Pfizer’s Maraviroc Receives Priority Review Status from FDA
Monogram Biosciences and Pfizer, two companies that are currently in an Rx/Dx co-development partnership for the HIV tropism drug Maraviroc, announced this week that the US Food and Drug Administration has granted Pfizer’s application priority review status and the European Medicines Agency has agreed to the accelerated review procedure for the marketing authorization.
Pfizer submitted the US and EU applications in December 2006 for Maraviroc as treatment for antiretroviral-experienced patients with CCR5-tropic HIV-1. For priority review applications, FDA completes its review on a six-month clock from the time the company submits its application, rather than the one year the agency takes to review standard applications.
“Priority review is granted by FDA to products that, if approved, would be a significant improvement compared to existing approved therapies,” Monogram said in a release.
Monogram’s co-receptor tropism assay, Trofile, was used for patient selection for Maraviroc’s clinical development program, and the two companies are engaged in a collaboration agreement to make Monogram’s assay available for patient use on a global basis [see PGx Reporter 12-06-06].
LabCorp to Develop Gene-Based Theranostic for ARCA Heart Failure Drug
Laboratory Corporation of America said this week it plans to develop a gene-based companion diagnostic to be paired with a cardiac drug being developed by ARCA Discovery, the companies said this week.
The test will identify genetic variations of the alpha-2c and the beta-1 adrenergic receptors, which appear to affect the way heart failure patients respond to the ARCA drug bucindolol.
Some variations of the receptors are associated with positive benefits in many patients, but other variants are associated with side effects, the companies said.
ARCA intends to seek approval for the drug along with the genetic test, which LabCorp will develop during the approval process.
Financial terms of the agreement were not released.
Beckman Coulter Extends License to Critical Therapeutics' HMGB1 Technology
Critical Therapeutics this week said Beckman Coulter has exercised a licensing option to continue using its high mobility group box 1 technology.
Critical Therapeutics said the companies penned a licensing deal in 2005 that gave Beckman the use of HMGB1 to develop an immunoassay to detect inflammatory diseases. HMGB1 has been identified as a possible mediator of tissue damage caused by inflammation.
Under the license, Critical Therapeutics would receive a milestone payment on initial product sales and royalties on net sales, but specific financial terms of the agreement were not released.
Critical Therapeutics CEO Frank Thomas said a HMBG1 blood-based test could be useful in diagnosing diseases such as multi-organ failure, sepsis, and inflammatory diseases such as rheumatoid arthritis.
Critical Therapeutics also said it is working with MedImmune on an HMGB1 antibody clinical trials candidate.
Illumina to Offer $350M in Convertible Notes; Will Use $202M to Repurchase Shares
Illumina plans to sell $350 million in convertible senior notes to help pay for corporate expenses, the company said this week.
The convertible senior notes will pay interest semiannually at a rate of 0.625 percent per year and are due in 2014. Illumina also granted the initial purchasers a 30-day option to purchase up to $50 million of additional notes to cover overallotments.
The offering is scheduled to close on Feb. 16, 2007.
Illumina estimates that the net proceeds from the offering will be around $341 million after deducting fees and expenses. The company said it expects to use around $202 million of the proceeds to purchase shares of its common stock in privately negotiated transactions.
Around $41 million of the proceeds will be used to fund convertible note hedge transactions and warrant transactions.
The company intends to use the balance of the net proceeds for other general corporate purposes, “which may include acquisitions and additional purchases of our common stock,” Illumina said in a statement.
FDA Clears AutoGenomics’ Thrombophilia Assay as IVD
AutoGenomics said this week its Infiniti Factor II and Factor V assays and automated instrumentation have received 510(k) clearance from the US Food and Drug Administration.
According to AutoGenomics, the assays may help diagnose the bleeding and clotting disorder thrombophilia.
The test is an in vitro diagnostic used on blood samples to detect DNA point mutations including Factor II Prothrombin G20210A and Factor V Leiden G1691A, the company said.
In December 2006 the company submitted to the FDA an assay for the enzyme CYP450 2C9/VKORC1 to help gauge warfarin dosing.
New Industry Group to Ask FDA to Reconsider IVDMIA Plans; Says New Oversight Could 'Impede' Innovation
A newly formed group comprising genomic, proteomic, and molecular diagnostic companies and investors today said they plan to ask the US Food and Drug Administration to consider altering its plan to regulate certain diagnostic products.
The Coalition for 21st Century Medicine said it is focused on the FDA’s intent to regulate products the agency has termed in vitro diagnostic multivariate index assays, or IVDMIAs. The agency outlined IVDMIAs and their regulatory framework in a draft guidance last fall. The agency is held a public hearing on the document last week (see related story).
The group said “the outcome of this discussion could profoundly impact the future of the diagnostics industry and the future of personalized medicine.”
The group said that if the guidance is implemented as drafted, “vital medical tests may become unavailable, innovation and improvements could be impeded, the cost of research and development could rise, and insurance coverage for laboratory tests could erode or disappear.”
The coalition includes Genomic Health, Fisher Healthcare, Nanogen, Bio-Rad, Ciphergen, Tm Bioscience, Combimatrix, Sequenom, Genetic Alliance, and other biotech and medical research and equipment companies.
“Labs have been a significant source of innovation for decades. Laboratory-developed tests, including tests and services that would be considered IVDMIAs under the draft guidance, are an essential part of public health and are the future of personalized medicine,” said Tom Tsakeris, president of devices and diagnostics consulting group and former director of the FDA's Division of Clinical Laboratory Devices. “To preserve this future, FDA should go through formal rulemaking procedures and carefully consider the alternatives.”
The FDA said IVDMIAs use mathematical formulas to interpret gene and protein data to guide medical decision-making. The FDA said such tests must be cleared by the agency; ordinarily they would be overseen by Clinical Laboratory Improvement Amendments regulations.
Regulations can have “unintended consequences,” the group said, and can hamper development and innovation of new products.
Paul Radensky, a coalition adviser, said in the statement that the coalition prefers a “formal FDA notice and comment” process for drafting rules and “urge[s] the FDA to pursue a process in which doctors, patients, and innovators can add their experience and voice to this important proceeding.”