Ask the Analyst
Our respected Ask-the-Analyst service offers answers to your questions about any of our pharma news stories, analysis, or data.
When you need answers, Ask-the-Analyst is there. Included as part of a Pharma Intelligence subscription, Ask-the-Analyst provides fast and accurate responses to your most pressing inquiries. Our expert teams of journalists and analysts use their wealth of experience, knowledge, and formidable network of contacts across the globe and in all sectors of the industry to deliver you the data you need most.
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Accessing the industry-renowned Ask-the-Analyst service is simple: first, click the Ask-the-Analyst button, present at the top of every page, and complete the form. Our Client Services Team then directs your query to the appropriate respondent, who acknowledges the question, clarifies the scope, and lets you know when you will receive a response.
The Pharma Intelligence Analysts provide immeasurable assistance, guidance and support to our clients.
Below are samples of just a few cases where the analysts helped our customers.
A1: We anticipate that Array’s combination (encorafenib/binimetinib/cetuximab) to be approved in the US in Q2 2020 and in the five major EU markets in Q3 2020 based on the Phase III BEACON trial (ClinicalTrials.gov identifier: NCT02928224). The combination is expected to gain its first approval for the treatment of patients with BRAFV600E-mutated mCRC that has progressed after one or two treatments.
The Tafinlar/Mekinist/Vectibix combination is still in Phase II and it’s not listed as being an active drug combination in development in Novartis’s pipeline (see attached). However the trial (ClinicalTrials.gov identifier: NCT02928224) is still ongoing and if Novartis were to pursue this combination based on this trial, we would expect a US approval in Q4 2018 and in the EU in Q4 2018 or Q1 2019 based on the primary completion date.
A2: Here are our perspectives on these drugs:
Xalkori: As the first-in-class ALK inhibitor approved for NSCLC, Xalkori (crizotinib; Pfizer/Merck KGaA) enjoyed almost three years of market control before any direct competition gained approval. However, the drug has begun to lose patient share as second-generation ALK inhibitors progress to earlier lines of therapy. Both Zykadia (ceritinib; Novartis) and Alecensa (alectinib; Roche/Chugai) have gained label expansions to include the first-line ALK rearrangement-positive treatment setting. Each drug has shown the potential to improve upon survival rates exhibited by Xalkori, especially in patients with brain metastases. Alecensa, in particular, will threaten Xalkori’s historical position as the standard of care for ALK rearrangement-positive NSCLC following positive results from the head-to-head Phase III ALEX and J-ALEX trials.
Lorlatinib: Lorlatinib is an orally administered small molecule inhibitor currently under development for ROS1- and/or ALK rearrangement-positive NSCLC. Data from the Phase I/II 1001 trial highlighted lorlatinib’s promising clinical activity in both ROS1- and ALK rearrangement-positive disease. Lorlatinib also appeared to be clinically active in this study in patients previously treated with two or more lines of therapy. Based on these data, regulatory filings have been submitted for lorlatinib in Japan, the US, and EU. This is a significant commercial opportunity for Pfizer, as patients with ROS1-positive NSCLC remain an area of high unmet need. Pfizer has also initiated the Phase III CROWN study, which will test lorlatinib head-to-head with Xalkori.
Dacomitinib: Dacomitinib (Pfizer) is a human epidermal growth factor receptor (HER) inhibitor in development for NSCLC. Although first-generation tyrosine kinase inhibitors (TKIs) Tarceva (erlotinib; Roche/Chugai/Astellas) and Iressa (gefitinib; AstraZeneca) have had a profound impact in NSCLC, their inhibition is reversible and patients usually acquire resistance to these therapies. As an irreversible inhibitor of multiple pathways, dacomitinib was hypothesized to be a suitable therapy to overcome such resistance. However, two Phase III trials testing the drug’s use as a second-line therapy have failed, leading to the suspension of the drug’s development in the US. Nonetheless, positive results from the Phase III ARCHER 1050 study conducted in Asia and Europe revealed that dacomitinib conferred superior median progression-free survival (PFS) versus Iressa in first-line EGFR mutation-positive NSCLC. These data may ultimately be sufficient for dacomitinib to gain regulatory approval in these markets.
Bavencio: Bavencio (avelumab; Merck KGaA/Pfizer) is a PD-L1 inhibitor currently under development for first-line treatment of advanced or metastatic NSCLC. Although the development of Bavencio was expedited, it is still forecast to be the fifth PD-1/PD-L1-targeted therapy approved for NSCLC. Early-phase studies have demonstrated the drug’s promising clinical activity in PD-L1-positive patients. However, results from the Phase III JAVELIN Lung 200 trial revealed that PD-L1-positive, second-line patients treated with Bavencio failed to exhibit a statistically significant improvement in overall survival (OS) over docetaxel. While improvements in OS were observed in high PD-L1-expressing patients, these data are still unlikely to support regulatory approval given that the study did not meet its pre-specified endpoint. Bavencio’s next opportunity for approval comes from the Phase III JAVELIN Lung 100 trial in first-line patients. Nonetheless, without any differentiating factors to enable it to take market share from its competitors or expand the market for immunotherapies, the commercial potential of Bavencio will be limited.
A1: Hi Bill, Thanks for reaching out with this inquiry! The best way to go about searching would be via the Advanced Drug Search (ADS). Under the “Molecule” section, select “Non-Viral Gene Therapy” and “Viral Gene Therapy”. The resulting excel will provide the drug names and associated companies developing the products, in addition to other useful information. Let me know if I can assist with anything else!
A2: Thanks for reaching out with this inquiry! After some review and discussion with our Scientific Analysts, I have suspended MSDC-0160 in both previously active indications (Parkinson’s disease and Alzheimer’s disease). The reasoning for both includes the lack of developments, in addition to the poor Phase IIa results for Alzheimer’s disease that you noted in your email. Suspension events can be seen in the links below. MSDC-0160 for Parkinson's Disease (PD) - https://www.biomedtracker.com/EventDetail.cfm?EventID=304441 MSDC-0160 for Alzheimer's Disease (AD) - https://www.biomedtracker.com/EventDetail.cfm?EventID=304443 Analysis of the Phase IIa Alzheimer’s disease results can be seen in the suspension event, and note that with no progress updates since the first announcement of Phase IIa data in 2013, and the subsequent p-value miss, we assume that this drug is no longer in active development. Any future development looks negative on the main hypothesis of the study, and it would be a pretty big leap for this to translate into a positive clinical effect on validated measures of Alzheimer’s disease such as cognition, function, and brain atrophy.
A3: Merck KGaA announced in February 2018 that they will file a regulatory submission for Mavenclad with the U.S. Food and Drug Administration in the second quarter of 2018. However, they have not yet disclosed a timeline for the US approval. I have reached out to the company about the approval and will provide you with the information if I hear back!
A4: We estimate that the relative distribution of Stage IIIb compared to all Stage III NSCLC is approximately 30-67%. Support for this can be found in several studies. In Table 4 of this first study, the authors show the percentage of Stage IIIb patients across several arms of a US Phase II study restricted to Stage III patients. Although the specific percentage of Stage IIIb patients varies slightly in each treatment arm, you can see that across all treatment arms, 37-60% of Stage III patients in this study were Stage IIIb. The second paper is a Taiwanese study of Stage I-III EGFR mutation-positive patients, which can be found here. Table 1 shows the distribution of patients by stage (Stage Ia-IIIb). Approximately 48% of all Stage III patients were Stage IIIb. Similarly, a Canadian study on population-based patterns of treatment in Stage III NCLC found 51% of Stage III patients were Stage IIIb. Notably, a European study investigating the changing pattern of NSCLC between the 1990’s and 2000’s found Stage IIIb patients to comprise as low as 22%. However, it’s worth noting that this lower percentage may be representative of different diagnostic trends and practices in past decades. 2. We defined “local relapse” as patients whose disease has recurred at or near the same place as the primary tumor, typically after a period of time during which the cancer could not be detected. This is considered equivalent to locally advanced disease. 3. Similarly, we defined “distant relapse” as patients whose diseases have recurred at other sites other than the primary tumor, indicating metastasis. Again, this is typically after a period of time during which the cancer was not detected. This is considered equivalent to metastatic disease. Tagrisso’s current prescribing label allows for use in EGFR mutation-positive NSCLC patients with metastatic disease, but the pivotal trials that led to the drug’s approval allowed for the inclusion of locally advanced or metastatic patients. Due to the severity of locally advanced disease and the lack of treatment options specifically indicated for this stage of disease, we assume Tagrisso’s use for locally advanced patients is just as high as if it was explicitly indicated for use on the prescribing label.
A1: Thank you for your inquiry. According to the FDA document below, Lyrica was not granted Pediatric exclusivity. It was, however, granted exclusivity for treatment of Fibromyalgia and exclusivity for being a new chemical entity. Details of the exclusivity can be found within the document. If you have any further questions, please do not hesitate to ask.
A2: Thank you for your inquiry. I have attached a file with the product sales from 2016 and 2017 along with forecasted sales to 2026. I went ahead and included the total for all product sales for 2016 and again for 2017 as well as totaling each forecasted year from 2018 to 2026. The best way to search for sales and forecasts is to create a product group and then apply that group to the Product Sales Analyzer tool. My product group consisted of the three monoclonal antibodies options found in the Chemical/Biological class search (see below). I created a product group from the results view, for instructions on creating a product group please refer to this link. After the product group is created, you can apply it to the Product Sales Analyzer tool along with the years of interest (2016 to 2026) and select “Total Global Sales”. Total Global Sales is a number that we create based on the reported sales across all geographies and by all companies for a single product, we take this data and come up with a single number to represent all sales taking into account double reporting, etc.
A3: Thank you for contacting Medtrack’s Research Request service with your inquiry regarding therapeutics for gastrointestinal pain. Pain involving the various indications you mention required some specialized searching and review since the diseases span multiple therapeutic categories. I identified 34 drugs in development specifically for the pain associated with those indications, as well as the companies involved, associated partnerships and global patent information (please see first attachment). Two of them are already marketed, but may not be as targeted to GI pain as some of the others still in development: -Buscopan - indicated for the treatment of abdominal pain -MuDelta- indicated for the treatment of patients with irritable bowel syndrome with diarrhea (its dual opioid activity is designed to treat the diarrhea and pain symptoms associated with IBS) Please refer to the individual product profiles on the Medtrack platform for detailed information on the development of these drugs. I identified generic drugs in that space as well, and they are included in the second download which separates all the drugs by focused therapy areas. I hope you find this information helpful, and please let us know if you have any further questions.
A4: Thank you for your inquiry. I have included all partnership deals in regards to generic drugs in the attachment, this includes publicly released financials such as upfront payments, total deal value, etc. There are several sub-categories that are available in the Advanced Search that might help you obtain more targeted results (I did not limit in the attachment), I have included some screenshots as well as directions to help you run this search if interested. Start in the Advanced Search by selecting ‘Generic’ from the product type: From the ‘Deals’ tab, you can target your partnership deal search by adding sub-categories, date ranges, etc. I hope this helps. If you have any further questions, please do not hesitate to ask.
A5: Thank you for your inquiry about companies in the prescription dermatology space. The first set of results include the pharma/biotech companies headquartered in the US or Europe that have a prescription dermatology drug in development or on the market and the related drugs. I removed any from the list that had only a manufacturing role in the drug’s development. Please note the list does not include any drugs (and related companies) in which the marketing status was OTC in at least one geographic region. The rows highlighted in yellow represent drugs that are approved or commercialized, but whose marketing status cannot be determined. You can decide whether to exclude those associated companies. The second set of results is a list of medical device companies headquartered in the US or Europe that describe themselves as working in dermatology. Because Medtrack does not cover the devices themselves, it is beyond our scope to determine the marketing status of the devices or the role these companies have in their development. I hope you find this information useful.
A1: I saw your ATA request regarding balloon material-related forecasts for coronary balloon catheters. Meddevicetracker report #MDT17017 Angioplasty Catheters Market provides coverage of the coronary and peripheral vascular angioplasty device markets for the years 2016-2021. However, the forecasts included in this report do not include data that compares semi-compliant and non-compliant balloon materials and their usage. Instead, this report focuses on forecasts by product type (ie drug-coated balloons, plain old balloons, cutting balloons, and scoring balloons) and the forecasted estimated usage of these devices in coronary and peripheral angioplasty procedures. The forecasts are focused on the US, five major European markets, Japan, and the Rest of the World.
During the research of this report, it was noted that semi-compliant balloons accounted for the majority of coronary angioplasty procedures, with an estimated 50-60% of all PCI procedures using semi-compliant balloon materials. Semi-compliant balloons have a majority share due to the flexibility of the balloon material, which allows for semi-compliant angioplasty balloons to navigate tortuous vasculature more efficiently than the more rigid non-compliant balloons. Non-compliant balloons are most frequently used in post-dilation cases to ensure proper stent delivery and “crack” hard lesions.
A2: Greetings, I have attached an Excel spreadsheet that includes all of the devices within Meddevicetracker under the “Hernia Repair” indication. Please do keep in mind that Hernia Repair is outside of the current scope of coverage for Meddevicetracker, therefore the product profiles included in the attached report will not be as comprehensive as products that do fall within our current scope of coverage.
A3: Hello Kellin, I’ve completed the requested custom search using the following parameters you provided:Devices that have received PMA Approvals or have filed a PMA application (not yet approved) in the following classifications:-Internal Radiation -Weight Management-Pain Management (We don’t have a device classification that would cover all devices here, so I included all pain indications to cover this area)-Spirometry -Sleep Apnea or CPAP-Pregnancy Monitoring Devices. I used the same parameters for devices with 510(k) approvals or 510(k) filings. Please note that some of the requested devices are currently considered out of scope and thus we would not have comprehensive coverage in those areas. Here is our current scope statement. Please let me know if there is anything else I can do to assist!
A1: Thank you for getting in touch using the Pharmpaproject’s ‘Ask the Analyst’ service, I hope you are well. I have looked throughout the public domain on this compound, and have found some information pertaining to some preclinical development by Pfizer several years back. In these sources, they disclose a lab-code (PF-06447475), so I have added this information to the associated Pharmaproject’s drug record. I have copied in some of these sources for your benefit below:
As these sources date back to 2015, and typically with PubMed studies the actual execution date of the investigations is even further back, I have kept the Pharmaproject’s drug record for PF-06447475 as ‘No development reported’. It is normal Pharmaproject’s procedure, in cases where we haven’t found any recent sources confirming ongoing development, to move to ‘No development reported’ status. Likewise, Pfizer’s most recent company pipeline includes no mention of this compound. I have copied in the drug profile with these updates below for you to access:
Thank you for bringing this to our attention and I hope this helps. Also, please get in touch with any further queries.
A2: I hope you’re well. The drug profile for rigosertib has now been reviewed and as you suggested, a number of diseases have been found not to be under obvious investigation and have been set to No Development Reported accordingly. The updated drug profile can be viewed at the below link. I hope this helps, and many thanks for letting us know about this. As ever, if we can assist with any future queries then please do get in touch. Have a great weekend!
A3: Within a drug record, when the latest change is stated as product details reviewed, this illustrates that drug the record has been recently reviewed by a member of the team and no updates or changes were made i.e. the record is an accurate reflection of information available in the public domain.
We use the products details reviewed the latest change to highlight to our clients the record has been checked and the status is still the same, it is preferred to leaving the latest change outdated.
In our record for Teikoku Pharma’s rasagiline transdermal patch, the record was reviewed on 27 March 2018, and the product was still represented in Teikoku Pharma’s pipeline but no new information was sourced. Therefore, the product was regarded as active but no new developments were found to update the record and latest change field. Please find a link to Teikoku Pharma’s pipeline below:
I hope this information beings some clarity surrounding the latest change field in our record for rasagiline, however, if you have any more questions please don’t hesitate to reach out again.
A1: Thank you for your patience whilst I consulted with my Trialtrove colleagues. The best way to conduct the search would be to start off in Pharmaprojects:
+ Disease: Primary sclerosing cholangitis and NASH and Disease Status: Preclinical or Phase I or Phase II or Phase III or Pre-registration or Registered or Launched
Here are the results from the Trialtrove side. What I did was I manually input the names of the above Pharmaprojects drugs, filtered by status for ongoing trials, and added on MeSH terms for “Sclerosing Cholangitis” and “Cholangitis”. Of the 7 drugs from Pharmaprojects, I omitted one drug “liver diseases therapy, Seres” which is in preclinical for both Primary Sclerosing Cholangitis (PSC) and NASH. It is my reading of your query that you are interested in PSC clinical trials for drugs that have been developed in both PSC and NASH, however, if you are interested in all ongoing trials for these drugs, these can be found by omitting the MeSH terms from the above Trialtrove search.
To locate trials with results as well, this can be achieved through a separate search by Completed/Terminated status and then filter by Primary Endpoints Reported in columns. I hope this helps, if you have any other questions or would like anything further, please don’t hesitate to get back in touch with me.
A2: Thank you for contacting Trialtrove’s Ask the Analyst service. In general, to retrieve industry-sponsored trials that are stratifying or preselecting patients based on a specific pharmacogenomic biomarker, I recommend adding the Trial Tag/Attribute “PGX-Patient Preselection/Stratification” to your search strategy. I modified your search criteria for industry-sponsored trials from the past five years by adding this trial tag and keyword variations for PD-L1, MSI-high, and TMB in the text field. If a broader trial set was needed for a rare biomarker, I suggest expanding the text field to include the Title and Objectives.
Search Criteria: Oncology + Phase I, I/II, II, II/III, III + Industry Only + United States + + Start Date: 1/1/2012 to 12/31/2017 + Inclusion Criteria: "PD-L1" OR PDL1
Search Criteria: Oncology + Phase I, I/II, II, II/III, III + Industry Only + United States + + Start Date: 1/1/2012 to 12/31/2017 + Inclusion Criteria: "MSI-H " OR "MSI-high" OR dMMR OR "mismatch repair deficient" OR "microsatellite instab* high"
Search Criteria: Oncology + Phase I, I/II, II, II/III, III + Industry Only + United States +
(1 trial) + Start Date: 1/1/2012 to 12/31/2017 + Inclusion Criteria: "TMB" or "tumor mutation* burden"
Because of your interest in generating the number of trials initiated in each of the past five years, you would find useful the expanded set of dynamic dashboards available in next-generation Trialtrove. I recreated the search strategy shown above for PD-L1 in next-generation Trialtrove (here) and selected the Dashboard for Start Date as shown below.
If you have not already done so, I encourage you to register for access to next-generation Trialtrove (https://citeline.informa.com) to take advantage of the enhanced Boolean logic, dynamic filtering, customized result views and expanded set of dashboards.
A1: It’s great to hear from you again! Thank you for contacting Sitetrove’s AtA service with your request for the best search strategy to identify investigators with experience administering vaccines to children. I’d be happy to help you today. Your search is a great place to start! To maximize your results, I broadened your search to be more inclusive of investigators with experience in administering any vaccine and then added text field search parameters to identify trials involving pediatric patients: Click Here to View Results. This nearly doubles your results to 413 investigators and 321 organizations. As you’re reviewing these results, you may wish to export these results into Excel and apply filters to remove investigators with specialties that are not of interest to you. For example, while the majority of the investigators are specialized in pediatrics, family medicine, and infectious diseases, there are also some specializing in sleep medicine, emergency medicine, surgery, etc. which likely will not meet your needs.
You may also wish to run a specialty search in Sitetrove to identify further investigators who may be qualified to participate in a pediatric vaccine study. For this search, I’ve selected the specialties Family Medicine, Pediatric Infectious Diseases, and Pediatrics – General: Click Here to View Results. This identifies 370 investigators and 507 organizations. By combining these results with the investigators and sites from the above search into Excel and using the Remove Duplicates function, I was able to obtain a master list of 532 investigators and 920 organizations which I have attached for your reference.
A2: First, we suggest a targeted search for investigators experienced in systemic sclerosis or scleroderma in Belgium and the Netherlands:
I hope this information has been useful. Please let me know if I can be of any additional assistance.
A3: I recommend starting with the following search in Chinatrove to identify hospitals that have previously been certified by the CFDA to run a GI study. Please note that while a CFDA certification is no longer required to conduct a drug study in China (URL), Chinatrove is still a good place to start your search to identify which sites have been found to follow good clinical practice and approved by the CFDA for these studies.
Chinatrove Search Criteria: CFDA Certifications: Gastroenterology or Gastrointestinal Surgery or Pediatric Gastroenterology
Results: 292 Hospitals
I have exported the hospital results into Excel and filtered the results by physician specialty (column M of the ‘Hospital Department’ tab) to identify the number of qualified physicians for your study. Tab #3 of the file contains the laboratory, diagnostic, and treatment equipment at each hospital. I recommend reviewing this worksheet to confirm the site has the necessary equipment for your study. Please note that when a brand or model number is available in the public domain, we include that in the equipment name (column I of the ‘Hospital Equipment’ tab).
Additionally, you can select any GI disease of interest and identify which trial sites in China have the most experience in these studies by using Sitetrove. Here I have selected a few GI indications that fall within our autoimmune/inflammation and oncology therapeutic areas.
Next Generation Sitetrove Search Criteria: Trial Country is China AND Organization Country is China AND Disease is Oncology: GIST OR Colorectal OR Autoimmune/Inflammation: Crohn's Disease OR Irritable Bowel Syndrome OR Ulcerative Colitis
Results: 525 Organizations (available here)
I have exported the organization results into Excel and sorted by greatest matching trial experience (column M in descending order), so organizations that have the greatest experience running GI studies within the five diseases included in this search are listed at the top of the workbook (tab #5). You can filter the results by organization types of interest (column C of the “Organizations (Next Gen)” tab; for example you can select hospitals only). Finally, to identify investigators for this study and obtain their contact details, click on the view related investigator results tab. The respective 1,618 investigators are available here. You can filter the investigator results further in Sitetrove by specialty or last trial start date to find qualified physicians with recent trial experience for your next GI study.
By Elizabeth Orr 18 Oct 2018
Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.
By Michael McCaughan 18 Oct 2018
Treating mandatory wholesale acquisition cost disclosure in TV ads as a major drug pricing reform is close to ludicrous. But the broad approval of the action is an important sign of the continued public image cost of the ads to the drug companies.
By Ian Schofield 18 Oct 2018
Companies wanting to compete in the newly off-patent adalimumab market in England have until Oct. 22 to submit their bids. They will need to offer “competitive prices” if they are to secure the highest share of sales to the national health service. At the same time, NHS trusts and clinical commissioning groups have been warned not to accept discounted interim offers from suppliers keen to get a foot in the door.
By David Filmore 18 Oct 2018
A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.
By Jessica Merrill 18 Oct 2018
PhRMA unveiled a voluntary policy under which drug makers will provide information in DTC ads about how to access drug prices and cost information. But hours later HHS issued a proposed rule on the same topic, only requiring drug makers to include WAC prices in TV ads.
By Alexandra Shimmings 18 Oct 2018
On the brink of an expanded US approval for asthma, Sanofi/Regeneron’s interleukin-4 receptor blocker Dupixent has produced positive topline Phase III data in a lucrative third indication, rhinosinusitis with nasal polyps.
Topic Influenza virus
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