Acquisitions /mergers/joint-ventures

According to Bloomberg, Shire is in advanced talks with Baxalta (Bannockburn, Ill, USA), the biopharma spin off company of Baxter, in a deal expected to reach $32 billion. In August of 2015 Baxalta’s management had rejected an unsolicited offer by Shire worth $30 billion.

Business

Baxalta (Bannockburn, Ill, USA) and Symphogen (Copenhagen, DK, USA) enter a collaboration on the development of six investigational immune-oncology therapies in a deal worth $1.6 billion.Under the terms of the agreement, Baxalta will pay an upfront payment of $175 million and up to $1.4 billion in contingent development and regulatory milestone fees.

Merck KGaA, Pfizer and Syndax Pharmaceuticals (Waltham, MA) enter into an exclusive strategic collaboration to evaluate the activity and safety of the combination of avelumab, an anti PD-L1 IgG1 monoclonal antibody, and Syndax’s entinostat, a small molecule HDAC inhibitor, in patients with recurrent ovarian cancer. Avelumab is currently being tested across a range of tumor types.

Fibrocell Science (Exton, PA, USA) and Intrexon (Germantown, MD, USA) partner to develop genetically modified fibroblasts for the treatment of joint diseases such as arthritis. Under the terms of the deal Fibrocell will pay a $10 million access fee in cash and up to $52.5 million in milestone fees and royalties on sales of products emerging from the collaboration. The partnership will allow the combination of Fibrocell’s proprietary technology for culturing and multiplying a person’s own fibroblasts with Intrexon’s cellular engineering capabilities to generate cell-based therapeutics.

Bristol-Meyers Squibb and Oncodesign (Dijon, France) enter a strategic collaboration to discover, develop and commercialize novel macrocyclic anti-cancer drugs. The alliance will use Oncodesign’s platform of small macrocycles, Nanocyclix, to generate novel compounds for targets of interest to BMS. Under the terms of the deal BMS will make an upfront payment of $3 million and subsequent development milestone payments of up to $80 million per target, as well as tiered royalties and sales-based milestones.

Roche partners with UK Department of Health, the research arm of the National Institute for Health Research (NIHR), to assess the potential of toclizumab, a marketed arthritis biologic, as a treatment for pulmonary arterial hypertension. The partnership is part of the NIHR’s Rare Disease Collaboration, set up in 2013 and supported by a £20 million investment to accelerate research into rare diseases.

Sanofi terminates its license and collaboration agreement, announced in August 2014, for the development and commercialization of Mannkind’s Affreza, an inhaled insulin powder. Under the initial agreement Sanofi had paid a $150 million upfront and had committed up to $775 million in milestones

Approval of drugs, vaccines, diagnostics and devices

US FDA has approved 45 new medicines in 2015, overshooting the 2014 figure of 41 and hitting a record high since 1996. Similar to last year approvals of rare disease therapies accounted for 40%. Meanwhile, the European Medicines Agency recommended the approval of 93 new medicines in 2015, 11 more than in the prior year (thesefigures include generics). Counting just drugs with new active substances, the EMA positive opinions are on a par with the approvals of the US FDA.

Sanofi Pasteur (Lyon, France) announced that Brazil has granted regulatory approval to Dengvaxia, its dengue vaccine, representing the third approval after Mexico and Philippines.

Chinese FDA approves two Enterovirus 71 (EV71) vaccines against hand, foot and mouth disease (HFMD) a common disease often found in children; the first one made by the Institute of Medical Biology at the Chinese Academy of Medical Sciences and the second one developed by Sinovac (Beijing, China). According to the World Health Organization, in 2014, China reported 2.7 million cases and 394 deaths, far more than its neighbors countries did in the same year.

Drugs at clinical stage

US FDA grants rare pediatric disease designation to RegenXBio (Rockville, MD, USA) RGX-111, a gene therapy product, for the treatment of mucopolysaccaridosis type 1, an inherited disorder caused by the lack of an enzyme called alpha-L-iduronidase which plays an essential role in the breakdown of long chains of sugar molecules.

US FDA grants orphan status to:

• TapImmune’s (Seattle, WA, USA) TPIV 200 multi-epitope folate receptor alpha vaccine to treat ovarian cancer. Of the evaluable patients in the phase 1 trial, 95% showed an initial immune response after treatment, and 80% showed a continued response after three months.
• Pluristem Therapeutics’ (Haifa, Israel) PLX-PAD cells as a treatment for women with severe preeclampsia, a complication of pregnancy characterized by high blood pressure and signs of organ damage occurring in about 1% of pregnancies in the Western world. PLX-pad are mesenchymal-like adherent stromal cells derived from full term human placentas.
• Global Blood Therapeutics (South San Francisco, CA, USA) for GBT 440 as a treatment of sickle cell disease, also known as sickle-cell anaemia, a hereditary blood disorder caused by an abnormality in red blood cells This leads to a propensity for the cells to assume an abnormal, rigid, sickle-like shape sticking and accumulating at the branching point in a vein.  GBT440 is an oral, once-daily drug that works by increasing hemoglobin's affinity for oxygen. Oxygenated sickle hemoglobin does not polymerize and since GBT 440 blocks polymerization it prevents the sickling of red blood cells.
• Ionis Pharmaceuticals (former Isis Pharmaceuticals, Carlsbad, CA, USA), IONIS-HTTrx, a Gen. 2.0+ antisense drug, for the treatment of patients with Huntington’s disease. IONIS-HTT_Rx is the first therapy designed to directly target the cause of the disease by reducing the production of the protein involved.. In Huntington’s disease, the gene that encodes for the HTT protein contains a trinucleotide sequence that is repeated in the gene more than 36 times. The resulting HTT protein is toxic and gradually damages neurons in the brain. The drug is being developed in partnership with Roche which also received orphan designation by the European Medicines Agency.

Science and Technology

Recurrence of HER2-positive breast cancer after treatment may be due to a specific and possibly cancer-induced weakness in the patient's immune system — a weakness that in principle could be corrected with a HER2-targeted vaccine — according to a new study from the Perelman School of Medicine at the University of Pennsylvania. Results of the study show that T cells from patients whose breast cancer had recently recurred showed far weaker response to the HER2 receptor protein, compared to T cells from patients whose breast cancer had not recurred over a long period following treatment.

Medical Devices and Diagnosis News

Novartis and Qualcomm Life (San Diego, CA, USA), a world leader in 3G, 4G, and next-generation wireless technologies, extend their collaboration on the development of a digital version of Breezhaler, a device used to treat chronic obstructive pulmonary disease. The new device which incorporates a small, disposable low power module and a Novartis dedicated smart phone application, will enable patients and health providers to have access to real-time data related to the use of the product and the monitoring of the condition. Novartis plans to launch the device in 2019.

Unilife (York, PA, USA) enters a non-exclusive deal to supply Amgen with already existing wearable injector devices “for use with certain large volume drug products” as well as its 1 ml wearable injector “for use with certain small volume drug products”. Under the terms of the deal, Amgen will pay a $15 million upfront payment as well as payments for each device manufactured. The agreement also calls for the two companies to exclusively negotiate a grand alliance until at least Jan. 31.

Miscellaneous

Abbott closes its Redwood City (CA, USA) vascular devices manufacturing facility and lays off 144 employees.

Bioevents

Notice that Pharma-Biotech and IVD events have been up-dated for 2016 : 

      Pharma-Biotech Events 2016

       In vitro Diagnostic Events 2016

• ChinaBio and BayHelix 13^th Annual Conference on January 10 in San Francisco (USA)
• 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)
• BIO Pharm America on September 13-15 in Boston (USA)
• 7^th Innovation Days on October 3-4 in Paris (France)
• Biofit 2016 on November 30-December 1 in Lille (France)

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

Notice that next newsletter will be published for the end of January.

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