Thursday, July 16, 2009

Obama offers 7-year protection for biotech drugs

The Obama administration said biogeneric drugs should be protected from competition for seven years.

The biopharmaceutical industry has argued that the five years of protection offered by Waxman in H.R. 1427 would stifle innovation. But the Federal Trade Commission in a report earlier this month said the 12 to 14 years that the industry has said publicly that it wants also would hurt innovation and delay patients’ access to cheaper drugs.

Eshoo’s H.R. 1548 calls for a 12-year period of data exclusivity, basically protecting the patents covering innovative biotech therapies.

In a letter to Waxman, Nancy-Ann DeParle, Obama’s health-care reform director, and budget director Peter Orszag said “the seven-year policy in the FY 2010 Budget is a generous compromise between what the FTC research has concluded and what the pharmaceutical industry has advocated.”

The Biotechnology Industry Organization, however, said it is “extremely concerned” that the seven-year plan is “a risky shortcut to biosimilars.”

“We believe this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS as well as unmet medical needs,” BIO President and CEO Jim Greenwood said in a statement.

Besides patent exclusivity, the industry has argued that drugs like those developed by South San Francisco’s Genentech and other biotech companies can’t be copied like pharmaceutical drugs because they are complex to make and the finished products can differ.


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Thursday, June 11, 2009

BIO hosts events at UNFCCC in Bonn

BIO to Host Side Event at Bonn Climate Change Talks “Biotechnology: Solutions for Climate Change”

WHAT: The Biotechnology Industry Organization (BIO) will host a side event at the upcoming UNFCCC Climate Change Talks in Bonn. Biotechnology offers a broad range of tools to address climate change. This briefing will focus on clean, renewable alternatives to petroleum-based fuels and products, reduction of greenhouse gas emissions from industrial processes, and the use of sustainable agricultural practices.

WHO: Stephanie Batchelor, Manager, Industrial & Environmental Section, BIO;
Willy De Greef, Secretary General, EuropaBio.

WHEN: Monday, June 1st from 7:30 p.m. to 9:00 p.m.

WHERE: Ministry of Environment, WIND Room
Robert-Schuman-Platz 3
53175 Bonn

NOTE: For additional information, please contact Stephanie Batchelor at 202-742-6498, sbatchelor@bio.org, or Paul Winters at 202-962-9237, pwinters@bio.org.

For a full list of side events at the Bonn Climate Change Talks, visit http://regserver.unfccc.int/seors/reports/events_list.html.

About BIO

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology technologies. BIO also produces the annual BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

Upcoming BIO Events

BioEquity Europe
June 9-10, 2009
Munich, Germany

World Congress on Industrial Biotechnology & Bioprocessing
July 19-22, 2009
Montreal, Quebec, Canada

Contacts

Biotechnology Industry Organization (BIO)
Paul Winters, 202-962-9237
pwinters@bio.org
www.bio.org

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Celera cuts its last tie to Maryland biotech

It’s official, the end of an era. Celera Corp., once among the biggest biotech brand names in the Washington area, is shuttering its last remaining operation in the region.

The company, which moved its home base to Alameda, Calif., last year, is laying off 20 of its 25 local employees and closing its 41,000-square-foot operation in Rockville by the end of the third quarter.

A small number of employees working on lung cancer diagnostic tests could move to the West Coast, while only one or two employees might stay in Rockville.

In its heyday, Celera employed 550 people in the company’s 220,000-square-foot headquarters on West Gude Drive, making it one of the region’s biggest success stories as it raced to map the humane genome.


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Tuesday, April 28, 2009

Swine Flu fear Boosts Biotech Stocks

The U.S. Government declared an emergency Sunday and released 25% of Relenza and Tamiflu antiviral treatment courses for use by healthcare providers should cases escalate. Tamiflu was developed by Gilead and manufactured and sold by Roche; Relenza is made by GlaxoSmithKline. A travel advisory to Mexico may be issued today where there are 2000 cases and about 150 deaths.In the U.S. there are several cases in CA,NY and TX for a total of 40.

GSK was up 7.8% and GILD up 4% at midday trading. More speculative biotechs are quite volatile with BCRX up 68%,CRXL up 6.5%, and NVAX up over 90%.Be careful here.

Leerink Swann has a Market Perform on BioCryst (BCRX), which has Peramavir an IV/IM neurominidase inhibitor currently in Phase III studies in the U.S. and Phase IV in Japan and LS says the drug is likely to be effective against H1N1 swine flu.

Rodman and Renshaw has a Market Outperform on Novavax (NVAX) which has a Phase II seasonal flu vaccine in trials and could move due to the potential of a swine flu development.

Diagnostic stocks perked up as well with Becton-Dickinson (BDX) up 4.4%,Inverness (IMA) up 11.5%,Quidel(QDEL) up 7%,and Meridian(VIVO) up 11.5%.

Although it is way too early to forecast the impact of swine flu on the biotechnology stocks the sector will attract more investors as diagnostics and drugs have been languishing in the current rally.

We recommended IMA at 20 (now 30) and continue to like the stock on pullbacks and would add to healthcare positions with BDX GILD and GSK for the longer term.


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Thursday, April 02, 2009

Generic Versions Of Biotechnology Drugs Allowed

Senate Measure Would Allow Generic Versions Of Biotechnology Drugs After Five Years

Sens. Charles Schumer (D-N.Y.) and Susan Collins (R-Maine) on Thursday (March 26, 2009) introduced legislation (S 726) that would allow FDA to approve generic versions of biotechnology drugs after a five-year period of brand-name patent exclusivity, the New York Times reports.

President Obama has emphasized the need for generic competition in the biotech industry and has estimated that it could save $9.2 billion over 10 years, which could be used to finance his health care reform plan. A similar bill passed by the Senate Health, Education, Labor and Pensions Committee last year would have given biotech products 12 years of exclusivity, but it died without being voted on by the full Senate.

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