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Navitas Pharma (Navitas) is developing a new class of cardiovascular drug for the US.  On the basis of recent, proprietary research, Navitas has filed patents for use of its drug platform in three disorders for which no drugs are currently approved in the US.  Each has over 1,000,000 patients in the US:

> Portal hypertension (PHTN; hypertension of the liver)

> Heart failure with preserved ejection fraction (HFpEF)

> Group II pulmonary hypertension (Group II PH; lung hypertension secondary to left-sided heart failure)

Technology Platform

Navitas’ main platform is a new chemical class of compounds, known as furopyridines.  Cicletanine (CIC), the lead drug from this platform, has been launched for hypertension in France, and introduces a new mechanism of action to the US.  The drug activates endothelial nitric oxide synthase (eNOS), thereby reversing endothelial dysfunction, a root cause of hypertension and heart failure.  As part of this eNOS-activation mechanism, CIC has recently been shown to activate protein kinase G (PKG), an enzyme whose inactivation is important in HFpEF.

CIC is significantly de-risked:

> Launched in France for general hypertension, in which the drug has a long-established track record of efficacy and safety.

> Extensive safety data from

   > Clinical trials in >10,000 patients

   > Post-launch pharmacovigilance of ~2 million patient-years in France and Germany

> Clinical proof-of-concept data in several disorders, including

   > Hypertension

   > Group II pulmonary hypertension

   > Hypertensive hypertrophy (relevant to HFpEF)

   > Angina

   > Diabetic claudication

   > Diabetic microalbuminuria (early-stage kidney disease)

> Proof of relevance in an established animal model of portal hypertension

> Extensive data supporting new mechanism of action via eNOS

Target Markets

Portal Hypertension (PHTN; high blood pressure in the liver) is a significant, unmet medical need, with over 1 million patients in the US.  Current treatments involve decreasing blood flow into the liver, either with drugs or with surgery, rather than getting at the core problem of blood-flow resistance in the liver itself.  Recent laboratory research shows cicletanine directly (within the liver) reversing an accepted, reliable animal model of portal hypertension.  CIC looks promising as the first direct treatment of portal hypertension.  Conservative forecast puts revenues at $3 billion. 

Heart failure with preserved ejection fraction (HFpEF) accounted for a minority of diagnosed heart failure until recently.  With about 3 million US patients, it now accounts for 50 – 60% of heart failure diagnoses.   The increasing prevalence of HFpEF is driven to a large degree by metabolic syndrome (“pre-diabetes”) and diabetes.  This is important, as retrospective analysis of hypertension trials have associated CIC with significant decreases in glucose, cholesterol and triglycerides among patients in whom these were elevated.  Additionally, HFpEF is now thought to be driven by inactivation of protein kinase G (PKG), an enzyme recently shown to be activated by CIC.  Navitas therefore believes that CIC has the potential to reverse the root, molecular basis underlying much of the pathology of HFpEF.

Group II Pulmonary Hypertension (Group II PH) is hypertension of the lungs associated with left-sided heart failure.  A small CIC study showed marked improvements in functional status vs. placebo and significant improvement of pulmonary pressures.  The drug appears to have a dual action directly on both heart failure and hypertension within the lungs.  With over 1 million Group II PH patients in the US and no approved drugs, CIC has breakthrough-treatment potential.

Management

Glenn Cornett, MD, PhD (founder, CEO) has over 20 years of consulting and industry experience.  His work at Eli Lily included strategy and financial modeling, including work on licensing Cialis, establishment of a competitive-strategy unit in R&D and a corporation-wide assessment of new therapeutic targets.  At McKinsey, he consulted on engagements in health care, technology and manufacturing.  He also served on the Core Groups for Complexity and Business Dynamics at McKinsey.  While consulting at Los Alamos National Laboratory, Dr. Cornett authored a book on plutonium and public policy.

Running his own consulting firm, Glenn has done financial modeling and structuring for strategic transactions driving the addition of several hundred million dollars of market capitalization to his clients.  Dr. Cornett founded Navitas in 2004 and led it through its first liquidity event 3.5 years later in 2008.  He has run ten marathons (most recently: Cayman Islands in December 2014), and holds a black belt in karate.  He has a neuroscience PhD (UCLA) and an MD (Distinction in Research, U. Michigan).

Mark Alvino (corporate development) has extensive experience in investor relations, public relations and investment banking.  He held senior investment banking positions at Bradley Woods, Griffin and SCO Capital.  At the latter institution, he was responsible for over 20 transactions, driving in aggregate over $500 million of private financings in the biotech / pharma sector.  He was SVP at Ogilvy’s Feinstein Kean Healthcare, a pubic relations business focused on health care.   He was a Vice President at the investor relations firm Allen & Caron.  As an entrepreneur, he founded Advent Consumer Healthcare, where he holds multiple patents on a consumer-health product now available at 7200 CVS stores.  He remains active in competitive sailing.  He holds a degree form George Washington University.

Jim Page, MD, JD, MPH (founder, senior advisor) is a board-certified psychiatrist (residence: Stanford) and graduated first in his law school class.  Earlier, he was in natural resources, where he was a strategist and analyst for Fortune 500 corporations. 

NeuroTronik Limited is a development-stage, venture-backed medical device company pursuing a unique neuromodulation approach to improve cardac output for patients who come to the hospital with Acute Heart Failure Syndrome. With a seasoned team of engineers, advisors, and investors, NeuroTronik is on-track in project milestone achievement. Though a moderately-sized project, the market potential is exceptional.

NeuroTronik is planning a $20 million Series B preferred stock financing in late 2015. Those proceeds are designed to take the therapy through and into commercial sales in Europe.

Our named investors are Hatteras Venture Partners, Synergy Life Science Partners, Mountain Group Capital, and Lord Baltimore Capital.

The CEO is Fred McCoy. The CTO is Steve Masson.

NSF Health Sciences offers clinical, regulatory, and quality consulting services across the total product lifecycle for innovative medical device, pharmaceutical, and biotechnology companies.  We specialize in helping companies balance FDA and worldwide regulatory requirements with their business needs. 

NuvOx Pharma is developing a series of biologics that increase tissue oxygenation. The company's first market will be in oncology, where increased tumor oxygenation increases the response of tumors to radiation therapy. The company recently started a Phase 1b clinical trial in Glioblastoma Multiforme, and is raising a $2.5 million Series A to complete this trial. Afterwards it will seek partners for a Phase 2b in Glioblastoma, and Phase 1b trials in lung cancer and other oncology indications. After growing to a critical mass in oncology, the company will seek to become standard treatment to increase tissue oxygenation for patients suffering from heart attack, stroke, hemorrhaggic shock, and traumatic brain injury.

ORIG3N is a biotech company based in Boston, MA. The scientific mission is to deliver a disease-modeling platform targeting rare genetically inherited diseases. By advancing screening projects using iPSC-derived differentiated cells and rapidly delivering the resulting data to inform therapeutic decisions, ORIG3N will replace trial & error guess work of treating disease and enable longer, healthier lives. 

Orphagen’s focus is small molecule discovery at novel drug targets. We create programs leading to first-in-class drugs. Our goal is to partner these with development stage pharmaceutical companies.

We have been first mover in creating three discovery programs for novel targets, including one program that initiated Phase 1 clinical trials with a strategic partner (JT Pharma) in 2013 for autoimmune disease.

We work with novel drug targets from a very productive target class, the nuclear receptors.

Our work has so far been funded by $15 M in federal grants and partnership revenue. Orphagen is in the process of raising equity funding to accelerate current programs.

Orphagen’s lead internal program is for retinitis pigmentosa, the major form of hereditary blindness. Closely following are antagonists to SF-1, a promising target for treatment of Cushing’s syndrome, a life-threatening endocrine disorder, and two cancers with an endocrine connection: prostate cancer and adrenocortical cancer. New target screening may lead to first-in-class programs for glioblastoma, sickle cell anemia, and cancer immunotherapy.

Pfizer Venture Investments (PVI) is the corporate venture capital arm of Pfizer and was founded in 2004. PVI has an annual investments budget of $50 million and invests up to $10M per investing round. The firm focuses mainly on U.S. startups but has global reach. PVI attempts to allocate 80% of its funding to U.S. based companies and utilizes the remaining 20% for international ventures. PVI provides equity funding for private companies in need of seed, growth, or venture financing. Remaining opportunistic, PVI focuses entirely on high growth prospects in all sectors and all phases of development. The ideal candidate has a potential for high growth and returns. Additionally, PVI will seek to in-license products and buyout companies if the opportunity arises.

Pharmatek is a contract development & manufacturing company providing dosage form development & cGMP manufacturing of oral, injectable & topical products. Founded in 1999, our services focus on the rapid advancement of small molecule & peptide drug candidates from the bench to the clinic & include:

·         Formulation & Analytical Development

·         cGMP Manufacturing

·         Clinical Packaging, Labeling & Worldwide Distribution

Our experience includes first-in-man strategies, solutions for poorly soluble compounds, controlled release formulations & separate facilities for the handling of cytotoxic & potent compounds.  Pharmatek’s drug delivery technologies include:

·         Solid Dispersions

·         Particle Size Reduction

·         Lipid Delivery

·         Complexation

·         Lyophilization

·         Suspensions & Emulsions

Pharmatek’s 68,000 sq. ft. facility includes 9 class 100,000 cGMP manufacturing suites, formulation & analytical laboratories, & ICH stability storage.  Pharmatek has over 150 clients globally, ranging from virtual to large pharmaceutical companies. Having manufactured product for clinical trials in the North America, Europe & Asia; Pharmatek has successfully completed several large pharma quality, EH&S & QP audits.

Phoenix PharmaLabs, Inc. (PPL) is a privately held, preclinical drug discovery company focused on the development and commercialization of new potent, non-addictive treatments for pain and new therapies for the treatment of opiate addiction.

PPL has developed a novel family of New Molecular Entities (NMEs) with high binding affinity at all three opiate receptors: mu, kappa and delta.  These unique ligands, derived from opioid backbones using proprietary technology, have high binding affinity at all three opioid receptors (mu, delta and kappa) and more balanced receptor activity than morphine and other opioids, with partial agonist / antagonist activity at mu, somewhat higher, but not full, kappa agonist activity, and moderate delta activity.  This profile results in first-ever opiate analgesics that appear to be non-addicting and free of all significant dangerous side effects. 

Studies of the drugs have been conducted by prominent scientists at leading institutions including Lou Harris and colleagues at Virginia Commonwealth University (VCU), Jim Woods and colleagues at the University of Michigan, and Larry Toll and colleagues at SRI International and Torrey Pines Institute for Molecular Studies.  Study results in rodents and monkeys performed by the National Institutes of Health (NIH) / National Institute on Drug Abuse (NIDA) and SRI International Laboratories demonstrated the following:

• Robust analgesic potency (10-20x stronger than morphine)
• Little or no euphoric reward / abuse and addiction potential in rodents and monkeys (multiple studies)
• No dysphoria in rodents and monkeys (multiple studies)
• Only moderate signs of respiratory depression – even at 150x dosage
• No death from overdose - even at 350x dosage
• LD50 = 500x dosage
• No physical dependence in naive rodents
• No inhibition of GI transport - even at 350x dosage
• No Long QT syndrome risk – hERG assay
• No significant diuresis in rodents
• Does not precipitate withdrawal in dependent monkeys

Since the drugs do not precipitate withdrawal, they offer very promising use for addiction therapy as a preferred substitute for methadone and buprenorphine, as well as for pain. 

The drugs are orally active and inexpensive to manufacture using PPL's patented manufacturing process.  A key patent on the lead molecule for Composition, Methods and Use will be issued in the US by January, 2015, and it is currently being internationalized.

The cost and risk of achieving a New Drug Approval (NDA) from the FDA is substantially lower than other NMEs with equivalent market potential.  Few drug classes have more longitudinal testing data than opioids for use as a predictor of success in trials.  Therefore, the risk of pharmaceutical product development is significantly reduced compared to the risk of developing less understood and potentially problematic drug classes.  As described above, the assets have been effectively de-risked in animal studies covering all risks that typically manifest themselves in opioids.

Furthermore, a vast amount of opioid testing data is available concerning the transition of effects of pure opioid compounds from animals to humans.  Consequently, our scientific experts and advisors predict that the risk of problems in toxicology and safety pharmacology is very low.  The prediction correlation from animals to humans is very high, and thus there is a high level of confidence that the compounds will be safe, effective and beneficial for humans.   

Recently our drug family has also attracted attention for Animal Health applications, primarily due to the lack of respiratory depression and GI tract side effects as well as the likelihood that the drugs would likely be unscheduled (or at most scheduled as Class IV or V).

The strategic objective of our company is to enter into one or more license agreements with appropriate market leader(s) that have the resources and motivation to further develop, commercialize, and maximize the market potential of PPL’s family of drugs.  We are making steady progress towards the achievement of that objective. Following submission of a BAA grant proposal to the DoD, we were invited by the U.S. Army Medical Research and Material Command (USAMRMC) to submit a full application for a $3.6 million grant for the advancement of our PPL-103 compound for pain, and we are currently awaiting the results. In the meantime we are exploring other potential funding opportunities and strategic collaborations. 

PhysioCue is a medical device company that has developed an anti-hypertension medical device, clinically shown to immediately reduce the high blood pressure of hypertensive patients. This device is non-invasive and works by controlled cold therapy with the carotid artery baroreceptor reflex. Unlike drug treatments, our PhysioCue therapy device is efficient, safe, easy to use, non-invasive, and has none of the side effects associated with anti-hypertensive drugs. We also develop mobile Health device.

PhysioCue’s Mechanism of Action is the body’s natural baroreflexive system which provides important monitoring and feedback for blood flow throughout the body. It activates baroreceptors in the wall of the carotid artery which stimulate the afferent and efferent pathways of the automatic nervous system. To lower excessive blood pressure the brain responds by modulating efferent pathways, which relaxes the blood vessels, slows the heart rate and reduces fluid in the body. These actions reduce the afterload on the heart by decreasing arterial resistance, which improves the heart’s ability to pump blood to the tissues. The increase in parasympathetic tone and decrease in sympathetic drive results in the restoration of sympathetic-vagal balance which reduces excessive blood pressure and improves cardiac structure and function.

PhysioCue’s video has been published on YouTube http://youtu.be/A1bMjg5a3MY ,