Acquisitions /mergers/joint-ventures

The Teva-Mylan-Perrigo saga goes on

Perrigo who has indicated it was not enthusiastic about being acquired by Mylan, claiming the offer substantially undervalued the company, announced the acquisition of a portfolio of OTC brands from GlaxoSmithKline for an undisclosed amount. Nearly six weeks after Teva publicly expressed interest in acquiring generics rival, Mylan indicates that it still has not received an actual offer and, in the meantime, the Israeli based company who already has a 1.8% stake in Mylan is seeking to buy more Mylan shares expecting an increase to about 4.6%.

Eurofins acquires Diatherix for $50 million

Eurofins Scientific (Nantes, France and Luxemburg), a provider of bio-analytical testing and genomic services has agreed to acquire Diatherix Laboratories (Huntsville, AL, USA) for approximately $50 million plus contingent fees upon sales targets.

Shire supposed to offer £12 billion for Actelion

According to the UK Sunday Time, Shire (Dublin, Ireland) is making a move to acquire Swiss based Actelion (Allschwil, Basle, Switzerland) for £12.4 billion, a premium of 20% over the last Actelion’s stock value.

Business

Oncology Combination Therapies

• Roche and Amgen agreed to collaborate to assess the combination of Roche’s atezolizumab and Amgen’s talimogene laherparepvec, or T-VEC for the treatment of triple-negative breast cancer and colorectal cancer. Terms of the deal are undisclosed.
• The news comes just days after Amgen announced its intention to investigate T-VEC combination with Merck’s Keytruda in head and neck cancer.
• Merck & Co and Dynavax (Berkeley, CA, USA) unveil a new collaboration to investigate combination of Merck’s anti PD-1 Keytruda and anti-interleukin 10 immunomodulator MK 1966 with Dynavax‘s SD-101 a toll like receptor 9 (TLR9) agonist.

More on CAR T cell therapies

• Juno acquires X-Body for $44 million: Juno Therapeutics (Seattle, WA, USA) announces a second technology focused acquisition of chimeric antigen receptor (CAR) T cell with the acquisition of X-Body (Waltham, MA, USA). Juno agreed to acquire X-Body for an initial $21 million cash plus 439,265 shares valued at $23 million as well as payments tied to contingent achievements and is preparing, with Novartis, a multi-center clinical trial of its chimeric antigen receptor T-cell therapy as a treatment for diffuse B-cell lymphoma after spectacular results in non-Hodgkin lymphoma.
• Celgene and Bluedbird restrict their ongoing CAR-T collaboration: Celgene (Summit, NJ, USA) and Bluebird Bio (Cambridge, MA, USA) have agreed to restrict their CAR-T collaboration started in 2013 to B-cell maturation antigen (BCMA) that is found on the surface of most multiple myeloma cells. Streamlining the alliance with Celgene will give Bluebird the opportunity to independently expand and drive a large pipeline of cancer therapies.
• Cellectis and Weill Cornel collaborate to accelerate targeted immunotherapies. Cellectis (Paris, France) and Weill Cornell Medical College (New York City, NY, USA) have entered a strategic collaboration in a translational research alliance to boost the development of UCART 123, a targeted immunotherapy for the treatment of acute myelogenous leukemia (AML) The deal will combine Weill Cornell's expertise and resources in translational stem cell science and developmental therapeutics with Cellectis' work in development and manufacturing of gene edited CAR-T cell product candidates.

AbbVie enters into collaboration with Halozyme

AbbVie (North Chicago, IL, USA) agrees to partner with Halozyme Therapeutics (San Diego, CA, USA) to develop and commercialise products combining Halozyme’s drug delivery platform and AbbVie’s therapies in a deal potentially worth $1.9 billion. The deal provides Halozyme with $23 million upfront and $130 million milestone fees for up to nine potential targets.

Astellas and Anokion form Kanyos Bio a new joint venture

Astellas (Tokyo, Japan) and Swiss based Anokion (Préverenges, Switzerland) agreed to create a new US based joint venture Kanyos Bio based in Cambridge (MA, USA) to work on drugs aimed at immune tolerance such as type I diabetes and coeliac disease. The firm will use Anakion’s tolerance-inducing technology to induce tolerance to protein drugs and autoimmune antigens. Under the terms of agreement, Astellas will finance research for Kanyos and has the option to purchase Kanyos contingent on the achievement of certain milestones.

AstraZeneca and Ardelyx end partnership

AstraZeneca and Ardelyx (Fremont, CA, USA) announced the end of their partnership consisting in the development of lead product tenapanor and the remaining of the sodium-hydrogen antiporter 3 (NHE3) inhibitors portfolio. Ardelyx may continue the development of the products on its own and pay AstraZeneca an upfront of $15 million and a 10% royalties on sales

Novartis turns down rights to acquire Gamida Cell

Novartis has decided not to acquire Israel-based stem cell company Gamida Cell. Under a 2014 agreement Novartis has made an initial investment of $35 million and agreed to pay Gamida shareholders a further $165 million if it exercised its option to buy the firm, as well as up to $435 million for certain development, regulatory and sales milestones.

Approval of drugs, vaccines, diagnostics and devices

European Commission approves Eisai’s thyroid cancer drug Lenvima

EU regulators have approved Eisai’s Lenvima to treat the most common forms of thyroid cancer following approvals in Japan and the US earlier this year. Lenvima (lenvatinib, a pan-kinase inhibitor) was reviewed in nine months from filing under Europe’s accelerated assessment program and Orphan designation in 2013.  Approval came on the back of clinical data showing patients given the drug lived on average 14.7 months longer without their disease progressing than those taking a placebo, and also experienced a rapid response with a median time to first objective response of 2.0 months. 

Drugs at clinical stage

US FDA grants priority review for BMS combination therapy Opdivo/Yervoy in skin cancer

US FDA have assigned priority review to BMS for its combination immunotherapies Opdivo and Yervoy in patients with previously untreated advanced melanoma. Opdivo and Yervoy are both US approved monoclonal antibodies and immune checkpoint inhibitors targeting separate, distinct checkpoint pathways, inhibition of which results in enhanced T cell function greater than the effects of either drug alone.

US FDA grants breakthrough status for Genzyme’s olipudase alfa

Genzyme (Cambridge, MA, USA) gets US FDA breakthrough status for olipudase alfa for the treatment of patients with non-neurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease type B, a serious and life-threatening disorder caused by insufficient activity of the enzyme ASM, which leads to sphingomyelin toxicity.  There are currently no approved treatment options for patients with Niemann-Pick disease type B.

US FDA Grants Orphan Drug status to Aptose’s APTO-253 for the treatment of Leukemia

Aptose Biosciences (San Diego, CA, USA and Toronto, Canada) received US FDA Orphan Drug status for APTO-253 for the treatment of acute myeloid leukemia (AML). APTO-253 is a small molecule inducer of tumor suppressor gene Kruppel-like factor 4 (KLF4) and expression of p21, a kinase inhibitor.

Advisory Committee planed for Sanofi/Regeneron Praluent

US FDA Endocrinologic and Metabolic Drugs Advisory Committee meets on June 9 to discuss Biologics License Application (BLA) submitted by Sanofi and Regeneron for the approval of Praluent (alirocumab) for the treatment of adult patients with hypercholesterolemia.

Technology

Novartis partners with Rani Therapeutics to develop oral biologics

Oral biologics are a challenge so far unsolved. Oral formulations of protein-based drugs were not effective because enzyme of the small intestine degrade proteins thus limiting their absorption. Rani Therapeutics (San Jose, CA, USA) novel oral biologic delivery system may be able to solve this problem and Novartis has now entered a feasibility study to assess the “robotic pill” technology with some of its proprietary biologics. The pill's drug delivery paradigm has a strong mechanical rather than chemical component explaining the name “robotic pill”.

"Robotic pill"–Courtesy of Rani Therapeutics

Following the robotic pill's passage through the stomach, the slightly acidic fluids of the small intestine dissolves the pill's casing, as well as a nanoscale valve. Once the valve is released, previously separated citric acid and sodium bicarbonate mix to form carbon dioxide, which in turn inflates a small balloon tipped with needlelike structures made of sugar. The needles rise on the edge of the balloon and embed themselves in the small intestine. No pain is felt because the organ doesn't have any pain receptors. Next, the needles detach from the robotic pill and release drugs into the proximate blood vessels while dissolving in the body. Meanwhile, the remainder of the pill passes through the body. Novartis made an equity investment in Rani worth a total of more than $25 million. Previous investors in the company include Google Ventures, InCube Ventures and VentureHealth.

Medical Devices and Diagnosis News

Vexim announces the initiation of a new clinical study intended to get US FDA 510 (k) approval for SpineJack for the treatment of vertebral fracture

Vexim (Toulouse, France) a medical device company specializing in the minimally invasive treatment of vertebral fracture announced that based on discussion with US FDA it will supplement its regulatory submission for the use of SpineJack® in the U.S. with a prospective European multicentric randomized study that compares the safety and efficacy at one year follow-up of the New Generation SpineJack® device with Medtronic’s balloon in 160 patients suffering from vertebral compression fractures due to osteoporosis.

Merck & Co enters into research collaboration with NanoString

NanoString Technologies (Seattle, WA, USA) is partnering with Merck to create a test that will assess the effects of anti PD-1 Keytruda on cancer patients. The assay will be designed to optimize the immune-related gene expression signatures needed to support further clinical development.

Tumor tests for immune-oncology drugs not reliable enough

Screening for biomarkers in tumors to assess which patients would benefit most from immunotherapies is still not adequate according to some experts. Using protein levels in a tumor is not as effective as looking at gene expression. For instance while clinical trials for PD-1 blockers Opdivo from BMS and Keytruda from Merck show the drugs work best in patients who test positive for PD-L1, a related protein, some patients who tested negative still benefited from therapy. "We shouldn't withhold immunotherapy from patients based on a biomarker yet," said Dr. Roy Herbst, chief of medical oncology at Yale Cancer Center, about Opdivo (as quoted by Reuters). "We don't even know if PD-L1 is the right biomarker."

Miscellaneous

NICE endorses drugs from Bayer, Novartis and Roche but rejects drugs from Ferring Novartis and AstraZeneca

The UK National Institute for Health and Care Excellence (NICE) has released draft guidance recommending the use of new drugs namely Bayer Healthcare’s Eylea or aflibercept for diabetic macular edema, Novartis’ psoriasis drug Cosentyx or secukinumab,  Roche’s Gazyvaro or obinutuzumab for the treatment for chronic lymphocytic leukemia and and Bayer’s Xofigo (a radio-pharmaceutical agent) for the treatment of prostate cancer

…and rejected Ferring’s Firmagon (degarelix) as a non-cost effective treatment of hormone dependent prostate cancer as well as Novartis’ Certican as a treatment for organ rejection in liver transplant patients and AstraZeneca’s Lynparza for the treatment of ovarian cancer because they are too expensive compared to treatment already available. Pascal Soriot, AstraZeneca’s CEO, commented at this refusal in stating “On that basis we should stop all cancer research in the world. How can a government say they want this country to be an innovation center with a strong focus on life sciences, and yet when we discover new innovation it doesn't find a market?"

Takeda consolidates its US vaccine business in Cambridge

Japanese Takeda will leave its different US vaccine facilities in Bozeman (MT), Madison (WI), Fort Collins (CO) and Deerfield (IL) to relocate in a new hub in Cambridge (MA). The other vaccine facilities will remain in Zurich, Switzerland, Hikari, Japan, Durham NC and Singen, Germany. Takeda's move follows GlaxoSmithKline's recent announcement that it's closing a vaccines R&D facility in Cambridge inherited from Novartis instead opening a global vaccines R&D headquarters in Rockville, MD.

Bio and Business Events

• 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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