Power3 converts 'Biomarkers for Neurological Disease' provisionals

Four provisional applications claiming biomarkers used in diagnostic procedures for early detection of neurological disease filed by Power3 Medical Products have been converted to utility patent applications.

The filed patents aim to protect the diagnostic testing procedures utilized by the Company in identifying and tracking specific protein biomarkers that could lead to the early detection and diagnosis of neurodegenerative disease. The latest patent applications add to Power3's IP portfolio consisting of numerous patents filed over the last few years for disease biomarkers and diagnostic assays.

Medco reports $1.2 billion in EBIDTA for 2004

The flip side of all the articles bemoaning big pharma's loss of market to generics: the generic companies are reporting record earnings.

"We increased the efficiency of our operations and demonstrated the value to our clients and shareholders of higher mail order penetration and the use of lower-cost generic drugs. We believe there are opportunities to continue this progress over the next several years as the benefits of mail order are more broadly appreciated by the marketplace, and brand-name drugs lose their patent protection from generic equivalents," added Snow.

Neuronal cell differentation promoter patent granted to Regen Therapeutics

Regen markets it as Colostrinin, with potential applications in the treatment of Alzheimer's Disease.

The new patent covers the use of Colostrinin(tm), its constituent peptides and analogues to promote neuronal cell differentiation. The selective loss of nerve cells in the hippocampus, a region of the brain associated with memory, is a key feature in the pathogenesis of severe neurodegenerative diseases, including Alzheimer's disease. Consequently, any treatment that can stimulate the production and maturation of nerve cells may be useful in preventing or slowing these disease processes. Potential utility of this patent is expected to be welcomed by people with Alzheimer's disease, because "the invention provides a method to promote differentiation and subsequent conversion of potentially damaged cells to functional neuronal cells", said Dr. Kruzel, Scientific Consultant and Adjunct Professor at UT Medical School at Houston.

Motley Fool: Glaxo "above the fray"

The investment mavens at Motley Fool have good things to say about Glaxo, in part because of the relative lack of litigation against them.

Glaxo has certainly suffered from generic competition but has weathered the storm better than most. Trading at less than 17 times trailing earnings, the stock is cheaper than the average pharmaceutical company, yet still boasts high operating margins and one of the highest dividend yields in the industry.

Drug companies conducting private sting ops to collar pharma counterfeiters

Overseas manufacture and importation of pills that look like the real thing - but have different or no pharmaceutical value - has led Pfizer and other companies to conduct their own investigations and sting operations independent of legal authorities.

With a global security staff of 40 investigators, many of them former federal agents, Pfizer runs its anticounterfeiting operations from New York, London, and Hong Kong. Its investigators routinely make undercover buys from suspicious Internet sites in what Pfizer executives call ''surveys" of the market. The company then tests drugs it receives in the mail at a special lab it set up at its research headquarters in Groton, Conn.

When company officials think they have gathered enough information to establish probable cause for a criminal prosecution, they turn nearly complete cases over to foreign officials, US investigators, or local police.

Generic form of Levaquin approved by FDA

Teva's Levofloxacin, a broad-spectrum antibacterial agent generic competitor to Ortho McNeil's Levaquin, has been granted tentative approval by the FDA. Though with approval comes a 180-day window of generic drug exclusivity, Teva will not market until litigation with Ortho in the District of New Jersey is settled.

Teva noted that the total annual sales of the brand product, in both configurations, are approximately $220 million.

Pharma research stalling; science "hard"

"The low-hanging fruit is all gone, and the unique opportunities are difficult to come by," said Irwin Lerner, a former chief executive at Hoffmann-La Roche, a Swiss drug maker with U.S. headquarters in Nutley. "There's been a real failure that, despite billions of dollars in investment, research hasn't conquered the diseases that haunt us."

Or, as Woodcock, director of FDA's Center for Drug Evaluation and Research, says, "Some of these things are going to be really hard."

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Human-animal chimera patent denied

Stuart Newman had filed the application in an attempt to prevent others from creating such a hybrid; Newman himself had no intention of creating one. The PTO rejected the application on the grounds that it could cover creatures "too human to patent."

The paper trail created by the Newman claim offers perhaps the best explication yet for that ban. One rationale in the documents sent to Newman is that such a patent would be "inconsistent with the constitutional right to privacy." After all, the office wrote, a patent allows the owner to exclude others from making the claimed invention. If a patent were to issue on a human, it would conflict with one of the Constitution's core privacy rights -- a person's right to decide whether and when to procreate.

EPO reaffirms revocation of broad Viagra patent

The European Patent Office has reaffirmed a previous ruling revoking a broad Pfizer patent covering erectile dysfunction drugs, which Pfizer sought to use to keep Cialis and Levitra from competing with Viagra in Europe.

Anti-diabetes composition patent awarded to Akesis

The PTO has issued a new patent to Akesis Pharmeceuticals for compositions and methods of treatment for diabetes and other glucose metabolism disorders.

"We believe this patent, which combines Akesis' unique formula of anti-diabetic trace minerals with the widely prescribed sulfonylurea class of medications is an important step in our mission to develop innovative formulations for the treatment of diabetes," said President and CEO Edward B. Wilson. "Given the growing public health burden of diabetes and associated metabolic disorders, we are encouraged by the opportunity for a synergistic effect on improved glycemic control offered with this newly patented formulation."

Strategies for retaining revenue in the face of patent expiration

PharmaLive reports on varying approaches to keeping patients currently on soon-to-expire drugs, as detailed by a Cutting Edge Information report. The $6,995 report, and a free summary, are available here.

Pfizer in steeper decline than rivals

Analysts are worried about Pfizer's rate of decline relative to others in the industry; the drug giant may lay off up to 30% of its sales force.

Although the share prices of rival large drugmakers have fallen an average of about 25 percent since Pfizer bought drugmaker Warner-Lambert for $114 billion in 2000, Pfizer's steeper decline has left many investors wondering if it is worth holding onto the stock.

"I've become concerned that Pfizer is too big to grow," said A.G. Edwards analyst Albert Rauch. "When you have $55 billion in annual revenue, a new $1 billion blockbuster only helps so much -- they need to launch bunches of them to maintain growth."

Open-source biotech takes a step forward

An article in this week's Nature publicizes two new biotech tools, both available as open-source applications to researchers willing to sign a "creative commons-type" license.

The paper describes two new technologies: TransBacter, a method for transferring genes to plants, and GUSPlus, a method of visualizing where the genes are and what they do. Behind the research, which was funded by the Rockefeller Foundation, is a team of scientists who want to provide the technologies as a "kernel," modeled on the Linux movement, as the beginning of perhaps the first practical offering in open-source biology.

Researchers who want to develop technologies based on this kernel can use it as they wish if they agree to a flexible license issued by Biological Innovation for Open Society, or BIOS.

Clemson researchers look to salvage IP rights to THC compounds

JWH-133, the best of the THC compounds, is unpatentable due to prior publication.

Huffman's research, however, centers on THC's bonding with the CB2 receptor, which was discovered in 1993 and is part of the immune system. Huffman and five colleagues work together in Hunter Laboratory creating compounds that also bond with the CB2. Huffman's compounds differ from THC and its synthetic cousin Marinol because they do not bond with the CB1; they do not produce a high or an increase in appetite.

Appeals court invalidates Merck osteoporosis drug

Another blow for Merck, which is embroiled in lawsuits over the withdrawal of Vioxx and facing the loss of the Zocor patents in mid-2006.

Pharmaceuticals analyst Tim Anderson of Prudential Financial predicted the Fosamax decision will leave Merck with flat earnings in 2008. A once-monthly osteoporosis treatment called Boniva, produced by Switzerland's Roche Group, is due out in several months and is "an underappreciated threat," he added.

Investors skittish about drug patent challenges

Forbes discusses waning investor confidence in the face of challenges to Lilly, Pfizer, and the other pharma giants' patents.

New buccal drug delivery patent for Generex

Generex Biotechnology has been granted a patent on "Pharmaceutical compositions for buccal delivery of pain relief medications."

The formulations covered by the patent are applications of the Company's proprietary RapidMist(TM) drug delivery technology and are designed to deliver pain relief medications such as morphine and fentanyl in a safe, simple, fast, effective and convenient alternative to injections and tablets.

Barr wins in SDNY

Barr Pharmaceuticals, looking to manufacture a generic version of the antidiuretic replacement therapy drug DDAVP (desmopressin acetate), has won at the district court level after being sued by Ferring and Aventis. The Ferring/Aventis patents were judged unenforceable and uninfringed.

DDAVP tablets had annual sales of $177 million last year. They are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus - a disorder of the pituitary gland characterized by intense thirst and by the excretion of large amounts of urine - and for the management of the temporary excessive urination and thirst following head trauma or surgery in the pituitary region. They are also indicated for the management of primary nocturnal enuresis, or bed-wetting.