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FDA, GSK, Abbott, DeCode, Transgenomic, Sequenom

FDA OKs GSK’s Tykerb for HER2-Positive Breast Cancer; GSK to Expand Drug to Other Cancer Populations
GlaxoSmithKline announced this week that the United States Food and Drug Administration has approved Tykerb (lapatinib) in combination with Xeloda for the treatment of patients with advanced or metastatic HER2-positive breast cancer who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
GSK said it is currently studying the small molecule in different cancer populations “to better identify patient populations that may respond to lapatinib.”
Tykerb received a priority review at FDA and is “the first targeted, once-daily oral treatment option for this patient population,” GSK said in a release. Lapatinib is a multi-targeted oncologic, inhibiting the EGFR (ErbB1) and HER2 (ErbB2) receptors.
The drug will be available in the US in two weeks. To support patient access, GSK has established Tykerb Cares, a information hotline in which consultants will answer patients’ product-related questions and reimbursement counselors will assist customers with insurance coverage and identify patients for assistance programs.
Tykerb’s approval was based on a 399-patient Phase III trial which found a median time to disease progression of 27.1 weeks on the Tykerb/Xeloda combination versus 18.6 weeks on Xeloda alone. “Differences between treatment groups based on unblinded
investigator assessments were smaller but continued to be clinically and
statistically significant,” GSK said.
The most common adverse events experienced by patients on Tykerb-Xeloda were diarrhea, hand-foot syndrome, nausea, rash, vomiting, and fatigue. Among 198 patients who received the combination therapy, three subjects experienced an asymptomatic decrease in left ventricular ejection fraction, a measure of how strongly the heart is pumping; one patient had a symptomatic decrease in LVEF.

Court Denies Abbott's Request to Continue Selling HCV Tech Pending Appeal
Innogenetics said that a US federal appeals court has rejected a request by Abbott Laboratories to postpone an injunction prohibiting the sale of certain hepatitis C technology until the drug maker has had a chance to appeal the original verdict.
On Jan. 10, the US District Court for the Western District of Wisconsin permanently barred Abbott from selling, using, or exporting any products that infringe on Innogenetics’ US Patent No. 5,846,704, which covers a method of genotyping the hepatitis C virus.
Abbott filed an emergency motion to stay the injunction pending its appeal. On Jan. 19 the Federal Circuit temporarily stayed the injunction while it considered Abbott’s motion.
Last week, the US Court of Appeals for the Federal Circuit rejected the motion. The ruling reinstates the injunction against Abbott.
The court’s decision “marks a positive first step in the appeal process and reinforces our belief that we will prevail in the court of appeals, just as we did at trial,” Innogenetics CEO Frank Morich said in a statement.
The ruling stems from a September 2005 suit Innogenetics filed against Abbott and Third Wave Technologies for allegedly infringing the ‘704 patent. While Third Wave and Innogenetics, settled their suit, the court found that Abbott was infringing the IP, and the following year a jury unanimously said that the ‘704 patent was valid in all respects.
That jury unanimously found that Abbott’s infringement was willful and directed it to pay Innogenetics $7 million in damages.
On Jan. 4, the judge in the case dismissed Abbott’s requests for a new trial, affirmed the jury’s original finding, and approved the award of $7 million in damages.
However, the judge overturned the jury’s finding that Abbott’s infringement had been willful. On Jan. 10, the judge granted Innogenetics’ request to permanently bar Abbott from selling, using, or exporting any products that infringe on the ‘704 patent.
Innogenetics later filed an appeal to reinstate the jury’s willfulness finding, and Abbott appealed to stay the permanent injunction pending appeal.

DeCode's Q4 Revenues Rise 17 Percent as Loss Grows on Increased R&D Costs
DeCode Genetics said last week that fourth-quarter revenues increased 17 percent as R&D spending rose 4 percent and losses increased 10 percent.
Total receipts for the three months ended Dec. 31, 2006, rose to $11.5 million from $9.8 million year over year. DeCode said it has $9.8 million in deferred revenue that will be recognized over future reporting periods.
R&D spending increased to $14.2 million from $13.7 million year over year.
The company said losses increased to $23.2 million from $21.1 million in the year-ago period.
The increase in losses came from increased selling and other costs, and increased R&D spending for clinical trials of the company’s arterial thrombosis and heart attack drugs, which are in Phase IIa and Phase I trials, respectively.
DeCode said it had around $152 million in cash and investments as of Dec. 31.

Transgenomic's Q4 Sales Rise 9.4 Percent
Transgenomic’s fourth-quarter revenues increased 9.4 percent as R&D spending rose roughly 28 percent and losses were cut by 91 percent, the company reported last week.
Total receipts for the three months ended Dec. 31, 2006, increased to $5.8 million from $5.3 million year over year.
The growth came from sales of the company’s Discovery Services unit, OEM sales, and placements of the company’s Wave system and related consumables, Transgenomic CEO Craig Tuttle said in a statement.
R&D spending increased to $641,000 from $502,000 year over year.
The company said net losses shrank to $1 million from $11.2 million in the year-ago period. The 2006 fourth-quarter results include a loss from discontinued operations of $164,000.
In the fourth quarter of 2005, Transgenomic took a loss of $9.4 million on discontinued operations as the company restructured its focus on its biosystems business and liquidated its nucleic acids manufacturing facility in Glasgow.
Transgenomic said it had around $5.9 million in cash and cash equivalents as of Dec. 31.

Sequenom's Q4 Revenue Jumps 80 Percent as R&D Spend Rises by One Third
Sequenom’s fourth-quarter revenues increased 80 percent as R&D spending rose 33 percent and losses decreased 24 percent, the company reported last week.
Total receipts for the three months ended Dec. 31, 2006, increased to $7.9 million from $4.4 million year over year. Sequenom said the jump in revenues was primarily driven by sales of its MassArray systems.
R&D spending increased to $4 million from $3 million year over year, due in part to “additional expenses associated with intellectual in-licensing and non-invasive prenatal diagnostic technology,” the company said.
Sequenom said losses declined to $5.3 million from $7 million in the year-ago period.
Sequenom said it had around $26.3 million in cash, cash equivalents, short-term investments, and restricted cash as of Dec. 31.
For 2007, the company said it expects annual revenues to grow to between $37 million and $39 million, or as much as 37 percent year over year. In addition, it said it expects R&D costs to jump to between $16 million and $17 million, or as much as 42 percent over last year, and its net loss to swell to between $23 million and $25 million, or as much as 42 percent over 2005.
The company also said it expects to begin selling its non-invasive prenatal diagnostic for RhD incompatibility on RT-PCR as a home brew test by the end of the second quarter. During the year, the firm expects to announce additional commercialization partnerships with CLIA-certified labs.
Sequenom said it also plans to launch the third version of its iPLEX assay, iPLEX III, by the end of the fourth quarter. The company said the platform will “reduce by half or more” the current $.035 cost per genotype for a typical study.
Finally, Sequenom said it expects to deliver by the end of the third quarter a proof-of-concept for intermediate-level fetal DNA enrichment, and a “commercially viable” product for fetal DNA enrichment for quantitative genomic tests such as CFTR or Tay-Sachs.

Filed under

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.