Editor’s Note

After a restful summer break, we are now back with business as usual with a full fletched version of our Biopharmaceutical NewsWeek. We have also received constructive comments following our short survey and we will consider them and hopefully improve our future weekly deliverable. We are starting with a very busy week already. We wish you an agreeable read.

Acquisitions /mergers/joint-ventures

Bristol-Myers Squibb acquires Promedior (Lexington, MA, USA) for $1.25 billion. The deal is structured around an upfront cash payment of $150 million, an exercise fee payable if BMS decides to buy the business, and subsequent clinical and regulatory milestone payments. BMS will gain worldwide rights to Promedior’s lead asset PRM-151, a recombinant form of human pentraxin-2 protein in Phase II development for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF).

… and enters into a deal with Australia’s based QIMR Berghofer Medical Research Institute (Brisbane) to discover novel therapeutic antibodies against an undisclosed immuno-oncology target. Financial terms were not disclosed.

Mylan still keen to acquire Perrigo. Mylan NV’s shareholders voted in favor of moving forward with a $33 billion hostile bid for OTC drugmaker Perrigo. The proposal received the support of two-thirds of votes cast, representing more than half of all outstanding shares. Mylan will take its formal offer directly to Perrigo shareholders in “coming weeks,” Mylan Chairman Robert J. Coury said. Mylan has until Sept. 14 to initiate the process for acquiring Perrigo, whose management is opposed to the deal. "We are confident that the majority of Perrigo shareholders will not tender their shares to Mylan," Perrigo Chief Executive Officer Joe Papa said in a statement.

Amicus Therapeutics (Cranbury, NJ, USA) acquires Scioderm (Durham, NC, USA) for up to $847 million. Scioderm is developing Zorblisa, a treatment for the rare skin disease epidermolysis bullosa. Under the terms of the deal Scioderm will receive $229 million of which $125 million will be in cash and $104 million in stock plus $361 million contingent development milestones and $257 million sales milestones.

Valeant Pharmaceuticals International acquires Synergetics USA (O'Fallon, MO, USA), a supplier of precision surgical devices with a primary focus on surgical disciplines of ophthalmology and neurosurgery, for $192 million.

Allergan acquires AqueSys (Aliso Viejo, CA), an ophthalmic device company with a microstent product, for $300 million upfront plus undisclosed approval and sales milestones. Aquesys has the XEN45 Gel Stent, which is a soft, 6mm long shunt made of collagen-derived gelatin which is injected via a small corneal incision with a pre-loaded injector. XEN45 is designed to protect against creating intraocular pressure that’s too low. The stent has a CE mark in European for use as part of cataract surgery or as a standalone procedure and is expected to be US FDA approved by the end of 2016.

Business

Sanofi and Google Life Sciences collaborate to improve diabetes monitoring. Both companies will work on finding better ways to collect, analyze and process multiple sources of information impacting diabetes. The end goal of the collaboration is to create devices that would combine multiple parts of diabetes monitoring into one system, with sensor devices and information on medication regimens, blood glucose levels and patient-reported data, and ultimately improve outcomes for patients. Financial details were not disclosed.

… and terminates its license deal with Ardelyx (Fremont, CA, USA). The agreement which started in February 2014, granted Sanofi an exclusive license to conduct research with Ardelyx Nap2b inhibitor for the treatment of hyperphosphatemia in patients with renal disease.

AstraZeneca licenses experimental psoriasis drug brodalumab to Valeant Pharmaceuticals for $445 million. Under the terms of the deal, Valeant will pay AstraZeneca an upfront fee of $100 million, additional development milestones of up to $170 million and sales related milestones of up to $175 million following launch. Brodalumab, an IL-17 receptor monoclonal antibody, was previously dropped by Amgen over concerns about the drug's "suicidal" side effects. The field is getting crowded with Novartis in front with its own IL-17 antibody Cosentyx or secukinumab, approved in January, Eli Lilly in late-stage studies with its IL-17-blocking ixekizumab, Merck's MK-3222 and Johnson & Johnson's IL-23 inhibitor guselkumab.

Eisai and Purdue Pharma (Stamford, CT, USA) have formed a worldwide development and commercialization agreement to promote experimental insomnia drug lemborexant. Lemborexant, a dual antagonist of orexin 1 (OX1) and orexin 2 (OX2) receptors, is currently in phase 3 development by Eisai for the treatment of insomnia. The companies intend to share the cost of further developing the drug and will co-promote it in the US, and potentially other territories, with related costs and profits shared.

Amgen and Novartis enter into a collaboration agreement to develop and commercialise innovative neuroscience treatments, specifically for Alzheimer’s disease and migraine. Under the agreement the companies will work together on BACE inhibitor programmes in Alzheimer's disease, with Novartis' oral therapy CNP520 the lead molecule, and migraine, including Amgen’s Phase III AMG 334 and Phase I AMG 301. Both companies will share responsibilities for development and commercialisation.

Daiichi Sankyo has signed an exclusive license to develop and commercialise AstraZeneca’s influenza vaccine Flumist Quadrivalent in Japan.  Financial terms were not disclosed, but companies indicated that Daiichi Sankyo will pay AstraZeneca an upfront fee and subsequent development milestones and sales-related payments post launch.

Incyte secures exclusive rights to develop and market Jangsu Hengrui Medicine’s (Lianyungang, Jiangsu Province, China) SHR-1210, for the treatment of solid tumors in a deal worth $795 million. SHR-1210 is an immune checkpoint blockade designed to work by inhibiting the interaction between PD-1 and PD-L1. Under the terms of the deal, Hengrui will receive a $25 million upfront fee and up to $770 million in payments linked to specified milestones.

NovoCure (Jersey Isle), a private oncology company pioneering a novel therapy for solid tumors called Tumor Treating Fields (TTFields), has filed an IPO to raise up to $300 million on the potential to receive US FDA approval for Optune as a treatment of newly diagnosed glioblastoma.According to the SEC filing,Optune  is a technology to treat solid tumors which "is a low-toxicity anti-mitotic treatment that uses low-intensity, intermediate frequency, alternating electric fields to exert physical forces on key molecules inside cancer cells, disrupting the basic machinery necessary for normal cell division, leading to cancer cell death.” Optune is already in use in 260 cancer centers and has been used on more than 1,600 glioblastoma patients. The first-line study, halted in November, found Optune met the endpoints on both progression free survival and in overall survival in combination with standard-of-care temozolomide versus temozolomide alone.

Approval of drugs, vaccines, diagnostics and devices

European Commission approves:

–      Two drugs from Novartis.

o   The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation, known to be the most aggressive form of skin cancer.

o   The combination of Farydak (panabinostat) and bortezomib (velcade) and dexamethasone for the treatment of relapsed/refractory multiple myeolama. Farydak is the first histone deacetylase (HDAC) inhibitor cleared in Europe. The drug had been approved by the US FDA in late February despite a negative Advisory Committee vote.

–      And two drugs from Alexion Pharmaceuticals (Cheshire, CT, USA)

o   Kanuma (sebelipase alfa) for patients with lysosomal acid lipase deficiency (LAL-D)

o   Strensiq (asfotase alfa) for paediatric-onset hypophosphatasia (HPP) to treat the bone manifestations of the disease.

o   Both are enzyme replacement therapies for two classified ultra-rareTdiseases.   LAL-D is a genetic condition causing chronic build-up of cholesteryl esters and triglycerides in various organs, leading to major damage and premature death. HPP is a genetic condition characterised by defective bone mineralisation that can lead to destruction and deformity of bones, profound respiratory failure and premature death.      

Drugs at clinical stage

Bayer initiates a Phase 3 study with finerenone (BAY 94-8862), a selective oral non-steroidal mineralocorticoid (MR) antagonist, for the treatment of heart failure and diabetic kidney disease. The drug blocks the unwanted effects of MR over-activation by aldosterone. Currently available steroidal MR antagonist are underutilized because they can induce hyperkalemia and other serious renal side effects.

Science and Technology

The Medicines Company and partner Alnylam (Cambridge, MA, USA) announce that their investigational RNAi drug, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83%, a comparable result to Sanofi/Regeneron’s Praluent and Amgen’s Repatha. ALN-PCSsc turns off PCSK9 synthesis in the liver, a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood. The other major differences are the dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent and Repatha are dosed once every two weeks or once per month at a higher dose. A Phase 2 study will commence at the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies. The results were presented at the European Society of Cardiology Congress in London.

Aspirin could boost cancer immunotherapies according to a study conducted at the Francis Crick Institute (UK). Cancer cells often produce large amount of prostaglandin E2 which dampens the immune system and may explain why some immunotherapies have not been effective. Cyclooxygenase (COX)-inhibitors such as aspirin inhibit the production of Prostaglandins (PGE2) and could help to boost the immune system and be given in combination with immunotherapies.

The U.S. Department of Defense announced a new FlexTech Alliance which is supported by more than 160 companies and nonprofits, in providing $75 million in addition to $90 million from academia, local government and industry groups, The consortium which features Apple, Lockheed Martin, top research institutions and universities including MIT and Stanford, intends to develop novel electronic innovations including wearable devices to improve medical health monitoring technologies and personal fitness devices. 

Medical Devices and Diagnosis News

Researchers have developed a fast paper-strip test that differentiates between Ebola, yellow fever and Dengue. Designed to be used in the field, it requires no power and no running water.

Miscellaneous

News on DPP-4 diabetes drugs.  FDA has issued a warning that the entire DPP-4 inhibitors class, to control diabetes, might cause “severe and disabling” joint pain. The biggest-selling DPP-4 drugs are Merck’s Januvia’s (sitagliptin) products. The class also includes AstraZeneca's Onglyza (saxagliptin) and Eli Lilly and Boehringer Ingelheim's Tradjenta (linagliptin) and the newest entry, Takeda's Nesina (alogliptin), and a large series of combination drugs.

…. at the same time, a new analysis presented at the European Society of Cardiology Congress in London, indicated that there was “no signal of any sort of heart failure risk” for patients treated with Merck’s Januvia.

Ebola virus back in Sierra Leone. Just four days after the last patient had been released Ebola virus free from hospital, a woman who died was tested virus positive in Sierra Leone. The entire village is now under quarantine and will be vaccinated. 

Amgen launches its PCSK9 cholesterol drug Repatha, in Europe, at highly discount price when compared to the US. According to a Reuters report, Amgen is pricing the drug at around $6,780 a year in the UK, substantially lower than its US list price of $14,100. Similarly, in Austria and Finland, the drug’s cost equates to around $8,220 and $8,820 a year, respectively.

Novartis makes history with the launch of Zarxio, the first biosimilar copy of a biotechnology drug approved in the US. Zarxio is the biosimilar of Amgen’s Neupogen. Biosimilar drugs have been on the European market since 2006.

Japanese Ministry of Health, Labor and Welfare has issued a business improvement order to Pfizer after it failed, to report 212 adverse drug reactions (ADR) within the timeframes required by the Pharmaceutical and Medical Devices Law. Earlier this year Novartis was obliged to cease its commercial activities in Japan, for 15 days, after a similar investigation had revealed the Swiss company had failed to report more than 3,000 ADRs within the requested timeframes.

Bioevents

• 3^rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
• Pharma Competitive Intelligence Conference on September 10-11 in Parsippany (USA)
• BioPharm America 2015 on September 15-17 in Boston (USA)
• 15^th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
• 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)
• BIO Investor Forum on October 20-21 in San Francisco (USA)
• 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

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