Celgene Announces Positive Recommendation by Scottish Medicines Consortium (SMC) for ABRAXANE® (Nab-Paclitaxel) in combination with Gemcitabine1 for Patients with Metastatic Pancreatic Cancer

Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that ABRAXANE^® (paclitaxel formulated as albumin-bound nanoparticles; nab-paclitaxel), in combination with gemcitabine, has now received a positive recommendation for the treatment of metastatic pancreatic cancer by the Scottish Medicines Consortium (SMC) within the National Health Service Scotland.¹ The decision follows the recent NHS England announcement to defer their review of ABRAXANE^® for metastatic pancreatic cancer, allowing the treatment to remain on the National Cancer Drugs Fund (NCDF) list until a final decision is made.²

The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women across the European Union.³ Patients diagnosed with metastatic disease have a median life expectancy, after diagnosis, of approximately two to six months.⁴ In the UK, pancreatic cancer is the fifth most common cancer killer with approximately 8,800 new cases diagnosed each year.^5,6 In Scotland an estimated 770 new patients are diagnosed and over 740 die from the disease each year.⁷

Professor Jeff Evans, Professor of Translational Research at the University of Glasgow said: “I welcome the Scottish Medicines Consortium decision to approve the prescribing of ABRAXANE ^® in Scotland. Pancreatic cancer has extremely low survival rates as the majority of patients are diagnosed at an advanced stage. ABRAXANE ^® has shown that it is able to increase survival for patients with metastatic pancreatic cancer and now sufferers of the disease in Scotland will be able to use this treatment.”

The SMC decision is based on results from the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, published in the October 2013 edition of the New England Journal of Medicine, which demonstrated an increase in median overall survival of 1.8 months when compared to gemcitabine alone [(8.5 months vs. 6.7 months respectively) (HR 0.72; P<0.001)].⁸ Updated results published in the February 2015 edition of the Journal of the National Cancer Institute demonstrated an increase in the median overall survival benefit of 2.1 months when compared to gemcitabine alone [(8.7 months vs. 6.6 months respectively) (HR 0.72; P<0.0001)]. ⁹ Grade 3 and higher adverse events that were reported more often with ABRAXANE^® plus gemcitabine versus gemcitabine alone were neutropenia, fatigue, and peripheral neuropathy.⁸

Ms Alex Ford, Chief Executive of Pancreatic Cancer UK, said: “We are absolutely delighted with the SMC’s decision. They have listened to the positive input received from patients and clinicians and they should be applauded for doing so.

The decision means that eligible patients in Scotland will be now be able to access this treatment for free on the NHS, alongside patients in England and Wales, which is fantastic news. It is particularly important as, currently, pancreatic cancer causes almost 5% of cancer deaths in Scotland and it is important that as many patients as possible are given every opportunity to access life-extending treatment. And whilst not every patient will be fit enough to be able to use ABRAXANE ^® , a significant number will and we hope this will give them the opportunity of spending more time with their loved ones.”

Ali Stunt, Founder and CEO of Pancreatic Cancer Action said: “This is fantastic news for metastatic pancreatic cancer patients in Scotland who have been waiting for this treatment for almost 12 months. The unmet need in pancreatic cancer is significant due to the terrible prognosis associated with the disease and the lack of new treatments that are coming through. At Pancreatic Cancer Action, we welcome the SMC’s decision to make ABRAXANE ^® available to all eligible patients in Scotland.”

Wim Souverijns, Vice President and General Manager, Celgene UK & Ireland, said: “Celgene is dedicated to working with all the reimbursement bodies in the UK and Ireland and across the world to make sure that as many eligible patients can be treated with ABRAXANE ^® as possible. Access to innovative cancer medicines generates clear benefits to patients. Therefore, widening access to life-extending treatments for cancer patients has the potential to reduce the rise in cancer mortality rates that has been seen over the last two decades and help to increase survival rates in pancreatic cancer which have hardly moved in decades.

The SMC have recognised the clinical benefit of ABRAXANE ^® , so Scottish patients will now be able to receive the treatment alongside their counterparts in England and Wales and in many countries across the European Union where the medicine is approved and available to patients.”

About Pancreatic Cancer in the UK

Pancreatic cancer is a difficult-to-treat cancer. Of those diagnosed in England and Wales, the one-year net survival rate for adults is approximately 20%.⁴ Men have a five-year net survival rate of 3.5% whilst for women the survival rate is 3.1%.⁴ Cancer Research UK has committed to increasing its investment by £50 million in cancers such as pancreatic cancer,¹⁰ highlighting the importance of the disease within its institutes.

The average life expectancy is only a few months for those people whose cancer has already spread to another part of their body and can also vary depend on how much the cancer has grown and where it has spread in the body.⁴ Pancreatic cancer is the tenth most common cancer in the UK and approximately 8,800 people are diagnosed each year.⁵ Pancreatic cancer is the fifth leading cause of cancer death in the UK. ⁵

About ABRAXANE ^® (nab-paclitaxel)

The European Medicines Agency (EMA) granted a licence for nab-paclitaxel in January 2008 for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated.¹¹

In December 2013, the EMA granted a licence for nab-paclitaxel, in combination with gemcitabine, for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.¹²

In January 2015, the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for nab-paclitaxel in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.¹³

Nab-paclitaxel has received pricing and reimbursement approvals internationally, including in Australia, Austria, Canada, Denmark, Germany, Greece, Slovenia, Spain, Sweden and USA.

For prescribing and safety information on nab-paclitaxel in the UK, please visit: https://www.medicines.org.uk/emc/medicine/21384/SPC/Abraxane+5+mg+ml+powder+for+suspension+for+infusion/

U.S. Regulatory Information for ABRAXANE

WARNING - NEUTROPENIA

• Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE
• Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS

CONTRAINDICATIONS

Neutrophil Counts

• ABRAXANE should not be used in patients who have baseline neutrophil counts of <1500 cells/mm³

Hypersensitivity

• Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with the drug

WARNINGS AND PRECAUTIONS

Hematologic Effects

• Bone marrow suppression (primarily neutropenia) is dose-dependent and a dose-limiting toxicity of ABRAXANE. In clinical studies, Grade 3-4 neutropenia occurred in 34% of patients with metastatic breast cancer (MBC), 47% of patients with non–small cell lung cancer (NSCLC), and 38% of patients with pancreatic cancer
• Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1 (for MBC) and Days 1, 8, and 15 (for NSCLC and for pancreatic cancer)
• Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1500 cells/mm³
• In the case of severe neutropenia (<500 cells/mm³ for 7 days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with either MBC or NSCLC
• In patients with MBC, resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level >1500 cells/mm³ and platelets recover to a level >100,000 cells/mm³
• In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly ABRAXANE and every-3-week carboplatin after ANC recovers to at least 1500 cells/mm³ and platelet count of at least 100,000 cells/mm³ on Day 1 or to an ANC of at least 500 cells/mm³ and platelet count of at least 50,000 cells/mm³ on Days 8 or 15 of the cycle
• In patients with adenocarcinoma of the pancreas, withhold ABRAXANE and gemcitabine if the ANC is less than 500 cells/mm³ or platelets are less than 50,000 cells/mm³ and delay initiation of the next cycle if the ANC is less than 1500 cells/mm³ or platelet count is less than 100,000 cells/mm³ on Day 1 of the cycle. Resume treatment with appropriate dose reduction if recommended

Nervous System

• Sensory neuropathy is dose- and schedule-dependent
• The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification
• If ≥ Grade 3 sensory neuropathy develops, withhold ABRAXANE treatment until resolution to Grade 1 or 2 for MBC or until resolution to ≤ Grade 1 for NSCLC and pancreatic cancer followed by a dose reduction for all subsequent courses of ABRAXANE

Sepsis

• Sepsis occurred in 5% of patients with or without neutropenia who received ABRAXANE in combination with gemcitabine
• Biliary obstruction or presence of biliary stent were risk factors for severe or fatal sepsis
• If a patient becomes febrile (regardless of ANC), initiate treatment with broad-spectrum antibiotics
• For febrile neutropenia, interrupt ABRAXANE and gemcitabine until fever resolves and ANC ≥1500 cells/mm³, then resume treatment at reduced dose levels

Pneumonitis

• Pneumonitis, including some cases that were fatal, occurred in 4% of patients receiving ABRAXANE in combination with gemcitabine
• Monitor patients for signs and symptoms and interrupt ABRAXANE and gemcitabine during evaluation of suspected pneumonitis
• Permanently discontinue treatment with ABRAXANE and gemcitabine upon making a diagnosis of pneumonitis

Hypersensitivity

• Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported
• Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug

Hepatic Impairment

• Because the exposure and toxicity of paclitaxel can be increased with hepatic impairment, administration of ABRAXANE in patients with hepatic impairment should be performed with caution
• Patients with hepatic impairment may be at an increased risk of toxicity, particularly from myelosuppression, and should be monitored for development of profound myelosuppression
• For MBC and NSCLC, the starting dose should be reduced for patients with moderate or severe hepatic impairment
• For pancreatic adenocarcinoma, ABRAXANE is not recommended for patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN and AST ≤10 x ULN)

Albumin (Human)

• ABRAXANE contains albumin (human), a derivative of human blood

Use in Pregnancy: Pregnancy Category D

• ABRAXANE can cause fetal harm when administered to a pregnant woman
• If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus
• Women of childbearing potential should be advised to avoid becoming pregnant while receiving ABRAXANE

Use in Men

• Men should be advised not to father a child while receiving ABRAXANE

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

• The most common adverse reactions (≥20%) with single-agent use of ABRAXANE vs paclitaxel injection in the MBC study are alopecia (90%, 94%), neutropenia (all cases 80%, 82%; severe 9%, 22%), sensory neuropathy (any symptoms 71%, 56%; severe 10%, 2%), abnormal ECG (all patients 60%, 52%; patients with normal baseline 35%, 30%), fatigue/asthenia (any 47%, 39%; severe 8%, 3%), myalgia/arthralgia (any 44%, 49%; severe 8%, 4%), AST elevation (any 39%, 32%), alkaline phosphatase elevation (any 36%, 31%), anemia (any 33%, 25%; severe 1%, <1%), nausea (any 30%, 22%; severe 3%, <1%), diarrhea (any 27%, 15%; severe <1%, 1%) and infections (24%, 20%), respectively
• Sensory neuropathy was the cause of ABRAXANE discontinuation in 7/229 (3%) patients
• Other adverse reactions of note with the use of ABRAXANE vs paclitaxel injection included vomiting (any 18%, 10%; severe 4%, 1%), fluid retention (any 10%, 8%; severe 0%, <1%), mucositis (any 7%, 6%; severe <1%, 0%), hepatic dysfunction (elevations in bilirubin 7%, 7%), hypersensitivity reactions (any 4%, 12%; severe 0%, 2%), thrombocytopenia (any 2%, 3%; severe <1%, <1%), neutropenic sepsis (<1%, <1%), and injection site reactions (<1%, 1%), respectively. Dehydration and pyrexia were also reported
• Renal dysfunction (any 11%, severe 1%) was reported in patients treated with ABRAXANE (n=229)
• In all ABRAXANE-treated patients (n=366), ocular/visual disturbances were reported (any 13%; severe 1%)
• Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients and included cardiac ischemia/infarction, chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension
• Cases of cerebrovascular attacks (strokes) and transient ischemic attacks have been reported

Non–Small Cell Lung Cancer (NSCLC) Study

• The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue
• The most common serious adverse reactions of ABRAXANE in combination with carboplatin for NSCLC are anemia (4%) and pneumonia (3%)
• The most common adverse reactions resulting in permanent discontinuation of ABRAXANE are neutropenia (3%), thrombocytopenia (3%), and peripheral neuropathy (1%)
• The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (24%), thrombocytopenia (13%), and anemia (6%)
• The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (41%), thrombocytopenia (30%), and anemia (16%)
• The following common (≥10% incidence) adverse reactions were observed at a similar incidence in ABRAXANE plus carboplatin–treated and paclitaxel injection plus carboplatin–treated patients: alopecia (56%), nausea (27%), fatigue (25%), decreased appetite (17%), asthenia (16%), constipation (16%), diarrhea (15%), vomiting (12%), dyspnea (12%), and rash (10%); incidence rates are for the ABRAXANE plus carboplatin treatment group
• Adverse reactions with a difference of ≥2%, Grade 3 or higher, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (28%, 7%), neutropenia (47%, 58%), thrombocytopenia (18%, 9%), and peripheral neuropathy (3%, 12%), respectively
• Adverse reactions with a difference of ≥5%, Grades 1-4, with combination use of ABRAXANE and carboplatin vs combination use of paclitaxel injection and carboplatin in NSCLC are anemia (98%, 91%), thrombocytopenia (68%, 55%), peripheral neuropathy (48%, 64%), edema peripheral (10%, 4%), epistaxis (7%, 2%), arthralgia (13%, 25%), and myalgia (10%, 19%), respectively
• Neutropenia (all grades) was reported in 85% of patients who received ABRAXANE and carboplatin vs 83% of patients who received paclitaxel injection and carboplatin

Pancreatic Adenocarcinoma Study

• Among the most common (≥20%) adverse reactions in the phase III study, those with a ≥5% higher incidence in the ABRAXANE/gemcitabine group compared with the gemcitabine group are neutropenia (73%, 58%), fatigue (59%, 46%), peripheral neuropathy (54%, 13%), nausea (54%, 48%), alopecia (50%, 5%), peripheral edema (46%, 30%), diarrhea (44%, 24%), pyrexia (41%, 28%), vomiting (36%, 28%), decreased appetite (36%, 26%), rash (30%, 11%), and dehydration (21%, 11%)
• Of these most common adverse reactions, those with a ≥2% higher incidence of Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared with the gemcitabine group, respectively, are neutropenia (38%, 27%), fatigue (18%, 9%), peripheral neuropathy (17%, 1%), nausea (6%, 3%), diarrhea (6%, 1%), pyrexia (3%, 1%), vomiting (6%, 4%), decreased appetite (5%, 2%), and dehydration (7%, 2%)
• Thrombocytopenia (all grades) was reported in 74% of patients in the ABRAXANE/gemcitabine group vs 70% of patients in the gemcitabine group
• The most common serious adverse reactions of ABRAXANE (with a ≥1% higher incidence) are pyrexia (6%), dehydration (5%), pneumonia (4%), and vomiting (4%)
• The most common adverse reactions resulting in permanent discontinuation of ABRAXANE were peripheral neuropathy (8%), fatigue (4%), and thrombocytopenia (2%)
• The most common adverse reactions resulting in dose reduction of ABRAXANE are neutropenia (10%) and peripheral neuropathy (6%)
• The most common adverse reactions leading to withholding or delay in ABRAXANE dosing are neutropenia (16%), thrombocytopenia (12%), fatigue (8%), peripheral neuropathy (15%), anemia (5%), and diarrhea (5%)
• Other selected adverse reactions with a ≥5% higher incidence for all-grade toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group, respectively, are asthenia (19%, 13%), mucositis (10%, 4%), dysgeusia (16%, 8%), headache (14%, 9%), hypokalemia (12%, 7%), cough (17%, 7%), epistaxis (15%, 3%), urinary tract infection (11%, 5%), pain in extremity (11%, 6%), arthralgia (11%, 3%), myalgia (10%, 4%), and depression (12%, 6%)
• Other selected adverse reactions with a ≥2% higher incidence for Grade 3-4 toxicity in the ABRAXANE/gemcitabine group compared to the gemcitabine group are thrombocytopenia (13%, 9%), asthenia (7%, 4%), and hypokalemia (4%, 1%)

Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations

• Severe and sometimes fatal hypersensitivity reactions have been reported with ABRAXANE. The use of ABRAXANE in patients previously exhibiting hypersensitivity to paclitaxel injection or human albumin has not been studied
• There have been reports of congestive heart failure, left ventricular dysfunction, and atrioventricular block with ABRAXANE, primarily among individuals with underlying cardiac history or prior exposure to cardiotoxic drugs
• There have been reports of extravasation of ABRAXANE. Given the possibility of extravasation, it is advisable to monitor closely the ABRAXANE infusion site for possible infiltration during drug administration

DRUG INTERACTIONS

• Caution should be exercised when administering ABRAXANE concomitantly with medicines known to inhibit or induce either CYP2C8 or CYP3A4

USE IN SPECIFIC POPULATIONS

Nursing Mothers

• It is not known whether paclitaxel is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

Pediatric

• The safety and effectiveness of ABRAXANE in pediatric patients have not been evaluated

Geriatric

• No toxicities occurred notably more frequently among patients ≥65 years of age who received ABRAXANE for MBC
• Myelosuppression, peripheral neuropathy, and arthralgia were more frequent in patients ≥65 years of age treated with ABRAXANE and carboplatin in NSCLC
• Diarrhea, decreased appetite, dehydration, and epistaxis were more frequent in patients 65 years or older compared with patients younger than 65 years old who received ABRAXANE and gemcitabine in adenocarcinoma of the pancreas

Renal Impairment

• There are insufficient data to permit dosage recommendations in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance <30 mL/min)

DOSAGE AND ADMINISTRATION

• Do not administer ABRAXANE to any patient with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN
• For MBC and NSCLC, reduce starting dose in patients with moderate to severe hepatic impairment
• For adenocarcinoma of the pancreas, do not administer ABRAXANE to patients who have moderate to severe hepatic impairment
• Dose reductions or discontinuation may be needed based on severe hematologic, neurologic, cutaneous, or gastrointestinal toxicity
• Monitor patients closely

Please see full Prescribing Information, including Boxed WARNING.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit http://celgene.co.uk/. You can also follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.

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REFERENCES

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3. Malvezzi M et al. European cancer mortality predictions for the year 2013. Ann Oncol 2013;24:792-800

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6. Cancer Research UK. Pancreatic cancer statistics. http://www.cancerresearchuk.org/cancer-info/cancerstats/types/pancreas/ (accessed January 2015)

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8. Von Hoff DD et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. NEJM 2013;369(18):1691-1703

9. Goldstein D et al. nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer: Long-Term Survival From a Phase III Trial. J Natl Cancer Inst (2015);107(2) pii: dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

10. Cancer Research UK: Our strategy to beat cancer sooner. http://www.cancerresearchuk.org/about-us/our-organisation/beating-cancer-sooner-our-strategy (accessed January 2015)

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12. European Medicines Agency. European Medicines Agency recommends extending use of Abraxane to include treatment of pancreatic cancer. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001974.jsp&mid=WC0b01ac058004d5c1 (accessed February 2015)

13. European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/news_detail_002250.jsp&mid=WC0b01ac058004d5c1 (accessed February 2015)

14. National Institute for Health and Care Excellence. The cost of nab-paclitaxel is not justified by its limited benefit, says NICE in draft guidance. http://www.nice.org.uk/news/press-and-media/the-cost-of-nab-paclitaxel-is-not-justified-by-its-limited-benefit-says-nice-in-draft-guidance-2 (accessed January 2015)

15. All Wales Medicines Strategy Group. Paclitaxel albumin-bound nanoparticles (ABRAXANE^®) Reference No. 1999. http://www.awmsg.org/awmsgonline/app/appraisalinfo/1999 (accessed January 2015)

16. National Centre for Pharmacoeconomics. Cost effectiveness of nab-paclitaxel (ABRAXANE^®) + gemcitabine as a combination therapy for metastatic pancreatic cancer in Ireland, eligible for reimbursement as a hospital only product. http://www.ncpe.ie/wp-content/uploads/2014/03/NCPE-Nab-Pac-Web-summary.pdf (accessed January 2015)

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