Biocon and Mylan’s Biosimilar Trastuzumab Receives Approval from ANVISA, Brazil Through their Partner Libbs

On December 29, 2017 Mylan N.V. (NASDAQ, TASE: MYL) reported that Biosimilar Trastuzumab, co-developed by Biocon Ltd. (BSE code: 532523, NSE: BIOCON) and Mylan N.V. (NASDAQ, TASE: MYL), has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company (Press release, Mylan, DEC 28, 2017, View Source [SID1234522788]).

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Co-developed by Biocon and Mylan, this is the first biosimilar Trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil.

Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: "This marks the first approval for a biosimilar Trastuzumab by Brazil’s ANVISA and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe. Cancer patients in India and some emerging markets have benefited with our Trastuzumab and the approval in Brazil will enable affordable access to this critical biologic therapy for the treatment of HER2-positive breast and gastric cancers in the country. We are committed to make global impact with our affordable antibodies against cancer."

Mylan CEO Heather Bresch commented: "The number of women diagnosed with breast cancer in Brazil is increasing. Sadly, many of the women with HER2-positive metastatic breast cancer in Brazil do not have access to Trastuzumab through the country’s public health system. The approval of Zedora, Brazil’s first Trastuzumab biosimilar, is an important step in our efforts to increase access to this critical product for patients with certain breast and gastric cancers and reduce the overall financial burden for health systems around the world."

Alcebíades de Mendonça Athayde Júnior, Libbs CEO, said: "The approval of Zedora will allow us to bring this first-of-its-kind biosimilar Trastuzumab to breast and gastric cancer patients in Brazil. Biosimilar Trastuzumab, co-developed by Biocon and Mylan, can help expand cancer­patient access to more affordable treatment and contribute to significant savings to Brazil’s healthcare system. Zedora will strengthen our current product portfolio as a new generation targeted therapy that can benefit cancer patients immensely."

Biocon and Mylan are responsible for the development of biosimilar Trastuzumab. While currently the trastuzumab will be manufactured by Biocon and supplied to Libbs for commercialization in Brazil; over a period of time the technology will be transferred to Libbs and the public partner Butantan through a Productive Development Partnership (PDP). Libbs have already built the biotechnological site to manufacture Zedora for the Brazilian market.

This is a significant approval as it sets the stage for the entry of our biosimilar Trastuzumab into Brazil, which is among the top three emerging markets globally for Trastuzumab. The pharmaceutical market in Brazil is predicted to grow to US$30 billion in 2021 from US$26 billion in 2016. (Source:GlobalData)

Breast cancer is the leading cause of cancer death in women in Brazil, where new cases are estimated to be over 57,000 annually, with an estimated incidence of 56 cases per 100,000 women. It is the second-most common type of cancer that affects women in Brazil, after non-melanoma skin cancer*. Trastuzumab is now included on the WHO list of essential medicines.

Earlier this month, Biocon and Mylan marked a major milestone with the U.S. Food and Drug Administration approval of their biosimilar Trastuzumab. Biocon and Mylan’s biosimilar Trastuzumab is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in several other countries around the world, including India, where it is providing increased access to this more affordable biologic for cancer patients.

About Biocon and Mylan Partnership
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Our biosimilar Trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Atara Biotherapeutics to Host Corporate Update Conference Call on Friday, December 29, 2017, at 8:00 a.m. EST

On December 28, 2017 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that it will host a live corporate update conference call and webcast on Friday, December 29, 2017, at 8:00 a.m. EST (Press release, Atara Biotherapeutics, DEC 28, 2017, http://investors.atarabio.com/news-releases/news-release-details/atara-biotherapeutics-host-corporate-update-conference-call [SID1234522784]).

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Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 2395468. The live webcast can be accessed on the Events and Presentations page in the Investors and Media section of the Atara website, www.atarabio.com. A replay of the webcast will be available on the Company’s website for 90 days following the live conference call.

Onconova Therapeutics to Present at Biotech Showcase in January

On December 28, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that it will present at Biotech Showcase taking place January 8-10 in San Francisco (Press release, Onconova, DEC 28, 2017, View Source [SID1234522785]). The Company’s CEO and President, Dr. Ramesh Kumar, will present and management will be available for one-on-one meetings.

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Presentation Details:

Date: Tuesday, January 9th, 2018

Time: 2:00 pm PDT (5:00 pm EST)

Location: Franciscan Room B at the Hilton San Francisco Union Square, 333 O’Farrell Street – Ballroom Level

The presentation will be available on the Investors section of the Company’s website at: View Source

Propanc Biopharma to Present at the 10th Annual Biotech Showcase™ 2018

On December 28, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that the Company’s Chief Executive Officer, Mr James Nathanielsz, reported that it will be presenting at the 10th Annual Biotech Showcase to be held on January 8 – 10, 2018, at the Hilton, Union Square, San Francisco, CA (Press release, Propanc, DEC 28, 2017, View Source [SID1234522786]). The Company’s presentation is scheduled for Wednesday, January 10, 2018, at 10:30 a.m., PST.

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Mr Nathanielsz will provide an overview of the Company and recent advancements of its lead product, PRP, during the live presentation and will be available to participate in one-on-one meetings with attendees who are registered to attend the conference.

Additionally, Mr Nathanielsz will be available to participate in investor and partnering meetings surrounding the 36th Annual J.P. Morgan Healthcare Conference to be held January 8-11, 2018 in San Francisco, CA. Investors are encouraged to contact [email protected] to request a meeting.

"I am looking forward to presenting at the upcoming conference and providing an update on the recent developments of PRP, as we prepare for filing our first clinical trial application in early 2018," said Mr Nathanielsz.

Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research.

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

About Biotech Showcase:
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year.

LIDDS: NanoZolid® with immune-stimulating agent demonstrates significant efficacy

On December 27, 2017 LIDDS reported that it has successfully completed the first steps in one of its projects assessing the feasibility of using the NanoZolid drug delivery technology for intratumoral immunotherapy with positive results (Press release, Lidds, DEC 27, 2017, View Source [SID1234555921]).

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In one of LIDDS immune-oncology projects, an immune-stimulatory agent was successfully formulated using the NanoZolid drug delivery technology. Chemical analytical methods demonstrated that the agent had a very promising release profile from the drug formulation. In a second step, the NanoZolid formulated immune-stimulatory agent was tested in an immuno-oncology model of a aggressive/hard to treat cancer in mice. In this model, a single dose of the locally delivered immunotherapy significantly reduced tumour growth and increased survival in the treated animals compared to control animals.

This demonstrates that that the NanoZolid drug delivery technology can be leveraged to develop novel immunotherapies that can act locally or intratumorally.

A locally delivered immunotherapy has the potential to act either as a monotherapy or in combination with systemic immunotherapies e.g. checkpoint inhibitors. A successful combination treatment could significantly increase the response rates and efficacy rates of current immunotherapies.

A recent review article in the highly ranked journal Annals of Oncology (Impact Factor 11.855) highlights the unique opportunity of intratumoral treatments to increase the efficacy of immunotherapy while reducing the potential side-effects.

Results from the other preclinical feasibility studies are expected in the first quarter of 2018.

Immunotherapy for the treatment of cancer aims to activate and utilize the body’s own immune system to recognize and attack tumors and cancer cells and is today the fastest growing and most promising area of cancer research.