Teva and Antares Pharma Announce Launch of Generic Imitrex in the United States

Teva Pharmaceutical Industries Ltd and Antares Pharma, Inc. announced the launch of the generic equivalent to Imitrex®1 (sumatriptan succinate) injection, 4 mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S. Sumatriptan injection is used to treat acute migraine with or without aura, and acute cluster headaches in adults.

Sumatriptan injection is self-administered subcutaneously into the back of arm or outer thigh.

Approximately 36 million people in the U.S. suffer from migraine and its various characteristics. According to the American Migraine Study II, 85 percent of respondents experience throbbing pain, 80 percent experience sensitivity to light, 76 percent experience sensitivity to sound and 73 percent experience nausea.

“We are pleased to add sumatriptan injection to our growing portfolio through our successful partnership with Antares,” stated Siggi Olafsson, President and CEO, Global Generic Medicines, Teva. “This achievement demonstrates our ability to leverage our leadership in the pharmaceutical industry, and our ongoing commitment to our patients, customers and the communities that we serve.”

Teva remains committed to strengthening its presence in the treatment of migraine and its generic injectable business globally. Teva continues investment in new, and higher-value generic injectable products. With approximately 370 generic medicines available, Teva has the largest portfolio of FDA-approved generic products and continues to bring new products to market for the patients who need them.

“We are delighted to offer this product to patients in the United States through our partner, Teva,” said Robert F. Apple, President and CEO, Antares Pharma. “With the approval and launch of sumatriptan injection, we remain optimistic on progress of our other combination product development programs with Teva, which are currently under FDA review.”

Sumatriptan injection had annual sales of approximately $183 million in the United States, according to IMS data as of March 2016.

About Sumatriptan Injection
Sumatriptan injection is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.

For more information, please see the accompanying Full Prescribing Information.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.

About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products. The Company’s product, OTREXUP™ (methotrexate) injection for subcutaneous use, is approved in the U.S. for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. Antares Pharma is also developing QuickShot® Testosterone for testosterone replacement therapy, and has recently received a therapeutically equivalent approval from the U.S. Food and Drug Administration for VIBEX® Sumatriptan USP for the acute treatment of migraine and cluster headache. The Company’s 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 teriparatide multi-dose pen. Our reusable needle-free injector for use with human growth hormone (hGH) is sold worldwide by Ferring B.V. The Company is also working with AMAG Pharmaceuticals on a subcutaneous method of administering Makena, a progesterone product indicated for use in lowering the risk of pre-term birth. For more information, visit www.antarespharma.com.

Teva Pharmaceutical Industries Ltd.
IR:United States
Kevin C. Mannix, 215-591-8912
or
United States
Ran Meir, 215-591-3033
or
Israe
Tomer Amitai, 972 (3) 926-7656
or
PR: Israel
Iris Beck Codner, 972 (3) 926-7687
or
United States
Denise Bradley, 215-591-8974
or
Antares:
Jack Howarth, 609-359-3016
jhowarth@antarespharma.com