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Synthetic Biologics, Inc. (SYN)

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Last Post: 7/21/2017 11:00:48 AM - Followers: 203 - Board type: Free - Posts Today: 0

Synthetic Biologics

Synthetics Biologics, Inc., a biotechnology company, focuses on development of novel anti-infective biologics and drug candidates targeting specific pathogens that cause serious infections and other diseases. The company?s product candidates include Trimesta, which has completed phase II clinical trials for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis; SYN-010 that is in preclinical stage for the treatment of constipation-predominant irritable bowel syndrome; SYN-004, which is in preclinical stage for the treatment of clostridium difficile infection prevention; SYN-005 that is in preclinical stage for the treatment of pertussis; SYN-001, which is in discovery stage for the treatment of acinetobacter infection; and SYN-007 that is in discovery stage for the treatment of irritable bowel syndrome. It has a sublicense agreement with Meda AB for the development and commercialization of Effirma (flupirtine) for fibromyalgia in the United States, Canada, and Japan. The company was formerly known as Adeona Pharmaceuticals, Inc. and changed its name to Synthetics Biologics, Inc. in February 2012. Synthetics Biologics, Inc. was founded in 2001 and is based in Rockville, Maryland.

As of November 2, 2015 the registrant had 90,810,086 shares of common stock outstanding.

management team rule

board of directors rule

advisors rule


collaborators rule

The initiation of monocloncal antibody (mAb) development for the treatment of pertussis is the second of three infectious disease indications Synthetic Biologics intends to pursue as part of its August 2012 collaboration with Intrexon Corporation.

To further the development of this potential mAb therapy for pertussis, Synthetic Biologics has entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. These research efforts are being conducted at the Cockrell School of Engineering in the laboratory of Assistant Professor, Jennifer A. Maynard, Ph.D., the Laurence E. McMakin, Jr. Centennial Faculty Fellow in the McKetta Department of Chemical Engineering. Dr. Maynard brings to the project her expertise in defining the key neutralizing epitopes of pertussis toxin to optimize the potential efficacy of antibody therapeutics

SYN-001 rule

Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins. Monoclonal antibodies (mAbs) can also be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under the Synthetic Biologics’ collaboration with Intrexon are intended to supplement a patient's own immune system by providing the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to utilize Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create potent candidate mAbs, SYN-001, for human testing and use to specifically treat Acinetobacter.

infectious diseases collaboration with Intrexon rule

Many infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. In August 2012, Synthetic Biologics announced a second worldwide exclusive channel collaboration with Intrexon Corporation. Using Intrexon’s comprehensive suite of proprietary technologies and processes, Synthetic Biologics intends to develop and commercialize a series of monoclonal antibody (mAb) therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies.

partnered program rule

Effirma™ for Fibromyalgia

Synthetic Biologics has partnered the development of Effirma (flupirtine), a centrally-acting investigational oral drug, for the treatment of fibromyalgia syndrome with Meda AB. Effirma is a selective neuronal potassium channel opener that also has NMDA receptor antagonist properties. Effirma is a non-opioid, non-NSAID, non-steroidal, analgesic. Preclinical data and clinical experience suggest that Effirma should also be effective for neuropathic pain since it acts in the central nervous system via a mechanism of action distinguishable from most marketed analgesics. Effirma is especially attractive because it operates through non-opiate pain pathways, exhibits no known abuse potential, and lacks withdrawal effects. In addition, no tolerance to its antinocioceptive effects has been observed. One common link between neuroprotection, nocioception and Effirma may be the N-methyl-D-aspartic acid glutamate system, a major receptor subtype for the excitotoxic neurotransmitter, glutamate. Effirma has strong inhibitory actions on N-methyl-D-aspartic acid-mediated neurotransmission. Flupirtine was originally developed by Asta Medica (subsequently acquired by Meda AB) and has been approved and is marketed by Meda AB in Europe since 1984, as well as other countries, for the treatment of pain. It has never been approved by the FDA for any indication.

On May 6, 2010, Synthetic Biologics and Pipex, its wholly owned subsidiary, entered into a sublicense agreement with Meda AB, a multi-billion dollar international pharmaceutical company, pursuant to which Meda AB assumed all future development costs and may commercialize flupirtine for fibromyalgia in the United States. As consideration for such sublicense, Synthetic Biologics received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon the FDA’s acceptance of the New Drug Application (NDA) for flupirtine for fibromyalgia and $10 million upon FDA approval of such NDA. Pursuant to the sublicense agreement, Synthetic Biologics will also receive a 7% royalty on net sales of flupirtine for fibromyalgia in the United States, Canada and Japan, with such royalties being shared equally with Synthetic Biologic’s licensor, McLean Hospital, a Harvard teaching hospital.

Flupirtine is approved and marketed by Meda AB and its distributors in Europe and other countries for indications other than fibromyalgia and has been prescribed to millions of patients worldwide. Synthetic Biologics believes that such substantial human experience with flupirtine should greatly assist the FDA in its evaluation of the safety of flupirtine upon review of an NDA of flupirtine for fibromyalgia. According to Meda’s 2010 Annual Report, flupirtine for fibromyalgia is currently in Phase II development.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, often accompanied by severe fatigue, insomnia and mood symptoms. According to the National Fibromyalgia Association, fibromyalgia affects an estimated 3-6% of the population worldwide, including an estimated 10 million patients in the U.S.

There are presently three FDA products approved for this indication in the United States – Lyrica®, Cymbalta® and Savella®. Flupirtine is differentiated from these products in that it employs a unique mode of action.

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SYN News: Additional Proxy Soliciting Materials (definitive) (defa14a) 07/18/2017 05:17:59 PM
SYN News: Proxy Statement (definitive) (def 14a) 07/18/2017 05:17:05 PM
SYN News: Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) 07/06/2017 05:02:30 PM
SYN News: Current Report Filing (8-k) 06/27/2017 07:01:11 AM
SYN News: Synthetic Biologics Announces Allowance of Key U.S. Patent Covering SYN-010 Intended for the Novel Treatment of Irritable Bow... 06/27/2017 07:00:00 AM
#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7505   I'm about maxed out here now. Like BooDog 07/21/17 11:00:48 AM
#7504   For me the greatest concern is if there big orange 07/18/17 11:09:47 AM
#7503   Nothing matters but FDA approval. Any ideas about dds2th 07/17/17 06:12:23 PM
#7502   If you draw the bottom uptrend line from Citrati 07/17/17 12:08:03 PM
#7501   Trying to get back in the game. BooDog 07/17/17 11:32:32 AM
#7500   Likely correct on not today. Citrati 07/13/17 11:25:00 AM
#7499   Welp, unless the wind shifts it ain't happinin BooDog 07/13/17 11:19:02 AM
#7498   Nice basing on this 10day 5minute. Citrati 07/12/17 08:44:27 PM
#7497   In the process of confirming reversal as we BooDog 07/12/17 01:46:46 PM
#7496   just a few pennies above the gap. fill TheHound 07/12/17 01:32:20 PM
#7495   Amicus therapeutics of cranberry New Jersey was just dds2th 07/12/17 12:07:50 PM
#7494   Reversal trying. Needs confirmation. BooDog 07/12/17 10:59:12 AM
#7493   in NYC. "September 7, 2017 at 9:00 someconcerns 07/09/17 03:59:01 PM
#7492   Is the AGM meeting in Ann Arbor? JJBHM 07/09/17 03:54:26 PM
#7491   Wish I lived close enough to go to blackcat 07/09/17 03:47:42 PM
#7490   The pre14 is out, so we know the BooDog 07/09/17 02:34:51 PM
#7489   When they issue more stocks at the annual 0cash 07/08/17 05:39:41 PM
#7488   I was under the opinion that SYN was big orange 07/07/17 05:16:49 PM
#7487   Welcome to start up bio's. eom BooDog 07/07/17 04:19:06 PM
#7486   Name one event that has brought value to DCInvestments 07/07/17 04:14:42 PM
#7485   I was looking to see .48. Could BooDog 07/07/17 08:06:46 AM
#7483   may be ready to fill the gap! TheHound 07/05/17 04:44:14 PM
#7482   maybe ready for reversing up.. Chance 07/05/17 10:48:00 AM
#7481   I will be at any reversal with dry Citrati 06/30/17 10:40:58 AM
#7480   gap fill/double bottom now in play. TheHound 06/30/17 10:35:57 AM
#7479   Isn't SYN supposed to meet with the FDA big orange 06/29/17 03:54:15 PM
#7478   At present SYN is struggling with overhead resistance Citrati 06/29/17 12:23:00 AM
#7477   "Synthetic Biologics: USPTO has issued a Notice of Citrati 06/27/17 11:20:13 AM
#7476   I hate gaps. The MMs love em. I BooDog 06/24/17 02:03:13 PM
#7475   unbelievable how oversold the 10day 15minute chart is. Citrati 06/23/17 03:52:56 PM
#7474   yep. i'm eyeing that gap again. long shot, TheHound 06/23/17 08:56:01 AM
#7473   Tomorrow is a significant chart day. Hold the Citrati 06/23/17 12:46:58 AM
#7472   Do they meet with the FDA? If big orange 06/22/17 03:02:10 PM
#7471   Breakthrough drug, if no need to run PIII DavidW2 06/21/17 06:32:14 PM
#7470   When does SYN meet with the FDA to big orange 06/21/17 12:22:13 PM
#7469   Wouldn't that be nice. Chart looks great. Citrati 06/20/17 03:26:58 PM
#7468   Trip and rip, challenging the top @ .72. BooDog 06/20/17 11:07:34 AM
#7467   GREAT INVESTOR INFORMATION on SYN wfarrance 06/17/17 06:38:49 PM
#7466   * * $SYN Video Chart 06-15-17 * * ClayTrader 06/15/17 05:26:30 PM
#7465   A nice close at/near HOD and B/O tomorrow Citrati 06/15/17 03:15:24 PM
#7464   SYN IMO will is Another QUESTCORE PARM. went Weedstockmillions 06/15/17 12:11:38 PM
#7463   Chugga chugga! Meant to get here earlier but BooDog 06/15/17 11:56:38 AM
#7462   Thank you C! Seel 06/15/17 11:48:24 AM
#7461   Nice action so far today off the midline. Citrati 06/15/17 10:30:25 AM
#7460   SYN continues to hold price above ema's stacked Citrati 06/14/17 09:19:06 PM
#7459   Breakout potential. Eom BooDog 06/03/17 01:16:06 PM
#7458   Just need to break that .70 mark! Great day!! RobberBarronINV 06/02/17 04:14:26 PM
#7457   Nice volume today for sure. Looking good. BooDog 06/02/17 04:00:58 PM
#7456   Big boy accumulation continues. Citrati 06/02/17 02:27:19 PM
#7448   So according to there's a gap to BooDog 05/31/17 07:45:44 AM