Auspex Announces The Issuance Of Patents On Deuterium-Containing Form Of Pirfenidone (SD-560)

LA JOLLA, Calif., March 25, 2014 /PRNewswire/ -- Auspex Pharmaceuticals, Inc. (Nasdaq: ASPX), a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, today announced the issuance of the following composition of matter and method of treatment patents covering its deuterium-containing form of pirfenidone (SD-560) drug candidate being developed for the potential treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic conditions:

• US Patent No. 8,680,123 covers the method of treatment, prevention or amelioration of, among other things, fibrotic conditions such as IPF with SD-560;
• US Patent No. 8,383,823 is a composition of matter patent covering SD-560; and
• European Patent No. 2170828B covers deuterium-containing form of pirfenidone, including SD-560, pharmaceutical composition and method of treatment using such deuterated pirfenidone for the treatment, prevention or amelioration of IPF and other fibrotic conditions.

"Our pioneering efforts in the field of selective deuterium modifications for improving the metabolic stability and pharmacokinetic profile of oral small molecules are continuing to be validated through the issuance of additional composition of matter and method of treatment claims worldwide," said Pratik Shah, President and CEO of Auspex. "The expansion of our intellectual property estate and, in particular, these new patents significantly enhance the value proposition for our SD-560 program."

About SD-560
SD-560 is a novel investigational drug in late pre-clinical development for the potential treatment of orphan indications such as IPF and other fibrotic conditions. SD-560 is on track to initiate Phase 1 clinical trials with data expected to be reported in 2015. Using our proprietary capabilities in deuterium chemistry, we have made chemical modifications within the pirfenidone molecule to create the novel drug candidate SD-560. Deuterium is a non-toxic, naturally occurring form of hydrogen. The substitution of deuterium (2H) for hydrogen (1H) at specific positions improves the stability of pirfenidone and attenuates the breakdown of the drug's active metabolite resulting in a differentiated pharmacokinetic profile compared to pirfenidone. This profile should enable less frequent dosing, improved tolerability, reduced interpatient variability in drug metabolism, as well as reduced drug interactions and potentially improved efficacy. Pirfenidone is known to reduce the proliferation of fibroblasts and inhibits the production of fibrogenic and inflammatory mediators such as TGF-beta, TNF-alpha and IL-1beta. Pirfenidone has been approved in Europe, Japan, Canada, India and other countries for the treatment of IPF, but has limited efficacy, significant side effects and must be taken three to four times daily. Auspex believes that SD-560 can potentially have significant benefits over pirfenidone in efficacy as well as safety and tolerability.

About Auspex Pharmaceuticals
Auspex Pharmaceuticals is a late clinical stage biopharmaceutical company focused on the development and commercialization of novel medicines for the treatment of orphan diseases. Auspex's pipeline includes product candidates to address unmet medical needs in hyperkinetic movement disorders, such as chorea associated with Huntington's disease, tardive dyskinesia and Tourette syndrome, as well as other orphan indications. Auspex's lead product candidate, SD-809, is in a Phase 3 registration clinical trial for the treatment of chorea (abnormal involuntary movements) associated with Huntington's disease. Auspex has employed its deuterium chemistry approach to optimize other deuterium-containing compounds in its portfolio that are at various stages of development. For further information, please visit the company's website www.auspexpharma.com.

Forward Looking Statements
Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Auspex's ability to successfully complete its ongoing clinical trials and development programs, Auspex's ability to further advance SD-560 in clinical development, obtain regulatory approval for SD-560, and market penetration and acceptance of SD-560. Risks that contribute to the uncertain nature of the forward-looking statements include: Auspex's future preclinical studies and clinical trials may not be successful; changes in regulatory requirements in the United States and foreign countries may prevent or significantly delay regulatory approval of Auspex's products; Auspex may change its plans to develop and commercialize its product candidates; the FDA may not agree with Auspex's interpretation of the data from clinical trials of SD-560; Auspex may decide, or the FDA may require Auspex, to conduct additional clinical trials or to modify Auspex's ongoing clinical trials; Auspex may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Auspex's ability to obtain regulatory approval; the third parties with whom Auspex may partner with for the development of SD-560 and upon whom Auspex may rely to conduct its clinical trials and manufacture its product candidates may not perform as expected; SD-560 may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of SD-560 could delay or prevent regulatory approval or commercialization; Auspex may be unable to obtain and maintain intellectual property protection or obtain orphan drug designation for its product candidates; the loss of key scientific or management personnel; Auspex's ability to obtain additional financing; and the accuracy of Auspex's estimates regarding expenses, future revenues and capital requirements. All forward-looking statements contained in this press release speak only as of the date on which they were made. Other risks and uncertainties affecting Auspex are described more fully in Auspex's filings with the Securities and Exchange Commission. Auspex undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SOURCE Auspex Pharmaceuticals