Navigation Links
Albemarle Optimizes Smallpox Drug Candidate for SIGA

Fine Chemistry Services unit demonstrates pilot production for "fast track"


BATON ROUGE, La., May 5 /PRNewswire-FirstCall/ -- Two American companies are teaming up for second-round test-phase production of a FDA-designated "fast track" drug candidate to treat smallpox, a deadly virus that is feared to be able to reach people through acts of bio-warfare or bio-terrorism.

(Logo: )

Albemarle Corporation (NYSE: ALB), a leading global provider of custom pharmaceutical manufacturing services, was selected by SIGA Technologies (Nasdaq: SIGA), a company specializing in the development of pharmaceutical agents to fight bio-warfare pathogens, to provide scale-up and manufacturing services for ST-246, SIGA's leading smallpox antiviral candidate.

Caused by the variola virus, smallpox is no longer found generally in the environment, but it is considered a formidable bio-warfare threat. SIGA's ST-246 has shown evidence of safety and high levels of efficacy against poxvirus disease in multiple animal trials, as well as continued success in human safety studies.

As a result of success in early trials and in one emergency compassionate use case, the FDA has designated ST-246 for "fast track" status. Activities supporting a New Drug Application (NDA) are currently in process.

Under its existing manufacturing agreement with SIGA, Albemarle's Fine Chemistry Services division will scale up the manufacturing process for SIGA's active pharmaceutical ingredient (API) to produce three cGMP registration batches at Albemarle's facility in South Haven, Mich. in anticipation of pivotal human safety trials.

Albemarle has already optimized and demonstrated a process for producing ST-246 in commercial quantities using SIGA's small-scale process as a starting point, and Albemarle recently proved the optimized process at pilot plant- scale with great success under cGMP conditions. Some of this material will be used to manufacture emergency-use capsules of ST-246, according to Dr. Dennis E. Hruby, SIGA's Chief Scientific Officer.

"Under the leadership of Dr. Shanthakumar Tyavanagimatt, SIGA's Director CMC operations & Formulations, Albemarle's R&D group have helped us flesh out a robust crystallization step that consistently delivers the most desired polymorph for this advanced API," said Dr Hruby. "Together we have developed a process that is suitable for commercial production, and can be used to create substantial quantities of the drug for stockpiling for emergency use."

"We have been very happy with the working relationship with Albemarle and the value that they have added to this important antiviral program," Dr. Hruby added.

"We are honored that SIGA has entrusted Albemarle with this significant new compound," said Dr. David Clary, Albemarle Division Vice President of Fine Chemistry Services. "Our ability to support our customers' most important and sensitive needs from pre-clinical trials into commercialization has resulted in a positive response from the pharmaceutical industry, as evidenced by the steady growth in our chemistry services business. Our success with SIGA's program underlines our proven abilities to support the chemistry needs of developing pharmaceutical companies."

New York-based SIGA Technologies applies viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. For more information about SIGA, please visit

Albemarle Corporation is a leading global developer, manufacturer and marketer of highly engineered specialty chemicals for consumer electronics; petroleum and petrochemical processing; transportation and industrial products; pharmaceuticals; agricultural products; and construction and packaging materials. The Company operates in three business segments-Polymer Additives, Catalysts and Fine Chemicals, and serves customers in approximately 100 countries. Learn more about Albemarle at

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Albemarle Corporation's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report on Form 10-K.

SOURCE Albemarle Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Chimerix Initiates a Multi-dose Clinical Trial of the Companys Lead Compound, CMX001, for the Treatment for Smallpox Infection
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
5. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
6. Upstream Biosciences Acquires Innovative Platform Technology and Drug Candidates for Tropical Parasitic Diseases
7. Phase 2 Clinical Studies Initiated for a Novel Therapeutic Candidate Identified Through Pharmacopeia Collaboration
8. BiPar Expands Management Team to Advance Lead PARP Inhibitor Product Candidate Into Phase 2 Trials for Cancer
9. Pharmacopeia Earns Milestone Payment From Schering-Plough on Initiation of Phase 1 Clinical Trials of Novel Therapeutic Candidate
10. Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candidate HZT-501
11. Survival Data for Avicenas Amyotrophic Lateral Sclerosis Drug Candidate, AL-02, to be Presented at 18th International Symposium on ALS/MND
Post Your Comments:
(Date:12/1/2015)... 1, 2015 Relmada Therapeutics, Inc. (OTCQB: RLMD), a ... pain, announced today that the company will present at the ... 1-3 at the Luxe Sunset Boulevard Hotel in ... of Relmada Therapeutics, will present on Thursday, December 3, at ... . Please register at least 10 minutes prior to ...
(Date:12/1/2015)... DIEGO , Dec. 1, 2015   MabVax ... drug development company, announces it has filed an Investigational ... Drug Administration (FDA) for the Company,s lead fully human ... to FDA acceptance, MabVax plans to initiate the Phase ... --> --> The planned Phase ...
(Date:12/1/2015)... 1, 2015   Craneware, Inc ., the ... today announced the company will showcase a new ... ® solution at the American Society for ... . The new features are focused on simplifying ... and managing enterprise-wide pharmacy charges to ensure compliance ...
Breaking Medicine Technology:
(Date:12/1/2015)... Diego, CA (PRWEB) , ... December 01, 2015 ... ... and scale , Visage Imaging Inc. (“Visage”), a wholly owned subsidiary of Pro ... mobile imaging results enhancements at the Radiological Society of North America (RSNA) 2015 ...
(Date:12/1/2015)... ... December 01, 2015 , ... McLean, VA., ... awarded a fixed price per sprint agile development contract to support the National ... over five years, provides software engineering, infrastructure, as well as operations and sustainment ...
(Date:12/1/2015)... ... December 01, 2015 , ... PYA’s latest white paper, ... addresses a main “pain point” for merging or aligning healthcare provider organizations—when mergers ... is signed. This quick-read guidance suggests that failing to recognize the power ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... With ... footage, and with full control over customization, the possibilities are truly endless, all with ... position randomization, overlay depth position, vertical flip, horizontal flip, depth of field and more, ...
(Date:12/1/2015)... ... December 01, 2015 , ... SonaCare Medical congratulates the University ... Innovation Award on November 18th. This prestigious award recognizes annually organizations that cultivate ... to the medical landscape. , The UCLH team won the award for their ...
Breaking Medicine News(10 mins):