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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
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Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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| Date of Report (Date of earliest event reported) March 11, 2013 | |||
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RETROPHIN, INC.
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(Exact name of registrant as specified in its charter)
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Delaware
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000-53293
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26-2383102
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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777 Third Avenue, Suite 22, New York, NY
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10017
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code (212) 983-1310
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Desert Gateway, Inc.
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(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13a-4(c))
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Item 8.01 Other Events
On March 11, 2013, Retrophin, Inc. issued a press release announcing positive results from a series of in vitro and in vivo experiments with its RE-024 development program. RE-024 is a molecule designed to treat pantothenate kinase-associated neurodegeneration (PKAN), an inherited, progressive and fatal neurodegenerative disease. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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Exhibit No.
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Description
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99.1
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Press Release, dated March 11, 2013
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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RETROPHIN, INC.
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Date: March 11, 2013
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By:
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/s/ Martin Shkreli | |
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Name: Martin Shkreli
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Title: Chief Executive Officer
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Retrophin Announces Positive Results from Preclinical Studies of RE-024 for PKAN
NEW YORK--(BUSINESS WIRE)--Retrophin, Inc. (OTCQB: RTRX), a biotechnology company focused on the discovery and development of orphan drugs for the treatment of rare and life-threatening diseases for which there are currently no viable patient options, today announced positive results from a series of in vitro and in vivo experiments with RE-024. RE-024 rescued the phenotype of pantothenate kinase associated neurodegeneration (PKAN) in vitro and in vivo, demonstrating successful replacement therapy proof-of-concept.
“We are delighted with the outcome of the experiments conducted by St. Jude Children’s Research Hospital, which assessed RE-024 in a broad array of customized assays in PKAN,” said Martin Shkreli, founder and chief executive officer of Retrophin. “The promising results we’ve seen to date are a testament to our chemistry team’s design of RE-024. On the basis of these results, we are accelerating the timeline for filing of an IND for RE-024.”
PKAN is an inherited, progressive and fatal neurodegenerative disease. Symptoms of PKAN vary but often include ataxia, dystonia, and a general failure to thrive. Onset usually occurs before 10 years of age and typically results in premature death. While the exact incidence of PKAN is uncertain, it is estimated to affect one to three per million people worldwide. There is currently no FDA approved treatment for PKAN.1, 2
Full results of the preclinical studies of RE-024 will be presented at an upcoming scientific meeting.
About Retrophin
Retrophin is a biotechnology company focused on the discovery and development of orphan drugs for the treatment of rare and life-threatening diseases for which there are currently no viable patient options. The Company is currently focused on several catastrophic diseases affecting children, including Focal Segmental Glomerulosclerosis (FSGS), Pantothenate Kinase-Associated Neurodegeneration (PKAN), Duchenne Muscular Dystrophy and others. Retrophin’s lead compound, RE-021, is scheduled to begin enrollment in a potentially pivotal Phase 2 clinical trial for FSGS during the first half of 2013.
Forward-Looking Statements
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect the Company’s business. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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1 National Institute of Neurological Disorders and Stroke: http://www.ninds.nih.gov/disorders/nbia/nbia.htm
2 Genetics Home Reference: http://ghr.nlm.nih.gov/condition/pantothenate-kinase-associated-neurodegeneration
Contacts
Retrophin, Inc.
Martin Shkreli, CEO
212-983-1310
martin.shkreli@retrophin.com
or
Rx Communications Group
Paula Schwartz (Investors)
917-322-2216
pschwartz@rxir.com
or
6 Degrees
Annie Starr (Media)
973-415-8838
astarr@6degreespr.com