AstraZeneca to strengthen therapy area franchise through acquisition of Takeda's respiratory business

AstraZeneca today announced that it has entered into a definitive agreement to acquire the core respiratory business of Takeda Pharmaceutical Company Limited ("Takeda"). The deal will include the expansion of rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral PDE4 inhibitor for the treatment of chronic obstructive pulmonary disease (COPD).
AstraZeneca has marketed Daliresp in the US since the acquisition of the rights from Actavis in the first quarter of 2015. Full acquisition of the global rights will support AstraZeneca's respiratory franchise and complement the company's portfolio of treatments for severe COPD. Recent data(1) reinforce the benefit Daxas brings to patients in reducing exacerbations as an add-on to dual and free-triple(2) inhaled combination therapies. The agreement will also provide AstraZeneca with access to other marketed respiratory medicines and early pipeline products.
Under the terms of the agreement, AstraZeneca will make a payment of $575 million. Approximately 200 staff will transfer to AstraZeneca upon completion.
Luke Miels, Executive Vice President Global Portfolio and Product Strategy at AstraZeneca, said: "The agreement with Takeda complements our respiratory business, one of our three main therapy areas, supports our return to growth and will be immediately accretive to earnings from 2016. Daxas in particular adds to our portfolio of treatments for patients with severe COPD."
Annual global sales of the three core medicines acquired, excluding any AstraZeneca sales of Daliresp in the US(3), were $198 million for the period ending in March 2015. The transaction will be accounted for as a business combination and is expected to close during the first quarter of 2016, subject to customary closing conditions. It is expected to be immediately accretive to earnings from 2016. The acquisition of global rights to Daliresp will also negate the Company's existing royalty payments for the medicine in the US. Full Year 2016 guidance is expected to be provided at Full Year 2015 results on 4 February 2016.

Genzyme to buy AstraZeneca's rare disease medicine Caprelsa for $300 million

AstraZeneca, a global, innovation-driven biopharmaceutical business, has entered into a definitive agreement with Genzyme to divest Caprelsa (vandetanib), a rare disease medicine.

Caprelsa was granted Orphan Drug Designation by the US FDA in 2005 and is currently available in 28 countries for the treatment of aggressive and symptomatic medullary thyroid carcinoma, with global product sales of $48 million in 2014.

Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300 million, including an upfront payment of $165 million to acquire the global rights to sell and develop Caprelsa, and further development and sales milestone payments of up to $135 million. The transaction does not include the transfer of any AstraZeneca employees or facilities. As an asset divestment, upfront receipt and any subsequent payments will be reported in Other Operating Income in the company’s financial statements.

Luke Miels, executive vice president, global product & portfolio strategy and corporate affairs, AstraZeneca, said: “Caprelsa is a rare disease therapy and the divestment to Genzyme, an expert leader in endocrinology, demonstrates our commitment to ensure patients continue to have access to this medicine while we sharpen our focus on key disease areas.”

AstraZeneca collaborates with Celgene to develop PD-L1 inhibitor

AstraZeneca and its global biologics research and development arm, MedImmune, announced that they have entered into an exclusive collaboration agreement with Celgene Corporation, a global leader in haematological cancers, for the development and commercialisation of MEDI4736 across a range of blood cancers including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.

MEDI4736 is an investigational immune checkpoint inhibitor, directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. Within the collaboration, MEDI4736 will be assessed both as monotherapy and in combination with other AstraZeneca and Celgene potential and existing cancer medicines. Over time, the collaboration could expand to include other assets.

MEDI4736 was accelerated into phase III clinical development in non-small cell lung cancer and head and neck cancer. The OCEANS clinical development programme will evaluate MEDI4736 as monotherapy and in combination with a CTLA-4 (tremelimumab) in lung cancer, across the spectrum of the disease. In head and neck cancer, MEDI4736 is being investigated both as monotherapy and in combination with tremelimumab, looking at patients with different PD-L1 expression status who have failed on chemotherapy.

AstraZeneca's tremelimumab receives US FDA orphan drug

AstraZeneca announced that the US Food and Drug Administration has granted Orphan Drug Designation for the anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma.

Mesothelioma is a rare, aggressive cancer that most often affects the lining of the lungs and abdomen. Available treatments for mesothelioma are very limited, particularly for patients with advanced disease.

“There is a significant need for new treatment options for patients with mesothelioma because fewer than five percent of patients currently survive beyond five years, even when they receive timely diagnosis and care. Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients,” said Robert Iannone, senior vice president, head of immuno-oncology, global medicines development at AstraZeneca.

The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

AstraZeneca, Daiichi Sankyo to jointly commercialise Movantik in US

AstraZeneca announced a co-commercialisation agreement with Daiichi Sankyo, Inc. for Movantik (naloxegol) in the US, in line with the Company’s strategy of delivering value through its own development and commercial capabilities as well as through external collaboration. Movantik is a first-in-class once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Movantik was approved by the US Food and Drug Administration in September 2014. It was descheduled by the US Drug Enforcement Administration in January 2015 and is no longer labelled as a controlled substance. The launch of Movantik in the US is planned for early April 2015.

Under the terms of the agreement, Daiichi Sankyo Inc. will pay a $200 million up-front fee and subsequent sales-related payments of up to $625 million. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi Sankyo, Inc. Both companies will be jointly responsible for commercial activities. AstraZeneca’s 2015 financial guidance, provided on 6 March 2015, is unaffected by today’s announcement.

Paul Hudson, president, AstraZeneca US and executive vice president, North America, said: “We are delighted to collaborate with Daiichi Sankyo to expand our commercialisation efforts in the US in order to get this important medicine to the large number of patients suffering with opioid-induced constipation. Our agreement reflects our evolving business model by creating value from our portfolio through externalisation activity. Together, we will grow the potential of this important treatment, while we retain our significant interest in the long-term commercial success of Movantik in our largest market.”

AstraZeneca's once-daily Xigduo XR tablets approved in US

The US Food and Drug Administration has approved AstraZeneca's once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.

Xigduo XR combines two anti-hyperglycaemic agents with complementary mechanisms of action, dapagliflozin (trade name in the US, FARXIGA), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.

Xigduo XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. XIGDUO XR is indicated as an adjunct therapy to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

“The addition of Xigduo XR to our US diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes,” said Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development, AstraZeneca. “The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalised approach to disease management.”

Xigduo XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. Xigduo (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.

AstraZeneca partners with Illumina to develop next generation

AstraZeneca has entered into a collaboration with gene sequencing company, Illumina, Inc., to develop its next generation sequencing (NGS) platform for companion diagnostic tests applicable across AstraZeneca’s oncology portfolio.

In the first instance, AstraZeneca intends to apply Illumina’s cutting-edge technology to a novel companion diagnostic test in pivotal studies for one of its investigational oncology compounds. This is expected to be one of the first NGS-based companion diagnostic tests for a novel drug in the world, and its application could speed the clinical trial process.

Illumina’s NGS technology allows rapid sequencing of multiple genes in a much faster and cheaper way than traditional DNA sequencing methods. Under the collaboration, it will be used to screen a panel of several gene sequences, scanning for all possible genetic variants — known and unknown — rather than specified mutations from a single tumour sample.

AstraZeneca reports positive results from phase III programme of CAZ-AVI

AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal phase III studies investigating the potential of the antibiotic ceftazidime-avibactam (CAZ-AVI) as a treatment for hospitalised adult patients with complicated intra-abdominal infections.










CAZ-AVI consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor (avibactam). CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming resistant to antibiotics and pose an increasing threat to public health. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.

The global RECLAIM-1 and RECLAIM-2 phase III studies both evaluated the safety and efficacy of CAZ-AVI, administered intravenously as a two hour infusion (2000 mg / 500 mg) plus metronidazole, compared to meropenem, administered intravenously as a 30 minute infusion (1 g), in hospitalised adult patients with complicated intra-abdominal infections. Data from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset with the agreement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In the RECLAIM-1 and RECLAIM-2 phase III studies, CAZ-AVI met the objective of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomisation (the Test of Cure visit). CAZ-AVI also treated cIAI patients infected with ceftazidime-resistant bacteria as effectively as meropenem.

Dow Corning opens application development centre in Mumbai

Dow Corning, one of the leading global players in innovative silicon-based technologies, has set up a new application development centre in Mumbai to serve the growing demand for silicone materials and services in the India region. This centre enables state-of-the art local support for Dow Corning’s global innovation and sustainability initiatives, as well as closer collaboration with customers to provide solutions customised for the region.

AstraZeneca to acquire rights to Almirall's respiratory

AstraZeneca has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments.

Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialisation of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira (aclidinium); LAS40464, the combination of aclidinium with formoterol which has been filed for registration in the EU and is being developed in the US; LAS100977 (abediterol), a once-daily long-acting beta2-agonist (LABA) in phase II; an M3 antagonist beta2-agonist (MABA) platform in pre-clinical development (LAS191351, LAS194871) and phase I (LAS190792); and multiple pre-clinical programmes. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca.