Intellipharmaceutics International Inc. (Nasdaq:IPCI)
The last trade on Monday's trading session for IPCI stock was at $1.89 per share.
IPCI reported that the FDA has granted final approval of the Company's dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths. Commercial sale of these strengths will be launched immediately by IPCI's commercialization partner in the U.S., Par Pharmaceutical, Inc.
As the first-filer for the drug-product in the 15 mg strength, IPCI will have 180 days of exclusivity of generic sales from the date of launch in the U.S. by its partner, Par Pharmaceutical.
IPCI's 5, 10, 20 and 40 mg strengths were also tentatively FDA approved, subject to the right of another party or parties to 180 days of generic exclusivity from the date of first launch by such parties. Par Pharmaceutical intends to launch these strengths immediately upon the expiry of those exclusivity periods.
IPCI's dexmethylphenidate hydrochloride extended-release capsules are the generic version of Focalin XR(R), a drug-used in the treatment of attention deficit hyperactivity disorder, marketed by Novartis Pharmaceuticals Corporation.
According to Source Healthcare Analytics, sales for the 12 months ended October 2013 of Focalin XR(R) 15 and 30 mg, respectively, in the U.S. were approximately $136 million and $69 million (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price). The remaining 5, 10, 20, 25, 35 and 40 mg strengths represent sales of approximately $478 million (TRx MBS Dollars).
IPCI is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage-drugs.
More about Intellipharmaceutics International Inc. (Nasdaq:IPCI) at www.intellipharmaceutics.com
Nektar Therapeutics (Nasdaq:NKTR)
NKTR closed Monday's market activity at $11.01 per share.
According to NKTR, its partner AstraZeneca reported that the FDA has accepted the New Drug-Application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA), which has been studied in opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid-pain medicines.
Naloxegol, developed using NKTR's oral small molecule polymer conjugate technology, has the potential to be the first once-daily oral PAMORA for patients with OIC in the U.S.
Naloxegol is part of the exclusive worldwide license agreement announced on 21 September 2009, between AstraZeneca and NKTR. Under the terms of the amended license agreement, AstraZeneca will make a $70 million milestone payment to NKTR within five business days of acceptance of the NDA by the FDA.
NKTR is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms.
More about Nektar Therapeutics (Nasdaq:NKTR) at www.nektar.com
POZEN Inc. (Nasdaq:POZN)
If you have osteoarthritis pain, even everyday activities you enjoy can be difficult when your joints are painful or stiff.
When it comes to treating osteoarthritis, NSAIDs (nonsteroidal anti-inflammatory-drugs) may provide effective pain relief, but these medications may come with a side effect of stomach problems that may impact your ability to continue taking the medication
VIMOVO(R) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory-drug (NSAID), and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibito, approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
POZN entered into a collaboration agreement with AstraZeneca on August 1, 2006 for the co-development and commercialization of VIMOVO.
POZN reported that AstraZeneca AB and Horizon Pharma USA, Inc. have entered into an agreement for Horizon to acquire the U.S. rights for VIMOVO.
According to the company and under the terms of the agreement, POZN will continue to receive a 10% royalty on Net Sales of products sold in the U.S., with guaranteed annual minimum royalty payments of $5 million in 2014, and $7.5 million each year thereafter, provided that the patents owned by POZN which cover VIMOVO are in effect and no generic forms of VIMOVO are on the market.
AstraZeneca will continue to have rights to commercialize VIMOVO outside of the United States.
POZN is a small pharmaceutical company that specializes in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization.
More about POZEN Inc. (Nasdaq:POZN) at www.pozen.com
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