Roche's strength now comes from a number of blockbuster cancer drugs. But sales of those therapies are slowing a bit as the brands mature, and the company's recent attempts to extend Avastin's label have been unsuccessful. Roche said yesterday it's investing 20 percent of its sales--or 10 billion Swiss francs--in R&D each year. Roche CEO Severin Schwan reminded investors that 2009 was a peak investment year. "We are certainly at the point where we have to control overall expenses" in R&D, he said, according to the Wall Street Journal. "At the end of the day, it is always, how much do you get out of your investments? We are uniquely positioned to deliver long-term growth."

Roche's future growth will come from expanding indications of existing cancer medications, as well as launching new oncology therapies. One near-term prospect is Trastuzumab-DM1, an update to Herceptin that is expected to be filed with the FDA by the end of the year. Additionally, the company will look outside the oncology market for growth. It's developing taspoglutide for diabetes and dalcetrapib for raising "good" HDL cholesterol. Dalcetrapib is in the same class of drugs as Pfizer's famous failure torcetrapib. Roche believes its drug avoids the problems experienced with Pfizer's version, but analysts still see the program as a big risk for the company.

- see this chart of Roche's late-stage pipeline
- here's the Wall Street Journal article

Related Articles:
Roche details pipeline strategy and its 10 leading programs
Roche pipeline close-up will focus on PhIII blockbusters
Trial failures put pressure on Roche
Roche CEO offers his vision for new R&D era

Created by the Global Alliance for TB Drug Development, the Critical Path Institute, and the Bill & Melinda Gates Foundation, the Critical Path to TB Drug Regimens initiative aims to reduce the time it takes to introduce new combination TB treatments from as much as a quarter century to as few as six years. TB remains one of the world's deadliest infectious diseases, killing approximately 1.8 million people annually.

Companies involved in the initiative include Johnson & Johnson, Sanofi-Aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals. The World Health Organization also has expressed its support.

"No single company or institution can do it alone," says Paul Stoffels, global head, pharmaceuticals R&D, Johnson & Johnson, in a statement. "Industry has to continue to focus on innovation and accelerate the discovery and development of new compounds with new mechanisms of action, and at the same time work in collaboration with regulators, non-profit organizations, and other partners to accelerate testing of new combination regimens as early as possible in development."

Word of the collaboration came a day after a day after cancer researchers and drugmakers launched a similar initiative.

- check out the press release
- read Reuters' coverage

Related Articles:
Experts: Provide more funding for TB drugs, vaccines
J&J, TB Alliance partner on TB drug
WSJ: FDA mapping new, faster path for cocktail drugs

Neovacs is developing immunotherapeutics for treating cancer and autoimmune and inflammatory diseases. Its most advanced product candidate--TNF-alfa Kinoid--is an immunotherapy that targets a number of inflammatory diseases involving TNF alpha. It is moving into Phase II clinical trials in rheumatoid arthritis and is also scheduled to enter Phase II in Crohn's disease in the middle of 2010. Its second up-and-coming product is IFN-alpha Kinoid, which targets interferon alpha in patients with lupus. That drug will soon be entering Phase I/II trials.

"We are now starting clinical phases on two products. Very soon we will have three or four clinical studies under way. This requires strong financial means," Neovacs CEO Guy-Charles Fanneau de La Horie told Reuters.

- read the Reuters article

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"We will be required to raise additional funds to finance our operations and remain a going concern; we may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us," according to the March 16 filing with the SEC.

The company also notes in the March filing that it has experienced net losses every year since its inception, and, as of Dec. 31, 2009, had amassed a deficit of about $183.9 million. And it anticipates incurring "substantial additional losses" over the next several years.

Last month, OXiGENE announced restructuring plans days after shareholders at VaxGen snubbed a buyout offer. The merger deal with VaxGen would have given OXiGENE the $33 million on VaxGen's books. But after winning support from shareholders with only 40 percent of VaxGen's shares, OXiGENE declined VaxGen's offer to regroup and seek more support.

As a result, OXiGENE said it was cutting its 41-person workforce by 20 and halting further enrollment for a Phase II/III trial on thyroid cancer. The developer added it will concentrate its efforts on a mid-stage study of Zybresta for non-small cell lung cancer.

Shares of the company fell 3 percent to $1.16 in premarket trade. They closed at $1.20 Thursday on NASDAQ, Reuters notes.

- check out the OXiGENE release
- read the SEC filing
- here's the Reuters coverage

Related Articles:
OXiGENE axes half its staff, halts enrollment in restructuring
OXiGENE swaps shares for VaxGen and $33M in cash
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Teva Pharmaceutical Industries Ltd announced today that it has entered into a definitive agreement to acquire Ratiopharm, Germany's second largest generics producer (Novartis AG’s Hexal unit is first and Stada Arzneimittel AG is third) and the sixth largest generic drug company worldwide, for €3.625 billion ($ 5.0 billion). Teva expects to complete the transaction by year-end 2010.

The acquisition will position Teva as the leading generic pharmaceutical company in Europe. Ratiopharm's extensive product portfolio includes 500 molecules in over 10,000 presentation forms covering all major therapeutic areas marketed in 26 countries. Also, Ratiopharm has valuable know-how in biosimilars (a market that Teva has entered and is extremely bullish on) which consists number of products in advanced stages of development and a well-established sales and marketing team. The combined company will have 40,000 employees worldwide, of which 18,000 will be based in Europe. The purchase will bolster Teva’s visibility and standing in European markets.

Late last month, Ratiopharm board members implored Pfizer to enter a new bid, after it had rejected an earlier offer by the company. Apparently, the new bid was not sufficient to prevent Teva from acquiring the highly sought after generics manufacturer. Iceland-based generics manufacturer Actavis also put in a failed bid to acquire Ratiopharm.

Standard protein purification methods generally include specific buffer and storage conditions that are necessary to ensure the protein remains soluble and intact, maintaining its specific activity. Sample contamination can cause proteolysis (decomposition by protease enzymes), and improper storage conditions may result denaturing of proteins which may form aggregates or simply lose activity. Several approaches are used for preventing loss of protein activity in purified samples:

• Storage at low temperatures
• Lyophilization
• Additives such as cryoprotectants (glycerol), protease inhibitors, antimicrobial agents, metal chelators (EDTA) and reducing agents (dithiothreitol; DTT)

Stabilizing Protein Preparations originally appeared on About.com Biotech / Biomedical on Wednesday, March 17th, 2010 at 20:01:06.

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We hope to run contests for best video, podcast, PowerPoint or poster presentation in the very near future. If you are already a BioCrowd member, please visit the site and upload your favorite multimedia files to the network.  For those of you who are not members yet, please drop by, check us out and join if you like!  If you have any problems or identify any bugs with the new upload feature please e-mail me.

I hope to see you at the BioCrowd!!!!

Until next time.... 

Good Luck and Good Job Hunting!!!!!!!!!

First, as many veteran jobseekers know, you will be asked a lot of seemingly irrelevant and whacky questions. Second, people who are interviewing for a job are expected to behave in professional and socially accepted manner. In other words, there are certain attitudes and behaviors that must be avoided at all costs if you want to get a job offer from a prospective employer. To that end, I found a couple of lists on the Internet—“The Top 50 Interview Questions that Employers Ask” and “50 Worst of the Worst (and Most Common) Job Interview Mistakes"—that are likely to be helpful to persons who may be preparing for an upcoming face-to-face job interview.

While many of the recommended behaviors to avoid may be fairly obvious to most of you, crafting appropriate answers to some of the questions on the Top 50 list may not be. By now, some of you may have googled “answers to the top 50 interview questions” and found a variety of lists that supply answers to some of the questions. However, while it may be helpful to look at those lists for guidance, I strongly advise that you come up with your own personalized responses. This is because prospective interviewers, like you may have found the same lists!

Until next time…

Good Luck and Good Job Hunting!!!!!!

Dyadic International a Model Success Story originally appeared on About.com Biotech / Biomedical on Tuesday, March 16th, 2010 at 20:46:58.

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1. One in six Americans aged 14 to 49 are infected with genital herpes, making the virus — herpes simplex 2 — one of the most common sexually transmitted diseases in the United States
2. Research shows that people with genital herpes are two to three times as likely to acquire H.I.V. as those without herpes
3. H.I.V.-infected individuals also infected with genital herpes are more likely to transmit H.I.V. to others
4. Infection rates for women are almost twice the rate of men
5. Blacks are three times as likely to be infected as whites
6. Black women have the highest rates of infection, with almost half infected

Looking back, it is understandable why HIV/AIDS took precedent over genital herpes infections. After all, most people usually don’t die from genital herpes. However, the rising infection rates of the disease suggest that the American public needs to be better educated the spread and prevention of genital herpes infections. There is no question that discussions about STDs are embarrassing and often difficult. However, these days, they can be the difference between live and death!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

After reading the passage:

campaigns to ban trans fats, post calorie counts in chain restaurants, reduce salt in processed food and tax high-calorie sodas. He had a supportive boss in Mayor Michael R. Bloomberg and a receptive populace in New York, but if he were to try anything similar at the C.D.C., tough Congressional hearings could be in his future because conservative lawmakers on Capitol Hill often oppose such measures

it finally dawned on me that conservatives, in general, don’t give a damn or care about human health. Or perhaps, the underlying message may be: “don’t tell me how to eat or take care of myself; it’s my life and I know what is best for my health and me.” Unfortunately, since over half of the American population is obese or overweight and the incidences of diabetes and hypertension among younger and older adults has reached unprecedented epidemic proportion it is becoming increasingly evident that most Americans, regardless of their political affiliations, don’t know how to adequately manage their health.  And, to make matters worse, the inability or unwillingness of these individuals to maintain their health increases the cost and may block access of otherwise healthy Americans to adequate healthcare.

As an American, I strongly believe in individuals’ rights and freedom of expression. However, I also believe that summarily opposing unobtrusive measures to improve human health—based almost exclusively on political philosophy or personal financial gain—is morally bankrupt and overtly un-American!

Until next time…

Good Luck and Good Eating!!!!

1. Amplified Fragment Length Polymorphism (AFLP); and,
2. Multiple Locus Variable Number Tandem Repeat Analysis (MVLA).

Examples of AFLP applications are the PCR-based BAX (Dupont) and Assurance GDS (BioControl) detection platforms. AFLP works much like RFLP, except that, following digestion of the DNA sample with restriction enzymes, the sticky ends of the resulting fragments are ligated (attached) to adapter sequences and specific combinations of adaptor-fragment sequences are then targeted by the PCR primers. The use of the adaptors adds sensitivity to the test. The BAX system detects Listeria spp., Salmonella spp. and E. coli O157:H7 with high sensitivity and allows the user to run one test for all species. Assurance GDS is a highly sensitive system with three levels of specificity beginning with an immunomagnetic separation (IMS) procedure, to isolate bacteria from the sample, followed by PCR using highly specific primers and a patented probe. IMS uses antibody-coated magnetic particles that are specific to the target organisms, E. coli O157:H7 and Salmonella spp.

Biotechnology Techniques for Tracing Food Pathogens originally appeared on About.com Biotech / Biomedical on Tuesday, March 9th, 2010 at 19:27:39.

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Mustard seed contains a natural anti-microbial compound called isothiocyanate, which is produced when the plant is attacked by bacteria or fungi. The precursor compounds to isothiocyanate, called glucosinolates, are stored in different cells of the plant than the enzyme myrosinase, which is required to cleave the glucose molecule and generate the anti-bacterial compound. When cells are damaged in the plant, the enzyme finds the substrate and the infection is stopped. The Holley lab has found that adding powdered mustard to sausages prevents contamination by bacteria. Mustard is a common spice and does not have to undergo regulatory testing as a food additive. The problem is that once the seed is powdered, the enzyme and glucosinolates are in contact and the meat will have a mustard flavor. To avoid this, the powder is heat-treated, inactivating the enzyme. The powder still has antimicrobial activity because the Holley lab has discovered that E. coli O157:H7 cells themselves produce myrosinase, probably because they detect the glucose ligand on the substrate and want to use it as an energy source. Unfortunately for them, the resulting side effect is production of the bactericidal isothiocyanate.

E. coli O157:H7 Duped by Built-in Food Safety Mechanism originally appeared on About.com Biotech / Biomedical on Monday, March 8th, 2010 at 06:30:40.

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Toronto (Canada) plays host next Tuesday and Wednesday to the 6th Annual North American Summit on Food Safety. Topics being covered include some very relevant issues in food biotechnology, such as pathogen management and building safety into food. A presentation on the latter, by Dr. Rick Holley (Dept. of Food Sciences, University of Manitoba), marks the beginning of the summit on Tuesday. I spoke with Dr. Holley today to get a preview of his presentation. Admittedly vocal with respect to government involvement in food safety, the take home message of Dr. Holleys presentation is that "we can't inspect food safety, we have to build it in". Applied biotechnologists should take this as a challenge to find ways to put food products together in such a way as to be "inhospitable to bacteria". Dr. Holley's own work utilizes a unique cascade of events that capitalize on the antimicrobial properties of mustard, in the production of sausages (watch my next blog for the fascinating details).

Another noteworthy presentation at the summit is by keynote speaker and USDA representative Dr. James Adams. His talk will outline the key regulations to comply with if you want to do business with the United States, and will forecast some possible future initiatives - something those working with GMOs won't want to miss, since the USDA has regulatory jurisdiction over transgenic crops.

Summit on Food Safety originally appeared on About.com Biotech / Biomedical on Friday, March 5th, 2010 at 00:16:13.

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