The Nobel Prize in Physiology or Medicine 2015 has been awarded to William Campbell and Satoshi Omura for their discoveries concerning a novel therapy (avermectin) against infections caused by roundworm parasites" and to Youyou Tu "for her discoveries concerning a novel therapy against Malaria". To the best of our knowledge this is the first time the price is awarded to a Chinese female physician as well as to a major drug (artemisin) discovered through Traditional Chinese Medicine.
Acquisitions /mergers/joint-ventures
Guangzhou Baiyunshan Pharmaceutical, a China-based pharmaceutical company, has signed a letter of intent with Siemens Medical Diagnostic to establish a medical diagnosis (51:49) Joint-Venture in Guangzhou (China).
Business
Vernalis (Reading, UK) has acquired US rights for the long acting antibiotic Moxatag, the only approved once-daily formulation of amoxicillin from Pragma Pharmaceuticals (New York, USA). Under the terms of the deal, Vernalis has paid Pragma an undisclosed up-front fee and will make further payments on the successful manufacture of the re-launch of the product, as well as sales based royalties.
Merck & Co and DNAtrix (Houston, TX, USA) will collaborate to assess the combination of Keytruda (pembrolizumab) with DNAtrix’s DNX-2401 as a treatment for recurrent glioblastoma. Keytruda is a monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. DNX-2401 is a replicative oncolytic adenovirus designed to specifically target cells defective in the Retinoblastoma pathway.
Illumina (San Diego, CA, USA) will collaborate:
…with Amoy Diagnostics, a China-based manufacturer of in vitro diagnostics, on next-generation sequencing (NGS) cancer diagnostics and plans to develop and commercialize oncology-related tests based on Illumina’s NGS platforms.
…and with Burning Rock, a China-based oncology diagnostics company, to develop molecular diagnostic kits for the Chinese oncology market.
TauRx Pharmaceuticals (Singapore) has raised $135 million to fund the Phase 3 development of LMTX, its Alzheimer’ candidate which focuses on the inhibition of the aggregation of tau tangles in the brain. LMTX, which contains methylthioninium, better known as methylene blue, is "currently being investigated as the first tau-based disease-modifying agent for the effective treatment of Alzheimer's disease."
Approval of drugs, vaccines, diagnostics and devices
US FDA approves the use of Gilead’s Leitairis in combination with Lilly’s tadalafil for the treatment of pulmonary arterial hypertension (PAH). Letairis is an endothelin receptor antagonist approved as a monotherapy for PAH to improve exercise ability and delay clinical worsening. Tadalafil is a PDE5 inhibitor approved to improve exercise ability in PAH patients. The drugs’ combination has been approved on the back of clinical data showing that patients are less likely to experience disease progression or be hospitalised, than those receiving either therapy alone.
US FDA has widened the scope of Merck & Co Keytruda to treat advanced non-small cell lung cancer (NSCLC) patients with PD-L1 tumor expression. The drug is already approved for the treatment for squamous and non-squamous NSCLC as well as for the treatment of advanced melanoma.
US FDA approves Boston Scientific‘s Synergy as its first third-generation bioabsorbable stent. The Synergy Bioabsorbable Polymer Drug-Eluting Stent System is supposed to improve long-term outcomes because its polymer coating starts to get absorbed by the body following the completion of the elution of the drug everolimus, which takes three months. The Synergy is considered a partially bioabsorbable stent because the devices' platinum chromium body and stent struts do not dissolve away from within the coronary artery. Abbott's Absorb BVS is expected to become the first fully bioabsorbable stent to gain FDA approval.
Drugs at clinical stage
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Novartis Entresto, a combination of sacubitril and valsartan, for the treatment of patients with symptomatic chronic heart failure. The drug is already approved in the US an in Switzerland.
US FDA designates Fast Track review to:
…Tarix Orphan’s (Cambridge,, MA, USA) TXA127 for the treatment of skeletal muscle damage and fibrosis in Duchenne muscular dystrophy.TXA127 is a formulation of the naturally occurring peptide Angiotensin 1-7.
… and for Merck KGaA and Pfizer‘s avelumab for the treatment of metastatic Merkel cell carcinoma, a rare and aggressive skin cancer also known as neuroendocrine carcinoma or trabecular cancer. Avelumab is a checkpoint inhibitor that blocks the interaction of PD-L1 with its receptor PD-1, restoring effective anti-tumour T-cell responses and inhibiting cancer growth.
US FDA grants Marathon Pharma deflazacort a rare pediatric disease status for the treatment of Duchenne muscular dystrophy. Deflacort, a steroid hormone with anti-inflammatory and immunosuppressant properties, has also Fast Track status from the FDA.
Roche reports
… positive phase 3 results with combination therapy Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of patients with BRAF V600-poistive advanced melanoma;
… and efficacy against primary progressive multiple sclerosis (MS) with ocrelizumab a humanized antibody designed to selectively target CD20-positive B cells. Roche said the fact that efficacy was shown across both forms of MS “validates the hypothesis that B cells are central to the underlying biology of the disease”.
DBV Technologies (Lyon, France) showed results from an open-label extension of previous Phase IIb trial, which found that the proportion of children who responded to Viaskin Peanut, its peanut allergy patch, increased after a second year of treatment.
Science and Technology
Researchers at the University of Lincoln and the University of Nottingham (UK) have shown that the chances of having a first stroke are reduced by almost 20% in the first 59 days after receiving a flu vaccine.
Medical Devices and Diagnosis News
New tests using a high sensitivity blood test, help to identify patients who are not a heart attack risks when presenting chest pain. According to a study funded by Edinburg University, if a person has a high sensitivity troponin-I concentration of less than 5 nanograms per litre, they are at very low risk of having had a heart attack or having one in the next days and there is no need for them stay in hospital. Under the current method, levels of troponin are tested when a patient with chest pain is first admitted and then again 12 hours later. The high-sensitivity of the current test is able to pick up much lower levels, and also only needs to be carried out once.
St Jude Medical revealed that US FDA had forwarded a warning letter for nonconformance of Good Manufacturing Practice regulations at the Atlanta manufacturing facility where it produces the CardioMEMS heart failure monitor. In the warning letter, the FDA said St. Jude has not "maintained an effective CAPA (corrective and preventive action) system and has not adequately investigated known problems identified through customer complaints, non-conformances, and other sources."
Cost, Pricing and Market Access
A series of recent debates are clearly showing that Market Access is becoming more and more prevalent on new innovative products as well as on already established products. Biopharmaceuticals dog watchers are now regularly publishing reports on companies which have hiked their prices in recent time.
In a rather unexpected move, US pharmacy benefits manager Express Scripts has decided to cover both Praluent from Regeneron/Sanofi and Repatha from Amgen. Each of these recently approved PCSK9 inhibitor, to treat high cholesterol levels, is priced at about $14,000 per annum. Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
Miscellaneous
New data on Multiple Sclerosis. An analysis of long-term data from two late-stage trials of multiple sclerosis drugs, Lemtrada (alemtuzumab) from Sanofi Genzyme and Gilenya (fingolimod) from Novartis confirmed the efficacy and effectiveness of these drugs in treating relapsing multiple sclerosis (RMS). In a separate study Sanofi said that Aubagio (teriflunomide) significantly slowed brain volume loss versus placebo over two years in people with RMS. The results were reported at the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona.
Sanofi signs a partnership with the French Centre National de la Recherche Scientifique (CNRS) as well as with 26 other academic biomedical laboratories to host and manage their National Chemical Library (up to 65,000 molecules and natural product extracts) at the Toulouse (France) site. Evotec, a strategic partner of Sanofi will be in charge to run the operations.
Bristol-Myers Squibb is to pay $14.7 million to settle a bribery charge in China. According to the authorities, the BMS Joint-Venture medical reps offered cash, gifts, meals, travel, entertainment and sponsorships "to secure new sales and increase existing sales." BMS "falsely recorded" the transactions as "legitimate business expenses."
Bioevents
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FierceBiotech Executive Summitt on October 12 in London (UK)
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BIO Japan on October 13-16 in Yokohama (Japan)
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BIO Latin America on October 14-16 in Rio de Janeiro (Brazil)
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2015 Pharmaceutical/Medtech Dealmaking Symposium on October 15-16 in Chicago (USA)
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BIO Investor Forum on October 20-21 in San Francisco (USA)
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BIO Europe 2015 on November 2-4 in Munich (Germany)
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Biofit 2015 on December 1-2 in Strasbourg (France)
…and announcement of the 7th Innovation Days on October 3-4 2016 in Paris (France)
Author: Jean-Claude Muller, Special Advisor at I&IR, jcm@btobioinnovation.com
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