Monday, April 13, 2009

Medtronic Completes Acquisition of CoreValve Inc

In a move to further expand a comprehensive cardiovascular portfolio, Medtronic, Inc. announced the completion of its acquisition of CoreValve Inc. CoreValve develops percutaneous, catheter-based transfemoral aortic valve replacement products. Medtronic also recently acquired Ventor Technologies, Ltd., a developer of percutaneous, catheter-based transapical aortic valve replacement products. “These acquisitions position us as a leader in one of the most exciting new markets in medical devices. We expect a significant number of people with aortic stenosis to benefit from these break-through technologies,” said Bill Hawkins, chairman and CEO of Medtronic. “We have the scale and expertise to accelerate the use of these life-saving technologies.”

Epilepsy Pipeline Conference 2009 to Showcase Cutting-Edge Therapies in Development and Advances in the Treatment of Epilepsy

MIDDLEBURG, Va.--(BUSINESS WIRE)--The Epilepsy Therapy Project today announced that more than 25 emerging companies as well as leading biotechnology and pharmaceutical investors and industry executives will gather to focus on preclinical and clinical development strategies and opportunities at the Epilepsy Pipeline Conference 2009. The one-day Epilepsy Pipeline Conference 2009 will showcase the most innovative therapeutic approaches currently in development for the treatment of epilepsy. The conference will take place Friday, April 17, 2009 at the Biltmore Hotel in Coral Gables, Florida, in conjunction with the Antiepileptic Drug Trials X (AED-X) conference.

“With more than three million patients in the US alone, epilepsy represents a huge and significantly unmet medical need. We are excited to see such a high caliber group of scientific entrepreneurs presenting the latest insights and approaches to addressing epilepsy, as well as other central nervous system disorders,” said Joyce Cramer, President of Epilepsy Therapy Project. “In addition to our commitment to funding clinical research, the Epilepsy Therapy Project plays a critical role in bringing together scientific entrepreneurs with venture capital and public equity investors and pharmaceutical industry partners. Through the Epilepsy Pipeline Conference 2009 we are creating a forum to drive innovation in the discovery and development of new treatments that we hope will ultimately eradicate seizures in the next decade.”

Pipeline conference attendees will hear the latest insights from research, clinical and industry leaders, supporting informed decisions about investment in epilepsy therapy development and broader central nervous system (CNS) therapeutic areas. Investors and industry business development executives are encouraged to attend.

"With well-characterized mechanisms, therapeutic approaches, functional models and defined clinical endpoints, epilepsy is gaining recognition as an excellent starting point for companies seeking to develop new CNS diagnostics and therapeutics," said Omar Amirana, MD, Partner at Oxford Bioscience Partners. "Forums such as this provide investors, research experts and industry leaders with an opportunity to understand the major scientific and clinical advances taking place in CNS and help optimize our collective investments in future therapies."

Presenting companies at the one-day conference include: Marinus Pharmaceuticals, Sepracor, Valeant Pharmaceuticals, Icagen, NeuroTherapeutics Pharma, Neuropace and SierraNeuro, among others. In addition, the conference will feature a dynamic panel discussion between private and public investors as well as commercial business development executives on financing new epilepsy and CNS therapies.

Will Emerging Agents Disrupt the Psoriatic Arthritis Market?

DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/e51325/will_emerging_agen) has announced the addition of Decision Resources, Inc.'s new report "Will Emerging Agents Disrupt the Psoriatic Arthritis Market?" to their offering.

Surveyed rheumatologists are open to prescribing emerging agents for psoriatic arthritis (PsA) patients upon approval. That is good news for the PsA patients who fail to respond to TNF-a inhibitors; treatment options are limited for these patients. Availability of the TNF-a inhibitors vastly improved treatment of the disease and effected a sweeping change in the approach to managing PsA. Several emerging agents offer novel approaches to treating PsA—will they prompt another shift in management of this chronic and debilitating disease?

Get the Answers You Need to Shape Your Strategy

  • PsA a chronic, debilitating disease that is both - underdiagnosed and undertreated. What are the symptoms of PsA? How is the disease diagnosed? What are the risk factors for the disease? How many people in the United States and Europe have PsA? How will this population grow over the next ten years?
  • TNF-a inhibitors were the first agents to receive approval for PsA. How are TNF-a inhibitors incorporated into rheumatologists' treatment choices? How will emerging treatments compete with TNF-a inhibitors?
  • Because of the high cost and increased use of TNF-a inhibitors, the PsA market has experienced strong growth over the past few years. Will the PsA market continue to grow? How will emerging agents perform in the market?

Scope

  • Primary research: survey of U.S. rheumatologists.
  • Overview of PsA: etiology, symptoms, and diagnosis.
  • Current treatments: nonsteroidal anti-inflammatory agents, conventional diseasemodifying antirheumatic drugs, and TNF-a inhibitors.
  • Epidemiology: prevalent cases of PsA in the United States, France, Germany, Italy, Spain, and the United Kingdom.
  • Emerging agents: Centocor/Schering-Plough/Janssen/Mitsubishi Tanabe's golimumab; Bristol-Myers Squibb's Orencia; Centocor/Medarex's Stelara; Celgene's apremilast; and Novartis's AIN-457.
  • Market overview: 2007 PsA market; outlook for current and emerging agents.

Major Pharmaceutical Company to Utilize Vemics iMedicor Medical Communications Portal

NANUET, N.Y.--(BUSINESS WIRE)--Vemics, Inc. (OTCBB: VMCI) today announced that its iMedicor HIPAA compliant medical communications portal will be utilized by a major pharmaceutical company in a specialized marketing program to commence June 1.

This company, which is traded on the New York Stock Exchange, will use iMedicor to distribute customized marketing messages on a pain management product to a targeted list of over 100,000 physician specialists nationwide. These messages will comprise product-specific educational resources and will be transmitted in real time on a 24/7 basis. Doctors receiving these messages may subsequently utilize iMedicor to order product samples, set appointments with pharma sales representatives and communicate directly with pharma medical science liaisons.

In return for use of iMedicor, Vemics will receive a start-up fee plus recurring fees for the transactions listed above.

The iMedicor program is expected to significantly reduce the need for live visits by pharmaceutical sales reps to physicians’ offices, and broaden the scope and quality of communications between pharmaceutical companies and physicians. In addition, iMedicor estimates its system will slash the cost of in-person marketing by as much as 80 percent per encounter and create a higher return on investment for the pharma.

The program’s messages will be created and managed by pharmaceutical marketing firm Franklyn Ideas, which currently serves some of the world’s largest pharmas and which has engineered marketing programs for hundreds of brands.

Vemics chief executive, Fred Zolla, said, “Today’s announcement marks a milestone in our drive to provide pharmaceutical companies with state-of-the art technology delivering targeted marketing messages proven to elicit the highest rate of response among healthcare providers.

“With the pharmaceutical marketing expertise of Franklyn Ideas, we anticipate making this program an unqualified success—and one that could encourage other pharmas to follow suit.”

For cancer cells, genetics alone is poor indicator for drug response

BOSTON, Mass. (April 12, 2009) — In certain respects, cells are less like machines and more like people. True, they have lots of components, but they also have lots of personality. For example, when specific groups of people are studied in aggregate (conservatives, liberals, atheists, evangelicals), they appear to be fairly uniform and predictable. But when looked at one person at a time, individuals often break the preconceptions.
Same with cells.
Researchers tend to identify characteristics of particular cells by looking at millions at a time. As a result, they'll find that, say, "group A" responds very well to a particular cancer treatment, whereas "group B" does not. They will then often compare group A to group B to find out why.
But often ignored is that not every cell in either group behaves in ways that the aggregate indicates. In a group of cells shown to be vulnerable to a particular cancer treatment, perhaps 10 percent resist it while 90 percent succumb. While researchers have offered various explanations for this, few have studied it.
Now a group of scientists in the lab of Harvard Medical School Professor of Systems Biology Peter Sorger have studied such "outlier" cells in the context of a new and highly touted cancer drug. They have found that vastly disparate reactions occur within genetically homogeneous cell groups. These discrepancies result from protein levels that vary from cell to cell, even among cells that are identical genetic twins. What's more, these protein levels and their subsequent traits can be passed down to daughter cells—a heritability that has nothing to do with genetics.
"Genetics are permanently heritable, while these protein levels are temporarily heritable," says Sorger. "But this temporary inheritance can make all the difference in the world when it comes to the effectiveness of certain medications."
These findings are published April 12 online in Nature.
In order to investigate this disparate behavior among cells, graduate student Sabrina Spencer and postdoctoral researcher Suzanne Gaudet, both in Sorger's lab, looked at a molecule called TRAIL, a protein that causes cells to, literally, commit suicide—a process scientists call apoptosis. While TRAIL is a natural cell product, drug makers have been investigating ways to harness its power so that it can directly target cancer cells.
While TRAIL continues to be a promising drug candidate, its success rate isn't 100 percent, and the researchers wanted to figure out why.
The researchers took both cancerous and non-cancerous cells and exposed them to varying doses of TRAIL. Although these cell lines were known to be vulnerable to the molecule, a fraction always managed to survive.
The researchers noticed that when this outlier group was isolated and once again exposed to TRAIL, the cells and their immediate progeny continued to remain highly resistant for a short time. An immediate explanation might be that this group had developed some sort of genetic defense. However, when this new "resistant" group was given several days to reproduce, the pattern soon reset to the original: 90 percent died, ten percent survived.
"We knew that there were clearly factors at work here that were not genetic," says Spencer. "Genetic resistance would remain uniform in subsequent generations. But the factors at work here were clearly more dynamic."
Using a variety of imaging techniques, the researchers soon discovered that even though these cells were genetically identical —the same cell in the same tissue doing the same thing, the actual numbers of proteins in each cell varied. Specifically, proteins involved in the cell-suicide mechanism triggered by TRAIL were affected. These protein levels altered the dynamics of the entire mechanism, sometimes making cells, for all intents and purposes, immune to TRAIL. While these protein levels were initially passed on to progeny, the heritability was transient. The scientists describe it as an extra layer of inheritance, one that is superimposed onto genetic inheritance.
As for what actually causes these protein levels to vary between identical cells, the researchers cited a simple explanation: It's completely random.
"For decades biologists have had this notion that cells produce proteins in orderly, uniform ways, like an assembly line, but they don't," says Sorger. "Rather, cells produce proteins in fits and starts, and the timing and degree varies from one cell to the next—even cells that are identical in every way. This randomness is something that we're just beginning to appreciate."
These findings also offer an alternative to the cancer stem-cell hypothesis. For that, scientists have posited that certain cancers survive standard treatments because a population of tumor-specific stem cells evades chemotherapy or radiation. This paper, however, offers an alternative explanation, namely, that purely through chance, certain cells produce quantities of proteins that fundamentally alter the cell's response to treatment.
Ultimately, Sorger and his group think that this new insight will make it possible to design anti-cancer treatments that are more effective than those available today.

Pfizer To Make A Tender Offer To Increase Stake In Pfizer Limited

MUMBAI, India - Pfizer Investments Netherlands B.V., an indirect wholly-owned subsidiary of Pfizer Inc, announced today that it will make a tender offer to acquire a 33.77% stake in Pfizer Limited from public shareholders at a price of Rs. 675.00 per share.
Successful completion of this offer, assuming full acceptance, would raise the indirect stake of Pfizer Inc in Pfizer Limited to 75% from the current level of 41.23%. The offer will represent a total value of up to Rs. 6.8 billion, or approximately USD 136 million.
A public announcement will be issued in India as required by the SEBI (Substantial Acquisition of Shares and Takeovers) Regulations, 1997 (“SEBI Regulations, 1997”). The offer for these shares, which are traded on the Bombay Stock Exchange Limited (“BSE”) and the National Stock Exchange of India Limited (“NSE”), is expected to open in June 2009 and is subject to regulatory approvals. The open offer will be managed by HSBC Securities and Capital Markets (India) Private Limited.
The offer will be made at a premium of 8.6% to the closing share price of Rs. 621.55 of Pfizer Limited on April 9, 2009, on the NSE (equivalent premium of 8.3% to the closing price of Rs. 623.00 on the BSE), which was the last trading day before the announcement of the tender offer. It will also represent a premium of 22.2% over Pfizer Limited’s average share price during the 30 days ending April 9, 2009, on the NSE (equivalent premium of 22.3% over the average share price during the 30 days ending April 9, 2009, on the BSE) and a premium of 45.2% over the requisite price determined in accordance with SEBI Regulations, 1997.