Biopharmaceutical News Week 19-20

Acquisitions /mergers/joint-ventures

Alexion acquires Synageva for $8.4 Bn and expands in rare-disease market

Alexion Pharmaceuticals (Cheshire, CT, USA) buys Synageva BioPharma (Lexington, MA, USA) for $8.4 billion, at twice its current value, to expand its activities in drugs for rare diseases.  The purchase of Synageva gives Alexion access to its lead product Kanuma (sebelipase alpha) which has been filed both in Europe and the US for LAL deficiency. The combined portfolio of both companies will consists of eight innovative products tackling eleven indications and substantially expands Alexion’s current potential which currently has only Soliris (eculizimab), for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare diseases on the market.


… and invests $513 M in a biologics manufacturing site in Dublin (Ireland)


Morphosys acquires Lanthio Pharma for €20 M

Morphosys (Martinsried, Germany) expands its drug portfolio through the acquisition of all outstanding shares of Lanthio Pharma (Groningen, The Netherlands), a peptide specialist, for roughly €20 million. The main asset in Lanthio’s portfolio is LP2, now MOR107, a selective angiotensin 2 agonist lanthipeptide, for the treatment of fibrotic diseases and diabetic nephropathy.


On the Teva, Mylan, Perrigo saga front

Mylan’s Chairman Coury repeated once more that his company is not interested to selling itself to Teva. He could consider a deal with the Israeli based company as long as he is doing the buying. Mylan’s CEO, Heather Bresch went as far as explaining that her management team would be more capable than Teva to lead the merged companies. In the meantime Perrigo has now thrice rejected the bid proposed by Mylan and analysts belive a sweeten offer is being prepared.


Gilead acquires Danish EpiTherapeutics for $65 million

Gilead Sciences (Foster City, CA, USA) moves into epigenetic research by acquiring EpiTherapeutics (Copenhagen, Denmark) for $65 million in cash. The Danish company has a library of small molecules containing inhibitors of histone demethylases implicated in cancer disease regulation.


Juno acquires German Stage Cell Therapeutics

Juno Therapeutics (Seattle, WA, USA) acquires Stage Cell Therapeutics (Munich and Göttingen, Germany) with an upfront payment of €52.5 million in cash as well as 486,279 Juno’s shares. Juno also agreed to make success milestones payments up to €135 million. Stage Cell Therapeutics has developed technology for isolating cells from donors that can be used to treat patients with viral infections, cancer and autoimmune diseases.




Beijing Sciences Sun Pharmaceutical (Beijing, China) has announced the filing of its ChiNext IPO application with the CSCR and plans to raise $174 million to fund its business expansion


WuXi’s CEO moves to take the company private

Ge Li, WuXi PharmaTech’s (Cayman and Shanghai, China) CEO has teamed up with Ally Bridge Group Capital Partners in an attempt to take the Chinese company private in proposing $46 for each share through a non-binding offer.


…and invests $150 million in a cell culture manufacturing facility

WuXi Biologics a subsidiary of WuXi PharmaTech invests $150 million in the construction of the world’s largest mammalian cell production facility using disposable bioreactors, in Wuxi (China), to support its biological manufacturing potential.


Galapagos raises $275 million in its Nasdaq IPO

Galapagos (Mechelen, Belgium) announces that it raised $275 million in its Nasdaq Initial Public Offering (IPO) after AbbVie has placed a provisional order for a $30 million stake. 


Bayer invests $155 M to access Isis anticoagulant

Bayer (Leverkusen, Germany) spends $155 million to access Isis Pharmaceuticals (Carlsbad, CA, USA) anticoagulant ISIS-FXIRx, a first in class antisense Factor XI inhibitor for the prevention of thrombosis. The deal is structured around a $100 million upfront payment, an additional $55 million should the drug advance past the current program and undisclosed regulatory and commercial milestones as well as tiered royalties.


Pfizer collaborates with 23andME on lupus research study

Pfizer and 23andME (Mountain View, CA, USA) have entered a collaboration to carry out research studies in lupus. Lupus Research Institute, a private organization, who supports pioneering research in the area will also be involved in the collaboration. 23andME will incorporate genetic information from participants’ medical records after securing their consent.

… and invests into AM-Pharma to develop novel anti-inflammatory agents

Pfizer has taken a minority stake investment of $87.5 million in privately owned AM-Pharma (Bunnik, The Netherlands) with an exclusive option to acquire the entire company in a deal potentially worth $600 million. The option becomes exercisable upon completion of an ongoing phase 2 trial assessing RecAP for the treatment of acute kidney failure related to sepsis. RecAP is a human recombinant form of the naturally occurring Alkaline Phosphatase that protects organs against inflammation and tissue damages.


GSK forms a public-private partnership in HIV with University of North Carolina

GlaxoSmithKline and the University of North Carolina team up to establish a HIV Cure center with the launch of a new jointly-owned company named Qura Therapeutics, located in Chapel Hill. The goal is to find a cure for HIV infection based on a “shock and kill” approach which aims to unveil hidden virus that persists despite successful drug therapy


Lilly partners with BioNTech on immunotherapies

Eli Lilly and BioNTech (Mainz, Germany) have entered into a research partnership to discover novel cancer immunotherapies in targeting T cell receptors. BioNTech will receive $30 million as an upfront payment and $300 million for each potential new drug hitting marketing approval.


…. and with Sandford-Burnahm on check point modulators

Eli Lilly partners with non-profit medical research institute Sanford-Burnham (La Jolla, CA and Orlando, FL, USA) to discover and develop new immunotherapies targeting multiple immune checkpoint inhibitors.


Baxter acquires Sigma-Tau leukemia drugs for $900 M

Baxter International (Deerfield, IL, USA) agreed to pay $900 million to acquire Sigma-Tau’s (Pomezia, Italy) leukemia drug Oncaspar, or pegaspargase. The deal also gives Baxter the rights to another acute lymphoblastic leukemia drug, calaspargase pegol. Both products will be handled by Baxalta which is expected to be spun off from Baxter later this year.


Selecta extends its collaboration with Sanofi in coeliac disease immunotherapy

Sanofi exercises option for exclusive rights to coeliac disease immunotherapy, an autoimmune disorder, from privately-held Selecta Biosciences (Watertown, MA, USA). Under the terms of the deal Selecta will receive up to $300 million in milestones and double-digit tiered royalties. The developed products are based on Selecta’s Synthetic Vaccine Particle platform.  Coeliac disease is a gluten induced chronic small bowel inflammation disorder causing a range of symptoms including diarrhea, abdominal pain, weight loss and hypoproteinaemia.


…..and collaborates with French Genethon

Selecta Biosciences and Genethon (Evry, France), a French non-profit organization, have agreed to collaborate in the research and development of gene therapies to treat rare diseases including muscular dystrophies and pediatric liver metabolic diseases. Terms of the collaboration were not disclosed.


Approval of drugs, vaccines, diagnostics and devices    


EU approves Novartis’ lung cancer drug Zykadia

Just one year after US FDA approval, the European Medicine Agency has approved Novartis’s Zykadia (ceritinib) for use in anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer who have progressed on or are intolerant to critozinib, the current standard care.


US FDA approves Roche’s KRAS mutations test

The US FDA has approved Roche’s diagnostic test for KRAS mutations to select the most effective treatment for patients with colorectal cancer. 


US FDA holds public meeting on off-label drug promotion

In conjunction with the 21st Century Cures Act, the US FDA has scheduled a public meeting this summer to address concerns by the pharmaceutical industry that regulatory restrictions on what it can say about the off-label use of their products violates the First Amendment right to free speech. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.


Drugs at clinical stage


US FDA grants breakthrough status to AbbVie’s leukemia drug venetoclax

US FDA has granted AbbVie’s venetoclax breakthrough-therapy status for the treatment of relapsed or refractory chronic lymphocytic leukemia patients who have 17p deletion genetic mutations. The drug is being developed in partnership with Genentech.


US FDA Grants orphan status to Retrophin’s neurodegeneration treatment

Retrophin (San Diego, CA, USA) has received orphan status from the US FDA for RE-024 to treat pantothenate kinase-associated neurodegeneration (PKAN), a rare and lethal autosomal neurodegenerative disease.  


US FDA grants fast track to Merck and Threhshold’s pancreatic cancer drug evofosfamide

Merck KgaA (Darmstadt, Germany) and Threshold Pharmaceuticals (South San Francisco, CA, USA) have received US FDA fast track status for their pancreatic cancer drug evofosfamide. Evofosfamide is a hypoxia-activated prodrug currently in late-stage trials for both pancreatic cancer and soft tissue sarcoma, for which it already carries fast track status in the US. The drug is also in earlier trials for other solid tumours and blood malignancies.


Takeda and Orexigen end a cardiovascular safety study on obesity drug Contrave

The termination of a cardiovascular safety trial of obesity drug Contrave (naltrexone HCl and bupropion HCl) has triggered a dispute between Orexigen Therapeutics (San Diego, CA, USA) and Takeda Pharmaceuticals (Tokyo, Japan). The Executive Steering Committee chaired by Dr Steven Nissen, from the Cleveland Clinic, issued its own statement that the study was halted because trial data was allegedly leaked by Orexigen in March and may have compromised data integrity.


Indivior (Slough, UK), a spinout of Reckitt Benckiser announces positive Phase 3 primary endpoint of its schizophrenia drug RBP-7000



Liberia declared Ebola-free

The World Health Organization (WHO) has declared Liberia free of Ebola after the country has gone 42 days- twice Ebola’s maximum incubation period- without discovering a new case. The disease is still spreading in Sierra Leone and Guinea though at a slower pace. One consequence of the slowing down of the outbreak is that there is a very low chance that the vaccine trials going on in the West Africa countries will show efficacy since the number of cases has dropped substantially.


EU’s investment bank supports Bavarian Nordic Ebola’s immunotherapy programs with €50 million



China will remove drug pricing controls

China’s National Development and Reform Commission has announced that from June 1 it will remove pricing controls governing the majority of medicines to give the market more power in regulating surging healthcare costs. The Agency said it would “cancel government-set prices on most drugs to improve purchasing mechanisms for drugs, control costs for medical insurance and allow the trade price of medicines to be set by market competition”. But according to Reuters, industry observers believe its impact will be rather muted given that the majority of medicines in China are actually sold through hospitals rather than retail channels, “where a separate tender process helps keep prices down”.


Alibaba intends to enter quick healthcare products delivery

Alibaba Group Holding, China’s Internet giant, plans a “Ji Su Da” (fast delivery) of healthcare products such as OTC drugs in 1,500 drug stores in 5 China cities right now and 14 by the end of the year.


Global spending on cancer drugs hits $100 billion

According to IMS Health’s Global Oncology Trend Report, global spending on cancer drugs topped $100 million in 2014, a raise of 10.3% over the previous year and forecasts that future spending will continue in the 6%-8% range over the next five years. The figures show that the US still dominate the market with 42% of the total spend. The last five years has seen the launch of 45 new cancer drugs for 53 uses, including 10 new medicines last year, five of which were biologic therapies and two immunotherapies. The report also indicates that cancer survival rates have “steadily improved” over the last 20 years. In the US,  two-thirds of those diagnosed with cancer now live at least five years, compared to just over half in 1990, because of the availability of new medicines as well as increased screening, earlier detection and advances in surgical and radiation oncology.


Bio and Business Events


  • 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)
  • 3rd 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,


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