The drug industry is usually out front in assisting disaster relief, and many manufacturers have already come forth with major donations of money and supplies to Haiti in the aftermath of this week's earthquake.

Abbott will donate $1 million and says it has donated drugs that are already "on the ground" in Haiti. 

Two of our favorite shows to cover during the fall conference season are the ISPE and AAPS annual meetings. Unfortunately, this year they came at exactly the same time. As ISPE kicked off earlier this week in San Diego, AAPS goers were flying into LA just up the coast.

No one is tracking pharma's social media presence better than WhyDotPharma, and the site/blog has done a nice review of which pharma companies are Twittering the most (Amgen, Boehringer, JNJ, Genentech), and how they're doing it. Some companies are using Twitter to establish a presence and get the word out on corporate news and policies, while others are using Twitter to follow and see what's being said about themselves and the industry.

While the term bailout is being tossed around liberally to suggest any government assistance in these challenging economic times, U.S. biotech leaders appear to asking for just that, or at least an indirect bailout. Members of major biotech companies and industry organization BIO will meet with Congress today to ask for changes in currect tax laws that would in effect open to the door to more government funding for the industry.

Once again, had to miss the best part of this presentation, but did hear Robert Bottone of Genentech discuss the problem that some managers in biopharm and pharma have with Operational Excellence. Many of them still expect “silver bullet’ solutions. This was also a conclusion reached by those who took our recent survey.

Silver bullets simply do not exist, Bottone said. Toyota took nearly 40 years to develop the TPS, so be patient and keep working at it, Bottone suggested. Worthwhile efforts take time.

Decided to ask the panel about error proofing and jidoka and where the industry stands. (For audio of responses, click here). Bottone said that drug manufacturers need to focus on this. William Botha , Director of Operations, Baxter, who will soon publish a book on the subject  of Op Ex(with Wiley) noted the fact that empowering workers is a tough but necessary job. It can’t be done by fiat from a corner office and by patronizing the individual. In addition, he said, operators thrive on challenge. They like it, they need to grow. Fundamental to the whole issue of jidoka and error proofing is respect for the people doing the work. Amen.

BTW, Gwendolyn Galsworth and Martin Hinckley, experts in error proofing and visual systems will be writing regular columns for us on just this topic. This promises to fill a need within pharma and biopharma. Stay tuned.

AMS

FDA issued a press release today (see below), noting that the Agency is calling for safety-related labeling changes for three biopharmaceuticals used to treat certain types of anemia. The release suggests that erythropoiesis-stimulating agents (ESAs) may pose serious health risks and have questionable efficacy in alleviating symptoms of anemia and fatigue in cancer patients.

In addition to being a blow to Amgen, which manufactures the ESAs Aranesp, Epogen and Procrit (the latter of which is marketed by Johnson & Johnson's Ortho Biotech unit), this news likely dismayed Sandoz and other biopharma companies that earlier this year urged members of the Senate Committee on Health, Education, Labor and Pensions to accelerate approval of "biosimilars."

Wouldn't you love to be a fly on the wall in strategic planning meetings at Amgen, J&J, Sandoz and other biopharma companies during the next several weeks?

-HP
FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs) Nov. 9, 2007 -- The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.

The labeling changes, which incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007, also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs.

Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer.  Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by zidovudine (AZT) therapy in HIV patients.

For Patients with Cancer

For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a  hemoglobin level of 12 grams per deciliter (g/dL) or greater.The boxed warnings also emphasize that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive an ESA dose that attempts to achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level commonly achieved in clinical practice.Health care providers determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient’s red blood cells.An earlier boxed warning, approved in March, described the results of six studies demonstrating that survival was shorter and tumors progressed faster when ESAs were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients.Today’s new boxed warning also clarifies that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Moreover, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

“Health care professionals need to consider the risks of increased tumor progression and decreased survival in patients with cancer when prescribing ESAs,� said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director of its Center for Drug Evaluation and Research. “ESAs should be used in patients with cancer only when their anemia is due to chemotherapy and only at the lowest dose necessary to avoid the need for blood transfusions.�

The FDA is working with the manufacturer to design and conduct clinical trials of different dosing regimens and tumor types to further characterize potential tumor progression associated with ESAs.

For Patients with Chronic Kidney Failure

For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure, the boxed warning states.

In addition to the boxed warning, the new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

The new labeling also emphasizes that there are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being for patients with cancer or for patients with HIV undergoing AZT therapy.

In March 2007, the FDA approved labeling changes and issued a public health advisory outlining the new safety information about ESAs. Safety concerns regarding ESAs were discussed during May 2004 and May 2007 meetings of FDA’s Oncologic Drug Advisory Committee and a September 2007 joint meeting of FDA’s Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ESA product labeling was previously revised in 1997, 2004 and 2005 to reflect new safety information.

The agency is currently reviewing a proposed Medication Guide that will better communicate the safety and effectiveness of ESAs to patients and will replace the existing patient labeling.

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. These drugs are manufactured by Amgen Inc., Thousand Oaks, Calif.  Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary of Johnson & Johnson.

For more information:  http://www.fda.gov/cder/drug/infopage/RHE/default.htm

Boehringer Ingelheim narrowly beat out Genentech and Amgen in Science’s annual survey of top employers in the biotechnology, biopharmaceutical, pharmaceutical and related industries. The survey was based on industry responses by participants to whom they regarded as the best, average and worst employers in the field. Respondents then rated the companies that they had chosen on 23 driving characteristics, such as financial strength, adaptation to change and a research-driven environment. Only those companies rated by at least 20 respondents qualified for inclusion in the survey.

While this survey might be seen as a popularity contest (63 percent of participants work for the employers that they regarded as best), the rankings for most important driving characteristics were interesting. The top six drivers in order were: 1. being an innovative leader; 2. treating employees with respect; 3. having work cultures aligned with personal values; 4. having loyal employees; 5. being socially responsible; and 6. doing important quality research.

Respondents also were asked about the industry as a whole. According to the survey, what should companies do to improve their own and the industry’s reputation? Be honest, ethical, and more accountable as well as educate and communicate with the public.

BS

We'd developed an RSS feed of Bloomberg and AP clips pertinent to pharma, but let it slide a bit, due to technical issues and the fact that Bloomberg et al. didn't cover the drug industry (at least on TV) as much as they generally do, in May. 

However, it's back in business now, and you'll find a number of potentially interesting shorts  (click here to access the entire feed):

An interview with Zymogenic's CEO.  (Bayer has just signed a $200+-million deal with them for a new blood clotting agent)

A report on Amgen by Montgomery and Lazzard analysts

An update on Gilead's new treatment for lung disease

An overview of the cancer and cardiovascular drug pipeline by Mark Monane of Needham

A look at weight loss drugs, in light of recent developments with Acomplia/Zimulti, with Citi analyst

An interview with Puerto Rico's governor about biotech

AMS

Play Video

Big Biopharma's Midlife Crisis - Analyst Ted Cohan on Amgen

Bloomberg - (BLOOM)

Apr. 10, 2007. 08:34 PM EST

The company's begun to look like a big pharma company as it has grown. Baker Boyar Bancorp analyst Ted Cohan offered these brief comments to Bloomberg yesterday.

Pharmalot reported today that Amgen's CFO resigned today. Here's how the International Herald Tribune reported the story.  But I'd missed previous reports that construction the company's much-anticipated $1-billion plant in Ireland will be postponed for two years. Here's one account of the story and its potential impact from the Irish press.  Guess big bio is becoming a lot more like big pharma.