0001193125-13-245423.txt : 20130603 0001193125-13-245423.hdr.sgml : 20130603 20130603171754 ACCESSION NUMBER: 0001193125-13-245423 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130529 ITEM INFORMATION: Completion of Acquisition or Disposition of Assets ITEM INFORMATION: Submission of Matters to a Vote of Security Holders ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130603 DATE AS OF CHANGE: 20130603 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HYPERION THERAPEUTICS INC CENTRAL INDEX KEY: 0001386858 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 611512713 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35614 FILM NUMBER: 13888804 BUSINESS ADDRESS: STREET 1: 601 GATEWAY BLVD. STREET 2: SUITE 200 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-745-7802 MAIL ADDRESS: STREET 1: 601 GATEWAY BLVD. STREET 2: SUITE 200 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 d549387d8k.htm 8-K 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 29, 2013

 

 

HYPERION THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   001-35614   61-1512713

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

601 Gateway Boulevard, Suite 200

South San Francisco, California 94080

(Address of principal executive offices, zip code)

Registrant’s telephone number, including area code: (650) 745-7802

(Former name or former address, if changed since last report)

 

 

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 (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.01. Completion of Acquisition or Disposition of Assets.

On May 31, 2013, Hyperion Therapeutics, Inc. (the “Company”) completed its acquisition of BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, an FDA-approved therapy for treatment of the most prevalent urea cycle disorders (“UCD”), from Ucyclyd Pharma, Inc. (“Ucyclyd”), a subsidiary of Valeant Pharmaceuticals International, Inc. The Company received a net payment of $11 million from Ucyclyd at closing, which represents the $19 million purchase price for BUPHENYL due to Ucyclyd and a $32 million payment due to the Company as a result of Ucyclyd ’s exercise of its option to retain AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, a hospital-based product used for the treatment of acute hyperammonemia in UCD patients, less costs of approximately $2 million in finished goods and active pharmaceutical ingredient due to Ucyclyd. The Company is obligated to pay subsequent milestone and royalty payments to Ucyclyd.

As previously announced, the Company exercised its right to acquire BUPHENYL and AMMONUL on April 29, 2013, pursuant to an Amended and Restated Collaboration Agreement between the Company and Ucyclyd, dated March 22, 2012 (the “Collaboration Agreement”). On May 17, 2013, Ucyclyd exercised its option to retain the rights to AMMONUL pursuant to the Collaboration Agreement.

 

Item 5.07. Submission of Matters to a Vote of Security Holders.

The Company held its 2013 Annual Meeting of Stockholders (the “Annual Meeting”) on May 29, 2013. There were 20,010,416 shares of common stock eligible to be voted at the Annual Meeting and 18,472,931 shares of common stock were presented in person or represented by proxy at the Annual Meeting, which constituted a quorum to conduct business.

There were two proposals submitted to the Company’s stockholders at the Annual Meeting. All proposals were passed. The final results of voting on each of the proposals are as follows:

Proposal 1: Election of Directors

 

Nominee

   Votes For      Votes Withheld      Broker Non-Vote  

Bijan Salehizadeh, M.D.

     14,849,970         1,724,715         1,898,246   

Donald J. Santel

     14,857,482         1,717,203         1,898,246   

Proposal 2: Ratification of Appointment of Independent Registered Public Accounting Firm

 

Votes For

 

Votes Against

 

Abstain

 

Broker Non-Vote

18,471,389

  1,542   0   —  

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

  

Description

99.1    Press Release, dated June 3, 2013.


SIGNATURES

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.

 

Dated: June 3, 2013     Hyperion Therapeutics, Inc.
    By:  

/s/ Jeffrey S. Farrow

      Jeffrey S. Farrow
      Chief Financial Officer


EXHIBIT INDEX

 

Exhibit
No.

  

Description

99.1    Press Release, dated June 3, 2013.
EX-99.1 2 d549387dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

CONTACT:

Sylvia Wheeler

Vice President, Investor Relations

(650) 745-7834

sylvia.wheeler@hyperiontx.com

HYPERION THERAPEUTICS ACQUIRES WORLDWIDE RIGHTS TO BUPHENYL

SOUTH SAN FRANCISCO, Calif., June 3, 2013 — Hyperion Therapeutics, Inc. (NasdaqGM: HPTX) today announced the completion of its acquisition of BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, an FDA-approved therapy for treatment of the most prevalent urea cycle disorders (UCD), from Ucyclyd Pharma Inc., a subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX). As part of this transaction, Hyperion received a net payment of approximately $11 million due to Ucyclyd’s exercise of its option to retain AMMONUL® (sodium phenylacetate and sodium benzoate) Injection 10%/10%, a hospital-based product used for the treatment of acute hyperammonemia in UCD patients.

Hyperion was granted an option to acquire both BUPHENYL and AMMONUL under a March 2012 collaboration agreement between Hyperion and Ucyclyd Pharma Inc. However as part of the agreement, Ucyclyd had an option to retain AMMONUL. The net payment to Hyperion reflects the $19 million purchase price for BUPHENYL due to Ucyclyd and a $32 million payment due to Hyperion as a result of Ucyclyd’s exercise of its option to retain AMMONUL, less costs of approximately $2 million in inventory due to Ucyclyd.

According to Donald J. Santel, Hyperion’s chief executive officer, “RAVICTI™ (glycerol phenylbutyrate) Oral Liquid remains the cornerstone of our commercial plan. However, the addition of BUPHENYL to our commercial product portfolio affords us an opportunity to serve the entire UCD patient population, including those under two years of age. BUPHENYL patients will also have access to our comprehensive patient assistance programs administered via Hyperion UCD Support Services.”


About BUPHENYL (sodium phenylbutyrate) Tablets and Powder

BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). BUPHENYL should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation. The most common adverse reactions associated with BUPHENYL were amenorrhea dysfunction, decreased appetite, body odor (probably caused by its metabolite phenylacetate) and bad taste or taste aversion. Patients with urea cycle disorders should not take valproic acid, haloperidol, or steroids as these drugs have been reported to increase blood ammonia levels, and probenecid may affect the kidneys’ excretion. Use with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.

Please see full Prescribing Information for BUPHENYL at http://hyperiontx.com/product

RAVICTI Safety Information

RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients >2 years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels. The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established. The use of RAVICTI in patients < 2 months of age is contraindicated.

For additional Important Safety Information, including Warnings and Precautions, Adverse Events, Drug Interactions, and Special Populations, please see full Prescribing Information (http://www.ravicti.com/files/RAVICTI_Prescribing_Information.pdf) and Medication Guide (http://www.ravicti.com/files/RAVICTI_Medication_Guide.pdf) for RAVICTI.


About Hyperion Therapeutics

Hyperion Therapeutics, Inc. is a commercial stage biopharmaceutical company committed to developing and delivering life-changing treatments for orphan diseases and hepatology. The company’s first commercial product, Ravicti™ (glycerol phenylbutyrate) Oral Liquid, was approved in February 2013 and is currently being marketed in the United States.

For more information, please visit www.hyperiontx.com.

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