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Tuesday, 26 April 2011

Diamyd Replaces CEO - Diamyd Medical - Pharmaceutical News


Diamyd Medical AB annunciates that Elisabeth Lindner today has left her position as President and chief executive officer (CEO) of the Company. Excecutive Vice President Peter Zerhouni has been appointed Acting President and CEO.

Elisabeth Lindner has left her position as President and CEO due to disagreement with the Board concerning certain important matters.

Peter Zerhouni has been involved in all aspects of the Company since 2006, including a key role in driving the Company's business and clinical trials forward. Zerhouni has a combined financial and biotechnology background, and studied at Lund University in Sweden, and University of California at Berkeley in USA. He has been working as head of business development for the last three years and played an instrumental part in securing the Company's agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. to develop and commercialize the Diamyd® diabetes therapy.

The Board acknowledges Elisabeth Lindner's contributions to successfully progress the Phase III program with Diamyd® in recent-onset type 1 diabetes. Top line results from a European Phase III study are expected to be available later this spring. Work is currently ongoing to compile and process all the study data, which remains fully blinded to Investigators and patients as well as to Diamyd Medical AB.



About Diamyd Medical

Diamyd Medical is a Swedish pharmaceutical company focusing on the development of pharmaceuticals for the treatment of growth-onset diabetes and pain. The Diabetes business area consists of the antigen-based drug candidate Diamyd® for the treatment and prevention of autoimmune diabetes. Phase III studies of Diamyd® are currently in progress in Europe and the US. In 2010 the Company signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc., for the development and commercialization of Diamyd®. The Pain business area consists of development projects that use the Company's proprietary NTDDS (Nerve Targeting Drug Delivery System) platform to administer drugs directly to the systema nervosum to treat chronic pain. A Phase II study of the candidate drug NP2 Enkephalin for cancer pain is ongoing in the US.

Diamyd Medical has offices in Sweden and in the US. Shares are listed on Nasdaq OMX in Stockholm (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink OTC Markets and the Bank of New York Mellon (PAL). Further information is available on the company's website: www.diamyd.com.

This information is disclosed in accordance with the Swedish Securities Markets Act, the Swedish Financial Instruments Trading Act, or the requirements stated in the listing agreements.

Diamyd Medical AB (publ.) Karlavägen 108,
SE-115 26 Stockholm,
Sweden. Tel: +46 (0)8 6610026,
Fax: +46 (0)8 661 63 68 ,
E-mail: info@diamyd.com.

Source: Cisionwire

Friday, 15 April 2011

Genzyme Corp presented Sanofi MS drug, Dermatology unit to be sold?


Genzyme corporation has demonstrated brighter data on its investigational disseminated multiple sclerosis treatment alemtuzumab, a drug which played a pivotal role in the firm acquiring a higher price from acquirer Sanofi-Aventis.


In Feb, the French drugmaker upped its $18.50 billion bid to $20.1 billion and also agreed a tradable 'contingent value right', entitling Genzyme shareholders to payments linked to the success of alemtuzumab, which will be sold as Lemtrada, for MS; it is already approved, as Campath, for B-cell chronic lymphocytic leukemia






Now, additional five-year data from a completed phase II clinical trial trial, presented at the American Academy of Neurology’s yearly meeting in Hawaii, shows that about two-thirds of MS patients in the analyse remained free of clinically-active disease as much as four years after receiving their last course of Lemtrada.


The master test, published in the New England Journal of Medicine in 2008, compared alemtuzumab with Merck KGaA's big-selling Rebif. The new five-year data shows that 65% of patients were free of clinically-active disease, compared to 27% on Rebif, while 72% of alemtuzumab-treated patients were relapse-free compared to 41% for Rebif.


The analysis also found that alemtuzumab patients were more than doubly as likely to experience sustained improvement in vision, a common complication of MS, compared to Rebif. Two phase III clinical trial analyses on Lemtrada are underway and filings in Europe and the USA in early 2012. Alemtuzumab has been granted fast track status by the Food and Drug Administration.


Dermatology sale could bring in 300 million euros


Meantime, Sanofi is looking to sell off its US dermatology business and pocket as much as 300 million euros.


Bloomberg, citing two people with knowledge of the matter, says that the first round of offers were submitted last week and Deutsche Bank is handling the sale. The sources claim that private equity groups are the most likely buyers for the dermatology division, which was formerly known as Dermik Laboratories and whose products include Sculptra (injectable poly-L-lactic acid), a filler to correct wrinkles and other effects of facial fat loss.


The two sources told the news organisation that a sale could bring in 200-300 million euros, but claimed the valuation has been hurt due to the introduction of generic versions of the acne treatment BenzaClin (clindamycin/benzoyl peroxide).


Sanofi confirmed to Bloomberg that it is "exploring strategic alternatives for the US dermatology business in keeping with its strategy to reallocate resources to high-growth areas including diabetes, oncology and atrial fibrillation”.

Friday, 1 April 2011

AVI BioPharma annunciates Proposed Public Offering of common shares


AVI BioPharma annunciates Proposed Public Offering of common shares


Source : Business Week, AVI BioPharma


AVI Biopharma, Inc. (NASDAQ: AVII) today annunciated its intention to offer, subject to market and other circumstances, contributions of its common shares in an underwritten public offering. The Company also expects to grant the underwriters a 30-day choice to purchase adequate to an additional 15 % of the shares of common stock offered in the public offering to cover over-allotments, if any. The Company presently intends to use the net proceeds from this offering for general corporate purposes, including research and product development, such as backing clinical trials, pre-clinical analyses and otherwise moving product candidates towards commercialization. The offering is expected to price before 9:30 am EDT on Friday April 1, 2011.


Lazard Capital Markets LLC and Piper Jaffray & Co. are acting as joint book-running managers for the offering.


The Company intends to offer and trade these securities pursuant to the Company's existing shelf registration statement (File No. 333-160922) filed with the Securities and Exchange Commission on July 31, 2009, which was declared effective on August 13, 2009. A prospectus supplement describing the terms of the offering will be filed with the Securities and Exchange Commission and will form a part of the effective registration statement. When available, copies of the red herring supplement, the final prospectus supplement and accompanying base prospectus related to this offering may be obtained from the Securities and Exchange Commission's website at http://www.sec.gov or Lazard Capital Markets LLC, 30 Rockefeller Plaza, 60th Floor, New York, NY 10020 or via telephone at (800) 542-0970 or by contacting Piper Jaffray & Co. at 800 Nicollet Mall, Suite 800, Minneapolis, MN 55402, or via telephone at (800) 747-3924.


This handout doesn't constitute an offer to sell or the solicitation of offers to buy any securities of the Company, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.


About AVI BioPharma






AVI BioPharma is concentrated on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets.


Advanced Statements and Information


This press release contains statements that are forward-looking, including statements about AVI's funding plans and prospects, including the statements about the proposed public offering of AVI's common shares. These advanced statements involve risks and uncertainties, many of which are beyond AVI's control. For a detailed description of risks and uncertainties AVI faces, you are encouraged to review the official corporate documents filed with the Securities and Exchange Commission. AVI doesn't undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.