Cantor Fitzgerald analyst Louise Chen thinks FDA approval of Amgen’s (AMGN) Aimovig is positive for Teva (TEVA) as well as other new potential migraine treatments coming to the market because it underscores the large unmet need. She notes, however, that Teva does not expect approval until later this year given its manufacturing issues. The analyst keeps a Neutral rating on Teva with an $18 price target.
Friday, May 18, 2018
Epizyme target upped by Wedbush
Epizyme price target raised to $25 from $20 at Wedbush. Wedbush analyst David Nierengarten raised his price target on Epizyme to $25 from $20, telling investors in a research note that abstracts from The European Hematology Association show responses are deepening in the EZH2-wt follicular lymphoma cohort, increasing his confidence that tazemetostat will find a broad use in FL regardless of mutation status. However, the analyst noted that he is “less certain” on the future for the drug in mesothelioma, where low response rates seen in a Phase 2 trial indicate a more challenging path forward.
Insys pain med misses FDA panel support
Shares of Insys Therapeutics (INSY) are moving lower in pre-market trading after the FDA posted documents in advance of the joint meeting of AADPAC and DSaRM to discuss a new drug application from Insys for a sublingual spray formulation of buprenorphine with the proposed indication of the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The proposed tradename for this product is Buvaya. The briefing document prepared by the FDA staff states: “In conclusion, the Applicant’s efficacy data demonstrate superiority of BSS over placebo for all doses tested, however time to onset of analgesia is later than is optimal for a drug intended to treat acute pain and the need for rescue analgesic was high. From a safety perspective, there is an unexpectedly high rate of nausea, vomiting and dizziness for BSS. And the Applicant showed in a comparative safety study that rates for BSS are markedly higher than rates for other opioids used in similar acute pain settings. The totality of data submitted by the Applicant does not support the use of this product in an acute pain setting, based on both efficacy and safety findings.” In pre-market trading, Insys shares are down 39c, or 5%, to $6.95.
https://bit.ly/2k6XzfB
https://bit.ly/2k6XzfB
J&J Kills Early Alzheimer’s Program
Johnson & Johnson’s Janssen division has decided to end its trials of atabacestat, a BACE inhibitor, for Alzheimer’s disease.
The company indicates that it is shuttering the program because of safety issues, rather than any question about the drug’s efficacy. Patients in the EARLY Phase IIb/III clinical trial with preclinical Alzheimer’s disease, as well as a Phase II long-term safety trial, had elevated liver enzymes. EARLY launched in 2015 and was scheduled to wrap in 2024.
The company stated that “the benefit-risk ratio is no longer favorable to continue development of atabacestat for people who have late-onset preclinical stage Alzheimer’s disease.”
Despite the setback, the company indicates it “continues to maintain a strong commitment to discovery and developing new treatments for this devastating disease.”
BACE1 is an enzyme involved in creating beta-amyloid, which forms and causes plaques in Alzheimer’s patients. It is the predominant theory about the damage caused by Alzheimer’s disease, although a very long string of drug failures has cast doubts on the theory.
Other companies have had failures with BACE inhibitors as well, including Eli Lilly for two of its drugs, including LY2886721, which also showed liver toxicity, and Roche’s RG7129.
In February, Merck & Co.’s verubecestat (MK-8931), being evaluated in the APECS Phase III trial, was halted after an external Data Monitoring Committee (eDMC) recommended ending it after an interim safety analysis. The committee indicated that the likelihood of benefits didn’t outweigh the risks.
Although many companies are still continuing work on developing treatments for Alzheimer’s, notably Biogen, it seems that a month doesn’t go by without news of a failed Alzheimer’s clinical trial.
Tim Anderson, an analyst with Sanford C. Bernstein & Co. was reported by Bloomberg to say, “Because the risk of failure is high, we have not been willing to give these compounds the benefit of the doubt. Neuroscience drug development is tricky, and Alzheimer’s disease is the trickiest of them all, it seems.”
FierceBiotech reports that Bernstein analysts queried Janssen’s head of research and development Roger Perlmutter last month on its Alzheimer’s portfolio, and he said the company was going to continue with Alzheimer’s work and BACE inhibitors.
“According to the analysts,” FierceBiotech writes, “Perlmutter said one of the imperatives is to gain a better understanding of the natural disease process so as to identify people early on who are at risk of developing Alzheimer’s. It’s also important to understand the nature of that progression and subset people into those that will progress early versus late, and then direct the right therapies to the right patients.”
Recent efforts, such as the relevant Janssen trials, have focused on patients with earlier and earlier stages of the disease. At least part of the rationale is to try and prevent the accumulation of beta-amyloid before it causes damage to the brain. Although many of the drugs developed to stop the development of beta-amyloid, and even clear it from the brain, are effective in doing so, study after study has shown that it doesn’t reverse the damage to cognition and memory. As a result, companies are working with patients with far earlier signs of the disease. So far, no luck.
Sweeping veterans policy bill passed overwhelmingly in the House
House lawmakers advanced a $52 billion veterans legislative package on Wednesday that would overhaul outside medical care options for Department of Veterans Affairs patients, expand stipends for veteran caregivers and launch a review of the bureaucracy’s national footprint.
Despite the cost of the plan, the measure easily passed the chamber by a vote of 347-70 and has the blessing of the White House, which said the legislation “will help to ensure that veterans choose the VA by getting them the right care at the right time with the right provider.”
It’s expected to move quickly through the Senate, with that chamber’s top Democrat on veterans issues — Montana’s Jon Tester — saying earlier in the day he supports the package, and Republicans in the chamber already offering support.
Lawmakers have until the end of the month to finalize legislation, including new funding for the department’s controversial Choice program or risk disrupting health care for tens of thousands of veterans using the account.
House Veterans’ Affairs Committee Chairman Phil Roe, R-Tenn., dismissed concerns from critics about the scope and cost of the measure, particularly charges that the package is part of a slow erosion of VA responsibilities and services.
“Opponents of this bill will tell you, falsely, that it is aimed at eventual privatization of the VA health care system,” he said just before the vote. “That misconception is based on nothing but fear and rhetoric.
“A yes vote is a vote for access, for quality, for choice, for the long-term success and sustainability of the VA health care system, for caregivers and for veterans.”
Among the legislation’s opponents (all Democrats) was the committee’s ranking member, Minnesota Democratic Rep. Tim Walz, who voiced concerns that Republicans rejected proposals to exempt the costs from mandatory budget caps scheduled to take effect in coming years.
He also said that implementation of the massive veterans bill will fall to President Donald Trump’s administration, which “has been 40 days without a VA secretary” since the firing of VA Secretary Shulkin two months ago.
** VA Choice and community care
The legislation, dubbed the VA Mission Act, is the culmination of nearly a year of work on the contentious issue of VA community care.
More than one-third of all VA-funded medical appointments last year took place in offices outside the Veterans Health Administration, but administration officials have pushed for more access to private-sector doctors to increase options for veterans facing long waits or travel for federal care.
In 2014, lawmakers passed the VA Choice program with that same idea. The program handles around 30,000 outside medical appointments a day, but has come under fire from conservatives for being too restrictive and bureaucratic for veterans looking for options outside VA.
Last month, acting VA Secretary Robert Wilkie said the Choice program will run out of money by the end of this month. The VA Mission Act include $5.2 billion in bridge funding to keep that program running for another year, until it is consolidated with other department care programs.
That consolidation is expected to simplify and expand the rules for accessing outside care, but still keeping VA officials involved in veterans’ over health care plans.
It requires veterans become eligible for private-sector care options if VA does not provide adequate medical options for patients, including long travel times, long wait times or poor service ratings. It revises payment rates for community care to Medicare rates, to ease concerns about reimbursement for those visits.
It would also authorize two walk-in visits at local private-sector offices for any veterans who have used department health care services in the last two years. Those appointments may require a co-pay.
Critics of the plan — including federal unions — have said the changes are a major step towards privatizing VA health services by shifting billions of dollars from VA accounts to private companies. They’ve also accused the White House of working towards that goal, in an effort to hollow out VA.
But VA officials have defended the idea as modernizing VA operations, and acknowledging that the medical needs of millions of veterans cannot be shouldered by the department alone.
Numerous House Democrats, who in the past have warned about the privatization push, backed the new legislation, saying it strikes the balance between medical access and preserving the department.
** Caregivers and asset review
In order to attract that Democratic support, Republican House leaders added a dramatic expansion of the current VA caregivers stipend to the measure.
The issue has been a top priority of veterans organizations in recent years, since currently only caregivers of veterans from the post-9/11 era are eligible for monthly stipends through the department. The new proposal would expand that to veterans of all eras, first starting with pre-1975 veterans and later phasing in the remaining group over two years.
The obstacle in getting that expansion has been the cost. The Congressional Budget Office estimates that more than 41,000 caregivers could be added to the program over the next five years, at a cost of nearly $7 billion. But that bill is expected to rise even more in following years.
But the community care overhaul is expected to total more than three times that total by 2023, making it a more palatable concession in the context of the larger legislative package.
The asset review portions of the package resembles the framework of the Defense Department’s base closure and review commissions, although supporters have bristled at the comparison.
Under the plan, the president would establish a nine-member Asset and Infrastructure Review Commission, with representatives from veterans service organizations, the health care industry, and federal facility management.
The panel would meet in 2022 and 2023 to issue recommendations on “the modernization or realignment of Veterans Health Administration facilities.” That could include closing, reducing or expanding a host of VA health facilities across the country.
The cost of that work is unknown. Lawmakers have been reluctant to back new military base closing commissions because of controversies surrounding the 2005 round, which produced disputed savings totals.
But VA officials have repeatedly warned that their current footprint includes hundreds of outdated or obsolete facilities, and department administrators have severe restrictions on managing those locations. Roe said a “politically insulated process” is needed to fix that “massive and misaligned physical footprint” of VA.
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** Veterans support
In advance of the House vote, 38 veterans groups issued a letter of support for the legislation, calling it “a major step towards … making improvements to and investments in the VA health care system, creating integrated networks so that veterans have access to care when and where they need it, and providing the further recognition and assistance to family caregivers of severely disabled veterans deserve.”
The list included the Veterans of Foreign Wars, Disabled American Veterans, Paralyzed Veterans of America, and Iraq and Afghanistan Veterans of America — all organizations that have repeatedly warned members about the threat of privatization to VA operations.
Denise Rohan, national commander of the American Legion, praised Wednesday’s vote as a critical step forward to “streamline and fund the Department of Veterans Affairs’ many community care programs, expand caregiver benefits to pre-9/11 veterans and their families, and review VA infrastructure holdings.”
The measure also received support from Concerned Veterans for America, which has close ties to the current White House and has argued against the privatization label in recent years.
“The Mission Act would go a long way towards resolving problems with the VA’s existing community care programs and stabilizing the VA’s health care system,” CVA Executive Director Dan Caldwell said in a statement. “We’re also encouraged that the MISSION Act mandates a long-overdue review of the VA’s infrastructure across the country.”
No timetable has been set for when the Senate may vote on the measure, but Senate Veterans Affairs Committee Chairman Johnny Isakson, R-Ga., said he hopes to take up the issue “without delay.”
In a gesture to colleagues, lawmakers changed the official name of the legislation to include Sen. John McCain, R-Ariz., Rep. Sam Johnson, R-Texas, and former Sen. Daniel Akaka, D-Hawaii. McCain and Johnson are both former prisoners of war, while Akaka (who died in April) was a longtime veterans advocate in his chamber.
Mannatech Commences Cash Tender for up to $16M of Its Common Stock
Mannatech, Incorporated (“Mannatech” or the “Company”) (MTEX), a global health and wellness company committed to transforming lives to make a better world, announces today it has commenced a modified Dutch auction cash tender offer to purchase up to $16 million of its outstanding common stock, par value $0.0001 per share, at a per share price not greater than $21.00 nor less than $18.50 (the “tender offer”).
The closing price of Mannatech’s common stock on The Nasdaq Global Select Market (“Nasdaq”) on May 16, 2018, two trading days prior to the commencement of the tender offer, was $15.65 per share. The tender offer is scheduled to expire at 12:00 midnight, New York City time, at the end of Friday, June 15, 2018, unless the offer is extended.
The Company believes that the repurchase of its stock pursuant to the tender offer is consistent with its ongoing goal to maximize shareholder value. The board of directors evaluated the Company’s operations, financial condition, capital needs, regulatory requirements, strategy and expectations for the future and believes that the tender offer is a prudent use of the Company’s financial resources and determined that a tender offer is an appropriate mechanism to return capital to shareholders that seek liquidity under current market conditions and allowing shareholders who do not participate in the tender offer to share in a higher portion of the Company’s future potential.
The tender offer is not contingent upon obtaining any financing; however, the tender offer is subject to certain terms and other conditions, which are described in the Offer to Purchase, dated May 18, 2018, and the related Letter of Transmittal and other materials pertaining to the tender offer that Mannatech has filed with the Securities and Exchange Commission (the “SEC”).
Georgeson Securities Corporation is the dealer manager for the tender offer. Georgeson LLC is serving as the information agent for the tender offer and Computershare Trust Company, N.A. is serving as depositary for the tender offer.
Hikma reaffirms full-year revenue forecast, cites better generics business
Hikma Pharmaceuticals Plc on Friday reaffirmed its revenue guidance for the full year, noting its generics business was performing better due to a favourable product mix, despite continued pricing pressure in the United States.
Shares of the company were up as much as 4 percent at the market open before settling up 0.7 percent at 0725 GMT.
The drugmaker, which was forced to cut revenue guidance for its generics business three times in 2017, said it continued to expect revenue from the business to be between $550 million (407 million pounds) and $600 million in 2018.
Sigurdur Olafsson, former generics chief at drug giant Teva Pharmaceuticals, was named Hikma’s chief executive officer in February.
The company suffered a setback in March for its generic version of GlaxoSmithKlineblockbuster lung drug Advair, after the U.S. Food and Drug Administration asked Hikma to conduct a further clinical study evaluating the drug, dashing hopes to get it to the market this year.
“The study is proceeding as planned and we expect to submit a response to the FDA with the new clinical data as early as possible in 2019”, the company said on Friday.
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