GW Pharmaceuticals Slaps Price Tag on Cannabis-Based Epilepsy Drug

GW Pharmaceuticals has finally revealed the price of its cannabis-based epilepsy drug Epidiolex. The medication, which is expected to be available by early fall, will have a $32,500 price tag.

Epidiolex was approved in June by the U.S. Food and Drug Administration (FDA) for the treatment of two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The company said the $32,500 price tag is in line with other branded antiepileptic drugs used to treat these conditions.

Julian Gangolli, North American president of Greenwich Biosciences, a subsidiary of GW Pharmaceuticals, said during a quarterly conference call that the pricing approach has been discussed with the patient community which it will serve. According to a call transcript, courtesy of Seeking Alpha, Gangolli said the payers are supportive of the rationale that “Epidiolex should be priced in line with the branded anti-seizure therapies prescribed for these intractable patients.”

“The analysis of the direct cost burden associated with LGS and Dravet syndrome in the U.S. showed a substantial cost burden for both conditions, and further highlights the need for this new therapeutic option,” Gangolli said.

GW Pharmaceuticals has implemented a patient support program to provide access to the new medication. The company said they have presented plans that could cover more than 80 percent of the patients who could use this medication in the United States. Prices could range from $5 to $10 per months on Medicaid programs and up to $200 per month under some private insurance programs, Gangolli said.

In preparation for the launch, GW Pharma said it has completed the groundwork for its U.S. commercial team ahead of the launch of Epidiolex. The commercial team includes sales, marketing and medical affairs professionals, the company said. There are two national directors, eight regional managers and 66 neurology account managers that will “target approximately 5,000 physicians who treat patients with LGS or Dravet syndrome,” Gangolli said during the quarterly call, according to a transcript.

The new commercial team has three primary responsibilities, Gangolli said. Those responsibilities include the promotion of the cannabis-based treatment, ensuring formulary access to Epidiolex and working with the local epilepsy chapters and caregiver groups.

Gangolli noted in the call that it may take time for physicians to become aware of Epidiolex, learn how to use it and adapt it for use in clinics. He said it may also take time for payers to provide reimbursement coverage.

Before the drug can be marketed though, the U.S. Drug Enforcement Agency will have to reclassify the medication for commercialization. Currently, all derivatives of the cannabis plant, including those that are not addictive, are classified as a Schedule I drug – something that is considered to have high abuse potential with no medical use. Epidiolex is derived from Cannabidiol (CBD), a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication like illicit use of marijuana. It’s the first in a new category of anti-epileptic drugs (AEDs), GW Pharma said.

GW Pharma Chief Executive Officer Justin Gover said the company is moving forward with plans for a fall launch of Epidiolex.

“The FDA has communicated its recommendation to DEA, and we understand that the rescheduling process is proceeding in a normal fashion and that it will be completed within the expected 90-day timeframe. We have been building commercial inventory in recent months and are in a position to ship product into the U.S. supply chain, once rescheduling is complete,” Gover said, according to the transcript.

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Deep Dive into Teva Financials Shows Significant Weakness and Optimism

Last week, Israel-based Teva Pharmaceutical released what tried to be an optimistic second-quarter financial report. Despite revenues that had decreased by 18 percent and softening sales of its biggest product, Copaxone, the company’s president and chief executive officer Kare Schultz said, “I am satisfied with our progress in the second quarter. The restructuring program is on schedule, we have already achieved a significant cost base reduction towards our target for the year and we continue to reduce our net debt.”

Investors and analysts, taking a deeper look at the company, do not appear to be nearly as optimistic. CTech, for example, noted that, “Over the past six quarters Teva’s North American sales have been in free fall. The company’s operating profit is in even worse shape. Mylan’s decision to slash the price tag on its generic Copaxone offering further threatens Teva’s revenues, meaning the company must hurry to provide the three potential trump cards it has up its sleeve.” Those trump cards are two possible strong products and major cost-cutting measures.

Much of the company’s troubles appears to be how hard it is being hit by cuts in generic drug prices, although some of it is related to Teva’s operations. The company picked up Actavis’generic business in 2016 for $40.5 billion. It appears that Teva may have been overly optimistic about this area’s profitability. In the first quarter of this year, Teva launched 10 generic drugs, but only one in the second quarter. CTech writes, “Teva’s first quarter generic sales in the U.S. were buoyed by the high sales of its exclusive generic version for Viagra, but those sales took a hit in the second quarter due to increasing competition.”

The company indicated it planned to launch 10 to 15 generics in the U.S. in the last five months of this year, and only launched one in July. Pricing pressures in the U.S. have eased up a bit since the second half of last year, so it is possible things will improve.

The company’s legal problems haven’t gone away either. Teva and Eli Lilly have been battling in court over five patents owned by Teva for its migraine drug fremanezumab. Lilly has a competing product, galcanezumab. Both are CGRP inhibitors. Lilly recently filed for an inter partes review of the five patents. Fremanezumab isn’t on the market yet, but the U.S. Food and Drug Administration (FDA) has a target action date of September 16, 2018, for the drug. Although, lawsuits notwithstanding, this looks promising, it’s not without its other hiccups. Celltrion’s manufacturing plant in South Korea, where fremanezumab is being made, received a warning letter earlier this year from the FDA after an inspection. However, a reinspection also found eight “observations,” ranging from failing to have written procedures for vial breakage to insufficiently trained employees. Celltrion said the citations were “manageable and correctable inspection observations” and believe they have it under control and won’t affect the PDUFA date.

It’s one of two drugs the company has a lot riding on, though, even if there will be competition from Lilly’s galcanezumab if it is approved, and Amgen, whose Aimovig was approved in the U.S. in May.

The other strong hopes for Teva are Austedo, a brand name drug for dyskinesia, which had sales of $44 million in the second quarter and continues to grow. It has a possibility of hitting $500 million in peak annual sales.

Teva’s cost-cutting and restructuring, as painful as it is, with 14,000 job cuts and the shuttering of half of its global manufacturing sites, is likely to help turn the company around. This should provide relief from its debt load, although some of the asset divestment and portfolio streamlining is likely to affect revenues, too, but should improve operating profit in 2019 and 2020.

Meanwhile, the company is moving its U.S. headquarters from North Wales, Pennsylvania to Parsippany, New Jersey. And Schultz, the sixth chief executive to try turn the company around since 2012, tries to assure investors that the company is on track. And although it did return to profitability in the first half of this year, revenue is still down 14 percent from last year.

New Jersey offered the company $40 million in potential tax breaks to get the company to move its U.S. headquarters there, which economist Joel Naroff told App looked reasonable given the spending power company employees bring with them, “assuming, of course, Teva survives.”

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FDA OKs New Apotex Generic Under Novel Pathway Aimed to Up Competition

The U.S. Food and Drug Administration approved a new generic potassium chloride oral solution under a novel term called the Competitive Generic Therapy designation. The new generic treatment, developed by Australia-based Apotex Inc., was approved to treat hypokalemia (low potassium blood levels) in patients who are on diuretics.

The FDA said the novel approval pathway was created to “expedite the development and review” of generic drugs that do not have any competition. The approval pathway could potentially close the door, or at least hinder, companies that significantly raise prices on a drug of which they are the sole manufacturer, like Turing Pharmaceuticals and the toxoplasmosis treatment Daraprim. After acquiring the nearly 70-year-old drug, the company raised the price by 5,000 percent. There were no other companies that manufactured the drug, so patients and payers were forced to pay the premium price for the medication.

FDA Commissioner Scott Gottlieb said the new Competitive Generic Therapy designation is designed to “encourage generic drug development for products with inadequate generic competition.” Gottlieb also noted that the new pathway was approved in its first cycle of review. He said that demonstrates the competitive generic therapy pathway is “efficient and open for business.”

“The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo,” Gottlieb said in a statement. “This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”

This novel pathway isn’t the only method the FDA has explored that could open the doors to greater generic competition for narrow supply chain generic drugs. Last month the FDA said it was looking to address such threats by potentially importing foreign drugs under a narrow scope if conditions develop (such as massive price hikes) that block patient access to drugs.

Apotex Inc.’s generic potassium chloride oral solution was approved to treat hypokalemia in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible. Low potassium levels can lead to abnormal heart rhythms, especially in people with heart disease.

The new generic designation was able to be implemented under recent authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA). Companies seeking approval under the new designation may receive review enhancements and expedited review of Abbreviated New Drug Applications, the FDA said. Additionally, applicants under this designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions, the FDA added.

The potassium chloride oral solution approved Wednesday is eligible for that 180-day period of exclusivity. The FDA said the applicant must commercially market the approved generic within 75 days of the regulatory approval or it will forfeit that exclusivity.

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New Guideline for Managing Vegetative and Minimally Conscious States

Accurate Diagnosis and Proper Management Could Improve Outcomes

For people in a vegetative or minimally conscious state caused by brain injury, an accurate diagnosis and ongoing medical and rehabilitative care based on the latest scientific evidence could mean a better chance for recovery, according to a new guideline by the American Academy of Neurology (AAN), American Congress of Rehabilitation Medicine and the National Institute on Disability, Independent Living, and Rehabilitation Research.

The guideline on prolonged disorders of consciousness is published in the August 8, 2018, online issue of Neurology^®, the medical journal of the AAN, and also published in the Archives of Physical Medicine and Rehabilitation. About four in 10 people who are thought to be unconscious are actually aware. This guideline gives recommendations to improve diagnosis, health outcomes and care of people with these disorders.

“People are sometimes misdiagnosed due to underlying impairments that can mask awareness,” said guideline lead author Joseph T. Giacino, PhD, of Harvard Medical School and Spaulding Rehabilitation Hospital in Boston. “An inaccurate diagnosis can lead to inappropriate care decisions and poor health outcomes. Misdiagnosis may result in premature or inappropriate treatment withdrawal, failure to recommend beneficial rehabilitative treatments and worse outcome. That is why an early and accurate diagnosis is so important.”

Consciousness is a state of being awake and aware of one’s self and surroundings. A conscious person is aware of things through thoughts and the five senses: sight, hearing, smell, taste and touch. A person with a disorder of consciousness has trouble being awake, or being aware or both. People in minimally conscious state have behaviors that show they are conscious, such as tracking people with their eyes or following an instruction to open their mouths, but the behaviors are often subtle and inconsistent.

A disorder of consciousness can be caused by a severe brain injury resulting from trauma, such as a fall, a car accident or sports injury. It can also be caused by a disease or illness, such as stroke, heart attack or brain bleed.

For the guideline, experts carefully reviewed all of the available scientific studies on diagnosing, predicting health outcomes and caring for people with disorders of consciousness, focusing on evidence for people with prolonged disorders of consciousness–those cases lasting 28 days or longer.

People with prolonged disorders of consciousness after a brain injury need ongoing specialized health care provided by experts in diagnosing and treating these disorders, the guideline states.

To get the right diagnosis, a clinician with specialized training in management of disorders of consciousness, such as a neurologist or brain injury rehabilitation specialist, should do a careful evaluation. The evaluation should be repeated several times early in recovery–especially during the first three months after a brain injury.

The outcomes for people with prolonged disorders of consciousness differ greatly. Some people may remain permanently unconscious. Many will have severe disability and need help with daily activities. Others will eventually be able to function on their own and some will be able to go back to work.

According to the guideline, approximately one in five people with severe brain injury from trauma will recover to the point that they can live at home and care for themselves without help.

There is moderate evidence that a person with a brain injury from trauma has a better chance of recovery than a person with a brain injury from other causes. Moderate evidence means future studies are unlikely to change the conclusion.

The guideline states that very few treatments for disorders of consciousness have been carefully studied. However, moderate evidence shows that the drug amantadine can hasten recovery for persons with disorders of consciousness after traumatic brain injury when used within one to four months after injury.

The guideline was endorsed by the American Academy of Physical Medicine and Rehabilitation, American College of Surgeons Committee on Trauma and Child Neurology Society.

Learn more about neurologic disorders at www.BrainandLife.org, the American Academy of Neurology’s free patient and caregiver magazine and website focused on the intersection of neurologic disease and brain health.

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Jefferies sees ‘excellent entry point’ for Sangamo after data

Jefferies analyst Maury Raycroft believes current share levels offer an “excellent entry point” into Sangamo Therapeutics following the company’s hemophilia A data. While early, the data is “looking good,” Raycroft tells investors in a research note. He believes Sangamo is aiming for best-in-class versus first-to-market. Two clinical catalysts for Sangamo have now been substantially de-risked, Raycroft contends. He recommends buying the stock and keeps a $28 price target for the shares.

https://bit.ly/2AWtkDl

Vaccinex 3.333M share IPO priced at $12.00

The deal priced at the low-end of the $12.00-$15.00 range. Oppenheimer and BTIG acted as joint book running managers for the offering.

https://bit.ly/2AWEEzb

Perrigo announces plans to separate Prescription Pharmaceuticals business

Perrigo announced that its board approved a plan to separate the company’s Prescription Pharmaceuticals, or Rx, business following the company’s previously announced strategic portfolio review. Continuing its focus on enhancing shareholder value, the board believes a separation of the Rx business will better enable this unique asset to capitalize on its platform of differentiated generic pharmaceutical products and allows Perrigo to focus on expanding its leading consumer business. The board will consider all value-enhancing options, including a possible tax-efficient separation to shareholders, a sale or merger.

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