|Amarin Expecting FDA Decision on AMR101; Pluristem Applies for Approval of Bone Marrow Drug|
|By Staff and Wire Reports|
|Monday, 23 July 2012 18:37|
The FDA is scheduled to make an announcement regarding the status of Amarin's (NASDAQ:AMRN) AMR101, a treatment for patients with very high triglyceride levels, on July 26. The time allotted for the agency to review the drug is due to expire on that day. A prescription-grade omega-3 fatty acid, AMR101 has significantly reduced the "bad" cholesterol of patients who take the drug in trials, compared with those who take placebos.
On May 29, Amarin announced that it had received a patent covering the pharmaceutical composition of AMR101. Last month the USPTO took positive action on three key Amarin patent applications, leading research firm Jefferies to predict that AMR101 could be protected through 2030. Meanwhile, in a note to investors earlier this morning, JPMorgan said there's a strong likelihood that AMR101 will be approved by the FDA on July 26.
Any delay in approval of the drug would be minor, said the firm, which thinks the drug could generate $1B+ in sales. JPMorgan believes that the stock could advance further following FDA approval, and the firm maintains a $22 target and Overweight rating on Amarin.
In early trading, Amarin rose 0.46% to $15.23, but closed Monday's session down one cent.
Pluristem Therapeutics Inc (NASDAQ:PSTI) will apply to the U.S. FDA for approval of its placenta-based stem cell treatment for aplastic bone marrow as an orphan drug or rare disease treatment.
Gaining orphan drug status is part of Pluristem's strategy for penetrating the bone marrow recovery market, starting with treatment of aplastic anaemia, a disease that affects five to 10 people in every million. Treatment costs range from $150,000 to $200,000 per person for the 60,000 bone marrow patients worldwide each year, though the majority of this is for hospitalisation. Pluristem said its treatment helps reduce hospitalisation time.
Orphan drug status has several potential benefits, including the possibility of an expedited regulatory process, availability of grant money, tax credits and seven years of market exclusivity.
In 2011, Pluristem received orphan drug status for its cell therapy in the treatment of Buerger's disease, a rare blood vessel disease.
Pluristem said on May 9 that its cells had saved the life of a seven-year-old girl suffering from aplastic bone marrow and who had undergone two failed bone marrow transplants. Its stock rose 32 percent.
"Orphan drug status in the U.S. would help accelerate our path to full FDA approval and we intend to apply for a similar designation in Europe and global territories," said Zami Aberman, chairman and CEO of Pluristem.
Axia Group (PINKSHEETS:AGIJ) Collagenna Skin Care Products/Melem Secret is pleased to announce that it has acquired an existing Vitamin E-Commerce Super Store and closed the transaction on all cash basis.
BIO-key International, Inc. (OTCBB: BKYI), a global leader in fingerprint biometric identification solutions and advanced mobile identification technology, today reported Indigo Identityware and BIO-key have successfully implemented Indigo's Password-free Strong Authentication & Single Sign-On solution along with BIO-key's award winning fingerprint biometric software to access electronic medical records for a variety of healthcare providers.
BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract media manufacturer, today announced that it has completed the expansion of its corporate office and operations workspace and also the build-out of its second current Good Manufacturing Practice (cGMP) clean room suite.
Biostem U.S., Corporation, (OTCQB: HAIR) (PINKSHEETS: HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, enters into an agreement with Pizarro Hair Restoration Clinics to offer The Biostem Method™ of stem cell hair re-growth treatments.
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a biopharmaceutical company focused on discovering small molecule drugs, is pleased to report that the Site Initiation Visit (SIV) required for commencement of the Company's Phase 1 clinical trial for its novel anti-cancer drug, Kevetrin™, at Harvard Cancer Center was successfully completed on Thursday, July 19, 2012.
Depomed, Inc. (NASDAQ: DEPO) today announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise® (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN).
DoMark International Inc. (OTCBB:DOMK), through its wholly owned subsidiary, MuscleFoot Inc., is pleased to announce that it has retained the services of RBL Communications ("RBL") to manage a complete social media program.
The X PRIZE Foundation today announced that Life Technologies Corporation (NASDAQ: LIFE) is the first team to officially register under the new guidelines for the Archon Genomics X PRIZE presented by Express Scripts where teams will compete for up to $10 million by being the first to rapidly and accurately sequence 100 whole human genomes at a cost of $1,000 or less each to a standard never before achieved.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), a leading provider of Personal Health Records (PHRs) and electronic document management and imaging systems for healthcare professionals, today announced that The RHL Group, Inc. will increase the credit line of MyMedicalRecords, Inc. by $1.5 million to a total of $4.5 million.
Newcardio Inc, (OTCBB:NWCI), a cardiac diagnostic and services company which develops proprietary platform technology to dramatically improve accuracy and significantly increase the diagnostic value of the standard 12-lead electrocardiogram (ECG), is finding success in their efforts to secure their intellectual property.
Life Technologies Corporation (NASDAQ: LIFE) has developed a complete rapid molecular testing workflow for multiple strains of pathogenic Shiga-toxin producing Escherichia coli (STEC), a bacteria found in undercooked beef.