Posted tagged ‘Biotechnology’

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.

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.

Venture Capitalists See Massive Opportunity in Biotech Sector

October 8, 2013

Lindsay Rosenwald co-manages an investpment partnership that specializes in biotechnology investment. In addition to his professional obligations, Lindsay Rosenwald contributes to a variety of philanthropic organizations through the Rosenwald Foundation.

BiotechInvestment in the biotechnology sector has surged in 2013, following more than a dozen initial public offerings. In addition to the funds raised through these IPOs, experts report that venture capitalists poured $1.3 billion into the industry in the second quarter. A 41 percent increase over the first quarter, the sum encompasses more than 100 deals. Furthermore, funding for early-stage start-ups doubled to $328 million in the second quarter, demonstrating an enthusiasm for the industry that has not existed since before the financial crisis.

Unlike pharmaceutical companies, which typically allocate sales profits from drugs on the market to fund new drug development, biotechnology firms generally operate at a loss during their extensive research and development phases. Biotech firms have produced some of the most innovative therapies on the market; however, as a result of their business model, they require increased investor funds.