Posts Tagged oncology

Life Sciences Industry Outlook for 2018: Post BiotechShowcase & JPM


Image result for Biotech Showcase 2018, JPM18JPM 2018 and concurrent events just ended with what may be one of its biggest draws.  As many as 10,000 people from life science industry and its related sectors are likely to have descended upon the city, during last four days.  In addition to JPM event itself, everything health was under review and up for discussion at various conferences including at EBD Group & Demy Colten’s #BiotechShowcase #DigitalMedicine #BTS18 and #WuXiGlobalForum2018 . Networking and deal making continued late in the nights at various receptions held across the city. Receptions by legal firms like #WilsonSonsini #MoFoLLP #ReedSmithLLP attracted some of the biggest crowds.

IMG_20180110_170128791.jpgOverall the tone for 2018, seemed highly optimistic.  BiotechShowcase held a media roundup and echoes of optimism were heard from almost all panelists @barbara_ryan12 @TriangleInsight @CarolineYLChen @adamfeuerstein @statnews @SFBIZronleuty @BrittanyMeiling @endpts @juliet_preston @medcitynews @ldtimmerman .

Image result for biotech innovationThere is a general agreement that the pace of #innovation in biotech greatly accelerated in 2017 and is likely to continue. According to Luke Timmeerman, “sheer velocity of news in healthtech innovation is fascinating”. Transformative therapies across huge and diverse range of diseases are increasingly focusing on cures and going beyond the short term treatment focus. The surge of innovation has been led by focus on oncology although concern was also raised in one of the panels that we still continue to get stymied and realize how friggin smart the disease of cancer is and if we will truly crack the code on cancer in the immediate upcoming years. All signs are however, that next year we may see critical data from some clinical trials in immuno-oncology space that can cause market spikes.

Here are some areas of concern raised in some of the panels. In 2017, a slight dip was observed in the areas of orphan and rare diseases. Also there seemed to be a general consensus that we need smart policies that incentivize new anti microbial drugs and other treatments for infectious diseases. Due to increasing resistance of antibiotics, there is an ongoing and real fear for some of the infectious diseases to turn into pandemics. These are areas that bold entrepreneurs may focus on. Also medical devices continues to remain somewhat underfunded. Discussions around accelerating healthcare costs and drug pricing issues creeped over into many panels. Entrepreneurs with disruptive pricing innovation in product development as well as healthcare can easily have a tremendous leverage. It can’t be overstressed that finding effective pricing solutions holds key to continued and sustainable growth in healthcare sector.

Discussion in one of the panels focused for a few minutes around large investments in life sciences and if that indicated a healthtech bubble that may be due for a crash.  Indeed, some experts observed that pace of 2017 is unlikely to continue and there may well be a slight dip in 2018. But overall the consensus seemed to be, that a steep and deep pipeline of innovation in R&D is likely to prevent a crash, and the venture funding blizzard is likely to continue. Overall, the feeling among investors and healthcare experts was that among the industry, there is a strong focus on science and people are pursuing innovation with discipline that will ensure unprecedented mechanisms and novel medicines. All this activity is taking healthcare to a new level of cures and sustainability and stability from temporary treatment focus. Exciting indeed to be living in this era of amazing healthcare innovation.

 

 

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2013 J P Morgan Healthcare Conference – Pharmaceutical & Biotech Company Presentations


2013 J P Morgan Healthcare Conference – Pharmaceutical & Biotech Company Presentations 

Disclaimer – Below is my best attempt to capture highlights from company presentations, at 2013 J. P. Morgan Healthcare Conference, in San Francisco, CA.  Please check details against more authentic sources, before making any financial decisions.  My writeup on the overview of the conference can be found at this link – http://bit.ly/UY1Cpk .  My article on the highlights from some of the medical device company presentations can be found at this link – http://bit.ly/WfhGmU .  Big Pharma industry historically enjoyed growth rates in double digits and 20% operating margins with growing demand and big profits.  But times are changing for big pharma with challenging healthcare environment, cost pressures, and patent expirations.  Many firms responded to initial challenges by investing heavily in next-generation drugs, often based on biotechnology.  Though promise of biotech has not panned out, many pharma companies have done restructuring, initiated serious cost containment and have nurtured the pipeline by investing in some promising molecules.  See below, highlights from some of these companies.

 

Amgen – 2011 & 2012 were solid years and advanced pipeline offers promise for 2013

Both 2011 and 2012 were solid years for Amgen, with revenue growth of 11%, said COO and CEO elect, Bob Bradway.  He credited the growth largely to the newly launched products, particularly denosumab franchise that include XGEVA and Prolia.  In first year in market, Amgen has recouped over $500M of revenues from this new franchise.  Amgen has returned 36% back to the shareholders.  Prolia accounts for $1B in sales in the US.

Besides growth in its core franchise and advanced footprint, Amgen also has exhibited strong commercial execution with solid performance in the US and international markets, said Barclay.  Sales of Neulasta grew and 40% of patients receive it during first chemo.  Enbrel is Amgen’s leading molecule in rheumatoid arthritis and psoriasis space and is steadily growing.  Sensipar, Nplate, and Vectibix also have strong and steady momentum. There was 18% growth in 2011 on these new products.

Additionally, there is a late stage pipeline emerging that looks promising.  It includes, molecules AMG 145, an antibody PCS K9 for hyperlipidemia for high cholesterol, AMG 785 antibody for post menopausal osteoporosis, AMG 827 (in collaboration with Astra Zeneca) for psoriasis, AMG 416 for secondary hypothyroidism, and several oncology molecules, including AMG 102 for gastric cancer and AMG 386 for ovarian cancer.

Amgen will continue collaborations with other significant players.  Recent acquisitions that are advancing its pipeline include Micromet, decode, and finally Mustafa Nevzat to help establish a presence in Turkey, an emerging market for Amgen.  Amgen will continue to return significant capital to shareholders and in 2013, Amgen will focus on growing revenue, operating efficiencies, advance its pipeline, and focus on ROI.

Bristol Myers Squibb – will its promising portfolio deliver in 2013?

While 2012 was a year of transition, BMS is now poised to deliver by driving growth of key brands, executing on new product launches, and driving late stage pipeline said, CEO, Lamberto Andreotti.

BMS’s diversified portfolio includes key brands Eliquis, Yervoy, forxiga, Orencia, Sprycel and so on.  Acquisition of Eliquis for stroke prevention and systemic embolism for Afib, offered a significant global opportunity and it was launched in Europe, US, Canada, and Japan.  BMS has a broad portfolio targeting diabetes, in partnership with Astra Zeneca and it includes Amylin, onglyza, forxiga, and Byetta.  A robust late stage portfolio targeting HCV includes some promising molecules.  Finally, immuno-oncology continues to remain an exciting portfolio.  Yervoy is showing encouraging 5 year survival data for melanoma patients, Nivolumab is in broad stage III program, and Elotuzumab phast III studies are looking promising, said Andreotti.

BMS is committed to 3% increase in dividend for 2013 versus 2012, has completed initial $3B share repurchase program and has announced additional $3B share repurchase program, and will continue to focus on business development through licensing, acquisition, and partnerships.  BMS is well poised to deliver with improved decision making, more efficient operations, and greater collaboration, said Andreotti.

Merck – Exciting Pipeline & Plans to Expand Geographic Footprint

Celebrating first year as a combined company, following the merger of Schering-Plough and Merck, the company is well poised to outperform the broader healthcare market, said Ken Frazier, President & CEO of Merck.  Its broad portfolio includes market leading medicines and vaccines, Merck has expanded geographic footprint in key markets, and has a strong exciting late stage pipeline.

While sales force was reduced in the US by 10%, in emerging markets like China, Brazil, and Russia, Merck was increasing the presence.  Despite 2012 being a year of maximum disruption, with blending sales forces, training reps on new products etc., the company maintained top line growth with 7 of the top 10 products growing at a steady pace, said Frazier.  The current late stage pipeline includes 55% legacy Merck compounds and 45% legacy Shering-Plough compounds, affirming the scientific productivity of both organizations, said Frazier.  Growth strategy going forward includes plan for geographic expansion in Japan and emerging markets, delivering on the pipeline, and expanding broader portfolio of business that include Merck BioVentures and animal health business. Some significant brands include, Simponi which is launched in 18 countries, with great success.  There are five new drug approvals including Dulera in the US, and Brinavess, Daxas, Elonva and Sycrest in Europe.

While strongly focusing on internal innovation, Merck has also signed 46 significant outside deals with external partners including most recently the SmartCells deal in diabetes.  Merck has over 20 drugs in Phase III incuding Vorapaxar, Tredaptive, Anacetrapib, and Odanacatib.  Merck will continue to remain committed to cardiovascular space, with currently over 100,000 patients in outcome studies and though costly now, the eventual aim is that these will lead to drugs that will reduce cardiovascular events, heart attacks, and strokes.  Vorapaxar is the largest study with 40,000 patiens and Tredaptive has 25,000 patients. While Merck is number two pharmaceutical company, globally, it is number five in emerging markets and going forward, plans to expand presence in these markets from current 18% total sales to 25% by 2013, said Frazier.  The plan is to grow the current portfolio in oral antibiotics and vaccines, as well as in women’s health.  Additionally, given the rise in chronic diseases, Merck plans to grow in respiratory, cardiac, and diabetes space.  Januvia is already number one oral diabetic product in emerging markets.   Merck acknowledges that countries like China are surrounded by strong science and innovation in those markets can be a huge contributor.  Merck aims to grow through value creating partnerships in those markets that would help in issues like pricing, reimbursement, market access, and low cost manufacturing.

Gilead – In addition to targeting Hep C, also continues to grow & remain a Leader in HIV Treatment

2012 has been a busy year for Gilead, said Chairman and CEO, John Martin.  Gilead’s current commercial portfolio includes HIV, liver, respiratory, cardiovascular and other areas.  The biggest part of revenue generation has been HIV.  Truvada, the single regimen pill is steadily growing and is made available in low and middle income countries at steeply discounted prices or through generic licensing partners.  In 2012, Gilead launched single table regimens, Atripla and Completera for HIV, distributed through join ventures with Merck and Janssen Therapeutics.  Also in 2011, Gilead extended licenses to Indian partners to grant them future rights to produce generic versions of single table regimen, Stribild.  Stribild was approved by US FDA, in August, 2012 and approval in Europe is expected in 2013.

Gilead’s pipeline includes Tenofovir, delivered directly to lymph nodes and showing greater efficacy, Sofosbuvir for Hep C, and Simtuzumab targeting Ideopathic Pulmonary Fibrosis.  While much of the focus in 2012 had been on Gilead’s Hep C pipeline, it seems the company’s HIV franchise may emerge as a strong growth driver, than previously anticipated.  The number of people in developing countries receiving Gilead antiretroviral therapy has increased from less than 30,000 in 2006 to over 3 million in 2012 and one-third of people treated for HIV in developing countries receive Gilead medicines.  

Eli Lilly – Poised to deliver with 13 molecules in Phase 3, and 20 molecules in phase 2

Chairman, President, and CO John Lechleiter shared that Lilly’s total revenue is over $20B, with gross margin of revenue, approximately 78%, $3 billion in net income with at least $4 billion in operating cash flow.  Lilly will continue to stay the course and implement the strategy that includes, replenishing and advancing the pipeline, driving growth in countercyclical growth areas, and increasing productivity to fund R&D.

In 2008, Lilly made the largest acquisition in Lilly’s history, by acquiring ImClone, to advance its oncology pipeline.  In 2012, Lilly launched Amyvid in US, got approval for Erbitux and Jentadueto.  Cymbalta and Zyprexa are approved for new indications in Japan and Cialis is approved in Europe for once daily use for BPH.    Some of the setbacks included slower emerging market growth, due to patent expirations.   Growth is expected from dulaglutide in collaboration with Boehringer Ingelheim to target diabetes, launch of Tradjenta in 30+ markets, and from Lilly’s animal health division Elanco’s acquisition of Janssen Pharmaceuticals animal health business.  Lilly is poised to deliver with rich pipeline that includes 13 molecules in Phase 3, and 20 molecules in phase 2, said Lechleiter.

Glaxo Smith Kline –  Refocused on Science & Revamped R&D Engine

Patrick Vallance, President of Pharmaceutical R&D opened the presentation  with assurances that GSK has re-engineered its drug discovery organization, has built a late stage pipeline, restructured its commercial and manufacturing to support the pipeline and will deliver value.  Given where GSK was a year ago, there seemed to be a marked progress in terms of its late stage pipeline.

Six new drugs that completed phase III studies in 2012 include dabrafenib and trametinib in oncology, albiglutide targeting diabetes, dolutegravir targeting HIV and Relvar and UMEC/VI for respiratory diseases.  In oncology, combination therapy with both molecules is indicating more complete blockade of critical pathway and ability to prevent or delay emergence of resistance.  For type II diabetes, albiglutide, first once-weekly fully humanized GLP-1RA regimen that can be administered with a pen device, is indicating opportunity to delay use of basal insulin and no weight gain.  For HIV, current trials indicate dolutegravir to be statistically superior to Atripla at week 48.  GSK has a broad portfolio targeting respiratory diseases.  Relvar/Breo for asthma and COPD, appears well tolerated and efficacious at lower doses and shows significant improvement in lung functions compared to FF or FP.  UMEC/VI for COPD, once daily, is potentially first in class in the US and indicates statistically significant improvement over placebo.  GSK has more advanced portfolio in respiratory disease space.  GSK has reengineered to deliver sustainable pipeline flow with visible multiple waves of pipeline delivery, said Vallance.  It seems that GSK has refocused on science and has revamped its R&D engine.  Will it deliver?

Baxter – Diverse Core Portfolio, Robust R&D Pipeline, Targeted Acquisitions – (stock worth watching)

Baxter CFO, Robert Hombach began the presentation with a reminder that this $38 billion healthcare company is one of the most diversified companies presenting at this conference.  Baxter focuses on acute and critical care business and on treatment of chronic diseases.  Emerging markets account for 20% of sales.  Baxter has a diverse core portfolio, a robust R&D pipeline, and engages in targeted acquisitions.

BioScience accounts for $6.1 billion business and represents vaccines, bio surgery and hemophilia.  Baxter is advancing pipeline of novel recombinant proteins.  Bio surgery business continues to be double digit growth driver.  Advate, a targeted therapy for hemophilia A, which affects approximately 1 in 5,000 males, is also a strong growth driver, showing to be very safe and efficacious and remains a gold standard of therapy. Investors believe Advate sales will continue higher, on account of FDA’s recent approved a higher dosage strength of the drug, in 2012. The higher dose allows patients to be treated only once every three days, which is a first in the hemophilia market and gives Baxter a sustainable advantage.  Medical products business account for $7.8 billion in sales in 2011.  Its key renal business accounted for 32%.  Baxter acquired Swedish-based Gambro, a kidney and liver dialysis company, for $4 billion, in late 2012, to integrate end stage renal market and enhance worldwide reach.

Baxter’s late stage product pipeline in 2012, includes 18 molecules in phase 3.  SubQ self-administration therapy of Gamnagard Liquid for Primary Immunodeficiency is showing favorable tolerability pipeline including low infusion site reaction and is advancing label indications.  A possible future blockbuster drug, Baxter has multiple data releases of Gamnagard for Alzheimer’s disease this year.  There is a probability that Baxter receives FDA approval for Gammagard Liquid in mild/moderate Alzheimer’s in coming years.  Baxter’s expanding portfolio to new therapeutic areas include, CD34+ stem cells as a possible treatment for chronic myocardial ischemia, anti-MIF antibody targeting MIF protein that influences tumor growth, and Rigosertib, a novel targeted anti-cancer compound.  Baxter has partnered with Momenta Pharmaceuticals, in a $452 million deal, to tap into the biosimilars market.   Baxter is continuing the innovation in home dialysis, with over 30 new products in the pipeline and has potential to contribute up to $250 million to its top line.  This is one of the richest pipeline in Baxter’s history, said Hombach.

Abbott – New Diversified Healthcare Company with Focus on Nutrition, Established Pharma, and Medical Devices

Abbott is a large cap diversified healthcare company and is now separate from new company, abbvie, a large cap biopharmaceutical company, said CEO, Miles White.  The new Abbott Laboratories is strongly position with $5.9 billion sales in medical devices and $5.4 billion in sales in established pharma market, in 2011.  Diagnostics accounted for an additional $4.2 billion in sales and nutrition accounted for $6 billion in sales, in 2011.  There is an increasing emerging market presence with sales targeted to approach 50%, by 2015.

Abbott enjoyed leadership position in large markets in several industry sectors.  In diagnostics, Abbott hold number 1 place in immunoassay diagnostics and in blood screening and has a leading point of care platform.  In nutrition, it is number 1 in adult and pediatric nutrition and is a leading science based nutrition company.  In medical devices, Abbott is number 1 in DES, BMS, BVS, and number 1 in Lasik and number 2 in cataract, said White.  Diabetes and vision care is driving growth in emerging markets.   Abbott also has robust vascular pipeline and in 2012, launched Absorb, a bioresorbable vascular scaffold for treatment of CAD, in Europe, Asia, and Latin America.  In established pharmaceuticals, Abbott is a leader in branded generics, with a broad portfolio that includes, 500+ branded generics, a strong development pipeline, and 60% presence in emerging markets.

AbbVie – Will other products pick up slack from Humira’s patent expiration for more agile new company?

AbbVie is the new spinoff company, from Abbott Laboratories, focused on “research-based pharmaceuticals.”   It is a global biopharma company, with focus and agility of a biotech, said CFO, Bill Chase.  AbbVie has revenues of about $18 billion and Humira, a prescription drug for rheumatoid arthritis, is its best asset.   Humira is a huge product, generating about $9 billion in sales.  There is a concern with Humira’s pending patent expiration in 2016, but Chase outlined some future plans.  AbbVie will focus on achieving Humira’s full potential through new indications, maximizing product portfolio, advancing pipeline, and leveraging global footprint.

Humira has recently been approved for ulcerative colitis.  Beyond Humira, other growth brands and durable performers include, Andro Gel, leading in testosterone replacement, Lupron, Synagis1, Creon, Synthroid, Kaletra, Norvir and Zemplar.  Humira faces stiff competition, in addition to patent expiration.  Will AbbVie’s other products easily take up the slack?

Bausch & Lomb – Only Global Company Focused on Eye Care Focused on Future Growth & New Products

B&L is the only global company found on caring for the eyes, said, President & CEO Brent Saunders.  B&L is an iconic brand with 160 year history.  The company manufactures and markets eye health products that include contact lenses and lens care products for Astigmatism, Presbyopia, Nearsighted/Farsighted, and cataract patients.  The company also provides intraocular lenses and delivery systems, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals; vision shaping treatment products; dry eye products; allergy/redness relief products; eye wash products; eye vitamins and so on.  Three important worldwide trends, the aging population, higher diabetes prevalence, and emerging middle class more interested in eye care, will lead to increased demand, said Saunders.

At B&L, 80% of business is in cash market.  Some of the upcoming B&L products to watch are, BioTrue, one day lenses made from a next generation, bioinspired material called HyperGel, Victus Fentosecond Laser platform for enhanced performance across cataract and corneal procedures, and enVista, new glistening free, hydrophobic acrylic IOLs.  What is in its future?  Will there be a buyer willing to offer multi-billion dollar deal or will this private equity firm turn to an initial public offering (IPO)?  Following the company presentation, Saunders mentioned that the company is focused on future growth and also “aspiring to return to public markets”.

Cerulean Pharma – Private Company with Nanoparticle Based, Dynamic, Targeted Drug Delivery Platform

Cerulean Pharma develops and markets novel, intelligently designed, nanoparticle based technology to target tumor agents, in fight against cancer, said CEO Oliver Fetzer.  Tumor is targeted via leaky vasculature, used at entry portals into the tumor tissue.  Cerulean nanoparticles are are small enough to penetrate these tumor blood vessels but are too large to enter health tissue.  These nanoparticles are transported through the tumor tissue up into tumor cells and then the drug is gradually released within tumor cells. The drug is covalently bound and dynamically releases within tumor cells and the nanoparticles eventually disintegrate over time.

While chemo works well in getting the tumor cells, it also harms the healthy tissue.  History of oncology is somewhat gloomy.  With surgery, radiation, combination therapy, chemo, personalized medicine, immunotherapy etc., 5 year survival is still only 50%.  This kind of dynamic tumor targeting has two important benefits.  By focusing on tumors and sparring healthy tissue from unwanted exposure, Cerulean nanopharmaceuticals leads to limited side effects, while also enhancing therapeutic results.  The linker that attached the drug to the nanoparticle is selected to provide optimal intra-tumor drug release, by gradually breaking apart inside the tumor and releasing the drug payload over time.  The current trials indicate significantly lower toxicity and higher effectiveness with drugs with high adverse profile, like Docetaxel, Erlotinib, and Pemetrexed.  Cerulean’s own small molecule oncology product pipeline in trials, includes CRLX101, CRLX301, and siRNA delivery platform.  Cerulean develops products with partners by marrying their molecules, marketed or in development, with their nanopharmaceutical platform.

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Cancer Pathways, Evidence Based Medicine & What it Means for BioPharma Industry


 

Ellen Licking, writer and analyst for Real Endpoints, a start-up focused on providing objective information about product reimbursement, discussed “what cancer pathways mean for biopharma industry at http://www.bio2devicegroup.org.

Cost containment in healthcare has emerged as a significant issue and the payers are looking at big cost diseases like oncology to find more effective care options. The use of cancer care pathways is emerging as a strategy to focus on providing efficient care, while also containing costs. Results from existing “cancer pathway” pilots underway at national and regional insurers are becoming available in 2012 and are shedding light on the use of evidence-based medicine to improve outcomes and lower costs. In Europe, they discuss rationing of care. But in the US, it is a more complex issue, given the diversity of stake holders and the necessity for implementing politically appropriate language and behaviors.

Cancer pathways provide an evidence based-approach to care that is based on efficacy (how well the treatment works), toxicity (how toxic is the treatment), and cost. In the event that two drugs provide similar efficacy and toxicity, then the choice comes down to cost. Clear winners for reimbursement, in this approach, are efficacious drugs; for products that are as good, the choice is made based on price. First and foremost, this approach is designed to reduce the existing wide variation in care. Second, it aims to improve outcomes with focus on treatments that provide the greatest survival benefit and the lowest toxicity. Third, these care pathways would contain cost, based on scientific evidence of best care.

These pathways are not commandments in that payers are not mandating providers adopt a certain pathway. To get buy in from physicians, payers are considering waiving the right to prior authorization and programs that allow doctors to share in any financial savings. In one study, the data indicated 35% cost savings for on-pathways patients compared to those not on pathways, while showing no difference in survival outcomes. Real world cost savings, at least initially, are expected to be more modest in the 10-15% range. However, even these savings would greatly contain costs. Cancer pathways are small but growing quickly. Currently, there are an estimated 29 programs in place from a variety of payers. One concern has been that the pathway approach may change how oncologists are paid. Most oncologists are paid in relation to the amount and cost of drugs they prescribe. If payer savings translate into dramatic pay cut for oncologists then it would become challenging to get their buy in. Besides pathways, a few payers are experimenting with episode-of-care, which pays oncologists a single payment for treating patients during a specified treatment period.

What ARE the implications of these changes for THE biopharma industry? Given the dreaded oncology diseases, the treatment programs have traditionally been treated with kid gloves. But under this strategy, there will be clear winners and losers and treatments that are not efficacious will be dropped to make room for possible newer treatment options. While finding winning oncology drugs have always been challenging and will continue to be challenging, in the pathway driven world, it will also be more difficult to establish best in class drugs. Licking offered the recommended options for biopharma industry that include, maintaining focus on first in class drugs given the advantage to first to market, redefine meaning of best in class based on not just clinical efficiency but based on endpoints important to payers, in consideration of efficacy, to focus on price in addition to quality of life issues, and consider risk-sharing schemes that are tied to adherence medtrics or provide clear cost information such as Astrzeneca’s single payment scheme for Iressa. The talk generated a great deal of interest and discussion and was followed by Q&A. Ellen Licking can be contacted at ellen.licking@realendpoints.com; You can learn more about Real Endpoints at http://www.valueandinnovation.com .

 

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