Weight Watchers (WTW) Tops Q1 EPS by 50c, FY EPS Guidance Beats

Weight Watchers (NYSE: WTW) reported Q1 EPS of $0.56, $0.50 better than the analyst estimate of $0.06. Revenue for the quarter came in at $408 million versus the consensus estimate of $388.49 million.

GUIDANCE:

Weight Watchers sees FY2018 EPS of $3.00-$3.20, versus the consensus of $2.57.

https://bit.ly/2juF0Bv

FDA on the hunt for its own EHR system

The Food and Drug Administration is looking for a “large electronic medical record system” to conduct research about adverse drug reactions.

The FDA’s Bioinformatics and Biostatistics Division will use the EHR to look into the “safety and surveillance of FDA regulated products,” according to the request for quote the agency posted earlier this week. Specifically, researchers will analyze VA data to look for adverse side effects from medications. It will use the EHR to develop “novel data mining and data visualization” to apply to the data.

Right now, those data exist in different versions of VistA, the VA’s home-grown EHR.

But they might eventually exist elsewhere. Since announcing almost a year ago it would switch to a Cerner EHR, the VA has been mired in contract delays. This week, several House Democrats asked the VA to investigate whether recent delays were due to unofficial presidential advisers getting involved in the negotiations.

The lawmakers were concerned specifically with the VA’s current level of interoperability, which they and the GAO said is lacking. Should the contract go through, the VA would eventually use the same EHR system as the Defense Department.

https://bit.ly/2roPhE3

House unveils VA Choice compromise bill

A key House committee on Thursday released compromise legislation to move forward with long-stalled VA Choice reforms.

House and Senate lawmakers and administration officials for months brokered a package that would require VA facilities to meet certain standards or release veterans to community providers, as well as launch a mandatory review of all the VA’s medical assets. Congressional and administrative aides view the House introduction as the quickest way forward for the legislation. The House Veterans Affairs Committee scheduled a markup for May 8.

President Donald Trump wants to sign the package into law by Memorial Day and urged swift movement on Choice over the last few weeks. Hours before House VA Committee Chair Phil Roe (R-Tenn.) released the legislation, the president took to Twitter to discuss it again.

“This spring marks 4yrs since the Phoenix VA crisis,” Trump tweeted. “We won’t forget what happened to our GREAT VETS. Choice is vital, but the program needs work & is running out of $. Congress must fix Choice Program by Memorial Day so VETS can get the care they deserve. I will sign immediately!”

The legislation is called Maintaining Internal Systems and Strengthening Integrated Outside Networks, or MISSION, Act.

The White House fully backs the MISSION Act, an aide told Modern Healthcare. The Trump administration has maintained steady pressure on lawmakers to keep working even amid the fallout from the firing of former VA Secretary Dr. David Shulkin and through allegations about his proposed replacement Dr. Ronny Jackson, who ultimately withdrew his name from consideration.

It isn’t clear how quickly the package could move through the House and Senate. A GOP Senate VA Committee aide told Modern Healthcare that the committee majority supports the legislation but did not respond to a question on timing.

A spokesperson for the House VA committee’s Ranking Democrat Jon Tester of Montana did not respond to a request for comment on his position. Tester supported the earlier draft version of the VA Choice reform bill that Congress failed to pass with the March spending omnibus. He urged his fellow lawmakers to pass the reforms for months.

The MISSION Act includes provisions from a bill Sens. Jerry Moran (R-Kan.) and John McCain (R-Ariz.) introduced in December 2017. Moran wanted to set into law certain access standards VA medical clinics must meet before releasing a patient to community care.

As part of the Moran provision, the VA must also set quality measures determined from surveys of veterans that show their satisfaction with timeliness, safety, efficiency and quality of care at VA medical clinics or centers within the past two years. Another provision from Moran-McCain mandates a deep study of the VA’s and community providers’ caring capacity as well as demand versus capacity at VA medical centers across the country.

Moran pushed these measures with the committee and had a public altercation with former Shulkin over what he viewed as Shulkin’s reluctance to support codifying the access standards into law. On Thursday, Moran came out with strong support for the current package.

“I have long been a vocal advocate for giving veterans greater choice and flexibility in their health care,” Moran said in a statement. “After months of extensive debate and negotiations, I am pleased Rep. Phil Roe introduced legislation to reform VA healthcare and fund the Choice Program until the new program created by this bill is up and running.”

The House GOP VA Committee noted that the MISSION Act largely reflects the compromise legislation lawmakers and the administration had quickly hammered out in March in order to try to include it with the $1.3 trillion spending omnibus. House Democrats blocked it, however, saying that rather than streamline the Choice program the partial agreement created uncertainty in the VA budget, “opened the floodgates to privatizing VA’s mental health services and beyond,” and removed congressional oversight on the VA’s infrastructure.

In addition to the new expansions of community care, the MISSION Act includes a $5.2 billion boost to keep the current Choice program running until the VA can implement the new one. VA Choice is expected to run out of money and shut down by mid-June if Congress does not appropriate additional funding.

Lawmakers, aides and veterans groups that have worked closely with the legislation believe that the uncertainty around future leadership of the VA won’t stop the package from smooth sailing to the president’s desk.

Acting VA Secretary Robert Wilkie promised he “will work with House and Senate leaders to get this done on President Trump’s timetable.”

Trump has not yet nominated another candidate to replace Shulkin, while rumors continue to rumble around Washington over whom he will pick. Ascension President and CEO Anthony Tersigni, former Florida GOP congressman Jeff Miller, who served as House VA Committee chair, and even Trump’s chief of staff John Kelly have all been floated as possible nominees.

https://bit.ly/2KwnTvA

FDA chief questions protections on drug rebates

U.S. Food and Drug Administration chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing.

Gottlieb was referring to the common practice of pharmaceutical companies setting a high “list price” for a drug, and then lowering the cost for health plans through hefty rebates in exchange for the broadest access to patients. In recent weeks, he has criticized these practices for keeping drug prices high and locking out competitors.

“What if we took on this system directly, by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute?” Gottlieb said in remarks prepared for a Food and Drug Law Institute conference and posted on the FDA’s website.

“Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition.”

The anti-kickback law makes it illegal to pay an incentive for drugs or services that Medicare, Medicaid or other federal healthcare programs cover.

President Donald Trump is expected to unveil new proposals next week to curb rising drug costs for Americans and until recently, Wall Street had expected that they would stop short of measures that would have a major impact on drugmakers.

However, Health and Human Services Secretary Alex Azar on Wednesday signaled Trump’s intention to take stronger action. Gottlieb’s remarks on Thursday suggested the administration would take a harder line.

“The speeches by Azar and now Gottlieb increase the uncertainty and show a willingness by the administration to get more aggressive,” Evercore ISI analysts Ross Muken and Michael Newshel wrote in a research note. “The government could threaten fines or other legal action to force changes in the rebate system that could potentially pressure the gross-to-spread and impact economics in the drug channel.”

The shares of some drugmakers fell after Gottlieb’s comments. Biogen Inc lost 2.8 percent to $266.44, Celgene Corp dropped 1.7 percent to close at $85.40 and Amgen Inc fell 1.7 percent to $166.39.

The administration and members of Congress have demanded that insurers and pharmacy benefit managers pass on more of the rebates they receive to consumers outraged over rising costs at the pharmacy counter. Many Americans now have health plans with higher deductibles or co-payments, making them responsible for more of their medical costs.

In his speech, Gottlieb also focused on a need to encourage competition between drugmakers by changing policies allowing them to take temporary advantage of protections under Medicare’s prescription drug plan.

The FDA chief also repeated previous calls to close loopholes that can delay the entry of generic drug competition, including for so-called “biosimilar” versions of biotech drugs.

https://reut.rs/2waBYf9

CRISPR-edited liver cell transplant could replace life of injections for hemophilia B

A Salk Institute team transplanted liver cells into mouse models of hemophilia B, finding that the treatment restored their ability to form blood clots for a year. The hope is that this one-and-done treatment could replace the frequent injections of clotting factors that are currently used to treat the inherited blood disorder.

Hemophilia B is caused by a faulty F9 gene, which codes for clotting factor IX (FIX). Hemophiliacs produce limited amounts of FIX, or none at all, which causes potentially life-threatening prolonged bleeding. To ward off abnormal bleeding and its complications, patients receive regular injections of clotting factors, sometimes multiple times a week. This treatment is expensive and time-consuming. And because it requires an injection, patient adherence can become an issue.

The Salk scientists previously tried to address the genetic defect by injecting mice with messenger RNA encoding the FIX gene. While their blood was able to clot within hours of the treatment, its effects lasted less than a week, necessitating constant injections.

So they set about to find a more permanent solution. FIX is made in the liver, so they thought transplanting liver cells into hemophilic mice might restore FIX production.

To avoid supply issues that come with organ donation, the researchers decided to grow synthetic livers. They took blood cells from patients with hemophilia B and reprogrammed them into induced pluripotent stem cells. They then fixed the genetic mutation using CRISPR and nudged the cells to become liver precursor cells, called hepatocyte-like cells (HLCs).

They injected the HLCs into the mice and found the treatment restored clotting function. The improvement was “at least 10-fold higher than the levels that would be needed for a significant improvement in treating the disease,” they wrote in their study. And it was durable—the HLCs survived in the mice and continued making FIX for at least one year after transplantation. The study is published in Cell Reports.

First author Suvasini Ramaswamy, who recently left Salk for Boston Consulting Group, cautioned that more work is needed before the approach can be translated into humans. But creating healthy, FIX-producing HLCs from a patient’s own cells could prevent immune complications that often accompany cell therapies, the team said.

While patients with hemophilia can control bleeding with clotting factors and drugs, there is no cure for the disorder. Spark Therapeutics’ gene therapy SPK-9001 aims to tackle the same mutation as Salk’s method. But rather than editing the gene before infusing healthy cells into the patient, it does so by delivering a functional copy of the gene to the patient.

One-year data from a phase 1/2 trial showed that nine out of the 10 hemophilia patients had no bleeding episodes after undergoing the gene therapy. Eight of them no longer needed FIX infusions. A December editorial in the New England Journal of Medicine suggested that replacing clotting factor infusions with gene therapy could save up to up to $200,000 per patient per year in healthcare costs.

https://bit.ly/2FGT4R9

Spectrum Licenses Cancer Med to MD Anderson Cancer Center

 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today an exclusive licensing agreement with The University of Texas MD Anderson Cancer Center for intellectual property related to certain methods of use of poziotinib.

“We have been aggressively pursuing the potential of exon 20 mutations and treatment with poziotinib since the inception of our relationship with MD Anderson, but we’ve both only begun to scratch the surface of the science and poziotinib’s potential as a targeted treatment for various solid tumors,” said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. “Late-stage poziotinib clinical data targeting the exon 20 mutations are promising, and we are thrilled to enter this new agreement that strengthens and potentially extends our patent protection until 2037 as we continue this journey of discovery together.”

“Dr. John Heymach and his Lung Cancer Moon Shot team uncovered the potential of Spectrum’s drug poziotinib to help a neglected group of lung cancer patients and then worked closely with the company to bring this targeted therapy to clinical trial rapidly,” said Ferran Prat, Ph.D., J.D., MD Anderson senior vice president, research administration and industry relations. “We are delighted to continue our collaboration with Spectrum under this agreement, which highlights how MD Anderson allies with private sector partners to provide new options for cancer patients.”

Under the terms of the agreement, Spectrum has been granted a license that includes rights to filed patents related to exon 20 as well as any unidentified discoveries related to the use of poziotinib that may come from Dr. Heymach’s lab at MD Anderson in the future. The filed patents, if granted, are expected to extend the intellectual property protection to 2037. This agreement with MD Anderson further solidifies and extends Spectrum’s intellectual property protection for poziotinib.

Poziotinib is a novel, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture, and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

https://bit.ly/2riyiD5

FDA Issues Complete Response Letter to Novartis’ Copycat of Roche’s Rituxan

The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to Sandoz,a division of Novartis, for its Biologics Licensing Application (BLA) for its biosimilar to Roche/Genentech’s Rituxan.

Rituxan is used to treat blood cancers and some immunological diseases. It brings in around $4 billion per year in U.S. sales.

A CRL isn’t exactly a rejection, although it can be perceived as such. It typically outlines why the FDA is not currently approving a product, typically leading to steps that can be made by the company to fix them.

Reuters notes, “Deutsche Bank analyst Tim Race said Rituxan could now remain free from biosimilar competitors in the United States this year, with erosion threatening only from 2019…. Race said he had been expecting a sales loss to biosimilars of about $150 million in 2018 and Roche earnings would be around 0.5 percent higher if this was removed. For 2019, Race assumes a $1 billion fall in U.S. Rituxan sales versus 2017, so if biosimilars enter from mid-2019 there could be an earnings uplift of about two percent.”

Last month, the FDA issued CRL letters for Celltrion’s biosimilars to Roche’s Herceptin and Rituxan. The rejections appeared to be related to issues with Celltrion’s manufacturing facility. In February, the European Medicines Agency (EMA) approved Celltrion’s Herzuma, a Herceptin copycat, for early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The EMA approved Celltrion’s Truxima, a biosimilar for Rituxan last year.

Last year, Celltrion partnered with Israel’s Teva Pharmaceutical to commercialize Truxima in the U.S. and Canada. The deal, which was $160 million upfront, also included Celltrion’s Herzuma. Genetic Engineering & Biotechnology News notes the deal “was made after the firm’s previous Truximab partner Pfizer passed back its rights to the drug when it bought the biosimilars developer Hospira for $17 billion in 2015. Pfizer held on to its U.S. partnership with Celltrion for the inifliximab (Janssen Biotech’s Remicade) biosimilar, Inflectra (Remsima in Euurope), which won FD approval in April 2016.”

In a statement, Sandoz said it “stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to U.S. patients as soon as possible.”

The U.S. has been slow to approve biosimilars compared to Europe. But there the biosimilars market is having a significant effect on the name brand products they are designed to compete with. For example, in the first quarter of this year, Rituxan sales dropped by 44 percent in Europe due to biosimilar competition.

Reuters writes, “The tussles in the biosimilars market are a growing focus for investors, with soaring valuations for some pioneers in the field, such as South Korea’s Celltrion, and worries about the long-term sales threat to makers of original drugs, such as Roche and AbbVie. Overall, U.S. regulators have lagged behind Europe in approving biosimilars, while a complex system of rebates offered to insurers by original-brand drugmakers has also created barriers to use.”

https://bit.ly/2w7WAon