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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) 05/22/2018 07:01:49 AM
SYN News: Synthetic Biologics Announces Acceptance of Compliance Plan by NYSE American 05/22/2018 07:00:00 AM
SYN News: Sýn hf. : 69% increase in income but no synergies realized yet 05/16/2018 01:31:35 PM
SYN News: Notice of Effectiveness (effect) 05/16/2018 06:15:34 AM
SYN News: Quarterly Report (10-q) 05/08/2018 04:57:46 PM
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#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7869   I knew they would take it back down. BooDog 06/12/18 03:39:25 PM
#7868   They're still trying to tease with .0001 with BooDog 06/12/18 01:23:31 PM
#7867   In due time if you believe in the JJBHM 05/23/18 08:18:30 PM
#7866   Dead? Jumpinjackas 05/23/18 11:49:02 AM
#7865   ROCKVILLE, Md., May 22, 2018 /PRNewswire/ -- Synthetic BooDog 05/22/18 07:21:41 AM
#7864   Looks like they're building a solid protocol for BooDog 05/10/18 06:16:01 AM
#7863   got caught on the wrong side of that my name is 04/23/18 08:47:31 PM
#7862   The big "IF" factor in play here for sure. $SYN BooDog 04/23/18 04:08:23 PM
#7861   High odds for making green on those shares. Citrati 04/23/18 03:07:20 PM
#7860   I think the loss of Breakthrough Therapy Designation blackcat 04/23/18 02:02:25 PM
#7859   Over reaction. I just loaded up at 21 gator16 04/23/18 12:59:18 PM
#7858   Is FDA’s agreement for P3 a bad news? sage4 04/23/18 12:18:07 PM
#7857   Nope, always has had another move for six Citrati 04/14/18 11:34:53 PM
#7856   Not yet calling it a day here? noretreat 04/14/18 05:09:25 PM
#7855   this thing could run. my name is 04/11/18 05:56:45 PM
#7854   Hard to tell as it could retest the Citrati 03/28/18 05:37:13 PM
#7853   Wow! Will 0.30 even hold? billmick11 03/28/18 01:15:57 PM
#7852   maybe my buy will fill my name is 03/27/18 09:54:33 PM
#7851   .40 was too strong and the descending bb Citrati 03/15/18 01:54:06 PM
#7850   For now the ceiling to eliminate is .40. Citrati 03/13/18 11:13:28 AM
#7849   me rike my name is 03/12/18 06:27:14 PM
#7848   My heart is beating boom bang $ sindram 03/11/18 05:27:17 AM
#7847   let's just relax boys it's just starting to my name is 03/10/18 10:08:53 AM
#7846   100000 block went through! Second leg was build. sindram 03/09/18 11:37:32 AM
#7845   Not quite sure how to reply to that. BooDog 03/08/18 07:45:31 PM
#7844   you moderate the board homie. it can't be my name is 03/08/18 07:37:02 PM
#7843   You know this how? big orange 03/08/18 07:27:05 PM
#7842   Stay tuned... good news will come soon! sindram 03/08/18 12:14:47 PM
#7841   You seem to be correct, BooDog. Kind Ann1 03/08/18 10:37:54 AM
#7840   Looks like someone had a heads up of BooDog 03/07/18 04:45:21 PM
#7839   All I can think is that a big steppe 03/07/18 03:57:46 PM
#7838   oh papi my name is 03/07/18 01:51:23 PM
#7837   Anyone know what's going on here?!! 30%+ move?!! Ann1 03/07/18 12:33:35 PM
#7836   i can hold my name is 03/06/18 08:57:46 PM
#7835   Well that is why it is best not Citrati 03/02/18 03:33:48 PM
#7834   fast stocastics started its cross from todays low. BooDog 03/01/18 10:37:48 AM
#7833   Perhaps todays .37 low will make a double Citrati 02/27/18 12:07:07 AM
#7832   still could my name is 02/26/18 10:09:31 PM
#7831   it broke above the 10 day with a my name is 02/26/18 10:08:11 PM
#7830   Ribaximase is a supplement not a drug. It dds2th 02/26/18 09:45:39 AM
#7829   Actually, SYN is looking for a CEO, whereas Citrati 02/25/18 08:41:28 PM
#7828   They are nothing alike and you know it. Citrati 02/25/18 08:37:53 PM
#7827   Both bought worthless drugs from failed companies and WBillCody 02/23/18 09:51:29 PM
#7826   The really bad news is that the compound big orange 02/22/18 04:58:09 PM
#7825   The really bad news is that the compound big orange 02/22/18 04:58:09 PM
#7824   SYN is not looking too good these days. noretreat 02/22/18 03:22:09 PM
#7823   Yes. Transcript is out... BooDog 02/22/18 01:58:29 PM
#7822   Guess some didn't like the CC. Citrati 02/22/18 01:46:41 PM
#7821   Fairly conservative. Could be better on cutting BooDog 02/22/18 07:32:42 AM
#7820   Don't think it is accurate to label today Citrati 02/21/18 08:29:30 PM