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Synthetic Biologics, Inc. (SYN)

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Last Post: 3/24/2017 6:04:10 AM - Followers: 194 - 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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Current Price
Bid Ask Day's Range
SYN News: Statement of Changes in Beneficial Ownership (4) 03/16/2017 06:53:38 PM
SYN News: Synthetic Biologics to Present at the 29th Annual ROTH Conference 03/07/2017 07:00:00 AM
SYN News: Annual Report (10-k) 03/02/2017 05:06:20 PM
SYN News: Current Report Filing (8-k) 03/02/2017 04:15:52 PM
SYN News: Synthetic Biologics Reports 2016 Year End Operational Highlights and Financial Results 03/02/2017 04:05:00 PM
#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7307   See post 7298. BooDog 03/24/17 06:04:10 AM
#7306   Hello..... is anybody out there? Ithink I hear perfusionist 03/23/17 05:18:41 PM
#7305   Thanks. Hope this is just a correction today Stockyang 03/21/17 11:55:29 AM
#7304   IBB just got whacked. Many bios going down Citrati 03/21/17 11:39:48 AM
#7303   Thanks! Will hold. Stockyang 03/20/17 07:33:01 AM
#7302   First target would be break .90 the top Citrati 03/19/17 11:00:12 PM
#7301   Besides pinching bb's I like the positive divergence Citrati 03/19/17 10:52:19 PM
#7300   Any price target for syn ? Thanks. I Stockyang 03/19/17 10:20:21 PM
#7299   LOL, yeah I'd go to Barcelona just to Citrati 03/19/17 03:54:39 PM
#7298   Bollingers coming in again. BooDog 03/19/17 11:12:01 AM
#7297   Exercising .09 warrants seems like a good deal Citrati 03/17/17 08:52:07 AM
#7296   Informative presentation. Curious that no one has commented G Bert 03/17/17 08:33:06 AM
#7295   form 4 out. TheHound 03/16/17 11:56:36 PM
#7294   SYN Roth slidedeck. Citrati 03/16/17 03:25:49 PM
#7293   Here's how the 10 day support resistance looks Citrati 03/10/17 06:22:01 PM
#7292   Riley reaffirmed on the call that a partnership ericseb2003 03/06/17 10:32:40 AM
#7291   A good core to trade around as well. Citrati 03/05/17 11:42:03 PM
#7290   I'll be adding over next few months to ericseb2003 03/03/17 11:07:41 AM
#7289   Upcoming Events BooDog 03/03/17 08:38:47 AM
#7288   Conference call transcript. Citrati 03/03/17 12:06:14 AM
#7287   10K out. TheHound 03/02/17 06:15:57 PM
#7285   First batch. Rymankoly 02/24/17 09:58:53 AM
#7284   Why not wait until new dilution and RS? Jumpinjackas 02/24/17 09:50:12 AM
#7283   I just did and bought some back... Rymankoly 02/23/17 04:13:20 PM
#7282   I saw it coming, I just didn't have BooDog 02/23/17 04:09:57 PM
#7281   Holy S**t! 74 cents. Might be time noretreat 02/23/17 03:44:55 PM
#7280   The ace will eventually play. Patiently waiting. TheHound 02/23/17 03:24:40 PM
#7279   Same. I'm watching for entry. It will run Jumpinjackas 02/23/17 11:43:17 AM
#7278   Trying to raise money in a down market Citrati 02/23/17 11:41:58 AM
#7277   Syn is dropping due to market. They need Jumpinjackas 02/23/17 11:32:27 AM
#7276   How much is IBB effecting SYN? Citrati 02/23/17 11:07:57 AM
#7275   Isn't about lack of funds that is taking Jumpinjackas 02/23/17 05:33:59 AM
#7274   Seems like we should be getting close to tradeherpete 02/21/17 11:35:55 PM
#7273   Sure does test one's patience/resolve here. Citrati 02/16/17 10:17:46 PM
#7272   Any word on today's presentation? JJBHM 02/13/17 04:41:52 PM
#7271   Are you feel'n pinched yet? :-) Citrati 02/13/17 01:09:49 PM
#7270   Have not seen that furry cymbal clapper in Citrati 02/06/17 11:44:58 PM
#7269   I think I'm good here. Whenever you're BooDog 02/06/17 01:03:23 PM
#7268   Looks to be warming up. Tightening for sure. Citrati 02/06/17 01:02:36 PM
#7267   Two great pices of news BooDog. Citrati 02/03/17 01:59:06 PM
#7266   SYN to Present at the 2017 BIO CEO BooDog 02/03/17 07:11:24 AM
#7265   Pinch, pinch. Citrati 02/01/17 08:31:43 PM
#7264   LOL, my powder is dry, nicely aged and Citrati 01/31/17 03:18:59 PM
#7263   Support line holding nicely SO FAR. Bollingers coming BooDog 01/31/17 03:09:07 PM
#7262   Hi Citrati! I've been in New Orleans for Seel 01/26/17 05:16:35 PM
#7261   Looking to cut some resistance. :-) BooDog 01/22/17 08:14:56 AM
#7260   Agreed. Those are big differences IMO. Citrati 01/20/17 10:28:05 AM
#7259   "Ours is better than theirs" I was talking BooDog 01/20/17 10:22:52 AM
#7258   Ours is better than theirs. Without the BooDog 01/20/17 07:57:50 AM
#7257   Looking to rebuy on a signal. Citrati 01/19/17 10:09:42 PM