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MedNess Special: Bringing North America, Europe and Asia together

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Hello everyone and welcome to MedNess Global! Here at ClubSciWri, we are constantly trying to present the most impactful news in an ever-evolving innovative fashion. In this special edition, we bring business news from pharma and healthcare sectors in North America, Europe and Asia. Know what defines the industry space in each continent. Where is big capital invested on pharma research? And where does the manufacturing happen? What regulations underlie the drug making and selling processes across continents? This is an effort to give our readers a holistic understanding of international collaborations and deals in the industry. We thank our additional team of writers for their input; MedNess North America: Vinita Bharat; MedNess Europe: Czuee Morey; and MedNess Asia: Somdatta Karak

 

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MedNess North America

Merck Ventures supported Inthera Bioscience with their $11M investment

Protein-protein interactions (PPIs) are the basis of multiple control points in the body and play a pivotal role in multiple diseases, including cancer. PPI’s serve as the important target classes in oncology but are extremely intractable to work with.  Inthera bioscience, a Swiss based biopharma aims to design oral small molecules which can inhibit these PPIs, leading to the targeted approach for the treatment of solid tumors.  

For this innovative, novel and promising approach, Inthera drew the seed money of $3.8M in 2005, and now once again Merck Ventures invested $10.8M to wrap up pre-clinical developments focusing on HPV-associated cancers and hypoxia-inducible signaling  (FierceBiotech).

MedNess: Inthera Biosciences is a private biopharmaceutical company focussing on PPI’s. Inthera’s research group focuses on HPV-associated cancers and hypoxic signaling. Merck Ventures is the venture capital wing of Merck. This wing invests in novel products and technologies with significant potential to impact Merck’s core research areas (Biospace)

Novartis fully concentrated on its CAR-T cell therapy for “ALL” cancer

Novartis is specifically betting on its CAR-T cell therapy even though acknowledging that there is a gap in the other major I-O driven therapies like, IDO, BTK and PARP inhibitors. CAR-T is patient specific and looks likely to be the first of this new cancer class to reach the market by this fall.

CAR-T cell therapy involves the drawing of T-cells from patient’s blood and then reprogramming it in laboratory to hunt patient’s cancer cells and other B-cells expressing a particular antigen. Novartis touts this week data of its CAR-T candidate, CTL119 which when used with Janssen/Pharmacyclics’ Imbruvica (ibrutinib) gave complete responses with no evidence of disease in the bone marrow at three months (FierceBiotech).

MedNess: Novartis on June 1 opened with 81.78 and closed by 81.86 (Nasdaq.com). Novartis stock price has increased by 12.3% in the last 12 months. According to Zack’s classified, Novartis ranks number 3 and with its innovative technology, the stocks are advised to be hold onto (Zacks.com; TheStreet.com).

 

Tesaro’s new FDA approval med Zejula is waiting for its response

Tesaro’s PARP inhibitor based drug Zejula has one of 2017’s biggest launches, with an estimate of $1.9 billion till 2022. The company requested offers from the potential bidders but seems like they are waiting to hear from them.

Apart from the high price of this drug, buyers seem to wait for ASCO meeting where they can compare the results of Zejula with AstraZeneca’s Lynparza, Merck’s Keytruda and others. Hence, Zejula clealry opens up a PARP market and its big response is now relying on its ability to rack up new indications in prostate and breast cancer (FiercePharma).

 MedNess Europe

Therapeutic antibody against non-Hodgkin’s lymphoma developed by MorphoSys enters Phase 3 clinical trials

The German biotech MorphoSys announced that its therapeutic antibody, MOR208, has entered Phase 3 clinical trials after successful completion of the phase 2 part of the combined phase 2/3 trials. The randomized, multicenter phase 2/3 study is designed to investigate the efficacy of MOR208 plus bendamustine versus rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL), the most common form of non-Hodgkin’s lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

MOR208 is an Fc-enhanced monoclonal antibody that targets CD-19 homogeneously expressed on the surface of all B-cells. MOR208 is intended to induce direct apoptosis by binding to CD-19 along with significant potentiation of antibody-dependent cell-mediated cytotoxicity and cellular phagocytosis, thus aiming to improve a key mechanism of tumor cell killing.

MOR208 can therefore be useful to treat various B-cell malignancies such as non-Hodgkin’s lymphoma and chronic lymphocytic leukemia (CLL). Each year about 150,000 people are afflicted by B cell malignancies in the seven major markets. MOR208 was granted orphan drug designation in DLBCL and CLL across US and Europe. Additionally, the FDA has granted fast track designation for the treatment of DLBCL. MOR208 is under investigation in a separate clinical trial for CLL.

The dosing of the first patient in the phase 3 part will trigger an undisclosed milestone payment to Xencor, Inc., from whom MOR208 was in-licensed in 2010. MorphoSys has worldwide rights to MOR208. If this clinical trial is successful, MOR208 will be the first therapy that MorphoSys develops in clinical trials independently. However, MorphoSys has had a lot of success with its Human Combinatorial Antibody Library (HuCAL) that generates human antibodies in bacteria, after having been screened with the aid of specific phages. In partnership with Big pharma companies, MorphoSys has funneled over 100 monoclonal antibodies into the clinic with this platform (Labiotech.eu, Morphosys website).

MedNess Asia

Mismatch between FDA regulations and its implementation in Chinese API manufacturing companies

Cheaper manufacturing processes in China and India attract pharma companies in getting their Active Pharmaceutical Ingredients (APIs) manufactured for cheap in Asia. However, the manufacturing companies have to comply with regulations of the country where the drug is sold and intended to be used. Of the companies facing non-compliance with this are Chinese API makers, Teva Pharmaceutical Industries and Changzhou Jintan Qianyao Raw Material Factory failed US FDA inspection and has consequently been banned to ship all their products to the USA. The company had failed to meet with the Good Manufacturing Practice (GMP) expectations from  the US FDA. (GEN, FiercePharma)

MedNess: China is currently the world’s leading producer of pharma ingredients, covering 40% of global production, primarily because of the price advantage that they offer. It will be interesting to see if the API companies are willing to increase their costs by adding more regulatory expenses or let go of the multinational companies. On the other hand, China FDA (CFDA) has tightened its regulations to stop sub-standard operations.

Pricing pressures and non-compliance with US FDA regulations make difficult times for Sun Pharma

At the end of FY2016, Sun Pharmaceuticals Ltd., India’s largest pharma company, took a hit in its US sales for numerous reasons. Its key API maker for the US market, Halol faces US FDA regulatory limitations since 2014. US FDA slammed Halol with warning letters twice for reasons from inadequate data protection on computer to possibilities of contamination in their products despite Sun seeking help from consultants to make the plant US FDA compliant. In addition, Sun faces pricing pressure like the other generic drug companies. In addition, its US subsidiary specialty generics drugmaker, Taro faced a 26% drop in their sales.

More than 70% of Sun’s sales are from outside India, with US contributing to 50% of its turnover. With multiple worries continuing, Sun’s Managing Director Dilip Sanghvi has warned of single digit declines in the FY2018 revenues. (FiercePharma, Business Standard)

MedNess: Over the last 6 months Sun Pharma has seen a 28% drop in its stock prices (NSE). While resolving US FDA warning letters can take long, generic drugs pricing pressures might bring more mergers and acquisitions in the field.

 

China’s steps beyond generic drug making in healthcare sector

Founded in 2012, in Beijing, privately-held and venture-capital (VC) backed, CANbridge Life Sciences Ltd. has paved its path towards developing leading candidates in solid-tumor oncology, primarily in China, Taiwan and Korea by gathering funding worth $40mn, together after its second round of funding. Currently it focuses on two of its prime compounds – CAN008 and CAN017, and the former is already in phase I/II trial for glioblastoma multiforme, in Taiwan and will begin its phase II in China in 2018. CAN017 is designed against esophageal squamous cell cancer – the most prevalent form of cancer in Asia and has already been successful in phase I study in Greater China. CANbridge partners with AVEO Oncology (for the rights on the compounds) and Böhringer Ingelheim (for manufacturing) in development of CAN017. CANbridge talks of plans of more strategic transactions in 2017 – backed by strong finances and executive team – in direction of developing specialty healthcare products.  (Fierce Biotech, Biospace)

MedNess: China’s huge aging population and increase in lifestyle disorders as well as growth in per capita earning and expenditure is a promising ground to get into specialty healthcare products in China. CANbridge is an interesting example to study commercialization of healthcare products that are under-served in China and North Asia, by partnering with its developers and manufacturers in western countries. Since CANbridge is still VC backed, stocks are not yet for sale.

 

 

Featured Image by: 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.

Czuee Morey has a PhD from University of Lausanne and pursued a postdoc from University of Geneva. She has broad interests in healthcare and technology as evidenced by her research experience in fields such as protein biophysics and genomics. She has previously worked as a patent analyst and also built the business plan for her startup project. She is currently working in market intelligence for digital healthcare at Debiopharm in Lausanne, Switzerland.

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.

© The contents of Medness are the copyright of the PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs)

Blog design: Abhinav Dey

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MedNess- At the frontier of Medicine, Pharmaceutical and Healthcare Business

in Poli-Scie/SciBiz/Uncategorized by

Hello and welcome to the biweekly roundup of Healthcare business top stories. Please follow us on Twitter and LinkedIn

MedNess 

BMS’s injectable Opdivo approved by FDA for bladder cancer

FDA approved intravenous use of Opdivo (nivolumab), a PD-1 checkpoint inhibitor for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have not benefitted from platinum-containing chemotherapy or in cases where the disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. Last year, FDA approved Roche’s Tecentriq, a checkpoint inhibitor, for the treatement of bladder cancer.

From the business standpoint, this was much awaited good news for BMS as the Opdivo did not make the cut as first line monotherapy study in non small cell lung cancer (NSCLC) in 2016. However, Merck’s Keytruda gained FDA approval soon after Opdivo failed in NSCLC study (Fierce Pharma).

 

The battle of patents: bad news for Teva Pharmaceuticals

Genric drug maker giant: Teva Pharmaceuticals lost the patent challenge in U.S. District Court, safeguarding their star drug Copaxone against generic competition. Copaxone, approved in 1996, became the most prescribed drug for the treatment of multiple sclerosis. The patents protecting Copaxone against generic competition expired two years ago for 20mg dose. Novartis and Momenta launched their 20 mg alternative (Glatopa) in 2015. To recuperate, Teva launched a 40 mg formulation of Copaxone. However, this week, U.S. District Court invalidated Teva’s last and fourth key patent protecting 40 mg Copaxone from generic drug competition. Teva lost other 3 patents last year (Madison.com).

Trump pledges to bring drug costs down

Pharmaceutical industries were told by Trump that the drugs should be manufactured in the USA and the foreign countries buying US manufactured drugs should pay “fair share”. These changes in addition to “better innovation” will help bringing prices down for the US patients (CNBC).

MedNess from MedPol: Amgen CEO Robert Bradway announced that soon nearly 1600 jobs will be added. Bank of America Merrill Lynch predicted that Trump’s policies could help Amgen recover their stocks by 23% in the next 12 months (CNBC)

MedPol

US President’s executive order on immigration: the aftermaths

This is not a political blog, but the executive order has a very significant impact on the scientific, medical and healthcare community. In the following paragraphs, I will brief you with the sectors that have been affected.

  • NRMP issues the statement for the upcoming Match

Nearly 260 people from seven nations affected by travel ban, applied through National Resident Matching Program (NRMP) for medical residency in the USA (Association of American Medical Colleges, AAMC). Both the applicants and the hospital programs are concerned and affected by the travel ban. However, NRMP has urged the programs and the applicants to be discrete in their decisions that are in the interest of healthcare. The official statement issued by NRMP on their website states, “The medical education community must support all international medical graduates and their families during these difficult times. As for the current Match cycle, NRMP encourages applicants and programs to make the best decisions they can under current circumstances. For its part, NRMP will be liberal in granting waivers to applicants and programs if they cannot meet their respective Match obligations because of the effects of the Executive Order” (NRMP.org).

  • Dark times for the US hospitals and patients from seven nations affected by travel ban

Ill patients scheduled for treatment at the USA’s premier healthcare centers, John Hopkins Medicine and Cleveland Clinic are uncertain of their treatment options. Hopkins is taking a step ahead by either urging the patients to postpone their travel or sending their staff abroad for their treatment (STAT News)

We wrap up our biweekly MedNess and MedPol news section. Have a great weekend!

Image source: https://unsplash.com/search/medicine?photo=nss2eRzQwgw

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