Healthcare Companies Report Regulatory Affirmations, MPA Inspections, Enrollment in Trials, Stock Movements - Analyst Notes on Halozyme, Align Technology, Cambrex, Receptos, and Anacor Pharmaceuticals
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NEW YORK, April 9, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Halozyme Therapeutics, Inc. (NASDAQ: HALO), Align Technology Inc. (NASDAQ: ALGN), Cambrex Corporation. (NYSE: CBM), Receptos, Inc. (NASDAQ: RCPT), and Anacor Pharmaceuticals, Inc. (NASDAQ: ANAC). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.AnalystsReview.com/register
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Halozyme Therapeutics, Inc. Analyst Notes
On April 4, 2014, Halozyme Therapeutics, Inc. (Halozyme) announced that it is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer as a result of a recommendation which the Company received from an independent Data Monitoring Committee (DMC). According to the Company, DMC is assessing clinical data that indicates a possible difference in the thromboembolic event rate between the group of patients treated with PEGPH20, nab-paclitaxel and gemcitabine versus the group of patients treated with nab-paclitaxel and gemcitabine without PEGPH20. The Company stated that it is halting enrollment and dosing of PEGPH20 as precautionary actions while the DMC's full evaluation of the data is ongoing. Commenting on the development, Dr. Helen Torley, President and CEO of the Company, stated, "Patient safety is our first priority. We will be providing additional information to the DMC as quickly as possible so they can complete their assessment and we can determine next steps." The full analyst notes on Halozyme Therapeutics, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/HALO/report.pdf
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Align Technology Inc. Analyst Notes
On April 3, 2014, Align Technology Inc. (Align Technology) reported that it has received notice, that the International Trade Commission (ITC) has affirmed the Administrative Law Judge's (ALJ) Initial Determination that the ClearCorrect entities (ClearCorrect Operating, LLC and ClearCorrect Pakistan (Private) Ltd.) infringe five of the patents asserted by the Company in its ITC investigation. Align Technology stated that the Commission ruled in favor of the Company, with regard the patents, issued cease-and-desist orders directed to the ClearCorrect entities, and terminated the investigation. Roger E. George, Align Technology Vice President and General Counsel, stated, "While we have not yet had the opportunity to review the opinion, we have been notified that the Commission found a violation of Section 337 based on the finding that the ClearCorrect entities infringe at least 18 claims of Align's patents, The ITC has spoken, and it agrees with the ALJ, Align, and the ITC Staff Attorneys that these patent claims are valid, and that ClearCorrect infringes them. ClearCorrect can no longer use Align's patented process to generate infringing digital data and then simply import that data from Pakistan to print out molds used to make aligners in the US. We appreciate the ITC's assistance, and we will continue to vigorously defend our patents against infringement by domestic and foreign competitors." The full analyst notes on Align Technology Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/ALGN/report.pdf
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Cambrex Corporation. Analyst Notes
On March 26, 2014, Cambrex Corporation. (Cambrex) announced that the Medical Products Agency (MPA) of Sweden has completed an inspection of Cambrex's active pharmaceutical ingredient (API) manufacturing facility located in Karlskoga, Sweden. According to the Company, the inspection which was conducted in September 2013, found the site to be compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and the site's GMP certificate was renewed. Bjarne Sandberg, Managing Director of Cambrex Karlskoga AB, said, "We are extremely pleased with the results of this latest MPA inspection. The renewing of our GMP certificate demonstrates continuing dedication to outstanding regulatory compliance at Cambrex Karlskoga." The full analyst notes on Cambrex Corporation. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/CBM/report.pdf
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Receptos, Inc. Analyst Notes
On April 4, 2014, Receptos, Inc. (Receptos) stock price went down by 8.62%, closing at $37.93 per share. For the past one month, the Receptos shares have slipped by 18.54% compared to the Nasdaq Composite which has also lost 5.15% over the same period. The full analyst notes on Receptos, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/RCPT/report.pdf
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Anacor Pharmaceuticals, Inc. Analyst Notes
On March 31, 2014, Anacor Pharmaceuticals, Inc. (Anacor) announced that the first patient has been enrolled in the Phase 3 trial of AN2728, a novel boron-based phosphodiesterase-4 (PDE-4) inhibitor, used towards the topical treatment of mild-to-moderate atopic dermatitis. According to Anacor, the Phase 3 trial comprises of two multi-center, double-blind, vehicle-controlled studies which will enroll approximately 750 subjects per study who will be randomized 2:1 (active:vehicle). The Company informed that both studies will be conducted at multiple sites and enroll subjects ages two years and older with mild-to-moderate atopic dermatitis, defined as an Investigator Static Global Assessment (ISGA) score of 2 ("mild") or 3 ("moderate") on the ISGA 5-point scale from 0 ("clear") to 4 ("severe"). Anacor added that the primary efficacy endpoint of the study will be treatment success at Day 29, defined as an ISGA of "Clear" or "Almost Clear" with at least a 2-grade improvement from baseline. The full analyst notes on Anacor Pharmaceuticals, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04092014/ANAC/report.pdf
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