- ASCO 2017: What you missed (biopharmadive.com)
Loxo Oncology opened this past weekend's annual conference of the American Society for Clinical Oncology with compelling data showing its drug's efficacy across an array of 17 different cancers...the results were unquestionably positive for Loxo, larotrectinib's performance also marks another step forward in the lofty and still yet unrealized goal of precision oncology...Merck's flagship immunotherapy Keytruda (pembrolizumab) won a landmark approval from the Food and Drug Administraiton for tumors with a specific biomarker...Treating cancer based on solely on the genetic profile of a patient's cancer has been a long-talked about objective, and progress from Merck, Loxo and others show what's possible beyond the molecularly targeted therapies that have advanced clinical care in the past decades...improving precision could also be seen in data presented by Bluebird Bio and Nanjing Legend Biotech, which showed the broader potential for CAR-T therapy outside of leukemia and lymphoma. While checkpoint inhibitors have transformed oncology by broadly unlocking the immune system, CAR-Ts specifically engineer patient's T-cells to seek out specific targets expressed by different cancer types...for a round-up of some of the biggest developments from oncology's biggest conference.
- CAR-Ts steal the show - Impressive data from Bluebird Bio and Nanjing Legend Biotech point to CAR-T's relevance outside of leukemias and lymphomas.
- Roche's Perjeta cuts risk in Aphinity, but is it enough? - The large Phase 3 study has been closely watched as potentially practice changing but the modest benefit could limit its impact in adjuvant treatment of breast cancer.
- Loxo shows promise of biomarker approach to cancer - Clinical data presented Saturday showed treatment with Loxo Oncology's larotrectinib shrank tumors in three-quarters of patients with a range of 17 different advanced cancers.
- Juno marks progress with second-gen CAR-T - Updated results for JCAR017 looked competitive in lymphoma as Juno hopes to recover from its earlier safety setbacks with its now shuttered JCAR015 program.
- J&J seeks label expansion for Zytiga - The pharma's prostate cancer drug was a big winner at ASCO, with data showing a 38% reduction in the chance of death for high-risk patients when adding Zytiga to standard hormonal therapy.
- Incyte pads its IDO numbers - IDO inhibitors have been pegged as the next step in immuno-oncology combinations, but Incyte's rising market value prompts questions over what that's worth.
- Roche's Alecensa bests Xalkori in lung study - The ALK inhibitor from the Swiss pharma dramatically improved progression-free survival over Xalkori, potentially positioning itself as the new standard of care.
- AstraZeneca's Lynparza stays step ahead of PARP rivals - Data showing a 42% risk reduction in disease worsening compared to chemo in breast cancer patients should help build Lynparza's profile outside of ovarian cancer.
- Merck touts Keytruda bladder benefit post Tecentriq failure - Data announced for Keytruda in bladder cancer raises questions about the differences in checkpoint inhibitors after Roche's recent failure in the space.
- Chi-Med, Lilly tout cancer med's efficacy in the colorectal setting - Median overall survival was about three months longer for patients receiving fruquintinib versus those on placebo.
- 20,000 leagues for biotech to explore (biopharmadive.com)
The sea covers around 70% of the earth, and contains around 97% of the world's water. It's also home to almost 240,000 species...as a resource, it is still untapped...Bioprospecting is the discovery and development of new products based on resources from the natural world...We are not marine organisms, so until about 1970, no one even thought of the ocean. It was left as a deep secret. It seemed ridiculous to me that the ocean — with such a vast habitat — had escaped anyone's notice. But there are good reasons. People fear the ocean; it has been considered a very hostile, inhospitable place...the history of drugs from the sea isn't particularly long. Red algae have traditionally been used to make a treatment for colds, sore throats, chest infections including tuberculosis, kidney trouble, burns, cancer and indigestion...There are plenty of high-profile drugs that have gotten their origins from the sea…There are more than 25 marine-derived molecules in clinical trials, with over a thousand in pre-clinical development...There are still many societal challenges that the marine environment could help us to meet, such as antibiotic resistance...It is a source of chemical diversity, with novel targets and novel modes of action...
A snapshot of late stage development:
- PharmaMar...Plitidepsin and lurbinectedin, both derived from sea squirts... T-cell lymphoma...
- BeyondSpring...linabulin...is based on a marine fungus…non-small cell lung cancer...
- Ohr Pharmaceutical...Squalamine...found in dogfish shark tissues...a wide variety of indications…antimicrobial against bacteria, fungi, protozoa and viruses, as well as in cancer, macular degeneration, diabetic retinopathy and fibrodysplasia ossificans progressive...
- Wex Pharmaceuticals...puffer fish...neurotoxin tetrodotoxin...a non-addictive and rapid-acting pain killer without opioid-like side effects....
- Why biosimilars could be market disruptors (biopharmadive.com)
Just as generic drugs revolutionized the small molecule space, biosimilars are poised to have a major impact on the development and commercialization of biologics. These highly similar, but not necessarily interchangeable drugs, have been part of the European drug market for years, but are just starting to emerge in the U.S. While still early days, the developing biosimilars market is one to watch.
- Device makes single doses of drugs on demand (upi.com)Synthetic biology and microbioreactor platforms for programmable production of biologics at the point-of-care (nature.com)
A portable device may allow doctors to create single doses of biopharmaceutical medications on demand, potentially speeding the treatment of diseases that include diabetes and cancer...The portable production system was developed by scientists at the Massachusetts Institute of Technology, with funding from the U.S. Defense Advanced Research Projects Agency, expecting the device could be useful for the battlefield and remote areas to produce treatments immediately at the point of care...The system...can currently produce two biologic drugs from a single yeast strain in the device, creating near-single-dose production in less than 24 hours with limited infrastructure...The production system uses a programmable strain of yeast, Pichia pastoris, which produces two proteins used for disease therapy...The strain of yeast, which can grow at very high densities when exposed to carbon sources, expressed recombinant human growth hormone when exposed to estrogen β-estradiol and expressed the protein interferon when exposed to methanol...The potential use for the device is significant, as it can be used for everything from treatments on a battlefield where immediate care is required to prevention of a disease outbreak in a remote village...
- WHO to help bring cheap biosimilar cancer drugs to poor (reuters.com)
The World Health Organization is to launch a pilot project this year to assess cheap copies of expensive biotech cancer drugs in a bid to make such medicines more widely available in poorer countries...The U.N. agency said...it would invite drugmakers in September to submit applications for pre-qualification of so-called biosimilar versions of two such drugs on its essential medicines list, Roche's Rituxan (rituximab) and Herceptin (trastuzumab)...The move is a boost for biosimilars which are expected to account for a growing proportion of treatments, particularly for cancer, as patents on the original branded products expire...The WHO plays a critical role in monitoring drug quality in poorer countries through its pre-qualification program, which ensures that treatments supplied by U.N. agencies such as UNICEF are of acceptable quality...
- China updates national drug list, adding some blockbuster Western meds (fiercepharma.com)
China has updated its list of medicines covered by national medical insurance, adding some new drugs with a focus on pediatrics and major illnesses such as cancer, hepatitis, and renal and cardiovascular diseases…The overhaul, the first since late 2009, saw the number of "Western-style" and traditional Chinese medicines included in the list grow by 15% to 2,535, among which 1,297 are Western-style meds, an 11% increase...The additions include some blockbuster meds like tenofovir, an antiviral drug to treat hepatitis B and HIV...and cancer drug gefitinib...China’s own non-small cell lung cancer med icotinib…The ministry (Ministry of Human Resources and Social Security) also put 45 drugs on a “to-be-negotiated” list, half of which are targeted cancer therapies...inclusions of new drugs would reduce the financial burden on patients and help support innovations in China's pharmaceutical market...The National Reimbursement Drug List names all the drugs covered by the insurance program, some in full and others partially. Patients must pay the full price out of pocket for those drugs outside the list, which means a huge financial burden, especially when new but more effective drugs are not covered..
- The public’s view of pharma just keeps getting worse (statnews.com)
The pharmaceutical industry theme song may be Joan Jett’s "Bad Reputation."...Of 25 different business sectors, only the federal government is held in lower esteem by most Americans, according to a recent Gallup Poll. What’s more, the pharmaceutical industry last year registered its worst showing in the 16 years that Gallup has been tracking how different sectors are perceived...The findings are not all that surprising. There may be a steady stream of stories about new medicines that are producing unprecedented patient outcomes in tackling such hard-to-treat diseases as cancer and hepatitis C. But the ongoing controversy over the cost of prescription drugs may be overshadowing many of the advances made by the pharmaceutical industry...
- Illuminating drug discovery by mapping all known drugs (pharmaceutical-technology.com)
A comprehensive map of all existing drugs and how they work, created from information from several huge datasets, could be used to kick-start the next wave of drug discovery. Not only could scientists use the map to suggest promising new targets for diseases as diverse as cancer, mental illness and inflammatory conditions, it could also provide invaluable insight into where existing drugs can be used to treat different diseases...Jointly led by scientists at the Institute of Cancer Research...the research brought together vast amounts of information from datasets including the canSAR database...the ChEMBL database...the...DrugCentral database to create a map of all 1,578 licensed drugs and their mechanisms of action...Dr Bissan Al-Lazikani, explains how this first-of-its-kind map could help tackle one of the biggest challenges facing the drug discovery field: how do you innovate without taking risks that make the whole system unviable?
- Why did you decide that a comprehensive map of all existing drugs and their mechanisms of action was needed for the drug discovery community?
- How did you put the map together? It must have been quite a task!
- What were the most interesting findings of the latest study?
- What are the biggest challenges facing the drug discovery field at present and how will your comprehensive map help overcome these?
- Big Pharma’s Offer to Trump: Discounts When Drugs Don’t Work (bloomberg.com)
President Donald Trump says drug prices are astronomical and something needs to be done...Pharmaceutical giants have an answer that doesn’t involve lowering list prices: refunding some of the money to insurers if a drug doesn’t work as expected...The concept of pay-for-performance isn’t new in the industry. But the number of such agreements between drugmakers and insurers has grown in the past year as Big Pharma seeks to defuse criticism over the soaring prices of some brand drugs...In a sign of how central value-based programs have become in the pushback, the lobby group Pharmaceutical Research and Manufacturers of America plans to roll out the concept later this month to the media as part of proposals on addressing drug pricing concerns...While reimbursing part of the cost for a treatment that doesn’t perform well sounds like a sensible solution, the concept is hard to execute. In conditions like diabetes or high cholesterol, results can be tracked with simple numerical measures -- but it may be harder to pull off in areas like depression or cancer. There’s also little evidence that pay-for-performance will significantly lower drug prices overall...
- Putting the cost of medicines in context (catalyst.phrma.org)
Discussions about costs are important. No patient should have to worry about whether they can afford the care they need. At the same time, it is important to look at costs across the health care system and not just the share going toward life changing medicines...new therapies are transforming care for patients fighting debilitating diseases like cancer, hepatitis C, high cholesterol and more. In the midst of all this progress, the share of spending on retail medicines remains the same as it was 50 years ago. In fact, government actuaries project the share of health care spending attributable to medicines will continue to grow in line with overall health care cost growth for at least the next decade...Our updated Prescription Medicines: Costs in Context explains how competition among brand-name medicines, high generic utilization rates and aggressive tactics by insurers and pharmacy benefit managers to negotiate lower prices all help to keep costs under control...