Via 401(K) 2012
The more tools you have in your toolbox as an investor the better your long term performance is going to be. There will be times where certain sectors are and aren’t attractively valued. Because of that you need to be able to invest across different industries so that new money can be deployed at sensible valuations.
Today the S&P 500 is in a bull run that has reached epic proportions. This is the second longest bull market ever. The obvious result of that is that most stocks are expensive. One sector that isn’t is healthcare, which makes that a good place for investors to be looking.
Here are three under-followed healthcare ideas that have had positive developments in the past year that I think are worthy of further investigation.
Mabvax (MBVX) – A Potential Solution For A Problem That Desperately Needs One
Learning that you have cancer is a terrible. Learning that you have pancreatic cancer is as bad as it gets, pancreatic cancer is very nearly a death sentence.
The problem with pancreatic cancer is that it is rarely discovered until it has spread to other parts of the body. Detection is the critical problem with this version of cancer.
The numbers paint a solemn picture.
Currently six to eight percent of patients live five years after diagnosis. Pancreatic cancer is the only one of the top ten cancers with a survival rate in the single digits.
Mabvax (MBVX) discovered and is developing products based on human antibodies that are aimed at both the diagnosis and treatment of metastatic solid tumors including pancreatic cancer. It isn’t a sure thing, but it is a ray of hope for a disease that desperately needs one.
Recent news out of Mabvax put it back on my radar screen. The company just received notice from the FDA that it had authorized the start of a Phase I clinical trial for Mabvax’s MVT-1075 as a treatment for pancreatic cancer.
The trial is slated to start in the first half of 2017.
The announcement of this trial follows on positive results from two other phase I trials that MabVax announced late in 2016. The first of those trials evaluated Mabvax’s therapeutic antibody MVT-5873, in which safety was reported to have been established at three incremental dose levels by treating patients at three clinical sites.
The second trial which evaluated the Company’s Immuno-PET diagnostic agent MVT-2163. The Company reported that phase I trial results demonstrated acceptable interim safety, pharmacokinetics, and biodistribution.
Mabvax is still very much a speculative development stage company but its progress merits tracking it further given what it is trying to accomplish.
While speculative to be sure the upside here is interesting. Pancreatic cancer alone if a $1.6 billion market with no current solution. There are 53,070 new cases of pancreatic cancer each and every year. If successful Mabvax would be the standard of care for treatment.
Opportunity also exists for Mabvax in colon, rectum, small cell lung and stomach cancer. The combined markets here are also in the billions.
Pulmatrix (PULM) – A Double Dosage Of Positive Developments
Like MabVax, Pulmatrix (PULM) has had positive developments over the past year.
Pulmatrix has two main products under development, both products are tied to the company’s inhalation technology iSPERSE. iSPERSE stands for “inhaled small particles easily respirable and emitted” and it is a new method of highly efficient drug delivery using dense, high drug load, engineered particles delivered through the airways.
The product that has perked my interest in Pulmatrix is PUR1900 which is a potential treatment for an infection that is caused by cystic fibrosis. There have been two pretty important pieces of news relating to PUR1900 over the past six months.
In August 2016, Pulmatrix announced that the FDA had granted Orphan Drug to PUR1900. The FDA provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
The benefits to Pulmatrix of having PUR1900 obtain orphan status can include grant funding, tax credits, assistance in clinical research study, seven years of market exclusivity after the orphan drug is approved and a waiver of the Prescription Drug User Act filing fees (which is $1.3 million in 2016).
All of these benefits are designed to help companies recover the big costs of developing a solution for a rare disease that has an unmet need but a very limited patient population (small market to sell into).
The second piece of good news for PUR1900 just arrived in January 2017 as the FDA has further granted what is called Qualified Infectious Disease Product (QIDP) Designation to the drug. The QIDP program is designed to increase the speed of development of novel drugs that are viewed as key to treating important pathogens. That will help speed PUR1900’s development along and it also provides five years of additional exclusivity on PUR1900 for Pulmatrix.
Both of these approvals from the FDA are clearly very bullish for PUR1900 and Pulmatrix.
VBI Vaccines – A Proven Solution Just Working Through Some Red Tape
Unlike most every development stage drug company (including the two above) VBI Vaccines has a product (Sci-B-Vac) that is already proven and in commercial use. What VBI is lacking is getting its product into the two most important markets which are the United States and Europe. I believe that achieving that is a matter of time.
VBI is looking to provide a solution for a specific group of patients that are currently not suitable for Hepatitis B vaccination. A $1 billion opportunity.
Hepatitis-B is a global problem. The key facts about Hepatitis-B according to the World Health Organization are as follows:
– Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease.
– The virus is transmitted through contact with the blood or other body fluids of an infected person.
– An estimated 240 million people are chronically infected with hepatitis B (defined as hepatitis B surface antigen positive for at least 6 months).
– More than 686 000 people die every year due to complications of hepatitis B, including cirrhosis and liver cancer 1.
– Hepatitis B is an important occupational hazard for health workers.
– Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus. It is a major global health problem. It can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer.
In North American and Europe GlaxoSmithKline’s (GSK) Engerix-B is the current standard of care for Hepatitis B vaccines. Engerix-B works fine for young, healthy people. It is not suitable for people with liver conditions, diabetics and people over 40 with weaker immune systems.
For these people VBI Vaccines has the solution with Sci-B-Vac.
This point was brought forward once again with VBI’s Phase IV study on 88 seronegative people (without previous immunity to Hepatitis B). Of the 88 subjects in the study data revealed that 98.8% of participants were seroprotected at Month 3, two months after receiving a second dose of Sci-B-Vac, and prior to receiving a third dose.
These results should not come as a surprise. Sci-B-Vac has already been proven through more than 20 clinical trials and has been used by more than 4,500 patients. The vaccine is the standard of care in Israel and has been approved for use in 15 countries.
Bringing this vaccine to market is exactly why VBI Vaccines and SciVac Therapeutics merged in 2016. SciVac had the vaccine and VBI provided the financial and corporate capability to bring that vaccine to the larger markets in the United States and Europe.
