Market Overview

Teva Announces Updated Indication and Vial Presentation for GRANIX® (tbo-filgrastim) Injection in United States


Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced
today that the U.S. Food and Drug Administration (FDA) has approved
GRANIX® (tbo-filgrastim) Injection for a new vial
presentation and indication in pediatric patients 1 month and older.
GRANIX is indicated to reduce the duration of severe neutropenia in
adult and pediatric patients 1 month and older with nonmyeloid
malignancies receiving myelosuppressive anticancer drugs associated with
a clinically significant incidence of febrile neutropenia.

The new vial presentation of the product will be available for use in
300mcg/1mL and 480mcg/1.6mL single-dose vials. The prefilled syringe
presentations will continue to be available as well.

"The new pediatric indication and vial presentation of GRANIX expand the
range of treatment options that can be of benefit to both patients and
healthcare providers," said Brendan O'Grady, EVP and Head of North
America Commercial at Teva.

GRANIX was approved by the FDA in August 2012. GRANIX vials are expected
to be available in the U.S. shortly.

Important Safety Information

  • Contraindication: GRANIX is contraindicated in patients with a
    history of serious allergic reactions to filgrastim or pegfilgrastim
  • Fatal Splenic Rupture: Splenic rupture, including fatal cases,
    can occur following the administration of filgrastim products.
    Evaluate patients who report upper abdominal or shoulder pain for an
    enlarged spleen or splenic rupture. Discontinue GRANIX if splenic
    rupture is suspected or confirmed.
  • Acute Respiratory Distress Syndrome (ARDS): ARDS can occur in
    patients receiving filgrastim products. Evaluate patients who develop
    fever and lung infiltrates or respiratory distress after receiving
    GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.
  • Serious Allergic Reactions: Serious allergic reactions,
    including anaphylaxis, can occur in patients receiving GRANIX.
    Reactions can occur on initial exposure. The administration of
    antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may
    reduce the severity. Permanently discontinue GRANIX in patients with
    serious allergic reactions. Do not administer GRANIX to patients with
    a history of serious allergic reactions to filgrastim or pegfilgrastim.
  • Sickle Cell Disorders: Severe and sometimes fatal sickle cell
    crises can occur in patients with sickle cell disorders receiving
    filgrastim products. Discontinue GRANIX if sickle cell crisis occurs.
  • Glomerulonephritis: Glomerulonephritis can occur in patients
    receiving filgrastim products. The diagnoses were based on azotemia,
    hematuria (microscopic and macroscopic), proteinuria, and renal
    biopsy. Generally, events of glomerulonephritis resolved after dose
    reduction or discontinuation of the filgrastim product. If
    glomerulonephritis is suspected, evaluate for cause. If causality is
    likely, consider dose-reduction or interruption of GRANIX.
  • Capillary Leak Syndrome (CLS): CLS can occur in patients
    receiving filgrastim products and is characterized by hypotension,
    hypoalbuminemia, edema and hemoconcentration. Episodes vary in
    frequency, severity and may be life-threatening if treatment is
    delayed. Patients who develop symptoms of CLS should be closely
    monitored and receive standard symptomatic treatment, which may
    include a need for intensive care.
  • Potential for Tumor Growth Stimulatory Effects on Malignant Cells:
    The granulocyte colony-stimulating factor (G-CSF) receptor, through
    which GRANIX acts, has been found on tumor cell lines. The possibility
    that GRANIX acts as a growth factor for any tumor type, including
    myeloid malignancies and myelodysplasia, diseases for which GRANIX is
    not approved, cannot be excluded.
  • Leukocytosis: White blood cell counts of 100‚000/mm3 or greater
    were observed in approximately 2% of patients receiving filgrastim
    products at dosages above 5 mcg/kg/day. In patients with cancer
    receiving GRANIX as an adjunct to myelosuppressive chemotherapy‚ to
    avoid the potential risks of excessive leukocytosis‚ it is recommended
    that GRANIX therapy be discontinued if the ANC surpasses 10‚000/mm3
    after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at
    least twice weekly during therapy. Dosages of GRANIX that increase the
    ANC beyond 10‚000/mm3 may not result in any additional clinical
    benefit. In patients with cancer receiving myelosuppressive
    chemotherapy‚ discontinuation of filgrastim products therapy usually
    resulted in a 50% decrease in circulating neutrophils within 1 to 2
    days‚ with a return to pretreatment levels in 1 to 7 days.
  • Simultaneous Use with Chemotherapy and Radiation Therapy Not
    d: The safety and efficacy of filgrastim products,
    including GRANIX, given simultaneously with cytotoxic chemotherapy
    have not been established. Because of the potential sensitivity of
    rapidly dividing myeloid cells to cytotoxic chemotherapy‚ do not use
    GRANIX in the period 24 hours before through 24 hours after the
    administration of cytotoxic chemotherapy. The safety and efficacy of
    GRANIX have not been evaluated in patients receiving concurrent
    radiation therapy. Avoid the simultaneous use of GRANIX with
    chemotherapy and radiation therapy.
  • Nuclear Imaging: Increased hematopoietic activity of the bone
    marrow in response to growth factor therapy has been associated with
    transient positive bone-imaging changes. Consider this when
    interpreting bone-imaging results.
  • Aortitis: Aortitis has been reported in patients receiving
    another filgrastim product. It may occur as early as the first week
    after start of therapy. Manifestations may include generalized signs
    and symptoms such as fever, abdominal pain, malaise, back pain, and
    increased inflammatory markers (e.g., c-reactive protein and white
    blood cell count). Consider aortitis in patients who develop these
    signs and symptoms without known etiology. Discontinue GRANIX if
    aortitis is suspected.
  • Most common treatment-emergent adverse reaction: Most common
    adverse reaction (≥1%) to GRANIX is bone pain.

Please see Full Prescribing Information for GRANIX here.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a global leader in generic medicines, with innovative
treatments in select areas, including CNS, pain and respiratory. We
deliver high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an established
presence in generics, specialty, OTC and API, building on more than a
century-old legacy, with a fully integrated R&D function, strong
operational base and global infrastructure and scale. We strive to act
in a socially and environmentally responsible way. Headquartered
in Israel, with production and research facilities around the globe, we
employ 45,000 professionals, committed to improving the lives of
millions of patients. Learn more at

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of
which are based on management's current beliefs and expectations and are
subject to substantial risks and uncertainties, both known and unknown,
that could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:

  • our ability to successfully compete in the marketplace, including:
    that we are substantially dependent on our generic products;
    competition for our specialty products, especially COPAXONE®, our
    leading medicine, which faces competition from existing and potential
    additional generic versions and orally-administered alternatives;
    competition from companies with greater resources and capabilities;
    efforts of pharmaceutical companies to limit the use of generics,
    including through legislation and regulations; consolidation of our
    customer base and commercial alliances among our customers; the
    increase in the number of competitors targeting generic opportunities
    and seeking U.S. market exclusivity for generic versions of
    significant products; price erosion relating to our products, both
    from competing products and increased regulation; delays in launches
    of new products and our ability to achieve expected results from
    investments in our product pipeline; our ability to take advantage of
    high-value opportunities; the difficulty and expense of obtaining
    licenses to proprietary technologies; and the effectiveness of our
    patents and other measures to protect our intellectual property rights;
  • our substantially increased indebtedness and significantly
    decreased cash on hand, which may limit our ability to incur
    additional indebtedness, engage in additional transactions or make new
    investments, may result in a further downgrade of our credit ratings;
    and our inability to raise debt or borrow funds in amounts or on terms
    that are favorable to us;
  • our business and operations in general, including: failure to
    effectively execute our restructuring plan announced in December 2017;
    uncertainties related to, and failure to achieve, the potential
    benefits and success of our new senior management team and
    organizational structure; harm to our pipeline of future products due
    to the ongoing review of our R&D programs; our ability to develop and
    commercialize additional pharmaceutical products; potential additional
    adverse consequences following our resolution with the U.S. government
    of our FCPA investigation; compliance with sanctions and other trade
    control laws; manufacturing or quality control problems, which may
    damage our reputation for quality production and require costly
    remediation; interruptions in our supply chain; disruptions of our or
    third party information technology systems or breaches of our data
    security; the failure to recruit or retain key personnel; variations
    in intellectual property laws that may adversely affect our ability to
    manufacture our products; challenges associated with conducting
    business globally, including adverse effects of political or economic
    instability, major hostilities or terrorism; significant sales to a
    limited number of customers in our U.S. market; our ability to
    successfully bid for suitable acquisition targets or licensing
    opportunities, or to consummate and integrate acquisitions; and our
    prospects and opportunities for growth if we sell assets;
  • compliance, regulatory and litigation matters, including: costs and
    delays resulting from the extensive governmental regulation to which
    we are subject; the effects of reforms in healthcare regulation and
    reductions in pharmaceutical pricing, reimbursement and coverage;
    governmental investigations into S&M practices; potential liability
    for patent infringement; product liability claims; increased
    government scrutiny of our patent settlement agreements; failure to
    comply with complex Medicare and Medicaid reporting and payment
    obligations; and environmental risks;
  • other financial and economic risks, including: our exposure to
    currency fluctuations and restrictions as well as credit risks;
    potential impairments of our intangible assets; potential significant
    increases in tax liabilities; and the effect on our overall effective
    tax rate of the termination or expiration of governmental programs or
    tax benefits, or of a change in our business;

and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2017, including the sections thereof captioned
"Risk Factors" and "Forward Looking Statements," and in our subsequent
quarterly reports on Form 10-Q and other filings with the Securities and
Exchange Commission, which are available at
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to put undue reliance on these forward-looking

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