Archive for the ‘Biotechnology’ category

Biotechnology’s Banner 2014 Driven by Big-Data-Wielding Investors

October 13, 2014

big data pic Midway through 2014, the biotechnology industry has significantly outperformed the general market. The Standard & Poor’s biotech index shows a 13.6 percent gain in valuation over the past six months, a 175 percent increase over the previous year. While some, including Janet Yellen, chair of the Federal Reserve, have expressed concern over the sharp rise in biotech investments, industry experts have found that much of the growing activity in the market is the direct result of increasingly shrewd investors. While the biotech market continues to be volatile, big valuations seem to be coming as the result of big data.

Many investors – rather than looking at individual companies – have begun performing cross-analyses of the drug development pipelines of numerous companies, charting the growth of specific therapies and treatments, as multiple firms explore specific research opportunities. Biotech companies, which have begun offering more data than ever before, have made it easier for investors to see which new initial public offerings are launching with promising technological and medical foundations. Investors, with the knowledge necessary to digest the research coming out of new firms, have the ability to make smart decisions in a market that has been known to be capricious, creating opportunities that have driven huge gains in valuations, as well as 43 percent more IPOs compared to the previous year.


The Development of Targeted Cancer Therapies

January 30, 2014

Targeted therapies for cancer have created a revolution within the health care and pharmaceutical industries. Many current products exist in this expanding market, and many others are in various stages of research and development.

A targeted cancer therapy is a medication or other substance that interferes with the development and metastasis of the disease through defusing particular molecules involved, thus halting the disease or delaying its progression. Breast cancer was among the first types of cancer to receive targeted therapies.

Medical professionals frequently refer to the molecules involved as “molecular targets” when treating the disease. Because of this specific targeting, this type of treatment may be more effective, and less damaging to surrounding tissues and organs, than radiation or chemotherapy.

Most targeted therapies consist either of monoclonal antibodies or small-molecule drugs.

Different types of targeted cancer therapies interfere with cellular division and tumor growth in a variety of ways. Some attack cancer cells directly, while others focus on an indirect method through stimulating the immune system to deliver toxins to the cancer cells. Many other targeted therapies disrupt communication along cell pathways by engaging with the proteins involved in network signaling. Such blocking can destroy the cancer cells’ ability to divide and develop, and therefore can result in their destruction.

On the biotechnology investment front, one recent report forecasts nearly $33 billion in global revenue for small-molecule therapy products by the year 2016, which represents an increase of more than $10 billion from 2011 figures. The prospects for ongoing success in research and development of small-molecule therapies should remain strong over the next decade, with demand high in most of the world as populations age.

The Ongoing Legislative Debate over Generic Biologic Drugs

November 18, 2013

Biologic DrugsDr. Lindsay Rosenwald of Opus Point Partners co-manages one of the premier biotechnology investment funds available today. As an entrepreneur with a background in medicine and nearly three decades of experience in financing and incubating biotechnology firms, Dr. Lindsay Rosenwald has established himself as one of Wall Street’s preeminent biotechnology investors.

During the summer of 2013, various state-level legislative battles took place as pharmaceutical companies encouraged policymakers to enact physician notification requirements regarding generic biologic drugs. These companies, led by Amgen and Genentech, have faced resistance from pharmacists and the Generic Pharmaceutical Association, which represents manufacturers of generic drugs.

Biologic drugs are especially complex molecules which require exacting manufacturing processes to produce. Hence, generic versions tend to be “biosimilar” rather than identical to brand-name drugs: they behave the same medically without necessarily being perfectly chemically identical.

Because biologics currently make up around a quarter of the $320 billion market for medications in the U.S., the ways in which their generic versions are approved, tested, and regulated are worth tens of billions of dollars to the different actors in the pharmaceuticals industry. So far, in all but one of the fourteen states where the measures have come up for debate, the generic manufacturers have prevailed.

In the coming decade, patents on several high-profile biologics will expire and the FDA will be faced with approving generic versions. Legislation like doctor notification rules will impact many aspects of the generic drug industry.

Breakthrough Opens Up New Avenues for Antibiotic Research and Development

November 8, 2013

In an article published in PLOS Genetics on October 31, 2013, Oregon State University researchers disclosed details of a discovery they made during studies of the DNA sequencing of the common cereal fungi fusarium graminearum. Conducted with support from the American Cancer Society and the National Institutes of Health, the research revealed that one gene in the pathogen acts as a switch or “master regulator” that silences more than 2,000 other genes. By deleting the gene, researchers have gained access to numerous gene expressions that could produce previously unknown compounds with applications in biofuel manufacturing, agriculture, and numerous other industries.

Because fungi have antibacterial properties, the discovery is of particular note to medical professionals, who have long been struggling with the advent of antibiotic-resistant bacteria. Concurrent with the increasing concern over antibiotic resistance is an alarming dearth of new drugs to combat the problem. To encourage the research and development of new antibiotics, the United States government passed the GAIN (Generating Antibiotics Incentives Now) Act in 2011, which extends the exclusivity period of new drugs that meet the qualifications for an infectious disease product set by the Secretary of Health and Human Services (HHS). Despite this, the development of new antibiotic compounds has continued to stagnate, with just two new antibiotics gaining FDA approval in the last five years. Because the return on investment for the development of new antibiotic drugs is so small, large pharmaceutical firms in particular are shying away from antibiotics research.

Fortunately, several biotech companies, such as GlaxoSmithKline, Cempra, and Evotec AG, have positioned themselves to meet the need created by antibiotic resistant bacteria by forming partnerships to accelerate drug development. With the announcement of the breakthrough by Oregon State University researchers, possible new research avenues might entice more companies to establish similar partnerships or create programs of their own.

Amgen Purchases Rights to Filgrastim and Pegfilgrastim

November 7, 2013

Leading biologics manufacturer Amgen, Inc., recently announced its acquisition of the rights to sell and distribute the drugs filgrastim and pegfilgrastim in close to 100 markets. Previously owned by F. Hoffmann-La Roche (Roche) under license from Kirin-Amgen, Inc., a partnership between Amgen and Japanese company Kirin Holdings Co. Limited, the franchise rights to the African, American, Asian, Eastern European, Latin American, and Middle Eastern markets earned $200 million in sales for Roche in 2012 alone. Sold under the names Neupogen and Neulasta in the United States and Europe, filgrastim and pegfilgrastim boost white blood cell counts of patients undergoing chemotherapy, thus helping them resist infections.

The deal will begin to take effect January 1, 2014, in a gradual transition designed to ensure that doctors and patients continue to have access to these potentially life-saving drugs. Consequently, Roche will distribute the drugs in countries where Amgen does not have a market presence until Amgen is able to establish a distribution pipeline. The resulting growth in previously untapped markets will enable Amgen to create reliable distribution networks in these areas and reach more patients worldwide.

Indicative of Amgen’s faith in its ability to drive sales effectively in the formerly Roche-controlled areas, the acquisition closely precedes the expiration of Amgen’s patent on filgrastim, which will be facing new competition from tbo-filgrastim, an unofficial filgrastim biosimilar manufactured by Teva Pharmaceutical Industries, Ltd. Although biotech insiders predict that Amgen may lose up to 40 percent of franchise sales from both filgrastim and pegfilgrastim by 2018, the biotech giant continues to show sales growth, as reported in its third-quarter results for 2013. Amgen experienced total revenue growth of 10 percent over the third quarter as well as an 11 percent increase in product sales, which were generated in part by revenue from its brand-name pegfilgrastim (Neulasta) and filgrastim (Neupogen) drugs.

ACADIA Pharmaceuticals – Potential Big Pharma Buyout Candidate

October 29, 2013

Lindsay Rosenwald leverages more than two decades of experience in the biotechnology investment sector. Over the course of his career, Lindsay Rosenwald has helped grow several biotechs from early-stage start-ups into successful buyout candidates.

While 2013 has been a landmark year for biotech firms across the country, the industry has become even more enticing to potential investors over the last two months. Six biotechs completed initial public offerings in June, and share prices across the industry jumped when Onyx Pharmaceuticals Inc. turned down a buyout offer from Amgen Inc. Furthermore, dozens of biotechs have exciting new drugs in their pipelines. With this in mind, industry experts are predicting which firms will receive the next buyout offers.

One such company is ACADIA Pharmaceuticals Inc., a small biotech that has focused its efforts on drugs related to Alzheimer’s disease, schizophrenia, and Parkinson’s disease. If approved, these drugs will find a lucrative market in the aging U.S. population. Moreover, the company received notice from the U.S. Food and Drug Administration that it could forego another Phase III trial. ACADIA now plans to submit a new drug application for pimavanserin, which is designed to treat Parkinson’s disease psychosis, by the end of 2014. Although sources report that there are no deals in the works, some experts point to ACADIA as a potential candidate for a big pharma buyout.