Covid updates – July, 2020

Here are some covid updates from last couple of weeks. I have gathered info from zoom sessions. For more details, accurate sources, and veracity, please research further.

• CA expecting 19000+ deaths by Nov. 1
• US covid deaths top 150,000
• More than 6,300 covid cases in the US, are linked to colleges
• After some decline in people dying, now daily death counts are rising in 21 states
• 47% (that is, almost half the population) of US adults have some underlying condition that slightly increases the chance of severe covid illness
• Blood glucose level of 7 or higher leads to 33% chance of dying 60% chance of contraction
• Spain had 2,255 more cases in last 24 or so hours.  Britain imposed quarantine on travelers from Spain
• WHO warns of new EBOLA outbreak in Congo
• China reports biggest virus spike since end of Wuhan outbreak
• India has the fastest growing coronavirus cases in the world
• 23% of Delhi residents seem to have antibodies 
• North Korea is reporting their first covid case
• Plastic visors in place of masks are NOT effective
• Israel & Japan experience huge spikes in covid cases
• Chinese study found that people with type 2 diabetes had shorter telomere length
• Study found that aerosoles in covid patients’ rooms, had live virus floating around even after 5-6 days
• Research found no transmission of covid from infected moms to newborn babies, even after 2 weeks of breast feeding with proper cleaning protocols
• In another study, pregnant women who had virus, their placenta also had virus
• Study says mosquitoes cannot pass on covid from infected patients to non infected patients
• From 3334 patients with covid in NY hospitalized, 16% had DVT, stroke or heart attacks
• Presence of virus in the gut likely means that virus takes longer to leave the system and would lead to higher risk of liver injury
• Spain study found that about 5% of those who contracted covid  in large cities had antibodies while only 3% of those of contracted covid near the coast, had antibodies
• In one study, over 50% of people who contracted covid show some heart damage
• 85 babies under age 1 tested positive in one county in Texas
• Overwhelming fatigue, palpitations, muscle aches are symptoms that linger for 4-6 weeks after recovery from covid

On potential vaccines & treatments & safety products

• There are 42 potential vaccines — Most in phase 1, 14 of them are in phase 2 and 4 are in phase 3 
• Oxford/ AZ vaccine results look good in phase 1 / 2
• China’s Sinopharm is in phase 3 trial for covid vaccine
• Cage Bio developed sanitizers that offers protection for up to 4 hours
• Steroid treatment slightly reduces the need for mechanical ventilation 
• A client has very exciting and fascinating prevention strategy. If interested in investing then let me know & I’ll put you both in contact.
• Boehringer Ingelheim identified 28 new antibodies to fight the virus

Speedy identification of pathogens: Reduces sepsis, saves lives, cost & lowers antibiotic resistance problem

At a recent Bio2DeviceGroup (www.bio2devicegroup.org) event, Kevin Hacker, CEO of BioAffinity Sciences talked about their new technology that when fully developed will identify pathogens more than 100 times faster than the traditional blood culture and related technologies currently in use.

Sepsis Problem

Every year, in the US, 500 thousand people die due to sepsis related complications. Sepsis is a final common pathway for many infections, particularly when an individual’s immunity is low. Body normally releases chemicals into the bloodstream to fight an infection. When the body’s response to these chemicals is out of balance, it results in Sepsis. That is when body’s immune system launches a massive counter attack that harms body’s own tissues and organs. The triggering changes begin to damage body’s vital organ systems that results in dramatic drop in the blood pressure, ultimately leading to death.

Sepsis and septic shock are more common if the individual is very young or very old, have a compromised immune system, have diabetes or cirrhosis, is already sick and frequently in a hospital intensive care unit, have wounds or injuries or severe burns, have invasive devices inserted into the body, and have previously received antibiotics or corticosteroids. Often people can recover from mild sepsis. However, if the body goes into septic shock, the average mortality rate for septic shock is about 40%. Additionally, an episode of severe sepsis may place a person at higher risk of future infections.

Given that widespread infections can progress to Sepsis and Sepsis shock in a matter of few hours, it is imperative that such infections be treated immediately with antibiotics. When given the right antibiotics, there is often a dramatic improvement and speed of cure.

Problem with speedy identification of pathogens

Given that early treatment of sepsis is associated with vastly improved outcomes, rapid diagnosis is essential. However blood culture work is slow and often takes 1-3 days. The diagnosis of sepsis in critically ill patients, housed in hospitals is also challenging because it can be complicated by the presence of inflammation resulting from other underlying diseases and from prior use of antibiotics, making cultures negative. Most testing is done through mass spectrometry that gives mass to charge ratio of ions. Since culture-dependent diagnosis of infection is slow, sometimes patients are given antibiotics, before the results of the culture are available. Patients are given broad spectrum antibiotics and 40% are not effective. In such instances, antibiotics are withdrawn after one cycle of treatment, when the cause of the illness is found to be something else and this can lead to antibiotic resistance.

Bioaffinity Sciences solution will be able to identify pathogens within 10 minutes, 430 fold faster than blood culture. This is cell affinity based, low cost technology. Pathogens are run through microchannels comprising of a surface- grafted scaffold of reactive polymer onto which affinity molecules (sugars, aptamers, vancomycin, and methicillin) have been bio-conjugated. High capacity of the channels allows low numbers of microbes to be quickly identified. The unknown pathogen’s pattern of binding to the channels is recorded, and this pattern is compared to a library of known pathogens. When a match is made, the identity of the pathogen is reported. In addition to speed, this is also more sensitive in terms of the number of different pathogens detected than blood culture.

Disease burden to the healthcare system in the US due to Sepsis

Sepsis management is a major challenge and results in disproportionately high burden in terms of hospital utilization. The average length of stay for sepsis patients in the US is approximately 75% greater than for other conditions. The cost of sepsis management ranks highest among hospital admissions for all disease states. The cost is estimated to be between $25 billion and $27 billion, and represents 13% of total US hospital costs.

Considering that poor sepsis outcomes are directly tied to the delay in diagnosis and treatment, such a dramatic improvement in speed and accuracy of diagnosis leading to speedy and accurate treatment can not only dramatically improve outcome and quality of patient care but also significantly reduce cost of care for hospitals.

The talk was followed by Q&A.

 

New Waves in Biotech – Chinese Bioscience Association Annual Conference Review

The Chinese Bioscience Association (CBA) is a non-profit organization, with a mission to promote education, networking, and community building for life science professionals.

At its recent annual conference in San Francisco Bay Area, an impressive array of speakers discussed new trends, promises, and challenges in the biotech industry.

English: A diagram illustrating the distinction between cancer stem cell targeted and conventional cancer therapies (Photo credit: Wikipedia)

In his keynote address, Dr. Frank McCormick, Professor at UCSF and founder of Onyx Pharmaceuticals, talked about targeted cancer therapies and some of the lessons learned from Onyx.  Almost 30% of all mutated cancers happen in oncoproteins like BCR-ABL and RAS.  In 1994, Onyx initiated a 5 year collaboration with Bayer that led to $25M study for drug development, based on RAS pathway.  Unfortunately, it did not lead to drug leads.  In hindsight, “we realized that it was too early to jump into the pathway based on our feeble understanding of RAS pathway”, said McCormick.  However, Onyx has had several successes, despite the fact that finding new targets has become increasingly difficult, said McCormick.  Sorafenib, a kinase inhibitor, was approved for treatment of renal and liver cancers.  Onyx also has had success in viral therapies.  In 2009, Onyx sued Bayer, its longtime partner, and won the lawsuit.  Removal of the “change of control” clause in the original collaboration agreement, in favor of Onyx, has resulted in Onyx going from a $10M company in 1994 to $10B company in 2014.

English: Listeria monocytogenes grown on Listeria Selective Agar (Photo credit: Wikipedia)

Dr. Stephen Issacs, Chairman and Founder of Aduro Biotech talked about the importance of embracing change to keep growing.   Issacs shared his story from 1978 where his career began in psoralen photochemistry and then teaching at UC Berkeley.  In 1991, he found Cerus Corporation, a biomedical products company commercializing the Intercept Blood Systems.  He raised over $650M and negotiated a $200M partnership with Baxter International and took the company public.  He then found Aduro BioTech.  Here is my previous article on his company Aduro Biotech http://bit.ly/JqDJ3K that uses a bacterial vector, in the form of genetically modified listeria, to stimulate the immune system to fight cancers and infectious diseases.  Issacs also talked about his volunteer work in Kasigau, Kenya through his family non-profit organization, a cause that is very dear to his heart and to which he is highly dedicated.

Kayser-Fleischer ring: copper deposition in Descemet’s membrane of the cornea. These rings can be either dark brown, golden, or reddish-green, are 1 to 3 mm wide, and appear at the corneal limbus. With rare exceptions, they are diagnostic of inherited hepatolenticular degeneration—Wilson’s disease. This 32-year-old patient complained of longstanding difficulty speaking. He also had a tremor. (Photo credit: Wikipedia)

Dr. Chandler Robinson shared his incredible story of how he went from being an undergraduate researcher to becoming a CEO of Tactic Pharmaceuticals, a privately held biotech, in Chicago. Tactic acquires and develops pre-clinical and clinical stage compounds.  Somewhere in between his strenuous MD program at Stanford and pursuing his MBA in UK, Robinson acquired an abandoned drug, Decupratetm, and after couple of years, published his research in Science.  In early 2013, Decupratetm got Orphan Drug Designation from European Commission for treatment of Wilson’s Disease.  Wilson’s Disease is characterized by its disturbed copper metabolism that leads to copper accumulation in the body, resulting in severe disability or death. Tactic Pharma has acquired 3 compounds to date.

Diseases and conditions where stem cell treatment is promising or emerging. (See Wikipedia:Stem cell#Treatments). Bone marrow transplantation is, as of 2009, the only established use of stem cells. Model: Mikael Häggström. To discuss image, please see Template talk:Häggström diagrams (Photo credit: Wikipedia)

At Stanford Cardiovascular Institute (SVI), Dr. Joseph Wu and his team work with iPS cells (induced pluripotent stem cells).   Wu is recipient of several awards and his clinical activities involve adult congenital heart disease and cardiovascular imaging.  According to Wu, iPS will be a game changing platform for drug discovery research.  Familial hypertrophic cardiomyopathy (HCM) is one of the most prevalent cardiovascular disease.  At some point, we should be able take blood and make iPS cells, differentiate them into cardiac cells or other cell types, and expose them to different drugs to find out what would be the ideal drug for that patient, said Wu.  Wu said, it is important to study different ethnicities; different ethnic groups metabolize drugs differently.  CVI has received $20M grant and Wu’s team is trying to create a bank of 1000 cell lines, for drug discovery research.  (iPSCs) seem to have exciting therapeutic implications in regenerative medicine, particularly for myocardial infarction and possibly for neurodegenerative diseases, diabetes and other disorders.  However, stem cell biology is as yet incompletely understood and  some of the challenges include immunogenicity, tumorigenicity and so on.  Drugs can be tested on surrogates of patients, before giving them to the patients, said Wu.

Inhaler (Photo credit: Wikipedia)

Dr. Moninder Hora, SVP at Nektar Therapeutics talked about Nektar’s pipeline and technologies.  Nektar’s technology is based on polymer conjugation platform, said Hora.  Nektar has a robust pipeline of novel therapeutics and Nektar also partners with top biopharmaceutical companies to bring new products to market.  Nektar’s pipeline of late stage molecules include Amaikacin, Ciprofloxacin, Fovista, BAX 858, and NKTR-102.  Amaikacin Inhale is delivered directly to lungs to treat gram-negative ventricular pneumonia.  NKTR-102 is first PEGylated small molecule, first in its class, to treat breast cancer.  It has passed safety and efficacy markers and is showing to significantly improve overall survival and endpoints will be announced next year.  Nektar is also getting positive results from some of its early stage molecules.  Recently Nektar presented positive preclinical data for NKTR-214 for immunotherapy treatment.  Nektar is developing pain management portfolio and recently got fast track designation for NKTR-181, a new oral opioid analgesic molecule for the treatment of moderate to severe chronic pain.  NKTR has filed for regulatory approval in EU for MOVENTIG, comprising of once only daily oral tablet, to treat opioid induced constipation.  Hora concluded saying that Nektar has very robust pipeline of highly promising molecules.

English: Example transdermal patches. On left is a ‘reservoir’ type, on the right a ‘matrix’ version. Both contain exactly the same level of the same active ingredient. (Photo credit: Wikipedia)

Dr. Zander Strange, VP of Bus Dev. and Corp. Dev. at Zosano Pharma shared about their products based on novel transdermal delivery technology.  Zosano’s rapid onset system allows drug delivery to occur, almost painlessly.  The drug is delivered close to the capillary bed, allowing it to quickly dissolve.  The short-wear-time patch consists of microneedles coated with Zosano’s proprietary formulation of an existing drug, attached to an adhesive patch.  Therapeutic effect is expected to occur within 30 minutes or less, in an easy, pain free administration.  Zosano products are in dry formulation, thus vastly improving product stability and long shelf life, in addition to allowing for easy travel and storage at room temperature.

CBA annual conference was packed with impressive lineup of speakers, interspersed with plenty of networking opportunities.  For additional information, please go to www.cbasf.org .      

PS – EPPIC Digital Health event http://bit.ly/1uwQ6af is today at 6 pm in Palo Alto. Please register ASAP at http://www.eppicglobal.org .

Diabetes & Cardiovascular Disease Risk Factors among South Asians Compared to other Ethnic Groups

Dr. Alka Kanaya talked about Diabetes and cardiovascular disease risk factors in multi-ethnic groups comparison studies, at a joint event hosted by  www.eppicglobal.org and  www.bio2devicegroup.org .  Dr. Kanaya is Professor of Medicine, Epidemiology, and Biostatistics at UCSF and a principal investigator in Mediators of Atherosclerosis in South Asians Living in America or MASALA study, for short.  Primary objective of the study was to research and understand the high incidence of diabetes and CHD among people of South Asian origin.

Kanaya first shared information on South Asians (will be referred here as SA) and then discussed the study results in the context of multi ethnic comparison.  Currently there are 3.4 M people from South Asia living in the US.  It is the second fastest growing racial/ ethnic minority in the US.  They constitute 20% of all Asians and 75% of them are foreign born.  Although there is little organized medical data on SAs, overall they have relatively lower body weight (BMI), have more central abdominal obesity, and experience higher rates of diabetes and indicate high risk of early heart disease.

MASALA study began in March, 2010 and constitutes a total sample of 906 people, between the ages of 40 and 84.  People with prior history of any cardiovascular disease, those in active cancer treatments, those planning to move out of the area in the next 5 years, and nursing home residents, were excluded.  Data collected included weight, height, waist, seated BP, Ankle-brachial index (ABI predicts the sevearity of PAD, peripheral artery disease), 2 hour OGTT (oral glucose tolerance test), abdominal CT, and several blood tests and extremely detailed questionnaires regarding family history and information about personal habits like alcohol, smoking, sleep, diet and exercise.

Results from MASALA study were compared to results on almost all similar measures with Whites, Latinos, African-Americans and Chinese populations in ongoing MESA study.  See the websites of MESA (www.mesa.nhlbi.org) and MASALA (www.masalastudy.org) studies to see many interesting details on several patterns that emerged.  Kanaya specifically discussed some patterns among South Asians when compared with other ethnic groups.

When adjusted by sex and age, South Asians had significantly high rates of hypertension.  However, there weren’t major or alarming differences in cholesterol.  One of the reasons could be that South Asians were overall more educated, from higher socio-economic background, and were more likely to be using statins and other cholesterol lowering drugs

Most alarming differences were observed in diabetes and pre-diabetes levels.  Almost 30% of men and almost 15% of South Asian women had Diabetes Mellitus, versus 20% or lower among other groups of men, and 13% or lower among other groups of women.  Nearly 37% of SA men and 29% of SA women had IFG (impaired fasting glucose indicative of pre-diabetes), compared to 20% or less for men and 13% or less for women from other groups.  When adjusted for many indicators including age, sex, cholesterol, triglycerides, hypertension etc., South Asians were significantly more likely to have type 2 diabetes.

When adjusted for age, sex, BMI, and waist and excluding those on diabetes meds, this high incidence of Diabetes Mellitus among South Asians seemed to be associated with higher levels of insulin resistance, lower pancreatic B-cell function, and (as confirmed by abdominal CT data) high amount of body fat around abdominal regions and in the liver.

Mercat de la Boqueria, fruits & vegetables (Photo credit: Wikipedia)

Among lifestyle factors, the high rates of DM (Diabetes Mellitus) among SA was attributed to poor diet with less fruits and vegetables and more Western diet (including pizza, pasta etc.), sweets, refined grains, and consumption of high animal based protein in the diet and low levels of exercise.  Considering that even on a relatively leaner body, South Asians carry more fat, the study concluded that guidelines for BMI should be lower for people of South Asian origin.

The study concluded that 75% of South Asians were overweight or obese using the recommended BMI cut-points in Asians.  Compared to other racial/ ethnic groups, South Asians were from higher socio economic status, had low smoking rates, and low to moderate alcohol use.  They also indicated very low physical activity, higher diabetes prevalence (specially among men), second highest prevalence of high blood pressure, and men have more coronary calcium than other groups.

A yoga class. (Photo credit: Wikipedia)

Some of the recommendations for South Asians from the study were, to know the risk factors, work towards ideal BMI goal (less than 23 kg/m2 for SA), remember waist size matters more than BMI, walk at least 30 minutes a day 5 days a week, avoid a diet high in animal protein and refined carbs, and then something interesting – do Yoga!

Kanaya also shared results from her PRYSMS study that assigned subjects with metabolic syndrome into two groups, one practicing Restorative Yoga (included lot of lying down and relaxing poses) and other, Stretching Exercises.  In 6 months, both groups improved their PA and calorie intake.  Favorable changes in the stretching group included, lowered triglycerides and improved mental health.  Restorative yoga group reduced and sustained weight loss and weight girth loss but not visceral fat area.  Finally, only yoga group indicated reduction of fasting glucose and overall favorable metabolic changes in the yoga group included lowering of fasting insulin, glucose, HbA1c and HDL.

One wonders if very determined focus on material wealth goes with more stress.  In any case, it shows once again that stress relief is a key for improved health.  This was a fascinating talk and was followed by Q&A and animated discussion.

Role of Lipid Mediators in Metabolic Diseases & Malignant Tissue Growth – Two Distinct Diseases, One Common Denominator

Dr. Ayala Luria, scientist in the Department of Urology and Institute for Regenerative Cures at UC Davis Medical Center, and a Consultant in a startup company, Adipocyte Therapeutics, discussed about the role of lipid mediators in various diseases, at www.bio2devicegroup.org event.

Diabetes is a disease of glucose homeostasis.  We need glucose for brain activity, energy for muscles etc.  But too much glucose can cause osmosis and affect the vessels and organs.  Under normal circumstance, the body can balance the amount of glucose, or sugar, in the blood with the amount of glucose that the cells need for fuel. The hormone insulin, produced by the pancreas, helps transport the glucose into the cells.  However, under diabetic conditions, the insulin secretion is not sufficient or is not working properly.  There is a strong correlation between obesity, particularly abdominal fat and diabetes.   Adipose tissue is implicated in the development of a systemic inflammatory state that contributes to obesity-associated coronary heart disease.

Dr. Luria’s research project relies on the concept of small lipid mediator, the autacoids that are metabolites of arachidonic acid. About 40% of the drugs in the market targeted towards treatment of inflammatory diseases, asthma and allergy are based on the a class of chemical compounds or small molecules of the archidonic acid pathway.  This small molecule can be diverted to prostaglandins and thromboxanes to treat inflammation and blood clothing.  It can also be diverted to leukotrienes to target asthma, allergies and so on.  There is however, yet another pathway through epoxyeicosatrienoic acids (EETs).  Luria’s research indicated that increasing EETs either pharmacologically or through genetically modified animals, helped obese mice regulate glucose levels.

Luria then discussed her work in angiogenesis.  Angiogenesis refers to the formation of growth of blood vessels, which is at the core of sustaining life.  Without blood, without oxygen, we cannot survive.  In diabetics, impaired wound healing, retinopathy etc. are caused due to impaired angiogenesis.  Insufficient angiogenesis also is considered to be one of the causes in stroke, CHS and so on.  Whereas in cancer, excessive angiogenesis causes malignant tumor growth and many drugs on the market are targeted towards killing angiogenesis.    Luria’s collaboration research indicated that (EETs) stimulate angiogenesis, although the mechanisms involved are not entirely understood.  She tried to use angiogenesis as a vehicle for chemotherapy drugs in low doses.  Combining EETs with inhibitors, led to stark decline in tumors.  She arrived at the conclusion that it might be interesting to target diabetes treatment as benign tumor growth by inhibiting angiogenesis and further use angiogenesis as a vehicle to target tissue growth.

This interesting talk generated lot of response and was followed by Q&A.

Please join us on this Tuesday, April 21, 2013 for continuing discussion on metabolic diseases.  Next week’s talk is titled “Obesity 360” and panelists include – Dr. Darshana Nadkarni, Dr. Alex Nedvetsky, and Mr. Nat Bowditch –  http://bit.ly/ZExFfQ

How Technology Solutions can be Scaled to Improve Medical Adherence

 

 

Worldwide, medical adherence or patients prematurely stopping their medications, is a major obstacle to the effective delivery of health care.  David Parpart and Sunit Gala talked about the complexity of the problem, the enormous cost to the healthcare of non-compliance and the technology-based solutions they are offering (www.impactmeds.com) to improve adherence at a www.bio2devicegroup.org event.
To give a sense of the enormity of the problem, Parpart shared a typical scenario where out of 100% prescriptions, only 50-70% go to the pharmacy, and out of that only 48-66% come out of pharmacy, out which only 25-30% of the medications are taken as prescribed and finally a miniscule 15-20% are refilled as prescribed by the physician.  Among new prescriptions for medicines used to treat chronic conditions associated with increased cardiovascular risk, such as hypertension, diabetes, and dyslipidemia, according to some estimates, one-third of all new prescriptions go unfilled. About 350 daily deaths in the US are attributed to lack of medical adherence, said Parpart.

 

Non-adherence to prescribed medications not only costs huge amount of lost revenue to the pharmaceutical companies and lost sales to the drug stores, but also it also burdens hospitals with readmissions and burdens the payers, in addition to the impact on patients.  On account of non adherence, many patients suffer from bad health, and in many cases, particularly those suffering from chronic diseases, die early.   Chronic diseases account for 70% of all deaths and are the leading cause of mortality in the United States.  Patients who don’t take their medications as prescribed cost the U.S. health care system an estimated $290 billion.  Non-compliance costs pharmaceutical companies $300 billion in lost revenues.  Added cost to the society is $100 billion in preventable hospital visits and $350 billion in productivity losses.  There is a huge opportunity here to reduce costs and improve outcomes.  About 1 million unnecessary deaths can be prevented just within the United States this decade, with improved medical adherence, said Parpart.

 

So what are major barriers to medical adherence?  Some of the major barriers include the complexity of medication regimens, especially in case of chronic diseases when the patient is often taking 9 to 12 medications multiple times per day; the occurrence of side effects, which are sometimes unknown to the patients; the cost of prescription medications; and poor communication and lack of trust between the patient and their health care provider.  Just providing a planned opportunity for the patient to interact with the pharmacist regarding side effects and the necessity of sticking with the regimen greatly improves compliance according to numerous well-documented studies conducted by organizations such as the American Pharmacists Association.

 

Parpart and Gala shared the Impact Meds solution to this enormous challenge.   They leverage technology with a cloud-based software platform, RFID,  and offer an array of solutions that can be tailored and customized, starting with an opportunity for patients and pharmacists to register on their website with easy access for patients to get their questions answered and get pharmacist led counseling.  Their solution is a combination of availability of medical information, easy access points for patient-pharmacist interaction, tools for caregivers, medical tracking solutions, tracking biometrics and purchase refills, and scaling it to have maximum impact in terms of lowered medical costs to society and improved health for patients.  An important aspect of the solution is how it incentivizes pharmacists, physicians and patients through a combination of respect, regard and reward. Impact Meds is a recipient of 2012 Sanofi US Innovation Challenge Award, as well The Palo Alto Medical Foundation’s Developer Challenge.  The presentation was followed by Q&A from an enthusiastic audience, with the event running over-time.

 

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.