Celgene Corporation
Feb 10, 2015
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Celgene Announces Positive Recommendation by Scottish Medicines Consortium (SMC) for ABRAXANE® (Nab-Paclitaxel) in combination with Gemcitabine1 for Patients with Metastatic Pancreatic Cancer

New decision by SMC makes ABRAXANE® available to all eligible pancreatic cancer patients in Scotland

BOUDRY, Switzerland--(BUSINESS WIRE)-- 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

CONTRAINDICATIONS

Neutrophil Counts

Hypersensitivity

WARNINGS AND PRECAUTIONS

Hematologic Effects

Nervous System

Sepsis

Pneumonitis

Hypersensitivity

Hepatic Impairment

Albumin (Human)

Use in Pregnancy: Pregnancy Category D

Use in Men

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

Non-Small Cell Lung Cancer (NSCLC) Study

Pancreatic Adenocarcinoma Study

Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Nursing Mothers

Pediatric

Geriatric

Renal Impairment

DOSAGE AND ADMINISTRATION

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: @CelgenePinterest 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.

All registered trademarks are owned by Celgene Corporation.

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REFERENCES

1. Scottish Medicines Consortium. Treatment Assessment. January 2015

2. NHS England. National Cancer Drugs Fund list version 3. http://www.england.nhs.uk/wp-content/uploads/2015/01/ncdf-list-dec14.pdf (access January 2015)

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

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

5. Cancer Research UK. Pancreatic cancer key stats. http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/pancreatic-cancer/cancerstats-key-facts-on-pancreatic-cancer. (accessed January 2015)

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

7. Information Services Division Scotland. Cancer Statistics: Pancreatic Cancer. http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Pancreatic/ (accessed February 2015)

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)

11. eMC. Abraxane 5 mg/ml powder for suspension for infusion. http://www.medicines.org.uk/emc/medicine/21384/SPC/ (accessed January 2015)

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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