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Archive for the ‘Pharmaceutical Industry Competitive Intelligence’ Category


 

Executive Compensation of Big Pharma in 2016 & 2017 New Teva’s CEO, Third from the Top paid among his peers

 

Reporter: Aviva Lev- Ari, PhD, RN

 

This is a QUOTE from FiercePharma

http://www.fiercepharma.com/pharma/teva-poaches-lundbeck-chief-schultz-52m-package?utm_medium=nl&utm_source=internal&mrkid=993697&mkt_tok=eyJpIjoiTkdFelpqZGxaamxoT0dNMSIsInQiOiJLcjlnb2RqQ1hWVU9IU0F4NCt3Kzl0QlNDOFh2SldHMTlyOUMzcUxMc2xZMTNHYkJzY09TOUJsRXFnZEVVYkdWNzNiVVpVY1wveDRyRUo5dWpjUWtPVmhqTmZSbzVsUFhXUDVJOTR2TkxvRWJDcnN3bjc4N0ZDd0VOUnBuN1g2dHAifQ%3D%3D

Teva enticed Schultz with a pay and welcome package worth up to $52 million, including $20 million in cash upfront, according to an SEC filing on the Monday hire. The new helmsman will also receive a restricted stock award of $5 million and two performance unit stock awards each worth $7.5 million.

Schultz’s base salary is $2 million, with an annual bonus opportunity worth 140% to 200% of his salary. Under the agreement, he’ll also receive $6 million in annual equity incentives.

For Teva, the pay will be well worth it if Schultz is able to engineer a turnaround. The Israeli drugmaker has had its stock price and business prospects battered over the last year as the generic pricing environment worsens and other threats continue to unfold. Knowing the challenges the company faced, Teva’s board said during the search that it was looking for a world-class pharma vet.

And Schultz has fixed things at an ailing drugmaker before. After Lundbeck’s former CEO stepped down and as it was laboring to launch new meds, it hired Schultz in 2015. He had already made a name for himself during a long tenure at Novo Nordisk and during his two years at Lundbeck, he won praise for improving revenue and profits.

If ranked among last year’s top-paid pharma executives, Schultz package would place him at No. 3, behind Mylan chairman Robert Coury’s $97 million and Valeant CEO Joseph Papa’s $62.7 million. Like Schultz, Papa also joined a drugmaker suffering from a barrage of negative developments in recent years.

Aside from tough pricing on generics, Teva is also dealing with a price fixing investigation and a generic threat to key multiple sclerosis drug Copaxone. The company recently kicked off a restructuring set to affect 7,000 employees around the world after its $40.5 billion buyout of Allergan’s generic business became more of a drag than a boost for the company.

 

RELATED: The top 15 highest-paid biopharma executives

SOURCE

http://www.fiercepharma.com/special-report/top-15-highest-paid-biopharma-executives

 

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Teva names Danish veteran Kare Schultz as new CEO, Compensation: $52M package that makes him among pharma’s top paid

 

Reporter: Aviva Lev-Ari, PhD, RN

Teva Pharmaceutical Industries Ltd., the world’s biggest seller of generics medicines, named Kare Schultz as its new chief executive, choosing an industry veteran to navigate a series of daunting challenges, from falling drug prices to the company’s high debt.

The appointment of Mr. Schultz, a Dane, ends a months-long period during which Teva had no permanent top executive. It recently shuffled its board and is shedding assets, while coping with new competitors. Teva shares have been under pressure for months.

The new chief executive joins from Denmark’s H. Lundbeck A/S, where he was president and CEO since May 2015. He has also worked as chief operating officer of Novo Nordisk A/S, the world’s biggest producer of insulin.

SOURCE

http://www.marketwatch.com/story/teva-names-danish-veteran-kare-schultz-as-new-ceo-2017-09-11

 

Struggling Israeli Generics Maker Teva Finally Names New CEO

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Novartis’ Kymriah (tisagenlecleucel), FDA approved genetically engineered immune cells, would charge $475,000 per patient, will use Programs that Payers will pay only for Responding Patients

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 9/1/2017:

This Pioneering $475,000 Cancer Drug Comes With A Money-Back Guarantee

Novartis defends the eye-popping price of its pioneering gene therapy with arguments about its $1 billion expenditure—and novel “value-based” pricing.

https://www.fastcompany.com/40461214/how-novartis-is-defending-the-record-475000-price-of-its-pioneering-gene-therapy-cancer-drug-car-t-kymriah

 

On 8/30/2017 we wrote:

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of KitePharma, no approved drug and Canakinumab for Lung Cancer (may be?)

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/08/30/fda-has-approved-the-worlds-first-car-t-therapy-novartis-for-kymriah-tisagenlecleucel-and-gileads-12-billion-buy-of-kite-pharma-no-approved-drug-and-canakinumab-for-lung-cancer-may-be/

 

The Price for the Treatment was published on 8/31/2017, a Value-based Pricing Payment Model of a $475,000 per patient charge for the responding patients after ONE month of treatment. Novartis says it takes an average of 22 days to create the therapy, from the time a patient’s cells are removed to when they are infused back into the patient. Kymriah will initially be available at 20 U.S. hospitals within a month, Novartis says. Eventually, 32 total sites will offer the therapy. 

CAR-T gained national attention three years ago when Carl June, a researcher at the University of Pennsylvania, used to put a young girl’s acute lymphoblastic leukemia. Genetically altering the girl’s immune cells had made her deathly ill, but June had used a Roche drug, Actemra, to treat the side effects. She lived, and the results were published in The New England Journal of Medicine. Novartis bought the rights to the Penn treatment for just $20 million up front.

Pharma Buying the right to use from an Academic Institution is a known route to leap frog the R&D lengthy process of Drug discovery.

“I’ve told the team that resources are not an issue. Speed is the issue,” says Novartis’ Chief Executive Joseph Jimenez, told Forbes in a cover story about the work then.

The FDA calls this CAR-T therapy treatment, made by Novartis, the “first gene therapy” in the U.S. The therapy is designed to treat an often-lethal type of blood and bone marrow cancer that affects children and young adults. The FDA defines gene therapy as a medicine that “introduces genetic material into a person’s DNA to replace faulty or missing genetic material” to treat a disease or medical condition. This is the first such therapy to be available in the U.S., according to the FDA.

Two gene therapies for rare, inherited diseases have already been approved in Europe.

To further evaluate the long-term safety, Novartis is also required to conduct a post-marketing observational study involving patients treated with Kymriah.

The FDA granted Kymriah Priority Review and Breakthrough Therapy designations. The Kymriah application was reviewed using a coordinated, cross-agency approach. The clinical review was coordinated by the FDA’s Oncology Center of Excellence, while CBER conducted all other aspects of review and made the final product approval determination.

The FDA granted approval of Kymriah to Novartis Pharmaceuticals Corp. The FDA granted the expanded approval of Actemra to Genentech Inc.

FDA commissioner Scott Gottlieb in a statement.

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” 

“Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials.”

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm

The Protocol

A patient’s T cells are extracted and cryogenically frozen so that they can be transported to Novartis’s manufacturing center in New Jersey. There, the cells are genetically altered to have a new gene that codes for a protein—called a chimeric antigen receptor, or CAR. This protein directs the T cells to target and kill leukemia cells with a specific antigen on their surface. The genetically modified cells are then infused back into the patient.

In a clinical trial of 63 children and young adults with a type of acute lymphoblastic leukemia, 83 percent of patients that received the CAR-T therapy had their cancers go into remission within three months. At six months, 89 percent of patients who received the therapy were still living, and at 12 months, 79 percent had survived.

https://www.technologyreview.com/s/608771/the-fda-has-approved-the-first-gene-therapy-for-cancer/?utm_campaign=add_this&utm_source=email&utm_medium=post

CAR-T Therapies: Product/Molecules/MOA under Development:

  • Similar CAR-T treatments were being developed at other institutions including
  • Memorial Sloan-Kettering Cancer Center,
  • Seattle Children’s Hospital, and
  • The National Cancer Institute.
  • The Memorial and Seattle work was spun off into a startup called Juno Therapeutics, which has fallen behind. Juno Therapeutics ended a CAR-T study earlier this year after patients died from cerebral edema, or swelling in the brain.
  • The NCI work became the basis for the product being developed by Kite Pharma. Kite Pharma, which is awaiting FDA approval for its CAR-T therapy to treat a form of blood cancer in adults, was this week bought out by Gilead in a deal worth $11.9 billion.

On Cambridge Healthtech Institute’s 4th Annual Adoptive T Cell Therapy, Delivering CAR, TCR, and TIL from Research to Reality, August 29 – 30, 2017 | Sheraton Boston | Boston, MA

TUESDAY, AUGUST 29 – I covered in Real Time the talk on Juno Therapeutics: Building Better T Cell Therapies: The Power of Molecular Profiling by Mark Bonyhadi, Ph.D., Head, Research and Academic Affairs, Juno Therapeutics

https://pharmaceuticalintelligence.com/2017/08/29/live-829-chis-oncolytic-virus-immunotherapy-and-adoptive-cell-therapy-august-28-29-2017-sheraton-boston-hotel-boston-ma/

 

Precision Medicine is Costly and not a Rapid manufacturing process

All of the CAR-T products are expensive to make, and must be manufactured on an individual basis for each new patient from the patient’s own T-cells, a type of white blood cells, a process that takes weeks.

  • How quickly companies can speed up manufacturing.
  • Kymriah will be manufactured at a facility in Morris Plains, N.J.
  • CAR-T technology, which has so far been used only in patients with blood cancers that have not been cured by other treatments, can be used earlier in the disease or for solid tumors: Breast, Prostate, Melanomas.

https://www.forbes.com/sites/matthewherper/2017/08/30/fda-approves-novartis-treatment-that-alters-patients-cells-to-fight-cancer/#2aecb25b4400

Prediction How Patients will Far Well – Researchers use a big-data approach to find links between different genes and patient survival.

https://www.technologyreview.com/s/608666/a-cancer-atlas-to-predict-how-patients-will-fare/?set=

A pathology atlas of the human cancer transcriptome

+ See all authors and affiliations

Science  18 Aug 2017:
Vol. 357, Issue 6352, eaan2507
DOI: 10.1126/science.aan2507

Modeling the cancer transcriptome

Recent initiatives such as The Cancer Genome Atlas have mapped the genome-wide effect of individual genes on tumor growth. By unraveling genomic alterations in tumors, molecular subtypes of cancers have been identified, which is improving patient diagnostics and treatment. Uhlen et al. developed a computer-based modeling approach to examine different cancer types in nearly 8000 patients. They provide an open-access resource for exploring how the expression of specific genes influences patient survival in 17 different types of cancer. More than 900,000 patient survival profiles are available, including for tumors of colon, prostate, lung, and breast origin. This interactive data set can also be used to generate personalized patient models to predict how metabolic changes can influence tumor growth.

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The Top 10 Drug launches of 2017 following FDA green light to 22 drugs in 2016

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/3/2017

Fears over a medical gold rush in cancer drug race

With almost 800 trials under way observers warn scientific rigour is being compromised
“There is some pushback,” said Jill O’Donnell-Tormey, chief executive of the Cancer Research Institute. “Are there too many trials? Are we just throwing spaghetti at the wall, by taking compound ‘X’ or ‘Y’ and adding it together just to see what happens?”  Most scientists say checkpoints do not need to be replaced with something else, but rather augmented with new drugs that can further cajole the immune system into fighting cancer. This has led to an unprecedented amount of clinical research sponsored by drugmakers, which are combining checkpoints with other medicines to try to find a magic bullet to treat cancer.  The sheer number of studies has sparked fears that some companies are engaging in a medical gold rush, hoping to chance upon the right cocktail without doing the appropriate scientific groundwork.

https://www.ft.com/content/00092dde-578c-11e7-9fed-c19e2700005f?mhq5j=e3

 

After an unusually slow year for new drug approvals—the FDA green lighted just 22 meds in 2016—it remains to be seen whether drugmakers can do much better in 2017. One thing’s for sure, though: No matter what total the industry tallies up this year, the crop will bring some would-be blockbusters and market disrupters.

At the top of the list, according to EP Vantage’s 2017 preview, which ranks the year’s rollouts by 2022 sales, is Ocrevus (ocrelizumab), the Roche multiple sclerosis drug that’s promising to shake things up in more ways than one. In clinical trials, the candidate bested Merck KGaA’s standard therapy Rebif, and it’s also gone where no other MS drug has gone before, posting positive data in patients with the primary progressive form of the disease. Those data will put the heat on other meds—and invite payers to pile pressure onto the segment, too.

The top 10 drug launches of 2017

The top 10 drug launches of 2017

SOURCE

http://www.fiercepharma.com/special-report/top-10-drug-launches-2017

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Drug Price-increase Caps by Big Pharma

Reporter: Aviva Lev-Ari, PhD, RN

 

Sanofi’s new pricing promises:

  • The company committed not to increase the list price of existing drugs in the US by more than the rate of healthcare inflation, as measured by the Centers for Medicare and Medicaid Services’ National Health Expenditure. In 2015, the NHE rate is expected to be 5.4%, and it’s expected to increase by 5.6% each year on average through 2025.
  • Sanofi also plans to launch new drugs with included rationale regarding how it set the price.
  • The company also decided to release its average list and net price increases going forward. It’s something other companies have been doing as well.

Sanofi’s list price increased 4% in 2016, but after factoring in discounts and rebates paid to pharma middlemen, the net price decreased by 2.1%.

Allergan committed to only single-digit drug-price increases (a line it closely hugged for some drugs), since September 2016.

Novo Nordisk, another diabetes drugmaker, also committed to capping increases to single digits.

SOURCE

http://www.businessinsider.com/sanofi-commits-to-not-raise-drug-prices-above-health-inflation-2017-5

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Tax Cuts Potential Impact on Overseas (ex-US accounts) by Top 9 Biopharma holdings of $133B in M&A 

Reporter: Aviva Lev-Ari, PhD, RN

 

Amgen has been sheltering a cache of about $35 billion in ex-US accounts, according to some numbers that EvercoreISI’s Umer Raffat put together as he began assessing the impact tax reform could have on the top players in overseas holdings.

 

SOURCE

The top 9 overseas accounts in biopharma hold $133B in M&A firepower by john carroll April 27, 2017 06:42 AM EDT, Updated: 08:15 AM

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World’s Top Ten Cancer Drugs by 2020  (million USD)

Reporter: Aviva Lev-Ari, PhD, RN

 

 

Image Source: Statista (www.statista.com)

Opdivo Setback May Yield Lessons for Pharma – Advancing Immunotherapies With PD-L1 Testing

Sep 12, 2016 | Turna Ray

The anti-PD-1/PD-L1 drug market is estimated to be worth around $30 billion by 2020. The negative Phase III results for Opdivo in first-line NSCLC shocked market analysts, and pharmaceutical companies developing drugs in this space “are taking stock of the situation” and surely assessing whether they have the right test methods in place in their drug studies, said Peter Keeling, CEO of consulting firm Diaceutics.

Most drugmakers developing anti-PD-1/PD-L1 drugs are evaluating whether their therapies work especially well in patients whose tumor cells express PD-L1, a protein that cancer cells use to hide from an immune system attack. But studies have demonstrated that PD-L1 expression status doesn’t neatly bucket responders and non-responders in the same way that testing for EGFR mutations or ALK rearrangements can, making it difficult for pharmaceutical companies to integrate PD-L1 testing for patient stratification in clinical trials.

In the absence of a universal diagnostic, Cancer Genetics is one lab that does offer all the FDA-approved companion and complementary PD-L1 tests, but also spends a lot of time educating doctors and pathologists on the differences between these tests and which to order for a particular immunotherapy. “There’s a big need for our pharma cousins to really push more knowledge about the associated diagnostics and tests and how to use them,” Sharma said. “That’s the only way they’re going to get uptake in the community setting.”

Despite the muddled messages around PD-L1 testing, healthcare providers and researchers nonetheless seem interested in PD-L1 testing as part of the tumor profiling workup for patients. Diaceutics’ surveys show a sharp uptick in the number of labs offering PD-L1 testing over the past year-and-a-half and 52 labs in the US offer at least one PD-L1 test. The company also reviewed biomarkers being studied in 95 Phase II/III NSCLC, and found that approximately half are incorporating patients’ PD-L1 status either alone or in combination with other markers, such as EGFR and ALK mutations.

At Cancer Genetics over the past year, there has also been a notable ramp up in orders for PD-L1 testing for lung cancer patients, but also for melanoma and head and neck cancer patients. “One our biggest volume increased tests this year has been PD-L1 testing,” Sharma said. “We think there is a lot of opportunity for significant additional growth.”

https://www.genomeweb.com/molecular-diagnostics/opdivo-setback-may-yield-lessons-pharma-advancing-immunotherapies-pd-l1

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