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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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Current Price
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SYN News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 05:08:56 PM
SYN News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 05:07:37 PM
SYN News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 05:06:20 PM
SYN News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 05:04:59 PM
SYN News: Statement of Changes in Beneficial Ownership (4) 12/02/2016 05:04:08 PM
#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7225   *Like* nice close! eom :-) BooDog 12/09/16 04:56:49 PM
#7224   You saw "that one" huh? lol Their story BooDog 12/09/16 01:59:37 PM
#7223   Congrats. Your in the pink, er green. :-) Citrati 12/09/16 01:55:40 PM
#7222   The congress passed the 21st century cures act. dds2th 12/09/16 10:34:47 AM
#7221   Full before a run into data usually pays Citrati 12/09/16 09:04:15 AM
#7220   Back to a full position yesterday .80. BooDog 12/09/16 08:53:54 AM
#7219   They gave themselves many many options (but none Rymankoly 12/05/16 04:33:59 PM
#7218   Thanks 'BooDog' for the updated info. Citrati 12/05/16 03:55:47 PM
#7217   Item 1.01. Entry into a Material Definitive Agreement. BooDog 12/05/16 07:01:03 AM
#7216   A good day with both "dogs" visiting in Citrati 12/03/16 03:37:28 PM
#7215   i took on #3 and am banking on TheHound 12/03/16 03:18:20 PM
#7214   Have a great day. 'Leafman' ;-) Citrati 12/03/16 12:32:56 PM
#7213   There has been some excellent bio plays and BooDog 12/03/16 08:28:29 AM
#7212   Nice post BooDog. Citrati 12/02/16 11:42:05 PM
#7211   I just went through my trade history on BooDog 12/01/16 05:02:04 PM
#7210   this has dropped over 50% from a buck TheHound 12/01/16 12:57:53 PM
#7209   another great scottsmith call! scottsmith 12/01/16 11:58:50 AM
#7208   Hound, IMO it will have more to do Citrati 11/30/16 11:37:27 PM
#7207   Thankyou Seel. I knew you could get right Citrati 11/30/16 11:28:58 PM
#7206   .50 before next announcement. dds2th 11/30/16 10:48:45 PM
#7205   there's my $0.70's. anyone think this will see TheHound 11/30/16 05:23:21 PM
#7204   I read it. Good post. Couple of things Seel 11/29/16 07:30:47 PM
#7203   Seel, what do you think of this post Citrati 11/29/16 11:55:38 AM
#7202 Cbdpotential 11/24/16 12:20:51 PM
#7201   Oh baby. SilverNick 11/22/16 09:57:13 AM
#7200   If I'm not mistaken results should be released big orange 11/20/16 04:40:31 PM
#7199   When are the results? SilverNick 11/18/16 06:01:05 PM
#7198   I picked up some more shares and stil big orange 11/18/16 05:15:46 PM
#7197   I've been stunned into silence by this offering. Seel 11/18/16 12:36:12 PM
#7196   Here we go SilverNick 11/18/16 10:47:48 AM
#7195   Picked up Sabby Healthcare Master Fund, Ltd. BooDog 11/18/16 09:03:57 AM
#7194   What say Seel? Always appreciate your clear and JJBHM 11/17/16 05:26:12 PM
#7193   Stand corrected 6 mill thank you rarefind 11/17/16 01:38:20 PM
#7192   6MM shares (5.14%) Rymankoly 11/17/16 01:34:08 PM
#7191   Offer closes we see now the funds rarefind 11/17/16 01:21:17 PM
#7190   Good to see new faces here, even if Citrati 11/17/16 12:58:57 PM
#7189   I'll be out way before then if that happens SilverNick 11/17/16 11:01:48 AM
#7188   bring on the .70's! TheHound 11/17/16 10:51:17 AM
#7187   Picked up 500 more shares at .86. In SilverNick 11/17/16 10:33:06 AM
#7186   i feel it will have a pop.. its Green Money 00 11/16/16 11:20:04 AM
#7185   Green Money, Why?? Theboy56 11/16/16 10:53:10 AM
#7184   grabbed 50K share lotto at .88 Green Money 00 11/15/16 03:41:13 PM
#7183   Got into a new position in SYN at rarefind 11/15/16 03:25:58 PM
#7182   Kevlar for sure. :-) Why they decided BooDog 11/15/16 01:43:25 PM
#7181   Not sure if they have any near term Rymankoly 11/15/16 01:29:23 PM
#7180   Gunny sack, brown paper or "Brinks" type? ;-) Citrati 11/15/16 01:25:08 PM
#7179   Nice understanding of the details and the importance Citrati 11/15/16 01:23:09 PM
#7178   It looks like it might take a couple porgyrusty 11/15/16 01:19:55 PM
#7177   im in the process of closing other positions TheHound 11/15/16 12:43:45 PM
#7176   I'll be adding to my bag. lol BooDog 11/15/16 11:50:15 AM