British Pharma Industry Faces Challenges Post-Brexit

Posted by Tom Penrice on Mon,Dec 12, 2016 @ 09:00 AM
The British pharmaceutical industry is facing new challenges following the UK’s decision to leave the European Union, a white paper has revealed. Published by Global Data, it warned of wide-reaching impacts.

The British pharmaceutical industry faces important challenges since the Brexit, with implications for drug development, grant funding, workforce movement.51% of Britain’s medicinal and pharmaceutical products are exported to the European Union (EU). But in June, a referendum indicated the UK should leave the EU – the so-called “Brexit”.

While Big Pharma companies emerged from the vote largely unscathed – some even enjoyed a small but immediate increase in their share prices – the result is likely to create challenges industry-wide, as a new white paper published by Global Data has forecast.

Question mark over drug regulation

Drug manufacturers will face an “immediate impact in the area of drug and medical device regulation,” explained Global Data in its paper.

The European Medicines Agency (EMA), which is responsible for the evaluation and monitoring of all drugs marketed in the EU, is currently headquartered in the UK. If it relocates to the EU when Brexit commences, companies may need to file for approval separately between the UK and the EU.

Then there is the EU Clinical Trials Directive. Although it is fully implemented into UK law, a new directive is expected to take effect in October 2018. Participation is necessary in order to gain drug approval within the EU.

Global Data warned that if the UK does not adopt the upcoming legislation, then the number of multi-center clinical trials in both the UK and EU is likely to be reduced, since “it will be very difficult and costly to integrate national trial authorization procedures with the new EU centralized trial authorizations”.

The issue of grant funding

Another big post-Brexit issue is funding and investment, as Britain’s The Telegraph reported. It explained that UK institutions and researchers receive a significant amount of European funding through grants, including Horizon 2020 and the European Investment Fund.

Up to £8.5 billion of funding and investment in UK science could be lost over the next four years, potentially isolating UK research and development and reducing its influence within the global scientific community.

In order to keep the money from these grants flowing, Britain needs to show why it is an attractive place to invest in life sciences, including pharmaceuticals and medical devices – a sector that accounts for more than 180,000 jobs and generates revenue of over $80 billion in the UK, according to UK Trade and Investment.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, told The Telegraph: “We have a fantastic asset, which is the NHS, and a fantastic science base. We need to connect those two together so the industry can see that as well as investing in our science base at the early stage of research, we have the potential for those medications to flow through the system [into commercialisation].”

Restrictions limit pharma workforce

Meanwhile, there is uncertainty surrounding the pharmaceutical workforce. If restrictions are placed on freedom of movement within EU countries, this could limit the UK’s reach across Europe’s skilled workers.

A PWC blog explained that around 7% of the pharmaceutical and life sciences industries’ employees are non-British EU citizens, warning that many academics and senior pharmaceutical staff who frequently move around Europe could be affected.

Swiss pharma industry sets example

It is not yet known whether Britain will opt for a “hard Brexit” or “soft Brexit”, with the latter being less of a threat to biotech and science, according to Forbes. It is however expected that the EU will make the terms of Brexit as harsh as possible, the site reported, “with little protection for biotech or science”.

Luckily, it is not all doom and gloom. Global Data cited Switzerland as the leading example of successful pharma and medical devices industries outside of the EU.

The country boasts low effective corporate tax rates and flexible labor laws, allowing for more liberal contracts, longer working hours, and reduced union involvement. Perhaps following in Switzerland’s footsteps, British Prime Minister, Theresa May, recently pledged to deliver the lowest corporation tax rate in the G20.

Global Data concluded: “The solution might lie in creating a uniquely British solution. The European Economic Area (EEA) has already been cited by commentators as an alternative approach for the UK to maintain access to the Single Market, albeit at the cost of accepting freedom of movement between the EEA and EU.”

Pennside Partners has also expanded its European presence with a new UK office located south of Manchester. Find out more here.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Development, Big Pharma, British Pharma Industry, Pharma UK, Pharma Europe, British Pharma

Is 3D Printing The Next Big Thing In Pharma?

Posted by Tom Penrice on Wed,Feb 10, 2016 @ 06:00 PM

A Brief History of 3D Printing in the Medical Industry

Are 3D printed drugs the next big thing for the pharmaceutical industry? 3D printing has been making waves since 1984 when its inventor, Charles Hull, used the technology to make a 3D model from a picture, demonstrating that this technology would be a revolutionary way to test a product design before sinking big money into a large manufacturing program. The power of 3D printing limited innovators only to their imagination and took the world by storm in the intervening years- everything from fashion to firearms was transformed.

The medical industry is just one of the industries revolutionized by 3D printing. In 1999, 3D printing allowed scientist to implant a lab grown organ into patients undergoing urinary bladder augmentation. In the early 2000’s, researchers engineered a functioning kidney, giving scientists the ability to “print” organs and tissues. In 2009, a 3D printer was used to “print” the first blood vessel.

3D-Printing, the FDA, and the Pharma Industry

A few years later, headway is still being made in the medical industry. In early August 2015, the U.S. Food and Drug Administration (FDA) approved the first 3D- printed pill. SPRITAM LEVETIRACETAM, manufactured by the pharmaceutical company Aprecia, is used for reducing seizures in epileptics. The manufacturing of SPRITAM LEVETIRACETAM is done through the 3D printing process of layering the active and inactive ingredients layer by layer. The unique process of 3D printing is beneficial to its patients, as it can make each pill more potent than the traditional tableting machine can produce.

The FDA’s approval of SPRITAM LEVETIRACETAM means that Aprecia is the first major pharmaceutical company to “print” drugs, and they now own the rights to their successful technique. Aprecia’s ZipDoseâ Technology is a combination of science and 3D printing, protected by numerous patents through 2033.

The Future of 3D Printing in the Pharma Industry

No one is certain of how the concept of 3D printing will continue to change the pharmaceutical/ medical industry. But the concept of 3D pill printing brings the process closer to patients in need and may allow for hospitals to adjust doses to individual patients. In addition, the effective layer by layer printing concept in SPRITAM LEVETIRACETAM could be beneficial to other similar drugs where potency and precise dose release are important.

The FDA approval of SPRITAM LEVETIRACETAM is likely to lead to more novel 3D-printed therapies. So what’s next? Pharma companies in the UK are already experimenting with everything from pyramid to donut shaped pills, and many other companies are taking a look at the best way to structure pills for the patients who need them.

The above post is a condensed and edited summary of a Brief History of 3D printing , the Business Insider article: 3-D printing is revolutionizing the pharmaceutical industry and TheGuardians: The first 3D-printed pill opens up a world of downloaded medicine


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Development, 3D Printing Pharmaceuticals, 3D Printed Drugs

Drug Development Clinical Trial Data – Public or Private?

Posted by Judi Space on Thu,Jan 23, 2014 @ 06:00 PM

Should drug development information from clinical trials be made public or kept private? In the past, data from clinical trials of new drugs and medical devices have been the property of the companies that designed them, and they were allowed to control how and what data was released. The FDA and international equivalents research new products before granting approval, so data the company generated during drug development was up to the company to disseminate as it wished. Now, with the widely held perception that companies have only been releasing results that favored their products, the pendulum is swinging toward regulation making all data on approved drugs and devices available to the public.

The Transparency Campaigners

In Britain, the transparency initiative has been headed by the British Medical Journal, which now requires all authors of drug or device clinical trials who publish in the Journal to provide full scientific study data to anyone with a reasonable request. Also, the Cochrane Collaboration (an international non-profit) began campaigning for increased transparency when it was attempting to verify the efficacy of TamiFlu and was unsatisfied with the available data. 

These major players are joined by doctors, researchers, medical journals, and scientific societies who advocate more transparency in publishing detailed results of clinical trials and as much data about the specifics of the trials as possible. They have been pressing for this data not only going forward, but also for all medicines currently on the market.

The Drug Regulators: EU, EMA, FDA

In December 2013, the EU drafted a clinical trials regulation that will require clinical trials to be registered and results uploaded to a database that can be accessed by the public. This legislation is expected to be formally approved this year. Also, the Public Accounts Committee (of British Parliament), has issued a report this monththat calls for “full methods and results” to be released from all clinical trials, future and past.

Meanwhile, the European Medicines Agency (EMA), which is the European equivalent of the FDA, is considering a new policy on proactive disclosure of trial results, but further discussion of the issue has been tabled until March. Last year, The EMA received injunctions from both AbbVie and InterMune received injunctions against the EMA to prevent it from releasing trial data to competitors, but these injunctions were lifted last month.

In the United States, basic results of all clinical trials must now be registered in a national database that is accessible to the public (www.clinicaltrials.gov). The FDA also publishes staff reviews and other documents when it approves a new drug. However, federal laws restrict what kinds of information can be released, especially data that could reveal personal or commercially confidential information.

Self-regulation by the Pharmaceutical Industry

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) are fighting back by drawing up “principles for responsible data sharing” for pharmaceutical companies to voluntarily abide by. Some companies have already promised to release years of detailed clinical data upon request, in response to public relations issues.

The ABPI (Association of the British Pharmaceutical Industry) has pointed out that a peer-reviewed study it commissioned in 2013 showed a “positive trend” of increasing levels of disclosure – almost nine out of ten of all industry-sponsored trials were disclosed as of January 31, 2013.

Balancing Economic Interests with the Public’s “Right to Know”

PhRMA has argued that proposals for mandates to release all trial information go too far. “If you dump onto the sidewalk all the data, and you include commercially protected information,” he said, “then you’re essentially giving to competitors what we invested billions of dollars in.”

PhARMA claims that if the medical research industry is forced to disclose data that allows competitors to replicate their products, companies will be deterred from developing new drugs and devices that could improve quality of life for many people. On the other hand, patent protection prevents this kind of product replication. At the same time, publication bias can be used by unscrupulous members of the industry to mislead the public.

When the EFPIA/PhRMA pact was announced last year, EFPIA acknowledged that the industry was slow in affecting change. Given the exposure this topic has received recently, efforts to self-regulate may be too late to affect the groundswell of opinion in favor of legislating more transparency in drug development.

This post is based on an article by Ian Schofield – “The rising tide of trial transparency.” 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Developers, EMA, Drug Development, Clinical Drug Trials

New Cancer Drugs Fuel Debate over Drug Testing Process

Posted by Judi Space on Thu,Oct 17, 2013 @ 06:00 PM

Question:
If the results of initial testing on a drug are amazing – and could mean the difference between life and death – should pharmaceutical companies be required to go through the current long and costly process of drug testing before making it available to the public? 

Is the FDA's quick drug approval process better, or is NICE's cost/benefit approach the right way to go? Read and decide.If a drug is fine-tuned to treat a specific genetic profile, does it make sense to do randomized controlled trials, even if it means delaying the availability of the drug and possibly increasing the cost, thereby rendering it unattainable to certain patients?  

The Renewed Debate over Drug Testing

Two drugs that were recently approved by the United States Food and Drug Administration (FDA) have helped renew this debate. In 2011, Zelboraf, a drug that targets specific mutations in cancer cells, was approved by the FDA after an early-stage trial showed eight out of ten patients experienced significant tumor shrinkage.  Earlier this year, another drug – Tafinlar, a drug targeting the same mutant genes as Zelboraf - was approved by the FDA based on a single clinical trial of just 250 patients. 

Tafinlar is available at 30 percent less the cost of Zelboraf. 

Are Randomized Controlled Trials Becoming Obsolete?

For many years, randomized controlled trials have been the most effective way of seeing if a drug works.  However, according to Richard Pazdur, M.D., the FDA expert who wanted to shorten the Zelboraf trial, “The types of drugs that we’re seeing now are different.  They are just simply better in terms of efficacy.”    Scientists have a better understanding of molecular changes that promote cancer growth.  For example, an estimated 50-60 percent of melanoma patients - the people Zelboraf and Tafinlar target - have a specific genetic mutation. For drugs that focus on patients with specific genetic mutations, randomized controlled trials may not make sense anymore.

Will Faster Drug Approval Impact Pricing?

Eleven of the twelve cancer drugs launched in the United States last year cost more than $100,000 a year per patient.  In April, more than 100 leukemia specialists from around the world spoke up in the American Society of Hematology’s journal Blood that cancer drug prices were “too high, unsustainable, may compromise access of needy patents to highly effective therapy, and are harmful to the sustainability of our national healthcare systems.”

Accounting for 36 percent of the total research expenditure in 2012, clinical trials are the biggest single cost in drug company R&D.  Many contend that if researchers were permitted to test certain treatments on just people with a specific targeted mutation, researchers could work more quickly, and with fewer patients, to determine if the treatment is effective - bringing these treatments to patients more quickly and, possibly, more cheaply.  Unfortunately, there has not been a significant decrease in medications with the most recent changes in testing procedures.  Paul Workman, head of drug discovery for Britain’s Institute of Cancer Research says, “The costs should be coming down tremendously.  What’s disappointing is that we haven’t seen it happen yet.”

European Drug Regulators Vs. FDA

Part of the issue is that European drug regulators and particularly government funding agencies, such as the National Institute for Health and Clincial Excellence (NICE), may not be willing to accept products based on the FDA’s more flexible clinical trial standards.  In Europe, even if a drug is approved by the European regulatory agencies, if the governments don’t approve funding for it, it will still not be available to many people.

It will be interesting to see what happens.  As Workman said, “We are in a fascinating but frustrating period of transition.”

This post is based on Insight: How new cancer drugs can skip randomized trials by Julie Steenhuysen and Ben Hirschler published in Reuters on September 26, 2013.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Cancer Drug Development, Drug Development, NICE, Clinical Drug Trials

Adherence to Drug Regimens: Implications for Drug Developers

Posted by Judi Space on Sat,Oct 12, 2013 @ 06:00 PM

Lack of Adherence in Prescribed Medications

What if patients adhered perfectly to their prescriptions? Is simplified dosing the answer? Implications for drug developers.Approximately 50% of patients do not take their medications as prescribed.  This lack of adherence severely compromises patient outcomes and increases patient mortality and is estimated to incur costs of approximately $100 billion per year.  Some physicians believe that increasing the number of patients that adhere to their prescribed medications could have a greater effect on health than improvements in specific medical therapy. 1

However, the increasingly complicated medical regimens make it more difficult for physicians to follow Hippocrates' exhortation to “not only be prepared to do what is right himself, but also to make the patient…cooperate.”  Between 2000 and 2002, the typical Medicare beneficiary saw a median of seven physicians per year - two primary care physicians and five specialists, and typically patients recall as little as 50% of what is discussed during those visits. Although the responsibility of medication adherence is primarily on the patient, the complexity of both health care and drug regimens is causing patients to prevaricate that responsibility. 1 

The Number One Cause of Death, Yet Less Than Half Adhering to Medications

Heart disease is the number one cause of death in the United States, with 26.5 million people suffering from the disease according to the Centers for Disease Control (CDC).  Taking aspirin, cholesterol-lowering and blood pressure-lowering drugs long-term more than halves heart attack and stroke recurrence; however only 50% of patients with coronary disease and 35% in those with stroke are adhering to the medications prescribed to them. 

Is Fixed Dose Combination the Answer?

Simon Thom, M.B., B.S., M.D. of the international Centre for Circulatory Health, Imperial College London, conducted the first study to compare a fixed dose combination (FDC) medication with usual care in patients with or at high risk of cardiovascular disease (CVD).  The FDC included aspirin for blood clots, simvastatin (Zocor) for high cholesterol and two blood pressure medications. The trial of 2,000 patients showed a significant improvement in medical adherence with the use of an FDC medication for blood pressure, cholesterol, and platelet control. 

Thom found that 86 percent of the people that received the FDC kept up with their medications, compared to 65 percent of patients on the usual care.  People who began the trial with the lowest adherence had the greatest improvement – 77 percent instead of 23 percent took their medication regularly.

Overall, the FDC group also had slight declines in two major CVD risk factors - systolic blood pressure and LDL cholesterol - compared to those receiving the usual care.

More Data Needed

J. Michael Gaziano, M.D., M.P.H., cautioned, “Although the potential remains for use of various CVD polypills in certain settings, the precise advantage of this strategy remains largely unproven.  Until additional rigorous data are available that demonstrate that the polypill improves clinical CVD outcomes, it may be more important to carefully assess the multiple medications many patients currently are prescribed, often by several physicians.”

Implications for Drug Developers

Helping patients to adhere to their drug regimens will ensure that they are used, resulting in more renewed prescriptions. The time and resources invested into developing patient adherance programs will be returned with the bonus of increased sales.

 

1 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3068890/


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Developers, Drug Development

Is NICE Denying Patients the Best Treatments Available Today?

Posted by Judi Space on Sat,Oct 05, 2013 @ 08:00 AM

NICE’s Policies Under Fire

Will NICE's stringent drug approval process discourage drug developers in the UK, or is their cost-benefit approach likely to entice other countries to follow suit?The National Institute for Health and Care Excellence (NICE), an organization given the responsibility of setting the standards for high quality healthcare in the UK, has come under fire for being too conservative and resource-intensive.  In a recent opinion piece in The Times of London, business editor Ian King cautioned that the pharmaceutical industry could abandon drug development in the UK if NICE doesn’t ease its practice of restricting access to drugs based on expense or side effects.

Quoting Jonathan Emms, Pfizer UK managing director, King said that NICE turned down 40 percent of new medicines last year, advising the National Health Service (NHS) that it cannot use them or restricting their use.  Enns pointed out that “19 out of 20 attempts fail before they reach the patient – even before any NICE review,” and added, “NICE is denying patients access to some of the best treatments available today.”  

Drug Developers and the Cost of Bringing a Drug to Market

NICE CEO Andrew Dillon said that his agency is chartered with providing the NHS the best medicines available at affordable prices.  He added, “NICE is, quite properly, scrutinized closely on its decisions and the methods we use to arrive at them. We have changed and improved over the decade and more that we have been advising the NHS.  We are not perfect, but we are respected throughout the world for our quality of work.”

Dillon added, “Companies are entitled to expect a return on their investment, but health services have to be confident that the extra benefit to patients justifies the price.  It mostly does so, though sometimes at a stretch.  If we are not sure, we have to say so, in the interests of all those of us who expect the NHS to apply its resources equitably across all of the demands we make of it.”  Using the widely-quoted estimate that it now costs 1.2 billion pounds (approximately $1.9 billion) to bring a new drug to market, NICE CEO Andrew Dillon countered, “if it really does cost 1.2 billion pounds to develop a new drug, the question the pharmaceutical industry must be able to answer is this: Are you absolutely confident that it needs to.”   Dillon contends that the “research and clinical environment (in the UK) holds too many advantages for companies” to abandon the country. 

Are the UK Market Advantages Enough to Keep Drug Developers Interested?

Stephen Whitehead, CEO of ABPI, the industry body negotiating on behalf of the branded pharmaceutical industry, warns that this “advantage” in biopharmaceutical R&D is “fragile and under constant challenge,” citing that UK’s share of global clinical trials fell from 6% to 1.4% in just 10 years.  He says, “The consequences of this is the closure of six research sites in the UK over the past six years.”

Whitehead concluded, “The biopharmaceutical industry has proven that it delivers solutions to healthcare challenges but the conservative and resource-intensive approach taken by NICE adds significant cost to the development of medicines.  Through its decisions, NICE has a role in repeatedly denying patients in the UK access to medicines that are routinely available in other countries.”

Clearly, drug companies are not going to abandon the development of new drugs just because a small segment of the market will not pay for them. There is plenty of incentive from the rest of the globe. NICE is the bellwether, far out in front of other countries that are trying to impose some control over the run-away cost of new drugs. What Big Pharma really fears is that other countries, particularly in Europe will take on the NICE attitude.

What do you think will happen?  


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Developers, Drug Development, NICE

Heads up for the European Cancer Congress in Amsterdam

Posted by Judi Space on Tue,Sep 24, 2013 @ 06:00 PM

ESMO EU Cancer Congress 2013

Clinical Trial Insights

The annual European meeting offers insights into new data from ongoing clinical trials as well as a chance to discuss the implications of recently reported trial outcomes presented a few short months ago at ASCO. Pennside has reviewed the program in detail and we offer our assessment of key presentations at the meeting for drug developers and biotech.

 

Our Assessment of ESMO Key Presentations:

CRC

  • Analysis of KRAS/NRAS and BRAF mutations in FIRE-3:A randomized phase III study of FOLFIRI plus cetuximab or bevacizumab as first-line treatment for WT KRAS (exon 2) mCRC (abst#17, embargoed)
    • Data at ASCO this past June showed that there was no benefit from Vectibix for patients with NRAS mutations—it will be interesting to see if this also holds true for Erbitux in this biomarker analysis from the FIRE-3 trial.
       
  • ASPECCT: a randomized, multicenter, open-label, phase 3 study of panitumumab (pmab) vs cetuximab (cmab) for previously treated WT KRAS mCRC (abst#18, embargoed)
    • This is a head to head trial of Vectibix vs. Erbitux in the 3rd line setting—maybe one agent will come out ahead of the other, but most likely they will report similar data, possibly with some differences in safety.
       
  • Effects of regorafenib therapy on health-related quality of life in patients with metastatic colorectal cancer in the phase III CORRECT study (abst#2156)
    • TKIs have a history of poor tolerability in CRC, and Stivarga in particular was concerning because of its use in the 3/4th line palliative setting. However, this analysis appears to show that Stivarga is not detrimental to QOL, and any AEs are manageable with dose modifications.

  • Aflibercept in combination with FOLFIRI for the second-line treatment of patients with metastatic colorectal cancer: Interim safety data from the global Aflibercept Safety and Quality-of-Life Program (ASQoP and AFEQT studies) (abst#2276)
    • There is growing concern within the CRC community that while Zaltrap’s efficacy is similar to Avastin in 2nd line CRC, the tolerability is poor. The data from this study suggests that Zaltrap’s AEs are manageable and may even be lower in the real-world setting vs. the VELOUR trial. 

NSCLC

  • A phase III study of belagenpumatucel-L therapeutic tumor cell vaccine for non-small cell lung cancer (NSCLC). (LBA2, embargoed)
    • Given the recent vaccine trial failure by GSK in melanoma, we eagerly await the results of the STOP trial for belagenpumatucel-L (aka Lucanix).
       
  • Clinical activity, safety and biomarkers of PD-L1 blockade in non-small cell lung cancer (NSCLC): Additional analyses from a clinical study of the engineered antibody MPDL3280A (anti-PDL1). (3408, embargoed)
    • Key question for followers of PD-1/PD-L1: is there an efficacy/safety differences between inhibiting either target? If not – then it is a race to “first to market”
       
  • Prognostic and predictive role of kras mutations in patients with advanced non small cell lung cancer treated with docetaxel or erlotinib as second line treatment in the TAILOR trial. (LBA32, embargoed)
    • Anything new to learn regarding Kras status in NSCLC? What does a positive Kras status mean for ~20%+ of patients with adenocarcinoma? Hopefully the data will shed new light on this area rather than just casting an intriguing shadow of continued confusion for those who follow NSCLC.

BrCa

  • T-DM1 for HER2-positive metastatic breast cancer (MBC): Primary results from TH3RESA, a phase 3 study of T-DM1 vs. treatment of physician's choice (15, embargoed)
    • The TH3RESA trial may provide rationale for the use of Kadcyla in the 3rd line setting for patients who have progressed on Herceptin and Tykerb.  This trial could provide Roche with even more of a stronghold on the HER2+ disease state.
       
  • PARP inhibition with BMN 673 in ovarian and breast cancer patients with deleterious mutations of BRCA1 and BRCA2 (29, embargoed)
    • This data release will provide evidence of the potency of next generation PARPs and will, if successful provide quicker enrollment in the Phase III trial. 

PnCa

  • Additional data from the MPACT trial of Abraxane + gemcitabine vs. gemcitabine in metastatic PnCa (PET response, 2577; peripheral neuropathy, 2583; dosing, 2586)
    • Abraxane was recently approved in the US for the treatment of pancreatic cancer. These three studies will give us more information on response, side effects, and dosing.
       
  • GVAX/CRS207 (2590)
    • This is a new immunotherapy approach for the treatment of pancreatic cancer.  The Ph II study was stopped early due to positive OS results for the combination of GVAX/CRS207 vs. GVAX alone.

Melanoma

  • As it was at ASCO, Melanoma and immunotherapy will be on the hot seat again at this meeting with key presentations in the opening session: Mobilizing the Immune System to Treat Cancer (S, Topalian)
    • With hundreds of mutations extant in patients with advanced cancer, the only way to address the disease is systemically. Immunotherapies are an excellent approach, and research is bearing fruit.
       
  • Vemurafenib and MEK inhibitor, cobimetinib , in advanced BRAFV600-mutated melanoma : Dose-escalation and expansion results of a phase IB study (3703)
    • This MEK/BRAF combination is a very fast follower  of the recently approved GSK agents trametinib and dabrafenib.  Although the two GSK drugs were approved separately, data from ASCO suggests that the combo is better, and KOLs seem to agree that this will become the new standard of care. The two drugs in this study are from Roche who aims to take market share from GSK as quickly as they can. 

HCC

  • Sorafenib alone versus Sorafenib combined with Gemcitabine and Oxaliplatin (GEMOX) in the first-line treatment of advanced hepatocellular carcinoma: Final analysis of the randomized phase II GoNext trial (a UNICANCER / FFCD / PRODIGE 10 study) (2467)
    • This is an update of the previous positive data that was presented at ASCO 2013 this past June—the regimen of Nexavar and GEMOX chemo appears to be active in this population of first line HCC.
       
  • Efficacy and safety of nintedanib vs sorafenib in Asian patients with advanced hepatocellular carcinoma (HCC): A randomised Phase II trial (2580)
    • This study demonstrated that nintedanib has similar efficacy to Nexavar, but with improved tolerability.  As toxicity is a major issue in HCC due to poor patient condition, any agents with improved safety and at least equal efficacy to standard of care would be a welcome addition to the treatment algorithm.
       
  • Subgroup analysis of prognostic factors for overall survival in the SHELTER trial evaluating resminostat in advanced hepatocellular carcinoma (HCC) - the SHELTER Study Group (2601)
    • Data released earlier this month at ILCA showed the potential for a biomarker to select patients most likely to respond to resminostat, and this analysis of subpopulations from the Ph I/II SHELTER study of resminostat alone or in combination with sorafenib may help further define the ideal patient population for this developmental HDAC inhibitor. In particular, the combination of resminostat and sorafenib shows encouraging activity in second line patients who progressed on prior sorafenib.

ThyCa

  • Progressive, metastatic medullary thyroid cancer: Baseline symptoms and disease characteristics among patients enrolled in the EXAM trial (3154)
    • The results from this analysis of the EXAM trial of cabozantinib in medullary thyroid cancer suggest that, despite the common perception that this is an indolent tumor, many patients that present with radiologic findings of progressive disease actually have high disease burden and related symptoms. This justifies approval of two targeted agents in MTC (cabozantinib and vandetanib), as many patients will inevitably need an efficacious therapy once they reach the point of high disease burden.
       
  • Association between tumor BRAF and RAS mutation status and clinical outcomes in patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC) randomized to sorafenib or placebo: Sub-analysis of the phase III DECISION trial (3155)
    • This biomarker analysis of the DECISION explored the effect of RAS and BRAF mutations on benefit from Nexavar. While all patients, regardless of mutational status, appeared to benefit from therapy, those with RAS mutations had lowered PFS, while patients with BRAF mutations had improved PFS. Since all patients benefitted from Nexavar, it is unlikely that these biomarkers would be used to select patients for therapy, but important to know that the benefit exists regardless of mutational status.
       
  • An open-label, multi-center phase 2 study of the BRAF inhibitor vemurafenib in patients with metastatic or unresectable papillary thyroid cancer positive for the BRAF V600 mutation and resistant to radioactive iodine (28, embargoed)
    • There is a lot of excitement surrounding the use of BRAF inhibitors in patients with BRAF V600 mutated thyroid tumors. This late-breaking abstract for vemurafenib will be a first look at the potential promise of these agents in RAI-refractory thyroid cancer. 

GBM

  • Bevacizumab, irinotecan and radiotherapy versus standard temozolomide and radiotherapy in newly diagnosed, MGMT-non-methylated glioblastoma patients: Updated results from the randomized multicenter GLARIUS trial (3300)
    • This is an update of the data presented at ASCO 2013 this past June. Again, it appears that Avastin/irinotecan therapy prolong PFS in patients with MGMT non-methlyated GBM, where SOC TMZ therapy is ineffective and an active regimen is needed.
       
  • Efficacy and safety of bevacizumab (Bv) plus standard combination temozolomide (T) and radiotherapy (RT) in newly diagnosed glioblastoma: Final results from AVAglio (3301)
    • An update of the AVAglio data presented at ASCO—final OS data will be presented at the meeting. The additional data coming at ESMO may help clarify the role of Avastin in GBM, where data has been inconsistent. 

STS

  • PICASSO 3: A phase 3 international, randomized, double-blind, placebo-controlled study of doxorubicin (dox) plus palifosfamide (pali) vs. dox plus placebo for patients (pts) in first-line for metastatic soft tissue sarcoma (mSTS) (3802)
    • The failure of the PICASSO trial once again shows the need for more targeted trial designs in Soft Tissue Sarcoma.  KOLs continue to press for better targeted trials in this difficult group of diseases.
       
  • Final results of sequential phase 2 studies of palbociclib
    (PD0332991) in CDK4-amplified liposarcoma  (3826)
    • The use of CDK4 amplification as a biomarker may provide palbociclib with a targeted approach in Sarcoma that will prove effective.  The Phase III trial is being planned. 

NET

  • A randomized, double-blind, placebo-Controlled study of Lanreotide Antiproliferative Response in patients with gastroenteropancreatic  NeuroEndocrine Tumors (CLARINET). (LBA3, embargoed)
    • IPSEN has announced that lanreotide has meet it’s primary endpoint in the CLARINET and ELACT trials.  The presentation on Saturday should give us insights into the robustness of the data and an expectation for ELECT at ASCO GI in January, 2014.  


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Drug Developers, Cancer Drug Development, Drug Development, Breast Cancer Drug Development, Breast Cancer Oncology, ASCO, ESMO

Do We Need Phase III Randomized Controlled Trials for EVERYTHING?

Posted by Judi Space on Thu,Aug 29, 2013 @ 09:00 PM

Targeted therapy agents

Phase 3 randomized controlled trials - time to drop in some cases?In clinical trials of targeted therapy agents, sometimes the target is such a crucial driver of the neoplastic process, that its inhibition is able to stop the growing tumor in its tracks. This appears to be the case for some recently approved agents such as vemurafenib for BRAF V600E melanoma and crizotinib for ALK+ NSCLC. Careful screening of patients for these mutations ensures the likelihood of improved progression free survival (PFS) and longer survival times. Unfortunately, because patients are switched from the control regimen in the Phase III trials, the chances of proving better survival are greatly diminished, if not completely eliminated.

In a recent opinion piece in Nature Reviews: Clinical Oncology, Robert Doebele argues that when patients are screened for the relevant oncogene "the burden of proof for approval should be adjusted for oncogene-targeted therapy in biomarker-selected patients....There might be oncogenes that will not follow this paradigm, but that should not deter us from trying to extend the benefit of this precision medicine approach to patients that may fall into one of these uncommon oncogene categories." 

Crizotinib for ALK+ NSCLC

One example is crizotinib, a tyrosine kinase inhibitor (TKI) for the treatment of ALK gene rearrangement-positive (ALK+) non-small-cell lung cancer (NSCLC), which was approved by the FDA in 2011 based on the results of phase I and phase II clinical trials. Phase I observed an objective response rate (ORR) of 61% and a PFS of 9.7 months.  Phase II observed an ORR of 53% and a PFS of 9.1 months.

Considering the estimated ORR and PFS for most single-agent chemotherapy drugs in pretreated patients with lung cancer is 10% and 3-4 months respectively, was there really a need for a Phase III RCT in this case? 

The outcome of a phase III randomized trial, PROFILE 1007, of crizotinib in patients with ALK+ lung cancer merely provided further proof that cizotinbin is superior to standard chemotherapy for these patients that included a better quality-of-life and physical and emotional function.  Based on the results of this study, it seems reasonable to argue that the burden of proof for approval should be adjusted for oncogene-targeted therapy in biomarker-selected patients, especially in lung cancer. 

Not limited to TKI

Calls for the elimination of Phase III trials are not limited to TKI. During the presentation of a melanoma Phase II trial of a combination of two immunomodulators, ipilimumab and nivolumab at ASCO this year, one of the questions from the audience was, "Do we really need a phase III trial?" The results of the trial being presented were certainly impressive, with one year survival in the 80% range.

Time to shift the burden of proof?

Based on these examples, some feel that it may be time to eliminate the Phase III trial in targeted therapy agents when such overwhelming proof is given that a therapy induces remarkable tumor responses in Phase I and II.  This will allow studies to move along more quickly, minimize the need to switch patients from the control regimen, and provide more rapid approval for certain therapies.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Oncology, Targeted Therapy, Cancer Drug Development, Drug Development

Breakthrough Therapy Opens Door to Streamlined Drug Development

Posted by Rebecca Levine on Wed,May 15, 2013 @ 07:51 AM

The FDA's New Breakthrough Therapy Designation

What does the FDA's new Breakthrough Therapy designation mean for pharma and biotech firms? Commentary by Pennside Partners, consultants to the pharmaceutical and biotechnology industries.The FDA recently added a new designation, ‘Breakthrough Therapy’, to its roster of pharmaceutical regulatory terminology in order to ensure that truly innovative compounds get to the patients who need them most as soon as possible.  This new designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA).  The Breakthrough Therapy designation will provide companies with the opportunity for a streamlined developmental process, which could greatly shorten the development timeline. 

How the Breakthrough Therapy Request Process Works

A company can request the designation from the FDA at any time after the original IND submission, but is under no obligation to publicly announce the request.  Once the FDA grants the compound the Breakthrough Therapy designation, the process for approval becomes abbreviated.  The FDA representatives effectively form an advisory panel with the company, in order to determine the most efficient trial designs.  The review time will also be shortened due to the rolling NDA / BLA submission. 

Oncology Likely to Benefit Most

While the language of the bill does not specifically refer to oncology as a primary source of Breakthrough therapies, it is likely that a majority of these designations will apply to oncology compounds.  Other diseases that have already received Breakthrough Therapy status include the rare genetic disease epidermolysis bullosa, hepatitis C and cystic fibrosis. 

Flexible Approval Standards

These new breakthrough therapies must show early clinical evidence of a substantial improvement over existing therapies for serious or life-threatening diseases.  The bill purposefully left the approval standards vague, so that a judgment call can be made by the reviewers at the FDA.  There is no efficacy bar set; however officials warn that if a company wonders if their drug is in a grey area, it is unlikely to be a true breakthrough. 

Rigorous Data Requirements Remain

The data requirements for Breakthrough Therapies will be as rigorous as other submissions, but other faster trial designs may be possible for these compounds.  The options could include a phase Ib expansion or single-arm pivotal trial for diseases states where there is no standard of care.  A phase IIb randomized controlled trial with a modest-sized population might also be an option for some of these compounds where substantial efficacy benefit is seen over the standard of care.  Both these options and others could lead to either full or accelerated approval.

50% Breakthrough Therapy Approval Rate So Far

Over a dozen companies have already sought the Breakthrough Therapy designation, with approvals being granted to approximately half.  One of the compounds recently granted Breakthrough Therapy status is Pfizer’s palbociclib, an oral inhibitor of cyclin-dependent kinases (CDK) 4 and 6.  The designation was granted based on preliminary data from their phase II trial in first-line post-menopausal patients with ER+, HER2- locally advanced or metastatic breast cancer.  Interim data presented at the 2012 San Antonio Breast Cancer Symposium showed that women treated with the combination of palbociclib plus letrozole achieved a statistically significant improvement in median progression free survival (PFS) compared to women who received letrozole alone (26.1 months and 7.5 months, respectively).

Official FDA Guidance Set for July 2013

The official master guidance will be released by the FDA in July of 2013; however it is clear that this new designation will provide a significant benefit to qualifying extraordinary therapies. 

Pharmaceutical Industry Hurdles

What remains unclear at this time is how the already underfunded FDA will manage to provide even more time and attention to these compounds and how much the designation will actually streamline the regulatory pathway. 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Oncology, Cancer Drug Development, Drug Development, Breakthrough Therapy, FDASIA

Heads up for ASCO: Our List of Key Oncology Presentations

Posted by Judi Space on Tue,May 07, 2013 @ 06:00 PM

Expect the biggest data dump of the year at this annual cancer mega-conference

ASCO Oncology and Drug Development Conference Highlights May June 2013

 

 

 

For those of us taking an interest in Biotech and Drug Development the largest release of new clinical data is just around the corner at the annual American Society of Clinical Oncology (ASCO) meeting to be held in Chicago starting on May 31. In ASCO’s preliminary press release, the organization revealed what it thought were the key presentations to be presented at the meeting.  The actual abstracts will be posted on the ASCO website on May 15th, but the titles of the presentations are available now.

Pennside always sends a large team to ASCO to review the data and discuss its implications with experts in the field.  After reviewing the entire program, we have a hit list of what we believe are the most important studies to be presented at the meeting, especially regarding development of targeted therapies for a number of cancer indications.

Breast Cancer:

    • Phase III, randomized, double-blind, placebo-controlled multicenter trial of daily everolimus plus weekly trastuzumab and vinorelbine in trastuzumab-resistant, advanced breast cancer (BOLERO-3). (Abstract #505)

One of the most important data releases this year at ASCO in Breast Cancer will be the preliminary results from the BOLERO-3 trial of Afinitor in combination with Herceptin and vinorelbine in HER2+ metastatic Breast Cancer patients.  Results were expected at the San Antonio Breast Cancer Symposium in 2012; however there had not been enough events to report at that time.  This trial should clarify whether Afinitor can be used to reverse resistance to HER2 therapies as well as it does with hormonal therapies.  If successful, this will expand the reach of Afinitor into the 2nd line of HER2+ Breast Cancer therapy, where its side effect profile will not cause the hesitance that it has in the ER+ populations.

  • A phase II trial of an oral CDK 4/6 inhibitor, PD0332991, in advanced breast cancer. (Abstract #519)

Interest remains extremely high for the anti-CDK4/6 inhibitor palbociclib from Pfizer.  More data from the Phase II trial will be released during a poster discussion session at ASCO.  The preliminary data seen at SABCS in 2012 was very significant and if these further results support it, the approval of this compound will dramatically affect the 1st line treatment of advanced ER+ Breast Cancer.   Since the FDA granted palbocicllib the designation of Breakthrough Therapy, the oncology community is very focused on how this will affect it’s developmental pathway. 

Colorectal Cancer:

  • Analysis of KRAS/NRAS, BRAF mutations in the phase III PRIME study of panitumumab plus FOLFOX versus FOLFOX as first-line treatment for mCRC (abst# 3511)

ASCO granted an exception to its abstract policy so that data from this analysis could be released early (17 April) because it shows that patients with certain RAS mutations beyond KRAS may have a negative outcome from treatment with Vectibix. ASCO and Amgen strongly believe oncologists need this information now in order to make informed decisions about choosing effective treatments for their patients.

  • Randomized comparison of FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment of KRAS wild-type mCRC: German AIO study KRK-0306 (FIRE-3) (Abst# LBA3506)

Outcome of this trial may determine if patients truly benefit from this class of drugs in the first line setting.

Non-Small Cell Lung Cancer (NSCLC):

    • A randomized study of ganetespib, a heat shock protein 90 inhibitor, in combination with docetaxel versus docetaxel alone for second-line therapy of lung adenocarcinoma (GALAXY-1) (Abst# CRA8007)

This is Synta’s lead product for 2nd line NSCLC. Previous interim results from GALAXY-1 have been positive, which leads us to suspect that this interim analysis will continue in a positive trend.  Final data (PFS/OS) for GALAXY-1 should be ready in time for EMSO2013 in Amsterdam or WCLC2013 in Sydney. The key for ganetespib’s initial success lies in any additional toxicity in combination with docetaxel. Note that GALAXY-2 (Phase III 2nd line NSCLC with docetaxel) has recently began enrolling patients. Clinicians will clearly contrast ganetespib with nintedanib (see below).

    • Nintedanib (BIBF 1120) plus docetaxel in NSCLC patients progressing after first-line chemotherapy: LUME Lung 1, a randomized, double-blind phase III trial. (Abst# LBA8011)

This is Boehringer Ingelheim’s second foray into the NSCLC. Their lead agent, afatinib is currently under regulatory review with both the FDA and EMA. Like ganetespib above, the key issue for nintedanib is toxicity in combination with docetaxel (provided the data is positive).Nintedanib clearly has the early lead when compared to ganetespib for becoming the newest agent in 2nd line NSCLC. Positive data in  LUME Lung-1 would be the second shot in the goal for Boehringer Ingelheim and their NSCLC franchise.

Prostate Cancer (PrCa):

  • Abstract #5016: A randomized phase II study evaluating the optimal sequencing of sipuleucel-T and androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BRPC): Immune results (Abst# 5016)

With the increasing number of approved treatments available for prostate cancer the biggest challenge is how to best sequence the drugs to maximize efficacy and minimize toxicity.  Because Provenge does not alter PFS but does improve survival, there has been much discussion regarding the optimal place for its use.  This abstract may offer some guidance or at least improve understanding.

 

    • Abstract #5004: ERG rearrangements and association with clinical outcome in patients (pts) receiving abiraterone acetate (AA) (Abst#5016)

Results from the COU-AA-302 study in chemotherapy (chemo)-naïve metastatic castration-resistant prostate cancer (mCRPC): The increasing number of targeted cancer therapies in development has necessitated the need for biomarkers to aid in determining patients most likely to respond to and benefit from each treatment.  Biomarkers will be increasingly valuable for patients and physicians in the decision making process.   ERG rearrangement in prostate cancer at the time of diagnosis, are markers for predicting subsequent tumor behavior and can help in better predicting the clinical outcome.

Kidney Cancer (RCC):

    • Record-3: Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in mRCC (abst# 4504)

Trials evaluating sequencing of targeted therapies are always important in RCC, although mTOR use is uncommon in the first line setting. 

    • Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in mRCC (Abst# 4505)

This is early data, but it will be interesting to see how this agent compares to BMS’ nivolumab (anti-PD1), which is already in Ph III for RCC.

Melanoma:

    • Long-term follow-up data on the safety and efficacy of singe-agent nivolumab (an anti-PD-1 antibody) in patients with advanced melanoma (Abstract #CRA9006)

Nivolumab (BMS) , a new immunomodulator, made a big splash at last year’s ASCO and BMS has lost no time in fleshing out its development program across a number of tumor types.  Since its debut last year companies with other agents like nivolumab have sprung into action, with clinical data presentations for quite a few of them on the schedule.

    • Findings from a Phase III trial exploring the effect of the anti-PD-L1 antibody drug MPDL3280A in patients with locally advanced or metastatic solid tumors (Abstract #3000)

This study of MPDL3280A (Roche) in patients with solid tumors will be presented by Roy Herbst (Yale). It is most unusual for a Phase III trial to include patients with many different tumor types, and we are intrigued by what Roche plans to do with the data (should the study be positive).

    • BRAF inhibitor (BRAFi) dabrafenib in combination with the MEK1/2 inhibitor (MEKi) trametinib in BRAFi-naive and BRAFi-resistant patients (pts) with BRAF mutation-positive metastatic melanoma (MM). (Abst#9005)

Interest is high here for this combination of TKIs from GSK. Phase II data was very promising at last year’s ASCO, and NDA has been filed with the FDA, so any updates will be followed very closely by all stakeholders.

Glioblastoma (GBM):

    • RTOG 0825: Phase III double-blind placebo-controlled trial evaluating bevacizumab in newly diagnosed GBM (Abst# 1)

ASCO’s top abstract. Presentation of results from this trial, along with the previously-reported AVAglio trial, will help determine the benefit of adding Avastin to standard chemo and radiotherapy in newly-diagnosed GBM.

    • Bevacizumab, irinotecan, and radiotherapy versus standard temozolomide and radiotherapy in newly diagnosed, MGMT-nonmethylated GBM: First results from the randomized multicenter GLARIUS trial (Abst# LBA2000)

GBM patients with non-methlyated MGMT are resistant to treatment with the current standard of care chemotherapy (temozolomide), so if Avastin/irinotecan proves useful in this setting, it will be an important option for this group of patients who are currently without effective therapy.

Thyroid Cancer (ThyCa):

    • Sorafenib in locally advanced or metastatic patients with radioactive iodine-refractory differentiated thyroid cancer: The Ph III DECISION trial (Abst# 4)

Another top Abstract at ASCO: Earlier this year, Bayer announced that DECISION met its primary endpoint, so it will be exciting to see just how effective Nexavar is in this difficult setting in thyroid cancer.

    • Phase II study of everolimus and sorafenib for the treatment of metastatic thyroid cancer (6024)

It will be interesting to see if the addition of Afinitor to Nexavar (which is known to be effective in thyroid cancer) will add any additional benefit.

Liver Cancer (HCC):

    • Sorafenib alone versus sorafenib combined with gemcitabine and oxaliplatin (GEMOX) in first-line treatment of advanced HCC: Final analysis of the randomized Ph II GONEXT trial (UNICANCER/FFCD PRODIGE 10 trial) (Abst# 4028)

The GONEXT trial will show if the addition of Nexavar to chemotherapy can improve outcomes in HCC, where chemotherapy alone is not very effective. HCC is a difficult disease, and many patients have difficulty with the side effects of Nexavar alone—this combination will have to overcome the potential for increased toxicity with some significant benefit in survival in order to be successful.

    • Ph II trial of Pexa-Vec (pexastimogene devacirepvec; JX-594), an oncolytic and immunotherapeutic vaccinia virus, followed by sorafenib in patients with advanced HCC (Abst# 4122)

Oncolytic viruses are a novel approach in oncology, particularly in HCC. This Ph II data will hopefully be the first indication of whether Pexa-Vec will be effective and well-tolerated.


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Oncology, Cancer Drug Development, Drug Development, Breast Cancer, Breast Cancer Drug Development, Breast Cancer Oncology, Kidney Cancer, Liver Cancer, Thyroid Cancer, Glioblastoma, Melanoma, Prostate Cancer, Lung Cancer, Colorectal Cancer, ASCO

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