AssemblyBio's molecules might be in the class of heteroaryldihydropyrimidines (HAPs) or has a chemical structure that is similar. Zlotnick co-authored an article in 2006 titled, "BAY 41-4109 has multiple effects on Hepatitis B virus capsid assembly." BAY 41-4109 was an early (HAPs) drug from the company Bayer which either was not tested in humans or did not get further than phase 1.
There is also another article by seven researchers which included Zlotnick from 2008 titled, "Small-Molecule Effectors of Hepatitis B Virus Capsid Assembly Give Insight into Virus Life Cycle," in which 18 derived (HAPs) were compared for effectiveness.
AssemblyBio has not revealed their drug or structure or even announced it yet. So this is all just guessing.
Zlotnick, the lead researcher at AssemblyBio, co-authored in the year 2002 an article titled, "A small molecule inhibits and misdirects assembly of hepatitis B virus capsids." So calling the drug an "HBV capsid assembly inhibitor" is probably correct. I think "allosterically modifying core protein" describes what the "capsid assembly inhibitor" drug does. cccDNA target is over a decade old, so one would assume others might be researching it.
I found two companies in United States working on "capsid assembly inhibitors". Novira Therapeutics is in phase 1, which was started mid-2014. Enantigen is pre-clinical. Enantigen was recently acquired. AssemblyBio is already behind Novira.
There is also a company in China in phase 2 with a "capsid assembly inhibitor". But that is for China market.
Anyway, it will take years for HBV market players to play out. So just be aware that there are competitors and that AssemblyBio now calls their drug "best-in-class" instead of "first-in-class".
HBV drug has potential, but other companies also researching same target. Before the merger the drug was called "first in class", which implies they are at the fore-front with little competition. Notice after the merger the drug is described as "best in class", which implies they are the best out of a group. I guess AssemblyBio management did some searching around and found other companies also researching HBV capsid assembly inhibitors.
Seeing that there is little information on competitor's drug it is misleading to describe their drug as "best in class" of capsid assembly inhibitors. I was disappointed to find other companies researching the same target. So it is now a race between a couple of companies. So assuming drug class works, a couple of drugs might have to share the market.
Minor old news: Protalix completed Elelyso clinical trials September 9, 2014. Two Elelyso clinical trials were changed to completed at clinicaltrials.gov. So Protalix finished up Elelyso studies and can now focus attention and resources on Fabry and oral Anti-TNF.
Since the role of glucosylceramide is unclear, side-effects of reducing glucosylceramide output with Cerdelga is also unclear. A normal body has the enzyme that metabolizes glucosylceramide. Enzyme Replacement Therapy tries to replace that missing enzyme.
So it is probably better to use ERT, but convenience of an oral drug is probably tempting. Hopefully, Protalix can get oral Elelyso to market as soon as possible with some sort of accelerated approval path.
Pricing has been not determined for Cerdelga, but initial response is that it will be priced close to Cerezyme. For Elelyso to compete, Pfizer should lower Elelyso's price to 50% or more below Cerezyme. Assuming plant cell production is cheaper, there should be room to lower the price. Elelyso at 25% below Cerezyme has not captured much market share.
Elelyso market share is probably less than 3% with only a couple of million revenue in Q2. Gaucher market is probably around $1 billion annually.
Showing up on NASDAQ new lows list and NASDAQ biggest decliners list increases visibility. Protalix would probably show up in top 5 on NASDAQ decliners list today, since it is down over 10%.
Protalix should really move to NASDAQ where most biotechs trade to increase visibility. Moving to NASDAQ would also change to NASDAQ market makers. NYSE MKT is little followed, relatively small with about 290 stocks, and filled with mining, oil and gas stocks.
So how does that relate to Pernix? Pernix's drug, Khedezla, is supposed to be an alternative to Pristiq.
Can you even name some biotechs that trade on "NYSE Markets"? Note that is NOT the main NYSE.
Most if not all the top biotechs trade on NASDAQ. And over 95% of biotech IPOs choose NASDAQ. PLX needs to get off NYSE Markets and move to NASDAQ. Biotech IPO market has been active over the last two years.
HepB or HBV drug has potential. I assume Assembly merger goes through. I think only 86 shareholders on record. We will see July 10, 2014. The company handling the Ventrus Proxy has been calling shareholders to vote before the meeting. Did you get a call to vote your Proxy?
PLX trades on NYSE Euronext which has Liquidity Providers, which hold inventory of stocks. Holding inventory provides the opportunity for stock manipulation. Protalix should move to NASDAQ where market makers do not hold inventory to facilitate trading. NASDAQ is also where most biotechs trade.
PLX should move to NASDAQ. PLX should move to NASDAQ. NYSE Euronext market makers hold inventory to provide liquidity for stock trading. So Euronext market makers can manipulate PLX stock if they want to. NASDAQ market makers do not hold inventory to facilitate trading. Most if not all the top biotechs trade on NASDAQ.
I see Protalix on NYSE Markets new low list along with 4 other companies. On the "NYSE Markets" new highs list there are 7 companies, a couple of funds. So who checks out "NYSE Markets" new lows and new highs lists for investing ideas? My guess is probably few do. Moving over to NASDAQ would provide more visibility, since PLX can show up on NASDAQ new lows list, NASDAQ new highs list, NASDAQ most active, NASDAQ largest decliners and NASDAQ largest gainers.
Also, I think NYSE market makers hold inventory of stock. NYSE market makers can manipulate stocks to their advantage if they choose when there is little volume. NASDAQ market makers do not hold inventory. Over a hundred biotechs trade on combined NASDAQGS and NASDAQCM, including all the top, profitable ones. All shareholders tell Protalix to move stock to NASDAQ.
Correction, Remicade biosimilars have been approved in Europe in 2013, not Enbrel biosimilars. Enbrel patent in Europe expires in 2015. I would like to see Protalix do an injection Enbrel biosimilar outsourced to a partner, while Protalix starts development of oral Anti-TNF.
Anyway, potential blockbuster in oral Anti-TNF. You might see the company that owns Enbrel come knocking on Protalix's door. Or maybe Amgen or Pfizer might want it, since both companies currently license and market Enbrel.
For shareholders, PLX stock has done little over the 12 years he has been CEO. Pipeline was poorly scheduled with many years between potential commercial drugs. Gaucher drug was approved in 2012. Two years later most other drugs are in phase 1. Fabry drug is still two to three years away from reaching commercial stage. I do not know timing on oral version of Elelyso. Maybe it can get accelerated approval since it is the same active protein as injection Elelyso.
He could have found more partners. He has potential Enbrel injection biosimilar, but did not partner with any company to develop one for Europe, where the patent expired years ago. No news on TEVA partnership after they discontinued the two drugs they were developing together back in 2009. No partnerships resulted in the poorly scheduled pipeline with Protalix developing drugs by itself at a slow pace.
So I would agree that it is good news for stock that Dr. Aviezer is retiring as CEO. Hopefully, Protalix finds a new CEO which can speed development up.
NYSE has low visibility for biotech stocks.
Most biotechs trade on NASDAQ. Very few biotechs trade on NYSE. Only 16 of the biotechs from Yahoo's Biotechnology company list trade on NYSE, and most are insignificant. But around 120 biotechs trade on NASDAQGS and NASDAQCM, which include most of biggest and profitable biotech companies. I wish Protalix's stock would move to NASDAQ.
NYSE has the following biotech stocks: XON,BONE,BTX,CRMD,CUR,CVM,FCSC,HEB,IG ,IMUC,INO,MSTX,PIP,PLX,RNN. Most are insignificant biotechs. XON which went public within the last year has a 2 billion market cap. Protalix made a mistake listing on NYSE. Tell whoever in charge of Protalix's stock exhange listing to move to NASDAQ. I used Yahoo's Biotech companies list.
List of NYSE biotech stocks:
XON nyse Intrexon Corporation
BONE nyse Bacterin International Holdings, Inc.
BTX nyse BioTime, Inc.
CRMD nyse CorMedix, Inc.
CUR nyse Neuralstem, Inc.
CVM nyse CEL-SCI Corporation
FCSC nyse Fibrocell Science, Inc.
HEB nyse Hemispherx Biopharma, Inc.
IG nyse IGI Laboratories, Inc.
IMUC nyse ImmunoCellular Therapeutics, Ltd.
INO nyse Inovio Pharmaceuticals, Inc.
MSTX nyse Mast Therapeutics, Inc.
PIP nyse PharmAthene, Inc.
PLX nyse Protalix BioTherapeutics, Inc.
RNN nyse Rexahn Pharmaceuticals, Inc.