Gaucher Disease and FDA Fast Track for Protalix

On August 25th Protalix Biotherapeutics announced they have received FDA fast track status for their Gaucher treatment called prGCD. You may not know much about Protalix but they are an Israeli BioPharma which produces therapeutics from plant origins. Teva Pharmaceutical Industries Ltd. and Protalix Biotherapeutics Ltd. have a collaboration agreement for the development of two biopharmaceuticals, based on Protalix's recombinant plant cell expression technology.

After gaining nearly 30% August 17th, Protalix (PLX) is trading right now at 6.04 and was up only 1% today on the news. This could be due to a couple of reasonings.

1. Genzyme will eventually deal with the contamination and begin producing Cerezyme again within 6-8 weeks.

2. Shire Pharmaceuticals (SHPGY)has also been given FDA fast track status. Shire Gaucher Drug Passes Key Trial

3. Protalix had a astronomical stock meltdown in 2007 by having a public offering of only 5/share when shares were trading around 35-40. There was no valid reasoning behind the offering according to Protalix management in 2007

But the good news is that Cerezyme sales where 1.24 Billion in 2008. Gaucher disease is more common in those with Jewish ancestry so being an Israeli company this could help future sales of Protalix's prGCD compound. Currently, the disease is rare and affects around 1 in 50,000 to 100,000 people. The treatment must be taken on a life-long basis. Marketwatch published an article August 18th on the Protalix's David vs. Genzyme's Goliath

David Aviezer, the chief executive of Protalix, said in an interview on Tuesday that many doctors around the world have asked his company to supply them its medicine, due to shortages of Cerezyme. "Plant cells cannot be affected by human or mammalian viruses, like incidents that happened with Genzyme," he said. "We have a built-in biological firewall protecting against such situations." Aviezer said recent actions by the FDA, in approving the compassionate-use protocol and granting prGCD fast-track status, suggest the agency considers prGCD "a valid option." "We're confident in the way the drug is moving ahead, and are confident in our ability to compete with Cerezyme. We're building up our credibility."

Reuter's announced on August 17th the Protalix update for the approved treatment protocol. Another update was announced on August 25th for the FDA's Fast Track Status. Protalix Chief Executive David Aviezer says, "We expect to conclude our Phase III pivotal study next month and are looking forward to announcing top-line results from this study in October. We anticipate filing an NDA with the FDA by the end of this year."

Teva and Boston Scientific Thursday July 15 2009

BOSTON SCIENTIFIC CP(NYSE: BSX)
After Hours: 10.18 0.00 (0.00%) 4:39PM
Last Trade: 10.18
Trade Time: 4:01pm ET
Change: 0.05 (0.49%)
Prev Close: 10.13
Open: 10.32
1y Target Est: 11.65
Day's Range: 10.01 - 10.32
52wk Range: 5.41 - 14.20
Volume: 15,123,145
Avg Vol (3m): 14,615,000
Market Cap: 15.34B
P/E (ttm): N/A
EPS (ttm): -1.58
Div & Yield: N/A

Boston Scientific Corp. said it received European approval to introduce its Latitude remote-monitoring program for heart-failure devices and defibrillators across the continent in a move that could boost the adoption of its products there.

The remote-monitoring system is already approved for use in the U.S.

Analysts say that no single U.S. player in cardiac rhythm management has advanced far beyond the others in device function, so service aspects such as remote monitoring, sometimes called telemedicine, have the potential to help differentiate the companies.

The big U.S. players in cardiac rhythm management have been expanding, even touting, their possibly cost-saving telemedicine systems, as the federal government initiates widespread health-care changes. Boston Scientific, Medtronic Inc. and St. Jude Medical Inc. offer these programs in the U.S., although Medtronic has the lion's share of the market and offers its service for pacemakers, unlike the other two.

"This is where therapy is going," said Fred Colen, president of cardiac rhythm management for Boston Scientific. "Remote monitoring for patients, for any condition, is on the rise."

Boston Scientfic said it earned CE-mark approval, which certifies that the product meets consumer-safety and health standards in Europe, where the market for heart-failure devices and defibrillators is estimated to be around $1.5 billion.

So far, the Latitude program has been used for patients in the Netherlands and Denmark, and the company hopes to expand to 14 European Union countries in a phased approach.

Keay Nakae, an analyst with Collins Stewart LLC, said the company's recent U.S. growth hasn't been mirrored in Europe. Among the reasons is the lack of a monitoring system. The system "isn't a primary reason you'd use one device," he said. "But having it as a function and a capability is certainly a positive."

Telemedicine allows doctors to monitor their patients without in-office appointments and to intervene early if they see problems. This has the potential to reduce hospital visits and length of stays, though no company has completed clinical studies on the effect. Analyst Jan David Wald of Noble Financial said it will be helpful as the government begins to focus on medical cost efficiency.

"I think remote monitoring helps," he said. "On net, you're going to decrease the cost of health care."

The yearly cost of patient rehospitalization for congestive heart failure in the U.S. is estimated to be close to $10 billion, according to the West Wireless Health Institute, a research organization for wireless health technology.

The companies' services are included with the charge for the heart devices, and there is no monthly charge for patients. Doctors are reimbursed by insurance or Medicare for remote monitoring checkups as well.

Each company offers different amenities with its devices. For example, Medtronic's system monitors fluid levels automatically. Boston Scientific's system can monitor patients' weight and blood pressure. St. Jude plans to use its system for its pacemakers, pending Food and Drug Administration approval for the devices, and Boston Scientific plans to use it in its next generation of pacemakers, company representatives said.

Collins Stewart's Mr. Nakae thinks that telemedicine is more of a necessity than a bonus for the companies.

"I think it's something that everybody wants to have, and if you don't have it in the bigger picture, you could be at a disadvantage," he said.



Teva Pharma Plan B Approved by the FDA

Teva Pharmaceutical Industries (NasdaqGS: TEVA)
After Hours: 49.61 0.18 (0.36%) 4:24PM EThelp
Last Trade: 49.79
Trade Time: 4:00pm ET
Change: 0.29 (0.59%)
Prev Close: 49.50
Open: 49.71
Bid: 46.70 x 200
Ask: N/A
1y Target Est: 55.13
Day's Range: 49.51 - 49.99
52wk Range: 35.89 - 50.35
Volume: 4,219,948
Avg Vol (3m): 5,294,170
Market Cap: 42.47B
P/E (ttm): 43.91
EPS (ttm): 1.13
Div & Yield: 0.58 (1.20%)

WASHINGTON -- The Food and Drug Administration approved labeling
that will allow 17-year-olds access to the Plan B emergency-contraceptive pill
without a prescription.The agency also approved a one-dose version of the product called Plan B One-Step that will also be available over-the-counter to women age 17 and older. Both products are sold by Duramed Pharmaceuticals, a unit of Teva
Pharmaceuticals Industries Ltd.

Duramed loses market exclusivity on the traditional Plan B pill -- which is
taken in two steps -- next month, allowing generic versions to be made available.
Teva said the Plan B One-Step would be available in pharmacies next month. In March a federal court ordered the FDA to lower the age requirement set by the Bush administration for Plan B to be sold over-the-counter from 18 to 17.

In 2006, the FDA agreed to make Plan B available without a prescription to
women over 18 and required the product to be placed behind the pharmacy counter. In 2004, the FDA rejected an application to make Plan B available without a prescription even though an advisory panel of outside medical experts voted to support the switch from prescription to non-prescription status.

Plan B was approved as a prescription "emergency" contraceptive in 1999. It is
made of the hormone progestin, and is designed to prevent pregnancy if taken
within 72 hours of unprotected sexual intercourse. The original Plan B pill is designed to be taken in two doses 12 hours apart.

The pills are similar to birth-control pills but contain higher doses of
progestin to block a potentially fertilized egg from becoming implanted in a
woman's uterus.The court ruling came in response to a lawsuit filed in 2005 by the Center for Reproductive Rights, a women's health advocacy group.

World Pharma News Bayer files patent infringement against Teva Pharma

Okay sorry but I missed this article but this one is a large lawsuit against a large generic maker Teva Pharma. Lengthy court battle will likely be insued and a huge settlement for Bayer could mean a large fine for Teva. Bayer is the maker of Levitra which has been another ED drug like Viagra, or other ed pills out there. Bayer used to have the Levitra ad with the NFL a couple of years ago. So Im sure this will be a billion dollar lawsuit that could help or hurt the bottom line of either of the two companies.



Bayer files patent infringement lawsuit against Teva Pharmaceuticals
Thursday, 02 July 2009
Bayer Schering Pharma AG, Germany and Bayer HealthCare Pharmaceuticals Inc. together with Schering Corporation have filed a patent infringement lawsuit in the U.S. Federal Court in the District of Delaware against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. The lawsuit concerns Teva's application to the FDA for approval to market a generic form of Levitra®, Bayer Schering Pharma's therapy for the treatment of erectile dysfunction, prior to patent expiration. The patent at issue in the suit is Bayer Schering Pharma's U.S. Patent No. 6,362,178, expiring in 2018. In the US, Levitra® is marketed by Schering-Plough and GlaxoSmithKline.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.

Oh and on a side note I have included my bayer aspirin heroin ad from 1901. I used to think about the Nazi's when I worked there but thats another story. Get to Work. Work Faster. You must work it. Work it like a German. said with a heavy german accent