Teva Launches TevaGrastim(R) (filgrastim)

LEEDS, England, November 18 - Teva UK Limited has signalled its commitment to developing biosimilar
medicines by entering the G-CSF* therapy area. The launch of its proprietary
version of filgrastim, TevaGrastim(R), marks the Company's first biosimilar*,
and represents a major addition to Teva's Hospitals portfolio.

TevaGrastim(R) is licensed for a number of indications1, the most common
being the reduction of chemotherapy-induced neutropenia. The product is
available in two presentations, both are available from wholesalers:

- 30 MIU pre-filled syringe (5 pack)

- 48 MIU pre-filled syringe (5 pack)

TevaGrastim(R) is licensed for the same indications as the reference
product, Neupogen(R) (filgrastim)(1,2). Teva's pre-filled syringe will also
incorporate a needle guard to minimise the risk of needle stick injuries.

When comparing NHS list prices of filgrastim products, TevaGrastim(R) is
a competitively priced(3) G-CSF treatment.

To find out more about TevaGrastim(R) and Teva's other secondary care
products, visit www.tevahospitals.co.uk. For more on Teva UK Limited,
visit www.tevauk.com.

Photograph enclosed:

TevaGrastim(R)

Notes to Editors:

A biosimilar is defined as a similar biological medicinal product, and is
also sometimes called a biogeneric.

Teva UK Limited is one of the UK's leading pharmaceutical manufacturers,
with a presence in the generics, branded respiratory and hospitals markets.
Measured by the volume of boxes supplied, it is the biggest single medicines
supplier to the NHS. With over 500 product lines, it has the widest range of
any UK generic pharmaceutical company, and has a number of respiratory
products including the Qvar(R) (beclometasone dipropionate) CFC-free inhaler.

For media enquiries, please refer to the contact details below.
Adverse events should be reported. Information about adverse event reporting
can be found at www.yellowcard.gov.uk

Adverse events should also be reported to Teva UK Limited.

TevaGrastim Abbreviated Prescribing Information:

Presentation: Pre-filled syringe containing filgrastim 30 MIU
(300microg) in 0.5ml solution or 48 MIU (480microg) in 0.8ml solution.
Indications: Reduction in the duration of neutropenia and the incidence of
febrile neutropenia in patients treated with established cytotoxic
chemotherapy for malignancy and for the reduction in the duration of
neutropenia in patients undergoing myeloablative therapy followed by bone
marrow transplantation considered to have increased risk of prolonged severe
neutropenia. Mobilisation of peripheral blood progenitor cells (PBPC).
Treatment of persistent neutropenia in patients with advanced HIV infection.
Long term administration in children or adults with severe congenital,
cyclic, or idiopathic neutropenia with an absolute neutrophil count of 0.5 x
109/L and a history of severe or recurrent infections. Dosage and
administration: Only to be given in collaboration with an oncology centre
experienced in granulocyte-colony stimulating factor treatment and
haematology, and with the necessary diagnostic facilities. The use of
filgrastim is not recommended in the period from 24 hours before to 24 hours
after chemotherapy and within 24 hours of bone marrow infusion. For
subcutaneous injection or infusion diluted with 5% glucose solution. Dilution
to a concentration of <0.2 MIU (2microg) is not recommended. Established
cytotoxic chemotherapy: 0.5 MIU (5microg)/kg/day. Daily dosing should
continue until the expected neutrophil nadir is passed and the neutrophil
count has recovered to the normal range. In patients treated with
myeloablative therapy followed by bone marrow transplantation: Recommended
starting dose is 1.0 MIU (10microg)/kg/day given as a 30 minute or 24 hour
intravenous infusion or 1.0 MIU given by continuous 24 hour subcutaneous
infusion. Mobilisation of PBPC: When used alone, 1.0 MIU (10microg)/kg/day as
a 24 hour subcutaneous continuous infusion or a single daily subcutaneous
injection for 5 to 7 consecutive days. After myelosuppressive chemotherapy,
the recommended dose for PBPC is 0.5 MIU (5microg)/kg/day by subcutaneous
injection from the first day after completion of chemotherapy until the
expected neutrophil nadir is passed and the neutrophil count has recovered to
the normal range. Should be administered at 1.0 MIU (10 microg)/kg/day
subcutaneously for 4 to 5 consecutive days for PBPC mobilisation in normal
donors prior to allogenic peripheral blood progenitor cell transplantation.
Severe chronic neutropenia: Congenital neutropenia: 1.2 MIU (12microg
)/kg/day. Idiopathic or cyclic neutropenia: 0.5 MIU (5microg)/kg/day. For
reversal of neutropenia in patients with HIV infection: 0.1 MIU
(1microg)/kg/day with titration up to a maximum of 0.4 MIU (4microg)/kg/day.
Children: Safety and efficacy of filgrastim is similar in adults and
children. The dosage recommendations are the same as those in adults
receiving myelosuppressive cytotoxic chemotherapy. Elderly: Specific dosage
recommendations cannot be made. Impaired renal or hepatic function: No dosage
adjustments required. Contraindications: Hypersensitivity to filgrastim, or
any excipients. Precautions and warnings: Not to be used to increase the dose
of cytotoxic chemotherapy beyond established dosage regimens. Not to be
administered to patients with severe congenital neutropenia with abnormal
cytogenetics. Safety and efficacy has not been established in patients with
myelodysplastic syndrome, or chronic myelogenous leukaemia.. Administer with
caution in patients with secondary acute myeloid leukaemia. Monitoring of
bone density may be indicated in patients with underlying osteoporotic bone
diseases who undergo continuous therapy for more than 6 months. Patients with
a recent history of pulmonary infiltrates or pneumonia may be at higher risk
of rare pulmonary undesirable effects, in particular interstitial pneumonia.
In cancer patients, a white blood cell count should be performed at regular
intervals. During the period of administration for PBPC, filgrastim should be
discontinued or the dosage reduced if the leukocyte counts rise to >70 x
109/L. Regular monitoring of platelet and haematocrit is also recommended.
Special caution should be used when treating patients with high dose
chemotherapy. Donors who receive G-CSFs for PBPC mobilisation should be
monitored until haematological indices return to normal. Spleen size should
be carefully monitored. Monitor platelet counts closely in patients with
severe chronic neutropenia. Special care should be taken in the diagnosis of
severe chronic neutropenias to distinguish them from other haematopoietic
disorders. Filgrastim should be discontinued if myelodysplastic syndrome or
leukaemia occur. It is recommended to perform morphologic and cytogenic bone
marrow examinations approximately every 12 months in patients with severe
chronic neutropenia. Causes of transient neutropenia, such as viral
infections, should be excluded. Regular urinanalysis should be performed to
monitor haematuria/proteinuria. In patients with HIV infection, absolute
neutrophil count should be monitored closely. Caution when considering the
use of filgrastim in patients with sickle cell disease. Filgrastim contains
sorbitol. Patients with rare hereditary problems of fructose intolerance
should not use this medicine. Interactions: Preliminary evidence from
patients treated concomitantly with filgrastim and 5-Fluorouracil indicates
that the severity of neutropenia may be exacerbated. Lithium is likely to
potentiate the effect of filgrastim. Pregnancy and lactation: Not to be used
in pregnancy unless clearly necessary. It is unknown whether filgrastim is
excreted into breast milk. A decision should be made taking into account the
benefit of breast-feeding to the child and the benefit of therapy to the
woman. Effects on ability to drive and use machines: minor or moderate
influence on the ability to drive and use machines. If experiencing fatigue,
caution is advised when driving a car or operating machinery. Adverse
reactions: Very Common: Elevated alkaline phosphatase, elevated LDH, elevated
uric acid, nausea/vomiting, elevated GGT, chest pain, musculoskeletal pain,
leukocytosis, thrombocytopenia, headache, anaemia, splenomegaly, decreased
glucose, epistaxis. Common: Cough, sore throat, constipation, anorexia,
diarrhoea, mucositis, alopecia, skin rash, fatigue, generalised weakness,
thrombocytopenia, hepatomegaly, cutaneous vasculitis, injection site pain,
rash, osteoporosis. Serious Very Rare: Sweet's syndrome, cutaneous
vasculitis, allergic-type reactions, including anaphylaxis, angioedema,
dyspnoea occurring on initial or subsequent treatment. Serious Rare:
Pulmonary effects, including interstitial pneumonia, pulmonary oedema and
pulmonary infiltrates have been reported with an outcome of respiratory
failure or adult respiratory distress syndrome which may be fatal. Serious
Uncommon: Splenic rupture. Consult the Summary of Product Characteristics in
relation to other side effects. Overdosage: No cases of overdose reported.
Discontinuation: usually results in a 50% decrease in circulating neutrophils
within 1 to 2 days, with return to normal levels in 1 to 7 days. NHS List
Price: 30 MIU 0.5 ml, 5 pre-filled syringes GBP311.25; 48 MIU 0.8 ml, 5
pre-filled syringes GBP496.45. Legal category: POM. Marketing Authorisation
Number: PL EU/1/08/445/001-008. Marketing Authorisation Holder: Teva Generics
GmbH, Kandelstr. 10, D-79199 Kirchzarten, Germany. Date of Preparation:
October 2009 TVH09/AE/008

    References:

    1) TevaGrastim(R) Summary of Product Characteristics
    2) Neupogen(R) Summary of Product Characteristics
    3) MIMS November 2009

    * G-CSF = Granulocyte-Colony Stimulating Factor

For media enquiries, telephone the Teva Communications team on +44(0)1977-628500 or e-mail media.enquiries at tevauk.com