Biopharmaceutical News Week 43

Acquisitions /mergers/joint-ventures

NeoGenomics (Fort Myers, FL, USA) an oncology genomics company, acquires GE Clarient Diagnostic Services in cash in a deal worth $300 million. The two companies have also agreed to collaborate on a precision oncology bioinformatics initiative aimed at integrating genomics and imaging data. "Our vision is to become America's premier cancer testing laboratory, and this acquisition is a major step forward in achieving that vision," said NeoGenomics chairman and CEO Douglas VanOort. GE acquired Clarient in December 2010 for $587 million and expected to build it into a billion dollar business.

Eisai and Ajinomoto form a 60-40 joint venture to become Japan’s largest gastrointestinal specialty drug maker. According to a press release from Eisai, the new company, EA Pharmaceutical, will begin operations in 2016 as a subsidiary of Eisai. The company is expected to have sales of $666 million, and will work to develop new drugs including Ajinomoto's ulcerative colitis treatment and a Crohn's disease treatment under development at Eisai. EA Pharmaceutical will also receive $335 million in marketing rights to certain products.

Business

Novartis widen its immunotherapies portfolio with the acquisition of Admune Therapeutics (Danvers, MA, USA) and with licensing agreements with Xoma (Berkeley, CA, USA) and Palobiofarma (Pamplona, Spain). The acquisition of Admune provides Novartis with an IL-15 agonist currently in phase I trials for metastatic cancer. The agreement with XOMA gives Novartis development and commercialization rights to the company's TGF-beta antibody programs. The licensing agreement with Palobiofarma gives Novartis development and commercialization rights to PBF-509, an adenosine receptor antagonist currently in phase I trials for non-small cell lung cancer. All three programs will be explored as monotherapies and in combination with Novartis’ own immuno-oncology and targeted therapy portfolios. Novartis current immunotherapies portfolio consists of four clinical candidates and five new drugs expected to enter the clinic by the end of 2016.

Kite Pharma (Santa Monica, CA, USA) acquires exclusive global licensing rights to MAGE-directed T cell receptor candidates from the National Health Institutes (NIH). MAGE A3 and MAGE A6 (Melanoma associated antigens) are tumor-specific proteins that are associated with poor prognoses. The NIH will receive undisclosed upfront and milestone fees plus sales royalties.

Novo Nordisk extends its oral drug delivery platform with Emisphere Technologies (Roseland, NJ, USA). Under the new agreement, Emisphere will receive $5 million up front and up to $82.5 million in development and sales-based milestone payments, plus royalties on commercialized products. In return, Novo gets an exclusive license to develop candidates in three molecular classes and the nonexclusive right to develop candidates in a fourth molecular class. In addition the agreement grants Novo the option to obtain exclusive or nonexclusive rights for the development and commercialization of additional oral formulations. Novo also agreed to pay Emisphere $9 million in exchange for a reduction of future royalty payments.

AstraZeneca and Eli Lilly massively expand their ongoing immune-oncology collaboration to explore a large set of combination therapies for treating solid tumors. Under the broadened agreement both companies will assess AstraZeneca anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in combination with several Lilly’s drugs including: the TGF-beta kinase inhibitor galunisertib; a CXCR4 peptide antagonist; and an anti-CSF-1R monoclonal antibody. The latter will also be combined with AstraZeneca’s anti-CTLA-4 monoclonal antibody tremelimumab. In addition there are plans to study other combinations including Lilly’s abemaciclib with AstraZeneca’s Faslodex (fulvestrant) and both Cyramza (ramucirumab) and necitumumab with AstraZeneca’s AZD9291. Details of the finanacial terms were not disclosed.

Yabao Pharmaceutical (Beijing, China) and Eli Lilly expand their ongoing collaboration to co-develop Lilly’s sodium-glucose inhibitor (SGLT-1) for the treatment of diabetes. Yabao will receive China rights to develop and commercialize the drug while Lilly retains its rights for all other markets. Financial details of the agreement were not disclosed. Earlier this year Yabao licensed China rights to K13 from Primary Peptides (Canada) for stroke treatments and signed a deal with the University of South Australia for oncology treatments. In 2014 it has in-licensed China rights for a sepsis treatment from Lawson Health Research Institute (Canada) and entered an agreement with Medical Research Charity MRC Technology (UK) to develop new treatments for Parkinson’s disease. Earlier this month, Lilly had expanded its collaboration with Innovent Biologics (Suzhou Industrial Park, China) by including immuno-oncology bispecific antibodies in the scope of the new agreement.

EnGene (Montreal, Canada) announces a strategic collaboration with Johnson & Johnson Innovation to develop novel gene delivery of IL-10 for the treatment of inflammatory bowel disease. Under the terms of the deal enGene is eligible to receive various development, regulatory and commercialization milestone payments of up to $300 million, plus tiered royalties on potential sales.

The Scripps Research Institute (La Jolla, CA, USA) has teamed up with the Center for Integrated Psychiatry Kiel and the Fraunhofer Institute for Molecular Biology and Applied Ecology, two German research centers, to improve the quality of induced pluripotent stem cells (iPSCs). The teams will apply next-generation sequencing to analyze iPSCs that could improve the accuracy of preclinical disease and toxicity models.

Atara Biotherapeutics (South San Francisco, CA, USA) enters into an exclusive global license agreement with QIMR Berghofer Medical Research Institute (Brisbane, Australia) to develop and commercialize allogeneic cytotoxic T lymphocytes directed at a series of epitopes of the Epstein-Barr virus and cytomegalovirus, based on Berghofer technology. Expected applications include certain cancers including gastric cancer, nasopharyngeal carcinoma, glioblastoma and autoimmune disorders. Financial terms were not disclosed but Berghofer will receive an upfront payment, milestones and royalties on commercial sales.

Biotech billionaire Soon-Shiong’s umbrella organisation NantWorks (Culver City, CA, USA) is paying $50 million to acquire majority shares in Precision Biologics (Dallas, TX, USA), a therapeutic cancer vaccines company.

BeiGene (Beijing, China) which specializes in the discovery and development of cancer drugs, has filed an S-1 form with the US Securities and Exchange Commission (SEC) for an initial public offerings where it expects to raise $100 million. Over the past five years, the company founded by John Oyler, has developed clinical candidates targeting several specific cancer diseases as well as an immuno-oncology agent that inhibits the immune checkpoint protein receptor PD-1.

Approval of drugs, vaccines, diagnostics and devices

US FDA approves:

Coagadex, a coagulation factor X therapy from Bio Products Laboratory (Elstree, UK and Durham, NC, USA), for treating and controlling bleeding episodes in hereditary factor X deficiency patients, a rare bleeding disorder.

Veltassa (patiromer) from Relypsa (Redwood, CA, USA), as a treatment for hyperkalemia in patients with heart or chronic kidney disease. The drug will be co-promoted by Relypsa and Sanofi in the US.

Onivyde (irinotecan liposome injection) from Merrimack Pharmaceuticals (Cambridge, MA, USA) in combination with fluorouracil and leucovorin for the treatment of advanced pancreatic cancer, one of the most difficult-to-treat cancer. In a three-arm randomized study of 417 subjects, patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months compared with 4.2 months for those treated with fluorouracil/leucovorin alone.

and rejects Shire’s experimental drug Lifitegrast, a dry eye disease therapy. In the complete response letter, the FDA is requesting additional data which might partially be delivered through the ongoing OPUS-3 clinical trial. Shire acquired the drug through its $160-million take-over of SARcode Bioscience in 2013, and is expecting peak sales of more than $1 billion.

Drugs at clinical stage

US FDA grants:

Breakthrough therapy status to Pfizer’s inotozumab ozogmacin, an antibody drug conjugate (ADC) for the treatment of acute lymphoblastic leukemia. The inotuzumab ADC binds to the CD22 antigen on malignant B cells and internalizes calicheamicin, a highly cytotoxic agent.
Fast track and orphan status to Corbus Pharmaceutical’s (Norwood, MA, USA) Resunab, a synthetic oral endocannabinoid-mimetic anti-inflammatory agent for the treatment of cystic fibrosis.
Orphan status to Atara Biotherapeutic’s (South San Francisco, CA, USA) STM 434, an activing inhibitor for the treatment of ovarian cancer.STM 434 is a fusion protein called a ligand trap that binds Activin A and other ligands of the ActR2B receptor. Activin expression is associated with larger tumor volume and poorer prognoses in a range of malignancies, including ovarian cancer.

Science and Technology

Engineers from Stanford University led by Professor Zhenan Bao have created an artificial skin material which imitates the skin’s ability to flex and send signals to the brain that represent touch, temperature and pain. In the current prototype product the top layer of the material features a sensor that recognizes pressure, distinguishing pressure differences between a lighter finger tap to a firm handshake. The ultimate goal is to create a fabric with more sensors that will cover artificial limbs.

Medical Devices and Diagnosis News

Microsoft and John’s Hopkins University are collaborating to improve medical device interoperability in the intense care unit. The collaboration builds on Johns Hopkins' $9.4 million Project Emerge initiative, which aims to develop a tablet application that integrates data from monitors and information systems onto a centralized platform. "Today's intensive care patient room contains anywhere from 50 to 100 pieces of medical equipment developed by different manufacturers that rarely talk to one another," said Peter Pronovost, senior vice president for Johns Hopkins Medicine.

Cost, Pricing and Market Access

A Japan News report said the Japan Ministry for Health, Labor and Welfare (MHLW), as part of its review of medical fees scheduled for 2016, is working to persuade doctors to prescribe the older established medicines because they currently are less expensive than new drugs. According to the same report the MHLW will also consider ways to encourage and even force doctors to prescribe long-standing or generic drugs first and then, if those prove ineffective, allow a switch to new medicines.

US Democratic presidential candidate Hillary Clinton keeps proposing action to the FDA and the Federal Trade Commission (FTC) on questionable drug pricing. In her letter to the FTC, Hillary Clinton urged the agency to investigate the pharma industry for anticompetitive practices, including price-gouging. "I believe it would be a great service to the Congress and the Administration if the FTC would study and make recommendations on whether and how our laws might be amended to address this problem," she wrote.

Miscellaneous

Daiichi Sankyo (Tokyo, Japan) focusses on specialty care products including cardiovascular, oncology and pain management and will move out of its current maturing primary-care product business. The reorganization will mean the elimination of up to 1,200 positions from the US Commercial Home Office, located in Parsippany (NJ, USA) as well as field-based sales.

Regeneron (Tarrytown, NY, USA) invests a further $350 million into its Limerick (Ireland) plant and makes it “the largest-scale up bulk biologics production facility in Ireland” while adding 200 new jobs. Manufacturing will include marketed products such as Eylea (aflibercept) and recently launched Praluent (alirocumab), as well as Phase 2 and Phase 3 clinical candidates. Regeneron had acquired the 400,000 square feet plant from Dell, back in 2013, and had invested $300 million to convert it into a biopharmaceutical manufacturing site.

Pfizer has announced a total of 130 new jobs: 90 at its Grange Castle (Dublin, Ireland) biomanufacturing facility and 40 at its active pharmaceutical ingredients (API) manufacturing site in Cork (Ireland).

Welcoming this month’s job announcements, the Irish Minister for Jobs, Enterprise and Innovation, Richard Bruton said Industrial Development Agency (IDA) had been instrumental in attracting companies to invest in Ireland.

Ireland has become a major hub for biologics manufacturing “due to English language, close proximity to European customers, high quality and talented workforce and a favorable tax system”.

Bioevents

BIO Europe 2015 on November 2-4 in Munich (Germany)
BIO Pharma India Convention 2015 on November 3-4 in Mumbai (India)
BIO Latam on November 16-17 in Santiago (Chile)
Medica and Compamed on November 16-19 in Düsseldorf (Germany)
Biofit 2015 on December 1-2 in Strasbourg (France)

And some early 2016 Events

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)
Global Healthcare Forum on March 16-17 in Singapore
BIO Europe Spring on April 4-6 in Stockholm (Sweden)
BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)
China BIO Partnering on May 18-19 in Suzhou (China)
BIO International Convention on June 6-9 in San Francisco (USA)