Acquisitions /mergers/joint-ventures

AstraZeneca has agreed to acquire a 55% stake in Acerta Pharma (Oss, The Netherlands) for $4 billion, in order to acquire acalabrutinib, a treatment for cancer and autoimmune diseases, and has the option to acquire the remaining of Acerta for a further $3 billion.

Horizon Pharma (Dublin, Ireland) acquires Crealta Holdings (Glendale, WI, USA), in an all cash deal valued at $510 million, and gets access to Krystexxa the only US FDA approved drug for chronic refractory gout.

Business

Sanofi has entered in exclusive negotiations with Boehringer Ingelheim in a swap of Merial, its animal health business for Boehringer’s consumer health operation. Merial is valued at €11.4 billion, Boehringer’s consumer health business at €6.7 billion and the German group would pay Sanofi €4.7 billion as part of the deal. Boehringer's Chinese consumer healthcare unit would be excluded from the transaction.

AstraZeneca bets on Asia to sustain its growth:

through the acquisition of Takeda Pharmaceutical’s respiratory business for $575 million, including expanded rights to roflumilast or Daliresp for the treatment of chronic obstructive pulmonary diseases.

….and the expansion of its partnership with WuXi AppTec (Wuxi, China) to develop biologics in China in the areas of respiratory, inflammation, autoimmune, cardiovascular and cancer diseases. Under the terms of the deal AstraZeneca has the option to acquire WuXi’s biologics manufacturing facility in Wuxi City.

ViiV Healthcare (London, UK) acquires Bristol-Meyers Squibb’s investigational HIV drugs for $1.5 billion. ViiV will pay BMS an upfront of $350 million as well as development and regulatory milestone payments of up to $518 million for the clinical assets, and up to $587 million for the discovery and preclinical programs. The transaction does not include any of BMS’ already marketed HIV drugs. 

Eli Lilly and Merck are further expanding their ongoing collaboration in their immune-oncology alliance in order to evaluate the combination of abemaciclib, Lilly’s cyclin-dependent kinase 4 and 6 inhibitor and Merck’s Keytruda checkpoint inhibitor across multiple tumors types. Abemaciclib is currently in currently in Phase III development with two trials in breast cancer patients, as well as a Phase III trial in lung cancer. Last month both companies had already expanded their collaboration to test a combination of their respective drugs Alimta and Keytruda for the treatment of lung cancer.

Amgen regains rights to Prolia or denosumab, XGEVA or denosumab and Vextibix or panitumumab in 48 countries in Asia, South America, Europe, and other regions from GlaxoSmithKline. Under the terms of the agreement, Amgen will pay GSK undisclosed milestone payments upon signing and on the successful transition of the products which should occur within the next 12 months.

Takeda Pharmaceuticals makes a major move into regenerative medicine and enters a 10 years-partnership with Kyoto University Center for induced pluripotent stem cells (iPS) Cell Research and Application (CiRA) to research and develop induced pluripotent stem cell-based therapies against six initial targets including cancer, heart failure, neurodegenerative diseases, intractable muscle disorders and amyotrophic lateral sclerosis. Takeda will fund R&D costs of up to $164 million. Kyoto University professor Shinya Yamanaka, head of CiRA and Nobel Prize laureate in 2012 in physiology and medicine said the joint research provides best opportunity for clinical applications of drugs based on iPS cells. This agreement by Takeda follows a series of recent deals in the regenerative medicine field made by Japanese companies: Sumitomo Dainippon Pharma with CiRA for the treatment of Parkinson’s disease, Fujifilm Holdings through the acquisition of Cellular Dynamics and Astellas Pharma through the acquisition of Ocata Therapeutics.

AstraZeneca has entered a three-year collaboration with Sweden’s Wallenberg Center for Protein to explore new applications for proteins secreted by cells collectively known as the “secretome” which accounts for around one third of human proteins. The Wallenberg Foundation is providing a $37 million grant over eight years for the new center, while AstraZeneca will contribute $1.2 million a year for three years collaboration.

Evotec (Hamburg, Germany) extends its existing collaboration with Spero Therapeutics (Cambridge, MA, USA) aimed at discovering and developing new antibacterials.Financial details were not disclosed.

Approval of drugs, vaccines, diagnostics and devices

US FDA approves: 

Wellsat/BTG’s Vistogard (uridine triacetate) as the first and only drug to treat patients following an overdose of 5-fluorouracil (5-FU) or capecitabine (a pro-drug of 5-FU),or in patients or severe allergic reaction or life-threatening toxicity.

Roche/Genentech’s Alecensa or alectinib, a tyrosine kinase inhibitor, to treat patients with advanced metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer who do not respond to Xalkori or crizotinib.

Merck’s Bridion or sugammadex, as a treatment to reverse the effects of rocuronium bromide and vecuronium which are administered during surgery to induce neuromuscular blockade.

….And Eli Lilly’s Basaglar a biosimilar version of Sanofi’s Lantus or insulin glargine, a long-acting insulin analog. Both companies have settled their patent dispute in September (newsletter # 40).

European Commission approves Amgen’s Imlytic, or T-Vec (talimogene laherparepvec), the first oncolytic immunotherapy approved in the European Union for the treatment of metastatic melanoma. T-Vec is an oncolytic immunotherapy which is injected directly into tumor tissue where it replicates until the membrane of the cancer cells rupture.

Drugs at clinical stage

US FDA grants fast-tack status :

to MediciNova’s (La Jolla, CA, USA) MN-166, or ibudilast for the treatment of amyotrophic lateral sclerosis. MN-166 is an orally available, small molecule phosphodiesterase-4 and -10 inhibitor and a macrophage migration inhibitory factor inhibitor, that suppresses pro-inflammatory cytokines and promotes neurotrophic factors.

…and to Cardiorentis’ (Zug, Switzerland) Ularitide, a natriuretic peptide, for the treatment of decompensated heart failure.  

European Commission grants orphan status to OXIGENE’s (South san Francisco, CA, USA) OXi4503, for the treatment of acute myeloid leukemia. OXi4503 (combretastatin A1 di-phosphate/CA1P) is a dual mechanism vascular disrupting agent which destroys tumor vasculature and leads to necrosis and extensive tumor cell death.

Science and Technology

Scientists from the Systems Biology Laboratory at the University of Melbourne (Australia), led by Prof. Peter Gawthrop, have developed a mathematical model of cell energy flow in biochemical networks which could help understanding certain diseases. The model is based on what is known as the "bond graph approach," which was originally developed for modeling complex, man-made engineering systems, where energy generation, storage and transmission are fundamental.

Medical Devices and Diagnosis News

New technology, called spectral Computed Tomography imaging, can detect up to eight X-ray energy channels simultaneously allowing color assignment to specific molecular signatures for improved identification of abnormalities such as cancer tumors.

Cost, Pricing and Market Access

The UK National Institute for Health and Care Excellence (NICE):

has approved Biomarin’s (San Rafael, CA, USA) Vimizin or elosufase alpha for the ultra-rare disease mucopolysaccaridosis type IV. People born with the disease lack an enzyme that breaks down large sugar molecules the body does not utilize, leading to their accumulation in tissues and organs causing a wide range of symptoms such as joint and skeletal abnormalities, hearing and vision loss, heart valve disease and chronic pain. 

has issued draft guidelines recommending Novartis’s Entresto (an combination of sacubitril and valsartan) for the treatment of chronic heart failure with reduced ejection fraction. Entresto is the first treatment shown to offer a significant mortality benefit over enalapril, an ACE inhibitor, with data from the a 8,442 patient PARADIGM study demonstrating that it cuts cardiovascular deaths by 20%, as well as heart failure hospitalisations and all-cause mortality by 21% and 16%, respectively.

…. But rejects Roche’s Kadcyla for the treatment of breast cancer as well as Bristol-Meyers Squibb’s Opdivo for the treatment of squamous non-small cell lung cancer in claiming the drugs’ high price. NICE in a statement said Kadcyla was just too expensive to cover at £90,000 ($136,000) per patient, even Roche offered discounts and that Opdivo is too expensive at £ 86,600 ($130 000) to justify, despite substantial clinical benefits compared with the only other alternative for relapsed patients, Sanofi's Taxotere. 

Miscellaneous

BeiGene (Beijing China) has chosen GE Healthcare Flexfactory platform to produce its monoclonal antibody BGB-283, a RAF dimer inhibitor for the treatment of various cancers. The Flexfactory system to culture cell lines combines zinc finger nuclease gene editing and the glutamine synthetase CHO cell line.

A report by WHO shows that China has raised to the world top ranking with the most cancer cases, which is becoming an increasing healthcare cost issue. China's cancer crisis takes an estimated 2.2 million lives each year.

Novartis has opened a 550,000 square-foot, $600 million facility in Cambridge (MA, USA) and expands its R&D capabilities in the US.

Bioevents

• BIOTech ShowCase 2016 on January 11-13 in San Francisco (USA)
• JP Morgan 33^rd Annual Healthcare Conference on January 12-16 in San Francisco (USA)
• BIO CEO Investor Conference on February 8-9 in New York City (USA)
• BIO Asia 2016 on March 15-16 in Tokyo (Japan)
• 9^th European Life Science CEO Forum and Exhibition on March 15-16 in Zürich (Switzerland)
• Global Healthcare Forum on March 16-17 in Singapore (Singapore)
• BIOPharma Asia Convention on March 22-24 in Singapore (Singapore)
• BIO Europe Spring on April 4-6 in Stockholm (Sweden)
• BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)
• BIO Vision on April 13-14 in Lyon (France)
• BIO Trinity on April 25-27 in London (UK)
• BIOEquity Europe 2016 on May 10-11 in Copenhagen (Denmark)
• Strategic Alliance Management Congress on May 16-18 in Philadelphia (USA)
• China BIO Partnering on May 18-19 in Suzhou (China)
• BIO International Convention on June 6-9 in San Francisco (USA)

 IMPORTANT NOTICE: This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.

Author: Jean-Claude Muller, Special Advisor at I&IR, jcm@btobioinnovation.com

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