Pharmaceutical News: Apeiron, GSK begin phase IIa trial in Acute Lung Injury patients

Apeiron, GSK begin phase IIa trial in Acute Lung Injury patients

Apeiron Biologics announced that GlaxoSmithKline (GSK), that has licensed Apeiron´s new investigational recombinant human Angiotensin Converting Enzyme 2 (rhACE2, name: GSK2586881, formerly APN01), has commenced a phase IIa study in patients suffering from Acute Lung Injury.

The study being sponsored by GSK, will involve patients with a positive diagnosis of ALI and will be conducted throughout the US and Canada.

The efficacy of the enzyme was assessed in several preclinical animal models of ALI/ARDS.

A phase I study in healthy volunteers also investigated the safety, tolerability and pharmacology profile of rhACE2.

In January 2010, GSK acquired an exclusive license for the development and commercialization of GSK2586881 for EUR 230m, subject to reaching future development milestones in multiple indications.

Apeiron CEO Hans Loibner said the company is happy that their biologic APN01 is being tested by their licensee GSK in a multicentric phase II study in ALI patients.

“The study is designed to provide important information regarding the safety and pharmacologic profile of this recombinant enzyme in this severely diseased patient population, as well as first insights into its clinical efficacy,” Loibner added.

Valeant Pharmaceuticals to Hold Conference Call to Announce 2012 Financial Guidance

Valeant Pharmaceuticals International, Inc. VRX
+0.30% today announced that it will host a conference call and a
live Internet webcast along with a slide presentation on Friday, January 6, 2012 at 10:00 a.m. EST (7:00 a.m. PST) to announce 2012 financial guidance.

Piper Jaffray (PJC) Analysts Reiterate a “Neutral” Rating on Teva Pharmaceutical Industries Ltd (TEVA)

Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA)‘s stock had its “neutral” rating reaffirmed by equities research analysts at Piper Jaffray (NYSE: PJC) in a research note issued to investors on Thursday. The analysts currently have a $45.00 price target on the stock.

Separately, analysts at Needham & Company reiterated a “buy” rating on shares of Teva Pharmaceutical Industries Ltd in a research note to investors on Thursday. Analysts at Deutsche Bank (NYSE: DB) raised their price target on shares of Teva Pharmaceutical Industries Ltd to $48.00 in a research note to investors on Thursday. They now have a “buy” rating on the stock. Also, analysts at Wells Fargo & Co. (NYSE: WFC) reiterated an “outperform” rating on shares of Teva Pharmaceutical Industries Ltd in a research note to investors on Wednesday.

Teva Pharmaceutical Industries Limited (Teva) is a global pharmaceutical and drug company. It develops, produces and markets generic drugs in all treatment categories. The Company has a pharmaceutical business, whose principal products include Copaxone and Azilect. Teva’s active pharmaceutical ingredient (API) business provides vertical integration to Teva’s own pharmaceutical production. The Company’s global operations are conducted from North and Latin America to Europe and Asia. As December 31, 2010, it had direct operations in approximately 60 countries, including 40 finished dosage pharmaceutical manufacturing sites in 19 countries, 28 pharmaceutical research and development (R&D) centers and 21 API manufacturing sites. On October 14, 2011, it acquired Cephalon, Inc.

Shares of Teva Pharmaceutical Industries Ltd opened at 41.76 on Thursday. Teva Pharmaceutical Industries Ltd has a 52 week low of $35.00 and a 52 week high of $57.08. The stock’s 50-day moving average is $40.22 and its 200-day moving average is $41.84. The company has a market cap of $36.958 billion and a price-to-earnings ratio of 12.43.

Sucampo Reports Conclusion of Arbitration Hearing

Sucampo Pharmaceuticals, Inc. SCMP
+0.72% announced
that the hearing on the Company’s claims in the demand for arbitration under the applicable provisions of the Collaboration and License Agreement with Takeda Pharmaceuticals Company Limited, or Takeda, dated October 29, 2004, have concluded within the expected timeframe and we look forward to the arbitrators’ decision in the first quarter of 2012.

Under the current agreement, Sucampo and Takeda jointly commercialize AMITIZA(R) (lubiprostone) in the United States for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) and are developing AMITIZA for other gastrointestinal indications.

Sucampo Pharmaceuticals, Inc., an international pharmaceutical company, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymatic (15-PGDH) transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ Chairman and CEO. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding CEO and currently Executive Advisor, International Business Development and a member of the Board of Directors.

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