The move toward truly personalized medicine keeps moving forward. The FDA in late December gave marketing clearance to what Roche Molecular Systems (Pleasanton, California) calls the first laboratory test system that will allow physicians to consider a patient's specific genetic makeup to select medications and medication doses for a variety of common conditions such as cardiac disease, cancer and psychiatric disease. The new assay is named the AmpliChip Cytochrome P450 Genotyping Test. It was cleared for use with the GeneChip Microarray Instrumentation System from Affymetrix (Santa Clara, California). The FDA granted clearance for the Affymetrix GeneChip System 3000Dx, an instrumentation system to analyze in vitro diagnostic microarrays.

The new test is the first DNA microarray genotyping assay to be cleared by the FDA, and its approval paves the way for similar microarray-based diagnostic tests to be developed in the future, Roche said. A microarray is similar to a computer microchip; however, instead of using tiny circuits, the chip contains millions of tiny DNA molecules, the company noted.

Lester Crawford, acting FDA commissioner, said, "Physicians can use the genetic information from this test to prevent harmful drug interactions and to assure [that] drugs are used optimally, which in some cases will enable patients to avoid less effective or potentially harmful treatment choices." The FDA said that it cleared the test and the Affymetrix system scanner, based on results of a study conducted by the makers of "hundreds of DNA samples" as well as on a broad range of supporting peer-reviewed literature. The test is performed using DNA that is extracted from a patient's blood. A person's DNA sequence is determined based on the sequence of the probe molecule to which the DNA is most similar.

The FDA said that the new test analyzes one of the genes from a family called cytochrome P450 genes, which are active in the liver to break down certain drugs and other compounds. Variations in that gene can cause a patient to metabolize certain drugs more quickly or more slowly than average, or in some cases not at all, the agency said. The specific enzyme from the family that is analyzed by the test, called cytochrome P4502D6, plays an important role in the body's ability to metabolize some commonly prescribed drugs, including antidepressants, anti-psychotics, beta-blockers and some chemotherapy drugs. The agency said the test "is not intended to be a stand-alone tool to determine optimum drug dosage but should be used along with critical evaluation and other tools to determine the best treatment options for patients."

Affymetrix said that the agency's clearance of the GCS 3000 Dx system represents a major step toward the use of microarrays for clinical applications. "The detailed molecular snapshot that microarrays reveal should provide clinicians with more accurate diagnoses and allow for more effective treatments," the company said.

As to the FDA clearance of the system to be used with the test, Stephen Fodor, PhD, chairman and CEO of Affymetrix, said, "The FDA's decision is another milestone demonstrating Affymetrix' commitment to clinical diagnostic products. We can now offer our diagnostic partners an FDA-cleared system to develop and commercialize high-quality, reproducible diagnostic assays, such as Roche Diagnostics' AmpliChip CYP450 Test, which is [already] offered in the European Union."

Affymetrix reported the commercial availability of the GeneChip Mapping 10K 2.0 Array and the GeneChip Mapping 100K Array Set. The company said these products offer a more affordable array for genotyping more than 10,000 SNPs and a new information-rich array set for genotyping more than 100,000 SNPs. The Mapping 10K, introduced about a year ago, delivers the most markers and highest resolutions available for linkage analysis, Affymetrix said. The Mapping 10K Array Set is designed to enable scientists to perform high-density genome scans and genome-wide association studies on the genetics of complex diseases and drug response.

West spins off Drug Delivery unit

Saying that it will turn its main focus to development of pharmaceuticals, West Pharmaceutical Services (Lionville, Pennsylvania), a maker of drugs and drug delivery systems such as closure systems and syringe components said it will sell off "a substantial majority interest" in its Drug Delivery business, spinning it off to a new company formed by Warburg Pincus (New York). West said it would transfer substantially all of its technology-related drug delivery assets and receive $7.1 million in cash and roughly 14% of the stock of the new company. In addition, West is entitled to earn up to $19 million of contingent payments, based on royalties or other net profits from West's technologies earned by the new company.

Warburg Pincus has agreed to provide $40 million of new capital in two stages in order to finance further development of products based on West's technologies. Deal closing was expected in early 2005, West said. The second-stage payment from Warburg will be made a year after completion of the spin-out, it said. The Drug Delivery business will operate from West's facility in Nottingham, UK, and will employ all of the division's staff at that location. Drug Delivery operations at West's Lionville facility will wind down following the transaction, a move that eliminates about 30 jobs.

Donald Morel, PhD, West's chairman and CEO, in a conference call said that Warburg is "a partner with the financial strength and experience to advance the [drug delivery] products to commercialization the new company has a strong product base from which to grow." For West, the divestiture "frees up management for future growth and profitability of our core pharmaceuticals business," he said, calling the deal a "win-win" for both firms. "We did exactly what we wanted to do," Morel said in a question-and-answer period. "We gave the [drug delivery] business a very fair chance." But he said that changing market requirements had called for "amounts of capital we couldn't afford."

Last June, the company reported the launch of a "strategic review" of the drug delivery business, to be completed by the end of 2004. At the time, West said its prospects for future growth were in its Pharmaceutical Systems Division, which produced about 98% of its revenue in fiscal 2003.

West said it would continue to operate its clinical services business while it is held for sale or other disposition. Morel said that West would provide more information concerning trials of these drugs during its year-end conference call this month.

LSA a new 'angels' firm

A new private investment group, Life Science Angels (LSA; Palo Alto, California), has been formally launched, backed by what it termed 15 "exclusive sponsors." LSA was founded by life science executives and angel investors Allan May, Casey McGlynn and Greg Scott. May, chairman of LSA, characterized the new firm as "an organized angel group, in the classic angel tradition" rather than an equity fund. "When a company makes it through our screening process, we'll make an individual decision to participate" in that company, May told The BBI Newsletter. "Each deal will have its own LLC [limited liability corporation]."

Investments will range from $250,000 to $1 million with targeted companies to work with "a limited set" of angel groups, venture capitalists and "select outside investors," according to LSA. "We set out to build a team that represented the top-tier technology and service providers to the biotech and medical device industries and are pleased that we've been able to do just that," May said. He added: "The perfect target is an early seed or early-stage company where less than a million dollars can achieve identifiable milestones that we think will guarantee an up-round behind us the kind where, with that kind of money, our experience and contacts can, in 12 to 18 months, make a specific difference to achieve those milestones."

In medical devices, he listed cardiology, orthopedics and "neuro" as "classic areas" that LSA will be interested in backing. Supporting companies in biotech, he said, will be "more complicated," with the firm being "much more careful" in its model. As a type of developmental milestone, he described a company with a compound "in pre-clinicals, then in clinicals the next year. We're going to do a lot of early-stage stuff, but we're not averse to doing later-stage rounds."

LSA described its members as having "significant experience in life science operations and investing" and able to provide a range of services: from sponsor introductions to mentoring to working with realtors, bankers and auditors. The group will be mining opportunities at upcoming investor conferences, May said, and hold its first investment meeting late this month. LSA's founding sponsors are Wilson Sonsini Goodrich & Rosati (Palo Alto, California), Silicon Valley Bank (Santa Clara, California) and PricewaterhouseCoopers (New York).

Company pursues cervical cancer blood test

In the best of all possible worlds, what would be the alternative to the standard Pap test? A simple blood test, says Grant Life Sciences (Salt Lake City). Grant, a very-much-in-development-stage company, is in the process of pursuing that longed-for alternative, and it recently unveiled two key steps toward what it will require to achieve that goal. In late November, the company reported receiving notice from the U.S. Patent and Trademark Office that one of its patents "possesses novelty, inventive step and industrial applicability compared to known prior art" for the second of its applied-for patents. With the lengthy title "Peptides from the E2, E6 and E7 proteins of human papillomaviruses [HPVs] 16 and 18 for detecting and/or diagnosing cervical and other cancers," the patent application is part of the company's attempt to deploy a broad net over the analysis of peptides for cervical cancer detection by means of a blood test.

If finally achieved, such a test would provide a huge step forward very much in those countries that frown on medical viewing of female reproductive organs but also virtually everywhere, if a simpler alternative is available, according to Stan Yakatan, CEO and chairman of Grant. "This is the most exciting information I've gotten in 30 years in this business," Yakatan told BBI, in referring to his past experience in the field and the announcement from the patent office, noting that it refers to the second of two patents the company is pursuing.

The cervical cancer blood assay under development by Grant "doesn't require a cervical examination at all," Yakatan said, "You get a drop of blood just a fingerprick [and] put it on the test strip." He estimated 1.7 billion women outside of the U.S. who don't receive regular cervical cancer screenings, "either because of economic, cultural or religious reasons." And the screening test being developed could be sold international "for as low as $5, with us making a big profit." In the U.S., the product would be developed as a standard ELISA assay, with blood drawn at the doctor's office, the results sent to a lab for analysis, "no cervical exam, no fancy equipment required." The result, he added, would be a strong option to what he says "has been done archaically in the U.S." meaning the standard Pap smear and microscopic analysis.

Besides unveiling its good news form the patent office, Grant also recently reported the appointment of David Bolick, MD, to its executive team as chief medical director. Bolick will be responsible for the management of clinical programs and regulatory affairs for Grant. Bolick is a significant addition to the Grant team, Yakatan said, bringing with him a broad background in cervical cancer screening. Bolick called the blood assay being developed by Grant "a potential blockbuster test, a non-invasive test for cervical cancer that is more accurate than traditional Pap testing."

Yakatan called Bolick "one of the foremost advocates of replacing the Pap smear . . . and is a major advocate in terms of our test being commercialized and ultimately replacing a lot of these other tests. Everything that we're doing is based on blood or bodily fluids," he said, adding: "Nobody is doing exactly what we're doing. A couple of other companies in Europe have worked on it, but in reality we don't know of anybody else in the world that is actually working on a blood test for precursors to cervical cancer that will actually be a screening tool."

St. Jude invests in ProRhythm

ProRhythm (formerly known as Transurgical; Setauket, New York), a manufacturer of medical devices for the treatment of atrial fibrillation (AF), reported entering into a number of agreements with St. Jude Medical (St. Paul, Minnesota), providing, under certain conditions, for St. Jude to make two $12.5 million minority investments in ProRhythm, which the company anticipates will occur this year.

The agreements also provide that St. Jude has the exclusive right to acquire ProRhythm for $125 million in cash, with additional cash payments payable to the ProRhythm shareholders after completion of an acquisition if ProRhythm achieves certain milestones.

St. Jude said it is not obligated to exercise this acquisition right, which extends to March 31, 2007. In addition, the two companies have agreed to collaborate on the continuing development of ProRhythm's catheter-based, high-intensity focused ultrasound (HIFU) ablation system for the treatment of AF.

St. Jude also obtained distribution rights for ProRhythm's HIFU ablation system in the European Union. CE-marking is expected in the first half of 2005.

St. Jude will provide clinical research support services during ProRhythm's U.S. investigational device exemption pivotal trial, and the companies have agreed to a master research agreement providing an overall structure for collaboration on subsequent R&D.

And St. Jude will provide OEM manufacturing services to ProRhythm for a portion of the company's products.

The agreements are subject to ProRhythm stockholders' approval.

Reinhard Warnking, ProRhythm president and CEO, said, "We have long been convinced that HIFU is the ideal energy for the treatment of atrial fibrillation. This investment by St. Jude signifies their ongoing commitment to HIFU, and to the treatment of atrial fibrillation. Our clinical trials in Europe and the U.S. have indicated that our HIFU Ablation System may play a significant role in the catheter-based treatment of this disease."

He added: "St. Jude has made significant investments in the treatment of atrial fibrillation by forming a separate division dedicated to addressing this significant unmet medical need. I am excited by the potential that is created with the combination of the two organizations strengths. I am optimistic that this partnership will rapidly commercialize our HIFU system, and serve to establish HIFU ablation as the as the first choice for catheter-based treatment of atrial fibrillation."

The AF ablation procedure, commonly called pulmonary vein isolation, utilizes ProRhythm's balloon catheter, which is inserted through a vein in the leg and advanced into the left atrium of the heart. Controlled, discrete ablation lesions around the pulmonary veins, created with the HIFU catheter, are intended to prevent unwanted electrical impulses from disrupting the heart's normal rhythm. Unlike other energy forms used for this procedure, HIFU energy is focused within the myocardium, and holds the potential to reduce unwanted side effects of the procedure such as the formation of thrombus and stroke.

ProRhythm, since 1997, has been developing HIFU to advance the minimally invasive treatment of complex medical conditions. Its HIFU system is currently under investigation in clinical trials in Europe and the U.S. to treat AF.

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