Teva UK Limited Launches Temozolomide Capsules

CASTLEFORD, England, March 31, 2010 - We are pleased to announce the launch of temozolomide available in 5mg,
20mg, 100mg, 140mg, 180mg and 250mg strength capsules. Temozolomide is
indicated for the oncological treatment of brain tumours, specifically(1):

    - adult patients with newly-diagnosed glioblastoma multiforme
      concomitantly with radiotherapy (RT) and subsequently as monotherapy
      treatment.
    - children from the age of three years, adolescents and adult
      patients with malignant glioma, such as glioblastoma multiforme or
      anaplastic astrocytoma, showing recurrence or progression after
      standard therapy.

It is a generic version of Temodal(R) from Schering-Plough and is
available immediately in the award-winning Teva 360 livery, which is designed
to aid patient safety.

Robyn Hughes, Director of Primary and Secondary Care at Teva UK Limited
said "We are proud to be the first to bring temozolomide to the generic
market, and we view this product as an important addition to our oncology
portfolio."

References

1. Temozolomide - Summary of Product Characteristics

About Teva UK Limited: Teva UK Limited is one of the UK's top ten
pharmaceutical manufacturers, with a presence in the generics, branded
respiratory and hospitals markets. It has the widest range of any UK generic
pharmaceutical company and markets solid and liquid dose, injectable and
respiratory medicines to healthcare professionals. The company is part of
Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA) which has 38,000 employees
based in 70 countries around the world.

Adverse events should be reported. Reporting forms
and information can be found at www.yellowcard.gov.uk. Adverse events
should also be reported to Teva UK Limited

Temozolomide Teva 5mg / 20mg / 100mg / 140mg / 180mg / 250mg
hard capsules Prescribing Information:

Presentation: Each hard capsule contains 5 mg / 20 mg / 100mg
/ 140 mg / 180 mg / 250 mg temozolomide (TMZ). Indications: Treatment of
adult patients newly-diagnosed glioblastoma multiforme concomitantly with
radiotherapy (RT) and subsequently as monotherapy. Treatment of malignant
glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing
recurrence or progression after standard therapy in patients 3 years and
above. Dosage and administration: Should only be prescribed by physicians
experienced in the oncological treatment of brain tumours. Anti-emetic
therapy may be administered. Administer in fasting state, swallow whole with
glass of water and must not be opened or chewed. If vomiting occurs after
dose is administered, a second dose should not be administered same day.
Prior to dosing absolute neutrophil count (ANC) should be greater than or
equal to 1.5 x 109/L and platelet count greater than or equal to 100 x 109/L.
Children: under 3 years not recommended. Hepatic or renal impairment:
caution, dose reduction unlikely. Elderly: >70 years increased risk of
neutropenia and thrombocytopenia take special care. Consult product
literature. Contraindications: Hypersensitivity to any component, patients
with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption, pregnancy and lactation.
Hypersensitivity to dacarbazine and severe myelosuppression. Precautions and
warnings: Concomitant TMZ and RT increased risk of Pneumocystis carinii
pneumonia (PCP). Prophylaxis against PCP is required during concomitant TMZ
and RT treatment. To avoid nausea and vomiting anti-emetic therapy may be
administered prior to or following administration of TMZ. Adult patients with
newly-diagnosed glioblastoma multiforme; anti-emetic prophylaxis is
recommended prior to treatment. Patients with recurrent or progressive
malignant glioma: may require anti-emetic. Prior to dosing, the following
laboratory parameters must be met: ANC greater than or equal to 1.5 x 109/L
and platelet count greater than or equal to 100 x 109/L. Complete blood count
on day 22 (21 days after the first dose) or within 48 hours of that day, and
weekly until ANC > 1.5 x 109/L and platelet count > 100 x109/L. If ANC is <
1.0 x 109/L or platelet count is < 50 x 109/L during any cycle, next cycle
should be reduced one dose level. Men: should be advised not to father a
child up to 6 months after receiving last dose and to seek advice on
cryoconservation of sperm prior to treatment. Contains lactose. Interactions:
Temozolomide Teva hard capsules should be administered without food.
Co-administration with valproic acid was associated with a small but
statistically significant decrease in clearance of TMZ. Use of TMZ in
combination with other myelosuppressive agents may increase the likelihood of
myelosuppression. Pregnancy and lactation: Not recommended in pregnancy. If
used during pregnancy, patient should be appraised of the potential risk to
the foetus. Women of childbearing potential should be advised to use
effective contraception. Not recommended in breast-feeding.

Side-effects: Very common: nausea, vomiting, constipation,
anorexia, headache, fatigue, convulsions, rash, haematologic adverse
reactions, alopecia. Common: haematologic adverse reactions, infection,
herpes simplex, wound infection, decreased consciousness, somnolence,
aphasia, impaired balance, dizziness, confusion, memory impairment, impaired
concentration, neuropathy, paresthesia, speech disorder, tremor, hemiparesis,
dysphasia, dysphagia, neurological disorder, peripheral neuropathy, visual
field defect, vision blurred, diplopia, hearing impairment, tinnitus,
pharyngitis, candidiasis oral, neutropenia, thrombocytopenia, lymphopenia,
leukopenia , hyperglycaemia, anxiety, emotional lability, insomnia,
depression, anaemia, febrile neutropenia, haemorrhage, deep venous
thrombosis, oedema leg, oedema, dyspnoea, coughing, stomatitis, diarrhoea,
abdominal pain, dyspepsia, dry mouth, dermatitis, dry skin, erythema,
pruritus, muscle weakness, arthralgia, musculoskeletal pain, myalgia,
micturition frequency, urinary incontinence, allergic reaction, fever,
radiation injury, face oedema, pain, taste perversion, alanine transaminase
increased, weight decrease. Serious: myelosuppression (neutropenia and
thrombocytopenia), toxic epidermal necrolysis and Stevens-Johnson syndrome,
hallucination, amnesia, status epilepticus, cerebral haemorrhage, embolism
pulmonary, pancytopenia, anaemia (grade 3-4), leukopenia. Consult the Summary
of Product Characteristics in relation to other side effects. Effects on
ability to drive and to use machines: Ability to drive and use machines may
be impaired due to fatigue and somnolence. Overdosage: Pancytopenia, pyrexia,
multiorgan failure and death. Reports of patients taking recommended dose for
more than 5 days of treatment (up to 64 days) reported bone marrow
suppression, with or without infection, in some cases severe and prolonged
and resulting in death. In overdose, haematological evaluation is needed.
Supportive measures should be provided as necessary. NHS Price: Packs of 5:
5mg capsules GBP16.97; 20mg capsules GBP67.88; 100mg capsules GBP339.40;
140mg capsules GBP475.16; 180mg capsules GBP610.92; 250mg capsules GBP848.50.

Legal category: POM Marketing Authorisation Number:
Temozolomide Teva 5 mg hard capsules EU/1/09/606/001-002; Temozolomide Teva
20 mg hard capsules EU/1/09/606/003-004; Temozolomide Teva 100 mg hard
capsules EU/1/09/606/005-006; Temozolomide Teva 140 mg hard capsules
EU/1/09/606/007-008; Temozolomide Teva 180 mg hard capsules
EU/1/09/606/009-010; Temozolomide Teva 250 mg hard capsules
EU/1/09/606/011-012. Marketing Authorisation Holder: Teva Pharma B.V.,
Computerweg 10, 3542 DR Utrecht, The Netherlands. Date of preparation: March
2010

TVH10/DD01

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