Antares Pharma, Inc. (ATRS) is an emerging, specialty pharmaceutical company that focuses on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. Its strategy is to identify new or existing approved drug formulations and apply its drug delivery technology to enhance the drug compounds and delivery methods. The company develop, manufacture and commercialize, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to help improve safety and efficacy, reduce side effects, and enhance patient comfort and adherence. Its subcutaneous injection technology platforms include the VIBEX® pressure-assisted auto injector system suitable for branded and generic injectable drugs in unit dose containers, reusable needle-free spring-action injector devices, and disposable multi-dose pen injectors for use with standard cartridges. Antares Pharma has a portfolio of proprietary and partnered products, including approved commercial products and several product candidates in advanced stages of development and under active FDA review. Antares Pharma has formed significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Teva, AMAG, and Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”).

The company market and sell its proprietary product OTREXUP® (methotrexate) injection, which was launched in the U.S. in February 2014. OTREXUP® is the first FDA-approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. To date, Antares Pharma has received FDA approval for dosage strengths of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg and 25 mg of OTREXUP®.

With its commercialization partner Teva, the company launched Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults, in June 2016. The company received FDA approval of its Abbreviated New Drug Application (“ANDA”) for 4 mg/0.5 mL and 6 mg/0.5 mL single-dose prefilled syringe auto-injectors, a generic equivalent to Imitrex® STATdose Pen®, in December 2015. Sumatriptan Injection USP represents the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX® auto injector platform and is commercialized and distributed by Teva under the terms of a license, supply and distribution arrangement.

The company also make reusable, needle-free injection devices that administer injectable drugs, which are currently marketed primarily through its partner Ferring, for use with human growth hormone, and have two gel-based products that are commercialized through its partners pursuant to licensing arrangements.

Overview of Clinical, Regulatory and Product Development Activities

Antares Pharma is developing XYOSTEDTM (testosterone enanthate) injection for testosterone replacement therapy, and submitted a 505 (b) (2) New Drug Application (“NDA”) to the FDA in December 2016. The NDA submission was accepted for standard review by the FDA and assigned a Prescription Drug User Fee Act (“PDUFA”) target date for completion of its review by October 20, 2017. The company conducted a multi-center, phase 3 clinical study (“QST-13-003”) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot® auto injector in adult males diagnosed with testosterone deficiency, and the company previously announced positive top-line pharmacokinetic results that showed that the primary endpoint for this study was achieved. Based upon a written response the company received from the FDA related to its clinical development program for XYOSTEDTM, the company conducted an additional supplemental safety study QST-15-005. The study included a screening phase, a treatment titration phase and a treatment phase for evaluation of safety and tolerability assessments, including laboratory assessments, adverse events and injection site assessments. In September 2016, the company announced the successful completion of the QST-15-005 study. The results of these two studies formed the clinical basis of its NDA submission for XYOSTEDTM and are further discussed in the “Research and Development Programs” section below.

Antares Pharma is collaborating with Teva on a VIBEX® auto injector pen containing epinephrine used for the treatment of severe allergic reactions (anaphylaxis). Teva submitted an amendment to the VIBEX® epinephrine pen ANDA in December 2014 and received a Complete Response Letter (“CRL”) from the FDA in February 2016 in which, according to Teva, the FDA identified certain major deficiencies. Teva has advised it that they submitted a response to the CRL and are targeting a launch in early 2018.

Antares Pharma's other combination product development projects in collaboration with Teva include a multi-dose pen for a generic form of BYETTA® (exenatide injection) for the treatment of diabetes, and another multi-dose pen for a generic form of Forteo® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis. Teva filed an ANDA for exenatide, which was accepted by the FDA in October 2014 and is currently under FDA review. In 2016, the company announced that Teva had settled the patent litigation with AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and Amylin Pharmaceuticals, LLC (collectively “AstraZeneca”) relating to certain AstraZeneca U.S. patents and their drug, BYETTA® (exenatide). AstraZeneca and Teva entered into a settlement and license agreement pursuant to which AstraZeneca granted Teva a license to manufacture and commercialize the generic version of BYETTA® described in Teva’s ANDA. The settlement allows Teva to commercialize their exenatide product in the U.S. beginning October 15, 2017 or earlier under certain circumstances. Teva also filed an ANDA for a generic version of Forteo® (teriparatide [rDNA origin] injection), which was accepted by the FDA in February 2016 and is currently under review. In response to Teva’s paragraph IV certification contained in Teva’s ANDA for teriparatide, Eli Lilly & Co (“Lilly”) filed a lawsuit against Teva alleging infringement of six U.S. patents related to Forteo® (teriparatide [rDNA origin] injection) resulting in a 30-month stay in FDA approval of the ANDA. The stay will expire in August 2018 unless the litigation is resolved sooner. Teva also successfully concluded a decentralized procedure registration process in Europe. According to Teva, the Public Assessment Report for the decentralized procedure has been published and the product was filed in 17 countries, which addresses the majority of the market value in Europe.

In partnership with AMAG, Antares Pharma is currently developing a variation of its VIBEX® QuickShot® subcutaneous auto injector for use with AMAG’s Makena® (hydroxyprogesterone caproate injection) for the treatment of pre-term birth. Under a license, development and supply agreement, AMAG is responsible for the clinical development and preparation, submission and maintenance of all regulatory applications, the manufacture and supply of the drug, and the marketing, sale and distribution of the product. Antares Pharma is responsible for the design and development of the auto-injection device, the manufacturing and supply of the device, and assembly and packaging of the final product. AMAG initiated a pharmacokinetic (“PK”) study in October 2016 and disclosed positive top line results of the study in February 2017. According to AMAG, the study successfully demonstrated comparable bioavailability between subcutaneous injection of Makena® compared to intra muscular injection. AMAG submitted its sNDA for the Makena® subcutaneous auto injector in April 2017, which was accepted by the FDA and given a PDUFA target action date of February 14, 2018.

Product Portfolio

The following table provides an overview and brief description of products and product opportunities:

ProductDrugPartnerIndicationTerritoryStatus
OTREXUP®MethotrexateNoneRheumatoid Arthritis; pJIA, PsoriasisU.S.Approved/ Marketed
Sumatriptan Injection USP (generic equivalent to Imitrex® STATdose Pen®)Sumatriptan succinate (4mg and 6mg)TevaMigrainesU.S.Approved/ Marketed
ZOMA-Jet™ Needle-free InjectorhGH (5 mg and 10 mg)FerringGrowth RetardationU.S.Approved/ Marketed
ZOMA-Jet™ Needle-free InjectorhGH (4 mgFerringGrowth RetardationWorldwideApproved/ Marketed
Twin-Jector® EZ II Needle-free InjectorhGHJCRGrowth RetardationJapanApproved/ Marketed
VIBEX® QuickShot® Auto Injector (QST)TestosteroneNoneTestosterone Replacement TherapyU.S.NDA Filed
VIBEX® Auto InjectorEpinephrineTevaAnaphylaxisU.S.ANDA Filed
Disposable Pen InjectorExenatideTevaDiabetesU.S.ANDA Filed
Disposable Pen InjectorTeriparatideTevaOsteoporosisU.S., EuropeANDA Filed Approved
Makena® QuickShot® Auto InjectorHydroxy-progesterone caproateAMAGReduced Risk of Preterm BirthWorldwideClinical

 

Tags: US:ATRS
Created by Asif Farooqui on 2019/09/23 16:43
     
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