April 21, 2015

Teva offers $40 billion to acquire Mylan

In our newsweek15 we had indicated that the unsolicited offer of Mylan (UK and The Netherlands) to acquire Perigo (Dublin, Ireland) was a defensive move to avoid an imminent hostile takeover. Tuesday was bad news for Mylan when it got confirmation that Teva (Tel Aviv, Israël) had stepped out with a $40 billion offer (split of 50/50 between cash and stock) to acquire the company and that the targeted company Perigo rejected its offer of $29 billion, stating that 26 times EBITDA is to low.  As expected, in order to stay on a standalone path, Mylan increased its initial offer over Perigo which is now worth $31.2 billion. Industry analysts still believe that Teva will also boost its offer from $82 to about $90 a share and ultimately prevail.

St. Jude exercises option to acquire Spinal Modulation for $175 million

St. Jude Medical (St Paul, Minn, USA) will buy Spinal Modulation (Menlo Park, CA, USA) and acquire its Axium Neurostimulator system to treat chronic pain. St Jude will pay an upfront of $175 million with additional milestones upon FDA approvals. The Spinal Modulation system works via dorsal root ganglion (DRG) stimulation that targets nerves located along the vertebral column, while traditional spinal cord stimulation (SCS) targets nerves in the dorsal column.

Business

April 19, 2015

Takeda signs stem cell agreement with Kyoto University and R&D agreement with Keio and Niigata Universities

Takeda Pharmaceuticals (Tokyo, Japan) and Kyoto University Center for iPS Cell Research Application (CiRA) have entered an agreement to accelerate multiple research projects using induced pluripotent stem cells and discover new drugs. Shinya Yamanaka, CiRA’s director and Nobel laureate will direct the programme. Under the terms of the deal Takeda will fund up to $168 million over a ten-year period and $100 million in research support.

Takeda also unveiled an R&D alliance with Keio University of Medicine and Niigata University to study disease related RNA-binding proteins. Takeda indicated that there is increasing evidence that some disease onset and progression are directly linked to abnormalities of RNA-binding proteins. Terms of the deal were not disclosed.

April 20, 2015

Roche signs a $ 555 million cancer immunotherapy deal with Curadev

Roche announced a collaboration with Curadev (New Dehli, India) in the development and commercialization of IDO1 (indoleamine 2,3-dioxygenase-1) and TDO (tryptophan -2,3- dioxygenase) inhibitors, two enzymes involved in the mediation of cancer induced immune suppression. Dual inhibition of both enzymes is expected to maintain the immune response and prevent tumors from immune escape. This original approach gets Roche into the race for novel immunotherapies in particular when used in combination with its own cancer drugs. Under the terms of the deal Roche will pay a $25 million upfront and $530 million in milestones for Curadev’s lead candidate.

Quest collaborates with French INSERM to expand breast and cancer diagnostics

Quest Diagnostics (Madison, NJ, USA) is teaming up with INSERM (Paris, France) the French National Health and Medical Research Agency to create an extended database for breast and cancer ovarian cancer genes and discover novel diagnostics tools. The project intends to collect and maintain a database of BRCA1 and BRAC2 genetic testing data through laboratories that are part of the UniCancer genetic group. LabCorp had already signed onto the project as the first corporate participant.

April 24, 2015

AstraZeneca/MedImmune explores potential immune-oncology combination therapies of MEDI4736 with three new partners:

• With Innate Pharma (Marseille, France) to accelerate and broaden the development in solid tumors of IPH2201 – a humanized IgG4 antibody acting as immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic natural killer and CD8 T lymphocytes- as well as the combination with MEDI4736 – a monoclonal antibody against programmed cell death ligand (PD-L1) check point inhibitor. Under the terms of the agreement Innate will receive an upfront milestone of $250 million, a $100 million milestone upon start of Phase III, up to $925 million in regulatory and sales milestones and double digit royalties.

• With Celgene International II (Boudry, Switzerland) to develop and commercialize MEDI4736, a human monoclonal antibody PD-L1 checkpoint inhibitor in combination with Celgene’s cancer products in blood cancers. Under the terms of the agreement Celgene will pay an upfront payment of $450 million and lead the clinical trials. Celgene will receive global rights to MEDI4736 for hematology indications and receive royalties on sales.

• and with Juno Therapeutics (Seattle, WA;, USA) to explore the potential of the combination of MEDI4736 with Juno’s CD19-directed chimeric antigen receptor (CAR)-T cell candidates for the treatment of non-Hodgkin lymphoma.  A phase 1 study to assess the value of the combination of both drugs is expected to start later this year. Financial terms of the deal were not disclosed.

Approval of drugs, vaccines, diagnostics and devices    

US FDA approves Siemens breast 3D tomosystem

Siemens (Munich, Germany) gains US FDA approval for its Mammomat Inspiration with breast cancer Tomosynthesis Option, as the latest advance for 3-D imaging technology. Last September the Agency had issued a statement advocating companies for improvement in this technology. The newly approved system gives the option to use both 2-D and 3-D screening and moves in a circular mode around the breast to take an image at every two degrees through an angular range of 50 degrees which allows the 3-D construction. Tomosynthesis provides 50 to 100 times the amount of data as 2-D mammography. Main actors in the field are GE Healthcare, Senoclair, Koning, Siemens and VuComp.

Long term clinical data shows Lemtrada slows brain atrophy in MS patients

Genzyme’s Lemtrada (alemtuzumab) has been approved for the treatment of relapsing forms of multiple sclerosis (MS) by the European Commission in September 2013 and by the US FDA in November 2014. Data from an extension study of a phase 3 trial show a significant decrease in brain atrophy (measured by MRI) over a three years period.

Drugs at clinical stage

Immunotherapies will become a major weapon in the oncology arsenal

There is now mounting evidence that immunotherapies will become a major weapon in the oncology arsenal. New results were presented last week at the American Association for Cancer Research in Philadelphia.  Keytruda, or pembrolizumab, from Merck has been shown to be far more active that Yervoy (BMS) alone in the treatment of melanoma. BMS has also shown that Opdivo, in combination with Yervoy, was efficacious in 61% of patients with complete remission in 22% of the treated population. But even more striking are the recent results obtained with Keytruda and with Opdivo in the treatment of non-small cell lung cancer (NSCLC) which constitutes a much larger market than melanoma. Roche which is currently the leading company in the oncology field had not been present in the immunotherapy field until its recent agreement with CuraDev and AstraZeneca announced three deals this week to optimize possible combinations of its proprietary MEDI4736 – a monoclonal antibody against programmed cell death ligand (PD-L1) check point inhibitor. (see business activities above)

US FDA grants orphan status:

• to RXi (Marlborough, MA, USA) for Samcyprone. RXI Pharmaceutical has announced that is has received orphan drug designation from the FDA for Samcyprone, a topical treatment for use in stage IIb to IV malignant melanoma. Samcyprone is a topical formulation of diphenylcyclopropenone which works by eliciting a T-cell response through alteration multiple gene expression.

• to Oncolytics Biotech (Calgary, Canada) for Reolysin or pelareorep, an oncolytic virus, for the treatment of malignant gliomas. The drug had already received orphan drug status for pancreatic and ovarian cancer

• to Capricor (Los Angeles, USA) for CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive loss of muscle and weakness. CAP-1002 are cardiosphere-derived cells (CDCs) obtained from donor heart tissue which are directly infused into a patient’s coronary artery.

• to CymaBay Therapeutics (Newark, CA, USA) for MBX-8025 for the treatment of hyperproproteinemain types I or V. Type I is characterized by deficiencies related to lipoprotein lipase (LPL) and by an elevation of chylomicron particles, while type V is characterized by an elevation in very-low-density lipoprotein (VLDL). MBX-8025 is a potent and selective peroxisome proliferator-activated receptor delta (PPAR d) agonist which already received FDA orphan drug status for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).

April 21, 2015

US FDA grants Pfizer’s Xalkori breakthrough therapy for ROS-1 lung cancer

Pfizer’s Xalkori was granted a breakthrough therapy designation from the US FDA for treating patients with ROS1-positive form of non-small cell lung cancer, a subgroup representing around 1% of NSCLC cases. Xalkori is already approved in the US for the treatment of patients with metastatic NSCLC whose tumours are anaplastic lymphoma kinase (ALK)-positive

US FDA grants fast track designation to Eiger’s hepatitis delta virus inhibitor

Eiger Biopharmaceuticals (Palo Alto, CA, USA) was granted fast track designation by US FDA for Lonafarnib combination with Norvir (ritonavir from AbbVie) for the treatment of hepatitis delta virus infection (HDV).  Lonafarnib is an orally active agent that targets farnesyltransferase, which inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply. Lonafarnib was already granted orphan drug designation by the FDA and the European Medicines Agency in 2014.

Ebola

April 21, 2015

Advancing development of Ebola vaccine trials

As the current Ebola outbreak wanes, scientists have to prepare for future outbreaks and identify new, safe and effective Ebola vaccines. Texas supercomputers have aided researchers in modelling which types of clinical trials will provide the best information.

Bio and Business Events

• Swiss Italian Healthcare Licensing Groups, on May 7-8 in Lugano (Switzerland)
• Biotrinity 2015 on May 11-13 in London (UK)
• MedTech Partnering Forum on May 28-29 in Tokyo (Japan)
• IIR’s IN3 EuroMedtech 2015 on June 10-11 in Vienna (Austria)
• BIO International Convention on June 15-18 in Philadelphia (USA)
• Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
• 3^rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
• BioPharm America 2015 on September 15-17 in Boston (USA)

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

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