RB Pharma Inc. further announcement on Suboxone...

25 September 2012

                  Further US RB Pharmaceuticals Announcement                   

Reckitt Benckiser Group PLC announces US RB Pharmaceuticals Inc. has issued a
Citizen Petition today to request the U.S. Food and Drug Administration (FDA)
to require all manufacturers of buprenorphine-containing products for the
treatment of opioid dependence to implement national public health safeguards
involving pediatric exposure educational campaigns and child resistant,
unit-dosed packaging to reduce the risk of pediatric exposure.

This follows the confirmation announcement this morning that RB Pharmaceuticals
Inc. had advised the US FDA that it was voluntarily withdrawing Suboxone
tablets in the US over the next six months.

Below is the full RB Pharmaceuticals Inc. announcement in the US.

For further information
Investor enquiries, contact:
Richard Joyce, RB [phone]

Press enquiries, contact:
Andraea Dawson-Shepherd, RB [phone]
David Litterick, Brunswick [phone]

        Reckitt Benckiser Pharmaceuticals Inc. Submits Citizen Petition        
      to US FDA Requesting Action to Mitigate Risk of Pediatric Exposure       
                       with Opioid Dependence Treatment                        

Company Voluntarily Discontinues the Supply of Suboxone® Tablets (buprenorphine
         and naloxone sublingual tablets [CIII]) in the United States          

RICHMOND, Va., September 25, 2012/PRNewswire/ - Reckitt Benckiser
Pharmaceuticals Inc. issued a Citizen Petition today to request the U.S. Food
and Drug Administration (FDA) to require all manufacturers of
buprenorphine-containing products for the treatment of opioid dependence to
implement national public health safeguards involving pediatric exposure
educational campaigns and child resistant, unit-dosed packaging to reduce the
risk of pediatric exposure.

The company has had in place an extensive risk management program since 2003
designed to minimize the misuse, abuse and unintentional pediatric exposure
with buprenorphine products. A new analysis received by Reckitt Benckiser
Pharmaceuticals on September 15, 2012 based on data from U.S. Poison Control
Centers found consistently and significantly higher rates of accidental
pediatric exposure with Suboxone Tablets than seen with Suboxone Film
(buprenorphine and naloxone sublingual film [CIII]). The rates for Suboxone
Tablets were 7.8 - 8.5 times greater depending on the study period. This is the
first report provided to the company with conclusive outcomes since a
preliminary review in early 2012 that showed a noticeable numerical trend but
did not provide enough data points to make a statistical analysis.

Immediately following the review of this data, Reckitt Benckiser
Pharmaceuticals proactively notified the FDA on September 18, 2012 that the
company is voluntarily discontinuing the supply of Suboxone Tablets
(buprenorphine and naloxone sublingual tablets [CIII]) in the United States due
to these increasing concerns with pediatric exposure. While the data do not
isolate the root cause of these findings, the child resistant, unit-dose
packaging of Suboxone Film may be one of the key contributing factors to the
decrease in exposure rates compared to Suboxone Tablets that are distributed in
a multi-dose bottle containing 30 tablets, since the active ingredient of both
products is the same. Other factors may include Reckitt Benckiser
Pharmaceuticals' community and healthcare professional educational initiatives
in addition to the company's Risk Evaluation and Mitigation Strategy program.

"Based on these findings and the availability of treatment advancements in the
United States that have shown reduced pediatric exposure such as Suboxone Film,
it is critical for companies to be mandated to have safeguards in place to
ensure children are not put at unnecessary risk," says Richard Simkin,
President, Reckitt Benckiser Pharmaceuticals Inc. "We are committed to not only
providing evolved treatments for the chronic disease of opioid dependence but
protect public health and safety, as evidenced by our decision to discontinue
the U.S. supply of Suboxone Tablets. We recognize many patients have relied on
Suboxone Tablets to manage opioid dependence over the years and understand
there may be concerns about this discontinuation, and we are committed to
helping all patients and providers to ensure that managing this serious,
chronic disease is not interrupted."

Reckitt Benckiser Pharmaceuticals will be working with the FDA and broader
healthcare community to ensure patients currently taking Suboxone Tablets are
able to appropriately transition to the same active ingredient with Suboxone
Film while minimizing any risk to the continuity of their treatment. We
anticipate that distribution of Suboxone Tablets will be discontinued within
the next six months, possibly sooner depending on discussions with the FDA.

The different rates of pediatric exposure are not related to the active
ingredient found in both Suboxone Tablets and Suboxone Film. The company
encourages patients currently taking Suboxone Tablets to continue with their
treatment and consult their physician about how to transition to Suboxone Film.
Suboxone Film is covered by the majority of insurance plans, Medicare and
Medicaid. Additionally, patients can access a co-pay savings program at
Suboxone.com or from their physician to offset out-of-pocket costs associated
with their medication. Since the U.S. launch of Suboxone in 2003, it is
estimated that over three million Americans with opioid dependence have been
treated with the active ingredient in Suboxone Tablets and Suboxone Film,
buprenorphine and naloxone. Suboxone patients can visit Suboxone.com or call
866-973-HERE (866-973-4373) and prescribers can call 877-SUBOXONE
(877-782-6966) for more information.

About Opioid Dependence

Opioid dependence is a chronic medical condition caused in part by the changes
in the chemistry of the brain that can result from regular opioid drug use. The
World Health Organization and the National Institute on Drug Abuse define
opioid dependence as a chronic brain disease that can be fatal if left
untreated.

Approximately two million Americans abused or were dependent on prescription
opioid painkillers in 2010. In the same year, nearly 400,000 people abused or
were dependent on heroin. The Centers for Disease Control and Prevention in
November 2011 issued a report that showed prescription opioid painkiller
overdose has reached epidemic levels in the United States. Furthermore, taking
prescription opioid painkillers without a medical need increased 75 percent
from 2002 to 2010. A total of 12 million Americans reported misusing
prescription opioid painkillers in 2010. Men and individuals ages 26-49 saw the
largest increase in nonmedical use of prescription opioid painkillers, taking
the drugs 200 or more days a year.

About Suboxone Film

Suboxone Film was approved by the FDA on August 30, 2010, and combines
buprenorphine and naloxone in a 4:1 ratio of 2 mg/0.5 mg and 8 mg/2 mg dosage
formulations, respectively.  The 4 mg/1 mg, and 12 mg/3 mg dosage formulations
approved by the FDA in August 2012 should be available later this year.
Suboxone Film's main active ingredient is buprenorphine, a partial opioid
agonist that strongly binds to the opioid receptors in the brain and blocks
other opioids from attaching. Buprenorphine helps reduce opioid use and helps
increase retention in treatment by managing withdrawal symptoms and reducing
cravings. Suboxone Film also includes naloxone, an opioid antagonist, to help
minimize its attractiveness for deliberate parenteral misuse.  When Suboxone
Film is taken as prescribed, dissolved under the tongue, the naloxone has no
effect.

Only physicians certified under the Drug Addiction Treatment Act (DATA) 2000
can prescribe Suboxone. As part of the FDA requirements to ensure the benefits
of treatment with Suboxone Film outweigh potential risks particularly risks of
accidental overdose, misuse and abuse, the company has implemented a Risk
Evaluation and Mitigation Strategy program as a follow-on to the RiskMap.

Selected Safety Information

Buprenorphine can cause severe, possibly fatal, respiratory depression in
children. Advise the patients to store buprenorphine containing medications
safely out of the sight and reach of children and to destroy any unused
medication appropriately. Pediatric exposure to SUBOXONE in any form or
quantity may be dangerous.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids,
legal or illicit. Clinical monitoring appropriate to the patient's level of
stability is essential.

Adverse events commonly observed with the sublingual administration of SUBOXONE
Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache,
nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal,
insomnia, pain, swelling of the limbs, disturbance of attention, palpitations,
and blurred vision.


Indication

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for
maintenance treatment of opioid dependence as part of a complete treatment plan
to include counseling and psychosocial support.

Treatment should be initiated under the direction of physicians qualified under
the Drug Addiction Treatment Act.

Important Safety Information

SUBOXONE Sublingual Film should not be used by patients hypersensitive to
buprenorphine or naloxone, as serious adverse reactions, including anaphylactic
shock, have been reported.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids,
legal or illicit. Clinical monitoring appropriate to the patient's level of
stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid
decrease in dose may result in an opioid withdrawal syndrome that is typically
milder than seen with full agonists and may be delayed in onset.

SUBOXONE Sublingual Film can cause serious life-threatening respiratory
depression and death, particularly when taken by the intravenous (IV) route in
combination with benzodiazepines or other central nervous system (CNS)
depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely
dangerous to self-administer nonprescribed benzodiazepines or other CNS
depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS
depressants, SUBOXONE Sublingual Film, or both when both are being taken should
be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in
the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal,
respiratory depression. Emergency medical care is critical. Keep SUBOXONE
Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of
full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone)
have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported.

Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding
should only be considered if the potential benefit justifies the potential
risk.

Caution should be exercised when driving vehicles or operating hazardous
machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of SUBOXONE
Sublingual Film are oral hypoesthesia, glossodynia, oral mucosal erythema,
headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of
withdrawal, insomnia, pain, and peripheral edema.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic
shock, have been reported.

This is not a complete list of potential adverse events associated with
SUBOXONE Sublingual Film. Please see full Prescribing Information for a
complete list at

www.suboxone.com/pdfs/SuboxonePI.pdf

To report an adverse event associated with taking SUBOXONE Sublingual Film,
please

call 1-877-782-6966. You are encouraged to report adverse events of
prescription drugs

to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Reckitt Benckiser Pharmaceuticals Inc.

Reckitt Benckiser Pharmaceuticals Inc. is a specialty pharmaceutical company
committed to expanding education and access to medical therapies for patients
suffering from the chronic, relapsing brain disease of opioid dependence. The
company manufactures and markets medications that, in conjunction with
counseling and psychosocial support, treat opioid dependence. Reckitt Benckiser
Pharmaceuticals Inc. is a wholly owned subsidiary of Reckitt Benckiser Group
plc, a global company publicly traded on the UK stock exchange.

For further information, please contact:

Reckitt Benckiser Pharmaceutical Media Contacts: 1 [phone] or
[e-mail]

Richard Joyce, Director, Investor Relations: [phone]

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