Friday, November 24, 2017

Pharmaceutical Updates: Biodel, Orexigen, Cardiome, Helicos, OraSure

Below is a list of the companies that made news in the healthcare sector on Sunday, June 27, 2010.

Biodel Inc. (NASDAQ:BIOD) announced Friday after the bell the final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 diabetes were presented by Helena Rodbard, M.D., at the 70th Scientific Sessions of the American Diabetes Association.

The study showed that patients with type 2 diabetes receiving VIAject achieved hemoglobin A1c control similar to that for patients receiving regular human insulin, but with twice the reduction in rates of hypoglycemia and significantly less weight gain. Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups.

Dr. Rodbard commented, “This study demonstrated the non-inferiority of the new more-rapid-acting injectable human insulin versus regular human insulin and the favorable impact of the faster-acting insulin on hypoglycemia and weight gain, two key side effects of currently marketed insulins which can be difficult to manage. These findings are encouraging and suggest that we can achieve proper glycemic control with reduced hypoglycemia and weight gain through the use of a more-rapid-acting form of human insulin. I believe these results represent a meaningful advance in the treatment of type 2 diabetes.”

The results of the companion Phase 3 study of VIAject® in patients with type 1 diabetes will be presented at the ADA meeting on June 26. Biodel’s new drug application for VIAject® has been accepted for review by the FDA with a Prescription Drug User Fee Act action date of October 30, 2010.

Shares of Biodel rose 12 cents to $4.18 in the extended session.

Orexigen® Therapeutics, Inc. (NASDAQ:OREX) Friday after the bell announced data from the CORDiabetes trial for Contrave® showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.

Over twice as many patients lost at least 5% of their body weight on Contrave versus placebo on an intent-to-treat basis (44.5% vs. 18.9% respectively), according to the data presented today by Dr. Priscilla Hollander, M.D., Baylor Medical Center, at an oral session of the 70th Scientific Sessions of the American Diabetes Association. Importantly, Contrave-treated patients experienced clinically significant reductions in A1C. Average baseline A1C, the standard test for monitoring glycemic control, of approximately 8.0% was reduced by 0.6% for Contrave compared to 0.1% for placebo. This translated to over 44% of Contrave patients reaching the American Diabetes Association (ADA) treatment target for A1C of less than 7%. In comparison, 26% of placebo patients reached the same threshold.

“It is well understood that weight loss is beneficial for glycemic control and slows disease progression in patients with type 2 diabetes,” said Dr. Hollander, a lead investigator on COR-Diabetes. “The COR-Diabetes study demonstrated the potential utility of Contrave for obese patients with diabetes, where weight loss and weight management, coupled with a clinically meaningful improvement in glycemic control, improves overall health.”

Cardiome Pharma Corp. (NASDAQ:CRME) and Merck (NYSE:MRK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS™ (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

The CHMP issued the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of vernakalant. The proposed indication for vernakalant is for the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.

“Vernakalant has a unique mechanism of action. If approved in the EU, it will become a new therapy for physicians and hospitals to use for the rapid treatment of recent onset atrial fibrillation,” said Michael E. Mendelsohn, M.D. senior vice president and Head of Cardiovascular Research, Merck Research Laboratories.

Shares of Cardiome shot up 74 cents or more than 9% to $8.68.

Helicos BioSciences Corporation (NASDAQ:HLCS) announced that it is in the early stages of validating molecular diagnostic (MDx) tests that utilize its HeliScope® Single Molecule Sequencer. The HeliScope Sequencer’s ability to sequence single molecules of natural, unamplified DNA or RNA simplifies the diagnostic testing workflow obviating the need for the amplification steps utilized by most genetic analysis methods. This ability to eliminate amplification steps has several advantages including the potential for Helicos to sell its MDx tests for substantially less than the price of comparable existing diagnostic tests.

Helicos said it will first focus on developing a MDx test that will identify gene mutations indicative of a woman’s increased risk of developing hereditary breast or ovarian cancer. The test is scheduled to launch during the second quarter of 2011. Helicos is also developing additional MDx tests in well-established markets. Helicos intends over the longer term to use its core technology’s quantitative capabilities to explore developing MDx tests based upon the detection and quantification of foreign DNA/RNA circulating in the bloodstream, such as a non-invasive prenatal diagnostic test.

“Our plan to develop and market our own MDx (molecular diagnostic ) tests is driven by our confidence in the unique capabilities of the HeliScope Sequencer,” stated Ron Lowy, president and CEO, in a statement. “Over the past months, we have considered a number of alternatives to our long-term strategic focus and consulted with industry experts, many of whom shared our confidence in the HeliScope Sequencer. Ultimately, we decided developing tests for the nascent and expanding diagnostics sequencing market presented the best opportunity to deploy technology that will potentially drive rapid near term revenue growth by providing attractively priced MDx tests.”

Shares of Helicos surged nearly 18% on the news, closing Friday’s trading session at 51 cents, up 7 cents on the day.

OraSure Technologies, Inc. (NASDAQ:OSUR) announced Friday that its OraQuick(R) Hepatitis C (“HCV”) Rapid Antibody Test has been approved by the U.S. Food and Drug Administration for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.

“We believe that the OraQuick(R) HCV Rapid Antibody Test, with its simplicity and speed, will be a critical tool in identifying more at risk individuals infected with hepatitis C in the U.S., and thus represents a significant market opportunity,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “Obtaining FDA approval of our OraQuick(R) HCV Rapid Antibody Test for venous whole blood represents a major milestone for our Company.”

OraQuick(R) HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes. The OraQuick(R) HCV Rapid Antibody Test is the latest rapid test manufactured by OraSure to receive FDA approval. OraSure had previously received FDA approval for its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.

In the U.S., there are an estimated 4.1 million Americans, or 1.6 percent of the population, that are or have been infected with HCV. According to the Centers for Disease Control and Prevention (“CDC”), new infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.

According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.

In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.

As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick(R) HCV test. Under the terms of these agreements, the Company has been and will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians’ office market in those countries in which the Company has obtained approval.

Shares of OraSure rose to an intra-day high of $5.63 before pulling back and closing the day at $4.98, up 13 cents.

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