Biopharmaceutical News Week 28

Acquisitions /mergers/joint-ventures

 

Horizon launches a $3 billion hostile takeover bid over Depomed

Horizon Pharma (Dublin, Pharma) now made its takeover offer straight to Depomed (Newark, NJ, USA) shareholders after its initial approach was turned down by Depomed’s management. The offer consists in the acquisition of all outstanding shares of Depomed for $29.25 a share in an all-stock, tax free exchange which values the company at $3 billion, a 42% premium over its July 6 closing price.

Allergan acquires Oculeve a US medical device company for $125 million

Allergan (Dublin, Ireland) will acquire Oculeve (South San Francisco, CA, USA), an eye device company and its dry eye disease programmes for $125 million in an all cash transaction. Oculeve leading product, OD-01, consist in a non-invasive nasal neurostimulation device that increases tear production in patients with dry eye disease.

Business

Allergan acquires two migraine programmes from Merck for $250 million

Allergan (Dublin, Ireland) has acquired global rights to two Merck’s calcitonin gene-related development programmes to treat and prevent migraines. Under the terms of the deal Merck shall receive an upfront of $250 million plus undisclosed milestones fees and sales royalties.

AstraZeneca divests non US-rights of Entocort to Tilliots for $215 million

AstraZeneca sells its non-US rights to Entocort (budesonide) to Tilliots Pharma (Rheinfelden, Switzerland) for $215 million. Entocort, a corticosteroid, is indicated for the first-line treatment of mild-to-moderate Crohn's disease in the ileum and/or ascending colon.

Hospira wins contract with French AP-HP for Remicade biosimilar

Hospira, recently acquired by Pfizer, captured a large public contract with French’s Assistance Publique-Hôpitaux de Paris (AP-HP) to buy Remicade’s biosimilar version at a discount price of 45% over the Janssen’s branded version. AP-HP services cover nearly one fourth of the French population.

Sanofi extends its malaria collaboration with MMV

Sanofi and Medicines Malaria Venture (Meyrin, Switzerland), a nonprofit foundation created to discover, develop and deliver new, affordable antimalarial drugs through effective public-private partnerships, have announced the extension of their programme for the treatment of malaria. The groups began a three-year research project back in 2011 to develop OZ439/Piperaquine and OZ439/Ferroquine which both are single shot combination therapies independent of artemisin, which could offer crucial advantages given the growing resistance to artemisin.

Pfizer enters an immunology research programme with Jeffrey Modell Foundation

Pfizer and Jeffrey Modell Foundation (New York City, NY, USA) have entered a collaboration to conduct research into immunological diseases. Terms of the deal were undisclosed.

GSK partners with the University of California at San Diego on stem cells

GlaxoSmithKline will collaborate with University of California in San Diego to conduct research and development aimed at eradicating cancer stem cells to treat leukaemia and other diseases. The team will work on the discovery and development of a new therapeutic compound that inhibits RNA editing, a process cells use to enhance RNA diversity prior to translating genetic information into proteins. 

Novo Nordisk has stopped its collaboration with Zosano Pharma on a microneedle patch technology

Abivax with highly successful IPO on EuroNext

Abivax (Paris, France) has raised a record high $64 million IPO on Paris EuroNext and will be able to fund its vaccine programmes for hepatitis B and HIV.

Global Blood Therapeutics has filed its IPO

Global Blood Therpeutics (South San Francisco, CA, USA) has filed an IPO on and expects to raise as much as $115 million to develop sickle disease treatments

 

Approval of drugs, vaccines, diagnostics and devices

US FDA approves Novartis Entresto for heart failure

Novartis got FDA approval for Entresto for the treatment of heart failure six weeks early. In a large phase 3 study, the drug decreased heart related death by 20% when compared with enalapril. The drug is the first treatment shown to have a significant mortality benefit over an ACE-inhibitor. Entresto, also known as LCZ696, is acombination drug consisting of two antihypertensive drugs valsartan and sacubitril in a 1:1 mixture. The combination is often described as a dual-acting angiotensin receptor-neprilysin inhibitor (ARNi) achieved by two different molecules. The drug has the potential to become a megablockbuster.

EU approves:

MSD Simponi for the treatment of axial spondyloarthritis

Merck Sharp & Dohme’s received European Commission approval for the use of Simponi or golimumab for the treatment of non-radiographic axial spondyloarthritis. The drug was already approved for the treatment of ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis

….and Vanda Hetlioz for the treatment of sleep-disorder

Vanda Pharmaceuticals (Washington DC, USA) obtained approval from the European Commission for Hetlioz or tasimelteon as a treatment for non-24-hour sleep-wake disorder in blind adults. Hetlioz is a melatonin receptor agonist that and acts as a circadian regulator that resets the master body clock in the suprachiasmatic nucleus in the brain.

 

Japan MHLW’s approves Gilead’s Harvoni for the treatment of hepatitis C

The Japanese Ministry of Health, Labour and Welfare has approved Gilead Sciences’ (Foster City, CA, USA) Harvoni for the treatment of chronic hepatitis C genotyped 1 patients. Harvoni is a combination of ledipasvir and sofosbuvir which has already been approved by US and European regulators.

 

Drugs at clinical stage

US FDA grants breakthrough status to Dyax’s DX-2930 for the prevention of hereditary angioedema

Dyax’s (Burlington, MA, USA) DX-2930, received breakthrough status for the prevention of hereditary angioedema attacks for its fully human monoclonal antibody that inhibits plasma kallikrein.

 

and fast track status:

to Catabisis CAT-1004 as a treatment of Duchenne muscular dystrophy

Catabasis Pharmaceuticals (Cambridge, MA, USA) received fast track designation for CAT-1004 as a treatment for Duchenne muscular dystrophy (DMD).  CAT-1004 is a conjugate of the omega-3 fatty acid docosahexaenoic acid and salicylate that inhibits activated NF-KB, a protein that regulates muscle health.

to Summitt’s SMT19969 as a treatment of Clostridium difficile

Summitt Therapeutics (Oxford, UK) received FDA fast track designation for SMT19969, a novel antibiotic, as a treatment of Clostridium difficile.

 

Miscellaneous

AstraZeneca and Cepahalon settle US Department of Justice suit over Medicaire payments

The US Department of Justice (DOJ) reported that AstraZeneca has come to an agreement to pay $46.5 million to the US Federal Government and certain states to resolve allegations that it underpaid rebates owed under the Medicaid Drug Rebate Program (MDRP) Under a separate settlement in the same case, Cephalon, a unit of Teva Pharmaceuticals, agreed to pay $7.5 million to resolve the same allegation.  Under the MDR program, drugmakers are required to pay quarterly rebates based partly on the Average Manufacturer Prices (AMPs) they report to the government. AstraZeneca and Cephalon intentionally lowered AMPs for their drugs by paying service fees to wholesalers. As a result, the U.S. was overcharged for its share of state Medicaid spending, the DOJ said in a statement. The settlements partially resolve a whistleblower suit brought by pharmacist Ronald Streck.

Bio and Business Events  

  • Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
  • Pharmaceutical Congress Asia 2025 on August 3-6 in Singapore
  • 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)
  • Innovation Days on October 5-6 in Paris (France)
  • BIO Japan on October 13-16 in Yokohama (Japan)
  • BIO Latin America on October 14-16 in Rio de Janeiro (Brazil).
  • 15th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
  • BIO Europe 2015 on November 2-4 in Munich (Germany)
  • Biofit 2015 on December 1-2 in Strasbourg (France)

 

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

Discover our services in Marketing & Business Development:

 

See All News

See other Biopharmaceutical News

see other Pharma & Biotech events in 2015

 

 

 

Share :
  •  
  •  
  •  
  •  
  •