Posted tagged ‘Pharmaceuticals’

Despite New Onyx Drug, Amgen Performs Below Predictions

August 21, 2014

Amgen logo pic Last fall, Amgen Inc. made waves in the biotech industry by purchasing Onyx Pharmaceuticals Inc. for $10.4 billion. The deal came after Onyx turned down the company’s initial $10 billion offer in June 2013. In its first quarter since purchasing the biotech start-up, Amgen reported lower-than-forecasted earnings. Although sales increased from the same period in 2013, the pharmaceutical giant’s revenues fell $230 million short of estimates. The company attributes the gap primarily to a drop in sales of Enbrel, an anti-inflammatory drug. Meanwhile, analysis shows that Onyx’s multiple myeloma drug, Kyprolis, generated $68 million, and drugs such as Xgeva and Prolia helped drive sales growth by approximately 5 percent.

Despite the fact that Kyprolis contributed $68 million to the company’s bottom line, the purchase of Onyx also affected Amgen’s first-quarter earnings. According to officials, research and development costs increased by more than 15 percent during the quarter as Amgen integrated Onyx’s existing programs. Although Amgen may see some slowed growth as a result of the growing biosimilar market, analysts predict that Kyprolis could hit peak sales of $2.4 billion in five years.


Pfizer, AstraZeneca Continue to Attempt Merger

July 18, 2014

pfizer logo pic  In early 2014, pharmaceutical giant Pfizer, Inc., began pursuing the possibility of a merger with AstraZeneca PLC. Although talks stalled mid-January, Pfizer recently submitted a new proposal to the company on April 26th, which valued AstraZeneca at approximately $100 billion. The proposal offered shareholders a substantial cash payment as well as stock in the newly combined company. AstraZeneca has once again turned down the lucrative offer, but Pfizer has stated in a press release that it continues to believe that the merger would be extremely beneficial to both companies. Both firms would attain greater footholds in the global market and be able to streamline a variety of financial and operational functions. Furthermore, consumers would benefit from a “strengthened presence in breast cancer,” “opportunities for greater depth in immuno-oncology,” and a “complementary portfolio of important cardiovascular medicines.”

In the days following Pfizer’s proposal, the stocks of both companies saw notable increases. Shares in AstraZeneca jumped by 12.2 percent, while those of Pfizer increased by 4.2 percent. If talks do reignite and a deal is consummated, it would result in the largest foreign takeover of a British business.

Changing Attitudes toward Fibromyalgia

June 18, 2014

Fibromyalgia, which produces symptoms of chronic fatigue and aches and pains throughout the body, is an often-misdiagnosed condition. Yet, when identified and properly treated, it can be manageable and need not overly impact a person’s quality of life. One estimate by the American College of Rheumatology put the number of Americans with fibromyalgia at about one in 50.

In the 1800s, physicians first described fibromyalgia, which they called “muscular rheumatism,” listing it as a “mental” problem. At that time, the collection of symptoms indicative of the condition—aches, exhaustion, difficulty sleeping—had already been identified among its characteristics.

By the early 20th century, Ralph Stockman had conducted pathology studies that showed evidence of inflammation in the fibrous septa membranes dividing muscle tissue. At about the same time, Sir William Gowers coined the term “fibrositis” to describe the inflamed fibrous tissue that resulted in lower back pain for his patients. It was not until the mid-1970s that Gowers’ word was superseded by today’s “fibromyalgia.”

As contemporary medicine progressed and research better defined the parameters of the condition, fibromyalgia began to lose some of its unjustified reputation as a “mental” or “imaginary” disorder. In 1981, the reality of the tender points and other symptoms associated with fibromyalgia were validated through a controlled clinical research project. In addition, in 1990, the American College of Rheumatology published a set of diagnostic criteria intended to guide researchers. Physicians shortly adopted these standards in diagnosing and treating patients. In 2007, the Food and Drug Administration approved one of the several fibromyalgia-targeted drugs currently on the market

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.