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): March 31, 2015
ANTARES PHARMA, INC.
(Exact name of registrant specified in its charter)
|
|
|
|
|
Delaware |
|
1-32302 |
|
41-1350192 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
|
|
|
100 Princeton South, Suite 300, Ewing, NJ |
|
08628 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrants telephone, including area code: (609) 359-3020
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 7.01 |
Regulation FD Disclosure. |
On March 31, 2015, Antares Pharma, Inc. issued a press release
announcing that Ferring Pharmaceuticals Inc. (Ferring) has received U.S. Food and Drug Administration (FDA) approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON
(somatropin [rDNA origin]) for injection, and the needle-free delivery system to be marketed in the U.S. as ZOMA-Jet. Ferring also received approval from the FDA to market the 10 mg needle free injector device which, along with certain
consumables, is supplied by Antares to Ferring.
The full text of such press release is included as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
|
|
|
Exhibit No. |
|
Description |
|
|
99.1 |
|
Press Release, dated March 31, 2015, issued by Antares Pharma, Inc. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA, INC. |
|
|
|
|
|
Date: |
|
March 31, 2015 |
|
|
|
By: |
|
/s/ James E. Fickenscher |
|
|
|
|
|
|
Name: |
|
James E. Fickenscher |
|
|
|
|
|
|
Title: |
|
Senior Vice President, Chief Financial Officer |
EXHIBIT INDEX
Exhibit
|
|
|
Exhibit No. |
|
Description |
|
|
99.1 |
|
Press Release, dated March 31, 2015, issued by Antares Pharma, Inc. |
Exhibit 99.1
ANTARES PHARMA ANNOUNCES FDA APPROVAL OF
TEV-TROPIN® 10 MG
(HUMAN GROWTH HORMONE) NEEDLE-FREE INJECTOR
FDA APPROVES NAME CHANGE TO ZOMACTON
EWING, NJ, March 31, 2015 Antares Pharma, Inc. (NASDAQ: ATRS) today announced that Ferring Pharmaceuticals Inc. (Ferring) has received U.S.
Food and Drug Administration (FDA) approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON (somatropin [rDNA origin]) for injection, and the needle-free delivery system to
be marketed in the U.S. as ZOMA-Jet. Ferring also received approval from the FDA to market the 10 mg needle free injector device which, along with certain consumables, is supplied by Antares to Ferring. Ferring purchased the U.S. rights to
ZOMACTON, formerly TEV-TROPIN®, and to ZOMA-Jet, formerly Tjet®, in December 2014 from Teva Pharmaceutical Industries Ltd.
Ferring developed and has marketed ZOMACTON outside of the U.S. since 1988 and in 47 countries globally.
In the U.S., ZOMACTON is indicated
for the treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Growth hormone deficiency (GHD) in children can lead to short stature and delayed puberty.1 An estimated one in 4,000 to 10,000 children has GHD, and with early detection and treatment, many of these children can reach a normal height.2
Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of
scoliosis. Somatropin may alter the clearance of drugs metabolized by the CP450 enzyme system and careful monitoring is advisable. The following adverse reactions have been observed during appropriate use of somatropin: headaches (children and
adults), gynecomastia (children), and pancreatitis (children and adults). In studies of growth hormone-deficient children, injection-site reactions (e.g. pain, bruise) occurred in eight of the 164 treated patients. Leukemia and new-onset Type 2
diabetes mellitus have been reported.
We are excited that Ferring will be adding this new 10 mg dosage form to the previously approved 5 mg
strength, said Eamonn P. Hobbs, President and Chief Executive Officer of Antares Pharma. We are also pleased that the FDA has approved the use of another Antares device, which we believe continues to validate our technology and our
approach to designing novel, product-specific injector devices that keep patients needs in mind.
ZOMACTON is expected to be available
in the U.S. in the second quarter of 2015 as both a 5 and 10 mg option, with the 10 mg dose in a pre-filled diluent syringe. In addition, the ZOMA-Jet needle-free administration device supplied by Antares is expected to be available for the 5
mg dose and in a new 10 mg dose later this year.
1 |
Growth Hormone Deficiency Children. Medline Plus A service of the U.S. National Library of Medicine, National Institutes of Health. 2014. Available at:
http://www.nlm.nih.gov/medlineplus/ency/article/001176.htm. |
2 |
Growth Hormone Deficiency. Boston Childrens Hospital. 2010. Available at: http://www.childrenshospital.org/conditions-andtreatments/conditions/growth-hormone-deficiency. |
1 of 3
About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company markets OTREXUP (methotrexate) injection for subcutaneous use
in the treatment of adults with severe active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis. LEO Pharma markets OTREXUP to dermatologists for adults with severe recalcitrant psoriasis. Antares Pharma
is also developing QuickShot® Testosterone for testosterone replacement therapy, and VIBEX® Sumatriptan for the acute treatment of
migraines. The Companys technology platforms include VIBEX® disposable auto injectors, disposable multi-use pen injectors and reusable needle-free injectors. Antares Pharma has a
multi-product deal with Teva Pharmaceutical Industries, Ltd. that includes VIBEX® epinephrine, exenatide multi-dose pen, and another undisclosed multi-dose pen. Our reusable needle-free
injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V.
About ZOMACTON
ZOMACTON is indicated for the treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone.
Important Safety Information
ZOMACTON
stimulates linear growth in children lacking endogenous GH. Treatment of growth hormone-deficient (GHD) children with ZOMACTON produces growth rate and IGF-1 levels similar to those seen after treatment with hGH of pituitary origin.
Unless patients with Prader-Willi Syndrome (PWS) also have a diagnosis of GHD, ZOMACTON is not indicated for treatment of pediatric patients
who have growth failure due to genetically confirmed PWS. Because of reported fatalities, patients with PWS who are severely obese, have severe respiratory impairment, respiratory infections, or sleep apnea should interrupt use of GH.
Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment. Pancreatitis should be considered in any
somatropin-treated patient, especially a child, who develops persistent, severe abdominal pain.
Patients should be observed for evidence of Type 2
diabetes mellitus, glucose intolerance, hypopituitarism, malignant transformation of skin lesions, hypothyroidism, slipped capital femoral epiphysis and intracranial hypertension. Funduscopic examination of patients is recommended at the initiation
and periodically during the course of GH treatment. ZOMACTON should not be initiated in patients with acute critical illness as a complication of open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute
respiratory failure. ZOMACTON should not be used in patients with evidence of an active malignancy, progressive or recurrent underlying intracranial tumor, active proliferative or severe nonproliferative diabetic retinopathy, or closed
epiphysis. As with all therapeutic proteins, there is potential for immunogenicity.
When somatropin is administered subcutaneously at the same site over
a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site.
Because somatropin increases growth rate, patients
with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis.
Somatropin may alter the clearance of drugs
metabolized by the CP450 enzyme system and careful monitoring is advisable.
ZOMACTON should not be used by patients who have had an allergy
to growth hormones (somatropin) or any of the other ingredients in ZOMACTON. Benzyl alcohol associated with toxicity in newborns is contained in the diluent supplied with 5mg ZOMACTON.
When administering ZOMACTON 5 mg to newborns, it should be reconstituted with sterile normal saline. Practitioners should consider the combined
daily metabolic load of benzyl alcohol from all sources. The ZOMACTON 10 mg vial is reconstituted with bacteriostatic water for injection containing metacresol and should not be used by patients who are allergic to it. Treatment of
patients with coexisting ACTH deficiency should have glucocorticoid replacement dose adjusted to avoid inhibition of growth.
2 of 3
The following adverse reactions have been observed during appropriate use of somatropin: headaches (children and
adults), gynecomastia (children), and pancreatitis (children and adults). In studies of growth hormone-deficient children, injection-site reactions (e.g., pain, bruise) occurred in 8 of the 164 treated patients. Leukemia and new-onset Type 2
diabetes mellitus have been reported.
ZOMACTON and ZOMA-Jet are trademarks of Ferring B.V.
TEV-TROPIN® and Tjet® are registered
trademarks of Teva Pharmaceuticals USA.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of
1995, including statements made with respect to the growth of the Company and validation of its technology and approach to design novel, product-specific injector devices that keep patients needs in mind; whether and when ZOMACTON will be
available in the U.S. as both a 5 mg and 10 mg option, with a 10 mg dose in a pre-filled diluent syringe; whether and when the ZOMA-Jet needle-free administration device supplied by the Company will be available for the 5 mg dose and a 10 mg dose;
and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to
be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as
may, will, should, would, expect, intend, plan,
anticipate, believe, estimate, predict, potential, seem, seek,
future, continue, or appear or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Such
forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Additional information
concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the Risk Factors section of the Companys Annual Report on Form 10-K for
the year ended December 31, 2014, and in the Companys other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained
in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or
circumstances after the date of this press release, except as required by law.
Contacts:
Jack Howarth
Vice President, Corporate Affairs
609-359-3016
jhowarth@antarespharma.com
3 of 3
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Apr 2023 to Apr 2024