Category Archives: Biotechnology

NEW YORK, NY--(Marketwire -07/17/12)- The Biotechnology Industry has been soaring in 2012 as companies -- both large and small -- have shown impressive growth. The SPDR S&P Biotech ETF (XBI) and the First Trust NYSE Arca Biotech Index ETF (FBT) year-to-date are up 37 percent and 35 percent, respectively, outperforming the broader market by a wide margin. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Biosante Pharmaceuticals Inc. (BPAX) and Dendreon Corporation (DNDN).

Access to the full company reports can be found at:

http://www.ParagonReport.com/BPAX

http://www.ParagonReport.com/DNDN

Despite having to negotiate a more challenging regulation process biotech companies have continued to show investors strong gains in 2012. The FDA Amendments Act of 2007 forced regulators to increase standards for approvals of new drugs, introducing mandatory risk evaluation and mitigation strategies. According to a Pharmaceuticals & Biotechnology report from IMAP, several pharmaceutical firms have altered their drug portfolios from primary care driven blockbusters towards specialties such as oncology, immunology and inflammation, where the medical need is "so high that prices are more easily accepted by the regulators."

Paragon Report releases regular market updates on the Biotechnology Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at http://www.ParagonReport.com and get exclusive access to our numerous stock reports and industry newsletters.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. The company has recently regained compliance with the minimum bid price requirement for continued inclusion of its common stock on The NASDAQ Global Market.

Dendreon is a biotechnology company focused on targeting cancer and transforming lives through the discovery, development, commercialization, and manufacturing of novel therapeutics that may significantly improve cancer treatment options for patients. Dendreon's PROVENGE is the first autologous cellular immunotherapy to receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.paragonreport.com/disclaimer

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Despite Facing Tougher Regulation Process Biotech Industry Soaring in 2012

WASHINGTON & MUMBAI, India--(BUSINESS WIRE)--

The Biotechnology Industry Organization (BIO) is pleased to announce the 3rd Annual BIO India International Conference will be held September 12-13 at the Grand Hyatt in Mumbai, India. BIO will partner with the Association of Biotechnology Led Enterprises (ABLE), which represents Indian and Asian biotechnology and pharmaceutical companies, as well as leading investment banks and Venture Capital firms.

BIO India returns to India for its third year to bring together biotechnology and pharmaceutical companies from North America, Europe and Asia toexplore business opportunities with Indias emerging biotechnology sector, said Alan Eisenberg, Executive Vice President of Emerging Companies and Business Development at BIO. During this time of resurgenceof growth in the Indian economy and the healthcare sector in particular, it is critical for Indian and International biotechnology companies to capitalize on opportunities available within India. Working withABLE, we are committed to supporting the biotechnology industry in India by hosting this event that will connect U.S., European and Asian companies for potential deals and collaborations.

BIO India will feature high-level keynote speakers, educational India-focused panels, networking opportunities, company presentations, and the BIO One-on-One Partnering system. BIOs partnering system provides an interactive environment to intelligently search, contact and schedule private meetings with potential partners and investors.

Mr. Sam Pitroda, Advisor to the PM on Public Information Infrastructure and Innovation will address the conference. Mr. Pitroda is a visionary who has played a major transformational role in the Indian IT sector making it one of the major drivers of the Indian economy. His current mandate includes driving innovation down to the small and medium enterprises to help an inclusive and sustainable growth.

H. Thomas Watkins, President and Chief Executive Officer of Maryland-based Human Genome Sciences, will provide a keynote address at the conference. Mr. Watkins joined HGS in December 2004, and previously worked with Abbott Laboratories and its affiliates in the U.S. and Asia for nearly twenty years. Mr. Watkins is Chair of the Board of Directors of BIO and Chair of the Life Sciences Advisory Board of the State of Maryland.

Biotech industry in India is growing at 24% for the past decade and for this to happen year on year, collaborations andpartnershipsare vital to do business. BIO India is the most preferred platform for partnering, saidDr. Panchapagesa Murali President, ABLE.

The 2011 BIO India conference attracted more than 70 percent Indian attendance, and featured presentations fromtop Indian, U.S. and European biotech companies. Through the BIO One-on-One Partnering system, delegates scheduled more than 500 partnering meetings in the two day event.

Through this conference and ongoing advocacy efforts, BIO aims to help the industry flourish within India's borders and help patients and citizens benefit from the promise of biotech. BIO brings to India more than ten years experience and expertise in biotechnology and pharmaceutical partnering. BIO is renowned for its successful partnering meetings held around the globe, including the industrys largest partnering event the BIO Business Forum at the BIO International Convention.

About BIO

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BIO India International Conference to Bring Global Biotechnology Industry Leaders to Mumbai

ROCKVILLE, Md., July 16, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), CPL Biologicals (CPLB) and the International Centre for Genetic Engineering and Biotechnology (ICGEB), today announced that they have formed a new collaboration to develop a novel malaria vaccine in India. This unique public-private partnership will combine the advanced vaccine technology of Novavax with the malaria vaccine research capabilities of ICGEB and vaccine manufacturing capability of CPLB, to develop a new and effective malaria vaccine. The project is being funded by India's Department of Biotechnology Vaccine Grand Challenge Program and will be managed by the Malaria Vaccine Development Program, a New Delhi-based not-for-profit organization established to support the development of malaria vaccines.

Novavax's virus-like particle (VLP) vaccine technology platform will be applied to construct malaria vaccine candidates, which CPLB will manufacture for advanced preclinical studies, clinical trials and commercialization. The partners will develop and evaluate VLPs that express Plasmodium falciparum circumsporozoite protein (PfCSP), which has been used to develop the only recombinant malaria vaccine that has shown efficacy in field trials. After establishing the feasibility of Novavax's technology, the partners will explore the possibility of producing additional VLPs against antigens from other stages of malaria parasites. The partners believe a multi-stage VLP malaria vaccine has the potential for higher efficacy compared to vaccines based on a single antigen or that target only one stage of the malaria parasite.

Malaria remains a major public health problem in many regions of the tropical world. Forty percent of the world's population lives in malaria endemic regions of Africa, Asia and Central and South America. Despite the widespread use of insecticides, bed nets and other malaria control efforts, there are approximately 210 million cases of malaria each year that lead to around 650,000 deaths, primarily in children less than five years of age. There is an urgent need for malaria vaccines with high efficacy that can be used in conjunction with other control efforts to provide protection against malaria.

Dr. Virander Chauhan, Ph.D., Director of ICGEB, New Delhi, which will provide their extensive experience in pre-clinical and clinical development of vaccines, said, "ICGEB is excited about the possibility of working with Novavax and CPLB to advance malaria vaccine development."

Indravadan A Modi, Chairman of Cadila Pharmaceuticals Ltd, said, "CPLB will develop manufacturing processes for the vaccine candidates and will provide GMP production capability in support of this initiative." He also stated, "Malaria is a common health problem for tropical countries and efforts have been ongoing for years for its eradication. I am confident that a multi-stage VLP malaria vaccine will prove beneficial in saving precious lives by restricting morbidity and mortality associated with malaria."

Dr. Gale Smith, Novavax's Vice President Vaccine Development, stated: "Novavax is honored to be working with leading malaria experts at ICGEB and with the Department of Biotechnology of the Government of India to support the development and production of malaria vaccine candidates by Novavax and CPLB. By combining our knowledge and experience with these partners to pursue the most advanced malaria vaccine concepts, we hope to one day have an effective vaccine against one of the world's most devastating diseases."

About Novavax

Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces novel vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: http://www.novavax.com.

About CPLB

CPL Biologicals Pvt. Ltd., a joint-venture biotechnology company established by Novavax Inc. and Cadila Pharmaceuticals, one of the largest privately held pharmaceutical companies in India based in Ahmedabad, manufactures VLP-based influenza vaccines developed by Novavax. CPLB has made rapid progress with the completion and validation of its state-of-the-art manufacturing facility, which is now operational and capable of producing a significant volume of novel vaccine doses every year. This facility utilizes the identical single-use vaccine bioprocessing system that Novavax employs at its pilot plant in Rockville, Maryland.

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NOVAVAX, CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology Announce Collaboration ...

A biotechnology company that has licensed a drug for the treatment of neurodegenerative disease amyotrophic lateral sclerosis, or Lou Gehrigs disease, in phase 3 development withBiogen Idec (NASDAQ:BIIB) is raising $30 million to develop its product pipeline.

The financing is being done in two tranches of $15 million to help accelerate discovery of next-generation mitochondrial mediators for neurodegenerative disorders and to support near-term clinical development of a novel combination treatment for Parkinsons disease, according to an emailed statement from Tom Petzinger Jr., executive vice president for business development and public affairs.

Knopp Biosciences, based in Pittsburgh, Pennsylvania, was started to develop a cure for ALS and is led by CEO Michael Bozik. Life science accelerator LaunchCyte and Dr. Robert Bowser, a University of Pittsburgh School of Medicine associate professor of pathology and director of the universitys center for ALS research, co-founded the company.

The drug, which has been given fast-track approval by the U.S. Food and Drug Administration, is currently undergoing clinical trials that include 900 people globally, according to Biogens annual report.

As part of its research for developing dexpramipexole, Knopp researchers learned that it protects stressed neurons and other cell types from dying, according to the companys website. Knopps discovery team has found initial evidence of neuroprotection by dexpramipexole with in vitro models of Parkinsons disease.

Knopps biology and medicinal chemistry groups are collaborating to develop next-generation modulators of mitochondrial bioenergetics for conditions such as Alzheimers disease, diabetes and heart failure.

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Biotechnology firm raising $30M to advance Parkinson’s, neurodegenerative diseases

LAWRENCEBURG, Indiana, July 9, 2012 /PRNewswire/ -- PDS Biotechnology Corporation announced today that they have entered into an exclusive worldwide licensing agreement with Merck KGaA, Darmstadt, Germany, for use of PDS Biotechnologys novel Versamune nanotechnology platform in two of Mercks investigational antigen-specific cancer immunotherapies currently in pre-clinical development. Merck obtains the rights to utilize the technology with two investigational antigen-specific cancer immunotherapies which are in pre-clinical development.

Under the terms of the licensing agreement, PDS Biotechnology Corporation will receive an undisclosed upfront payment in cash, as well as development milestone payments, and commercial and sales milestone payments. PDS Biotechnology Corporation will also receive royalties on sales of the products incorporating the technology.

Dr. Frank Bedu-Addo, Chief Executive of PDS Biotechnology Corporation said, "We are very pleased that Merck which is experienced in the clinical development of cancer immunotherapies would like to utilize the Versamune technology. For PDS Biotechnology Corporation, this deal is important since the companys business strategy is focused on a few strategic out-licensing or partnering deals at a preclinical or early clinical stage. This is the stage where companies will be seeking to enhance their pipelines by taking advantage of a new technology that has broad potential applications in clinical research into the treatment and prevention of cancer and infectious diseases."

About PDS Biotechnology Corporation and Versamune PDS Biotechnology Corporation is a privately held biotechnology company founded to exploit the newly discovered properties of specific synthetic positively charged (cationic) lipids to commercialize a new generation of immunotherapies and vaccines. The proprietary Versamune platform nanotechnology, when combined with specific cancer-associated molecules, has been demonstrated to lead to increased tumor regression rates compared to leading clinical adjuvants in pre-clinical cancer models (Cancer Immunology Immunotherapy, 2008, 57: (4) 517-530). The Versamune nanotechnology presents a giant step forward in the development of the next generation of immunotherapies. PDS Biotechnology Corporations lead products are being developed to treat prevalent cancers such as cervical cancer, head and neck cancer and melanoma. The technology is also being applied to the development of vaccines which are designed to protect against pandemic diseases. Visit http://www.pdsbiotech.com [http://www.pdsbiotech.com/] for more information on Versamune and products in development.

PDS Biotechnology Corporation

Web site: http://www.pdsbiotech.com/

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PDS Biotechnology Corporation Signs Worldwide Licensing Agreement with Merck KGaA for Versamuneâ„¢

By The Canadian Press

VANCOUVER - Canadian biotechnology company QLT Inc. is cutting its workforce by two-thirds, leaving it with 68 employees after a downsizing brought in by new leadership following a proxy battle waged by some of its shareholders.

Among those leaving is Robert Butchofsky, who has been QLT's president and chief executive. He has agreed to stay until July 31 as part of the transition.

The Vancouver-based company (TSX:QLT.TO - News) had been one of Canada's most successful biotechnology firms based on its treatment for a common form of age-related blindness.

But sales of Visudyne have fallen and QLT has struggled in recent years to find another commercially successful product.

As a result, QLT's new chairman says the company is cutting 146 of its 214 remaining jobs.

He says the downsizing will reduce QLT's annual operating expenses by $45 million to $50 million in 2013. The downsizing will cost about $14 million to $17 million, mostly for severance and change-of-control payments.

QLT's new board of directors has also authorized a payout of $100 million to its shareholders in a process known as a return of capital.

"To understand why the Board is taking this new direction, it is critical to understand why it was elected and how QLT's previous strategic plan could have put the company in a precarious financial position," QLT chairman Jason Aryeh said in a letter to shareholders publishes Monday.

"Our board was elected by concerned and frustrated shareholders, disquieted that the company's spending and headcount seemed to be inappropriate given the nature of its assets, size and focus."

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Canadian biotechnology developer QLT slashes workforce by two-thirds, CEO to depart