FDA Approves Levemir® for Women with Diabetes; Keryx Announces Top-Line Data from the Perifosine

By Patrick Crutcher

BioMed Reports

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 2, 2012.

Novo Nordisk (NYSE:NVO), a world leader in diabetes care, announced the U.S. FDA has approved Levemir® (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that Levemir®, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby.

The label update makes Levemir® the first and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy. Now, Novo Nordisk is the only company that offers a complete portfolio of insulin analogs with a pregnancy Category B classification.

The FDA category change was based on a review of a large, randomized controlled trial examining Levemir® in pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir® against NPH insulin in the treatment of 310 women. The study found that patients taking Levemir® had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn.

"We are excited that the FDA has granted approval for this new category rating for Levemir®," said Lois Jovanovic, MD, MACE, Chief Scientific Officer, Sansum Diabetes Research Institute in Santa Barbara, California. "For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar.”

In the U.S., there are approximately 1.85 million women of child-bearing age with diabetes. For those who want to get pregnant, this development gives them another option to manage their diabetes.

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Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) reported the Phase 3 "X-PECT" (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

This Phase 3 trial was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. 468 patients at sixty-five U.S. sites participated in this study.

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are all extremely disappointed with the results of the study. We thank the investigators who participated in what we believe was a well-run study, despite the outcome. We will evaluate whether our Phase 3 study of Perifosine in relapsed/refractory multiple myeloma will continue as planned."

Mr. Bentsur commented further, "With approximately $31 million in cash as of March 31, 2012, and a well-controlled burn rate, we plan to focus our resources on the pending completion of the Zerenex (ferric citrate) long-term Phase 3 study for end stage renal disease (ESRD) patients with hyperphosphatemia, expected in the fourth quarter of 2012, and the New Drug Application (NDA) filing for Zerenex which will hopefully follow shortly thereafter."

Also Monday:

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the launch of a new interactive patient website called Ampyra Journeys (www.AmpyraJourneys.com).

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the presentation of new preclinical data on its investigational pan-BCR-ABL inhibitor, ponatinib, and its investigational dual EGFR-ALK inhibitor, AP26113, at the American Association for Cancer Research Annual Meeting in Chicago.

Astro-Med, Inc. (NASDAQ: ALOT), a world leader in the data acquisition and recording market, today introduced its new TMX®-18 High-Speed Data Acquisition System, offering best in class efficiency for general purpose data capture, review, archive, and analysis.

Bristol-Myers Squibb Company (NYSE:BMY) will announce results for the first quarter of 2012 on Thursday, April 26, 2012.

Cannabis Science, Inc. (OTCBB: CBIS) a pioneering U.S. biotech company developing cannabis pharmaceutical and over the counter nutraceutical products, is pleased to report it is moving forward with its FDA IND process.

Citadel EFT, Inc. (OTCQB: CDFT) (PINKSHEETS: CDFT), which offers U.S. merchants credit card terminals, online services, mail order and retail credit card processing services, announces today that it has signed on merchant credit card services for Buypureomega.com.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will issue its first quarter 2012 financial results at 4:00 p.m. ET on Wednesday, April 18th, 2012.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care announced today that Edward J. Quilty, the Company’s chief executive officer will present a corporate overview and update at the 11th Annual Needham Healthcare Conference taking place from April 3-4, 2012 at The New York Palace Hotel, New York City.

Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced the pricing of an underwritten registered direct offering of 2,125,000 shares of common stock at a price of $9.25 per share.

EasyMed Services Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6) ("ESI") is pleased to announce today that it has entered into a letter of intent dated April 1, 2012 (the "Letter of Intent") with Biosign Technologies Inc. (TSX VENTURE:BIO) ("Biosign") to complete a business combination (the "Transaction").

Exelixis, Inc. (NASDAQ:EXEL) announced today that its lead compound, cabozantinib, will be the subject of nine separate data presentations at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO).

Fibrocell Science, Inc. (OTCBB: FCSC), an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications, announced today that it has rescheduled its fourth quarter 2011 business update investor conference call to Tuesday, April 3, 2012 at 8:00 AM Eastern Time.

Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2012 Fourth Quarter financial results before the U.S. stock market opens on Tuesday, April 17, 2012.

Health Net, Inc. (NYSE:HNT) today announced that its subsidiary, Health Net Life Insurance Company, completed the sale of its Medicare stand-alone Prescription Drug Plan (Medicare PDP) business to a subsidiary of CVS Caremark (NYSE:CVS).

Illumina, Inc. (NASDAQ:ILMN) today announced estimated first quarter revenue of approximately $270 million.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today presented new preclinical data for saridegib (IPI-926), its novel oral molecule that inhibits Smoothened, a key component of the Hedgehog pathway.

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that data from the pivotal Phase III study with ZOSTAVAX® (Zoster Vaccine Live) in adults ages 50 to 59 were published in the April 1 issue of Clinical Infectious Diseases.

NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its previously announced pre-IND Meeting was held with the USFDA on March 29th, 2012, as scheduled.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF) ("Stellar" or "the Company"), an emerging specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada, today announced financial results for the year ended December 31, 2011.

Synageva BioPharma Corp. (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, announced today an expansion of its previous collaboration with Mitsubishi Tanabe Pharma Corporation (Head Office; Osaka, Japan, “MTPC”) to develop a second protein therapeutic for an undisclosed orphan disease using Synageva’s product development capabilities and proprietary protein expression platform.

Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") announced today that it successfully priced its debut EUR 1 billion and CHF 450 million debt offerings, and that it entered into a JPY 100 billion (approximately USD 1.2 billion) senior unsecured fixed-rate syndicated term loan facility.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has commenced commercial launch of both Irbesartan and Irbesartan-Hydrochlorothiazide Tablets, the Company’s generic versions of Sanofi Aventis’ high blood pressure treatments, Avapro® and Avalide® Tablets.

Walgreens (NYSE: WAG) (NASDAQ: WAG) and the Magic Johnson Foundation today announced a national campaign to address the health, educational and social needs of ethnically diverse, urban communities.

Copyright:	2012 BioMed Reports All rights reserved.
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