NICE to Hear Bayer's Appeal on the Institute's Decision not to Recommend NHS Funding for Nexavar(R) in Patients With the Most Common Primary Liver Cancer

NEWBURY, England, February 26, 2010 - The National Institute for Health and Clinical Excellence (NICE) will
convene today to decide the fate of UK patients with advanced hepatocellular
carcinoma (HCC). The institute will consider Bayer's appeal (submitted 3rd
December 2009) of its draft negative Final Appraisal Determination (FAD) for
Nexavar(R) (sorafenib) in HCC, published on its website on the 19th November
2009, after nearly two years of consultation. Bayer appealed on the grounds
that NICE failed to act fairly and in accordance with its own published
procedures. Following the outcome of today's hearing, NICE will issue their
final ruling in March 2010 (exact date tbc). The consultation process does
not allow for further appeals.

Nicole Farmer, Business Unit Head of Bayer Schering Pharma Oncology in
the UK, said: "It is so frustrating that for the 600 liver cancer patients
who could really benefit from Nexavar, there still remains the chance that
they will be denied. We really hope that NICE takes this opportunity to
reconsider some of the data and ensures that real innovations in healthcare,
like Nexavar, are made available to all who need it, not just those who could
afford to pay privately".

Today's appeal is not in isolation. A number of 'unofficial' appeals have
revealed a national sense of injustice and sadness throughout the UK since
the negative ruling in November. Patients and clinicians publicly expressed
their despair through a high profile media appeal, patient groups publically
damned the decision in published press statements and a systematic letter
writing campaign by oncologists to NICE and the media, revealed the extent of
the disappointment and frustration experienced by the UK medical community.

"In rare cancers such as HCC, the statistically proven benefit and
quality of life that sorafenib can offer patients is unique. That is why so
many members of the oncology community in the UK have spoken out publically
against the decision", commented Mr Graeme Poston, Director of the Liver
Surgery Unit at Aintree University Hospitals NHS Foundation, one of the
largest liver cancer surgery centres in Europe.

Nexavar(R) is the first systemic drug for advanced HCC to show a
significant survival benefit after 30 years of randomised, comparative trials
and has demonstrated a 44% increase in survival for advanced HCC patients,
compared to best supportive care alone(1). Cases of liver cancer have almost
tripled over the past three decades according to figures recently published
by Cancer Research UK2. In 1975 there were 865 cases of primary liver cancer
and in 2006 that had risen to around 3,200 new cases in the UK(2). HCC
accounts for 80-90% of these primary liver cancers(3).

Professor Karol Sikora, Professor of Cancer Medicine and Medical Director
of CancerPartnersUK said: "Since NICE's decision not to fund the drug in
November, many clinicians (a number of whom would have been involved in the
UK trials of the drug) have been put in the painful position of having to
deny their patients the only survival option for them. As we reach the end of
this laborious process, which has left both patients and clinicians in limbo
for far too long, we can only hope that NICE will use this final window of
time to properly consider the very strong recommendations from UK
oncologists, who only want the best for their patients".

    Bayer has appealed the decision on a number of counts, including that:

    - The Appraisal Committee has failed to explain why it has changed its
      conclusions with respect to the modelling of overall survival following
      Nexavar treatment, in the absence of new data regarding this effect. -
      The Institute has acted in a non-transparent and unfair manner by not
      stating the degree to which they considered evidence received during
      the appraisal regarding appropriate survival extrapolation methods -
      Insufficient time was allowed for consideration of the response to
      consultation by the Appraisal Committee in this case - In reaching its
      recommendation, the Institute has failed to place adequate weight on
      innovation and has therefore acted unfairly and not fulfilled its
      obligations to the Secretary of State in considering the long term
      benefits of innovation to the NHS

References

1. Sorafenib in advanced Hepatocellular Carcinoma. J. Llovet, S. Ricci,
V. Mazzaferro, P. Hilgard, J. Raoul, S. Zeuzem, M. Poulin-Costello, M.
Moscovici, D. Voliotis, J. Bruix, For the SHARP Investigators Study Group. N
Eng J Med 2008; 359:378-90.

2. Cancer Research UK Liver Cancer (Increasing incidence) website.
Accessed 18th February 2010
.info.cancerresearchuk.org/cancerstats/types/liver/incidence

3. Wilson JF. Liver Cancer on the Rise. Ann Int Med, 2005; 142(12):1029-
32. Sorafenib in advanced Hepatocellular Carcinoma. J. Llovet, S. Ricci, V.
Mazzaferro, P. Hilgard, J. Raoul, S. Zeuzem, M. Poulin-Costello, M.
Moscovici, D. Voliotis, J. Bruix, For the SHARP Investigators Study Group. N
Eng J Med 2008; 359:378-90.

Vanessa Leon, Leon PR, Mobile: +44-(0)7904-958-323, Email: vanessa.leon at leonpr.com