Delivering Drugs Straight to the Heart – InCarda’s Acute Atrial Arrhythmia Treatment

Narsi Rangachari, co-founder of InCarda Therapeutics talked about InCarda’s novel approach to delivering drugs straight to the heart.

Scheme of atrial fibrillation (top) and sinus rhythm (bottom). The purple arrow indicates a P wave, which is lost in atrial fibrillation. (Photo credit: Wikipedia)

Approximately 20 million patients a year in the US, experience one or more forms of acute cardiac conditions. Current therapies to treat acute conditions are not optimal. They are slow, have not effective presenting higher risk. Current therapies also seem to cause a great deal of patient discomfort, resulting sometimes in poor quality of life, frequent and continuing ER visits, and extended hospital stay. Cardiac conditions add a tremendous burden to the overall healthcare costs. Cardiac arrhythmias rank as number 7 among the top 10 reasons for hospitalizations. There are little to no acute interventions in treating patients with atrial arrhythmias.

Atrial Fibrillation (also called Afib or AF) is a serious but non-life threatening condition that causes irregular and often-rapid heartbeats and many a time where the patient experiences debilitating symptoms. Global prevalence of AF is over 34 million and growing, with more than 5 million Americans estimated to suffering from the disease. Oral tablets approved for chronic treatment of AF are 30-50% effective, have very slow onset and are generally not suited for acute intervention. Few of the new drugs have made it to the market and these have not proven to be safe and effective. Ablation is an expensive and invasive procedure requiring repeat procedures, require hospital stays and are often associated with serious adverse events.

InCarda’s patented technology focuses on targeting the drugs to the heart via the lungs, said Rangachari. He spoke about a variety of technologies available to deliver drugs to and through the lungs. These included portable nebulizers, dry powder aerosols and breath controlled pulmonary delivery. The benefit of inhalation in treating atrial arrhythmias is that it delivers a “first pass” to cardiac tissue, delivering a bolus of drug directly to regions of the heart where stimuli for acute atrial arrhythmias arise. This permits rapid onset, lower off-target tissue exposure of the drug and – importantly – can be self-administered by the patient. InRhythm currently under development to treat widespread symptomatic atrial arrhythmia conditions like paroxysmal atrial fibrillation (PAF) uses approved drugs in a new dosing paradigm. InCarda has developed a de-risked approach by employing well studied, first line drugs, with long histories of efficacy and safety. In addition, the Company is using validated endpoints with established clinical assays and using commercially available inhalation devices for clinical evaluation. It was a very interesting talk and was followed by Q&A.

PS – See similar article on Pearl Therapeutics http://bit.ly/NnPhwI , a tiny company that focused on inhalation drug delivery for conditions like asthma and COPD and was bought by Astra Zeneca for $1.15 Billion.

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, San Francisco, CA – Overview

2013 J. P. Morgan Healthcare Conference Overview– San Francisco, CA

(more details to be shared in next posts)

Whew!! The J. P. Morgan conference and all other related events are finally over. This conference is the largest and most important event of the year, for the health care sector. It brings together global industry leaders, investors, business analysts, emerging fast-growth companies, technology innovators, and other professionals in the industry. Despite 2012 year ending on a rather dismal note, improvement in the economic indicators point to a greater stability and the optimism at the conference was palpable. 2012 was a challenging year with weak domestic economy, ongoing financial challenges in Europe, contentious uncertainty of the long looming “fiscal cliff”, the big pharma dealing with patent expirations, and greater uncertainty in FDA regulations. Fundraising in 2012 lagged behind the pace in 2011. According to Bioworld Insight analysis, in 2012, approximately $14.3 billion was raised by biopharmaceutical public companies, compared with $18.9 billion, in the previous year. Public offerings accounted for $8.5 billion of this total figure, down from $10.2 billion in 2011. However, things seem to have greatly stabilized on many levels, towards the end of 2012. Market is showing signs of steady job growth, there is increasing stability in the financial markets, the fiscal cliff appears to be inching closer to complete resolution, and the big pharma has gone through restructuring and cost reduction to deal with the patent expirations and have promising pipelines that portend a sound and steady growth. In the next post, I will summarize some specific highlights from public and private company presentations.

In his opening remarks, Doug Braunstein, Chief Financial Officer for the firm, looked back at the first conference. Back in 1983, it featured 21 presenting companies, when US spent about $350 billion on healthcare. At the 2013 conference, a record 397 public and private companies presented and was attended by over 8,600 registered attendees that included over 4,000 investors. Braunstein observed that the U.S. expenditures in healthcare have increased “eight fold” to more than $2.8 trillion, which is also a driver for biotech companies to come up with technologies that are value differentiating.

For a dedicated democrat like me, politically speaking, JPM keynote presentations can be lonely affairs. But aside from the politics, the lunch time keynote presentations were made by influential figures and they did not disappoint. They included, Mr. Bob Woodward, Legendary Pulitzer Prize-Winning Journalist/Author and Associate Editor of The Washington Post, and Dr. William Frist, Surgeon and former U.S. Senate Leader, during the first two consecutive days. Quoting Sir William Osler, Frist observed, “variability is the law of life”, and emphasized the need for personalized medicine to help improve efficiency and lower healthcare costs. Frist demonstrated how the convergence of new technology with personalized medicine can help achieve dramatic results. While genome sequencing was very slow and expensive, now the cost is low enough, for it to be in common person’s reach and the process is much speedier. Big data however is a significant barrier, since we don’t yet know how to put the data to good use. Frist also wowed the audience with a dramatic demonstration of getting an instantaneous ECG recording of himself with Alive Cor iPhone app.

The palpable optimism and activity at J.P. Morgan Healthcare Conference, at the Westin, in San Francisco, resonated outward to dozens of other hotels, restaurants, bars and outdoor venues where meetings, lunches, and evening receptions, further facilitated deals between analysts, executives and other professionals. Concurrently occurring, the Biotech Showcase, an investor and partnering conference, devoted to providing private and small- and mid-cap biotechnology companies an opportunity to present to and meet with investors and biopharmaceutical executives, had attracted investors and biopharmaceutical executives from around the world. Also, simultaneously occurring OneMedForum, at Sir Francis Drake Hotel, attracted leading investors and management of some of the most promising emerging life science companies, with a slightly greater focus on medical devices. In one of the next few posts, I will discuss OneMedForum event, in greater detail.

Dedicated, passionate professionals in the healthcare sector know that for good health, playing is as important as working. The evening cocktail receptions sponsored by various law firms, banks, and other public and private companies, provided a much-needed respite from the breakneck pace of the J.P. Morgan Healthcare Conference and other events. There were anywhere between 50 and 60 evening receptions during the 3 days, taking place in various hotel penthouses and lobbies, art galleries, and stores like Saks Fifth Avenue. The receptions featured gifts, delicious finger foods served by waiters and waitresses, rare wine and expensive scotch at some events, and of course ongoing opportunity for deal making, well past into the mid-night.

In the next few posts, I will write about highlights from specific company presentations and also highlights from OneMedForum conference.