European Commission Approves Statement on Lipid Improvement for VIRAMUNE(R) Label

Ingelheim, Germany (ots/PRNewswire) -

- For Medical Media Outside the US only

Boehringer Ingelheim announced today that the European Commission
has approved an update of the Summary of Product Characteristics
(SmPC) for VIRAMUNE(R) (nevirapine) in the treatment of patients with
HIV. The decision followed a positive recommendation by the Committee
for Medical Products for Human Use (CHMP), the scientific committee
of the European Medicines Agency (EMEA) who reviewed the clinical
evidence and approved a statement in the SmPC recognising the
positive effect of nevirapine on the lipid profile of HIV infected
patients.

The SmPC has been updated to reflect clinical studies
demonstrating that nevirapine has been associated with an increase in
HDL cholesterol and an overall improvement in the total HDL
cholesterol ratio: "In clinical studies, VIRAMUNE(R) has been
associated with an increase in HDL- cholesterol and an overall
improvement in the total to HDL-cholesterol ratio. However, in the
absence of specific studies with VIRAMUNE(R) on modifying the
cardiovascular risk in HIV infected patients, the clinical impact of
these findings is not known. The selection of antiretroviral drugs
must be guided primarily by their antiviral efficacy."

A series of studies[1][2][3] demonstrated a favourable impact of
Viramune on the lipid profile for up to two years. The NILE
(Nevirapine Intensive Lipid Evaluation)[4] study discovered that
VIRAMUNE(R) increases the level of high-density lipoprotein
cholesterol HDLc by increasing the enzyme Apo A1. HDLc, is also
called "good cholesterol" because of its cardioprotective character.

The impact of VIRAMUNE(R)in the combination with Truvada(R) on
the lipid profile of HIV patients has been further assessed in the
ARTEN* trial. This head-to-head study closely mirrors modern HIV
treatment conditions and compares two regularly prescribed lipid
friendly antiretroviral therapies - VIRAMUNE(R)and atzanavir/r, a
protease inhibitor boosted with ritonavir. Results are expected to
be announced during the International Aids Society Congress in Cape
Town, South Africa from 19 - 22 July 2009.

Dr. Manfred Haehl, MD, Senior Vice-President Medicine at
Boehringer Ingelheim said, "We are very satisfied that VIRAMUNE(R)'s
positive impact on lipids has been recognized by the European
Commission. This is particularly important at a time when
cardiovascular disease has become an increasing cause of morbidity
and mortality in patients with HIV. Physicians treating patients with
HIV need to have a range of treatment options available so they can
tailor the therapy to the individual patient's need and response. We
are further exploring VIRAMUNE(R)effect on lipid profiles and hope to
provide further insights with the upcoming ARTEN study.'

Notes to Editors

About Viramune(R)

Viramune(R) is a product of original research done at Boehringer
Ingelheim. Viramune(R) was the first member of the non-nucleoside
reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs.
Viramune(R) is indicated for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection. This
indication is based on one principal clinical trial that demonstrated
prolonged suppression of HIV-RNA and several smaller supportive
studies. Studies have also shown that patients switching to
Viramune(R) from a PI-based regimen demonstrate an improved lipid
profile while maintaining viral suppression. The most clinically
important adverse events associated with Viramune(R) are rash and
hepatic events, which have included fatal cases. Any patient can
experience hepatic events; however, female gender and higher CD4+
cell counts at initiation of therapy place patients at greater risk.
Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk.
Viramune(R) should not be initiated in adult females with CD4+ cell
counts greater than 250 cells/mm3 or in adult males with CD4+ cell
counts greater than 400 cells/mm3 unless the benefit outweighs the
risk. The greatest risk of severe rash and hepatic events occurs in
the first six weeks of therapy. It is essential that patients be
monitored for these reactions at all times, and intensively during
the first few months of therapy. Viramune(R) should be discontinued
and not restarted following severe hepatic, skin or hypersensitivity
reactions.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 138 affiliates in 47 countries and 41,300
employees. Since it was founded in 1885, the independent,
family-owned company has been committed to researching, developing,
manufacturing and marketing novel products of high therapeutic value
for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion
euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.

For more information please visit
http://www.boehringer-ingelheim.com

---------------------------------

* Atazanavir/Ritonavir on a background of Tenofovir and
Emtricitabine (Truvada(R) a trademark of Gilead Science...) versus
Nevirapine

[1] van der Valk, M., et al., Nevirapine-containing
antiretroviral therapy in HIV-1 infected patients results in an
anti-atherogenic lipid profile. Aids, 2001. 15(18): p. 2407-14.

[2] van Leth, F., et al., Nevirapine and Efavirenz Elicit
Different Changes in Lipid Profiles in Antiretroviral- Therapy-Naive
Patients Infected with HIV-1. Plos Med, 2004. 1(1): p. e19.

[3] Fisac, C., et al., Metabolic benefits 24 months after
replacing a protease inhibitor with abacavir,efavirenz or nevirapine.
AIDS, 2005. 19(9): p. 917-25.

[4] Sankatsing R, Franssen R, Hassink E et al. Nevirapine
increases high density lipoprotein-cholesterol by stimulation of
apolipoprotein A-I synthesis. 4th IAS (International AIDS Society)
Conf. on HIV Pathogenesis, Treatment and Prevention, Sydney, 22 - 25
Jul 2007, Abstract WEPEB120LB

ots Originaltext: Boehringer Ingelheim
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