Acquisitions /mergers/joint-ventures

Novo Nordisk acquires Calibrium LLC and MB2 LLC, two privately-held biotechnology companies, to expand its reach in the diabetes and obesity field. Calibrium is focused on novel peptides and MB2 on first-in-class, mixed agonist drugs.  Financial details were not disclosed.

Medtronic acquires Twelve, a medical device company for up to $458 million. The acquisition will give Medtronic access to the transcather mitral valve replacement (TMVR) field joining Abbott, who acquired Tendyne for $250 million, and Edwards, who bought CardiAQ Valve Technologies for $350 million in July.

Shenzhen Hepalink Pharmaceutical (China) buys US-based biologics contract manufacture Cytovance Biologics for $207 million plus additional contingency payments and expands its manufacturing facilities.

Business

Google life sciences will become a standalone company standing under the newly formed Alphabet umbrella. Alphabet’s President Sergey Brin said  “They’ll continue to work with other life sciences companies to move new technologies from early stage R&D to clinical testing – and, hopefully – transform the way we detect, prevent, and manage disease”. 

AstraZeneca and Peregrine enter into a collaboration to evaluate the combination of their experimental immunotherapies with different mode of action in various solid tumors. Under the agreement both companies will assess the safety and the efficacy of the combination of Peregrine’s investigational phosphatidylserine-signaling pathway inhibitor, bavituximab with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab.

Medivation acquires BioMarin’s talazoparibin a highly potent, orally active PARP inhibitor as a treatment for BRCA 1 and BRCA 2 metastatic breast cancer, for $570 million.

Morphosys and Immatics Biotechnologies enter a partnership to focus on the development of novel immune-oncology treatments. The collaboration will allow MorphoSys to access several tumor-associated peptides (TUMAPs) discovered using Immatics' XPRESIDENT® platform. In return, Immatics will be allowed access to MorphoSys' Ylanthia® antibodies against a number of its TUMAPs, along with development rights.

GlaxoSmithKline enters into a collaboration with San Francisco-based incubator QB3@953 to translate early drug targets into medicines. QB3@953 is a full-service incubator for life science startups, created by QB3, a University of California research institute and biotech accelerator.

Approval of drugs, vaccines, diagnostics and devices 

A few days after the approval of Praluent from Sanofi/Regeneron, US FDA approves Amgen’s Repatha or evolocumab, an injectable PCSK9 inhibitor for the treatment of hypercholesterolemia, as well as clinical atherosclerotic cardiovascular disease. According to media reports, Repatha will be priced similarly to Praluent at around $14,000 a year (wholesale).The intense competition between the two drugs could also give health insurers leverage to drive down prices. "We plan to leverage this competition to achieve the greatest possible discounts for our clients and patients” said Steve Miller, chief medical officer at pharmacy benefit manager Express Scripts.

US FDA approves Eli Lilly and Boehringer Ingelheim’s Synjardi, a fixed-dose combination of empagliflozin and metformin for adjunctive therapy to treat type 2 diabetes. The combination had received European approval in May. Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor that removes excess glucose through the urine by blocking glucose reabsorption in the kidney, while metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilise glucose. Synjardy is the third empagliflozin-containing product approved by the FDA thus far.

SwissMedic clears use of Exelexis melanoma drug cobimetinib in combination with Roche/Genentech’s Zelboraf (vemurafenib) as a treatment for patients with advanced melanoma. This approval comes as the first global regulatory approval for Exelexis.

Eli Lilly and Boehringer Ingelheim have launched their biosimilar version of Lantus in the U.K. as their first major market. Called Abasaglar, the biosimilar drug carries a price of £35.28 per pack of five 100-unit injector pens or cartridges which compares with £41.50 for five Lantus cartridges.

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. Each product would also carry a four-letter suffix. Those suffixes could be individualized product-by-product, to allow a given company biosimilar to be differentiated from another company biosimilar of the same product. Under the FDA proposal, the suffixes wouldn't be derived from the manufacturer's name, however.

US FDA indicates faster approval times in a report on policies and initiatives at its device arm. Still, devices of all sorts are regularly approved in Europe years before they are permitted for commercialization in the U.S. Some highlights from the report (data as of March 31, 2015)

–      510(k) decision times for low- or moderate-risk devices decreased from an average of 132 days in FY 2010 to about 115 days in FY 2014.

–      PMA decision times for high-risk devices decreased from an average of 352 days in FY2009 to 242 days in FY 2014.

–      IDE decision times permitting use of a device in premarket trials fell from a whopping 442 days in FY 2011 to 30 days in FY 2015.

Drugs at clinical stage

US FDA grants orphan status to:

– Seres Therapeutics’ candidate SER-109 for the prevention of Clostridium difficile infection. The treatment contains bacterial spores from healthy donors and is designed to correct microbial imbalance underlying the infection.

– Tocagen’s glioblastoma gene therapy combination, TocA, 511 and Toca FC for the treatment of glioblastoma.

– Boehringer Ingelheim’s Gilofrib or afatinib, as a treatment for squamous cell lung carcinoma.

Eli Lilly ends an Alzheimer’s study, with solanezumab, conducted by University of California, San Diego (UCSD) as a legal battle over the control of the computer system and the database between UCSD and University of Southern California continues.

The combination of GlaxoSmithKline’s Volibris (ambrisentan) and Eli Lilly’s Adcrica (tadalafil) has met its primary endpoint in a phase IIIb/IV as a treatment of pulmonary hypertension (PAH). Both drugs are already marketed separately for PAH but the combination therapy resulted in a significantly lower risk of clinical failure, greater reductions in pro-brain peptide levels, greater improvement in 6-minute walk distance, and a higher percentage of patients with a satisfactory clinical response when compared to each single monotherapy.

Science & Technology

Recent new research suggests that beta-blockers could increase survival in women with ovarian cancer. Median survival in patients taking beta blockers was five months longer than those not using the treatment. More surprisingly among the women being treated with the drugs, those taking non-selective beta blockers had more than double the survival time of those taking selective beta blockers – 94.9 months versus 38 months.

Except for two countries, Pakistan and Afghanistan, the world could almost be declared polio-free and the eradication of the viral disease in the near future is a real possibility. However a new study reports results from an individual in the UK with an immune disease, whose stool samples have contained large amounts of live polio virus for over 20 years. Patients like this one, could start new polio outbreaks and complicate polio eradication as currently planned.

Medical Devices and Diagnosis News

Illumina joins forces with China Burning Rock to create a cancer diagnostics organization geared at the Chinese market. Under the terms of the deal, Burning Rock will bring its nucleic acid extraction, library preparation and data analysis software to the table and Illumina will provide next-generation sequencing (NGS) technology, instrument components and reagents. The partnership follows the announcement, in June, of a collaboration between Illumina with Chinese Annorad to develop noninvasive prenatal screening tools based on Illumina's NGS technology.

Scientist from the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust (UK) have developed a new blood test able to identify which patients with breast cancer are most susceptible to suffer a relapse after treatment. The test, which is based on the concept of “mutation tracking”, looks for circulating tumour DNA in the bloodstream via a digital PCR test, and was able to detect “very accurately” which patients would suffer a relapse.

Miscellaneous

Novo Nordisk plans to invest $2 billion in new manufacturing facilities in Clayton (NC, USA) to produce active pharmaceutical ingredients (API) for both oral semaglutide and a range of Novo Nordisk's current and future GLP-1 and insulin products and in Måløv, (Denmark) for tableting and packaging of oral semaglutide and future oral products.

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)
• 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)
• 15^th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
• BIO Europe 2015 on November 2-4 in Munich (Germany)
• Biofit 2015 on December 1-2 in Strasbourg (France)
• BIO International Convention on June 6-9, 2016 in San Francisco (USA)

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

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