ABRAXANE® Approved by European Commission for First-Line Treatment of Patients with Non-Small Cell Lung Cancer

On March 2, 2015 Celgene reported that the European Commission (EC) has approved ABRAXANE (paclitaxel formulated as albumin-bound nanoparticles, or 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 (Press release, Celgene, MAR 2, 2015, View Source [SID:1234502133]).

The ABRAXANE Marketing Authorisation has been updated across 28 member states in the European Union to include this new indication in non-small cell lung cancer (NSCLC), adding to the existing indications for the treatment of metastatic pancreatic and breast cancers.

Lung cancer is the fourth most commonly diagnosed cancer in both men and women, however it is the leading cause of cancer-related mortality in Europe. Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for 85 to 90% of all cases. The predominant cause of lung cancer is cigarette smoking, although environmental and occupational factors also can cause the cancer.

The EC decision follows the positive CHMP opinion received on 23 January and is based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. The study compared ABRAXANE in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer. The primary efficacy endpoint, overall response rate, was significantly higher for patients in the ABRAXANE/carboplatin arm at 33%, compared with patients in the control arm, at 25%. The most common adverse reactions (≥ 20%) of ABRAXANE in combination with carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.

Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “At Celgene, we are pleased that the EC’s approval of ABRAXANE in NSCLC allows patients in Europe who have been diagnosed with this devastating disease to access this innovative nanotechnology medicine. The expanded application of ABRAXANE across three difficult to treat tumors – breast, pancreatic and lung cancers – reinforces the value ABRAXANE provides and our commitment to advance transformational science, deliver life-enhancing medicines and serve patients with cancers the world over.”

U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Yervoy® (ipilimumab) as Adjuvant Treatment for Patients with Stage 3 Melanoma Who Are at High Risk of Recurrence

On March 2, 2015 Bristol-Myers Squibb Company reported that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection (Press release, Bristol-Myers Squibb, MAR 2, 2015, View Source [SID:1234502132]). The projected FDA action date is October 28, 2015.

For many stage 3 melanoma patients, there is a high risk of disease recurrence and there has been a low overall survival rate. By five years, the majority of patients experience disease recurrence, with nearly 90 percent in those considered at the highest risk. Once the disease returns, survival rates have been been very low historically, ranging from 11 to 20 percent.

“Four years ago, Yervoy was approved for the treatment of unresectable or metastatic melanoma, the most advanced form of the disease,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “Today’s announcement is a reflection of our commitment to investigate our immuno-oncology treatments for patients across lines of therapy and stages of the disease.”

This filing acceptance is based on clinical data from a randomized, double-blind Phase III trial, CA184-029 (EORTC 18071), assessing the efficacy of Yervoy, at the investigational dose of 10 mg/kg, in preventing or delaying recurrence after complete resection of high-risk stage 3 melanoma.

Novartis announces completion of transactions with GSK

On March 2, 2015 Novartis reported that it has completed a series of transactions with GlaxoSmithKline plc (GSK), including the acquisition of certain oncology products and pipeline compounds from GSK, the creation of a world-leading consumer healthcare business through a joint venture that combines the two companies’ consumer divisions, and the divestiture of the Novartis non-influenza Vaccines business to GSK (Press release, Novartis, MAR 2, 2015, View Source [SID:1234502155]). The transactions were announced in April 2014 as part of the Novartis global portfolio transformation.

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"The completion of the GSK transactions focuses Novartis, and further establishes our leading positions in key growing business segments," said Joseph Jimenez, CEO of Novartis. "We expect this evolution of our strategy to improve margin performance and position us well to meet future changes in the healthcare industry."

Since the end of 2013, Novartis has engaged in a series of transactions to sharpen the company’s focus on three core business segments with global scale: innovative pharmaceuticals, eye care and generics.

As a result of today’s announcement:

Novartis Oncology now manages a portfolio of 22 oncology and hematology medicines to treat more than 25 conditions worldwide. Newly-acquired therapies in melanoma, renal cell carcinoma and hematology complement Novartis Oncology’s existing group of practice-changing medicines to create a large portfolio of drugs in oncology and hematology targeting important biological disease pathways.
Based on the depth and breadth of the Novartis Oncology R&D and commercial capabilities, it is anticipated that Novartis will be able to optimize the therapies acquired from GSK. These include:
Tafinlar, a BRAF inhibitor, and Mekinist(TM), a MEK inhibitor, both approved for the treatment of metastatic melanoma. On February 6, 2015, GSK announced overall survival results from the COMBI-d trial which demonstrate a statistically significant reduction in the risk of death (Hazard Ratio [HR] 0.71 [95% Confidence Interval (CI): 0.55, 0.92], p=0.011) for the combination of Tafinlar and Mekinist compared to Tafinlar monotherapy in patients with BRAF V600E/K mutation-positive metastatic melanoma.
Votrient, a VEGFR inhibitor for renal cell carcinoma, which has shown significant efficacy as first-line treatment for renal cancer.
Promacta for thrombocytopenia, Tykerb for HER2+ metastatic breast cancer and Arzerra in chronic lymphocytic leukemia are also included in the transaction.
Novartis also has opt-in rights for GSK’s current and future oncology R&D pipeline (excluding oncology vaccines), which could be a source of new compounds and new targets. Sales of the acquired GSK oncology products in 2014 were approximately USD 2.0 billion and grew approximately 32% in local currency against 2013.*
Novartis OTC and GSK Consumer Healthcare jointly form a global consumer healthcare leader ("GSK Consumer Healthcare") in which Novartis maintains significant interest through the ownership of a 36.5% share. GSK Consumer Healthcare is expected to have leading positions in four key OTC categories – Wellness, Oral Health, Nutrition and Skin Health. The joint venture has scale and commercial presence in the developed world as well as in key emerging markets.
The Novartis non -influenza Vaccines business has been divested to GSK.

Since 2013, Novartis has executed other strategic transactions to transform the Company’s portfolio. In January 2015, the Company completed the sale of its Animal Health business to Eli Lilly and Company for approximately USD 5.4 billion. As a result of the transaction with Eli Lilly, Novartis will show in the first quarter of 2015 an exceptional pre-tax gain of approximately USD 4.7 billion.

In October 2014, the company announced an agreement to divest its influenza vaccines business to CSL Limited for USD 275 million, a transaction that is expected to close at the end of 2015. In January 2014, Novartis completed the sale of its blood transfusion diagnostics unit to Grifols S.A. for USD 1.7 billion.

Deal terms and financial impact
As a result of the divestment of the non-influenza Vaccines business to GSK and the creation of the Novartis OTC and GSK Consumer Healthcare joint venture, Novartis will record a substantial exceptional gain, which will be reported with the release of the Company’s 2015 first quarter results.

GSK oncology products
Novartis has acquired GSK’s oncology products, including two pipeline candidates, for an aggregate cash consideration of USD 16 billion. Up to USD 1.5 billion of this amount is contingent on certain development milestones.

Novartis OTC and GSK Consumer Healthcare joint venture
Novartis now owns a 36.5% share of the joint venture between Novartis OTC and GSK Consumer Healthcare. The investment will be accounted for using the equity method of accounting and will be reported as income from associated companies. Novartis also has four of eleven seats on the joint venture’s Board. Furthermore, Novartis has certain minority rights and exit rights, the latter of which would be executed using a pre-defined, market-based pricing mechanism.

Divestment of non-influenza Vaccines to GSK
Novartis has divested its Vaccines business (excluding its vaccines influenza business) to GSK for up to USD 7.1 billion plus royalties. The USD 7.1 billion consists of USD 5.25 billion paid upon completion and up to USD 1.8 billion in future milestone payments.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Seattle Genetics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Seattle Genetics, FEB 27, 2015, View Source [SID1234502508]).

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Qiagen has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, QIAGEN, FEB 27, 2015, View Source [SID1234502498]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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