Acquisitions /mergers/joint-ventures

The saga Mylan, Teva, Perrigo goes on

As expected, Mylan’s board has rejected Teva’s takeover offer of $40 billion indicating that the “proposal grossly undervalues the company” and that it would not even enter any discussions regarding an offer unless the starting point was “significantly in excess of $100 per share”. But at the same time and for precisely the same reasons Perrigo has also rejected Mylan’s two more recent offers arguing they are not high as it seems because Mylan’s stock has been inflated by Tevas’ takeover offer and remains under the original bid value of $205 per share. Meanwhile public exchanges between Teva and Mylan bosses are highly vehement and emotional. 

Celgene acquires Quanticel to advance cancer drug discovery

Celgene (Summitt, NJ, USA) acquires privately owned Quanticel Pharmaceuticals (San Francisco, CA, USA) for $485 million. The agreement gives Celgene full access to Quanticel’s single-cell genomic analysis platform as well as drug candidates targeting human cancers expected to enter clinical trials early next year. The deal is structured around a $100 million upfront payment in cash as well as contingent milestone payments worth up to $385 million upon development and regulatory achievements.

….extends it collaboration with Agios

Celgene expands its collaboration with Agios Pharmaceuticals (Cambridge, MA, USA) in partnering AG-881, a small molecule pre-clinical drug candidate for cancer treatments. Agios will receive a $10 million upfront payment and $70 million in additional milestones. Both partners will split the development costs.

….and enters into a strategic collaboration with Northern Biologics

Celgene and Northern Biologics (Toronto, Canada) agree to collaborate on a R&D program of therapeutic antibodies to treat cancer and fibrosis. Under the terms of the agreement Celgene will pay Northern Biologics a $30 million upfront plus undisclosed development and regulatory milestones. Celgene also got rights to acquire Northern Biologics.

Minority shareholders against Stallergenes-Greer merger

Ares Life Sciences, a Jersey based life sciences investment funds, encounters strong resistance from minority shareholders to merge Euronext traded Stallergenes (Antony, France) and privately owned Greer Laboratories (Lenoir, NC, USA) although it owns 77% of Stallergenes and all of Greer. The next major step will be Stallergenes’ annual general meeting on June 26^th, with the review of terms of the proposal by an independent committee.

Pfizer rumored to acquire Swedish Biovitrium

According to Reuters, Pfizer is negotiating the acquisition of Swedish Orphan Biovitrium (Stockholm, Sweden) also known as Sobi which is specializing in orphan diseases with top selling products such as Kineret (anakinra), Orfadin (nitisinone) and ReFactor AF which is partnered with Pfizer.

Business

Protagen launches NavigAid SLE, a stratification tool for lupus drug development

Protagen (Dortmund, Germany), a diagnostic company announces the launch of NavigAid SLE, a patient stratification array to support companies with their Systemic Lupus Erythematosus (SLE) drug development. “In order to develop effective and curative therapies it is pivotal to define homogeneous disease subgroups in SLE patients, and the new NavigAID SLE does exactly this” said newly appointed Board Member Bernd Kirschbaum.

Eisai collaborates with Nihon Medi-Physics to dementia with Lewi bodies

Eisai (Tokyo, Japan) and Nihon Medi-Physics (Tokyo, Japan) intend to collaborate on one of Japan’s major dementia, named “dementia with Lewy bodies” (DLB), a disease with abnormal massing of protein inside nerve cells. The collaboration aims at finding diagnostics as well as treatment of DLB which affects an increasing number of elderly patients. DLB is difficult to be diagnosed because the disease presents characteristic symptoms such as cognitive fluctuations, visual hallucinations, parkinsonism and progressive cognitive impairment. Financial terms of the agreement were not disclosed.

Approval of drugs, vaccines, diagnostics and devices     

EU Commission approves Sanofi’s Toujeo for diabetes treatment

Sanofi announced that the European Commission has approved Toujeo (insulin glargine), a next generation insulin for the treatment of type 1 and type 2 diabetes. Blood sugar with Toujeo was comparable to Lantus with a favorable safety profile. Toujeo also demonstrated more stable and more predictable glycemic control and low within-individual blood sugar variability that lasted beyond 24 hours compared with Lantus. Toujeo was already approved in the US in February 2015.

US FDA grants St Jude medical approval for Protégé MRI Spinal Cord Stimulation

St Jude Medical (St Paul, MI, USA), a medical device company, received US FDA approval for its Protégé MRI spinal cord stimulation (SCS) system. The Protégé MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) and the only upgradeable IPG which helps the patients to safely undergo head and extremity MRI scans.

Drugs at clinical stage

US FDA grants fast track to Genzyme’s Fabry disease

The FDA designates Genzyme’s (Cambridge, MA, USA) investigational drug GZ/SAR402571 fast track review for the treatment of Fabry disease, a rare inherited disorder caused by mutations in the GLA gene. The disease is characterized by the buildup of globotriaosylceramide, a type of fat which leads to progressive kidney damage, heart attack and stroke.

GSK shingles vaccine highly effective in a Phase 3 study

GlaxoSmithKline reports that its investigational vaccine HFZ/su showed that a two-dose schedule reduced the risk of herpes zoster by 97.2% in adults at least 50 years old. Hz/su is non-live and combines gE, a protein found on the herpes zosters virus boosted by the adjuvant ASO1B. Shingles is characterized by itchy rashes caused by latent chicken pox virus and varicella zoster reactivation.  Analysts believe GSK’s vaccine could take a major market share from Merck’s Zostavax because it maintains high efficacy in older people as the risk for shingles increases.

US FDA grants orphan drug status to Bio-Path liposomal Grb-2 for acute myeloid leukemia

Bio-Path Holdings (Houston, TX, USA) received US FDA orphan drug designation for liposomal growth receptor bound protein-2, or Liposomal Grb-2, as a treatment for acute myeloid leukemia. Grb-2 is an adaptor protein utilized by oncogenic tyrosine kinases to induce cancer progression. Liposomal Grb-2 is designed to interrupt the function or expression of Grb-2 and trigger a therapeutic effect.

European Commission grants VentiRx’s motolimod orphan status for ovarian cancer

VentiRx Pharmaceuticals (Seattle, WA, USA) gets European orphan drug status for ovarian cancer drug motolimod or VTX-2337. Motolimod is a Toll-like Receptor 8 (TLR8) agonist that directly activates multiple components of the innate immune system, including human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells. Motolimod had already received US FDA orphan status for the same indication in April 2014.

Technology

Sutureless surgical aortic valve replacement,  superior to transcatheter aortic valve replacements

Perceval SAVR–Courtesy of Sorin

Dr. Brain Duncan, US Medical director of the Sorin Group (Milan, Italy) indicated that recent studies demonstrated that the company’s sutureless surgical aortic valve replacement (SAVR) Perceval is superior to transcatheter aortic valve replacements (TAVR). This new information sustains the debate within the cardiology community about which treatment paradigm is better in intermediate-risk patients.

Miscellaneous

China FDA collaborates with US FDA to upgrade its international standards

159 representatives from both agencies completed a visit to the US FDA facilities in Washington DC (USA) in order to establish a program of reforming China’s regulatory procedures. The meeting was aimed to instruct CFDA officials the way US FDA regulates its approval processes.

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)

DUE TO BUSINESS HOLIDAYS THERE WILL BE NO NEWS LETTER IN WEEK 19

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

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