legislative repeal of capital punishment.
The judge’s ruling was upheld on appeal by the Eighth U.S. Circuit Court of Appeals. Company officials decided not to appeal to the U.S. Supreme Court.
Moore, 60, was put to death with the four-drug combination after spending 38 years on death row. He was convicted of the 1979 slayings of Omaha cabdrivers Reuel Van Nessand Maynard Helgeland.
Nebraska had gone 21 years between executions. The last one was carried out with the electric chair before the method was ruled unconstitutional in the state.
Arvinas lines up for $100M IPO
Arvinas has been on a roll this year, starting with a Pfizer R&D deal worth potentially $830 million and bagging a $55 million series C in April to push its cancer drugs into the clinic. Now, the Yale spinout has filed to raise up to $100 million in its IPO, which will get its lead assets through the IND stage and into phase 1.
The New Haven, Connecticut-based biotech is working on an androgen receptor program, ARV-110, in castration-resistant prostate cancer, and an estrogen receptor program, ARV-471, in metastatic ER-positive breast cancer. The bulk of the IPO funds is earmarked to carry these assets into the clinic; what’s left will go toward expanding its protein degradation platform and conducting preclinical work for its earlier-stage programs, Arvinas said in its S-1, filed Thursday.
Arvinas drew its series C round from the likes of Deerfield, Sirona Capital, Canaan Partners and OrbiMed, saying at the time that it aimed to start clinical studies in the fourth quarter.
Arvinas’ drugs are based on its PROTACs (proteolysis targeting chimeras) platform, which grew out of the work of Craig Crews’ lab at Yale University. PROTACs work by activating the body’s protein disposal system. They recruit an enzyme to tag target proteins for ubiquitination and degradation.
Ubiquitination is a process whereby a damaged or unneeded protein is tagged with the protein ubiquitin and then sent to a protein complex called a proteasome, where it is degraded. The hope is that by degrading proteins instead of just blocking them, Arvinas’ drugs will surmount challenges that come with small-molecule protein inhibitors.
The company’s pipeline focuses on cancer, but its multiyear deal with Pfizer centers on developing PROTACs for multiple disease areas. The pair didn’t disclose which indications they would be chasing, but protein degradation could have applications in central nervous system disorders and rare diseases.
Arvinas isn’t alone in the growing protein degradation field. Its Fierce 15 peer, C4 Therapeutics, is using small-molecule binders called degronimids that can target, destroy and clear proteins through the ubiquitin/proteasome system. And Cedilla Therapeutics, which launched in April, is studying protein stability in search of points in the protein degradation process it can intervene.
“Where we are looking is in pivotal events upstream of this machinery that govern the transition [of proteins] between an operational state to a susceptible state,” said Cedilla’s Chief Scientific Officer Brian Jones at the company’s launch.
Biogen, Teva benefit as payers ease up on multiple sclerosis meddling: analyst
The multiple sclerosis field has been a hotbed for payers pressing drugmakers to trade formulary spots for discounts. But that’s changed a bit in 2018—and that means some MS-dependent companies can breathe a big sigh of relief.
This year, MS formularies are “less restrictive,” Bernstein analyst Ronny Gal pointed out in a recent note to clients, with just 24% of drugs blocked versus last year’s 42%. And if you compare the 2018 figure to 2016’s peak of 48% of drugs blocked, this year represents an even bigger shift.
The way Gal sees it, there’s now a “recognition by payers that the category is challenging to manage,” and they’ve responded with a “willingness to cover multiple drugs with the same mechanism of action,” he wrote.
The result? More drugs now bear a “preferred” distinction among payers—77% versus 72% last year—and there is “no material advantage among them.” Companies with more than one MS drug have won formulary spots for a second drug, a “portfolio effect” that’s helped players such as Biogen and Novartis.
That’s not to say it’ll be all smooth sailing for those companies. Roche’s Ocrevus, which analysts expected to deeply disrupt the market when it hit the scene last March, is still grappling with under-coverage; it’s blocked for 42% of lives and 15% have to try another drug first. As Ocrevus wins over more payers, that’ll mean more competition to Biogen’s products—and the Massachusetts-based company is likely to offset that competition with price increases, Gal predicted.
Meanwhile, formulary management has yielded some surprises over at Teva, whose 20mg dose of blockbuster Copaxone has gotten the cold shoulder from payers in favor of generic Glatopa from Novartis’ Sandoz. But rather than switching to the generic, 20mg patients are instead switching drugs altogether, Gal noted.
And on the 40mg Copaxone side, where Teva’s branded therapy and Mylan’s copy have similar coverage, Teva has kept its market share intact. “This seems to reflect some sort of a half-hearted attempt by the PBMs to push for a generic,” Gal said in a video, adding that “a physician preference for the brand given the complexity of the reference drug” and Teva’s patient assistance services are likely also playing a role.
IRS Ruling Could Help Employees Match Student Loan Payments Into 401(k)s
Americans paying off student loan debt now have a new way to add to their 401(k) retirement savings.
What Happened?
A new private letter ruling by the IRS suggests the agency may be open to employers matching employee student loan payments with contributions to their 401(k), according to Forbes.
Why It’s Important
The rule could allow Americans who are too burdened with student debt payments to contribute to their 401K on their own to continue to pay down student debt while their employers contribute to their retirement fund.
Americans have $1.4 trillion in outstanding student debt, making student loans the single largest source of debt outside of the housing market. Total outstanding auto debt is $1.2 trillion and outstanding credit card debt totals $800 billion.
A recent Pew study found that only 52 percent of millennial workers are participating in employer-sponsored retirement plans, and student loan payments could be playing a large role in that lack of participation.
Under the plan approved by the IRS, American workers using at least 2 percent of their eligible pay for student loan payments could have their employers make a matching 401K contribution of 5 percent of their eligible pay.
Employees with no student debt will not be impacted by the ruling.
What’s Next?
It’s important to note that the IRS ruling is applicable only to the specific company that made the request for the exact plan outlined above. Americans will be watching for other companies to follow suit in requesting IRS permission for similar plans, and employees may start requesting that their own companies make similar proposals.
With so many Americans burdened by student loan debt, a trend toward student loan 401K matching could have a significant impact on American employers, students and lenders.
Sangamo call to review data on enzyme deficiency disease med
Sangamo Therapeutics, Inc. (Nasdaq: SGMO) announced today that management will host a conference call on September 5th at 9:00 a.m. ET to discuss clinical data from the CHAMPIONS Study, the Company’s Phase 1/2 trial evaluating SB-913 in vivo genome editing therapeutic candidate for MPS II. The call will follow the presentation of the data earlier that day at the 2018 Symposium of the Society for the Study of Inborn Errors of Metabolism in Athens, Greece.
Sangamo also announced today that management will participate in the following healthcare investor conferences in September.
- 2018 Wells Fargo Healthcare Conference, Boston, MA, September 5-6, 2018
Sangamo’s presentation is scheduled for 9:10 a.m. ET on Thursday, September 6th.
The Wells Fargo presentation will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentation will be archived on the Sangamo website for two weeks after the event.
- Bank of America Merrill Lynch Global Healthcare Conference 2018, London, UK, September 11-14, 2018
Sangamo’s presentation is scheduled for 3:25 p.m. BST on Wednesday, September 12th.
Webcasting services are not provided at the Bank of America Merrill Lynch conference.
SB-913 Conference Call
Sangamo will host a conference call on September 5, 2018, at 9:00 a.m. ET, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 8798741. For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 8798741.
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