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Thursday, May 31, 2018

Oncologist group sues to stop sequester cuts to cancer drug reimbursement

A national nonprofit organization representing oncologists filed a lawsuit on Wednesday against the Trump administration calling for an end to "illegal" cuts that impact cancer drug reimbursement.
The Community Oncology Alliance filed the suit (PDF) in the U.S. District Court for the District of Columbia, saying the Centers for Medicare & Medicaid Services should stop applying a 2% sequester cut to Medicare Part D drug reimbursement. The application of that cut to Part B reimbursement is "illegal and unconstitutional," the COA said in a statement.
"What's interesting about Part B drug reimbursement, as opposed to any other Medicare reimbursement, is that Medicare Part B reimbursement to physicians is defined in law. That rate is defined in law as average sales price plus 6%," said Ted Okon, executive director of COA, in an interview with FierceHealthcare. He was referring to the Medicare Modernization Act of 2003. "It's an overreach of the executive branch in terms of basically bypassing the Congress," Okon said.
The U.S. Department of Health and Human Services and the White House Office of Management and Budget are both named in the lawsuit. Neither had yet returned a request for comment on Thursday morning by press time.

The automatic across-the-board sequestration cuts have been applied to the Part B program since 2013 under the Obama administration. COA said it has raised concerns about their negative impact on the nation's cancer care system since with members of Congress and representatives at both HHS and OMB under both the Obama and Trump administrations.
The cuts hurt patients in the form of less access to cancer care as treatment is pushed into higher cost hospital settings, Okon said. Since sequestration cuts began being applied in 2013, about 135 independent community cancer clinics have closed and about 190 clinics have been acquired by hospitals.

"It has literally been a slow drip of torture" on the bottom line of independent practices which administer these drugs and have to cover the costs associated with procuring, preparing and disposing of cancer drugs for patients, he said. "It's pushed practices toward the hospitals. The hospitals, with half of them having 340B discounts, are ready to basically take the practice. Then when the patient goes into the hospital, the billing is done by the hospital system and patients pay more," Okon said. This also drives up overall costs to Medicare. COA research estimates consolidation cost Medicare (PDF) an extra $2 billion in 2014.
Most recently, he said the group received a letter from CMS which defended the application of the sequester cut to Medicare, Okon said. "This was a last resort. We were getting nowhere and exhausted every possibility," he said about the lawsuit.
COA said it also submitted a letter (PDF) to HHS Secretary Alex Azar explaining the legal action, as well as explaining concerns about how recent proposals to change Medicare Part B under the president's blueprint on drug prices would hurt cancer patients. For example, research released by Avalere Health last week finds that Medicare out-of-pocket costs vary significantly and in 2016, the average cost to patients for Part D covered cancer therapies was $3,200, compared to $2,400 under Part B, a 33% difference. The main driver between the cost difference is common use of supplemental coverage under Part B, which is limited under Part D.
https://bit.ly/2xtTFqL

FDA unveils guidance aimed to make it easier for generics to enter drug market

The Food and Drug Administration has officially unveiled new guidance that aims to increase competition in drug markets.

The agency released a pair of draft guidance documents that could allow generic drugmakers to apply to create their own Risk Evaluation and Mitigation Strategy (REMS) program if they’re struggling to acquire samples from branded companies to use in drug development.

FDA Commissioner Scott Gottlieb, M.D., previewed the plans earlier this month. The first guidance document (PDF) provides details on what a REMS program should look like, while the second (PDF) outlines when the FDA will consider the waivers.

Generic drug companies argue their brand-name peers can use REMS to hinder competition and make it harder for them to bring generics to market. Brand-name drugmakers have said there are a number of scenarios beyond gaming that could delay REMS agreements and said they can’t sell samples to generic companies because those competitors have not agreed to REMS limits.

Gottlieb said in a statement that the goal of the new guidance is to maintain the safety protocols REMS provide while also making it easier for generics to enter the market.

“The REMS shouldn’t become a tool that drug companies use to delay or block competition from generic products or hinder their entry to the market,” Gottlieb said.

Having a more clearly defined set of parameters for REMS should enable companies to operate better within them, according to the FDA. An efficient REMS program will promote, not hinder, drug market competition.

However, the FDA said it will consider waivers at any time, according to the document, though it does seek to encourage companies to effectively band together under the shared REMS system first.

“Our safety programs shouldn’t be leveraged as a way to forestall generic entry after lawful [intellectual property] has lapsed on a brand-name drug,” Gottlieb said. “Our market-based system for rewarding innovation is dependent on this kind of legal competition.”

The FDA rolled out its first initiative under the Trump administration’s “American Patients First” blueprint to reduce drug pricing in mid-May, when it launched a website that would detail which brand-name drugs generic drug companies had the hardest time accessing.

Gottlieb said at the time the website would ensure “branded companies are on notice” for behavior that could hold generic drugmakers back.

The FDA is also planning to reveal policies that overhaul its drug approval process in early June, Gottlieb said.

Department of Health and Human Services Secretary Alex Azar praised the FDA’s actions in a statement, saying the agency will “continue taking action to promote competition.”

“The FDA’s announcement today will help generic drug manufacturers bring low-cost competition to market faster and discourage brand-name companies’ misuse of laws meant to protect public health,” Azar said. “Greater competition in drug markets is one of the key pieces of our plan to bring down drug prices.”

https://bit.ly/2smTubB

Kitov Osteoarthritis Pain-Hypertension Combo Med OKd by FDA

Kitov Pharma Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Consensi™ (amlodipine and celecoxib) oral tablets for marketing.

Consensi™ is a patent-protected combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium channel blocker. Consensi™ was approved for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain.

“We are very pleased with Consensi™’s approval and would like to thank the members of Kitov’s team, consultants and investigators, as well as the FDA’s Division of Cardiovascular and Renal Products, for all of their support and assistance,” said Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer. “Consensi™ provides a safe and effective combination treatment option for the millions of Americans who suffer from osteoarthritis pain and hypertension.

“Now that Consensi™ has been approved for marketing, our clinical and regulatory teams will focus on leveraging their drug development expertise to advance NT219, an exciting investigational new drug candidate currently in development for various oncology indications.”

Isaac Israel, Kitov’s CEO, added: “This approval demonstrates the Kitov team’s ability and experience in expertly guiding Consensi™ through clinical trials and regulatory review, from Investigational New Drug (IND) submission to FDA approval in less than four years.

“Over 50 million Americans suffer from osteoarthritis. About 1 of 3 U.S. adults or about 75 million people have high blood pressure*, known as the “silent killer” due to the absence of noticeable symptoms. As a result, patients’ adherence to the hypertension treatment regimen is low. We believe that Consensi™, as a single pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.

“We recently expanded our commercialization network for Consensi™ by securing a second licensing agreement in Asia with a major Chinese pharmaceutical company. The FDA approval of Consensi™ puts us in a stronger position towards securing commercial partnerships for the U.S. and other key territories.”

The FDA-approved Consensi™ New Drug Application included the positive results from the Company’s Phase III clinical trial. These data demonstrated that the study met its primary endpoint of showing that the drug lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine besylate only, with statistical significance of p=0.001. Kitov also submitted the positive results from its randomized double-blind, placebo-controlled renal function Phase III/IV clinical trial of Consensi™. Data from this study validated the primary efficacy endpoint achieved in the completed Phase III clinical trial. This study also demonstrated that treatment with Consensi™ led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005), demonstrating improved renal function in patients treated with the combination. In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.

https://yhoo.it/2H5PYqJ

Abbott announces corrective action for HeartMate 3 heart pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3 Left Ventricular Assist Device, according to a statement on the FDA’s website. Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting. No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by Abbott remain in place for physicians managing patients implanted with HeartMate 3. Abbott is currently aware of 32 reports of outflow graft twisting in 4,467 HeartMate 3 devices worldwide, including reports of low blood flow, clotting, and three reported deaths that could be associated with outflow graft twisting. As a result, Abbott has contacted physicians managing patients implanted with a HeartMate 3 LVAD in the event their patients report persistent low flow alarms that could indicate outflow graft twisting. Twisting of the outflow graft can occur at any point after implant.

https://bit.ly/2kCTVKD

Mass layoffs at IBM Watson Health

IBM (NYSE:IBM) has reportedly laid off 50% to 70% of the workforce at its Watson Health operation, primarily at recent acquisitions for which Big Blue paid at least $3.6B.

Those include cloud-based services Explorys and Phytel, as well as medical image company Merge Healthcare and Truven Health Analytics.

One former employee wrote “the message was that there are about 7,000 people in Watson Health today and this was a cost-cutting exercise.”

Statement from IBM: IBM is continuing to reposition our team to align with our focus on the high-value segments of the IT market. We continue to hire aggressively in critical new areas that deliver value for our clients and IBM.

We’re not discussing specific numbers of employees affected, but it’s a small percentage of our global Watson Health workforce, as we move to more technology-intensive offerings, simplified processes and automation to drive speed.

https://bit.ly/2LKMmxM

Alder target for Allergan, Biogen? RBC

Developments at Allergan, Biogen indirectly positive for Alder, says RBC Capital. RBC Capital analyst Brian Abrahams noted that both Allergan (AGN) and Biogen (BIIB) have been viewed as companies that could potentially be interested in acquiring or partnering with Alder Biopharmaceuticals (ALDR) and he makes the case that developments in the past day or so for both of those large-cap drugmakers are indirectly positive for Alder. In terms of Allergan, Abrahams thinks the company stating that it plans to keep a primary care infrastructure to sell CGRPs and other CNS products maintains the likelihood they might have interest in Alder’s eptinezumab either as an acquisition or in a partnership. In terms of Biogen, Abrahams thinks the company’s hiring of a leader for a newly-created corporate development function who has extensive experience in business development potentially lays the groundwork for them to explore assets such as eptinezumab. The analyst maintains an Outperform rating and $24 price target on Alder shares.

https://bit.ly/2svRdtV

Alzheimer’s Firm Cortexyme Closes $76M Financing with Pfizer, Takeda, Google

South San Francisco-based Cortexyme closed on a $76 million Series B financing round. New investors included Sequoia Capital, Vulcan Capital, Verily Life Sciences (a Google/Alphabetcompany), EPIQ Capital Group, RSL Investments, Huizenga Capital, and one of the largest long-term mutual funds in the world. The company’s current investors also participated, including Pfizer, Takeda, Ventures, Lamond Family, Breakout Ventures, and Dolby Family Ventures.

In addition to the financing, the company reported it had completed a placebo-controlled single ascending dose trial and multiple ascending dose trial in healthy patients of COR388, the company’s lead compound to treat Alzheimer’s disease. The drug is a first-in-class, oral bacterial protease inhibitor that targets a specific pathogen discovered in the brains of patients with Alzheimer’s. It was originally discovered by the company’s co-founder and chief scientific officer, Stephen Dominy.

The company has engineered the compound to inhibit the pathogen in ways that a broad spectrum antibiotic can’t. It has the potential to rescue neurons from bacterial toxicity, which might prevent more cognitive decline in Alzheimer’s patients.

“Alzheimer’s has been a major medical and societal challenge for decades, and new approaches are clearly needed,” said Michael Dixon partner at Sequoia Capital, in a statement. “Cortexyme is approaching an old problem in a whole new way—moving upstream to target an underlying driver of disease. Sequoia is pleased to partner with the Cortexyme team as they move through Phase I clinical development and rapidly plan for later-stage trials to address conditions that affect millions of patients worldwide.”

Cortexyme began its existence in Johnson & Johnson’s JLABS accelerator facility in the Bay Area. Its successful completion of animal studies and a Phase I safety study in older healthy individuals lays the groundwork for a Phase II human clinical trial.

The predominant approach to Alzheimer’s drugs is focused on beta-amyloid, a protein plaque that accumulates in the brains of Alzheimer’s patients. Although still the leading theory, study after study has failed in Phase II and Phase III trials, typically for lack of efficacy. It has cast doubt on the beta-amyloid theory, at least among investors if not necessarily in the minds of scientists.

As recently as May 18, Johnson & Johnson shuttered a clinical trial of atabecestat, a BACE inhibitor, for Alzheimer’s disease. Instead of issues with efficacy, the program was halted because of safety issues. BACE1 is an enzyme involved in creating beta-amyloid.

Other recent high-profile Alzheimer’s failures include Merck & Co’s verubecestat, Axovant’s intepirdine, Eli Lilly’s solanezumab, Lundbeck’s idalopirdine and many others.

Cortexyme’s approach is different and caught the attention of a number of marquis investors. Casey Lynch, Cortexyme’s co-founder and chief executive officer stated, “Cortexyme is glad to count among its supporters some of the world’s most successful investors in innovation, both in the pharmaceutical industry and beyond. Our streamlined, efficient approach to drug development allowed us to move from seed funding to Phase I data in less than four years. We’re committed to continuing to move swiftly through Phase II proof of efficacy studies in service of bringing new therapies to patients suffering from Alzheimer’s and related conditions.”

https://bit.ly/2sv8HXt

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Thursday, May 31, 2018