Amylin, Eli Lilly And Alkermes Announces Phase 2 Study Results Print E-mail
By Staff and Wire Reports   
Friday, 24 June 2011 19:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 24, 2011.

Amylin Pharmaceuticals, Inc., (NASDAQ:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (NASDAQ:ALKS) announced additional results from a Phase 2 study of an investigational, once-monthly injectable suspension formulation of exenatide which showed substantial improvements in glycemic control, including reductions in A1C and fasting plasma glucose, with modest weight loss.

The 121-patient study assessed the efficacy, safety and tolerability of three different doses (5 mg, 8 mg and 11 mg) of exenatide once monthly, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist.

After a total of five injections (20 weeks of treatment), patients receiving exenatide once a month,  experienced average improvements in A1C from baseline of 1.3% points for the 5 mg and 8 mg doses and 1.5% points for the 11 mg dose. 50% of those treated with the 5 mg dose, 57% treated with the 8 mg dose and 70% treated with the 11 mg dose achieved an A1C of less than 7%, the ADA-recommended target for good glucose control.

Although some patients lost some weight, exenatide once monthly, is not being studied as a weight-loss product. Fasting plasma glucose was improved with all doses, with reductions of 25 mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL with the 11 mg dose.

The mean pharmacokinetic profile showed all three exenatide once monthly doses resulted in steady-state exenatide plasma levels within the known therapeutic range.


Also Friday:


AdCare Health Systems, Inc. (NYSE Amex: ADK), a leading skilled nursing and assisted living provider, is expected to join the Russell Microcap® Index when Russell Investments reconstitutes its family of U.S. indexes on June 24, 2011, according to a preliminary list of additions posted on www.russell.com/indexes.

Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved modified language in the prescribing information for the use of erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), in patients with chronic kidney disease (CKD).

Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN) today announced data from a new analysis characterizing the effects of SYMLIN® (pramlintide acetate) injection in patients with type 1 diabetes who used insulin pumps during two previously completed clinical studies.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, announced today that it has entered into an agreement with Deerfield Management, a leading institutional life science investor, as well as other institutional investors to purchase approximately $9 million of BIOLASE's unregistered securities in a private placement transaction.

China Agri-Business, Inc. (OTC: CHBU), a manufacturer and distributor of organic agricultural application products in China, announced that China Agri-Business , through its Chinese operating subsidiary, Shaanxi Xinsheng Centennial Agriculture & Technology Co., Ltd. (the "Company") acquired the right to manage and operate Shaanxi Qinfeng Agrochemical Inc. ("Qinfeng") in Xi'an, China.

Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Vectibix® (panitumumab) be approved for use in the European Union (EU) in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for patients with wild-type KRAS metastatic colorectal cancer (mCRC), following a successful re-examination procedure by Amgen.

CNS Response, Inc. (OTCBB: CNSO) announced today that it has filed a preliminary prospectus with the securities regulatory authorities in each of the provinces of Canada, other than Quebec, in connection with a best efforts initial public offering of securities in each of the provinces of Canada, other than Quebec, which offering will be conducted simultaneously in the United States pursuant to a registration statement filed with the United States Securities and Exchange Commission.

D. Medical Industries Ltd. (NASDAQ:DMED) (TASE:DMED) ("D. Medical" or "Company"), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, today announced that the Company, through its wholly owned subsidiary Spring Health Solution Ltd, has submitted an application for CE Mark approval of its Spring™ Zone Insulin Delivery System.

Heart Tronics, Inc. (PINKSHEETS: HRTT) (formerly Signalife, Inc.) filed Form 8-K with the United States Securities and Exchange Commission.

Insulet Corporation (NASDAQ: PODD) today announced the pricing of a public offering of $125 million principal amount of convertible senior notes due 2016 (the "notes"), an increase from the $110 million principal amount previously announced.

mPhase Technologies, Inc. (OTCBB: XDSL) today announced that it will be releasing a new video that will provide technical insight into how Smart Surface materials can be used to develop a multitude of applications.

Salus Labs International, Inc. (PINKSHEETS: IPEX) announced today it has spent the past few months evaluating certain areas of the solar products marketplace.

Sanofi (EURONEXT: SAN) (NYSE: SNY) announced today data from four studies of its once-daily GLP-1 receptor agonist Lyxumia® (lixisenatide) that is in Phase III clinical development, including data that demonstrates positive results in type 2 diabetes patients not at goal on oral therapies or with basal insulin.

World Health Energy Holdings, Inc. (OTCQB: WHEN) (PINKSHEETS: WHEN), a public holding company developing joint venture partnerships for algae production for biodiesel and commercial fish food, announced today that the company has signed a Memorandum of Understanding (MOU) for a joint venture with SHK Energy Projects Private Limited of India.

Zimmer Holdings, Inc. (NYSE and SIX: ZMH) announced today its second quarter 2011 sales and earnings conference call will be broadcast live over the Internet on Wednesday, July 27, 2011, at 8:00 a.m. Eastern Time.



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