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Synthetic Biologics, Inc. (SYN)

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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: Current Report Filing (8-k) 09/18/2020 07:01:05 AM
SYN News: Current Report Filing (8-k) 08/06/2020 04:23:36 PM
SYN News: Synthetic Biologics Reports 2020 Second Quarter Operational Highlights and Financial Results 08/06/2020 04:15:00 PM
SYN News: Proxy Statement (definitive) (def 14a) 08/04/2020 05:02:27 PM
SYN News: Synthetic Biologics Announces FDA Clearance of Investigational New Drug Application for SYN-020 Intestinal Alkaline Phosphata... 07/30/2020 07:00:00 AM
#8155   Anyway, thanks for the .42's. BooDog 09/24/20 04:38:29 PM
#8154   So, new incentive program launched. Think they BooDog 09/24/20 09:28:41 AM
#8153   I have been invested in this company from dds2th 08/10/20 04:18:49 PM
#8152   It's not that they don't have product. BooDog 08/07/20 09:20:17 AM
#8151   No product to sell. No sales no profit. dds2th 08/05/20 11:21:23 PM
#8150   DEF 14A https://www.otcmarkets.com/filing/html?id=14309297&guid=lOnFUnXj9hZlkyh barnyarddog 08/04/20 07:51:36 PM
#8149   ...Synthetic Biologics previously announced an agreement with Massachusetts barnyarddog 08/04/20 07:42:13 PM
#8148   Still no product to bring to market. Pathetic. dds2th 08/02/20 11:29:59 PM
#8147   News: $SYN Synthetic Biologics Announces FDA Clearance of whytestocks 07/30/20 02:30:42 PM
#8146   Another week another disappointment. We must demand new management dds2th 07/24/20 06:32:17 PM
#8145   This company is Pathetic. dds2th 06/30/20 05:14:21 PM
#8144   Maxim posted a buy target of $1.50 yesterday. BooDog 06/19/20 11:04:20 AM
#8143   What’s happening with SYN? Nice to billmick11 06/18/20 09:27:11 PM
#8142   MAXIM push. eom BooDog 06/18/20 02:06:57 PM
#8141   Makes one wonder. BooDog 05/29/20 04:30:24 PM
#8140   NEWS! With such a small float any funding BooDog 05/27/20 07:54:06 AM
#8139   Any hope for SYN getting back to its billmick11 05/08/20 12:55:23 PM
#8138   I think data from 010 has a chance...the Impailer 03/15/20 04:49:53 PM
#8137   Would love to see something move this low BooDog 03/15/20 01:31:46 PM
#8136   Whoooo! Snag some funding this time!! BooDog 02/04/20 07:19:51 AM
#8135   SYN gapping up nicely this am dr_praeses 01/21/20 09:33:28 AM
#8134   $SYN: Positive news out today..... entering now $0.57 makinezmoney 01/07/20 09:53:38 AM
#8133   Just makes you want to yell out "Is BooDog 12/24/19 08:17:32 PM
#8132   Sneaky? Or full of it? Any breath of BooDog 12/20/19 04:29:44 PM
#8131   One would think the insiders don't want to BooDog 12/06/19 12:38:29 PM
#8130   finviz.com can give you the float. They BooDog 12/04/19 11:55:05 AM
#8129   What's the Float on this one? Do they tmeier 12/04/19 11:45:41 AM
#8128   News: $SYN Synthetic Biologics Strengthens U.S. Patent Coverage whytestocks 09/26/19 10:50:23 AM
#8127   Took some of these 40s maybe I'm just BooDog 08/13/19 02:50:33 PM
#8126   Just about time for a swing imo. BooDog 04/12/19 12:15:59 PM
#8125   $SYN Momentum may be trying to push. BooDog 03/26/19 12:42:40 PM
#8124   $SYN very low vol today. The key to SpotOnTrade 03/22/19 04:37:13 PM
#8123   Love all this positive talk, once it goes Bmaintz 03/22/19 04:29:22 PM
#8122   Augustafriends from ORIONS Money Stocks said, " $SYN SpotOnTrade 03/22/19 03:19:54 PM
#8121   Patience is a virtue $SYN https://www.azquotes.com/picture-quotes/quote-suc SpotOnTrade 03/22/19 01:22:06 PM
#8120   Synthetic Biologics NYSE $SYN Upgraded H.C. Wainwright SpotOnTrade 03/22/19 01:18:57 PM
#8119   $SYN Undervalued Biotech Pipeline SpotOnTrade 03/22/19 12:17:20 PM
#8118   Can anyone tell me if SYN stock cheap theRASPYone 03/22/19 01:35:04 AM
#8117   $SYN was over $100.00 per share a few SpotOnTrade 03/21/19 07:30:45 PM
#8116   Synthetic Biologics, Inc. $SYN Pioneering Cutting-edge Research into SpotOnTrade 03/21/19 07:10:31 PM
#8115   $SYN the numbers are beautiful. If we get SpotOnTrade 03/21/19 06:46:33 PM
#8114   $SYN The Sleeping Giant Has Awaken SpotOnTrade 03/21/19 06:43:05 PM
#8113   $SYN 1 Year target from Yahoo Finance $3.63 SpotOnTrade 03/21/19 06:17:07 PM
#8112   Yeah right lol. $SYN Loading SpotOnTrade 03/21/19 03:55:50 PM
#8111   Keep in mind lots of open gaps a theRASPYone 03/21/19 03:21:13 PM
#8110   Gains traction soon imo, and with a low BooDog 03/21/19 03:05:45 PM
#8109   Wow Slappy getting buck wild! Analyst shouldn't even theRASPYone 03/21/19 02:58:20 PM
#8108   Solid support here $.72 $SYN SpotOnTrade 03/21/19 01:15:06 PM
#8107   $SYN higher lows. beautiful chart SpotOnTrade 03/21/19 12:31:02 PM
#8106   $SYN Video SYN-010 is intended to act primarily SpotOnTrade 03/21/19 11:59:29 AM
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