A nice CAB addition ...
AUSIB Board member wins 2012 Outstanding Asian Americans in Business Award June 14, 2012
June 14, 2012, Washington DC: The Alliance for US India Business (AUSIB) congratulates Robert Miglani on winning the 2012 Outstanding 50 Asian Americans in Business Award. Bob Miglani is a Board Member with AUSIB, and also Senior Director at Pfizer Inc.
The Award will be presented on Tuesday, June 19, 2012 at Cipriani Wall Street. The Outstanding 50 Asian Americans in Business Award honors achievements of Asian Americans across the US and recognizes the role of these entrepreneurs in driving the US economy. The award recipients represent the best of the Asian American community’s entrepreneurs and professionals engaged in a broad range of businesses.
AUSIB President Mr. Sanjay Puri said, “Bob Miglani is truly deserving of this award and we at AUSIB are delighted to be associated with him.”
Robert Miglani is Senior Director at Pfizer Inc. and has been with the company for 18 years in positions of increasing responsibility including sales, public affairs, communications, market access and alliance & partnership development. Bob is also a published business Author of Treat Your Customers: Thirty Lessons on Service and Sales That I Learned at My Family’s Dairy Queen Store, published by Hyperion Books in 2006. Bob acts as a volunteer, inspirational speaker and an advocate on youth empowerment and leadership development as part of the Albert Schweitzer’s Leadership for Life Program.
About AUSIB: The Alliance for U.S. India Business (AUSIB) is a leading non-profit trade association that offers a pathway to help your business succeed in the United States and India. AUSIB seeks to augment investment flows and trade between the U.S. and India and open new channels of communication between business and government leaders.
Omeros Announces FDA Acceptance of Omidria™ as Proprietary Name for OMS302
-- European Medicines Agency Review of Proposed Names to be Completed Soon --
SEATTLE, Nov. 20, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today reported that the U.S. Food and Drug Administration (FDA) accepted the proposed brand name Omidria™ for OMS302, the Company's proprietary product in development for use in intraoperative lens replacement (ILR) surgery. FDA's acceptance of the proprietary brand name is subject to the Agency's final determination prior to any approval of the product's New Drug Application (NDA) and market launch, expected in 2014. Omeros earlier received allowance of the trademark application for Omidria from the U.S. Patent and Trademark Office.
The FDA reviews proposed proprietary names, taking into account potential for confusion between the proposed name and the names of marketed drugs and pending products for which marketing applications are currently under review. The brand name Omidria was also submitted to the European Medicines Agency (EMA), with a decision anticipated later this year. Omeros recently registered Omidria as a European Community Trade Mark.
"Throughout branding analyses conducted with ophthalmic surgeons and nurses using both regulatory and marketing criteria, Omidria scored very high globally – across the US, Canada, Europe and Asia as well as in Mexico and South America," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "With FDA's acceptance, we can now accelerate the development of the Omidria brand in preparation for the product's anticipated market launch in 2014."
.... and it has interesting stuff.
Here, IMO, is a VERY important statement on page 9 of the proxy, under "Reasons for the Amendment" .....
"In particular, the Company’s drug product candidates (pharmaceutical preparations) in both the oncology and dermatology therapeutic areas have been shown through recent research to harness the immune system of those patients treated to aid in reducing their tumor burden in various cancer indications and to reduce the inflammation of those patients treated with various inflammatory dermatoses. Both of these approaches to treat disease relate to properly utilizing the patient’s biologic or immune system and not just the direct treatment of his or her disease."
Think about that. That is very specific, a statement of fact. No ambiguity.
"have been shown"
That is well beyond words like "under investigation" or "potentially" or "is showing promise".
"have been shown"
Stated in an SEC filing.
I don't think so, chaapa. OMER's share price gets tossed around like a small craft in a squall but it's pipeline is wide and deep. Patience will pay off nicely IMO.
FDA Agrees with Omeros' Pediatric Study Plan for OMS302
-- Completion of Pediatric Study Can Lead to Additional Marketing Exclusivity -
SEATTLE, Oct. 15, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) confirmed its agreement with the Pediatric Study Plan (PSP) proposed by Omeros to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. The FDA also issued a Written Request consistent with the PSP, which means that successful completion of the PSP would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S. Added to standard irrigation solution used during ophthalmological procedures, OMS302 is Omeros' proprietary PharmacoSurgery® product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery.
As announced in July, the European Medicines Agency approved Omeros' Pediatric Investigation Plan to study the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in Europe. Omeros has OMS302 marketing applications under review in the U.S. and Europe with anticipated market launch in 2014. Results of the pediatric studies are expected to be available during the post marketing period.
"The OMS302 studies in pediatric populations that have now been approved in both the U.S. and Europe are planned to begin in 2014 and, given the strength of our data in the adult population, we expect that OMS302 will show similar benefits in pediatric patients," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "With FDA's Written Request and agreement on our Pediatric Study Plan, we now have clear paths forward to obtain additional marketing exclusivity for our drug in both the U.S. and Europe." (A few more words in PR)
OMER's shorts have been over 5 million shares since the end of April and over 6 million shares since mid June. Why do you think they have to cover now? Note: I'm long OMER and feel the shorts are going to get nailed, but I see no reason why they're compelled to cover now ....... unless OMER pops major material news and it becomes "game over" for the shorts.
n.l., have you read the SeekingAlpha article on PVCT that came out yesterday? You can find it by using Google News to look for:
Provectus Pharmaceuticals Up 17% In A Month; Potential Still Huge
It gives some good info on PVCT's potential future valuation which is well above where it is now. I've been studying PVCT and buying its stock for years, and its blossoming time may be very close.
What's Moving These 3 Biotechs?
By Brian Nichols
October 4, 2013
Intro and OMER segment .....
The market may be crashing lower following a government shutdown, but biotech races on. In particular, three biotechs on Thursday posted very large intraday gains. However, what was moving these stocks -- and should you buy?
After large gains, is this stock still cheap?
The big jump of the day came from Omeros Corporation (NASDAQ: OMER ) , a stock that rallied 18% and has gained 155% in the last month alone.
On Thursday, it was a $12.5 million settlement paid to the company from insurer Carolina Casualty Insurance that sparked gains. The settlement came after a 2009 lawsuit where Omeros was forced to pay its previous CFO nearly $4 million. This $12.5 million payout to the company was related to that event.
This payout is significant because Omeros' lead candidate, an eye drug called OMS302, was recently accepted for review by the FDA and in Europe. However, Omeros' cash position is getting small, and many have feared that an offering is around the corner.
Hence, this new-found cash does provide a bit of security to shareholders as the company prepares for its date with regulators. With that said, Wedbush recently came out with a note, giving an 80% chance of an FDA approval next year and peak sales estimates on OMS302 of $479 million.
If accurate, then Omeros, with a market cap shy of $400 million, is presenting a favorable risk/reward opportunity. This is a company that does have a large pipeline, amid early stage, with one being a phase 2 Huntington's disease drug. In an industry that is rewarding preclinical companies with billion-dollar valuations via IPOs, Omeros looks to be worthy of this rally.
Omeros Settles Insurance Litigation
-- Omeros to Receive $12.5 Million --
SEATTLE, Oct. 3, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) announced today that it entered into a settlement agreement with its insurer, Carolina Casualty Insurance Company (CCIC), related to CCIC's defense of, and coverage obligations owed to, Omeros and its chief executive officer and chairman, Gregory A. Demopulos, M.D., in previously settled litigation with Omeros' former chief financial officer. The settlement includes a release of each party's respective claims in the insurance coverage lawsuit and payment by CCIC of $12.5 million to Omeros by October 25, 2013. While Dr. Demopulos released all of his claims in exchange for this settlement, he elected to receive no portion of the settlement funds and to have all proceeds be paid to Omeros.
"We are pleased with this settlement and what it represents for our shareholders," stated Dr. Demopulos. "We remain focused on advancing our pipeline, and we look forward to reporting additional clinical data from our OMS824 and OMS721 programs later this year and to the planned launch of our lead product, OMS302, in 2014."
(conclusion, but more info is in the full news release)
The marketed drugs currently available that target these receptors are all injectable, with 2012 annual sales of GLP-1R agents and PTH-1R agents exceeding $2.0 billion and $1.1 billion, respectively. Omeros' identification of small molecules targeting GLP-1R and PTH-1R could lead to the development of oral medications for these diseases that provide dosing advantages over the injectable agents on the market. Omeros is in the process of filing broad patent applications around its discoveries, and compound optimization efforts are in progress.
"Using our proprietary technology, we continue to add to the number of druggable Class A orphan GPCRs – now 52 and spanning a broad range of important disorders – that we believe Omeros exclusively controls," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Our team has now also turned to Class B GPCRs, starting with two receptors that are commercially validated but whose corresponding marketed drugs are only peptides or proteins, requiring daily or weekly injections. By identifying small molecules that functionally interact with these receptors, Omeros is opening the door to new oral treatments for diabetes and bone loss."
-- Brings Omeros' Total to 52 Class A Orphans and Opens Way to New Oral Drugs to Treat Diabetes and Osteoporosis --
SEATTLE, Oct. 3, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has identified compounds that functionally interact with each of six additional orphan G protein-coupled receptors (GPCRs) that have been linked to a wide range of diseases in the areas of neurologic disorders, cardiovascular disease and oncology. Identification of compounds that functionally interact with orphan GPCRs facilitates the development of drugs that target those receptors. Omeros has now unlocked 52 Class A orphan GPCRs, representing approximately 65 percent of these targets.
The six additional orphan GPCRs unlocked by Omeros are GPR37, GPR37L1, GPR132, GPR174, GPR176 and LGR5. GPR37 has been linked to Parkinson's disease. GPR37L1, GPR132 and GPR176 are associated with cardiovascular indications, specifically hypertension and cardiac hypertrophy (GPR37L1 and GPR132) and atherosclerosis (GPR176). GPR174 has been linked to melanoma and Grave's disease, while LGR5 is expressed in cancer stem cells and has been associated with esophageal adenocarcinoma.
In addition, using its proprietary Cellular Redistribution Assay (CRA) technology, which has already successfully "unlocked" 52 Class A orphan GPCRs, Omeros has identified small molecules that interact with two non-orphan Class B GPCRs; the glucagon-like peptide 1 receptor (GLP-1R) and the parathyroid hormone 1 receptor (PTH-1R). Both of these receptors are established drug targets—GLP-1R for diabetes and PTH-1R for osteoporosis.
(continued in next reply)
Upbeat comments from Wedbush on eye surgery drug send Omeros higher — again • 11:55 AM
•Wedbush's Liana Moussatos is out predicting a March 2014 PDUFA date and a July 2014 U.S. launch date for Omeros' (OMER +15%) OMS302.
•A little color from Moussatos: "Given the stellar clinical results from both Phase 3 trials, we do not anticipate any delays and expect a first pass approval."
•The analyst hasn't been shy about expressing a bullish opinion on OMER. Indeed it was Moussatos' September 16 call (doubling U.S. penetration estimates for OMS302) that sent the shares soaring more than 50%.
•Price target raised to $32 from $28.
-- OMS302 Remains on Track for Planned 2014 Commercial Launch --
SEATTLE, Oct. 2, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) announced today that the New Drug Application (NDA) for its ophthalmology product, OMS302, has been confirmed for filing by the U.S. Food and Drug Administration (FDA), which means that the application, submitted in July of this year, is sufficiently complete to permit a substantive review. The company also announced that its Marketing Authorization Application (MAA) for OMS302, submitted last month, has been validated by the European Medicines Agency (EMA). Validation of the MAA confirms that the submission package is administratively complete and is ready for formal review by Europe's Committee for Medicinal Products for Human Use (CHMP).
Use Google News to find this article ....... Metastatic Melanoma: blistering in PV-10 treatment predicts good outcome ECC Cancer meeting Amsterdam
Do NOT miss this last sentence in the pharmaweb article you find with that title:
"Provectus Pharmaceuticals believe they now have sufficient data to seek regulatory approval for PV-10."
FDA Grants Orphan Drug Designation to Omeros' OMS824 for Huntington's Disease
-- Phase 2 Clinical Trial in Huntington's Disease Slated to Begin This Year --
SEATTLE, Sept. 30, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) announced that OMS824, its phosphodiesterase 10 (PDE10) inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Huntington's disease. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. As previously reported, Phase 1 clinical results in healthy subjects demonstrated that OMS824 is well tolerated and suggest that it has a better clinical therapeutic index or "safety factor" than other PDE10 inhibitors in development. Omeros plans to begin a Phase 2 clinical trial evaluating OMS824 in patients with Huntington's disease later this year. A Phase 2 clinical trial of the drug is already underway in patients with schizophrenia.
Orphan designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and that are expected to provide significant therapeutic advantage over existing treatments. It qualifies a company for benefits that apply across all stages of drug development, including accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.
Huntington's disease is estimated to affect approximately 31,000 U.S. patients annually, and the only FDA‑approved treatment for the disease is tetrabenazine, which is indicated for Huntington's-related movement disorders. OMS824 has the potential to improve the cognitive and psychiatric abnormalities as well as the movement disorders associated with the disease.
(More in the PR)
9th International Symposium on Melanoma and Other Cutaneous Malignancies
Date/Time: 09/28/2013 07:00 AM - 09/28/2013 04:30 PM
Location: Moffitt Cancer Center 12902 Magnolia Drive Tampa, FL 33612
This symposium will provide participants with a comprehensive overview of state-of-the-art care of patients with melanoma and other cutaneous malignancies.
SEATTLE, Sept. 20, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, is scheduled to present at the NewsMakers in the Biotech Industry 2013 Conference in New York City next week. The presentation is scheduled for Friday, September 27, 2013 at 2:00 p.m. EDT.
The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the Company's website.