Hello and welcome to MedNess. This edition of MedNess covers the latest from small and big biotech and pharma companies. Stay tuned for MedNess Asco Coverage. In the meantime, please subscribe to ClubSciWri for our other articles and blog posts!
Celgene supports Dragonfly in enhancing NK-cell based immunotherapy
The discovery-stage company, Dragonfly Therapeutics, aims to enhance immunotherapy using Natural Killer (NK) cells. Dragonfly aims to harness the power of body’s innate immune system to vastly improved patient outcomes. They plan to stimulate NK cells so that these cells can attack tumors directly with support of T and B cells. This strategy has attracted the attention of a leading global pharmaceutical company, Celgene along with the Duke of Bedford, Disney family members and other organizations.
Celgene bagged the option on four NK cell based cancer therapeutics to treat myeloid leukemia, multiple myeloma and other hematological cancers by investing over $33 million in Dragonfly. This collaboration by Celgene shows that they saw immense potential in this discovery stage biotech to develop innovative therapies for cancer patients (Dragonfly Therapeutics, Fierce Biotech).
MedNess: Celgene recently reported positive data from Lupus trial. Its shares have been soaring with an overall gain of 19.8% in the last one year. As per Zack’s index, Celgene stocks are a strong hold. At the present, the shares are sold for $124.82 (Zacks).
Europe, US, and Japan joins hands to boost antibiotic development
The three drug regulators of the world; European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA,) and the Food and Drug Administration (FDA) participated in the tripartite meeting in Vienna, Austria to consider a robust response to boost antibiotic development.
They agreed to align their data requirements for certain aspects of the clinical development of new antibiotics so that the new meds can come in the global market. Also, in the meeting, they discussed in detail clinical trial recommendations for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. Even the areas of differences were talked about in this meeting, and an effort to work together to minimize them was discussed.
While all three of them are now working on updating their respective guidance documents, they are also willing to provide suggestions to the individual biopharma companies. The next meeting is scheduled for October 2017 ( Fierce biotech, EMA).
Astrazeneca terminates the plan for NASH drugs with SoCal’s Regulus
California based biopharmaceutical company, Regulus aims to discover and develop innovative medicines targeting microRNAs. They recently announced their pipeline updates and advancement in which a major setback was when Astrazenenca terminated the clinical development program for AZD4076 (RG-125) which is involved in the treatment of nonalcoholic steatohepatitis (NASH) in Type 2 Diabetes/Pre-diabetes.
Regulus also planned to discontinue clinical development of RG-101 for Hepatitis C Virus (HCV) upon completion of the one remaining clinical study, which is expected to occur in July 2017. Now, the company is majorly focussing on keeping the plans of the Phase II clinical programs for RG-012 which is used for the treatment of Alport syndrome on track. Also, the IND for RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD) is on track for filing by year end 2017 (Regulus, Fiercebiotech).
AstraZeneca’s Lynparza slows breast cancer progression, now a potential precision drug against prostate cancer
AstraZeneca announced statistically significant positive results from Phase 3 OlympiAD tested against breast cancer patients with BRCA gene mutations. The results demonstrated a clinically-meaningful improvement in progression-free survival (PFS) for patients treated with Lynparza (olaparib) tablets (300mg twice daily), compared to chemotherapy. In addition, a 42% reduction in disease worsening or death (HR 0.58; 95% CI 0.43-0.80; p=0.0009; median 7.0 vs 4.2 months) was observed in patients treated with Lynparza when compared to those who received chemotherapy. The results were reported in New England Journal of Medicine. Lynparza was earlier approved for ovarian cancer that is caused by BRCA. Now, in another study being carried out at the Institute of Cancer Research, London, Lynparza is showing a potential towards precision drug in prostate cancer. According to the researchers, the test designed by them, could distinguish the disease severity, treatment response and if prostate cancer is evolving genetically and can potentially become drug resistant. The results of these tests were reported in Cancer Discovery (AstraZeneca, Reuters)
MedNess: AstraZeneca has a strong pipeline of drug candidates. The stock has a market capitalization of $87 billion. Lynparza generated $218 million in sales in 2016. The current share price is a little over $34 with overall gain of 0.26% (Forbes, CNNMoney).
Clovis Oncology announces positive results from late stage ovarian cancer trial
Clovis Pharma’s, Rubraca, met its primary endpoint and a key secondary endpoint. The company is planning to request label expansion for Rubraca and gain approval for second line treatment and maintenance treatment for women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. Clovis Pharma’s drug is directly in competition with Tesar Inc’s Zejula and AstraZeneca Plc’s Lynparza. All the drugs belong to the class of PARP inhibitors, that blocks enzymes poly ADP ribose polymerases. These enzymes are involved in repairing damaged DNA (Clovis Oncology).
MedNess: Clovis Pharma’s shares are soaring. It shutdown at $59.97 on Friday, June 15. The stock opened at $87.73 (~ 50% surge in price) on Monday, June 19.
15 Stocks Moving In Monday's Pre-Market Session https://t.co/xKs3fnMoD9 #PreMarketGainers #AAOI #CLVS #EQT #EXEL #PreMarket #Markets
— Trade Alerts, Trade Ideas and Crypto 🇺🇸 (@AlertTrade) June 19, 2017
MedNess Asia:
Promising addition in cancer therapy from Chi-Med with a huge investment from U.S. partner Eli Lilly
Last week, Hutchison China MediTech Limited (Chi-Med) has submitted its New Drug Application (NDA) to China Food and Drug Administration (CFDA) for fruquintinib, developed jointly with Eli Lilly to treat advanced cases of colorectal cancer (CRC). In addition, fruquintinib is being tested to treat non-small cell lung cancer and gastric cancer. The drug selectively inhibits vascular endothelial growth factor receptor and helps preventing angiogenesis, i.e. development of new blood vessels essential for tumor growth and metastasis.
Chi-Med aims to break the Active Pharmaceutical Ingredient (API) manufacturer’s stereotype of Chinese pharma companies, and establish itself in bringing innovative and modern drugs in international market. The other drug that the company is evaluating at phase II trial for cancer research is sulfatinib, that also targets tumor angiogenesis and immune evasion. (Reuters, Chi-med press releases)
MedNess: CRC is the second most common cancer with 380,000 cases in China and 1.5 mn cases globally. Reports suggest that the number of new cases of CRC will increase by 13% over the next three years by 2020. Hopes are that fruquintinib can be used in combination with chemotherapy and targeted cancer therapy. Since the application of NDA for the drug on 12th June, Chi-Med has seen a surge of 2.6% in its stock prices (within two days).
CHN FDA accepts $HCM filing for fruquintinib as advanced #ColorectalCancer therapy https://t.co/31MhHjATLz
— CBPartners (@CBPartners) June 14, 2017
Market for internationally manufactured aesthetic medicine in China
Austria-based Croma-Pharma becomes the only second European producers of intradermal fillers approved in China. Intradermal fillers (biodegradable – like different forms of collagen and hyaluronic acid, semi-permanent – like different polymers and permanent – like silicone) help in skin aging management by restoring facial volume or treating wrinkles.
Croma-Pharma (CP) has registered Princess® VOLUME, a hyaluronic acid based filler in China by joining hands with Sihuan Pharmaceutical (SP) – CP brings in its products, experience and related intellectual property rights, whereas SP will provide its multi-channel distribution and marketing knowledge, being one of the largest pharma corporations and drug franchises in China. This joint venture aims to compete against the local manufacturers in the country and increase the quality of beauty products in China. (Croma news, Bloomberg)
MedNess: China has the largest market for aesthetic medicine in Asia-Pacific region growing at 20% annually, with its aging population, increasing awareness about aesthetic treatment and rise in disposable incomes. By taking advantage of a Chinese company’s distribution channels, Croma-Pharma hopes to reach a considerable market share, by competing against local manufacturers – an issue that has been bothering most foreign manufacturers in China.
NEWS: Croma-Pharma announces 2 major milestones in China: Princess® VOLUME approved by CFDA & forms joint venture. https://t.co/CwJ7MZNGzP
— Consulting Room (@Consulting_Room) June 13, 2017
Generic anticoagulant launched by Dr. Reddy’s Laboratories for US market
Indian multinational pharma company Dr. Reddy’s Laboratories launched bivalirudin, a therapeutic equivalent generic version of Angiomax® by the Medicines Company. Approved by US-FDA, it is to be used for injection as a blood anticoagulant.
Angiomax, a direct thrombin inhibitor (DTI) structurally similar to hirudin, is used for acute cardiovascular care. DTIs show a higher specificity in reaction with thrombin and lesser complications arising from its use, and hence are preferred over indirect thrombin inhibitors like heparin . Angiomax and its generics registered US sales of around $198 mn over the last year till March 2017. (Dr. Reddy’s Laboratories press release, The Medicines Company)
MedNess: The anticoagulants market is expected to grow at a CAGR of more than 6% by 2020. Within a week after the launch (on 6th June) by Dr. Reddy’s its stock prices went up by 4.5%.
#Dr.Reddys Dr. Reddy's Launches Angiomax' Generic Bivalirudin For Injection In U.S. Read more: https://t.co/UnrdOFrTT6 $RDY
— Heath Care News (@h_c_services) June 7, 2017
Featured Image: Vinita Bharat
About the Authors:
Imit Kaur, Ph.D. is a freelance scientific advisor, medical writer, editor, and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development. Follow Imit on LinkedIn (Imit Kaur) or Twitter (@imit_kaur)
Somdatta Karak, PhD is interested in pharma and healthcare sector in Asia. She also works with PhD Career Support Group / Club SciWri as its project coordinator. She aims to make a more and better informed world for all, and hence experiments with making effective platforms of education. She can be reached here.
Vinita Bharat Ph.D., is currently a postdoctoral research fellow at European Neuroscience Institute, Göttingen, Germany and had been an International Max Planck Research School (IMPRS) student here. Her research area focuses on cellular and molecular neuroscience. Other than enjoying ‘being a scientist’, she has also been working on science education. Presenting science in easy and fun way is what she loves doing through her platform “Fuzzy Synapse” (one can find fuzzy synapse on Facebook, Instagram and Twitter). She is a fun, enthusiastic and curious person, passionate about traveling, loves celebrations and bringing smiles around her.
