Editor’s Note: Terror strikes again in Paris where more than 128 people were killed during several terrorist attacks on Friday, November 13. Several French political leaders appeal for unity and solidarity after “Act of War” while Isis claims responsibility.

Acquisitions /mergers/joint-ventures

Boston Scientific acquires CeloNova Biosciences (San Antonio, TX, USA), an interventional radiology company for $70 million The acquisition consist in three microsphere loaded with chemotherapy agents, one to treat liver cancer and two to treat tumor-related vascular issues including hypervascular tumors, arteriovenous malformations and hepatoma. Under the terms of the deal Boston Scientific will pay an upfront payment of $70 million plus additional undisclosed regulatory and sales milestones.

Leo Pharma (Ballerup, Denmark) acquires Astellas Pharma’s worldwide dermatology business for €675 million. Under the terms of the agreement, the assets relating to Astellas’ global portfolio of dermatology products including Protopic and other products for the treatments of acne and skin infections will be transferred to Leo Pharma which establishes a strong foothold in markets such as China and Russia.

Mylan fails to get the necessary support from Perrigo’s shareholders to conclude its hostile takeover initiated April 8. On November 13, about 40% of Perrigo’s shares had been tendered missing the 50% threshold needed to succeed with the transaction.

Business

Johnson & Johnson enters into a $915 million worldwide agreement with Hanmi Pharmaceuticals (Seoul, South Korea) to develop and commercialize new therapies for metabolic diseases.  The agreement gives J&J access to HM12525A, a once a week oxyntomodulin-based GLP-1/glucagon receptor dual agonist, that has shown evidence of improving multiple metabolic parameters.  Under the terms of the deal, Janssen will pay an upfront payment of $105 million, and up to $810 million in potential clinical development, regulatory and sales milestones as well as double digit royalties on sales. Last week we have reported that Hanmi had signed a deal with Sanofi to license three antidiabetic agents. Earlier this year Hanmi had also inked a deal with Eli Lilly for an oral Bruton’s tyrosine kinase inhibitor and another one with Boehringer Ingelheim for non-small cell cancer therapies.

Alphabet’s Google Life Sciences teams with American Heart Association in a $50 million deal to explore new ways and new tools to address heart diseases. The partnership is a continuation of Google’s intention to deepen its medical and technical footprint through a series of recent deals and new plans to enter the mental health domain. 

Eli Lilly licenses Ignita’s (San Diego, CA, USA) cancer drug Taladegib for $53 million in a cash-and-stock deal. Taladegib is an oral bioavailable small molecule hedgehog/smoothened antagonist. Under the terms of the deal Eli Lilly will pay and upfront cash of $2 million and milestones fees of up $38 million. At the same time, Eli Lilly will invest $30 million in Ignita through a stock purchase agreement.

Royal Philips enters a $225 million, 18 years contract with Ontario’s hospitals. Under the terms of the deal, Philips will offer systems interoperability, diagnostic imaging equipment utilization, radiology practice management, patient-centric design, and alarm management offerings to the existing Mackenzie Richmond Hill Hospital and the future Mackenzie Vaughan Hospital, which should be completed in 2019. The deal is the largest of its kind in Canada and will ultimately cover an estimated half-million patients.

Eisai (Tokyo, Japan) signs two partnerships for the development of new malaria treatments. A first one with the Liverpool School of Tropical Medicine and the University of Liverpool to focus on preclinical studies of E2009, a novel, tetraoxane-based, second generation antimalarial compound . A second one with the non-profit public-private product development partnership Medicines for Malaria Venture to discover new antimalarial candidates.

Protagen (Dortmund, Germany) and Mikrogen (Neuried, Germany) enter into a collaboration to develop a new diagnostic assay to distinguish between previously infected, seropositive individuals from newly infected patients with active Lyme disease. Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by bacteria of the Borrelia type and is transmitted to humans by the bite of infected ticks of the Ixodes genus.

Pierre Fabre (Castres, France) has established a collaboration with the Ecole Polytechnique Fédérale de Lausanne (Switzerland) to use implantable biosensor chips in the development of a clinical trial project of F17464, its schizophrenia investigational drug.

Approval of drugs, vaccines, diagnostics and devices

US FDA approves:

Roche’s Cotellic (cobimetinib) for use in combination with Zelboraf (verumafenib) to treat patients with BRAF 600E or 600K mutation-positive unresectable or metastatic melanoma. The approved drug provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma.

AstraZeneca’s Breakthrough, Priority review, Orphan drug Tagrisso, or osimertinib, for the treatment of patients with T790M+ EGRF mutation positive non-small cell lung cancer (NSCLC). In a pivotal study as many as 61% of patients with the T790 M+ mutation treated with osimertinib experienced complete or partial reduction in their tumor size.

And concurrently Roches’ companion diagnostic test for TM790M+ NSCLC to select patients for the treatment with osimertinib.

Drugs at clinical stage

US FDA assigns breakthrough status to Teva’s (Jerusalem, Israel) SD-809 for the treatment of patients with moderate-to-severe tardive dyskinesia, a hyperkinetic movement disorder. SD-809, or deutetrabenazine is an oral, small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that regulates the levels of dopamine in the brain. SD-809 is also developed for the treatment of chorea associated with Huntington’s disease, and Tourette syndrome (see news week # 14).

And fast track status to Paratek Pharmaceutical’s (Boston, MA, USA) omadacycline as a treatment for community-acquired bacterial pneumonia, acute bacterial skin infections and complicated urinary tract infections. Omadacycline belongs to the aminomethylcycline subclass of tetracyclines.

Sanofi and Regeneron report positive results for sarilumab in a late stage rheumatoid arthritis (RA) pivotal study. The study met both co-primary efficacy endpoints – the reduction in signs and symptoms of RA- as well as secondary objectives.

AstraZeneca reports positive results for anifrolumab for the treatment of systemic lupus erythematosus. The drug achieved both primary and secondary endpoints at day 169 and after one year of treatment. Anifrolumab is a monoclonal antibody directed against all types of I interferon receptor. The drug is currently in Phase III development, and was recently assigned Fast Track status in the US.

Alnylam Pharmaceuticals (Cambridge, MA, USA) and development partner The Medicines Company (Parsippany, NJ, USA) announce positive results from a clinical trial evaluating ALN-PCS for the treatment of high cholesterol. In data presented at the American Heart Association, it was shown that subcutaneous administration of ALN-PCS reduced LDL cholesterol by up to 83% and that the effects were durable supporting a twice a year dosing regimen. The new drug, currently in Phase 2 will directly be competing with Amgen’s Repatha and Sanofi/Regeneron’s Praluent, both dosed every two weeks. Repatha and Praluent bind to PCSK9 in the blood whereas ALN-PCSsc inhibits PCSK9 synthesis in the liver.

Science and Technology

Several companies and organizations have been working on improved vaccines which would provide broader protections than the current ones and some expect to see the emergence of a universal flu vaccine as the ultimate goal in a rather short future. At the recent World Vaccine in Spain, Sanofi Pasteur announced that, in collaboration with the University of Georgia, it has developed a candidate vaccine named Cobra through genetic sequencing of many flu viruses which is designed to protect against multiple strains and over several years.

Cost, Pricing and Market Access

Amgen has negotiated a pay-for-performance deal with Harvard Pilgrim Health Care, gaining an exclusive spot on the payer’s formulary in return for an upfront discount and future rebates if Repatha, its cholesterol lowering agent, does not perform as outlined.

Miscellaneous

In our August issue #35 we had indicated that US FDA has proposed a system of names for biologics biosimilars. Under the FDA's plan, both branded meds and biosimilars would share a "core drug substance" name and each product would also carry a four-letter suffix.  The Federal Trade Commission (FTC) has now asked the FDA to reconsider its guidance arguing that the draft guidance on naming “could result in physicians incorrectly believing that biosimilars' drug substances differ in clinically meaningful ways from their reference biologics' drug substances.” The FTC also suggested that the FDA's proposal would hinder competition that was intended to lower prices on biologic medications.

Japan’s Ministry of Health, Labor and Welfare is again warning Novartis with a “business improvement order” for failing to report serious side effects on some of its drugs. This is the third time Novartis Pharma K.K., has been slapped with penalties over reporting delays. In its report the Japan Times said Novartis Pharma was hit with a 15-day suspension in February and was earlier hit with a business improvement order in 2014 for failing to report problems with its leukemia drugs.  Also in 2014, the Japanese Novartis unit and a former employee were indicted for "causing a medical research team to release manipulated data" related to the company's blood-pressure drug Diovan in 2011.

Roche is restructuring its manufacturing network in decreasing its foothold for small molecules while focusing on specialized drugs with smaller volumes. As a result, Roche will exit four manufacturing sites in Clarecastle (Ireland), Leganes (Spain), Segrate (Italy), and Florence (USA). It estimates that the closures will affect around 1,200 positions. Meanwhile Roche will invest 300 million Swiss francs (CHF) into a dedicated facility in Kaiseraugst (Switzerland) to support “future technology requirements” for this new generation of specialized medicines.

A US lawsuit is charging Sanofi with delaying the development of Lemtrada acquired through the Genzyme purchase. The deal included tradable certificates worth a substantial amount of money if Lemtrada was approved by March 32, 2014. American Stock Transfer & Trust also charges that after Lemtrada’s approval, in November 2014, Sanofi underfunded marketing for the drug and actively promoted another drug explaining why the sales benchmarks were missed.

Bioevents

• 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)

Early events in 2016: 

• 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 (Singapore)
• BIO Europe Spring on April 4-6 in Stockholm (Sweden)
• BIO Vision on April 13-14 in Lyon (France)
• BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)
• Strategic Alliance Management Congress on May 16-18 in Philadelphia (USA)
• China BIO Partnering on May 18-19 in Suzhou (China)
• BIO International Convention on June 6-9 in San Francisco (USA)

IMPORTANT NOTICE : This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.

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

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